    [Senate Hearing 110-100]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 110-100

                     THE NEED FOR FDA REGULATION OF TOBACCO

    =======================================================================

                                    HEARING

                                     OF THE

                        COMMITTEE ON HEALTH, EDUCATION,
                              LABOR, AND PENSIONS

                              UNITED STATES SENATE

                           ONE HUNDRED TENTH CONGRESS

                                 FIRST SESSION

                                       ON

     EXAMINING S. 625, TO PROTECT THE PUBLIC HEALTH BY PROVIDING THE FOOD
      AND DRUG ADMINISTRATION WITH CERTAIN AUTHORITY TO REGULATE TOBACCO
                                    PRODUCTS

                                   __________

                               FEBRUARY 27, 2007

                                   __________

     Printed for the use of the Committee on Health, Education, Labor, and
                                    Pensions

      Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                                     senate

                         U.S. GOVERNMENT PRINTING OFFICE

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              COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                   EDWARD M. KENNEDY, Massachusetts, Chairman
    CHRISTOPHER J. DODD, Connecticut     MICHAEL B. ENZI, Wyoming,
    TOM HARKIN, Iowa                     JUDD GREGG, New Hampshire
    BARBARA A. MIKULSKI, Maryland        LAMAR ALEXANDER, Tennessee
    JEFF BINGAMAN, New Mexico            RICHARD BURR, North Carolina
    PATTY MURRAY, Washington             JOHNNY ISAKSON, Georgia
    JACK REED, Rhode Island              LISA MURKOWSKI, Alaska
    HILLARY RODHAM CLINTON, New York     ORRIN G. HATCH, Utah
    BARACK OBAMA, Illinois               PAT ROBERTS, Kansas
    BERNARD SANDERS (I), Vermont         WAYNE ALLARD, Colorado
    SHERROD BROWN, Ohio                  TOM COBURN, M.D., Oklahoma
               J. Michael Myers, Staff Director and Chief Counsel
               Katherine Brunett McGuire, Minority Staff Director

                                      (ii)

                                C O N T E N T S

                                  ----------

                                   STATEMENTS

                           TUESDAY, FEBRUARY 27, 2007

                                                                       Page
    Kennedy, Hon. Edward M., Chairman, Committee on Health,
      Education, Labor, and Pensions, opening statement..............     1
        Prepared statement...........................................     3
    Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming,
      opening statement..............................................     6
    Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio,
      opening statement..............................................     8
    Burr, Hon. Richard, a U.S. Senator from the State of North
      Carolina, opening statement....................................     9
    Myers, Matthew L., President and CEO, Campaign for Tobacco-Free
      Kids, Washington, DC...........................................    11
        Prepared statement...........................................    13
    Huerta, M.D., M.P.H., Elmer, President, American Cancer Society,
      Washington, DC.................................................    19
        Prepared statement...........................................    21
    Land, D.Phil., Richard, President, The Ethics and Religious
      Liberty Commission of the Southern Baptist Convention,
      Nashville, TN..................................................    24
        Prepared statement...........................................    26
    Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah,
      opening statement..............................................    31
    Henningfield, Ph.D., Jack, Vice President, Research and Health
      Policy, Pinney and Associates, Bethesda, MD, and Professor of
      Behavioral Biology at Johns Hopkins University School of
      Medicine, Baltimore, MD........................................    33
        Prepared statement...........................................    34
    Connolly, D.M.D., M.P.H., Gregory, Professor, Harvard School of
      Public Health, Former Director of the Massachusetts Department
      of Public Health's Tobacco Control Program, Boston, MA.........    41
        Prepared statement...........................................    44
    Blum, M.D., Alan, Director, University of Alabama Center for the
      Study of Tobacco and Society, Tuscaloosa, AL...................    56
        Prepared statement...........................................    57
    Shames, Lisa, Acting Director, Natural Resources and Environment
      Team, Government Accountability Office, Washington, DC.........    61
        Prepared statement...........................................    63

                              ADDITIONAL MATERIAL

    Statements, articles, publications, letters, etc.:
        Clinton, Hon. Hillary Rodham, a U.S. Senator from the State
          of New York, prepared statement............................    93
        Statements and letters of support:
            Matthew L. Myers.........................................    94
            John Kirkwood, President and CEO, American Lung
              Association, New York, NY..............................    95
            Ron Davis, M.D., President-Elect, American Medical
              Association, Washington, DC............................    95

                                     (iii)

            American Medical Association, Washington, DC.............    96
            John R. Seffrin, Ph.D., CEO, American Cancer Society
              Cancer Action NetworkSM, Washington, DC.....    98
            American Dental Association, Chicago, IL.................   100
            Partners for Effective Tobacco Policy (PARTNERS),
              Washington, DC.........................................   101
            Raymond J. Gibbons, M.D., FAHA, President, Andrew B.
              Buroker, Esq., Chairman, American Heart Association and
              American Stroke Association, Washington, DC............   102
            John A. Strodsnider, D.O., President, American
              Osteopathic Association, Washington, DC................   102
            Faith United Against Tobacco, Washington, DC.............   103
            Jay E. Berkelhamer, M.D., FAAP, President, American
              Academy of Pediatrics, Washington, DC..................   104
            David A. Kessler, M.D., University of California San
              Francisco (UCSF), San Francisco, CA....................   105
            Mike Szymanczyk, Chairman and CEO, Philip Morris USA,
              Richmond, VA...........................................   105
        Statements and letter of opposition:
            Henry O. Armour, President and CEO, National Association
              of Convenience Stores (NACS), Alexandria, VA...........   110
            Laurie Comstock, Private Citizen, Elk Grove, CA..........   113
            K.H. Ginzel, M.D., Professor Emeritus of Pharmacology and
              Toxicology, University of Arkansas for Medical
              Sciences, Westhampton, MA..............................   114
            Stephen L. Hansen, M.D...................................   126
            Michael S. Givel, Ph.D., Professor of Political Science,
              University of Oklahoma, Norman, OK.....................   126
            William T. Godshall, M.P.H., Executive Director,
              Smokefree Pennsylvania, Pittsburgh, PA.................   128
            Anne Landman, Tobacco Document Research and Consulting,
              Glade Park, CO.........................................   157
            John R. Polito, Esq., Editor, WhyQuit, Mount Pleasant, SC   160
            Vicki Voldal Rosenau, Barnes County Tobacco-Free Network,
              Valley City, ND........................................   162
            Michael Siegel, M.D., M.P.H., Professor, Social and
              Behavioral Sciences Department, Boston University
              School of Public Health, Boston, MA....................   162
            Elizabeth Whelan, M.P.H., Sc.D., Gilbert L. Ross, M.D.,
              and Jeff Stier, Esq., The American Council on Science
              and Health (ACSH), New York, NY........................   174
            Joel L. Nitzkin, M.D., M.P.H., DPA, Chairman, American
              Association of Public Health Physicians (AAPHP) Tobacco
              Control Task Force, Rolling Meadows, IL................   175
        Response by Matthew L. Myers to questions of:
            Senator Kennedy..........................................   177
            Senator Enzi.............................................   190
            Senator Burr.............................................   192
            Senator Hatch............................................   192
            Senator Coburn...........................................   195
        Response by Elmer Huerta, M.D., M.P.H. to questions of:
            Senator Enzi.............................................   199
            Senator Burr.............................................   200
            Senator Hatch............................................   200
            Senator Coburn...........................................   201
        Response by Richard Land, D.Phil. to questions of:
            Senator Enzi.............................................   202
            Senator Burr.............................................   204
            Senator Hatch............................................   204
            Senator Coburn...........................................   205
        Response by Jack Henningfield, Ph.D. to questions of:
            Senator Kennedy..........................................   205
            Senator Enzi.............................................   208
            Senator Burr.............................................   209
            Senator Hatch............................................   210
            Senator Coburn...........................................   212
        Response by Gregory Connolly, D.M.D., M.P.H. to questions of:
            Senator Kennedy..........................................   212
            Senator Enzi.............................................   213
            Senator Burr.............................................   214
            Senator Hatch............................................   214
            Senator Coburn...........................................   215
        Response by Lisa Shames to questions of:
            Senator Enzi.............................................   216
            Senator Hatch............................................   217
        Response by Alan Blum, M.D. to questions of:
            Senator Enzi.............................................   217
            Senator Burr.............................................   223
            Senator Hatch............................................   223

                THE NEED FOR FDA REGULATION OF TOBACCO PRODUCTS

                                  ----------

                           TUESDAY, FEBRUARY 27, 2007

                                           U.S. Senate,
           Committee on Health, Education, Labor, and Pensions,
                                                        Washington, DC.
        The committee met, pursuant to notice, at 9:40 a.m., in
    Room SD-430, Dirksen Senate Office Building, Hon. Edward
    Kennedy, chairman of the committee, presiding.
        Present: Senators Kennedy, Reed, Sanders, Brown, Enzi,
    Burr, Isakson, Murkowski, Hatch, Allard, and Coburn.

                      Opening Statement of Senator Kennedy

        The Chairman. Good morning and I apologize to our panelists
    and to our members here. We have a ritual here in the Senate
    now, which is called the Early Bird Rules. So if you are on
    another committee and you have at least a little seniority,
    which I'm fortunate to have, you have to go down and check in
    at the start of the hearing, to preserve your questioning later
    on. All of my colleagues are familiar with it. You find out
    some of us come in here out of breath several minutes late at
    the opening of these hearings. So we appreciate your
    understanding and patience as I hope my colleagues do as well.
        I thank all of our witnesses for being here and I'll have
    an additional word on that. This hearing focuses on the need
    for FDA regulation of tobacco products, the most lethal of all
    consumer products. Used as intended by the companies that
    manufacture and market them, cigarettes will kill one out of
    every three smokers. Yet the Federal agency most responsible
    for protecting the public health is currently powerless to deal
    with the enormous risks of tobacco use.
        Public health experts overwhelmingly believe the passage of
    S. 625, bipartisan legislation that will at long last give the
    FDA authority to regulate tobacco products, is the most
    important action that Congress can take to protect children
    from this deadly addiction. If Congress fails to act and
    smoking continues at its current rate, more than 6 million of
    today's children will ultimately die from tobacco-induced
    disease.
        Smoking is the No. 1 preventable cause of death in America.
    Nationally, cigarettes kill well over 400,000 people each year.
    That's more lives lost than from automobile accidents, alcohol
    abuse, illegal drugs, AIDs, murders, and suicides combined and
    Congress cannot continue to ignore a public health crisis of
    this magnitude.
        Giving FDA authority over tobacco products will not make
    the tragic toll of tobacco use disappear overnight. More than
    40 million people are hooked on this highly addictive product
    and many of them have been unable to quit, despite repeated
    attempts. However, FDA action can play a major role in breaking
    the gruesome cycle that seduces millions of teenagers into a
    lifetime of addiction and premature death.
        What can FDA regulation accomplish? It can reduce youth
    smoking by preventing tobacco advertising that targets
    children. It can help prevent the sale of tobacco products to
    minors. It can stop the tobacco industry from continuing to
    mislead the public about the dangers of smoking. It can help
    smokers overcome their addiction. It can make tobacco products
    less toxic and less addictive for those who continue to use
    them. And, it can prohibit unsubstantiated health claims about
    supposedly ``reduced risk'' products.
        Regulating the conduct of tobacco companies is as necessary
    today as it has been in the years past. The facts presented in
    the Federal Government's landmark lawsuit against the tobacco
    industry conclusively demonstrate that the misconduct is
    substantial and ongoing. The decision of the Court states:

              ``The evidence in this case clearly establishes that
            Defendants have not ceased in engaging in unlawful activity. .
            . . Defendants continue to engage in conduct that is materially
            indistinguishable from their previous actions, activities that
            continue to this day.''

        Only strong FDA regulation can force the necessary change
    in their corporate behavior.
        We must deal firmly with tobacco company marketing
    practices that target children and mislead the public. The
    tobacco industry currently spends over $15 billion each year to
    promote its products. Much of that money is spent on ways
    designed to tempt children to start smoking before they are
    mature enough to appreciate the enormity of the health risk.
    The industry knows that nearly 90 percent of smokers begin as
    children and are addicted by the time they reach adulthood.
        If we are serious about reducing youth smoking, the FDA
    must have the power to prevent industry advertising designed to
    appeal to children wherever it will be seen by children. This
    legislation will give FDA the authority to stop tobacco
    advertising that glamorizes smoking to kids. The FDA's
    authority must extend to the sale of tobacco products as well
    to ensure that children under 18 are not able to buy
    cigarettes.
        The tobacco industry has a long dishonorable history of
    providing misleading information about the health consequences
    of smoking. The FDA must have clear and unambiguous authority
    to prevent such misrepresentations in the future. The largest
    dis-information campaign in the history of the corporate world
    must end.
        The nicotine in cigarettes is highly addictive. Medical
    experts say that it is as addictive as heroin or cocaine. Yet
    for decades, while tobacco companies were publicly denying the
    addictiveness of their products, they were actually chemically
    manipulating the nicotine in them to make it even more
    addictive. A newly released analysis by the Harvard School of
    Public Health demonstrates that cigarette manufacturers are
    still manipulating nicotine levels. Between 1998 and 2005, they
    significantly increased the nicotine yield for major brand
    cigarettes.
        FDA must have the power to take the necessary steps to help
    addicted smokers overcome their addiction and to make the
    product less toxic for smokers who are unable or unwilling to
    stop.
        This legislation will require manufacturers to submit
    ``reduced risk'' products to the FDA for analysis before they
    can be marketed. No health-related claims will be permitted
    until they have been verified to the FDA's satisfaction. These
    safeguards are essential to prevent deceptive industry
    marketing campaigns, which could lull the public into a false
    sense of health safety.
        Enacting this bill this year is the right thing to do for
    America's children. They are depending on us. By passing this
    legislation, we can help them live longer, healthier lives.
        [The prepared statement of Senator Kennedy follows:]

                     Prepared Statement of Senator Kennedy

        This hearing focuses on the need for FDA regulation of
    tobacco products, the most lethal of all consumer products.
    Used as intended by the companies that manufacture and market
    them, cigarettes will kill one out of every three daily
    smokers. Yet, the Federal agency most responsible for
    protecting the public health is currently powerless to deal
    with the enormous risks of tobacco use. Public health experts
    overwhelmingly believe the passage of S. 625--bipartisan
    legislation that will at long last give the FDA authority to
    regulate tobacco products--is the most important action
    Congress can take to protect children from this deadly
    addiction. If Congress fails to act and smoking continues at
    its current rate, more than 6 million of today's children will
    ultimately die from tobacco-induced disease.
        Smoking is the number one preventable cause of death in
    America. Nationally, cigarettes kill well over 400,000 people
    each year. They die from cancers, from lung diseases, from
    heart diseases and strokes--all caused by smoking. That is more
    lives lost than from automobile accidents, alcohol abuse,
    illegal drugs, AIDS, murder, and suicide combined. Congress
    cannot continue to ignore a public health problem of this
    magnitude.
        Giving FDA authority over tobacco products will not make
    the tragic toll of tobacco use disappear overnight. More than
    40 million people are hooked on this highly addictive product
    and many of them have been unable to quit despite repeated
    attempts. However, FDA action can play a major role in breaking
    the gruesome cycle that seduces millions of teenagers into a
    lifetime of addiction and premature death.
        What can FDA regulation accomplish?

         It can reduce youth smoking by preventing tobacco
    advertising which targets children.
         It can help prevent the sale of tobacco products
    to minors.
         It can stop the tobacco industry from continuing
    to mislead the public about the dangers of smoking.
         It can help smokers overcome their addiction.
         It can make tobacco products less toxic and less
    addictive for those who continue to use them.
         And it can prohibit unsubstantiated health claims
    about supposedly ``reduced risk'' products.

        Regulating the conduct of the tobacco companies is as
    necessary today as it has been in years past. The facts
    presented in the Federal Government's landmark lawsuit against
    the tobacco industry conclusively demonstrate that the
    misconduct is substantial and ongoing. The decision of the
    Court states:

              ``The evidence in this case clearly establishes that
            Defendants have not ceased engaging in unlawful activity. . . .
            Defendants continue to engage in conduct that is materially
            indistinguishable from their previous actions, activity that
            continues to this day.''

        Only strong FDA regulation can force the necessary change
    in their corporate behavior.
        We must deal firmly with tobacco company marketing
    practices that target children and mislead the public. The Food
    and Drug Administration needs broad authority to regulate the
    sale, distribution, and advertising of cigarettes and smokeless
    tobacco.
        The tobacco industry currently spends over $15 billion each
    year to promote its products. Much of that money is spent in
    ways designed to tempt children to start smoking, before they
    are mature enough to appreciate the enormity of the health
    risk. Four thousand children have their first cigarette every
    day, and one thousand of them become daily smokers. The
    industry knows that nearly 90 percent of smokers begin as
    children and are addicted by the time they reach adulthood.
        Documents obtained from tobacco companies prove, in the
    companies' own words, the magnitude of the industry's efforts
    to trap children into dependency on their deadly product.
    Studies by the Institute of Medicine and the Centers for
    Disease Control show the substantial role of industry
    advertising in decisions by young people to use tobacco
    products.
        If we are serious about reducing youth smoking, FDA must
    have the power to prevent industry advertising designed to
    appeal to children wherever it will be seen by children. This
    legislation will give FDA the authority to stop tobacco
    advertising that glamorizes smoking to kids. It grants FDA full
    authority to regulate tobacco advertising ``consistent with and
    to the full extent permitted by the first amendment.''
        FDA authority must also extend to the sale of tobacco
    products. Nearly every State makes it illegal to sell
    cigarettes to children under 18, but surveys show that those
    laws are rarely enforced and frequently violated. FDA must have
    the power to limit the sale of cigarettes to face-to-face
    transactions in which the age of the purchaser can be verified
    by identification. This means an end to self-service displays
    and vending machine sales. There must also be serious
    enforcement efforts with real penalties for those caught
    selling tobacco products to children. This is the only way to
    ensure that children under 18 are not able to buy cigarettes.
        The FDA conducted the longest rulemaking proceeding in its
    history, studying which regulations would most effectively
    reduce the number of children who smoke. Seven hundred thousand
    public comments were received in the course of that rulemaking.
    At the conclusion of its proceeding, the Agency promulgated
    rules on the manner in which cigarettes are advertised and
    sold. Due to litigation, most of those regulations were never
    implemented. If we are serious about curbing youth smoking as
    much as possible, as soon as possible; it makes no sense to
    require FDA to reinvent the wheel by conducting a new multi-
    year rulemaking process on the same issues. This legislation
    will give the youth access and advertising restrictions already
    developed by FDA the force of law, as if they had been issued
    under the new statute. Once they are in place, FDA will have
    the authority to modify these rules as changing circumstances
    warrant.
        The legislation also provides for stronger warnings on all
    cigarette and smokeless tobacco packages, and in all print
    advertisements. These warnings will be more explicit in their
    description of the medical problems which can result from
    tobacco use. The FDA is given the authority to change the text
    of these warning labels periodically, to keep their impact
    strong.
        The nicotine in cigarettes is highly addictive. Medical
    experts say that it is as addictive as heroin or cocaine. Yet
    for decades, tobacco companies vehemently denied the
    addictiveness of their products. No one can forget the parade
    of tobacco executives who testified under oath before Congress
    that smoking cigarettes is not addictive. Overwhelming evidence
    in industry documents obtained through the discovery process
    proves that the companies not only knew of this addictiveness
    for decades, but actually relied on it as the basis for their
    marketing strategy. As we now know, cigarette manufacturers
    chemically manipulated the nicotine in their products to make
    it even more addictive.
        A newly released analysis by the Harvard School of Public
    Health demonstrates that cigarette manufacturers are still
    manipulating nicotine levels. Between 1998 and 2005, they
    significantly increased the nicotine yield from major brand
    name cigarettes. The average increase in nicotine yield over
    the period was 11 percent.
        The tobacco industry has a long, dishonorable history of
    providing misleading information about the health consequences
    of smoking. These companies have repeatedly sought to
    characterize their products as far less hazardous than they
    are. They made minor innovations in product design seem far
    more significant for the health of the user than they actually
    were. It is essential that FDA have clear and unambiguous
    authority to prevent such misrepresentations in the future. The
    largest disinformation campaign in the history of the corporate
    world must end.
        Given the addictiveness of tobacco products, it is
    essential that the FDA regulate them for the protection of the
    public. Over 40 million Americans are currently addicted to
    cigarettes. No responsible public health official believes that
    cigarettes should be banned. A ban would leave 40 million
    people without a way to satisfy their drug dependency. FDA
    should be able to take the necessary steps to help addicted
    smokers overcome their addiction, and to make the product less
    toxic for smokers who are unable or unwilling to stop. To do
    so, FDA must have the authority to reduce or remove hazardous
    ingredients from cigarettes, to the extent that it becomes
    scientifically feasible. The inherent risk in smoking should
    not be unnecessarily compounded.
        Recent statements by several tobacco companies make clear
    that they plan to develop what they characterize as ``reduced
    risk'' cigarettes. Some are already on the market making
    unsubstantiated claims. This legislation will require
    manufacturers to submit such ``reduced risk'' products to the
    FDA for analysis before they can be marketed. No health-related
    claims will be permitted until they have been verified to the
    FDA's satisfaction. These safeguards are essential to prevent
    deceptive industry marketing campaigns, which could lull the
    public into a false sense of health safety.
        This legislation will vest FDA not only with the
    responsibility for regulating tobacco products, but with full
    authority to do the job effectively. It is long overdue.
        Enacting this bill this year is the right thing to do for
    America's children. They are depending on us. By passing this
    legislation, we can help them live longer, healthier lives.
        The Chairman. Senator Enzi.

                       Opening Statement of Senator Enzi

        Senator Enzi. Thank you, Mr. Chairman. Good morning. I'd
    like to thank my colleague, Senator Kennedy, for calling this
    hearing. I believe it is always a good idea to discuss
    controversial issues like this one in order to better educate
    ourselves and the American people about the problem and the
    possible solutions.
        We can all agree on what our common interest is, which is
    stopping people of all ages from starting to smoke and
    convincing current smokers to quit that deadly habit. While the
    tobacco industry may seemingly share our views on teen smoking,
    I am one who doubts they have bought into the idea of getting
    adult smokers to stop smoking.
        The bill that is now before the Senate proves this point.
    Today we should ask ourselves, what will it mean to have
    cigarette and tobacco products truly regulated by the Food and
    Drug Administration? The FDA is the gold standard among public
    health regulators the world over. For the past century, the FDA
    has protected the public from filthy conditions in meat packing
    plants to thalidomide, which caused thousands of birth defects
    in Western Europe. The FDA's constant vigilance is not just a
    historical artifact. Last week, there was a recall of peanut
    butter due to salmonella contamination and baby food that had
    been tainted with botulism. This is how we've come to depend on
    the FDA every day to protect us and our children from poisons
    that could harm or even kill us.
        Senator Kennedy and I have worked on FDA issues for the
    last 2 years. We held 10 hearings on the FDA during the 109th
    Congress. Again and again, we focused on the FDA's role in
    protecting and promoting the public health.
        In all of our work together, it was evident that the FDA is
    overworked and under funded. We as a Nation currently ask the
    FDA to be responsible for so many things: ensuring that new
    drugs and medical devices are safe and effective, safeguarding
    the Nation's food supply, regulating the manufacture and
    distribution of food additives and drugs that will be given to
    animals and increasingly, the security of our blood supply.
        In each of these key activities, the role of the FDA is to
    protect our health. In providing that protection, the FDA
    examines key scientific facts and ways to balance the benefit
    to our society and risks to our health. It baffles me why we
    are here today to talk about the FDA doing a risk/benefit
    analysis of tobacco and cigarettes. Everyone agrees that
    smoking kills. There is no such thing as a safe cigarette. Any
    public statement by the FDA under their current authority would
    necessitate the finding that there is no benefit to the use of
    cigarettes--only harm.
        The bill now before Congress would establish the FDA as a
    regulator for tobacco products. However, the bill explicitly
    states that the FDA will not be permitted to prohibit the sale
    of any tobacco product to adults 18 years or older. That's not
    true regulation. The bill would gut the authority that Congress
    has bestowed and staunchly defended for the FDA--the authority
    to remove health threats from the marketplace. Having the FDA
    review and approve cigarettes sends mixed and confusing
    messages to the public, creating the sense that cigarettes are
    safe or made safer. I can see it now. Tobacco companies being
    let off the hook in court because they can now say, ``But
    judge, our product was reviewed and approved by the FDA.'' The
    FDA can not be put in the position of approving a product that
    years of science and personal experience for far too many
    Americans have shown to be dangerous. Simply put, it kills
    people.
        So what can we do? I recognize we can't change behavior
    overnight but the data on smoking are trending in the right
    direction. Fewer people smoke and teenage smoking is down
    dramatically. We can always do more with educational outreach
    efforts.
        Where are the funds going to come from? I recognize that
    the money from the Master Settlement Agreement, MSA, with 46
    States came with no strings attached. We all know the genesis
    of the agreement was States suing for the cost of healthcare
    for smokers and former smokers. The spirit of that agreement
    was that the funds would be used for healthcare for smokers and
    former smokers, however that is not how the money is being
    spent. As the GAO will highlight later today, on average,
    States are spending less than 5 percent of the MSA funds on
    tobacco control and prevention, and the spending on healthcare
    items such as SCHIP may not be focused on assisting smokers
    with severe health conditions due to their use of cigarettes.
    While States are spending their funds on a variety of projects,
    they are not spending key funds on the care of smokers and
    former smokers or preventing tobacco use in the first place.
        In fiscal year 2007, only three States--Maine, Delaware and
    Colorado, are meeting the CDC minimum recommendation of 8
    percent of spending on tobacco prevention. The combined total
    the States are spending on tobacco prevention amounts to just
    2.8 percent of the $21.7 billion in tobacco generated revenue
    the States will collect this year from the tobacco settlement
    and tobacco taxes. I think the States can do better.
        The FDA approves cures not poisons. Forcing the FDA to
    regulate tobacco but not letting them ban it would undermine
    the long history of the agency protecting and promoting the
    public health. I ask my colleagues to think hard about what
    they are proposing. My record is clear when it comes to
    tobacco. I am no friend to big tobacco and I have never taken a
    dime of tobacco money. I don't intend to start now. I
    absolutely reject the notion that the way to show that you are
    for kids and against tobacco is by sending the Nation's
    premiere public health watchdog out to fight for safety with
    one hand tied behind its back and allowing this premiere agency
    to provide its FDA seal of approval on a deadly product that
    has no health benefit.
        Now, I have a number of statements from outside groups
    regarding this legislation. I ask unanimous consent that they
    be entered into the hearing record. I would mention that I
    think Philip Morris, by mistake, sent me their letter. I would
    still ask that it be made a part of the record but I would
    suggest that big tobacco figures that if the FDA controls
    tobacco, the cigarettes will have to be put behind the counter
    where nobody can see other brands, particularly not 18-year-
    olds, that will give the established brands a big push.
        So I look forward to the testimony today and hope that we
    can do better.
        [Editor's Note: The materials presented by Senator Enzi may
    be found in Additional Materials.]
        The Chairman. Well, there you go. I look forward to our
    panel, their testimony.
        Senator Burr. Mr. Chairman, could I ask consent of the
    Chair and of my colleagues to allow me to make an opening
    statement?
        The Chairman. Sure. I'd like to accommodate you because
    this issue obviously has a particular, very special effect on
    your State. My colleague, Senator Brown, who is going to
    another hearing, wanted to say a brief word, too. We're trying
    to accommodate schedules as best we can but still try to keep
    this process moving. But I'll be glad to let both of you speak.
        Senator Brown.

                       Opening Statement of Senator Brown

        Senator Brown. Thank you, Senator Burr and thank you Mr.
    Chairman. Senator Enzi, thank you for recounting the proud
    history of the Food and Drug Administration and the terrific
    work it has done for decades. I appreciate that. And Senator
    Kennedy, thank you for your work on tobacco issues.
        Generally, the story of tobacco addiction is all too
    familiar for far too many of our young people. In my State of
    Ohio, 20 percent or 134,000 it is estimated, high school
    students smoke. Over 18,000 kids under the age of 18 become new
    daily smokers each year. The CDC estimates that in just this
    one State, 293,000 kids under the age of 18 will die
    prematurely as a result of smoking. These children are not
    aware of these staggering statistics when they tried their
    first cigarette but we are aware of these staggering
    statistics. That's why it's our responsibility to make sure our
    children are safe and don't fall victim to that unhealthy
    addiction.
        I applaud the Chairman for holding this hearing and
    introducing bipartisan legislation that would grant the FDA
    authority to regulate tobacco products. Congress has a
    responsibility to the Nation to ensure that children are safe
    and are not the victims of suggestive marketing by tobacco
    companies and has an equal responsibility to ensure that
    citizens are protected from dangerous chemicals and are aware
    of all their risks associated with smoking. The Chairman's bill
    will give the FDA the authority to regulate tobacco as it does
    any other drug. I totally support this legislation. I again
    thank the Chairman for holding these hearings.
        I, for about a decade, was the Ranking Democrat on the
    Health Subcommittee in the House and saw so much of this
    testimony and heard so much about this issue. It's time finally
    that the Senate and the House act. Thank you.
        The Chairman. Thank you very much, Senator Brown. I
    appreciate your comments and your presence here.
        Senator Burr.

                       Opening Statement of Senator Burr

        Senator Burr. Thank you, Mr. Chairman. Mr. Chairman, you
    should be applauded for bringing this up and you and I have a
    rich history of working on this issue when I was in the House.
    We share concerns.
        Clearly, coming from North Carolina, I am somewhat
    passionate about this issue and as I told Matt Myers, we've
    been doing this a long time. The only difference is, we've both
    aged.
        The approach that we are still taking today is exactly what
    we took 13 years ago when we first started this but so much has
    changed. The master settlement brought a lot of changes to the
    long list of advertising, the target of children, the use of
    cartoon characters, the sponsorship of sporting events--places
    where kids might be influenced. It's all gone.
        But the framework of regulation that we've chosen to do is
    still the same thing. It doesn't take into account that. I'm
    not here to go through a long laundry list of items that I
    might take a different road than maybe what the Chairman would
    take.
        I would only say this--that some who have read this bill
    suggest that it shields the tobacco companies in the future
    from liability. Some have read the bill and said, ``This is a
    pathway to the elimination of tobacco products.'' And quite
    frankly, I'm not sure that any of us know what will happen if
    this legislation becomes law.
        I think there are some assumptions that we can make that
    are fairly accurate and I just want to point everybody toward
    the FDA today. The FDA and its jurisdictions--the authority
    that the FDA currently has of 25 cents of every dollar of U.S.
    economy--this is not just about whether, in fact, the blood is
    safe, whether drugs and biologics and medical devices are, in
    fact, approved, labeled correctly and monitored for advertising
    effectively. It's a question of whether the safety of the
    system has been maintained and Sherrod worked with me on FDA
    modernization, now 12 years ago. The No. 1 objective was to
    make sure that that gold standard was preserved.
        But there is so much that is currently in the FDA
    jurisdiction and that we count on as Americans. It's not just
    about children. This is about every American and a system that
    we are reliant on for our health.
        The reality is that we all have to ask ourselves, is this
    the appropriate place to put all the regulatory responsibility
    of the most regulated industry in America? I'm going to ask for
    the other chart to go up.
        To hear some describe the lack of regulation, the lack of
    oversight on this industry ignores the current regulatory
    framework that is in this country. Now granted, some of the
    Federal agencies have certain tobacco regulations internal to
    their areas of the Government. But when you look at the
    Department of Agriculture, when you look at the Federal Trade
    Commission, when you look at HHS, what you find is, you find
    the most regulated industry in America today before we ever
    talk about passing a bill.
        So, Mr. Chairman, it's only my hope and my pledge to you
    and to our panelists, who are passionate and knowledgeable on
    many of the issues, that it is my hope that we will throw away
    that template that we created 13 years ago, that we will focus
    on the areas where I think we need to make progress. I think it
    is reasonable to say, what does it take to assure Matt Myers
    that children are not the target of advertising, of marketing,
    of promotion? But what allows us to continue some degree of
    marketing to consenting adults.
        I used to be a tobacco smoker. I'm not today. You can quit.
    My children never started. They may be an anomaly. I don't
    think they are. It is reasonable for us as legislators, to
    expect that we can create a framework that provides more
    information for adults to make better choices? I think that is
    where our responsibility lies. When we can bring to the table
    new information, better information about the health
    consequences, then adults can choose, in fact, whether they
    want to participate in the use of this product.
        Mr. Chairman, it is my hope that over the next days, weeks,
    months--whatever your timeline is--that we can sit down in an
    informal capacity and talk about a different framework, one
    hopefully that we would find tremendous agreement on where we
    end up, but possibly the flexibility of how we accomplish that
    might be left up to something other than the formal hearing
    process. I think we can achieve that and I look forward to
    working with the Chairman. I thank you.
        The Chairman. Well, thank you very much, as always, a very
    provocative and well stated view, Senator. I think this has
    been helpful in trying to establish a framework. We've got a
    very experienced panel that have strong views from their
    vantage points. We all hope that they might be able to catch
    the spirit of this hearing. We've heard pretty diverse views
    about how we ought to approach it and the witnesses will be
    able to add to their own comments what they might, in terms of
    responding to some of these issues.
        We have very distinguished witnesses. Let me introduce
    three panelists at a time and then I will introduce the others
    after the first group has spoken. I think that is probably the
    most effective way to proceed.
        So we'll start with Matthew Myers, President and CEO of the
    Campaign for Tobacco-Free Kids, a privately funded organization
    established to reduce tobacco use and its devastating
    consequences in the United States and around the world. For
    over 25 years, Mr. Myers has participated in virtually every
    major national tobacco-related legislative effort, worked with
    State tobacco prevention advocates and officials around the
    country. In 1999, Mr. Myers was asked to serve on the first
    advisory committee established to advise the Director General
    of the World Health Organization on tobacco issues. In October
    2004, Harvard School of Public Health bestowed its highest
    honor, the prestigious Julie Richmond Award on Mr. Myers for
    his work as an advocate in preventing tobacco industry
    marketing to children.
        Elmer Huerta is the President-Elect of the National Board
    of Directors of the American Cancer Society, and a member of
    the American Cancer Society Action Network. Dr. Huerta is
    currently Director of the Cancer Preventorium at the Washington
    Cancer Institute at the Washington Hospital Center in
    Washington, DC., founded in 1994. He is President and Founder
    of Prevencion, a nonprofit company dedicated to the production
    and dissemination of educational materials for the Latino
    community. He was a founding member of the Board of Directors
    of the American Legacy Foundation. He is a prominent figure on
    Spanish language radio and television.
        Dr. Richard Land--Princeton and Oxford educated--has served
    as President of the Southern Baptist Convention Ethics and
    Religious Liberty Commission since 1988. He represented the
    Evangelicals before Congress and U.S. Presidents, and is a
    three-time commissioner of the U.S. Commission in National
    Religious Freedom. In 2005, Time named Dr. Land one of the 25
    most influential Evangelicals. A renowned scholar, Dr. Land has
    worked as a pastor, a theologian and a public policymaker. He
    is a leading member of Faith United Against Tobacco.
        I'm very grateful to have these three individuals here
    today.
        Let's begin with Mr. Myers.

        STATEMENT OF MATTHEW L. MYERS, PRESIDENT AND CEO OF THE
             CAMPAIGN FOR TOBACCO-FREE KIDS, WASHINGTON, DC

        Mr. Myers. Chairman Kennedy, Senator Enzi, Senator Burr and
    members of the committee, thank you very much for the
    opportunity to testify today.
        S. 625, in the view of virtually every major public health
    organization, has the potential to save literally hundreds of
    thousands if not millions of lives. Rarely is Congress faced
    with an opportunity to do exactly that.
        Today, tobacco--America's most dangerous consumer product,
    despite what Senator Burr said, is also the one consumer
    product that no Federal agency oversees for health and safety
    purposes, despite its other regulatory framework. This
    carefully crafted, thoughtfully balanced legislation would
    correct that glaring problem and bring to tobacco the kind of
    government oversight that is already provided to other consumer
    products.
        As you know, S. 625 was only introduced on February 15, but
    the need for legislation giving FDA regulatory authority over
    tobacco has been debated for years. Indeed, a bill virtually
    identical to S. 625 was debated and overwhelming approved by
    the full Senate twice in 2004.
        S. 625 has been examined by virtually every major public
    health organization in this country. It has broad bipartisan
    support, including liberals and conservatives and Senators from
    every geographic region of the country. It has been endorsed by
    every major national public health organization, many
    organizations representing healthcare providers as well as
    representative of a wide range of faith groups.
        As the letter attached to my testimony reflects, support
    for this legislation is a virtual Who's Who of this Nation's
    health community and includes 48 national organizations. Rarely
    do you see this kind of consensus.
        The need for FDA regulation is also supported by a wide
    range of Americans. We have just conducted a nationwide poll
    and found that 69 percent of voters favor FDA regulation of
    tobacco products. What is interesting about that poll is, that
    number does not vary by geographic region and it is also
    extraordinarily strong in the tobacco growing country.
        As you said, Senator Kennedy, more than five decades after
    the Surgeon General's historic 1964 report, more than 400,000
    Americans die prematurely every year from tobacco. That's
    roughly 1,200 people every single day. The critical word is
    prematurely. While some hope that the Master Settlement
    Agreement would end tobacco marketing to kids, as Federal Judge
    Gladys Kessler found just last August, the tobacco
    manufacturers continue to market in ways that appeal to young
    people and continue, to this day, to recruit children as new
    tobacco users. While helpful, the MSA addressed less than 20
    percent of the marketing and promotional expenditures of the
    tobacco company and it did not even completely eliminate those
    practices.
        Indeed, between 1998 and 2003, the last year for which we
    have data, promotional expenditures by cigarette companies rose
    from $6.73 billion a year to a staggering $15.15 billion a
    year. That means today and every day, the tobacco companies
    will spend more than $41 million marketing their products. We
    need to do more.
        This legislation will provide FDA with the authority it
    needs to appropriately oversee the marketing, manufacture and
    sale of tobacco products. In a nutshell, this bill ensures that
    oversight of tobacco is based on sound science and conducted by
    an agency and personnel with scientific expertise and the
    ability to make adjustments based on new scientific evidence.
        For the reason that FDA has previously been given authority
    of other products, the FDA is the only agency that possesses
    these qualities. It requires the tobacco industry to make the
    type of disclosures to FDA that other manufacturers are already
    required to make. It establishes commonsense standards for
    product regulations that are practical, achievable and directed
    toward protecting the public. It recognizes, as Senator Enzi
    did, that how a product is marketed can also have a major
    impact on the number of people who needlessly die from tobacco,
    both in terms of encouraging use and discouraging quitting.
        Last and very importantly, it provides the FDA with the
    resources to do the assigned job capably and without detracting
    from FDA's other important missions. It should be noted that
    this legislation provides an independent source of funds for
    FDA to adequately do the job but even that independent source
    of funds would amount to no more than about 2\1/2\ cents per
    pack.
        Let me just highlight one or two things quickly so that I
    don't use much time. Marketing--the bill would put in place a
    number of specific advertising restrictions that FDA has
    previously determined after a 2-year investigation, have the
    greatest impact on tobacco use on children, practices that
    continue until today.
        And most importantly, it would authorize FDA to take
    further action as new marketing practices are discovered, to
    address those but in ways that are extraordinarily sensitive to
    the first amendment.
        In terms of the new products and the products today on the
    market, today tobacco products contain more than 60 known
    cancer-causing substances and the incidence of disease among
    smokers, shockingly, has actually increased--not decreased,
    over the years. No Federal agency, no State agency currently
    has the authority to require tobacco companies to make
    technologically feasible changes to tobacco products to reduce
    the number and quantity of harmful substances in those
    products.
        For the first time in history, this bill gives a Federal
    agency the authority to require those kinds of changes in both
    new and existing products.
        Let me address an important issue. This bill does not use
    the same standards to evaluate products as is used for drugs.
    It recognizes that the standard FDA normally applies to many
    products under its jurisdiction, whether the product is safe
    and effective, does not make sense for tobacco products. There
    are approximately 50 million Americans already using these
    highly addictive products and there is no such thing, I think
    we can all agree, of a safe cigarette.
        The Chairman. I'm going to ask you to begin to wind up,
    please.
        Mr. Myers. I just have about 1 minute left. Thus, the
    standard in this bill--but the fact that the current standard
    doesn't apply doesn't mean there isn't anything we can do. The
    standard in this bill is one based on what actions are
    appropriate to protect the public health, which in this case,
    means those actions that will reduce the number of people
    likely to die from tobacco. Changes to tobacco products today
    can reduce those harms.
        Last, critically, this would prevent tobacco companies from
    making the kind of unsubstantiated health claims as they have
    for light and low-tar tobacco products and for a whole new
    generation of products, which have undermined efforts by the
    States and others, to encourage people to quit. This bill would
    eliminate the terms light and low-tar, producing an immediate
    benefit and equally important is it would set meaningful,
    reasonable scientific standards that would require a tobacco
    company to prove to FDA that any product for which they wanted
    to make a claim actually would result in a reduction in risks
    to both individual consumers and the population as a whole.
        In conclusion, Senator Kennedy and members of the
    committee, this bill is a thoughtful, balanced approach to a
    problem that has plagued this Nation for over 50 years. It
    isn't perfect but it will result in literally hundreds of
    thousands of lives being saved.
        Thank you.
        [The prepared statement of Mr. Myers follows:]
                     Prepared Statement of Matthew L. Myers
        Chairman Kennedy, Senator Enzi, and members of the HELP Committee,
    thank you for this opportunity to testify in support of S. 625, a bill
    to provide the U.S. Food and Drug Administration (FDA) with the
    authority to effectively regulate tobacco products and their marketing
    and to reduce the harms associated with tobacco use. My name is Matthew
    Myers, and I am President of the Campaign for Tobacco-Free Kids, the
    Nation's largest nonprofit, advocacy organization solely devoted to
    reducing the harm caused by tobacco use and exposure to secondhand
    smoke.
        S. 625 has the potential to save many lives. Today, America's most
    dangerous consumer product--tobacco--is also the one consumer product
    that no Federal agency oversees for health and safety purposes. This
    carefully crafted, thoughtfully balanced legislation would correct that
    glaring problem and bring the type of government oversight to the
    manufacture, marketing and sale of tobacco products that is already
    provided to other consumer products.
        As you know, S. 625 was introduced on February 15, 2007, but the
    need for legislation giving FDA authority over tobacco has been
    discussed for years, and legislation similar to S. 625 has been before
    the Senate for close to a decade. A bill virtually identical to S. 625
    was debated and overwhelmingly approved by the full Senate in 2004.
        It is essential for Congress to act if the public is to be
    protected. In 1996, after a 2-year investigation, the U.S. Food and
    Drug Administration asserted jurisdiction over tobacco under current
    law. Then, in March 2000, the U.S. Supreme Court ruled that the FDA did
    not have the statutory authority to regulate tobacco products, and that
    only Congress could grant FDA this authority. In a highly unusual
    commentary, the Court urged Congress to act given the seriousness of
    the public health problem.
        Thus, it is no surprise that S. 625 has broad bipartisan support
    including liberals and conservatives and Senators from every geographic
    region of the country. It has been endorsed by every major national
    public health organization, many organizations representing health care
    providers, and representatives of a wide range of faith groups.
    Virtually identical legislation was also previously endorsed by every
    major tobacco-farming group.
        The Campaign for Tobacco-Free Kids has measured voter support for
    FDA regulation of tobacco products and, not surprisingly, it has broad
    support across the country, with 69 percent of voters in a national
    poll favoring. State surveys from around the country have consistently
    found similarly high levels of support, crossing party and ideological
    lines. It even has majority support among smokers. Voter support is
    particularly strong for the specific provisions of FDA regulation. When
    asked if tobacco companies should be required to take measures to make
    cigarettes less harmful; if tobacco companies should be prevented from
    making claims that some products are less harmful than others unless
    FDA determines those claims are true; or if FDA should restrict tobacco
    marketing aimed at children, voter support for each of these elements
    exceeds 75 percent.
        It is truly time for Congress to act.
                            why this bill is needed
        S. 625 is essential for the protection of the public health. More
    than five decades after the Surgeon General's historic 1964 report,
    more than 400,000 Americans die prematurely every year from tobacco,
    roughly 1,200 people every day. The critical word is ``prematurely.''
    Fifty percent of the people who die from tobacco die in middle age, and
    almost every one of those deaths is a person who started smoking and
    became addicted before they were old enough to be sold tobacco products
    legally.
        Death from tobacco is almost always the last chapter of a book that
    begins in childhood. Every day, approximately 4,000 kids will try a
    cigarette for the first time. Another 1,000 will become new, regular
    daily smokers, and one-third of these kids will eventually die
    prematurely as a result.
        While some hoped that the 1998 Master Settlement Agreement (MSA)
    would end tobacco marketing to children, Federal District Court Judge
    Gladys Kessler found last July that the tobacco manufacturers continue
    to market in ways that appeal to young people and continue to recruit
    children as new tobacco users. The MSA, while helpful, addressed less
    than 20 percent of the marketing and promotional expenditures by the
    tobacco companies, and it did not completely eliminate even those
    practices. The tobacco companies have easily overcome these
    restrictions by dramatically increasing marketing expenditures and
    constantly finding new and sophisticated ways to market their products,
    many of which impact kids. Between 1998, the year of the MSA, and 2003,
    the latest year for which data are available, the major cigarette
    companies more than doubled their marketing and promotional
    expenditures from $6.73 billion to a staggering $15.15 billion--more
    than $40 million each and every day--much of it aimed at kids. As Judge
    Kessler concluded in her opinion:

              ``In fact, the overwhelming evidence set forth in this
            Section--both Defendants' internal documents, testimony from
            extraordinarily qualified and experienced experts called by the
            United States, and the many pictorial and demonstrative
            exhibits used by the Government--prove that, historically, as
            well as currently, Defendants do market to young people,
            including those under 21, as well as those under 18.
            Defendants' marketing activities are intended to bring new,
            young, and hopefully long-lived smokers into the market in
            order to replace those who die (largely from tobacco-caused
            illnesses) or quit.''

        It's no wonder that our surveys continue to show kids are almost
    twice as likely as adults to remember tobacco advertising.
        Judge Kessler also concluded that tobacco company marketing to kids
    is likely to continue in the future:

              ``Similarly, Defendants continue to engage in many practices
            which target youth, and deny that they do so. Despite the
            provisions of the MSA, Defendants continue to track youth
            behavior and preferences and market to youth using imagery
            which appeals to the needs and desires of adolescents.
            Defendants are well aware that over 80 percent of adult smokers
            began smoking before the age of 18, and therefore know that
            securing the youth market is critical to their survival. There
            is therefore no reason, especially given their long history of
            denial and deceit, to trust their assurances that they will not
            continue committing RICO violations denying their marketing to
            youth.''

        In addition to allowing virtually unfettered promotion of tobacco
    products, the absence of any meaningful regulation continues to allow
    the tobacco industry to manipulate their products in ways that can make
    them more addictive and/or more harmful. The introduction of so-called
    reduced risk products, with no oversight, can also deceive consumers
    and undermine their efforts to reduce their risk by luring them into
    switching to products that they falsely believe are less hazardous
    rather than quitting. It can also attract new smokers with the promise
    of less harm.
        The lesson is clear: more must be done. The status quo is not
    working and current efforts are inadequate. The need for FDA oversight
    of the tobacco industry is as great today as ever:

         The tobacco industry continues deceptive marketing that
    undermines prevention efforts and appeals to children.
         Tobacco products remain toxic and addictive and tobacco
    companies are free to manipulate products to make them more appealing
    and addictive.
         There continue to be unsubstantiated health claims made
    for new and low tar products.
         There are still critical gaps in the industry's
    acknowledgement of the health effects of their products.
                             what this bill will do
        This legislation will provide the FDA with the authority it needs
    to appropriately oversee the marketing, manufacture and sale of tobacco
    products. This authority will benefit public health by reducing illegal
    sales of tobacco to kids, by limiting marketing that targets kids to
    begin smoking and misleads smokers to discourage them from quitting, by
    ensuring that new products that purport to reduce harm actually do so,
    and by requiring tobacco companies to make changes in the products that
    make them less harmful to smokers unable to quit.
        Key principles of the legislation include:

         Ensures that oversight of tobacco is based on sound
    science and conducted by an agency and personnel with scientific
    expertise and the ability to make adjustments based on new scientific
    evidence;
         Requires the tobacco industry to make the type of
    disclosures to FDA that other manufacturers are already required to
    make and that are essential to enable the agency to make well-informed
    decisions and take effective action;
         Establishes common-sense standards for product regulation
    and agency action that are practical, achievable and directed toward a
    single common goal--to protect the public health and reduce the number
    of Americans who die prematurely as the result of their use of tobacco
    products;
         Recognizes that how a product is marketed can also have a
    major impact on the number of people who needlessly die from tobacco
    use and establishes marketing standards that are both consistent with
    the first amendment and the FDA's public health mission; and
         Provides the FDA with the resources to do the assigned job
    capably and without detracting from FDA's other important missions.

        I want to highlight just a few key provisions of the bill and also
    address some of the concerns that have been raised about the
    legislation.
        Marketing.--Since the Master Settlement Agreement, the tobacco
    industry has more than doubled its marketing expenditures with
    knowledge of the impact of its marketing on children; continued
    marketing ``light'' and ``low tar'' cigarettes despite the evidence
    that they do not reduce the risk of disease and the public is misled by
    how they are labeled and sold; and introduced new tobacco brands backed
    by new unsubstantiated and unproven health claims that mislead the
    public. It has become even clearer that State lawsuits, prior voluntary
    codes, and current laws have not prevented the tobacco industry from
    marketing to children or misleading the public.
        This bill would put in place a number of specific advertising
    restrictions that FDA previously determined, after a 2-year
    investigation, impact tobacco use by children; would require the
    elimination of the use of the terms ``light,'' ``low tar'' and similar
    terms unless the industry could scientifically demonstrate that
    products labeled ``light'' and ``low tar'' actually reduce the risk of
    disease; and would otherwise prevent the use of other health claims
    unless a manufacturer presents scientific evidence to support those
    claims. These are not radical concepts. Manufacturers of other products
    regulated by FDA are not allowed to make claims without adequate
    scientific substantiation because of the adverse impact on the health
    of potential consumers. This bill would finally force the tobacco
    industry to play by these reasonable rules.
        Equally as important, this bill recognizes that the tobacco
    industry has often circumvented rules designed to curtail both
    marketing to children and misleading of the public and provides FDA the
    needed authority to adopt new rules to address new conditions as they
    arise.
        Any advertising regulations must be consistent with the first
    amendment. The bill states that the authority to develop regulations
    that impose restrictions on the advertising and promotion of tobacco
    products must be consistent with, but can be exercised to the full
    extent permitted by, the first amendment. Given the history of the
    tobacco industry's aggressive and misleading marketing, strong
    authority to restrict marketing is justified.
        The kinds of Federal restrictions on tobacco marketing contained in
    S. 625 are consistent with the U.S. Supreme Court's analysis in
    Lorrilard Tobacco Company v. Reilly. They would survive constitutional
    challenge because they are carefully tailored, scientifically proven
    measures to protect the recognized legitimate interests of the
    government in protecting (1) children from marketing that contributes
    to tobacco addiction and (2) adults from misleading marketing that
    encourages tobacco use and discourages quitting. Federal action is
    clearly needed because over 50 years of voluntary and State
    governmental efforts to change the tobacco industry's behavior have not
    solved the problem.
        Establishing Appropriate Standards for the Content of Tobacco
    Products.--Today, tobacco products contain more than 60 known cancer-
    causing substances, and the incidence of disease among smokers has
    actually increased, not decreased, over the years, according to the
    National Cancer Institute.\1\ Even as the tobacco industry touted that
    it had reduced tar and nicotine levels in its products, the level of
    potent carcinogens, like nitrosamines, increased without any public
    agency having any authority to evaluate the impact of that change.
    ---------------------------------------------------------------------------
        \1\ Risks Associated with Smoking Cigarettes with Low Machine-
    Measured Yields of Tar and Nicotine. Smoking and Tobacco Control
    Monograph No. 13. Bethesda, MD: U.S. Department of Health and Human
    Services, National Institutes of Health, National Cancer Institute, NIH
    Pub. No. 02-5074, October, 2001. http://cancercontrol.cancer.gov/tcrb/
    monographs/13/.
    ---------------------------------------------------------------------------
        No Federal agency currently has the authority to require tobacco
    companies to disclose, in a meaningful way, what is in each product;
    \2\ to require manufacturers to provide evidence of the impact of
    product changes; or to require manufacturers to make technologically
    feasible changes to products to reduce the number or quantity of
    harmful substances in tobacco products and the smoke of tobacco
    products. S. 625 would address this gap in a practical and reasonable
    way. It recognizes that the standard FDA normally applies to many
    products under its jurisdiction--whether the product is ``safe and
    effective''--does not make sense for tobacco products because there is
    no such thing as a ``safe cigarette.'' A ``safe and effective''
    standard would thus dictate a total ban on tobacco products, and with
    close to 50 million Americans addicted to tobacco use, virtually all
    public health experts recognize this as infeasible and unproductive. S.
    625 recognizes that the goal is therefore to reduce the number of
    people who needlessly die prematurely from tobacco use. Thus, the
    standard in the bill is one based on what actions are ``appropriate to
    protect the public health,'' taking into account the impact of any
    proposal on the health of the ``population as a whole, including users
    and nonusers'' of tobacco products. The bill puts in place measures to
    prevent kids from starting to smoke and to ensure that smokers are not
    dissuaded from quitting by misleading claims, and it establishes a
    process to reduce the harm from tobacco products to those who are
    unable to quit.
    ---------------------------------------------------------------------------
        \2\ The ingredient disclosure requirements of the 1984
    Comprehensive Smoking Education Act have proven wholly inadequate for
    this purpose. They do not provide the government with information to
    identify what chemicals and other ingredients are in each brand of
    cigarettes, the quantity of the different chemicals, in each cigarette
    or the type of information that is needed to understand or evaluate or
    warn the public about what is in each brand of cigarette.
    ---------------------------------------------------------------------------
        The standard in S. 625 recognizes the unique issues raised by the
    regulation of tobacco products. This standard looks at the overall
    impact on the number of people who will die needlessly from tobacco and
    allows the FDA to broadly consider all factors that will affect whether
    a proposed product change will increase or decrease the death and
    disease caused by tobacco. It instructs the FDA to look at how a
    mandated product change will impact individual tobacco users but also
    look at its impact on the number of tobacco users by examining its
    effect on discouraging smokers from quitting or encouraging nonsmokers
    to start. The goal is protecting the pubic and saving lives, and the
    standard set forth in S. 625 is right on the mark.
        Preventing Unsubstantiated Health Claims While Encouraging Real
    Scientific Innovation to Reduce the Harm Caused by Tobacco Products.--
    For decades, tobacco manufacturers have been marketing ``light'' and
    ``low tar'' products with claims that these cigarettes are less risky,
    leading millions of consumers to switch to these products thinking they
    are actually reducing their risk of disease or that they were taking a
    first step toward quitting. The National Cancer Institute, the U.S.
    Surgeon General and other credible scientific bodies have subsequently
    concluded that ``light and ``low tar'' products did not reduce the risk
    of disease and did deter millions of smokers from quitting. Subsequent
    to the release of the scientific evidence demonstrating that ``light''
    and ``low tar'' products have not reduced the risk of disease, tobacco
    companies have continued to mislead consumers and have come out with
    new products whose advertising includes even more specific claims of
    reduced risk.
        The absence of any regulatory body to review health claims has led
    to a public health tragedy that has thwarted the well-intended personal
    efforts of tobacco users who have attempted to reduce their risk of
    disease. This bill would address that problem in a manner consistent
    with sound scientific standards. It requires FDA to prevent
    unsubstantiated and unproven claims, while permitting a manufacturer
    who produces a genuinely less hazardous product, and develops sound
    scientific evidence of its impact, to responsibly make claims about any
    such innovative product.
        This provision by itself has the potential to save many lives.
    Before a manufacturer can make a health claim for a product, the
    legislation simply requires that manufacturer to demonstrate to FDA
    that the product significantly reduces the risk of disease when
    compared to other tobacco products, and when used in the manner a
    consumer will actually use the product. It also requires the
    manufacturer to show that any public health benefit for individual
    users will not be offset by the harm caused by marketing of the product
    resulting in increased tobacco use or decreased cessation.
        This section will benefit manufacturers who develop a genuinely
    safer product and will adversely impact only those manufacturers who
    have been making unproven claims or marketing their products in ways
    that encourage nontobacco users to start or discourage potential users
    who would otherwise quit.
        Concerns of Tobacco Product Retailers.--Convenience store owners
    have expressed concerns about provisions in the bill, including those
    that require retailers to check the ID of young persons seeking to
    purchase tobacco products. The youth access provisions of the original
    FDA regulations in place from 1996 to 2000 were effective in reducing
    illegal sales to youth. Congress appropriated funding for this program,
    and FDA enforced the youth access restrictions, not by employing
    Federal agents, but by contracting with State and local officials, such
    as health departments and police departments. By 2000, the FDA had
    contracts with every State to conduct the compliance checks and had an
    extensive outreach program that provided resources and information to
    retailers. This was a program that was producing solid results in
    reducing illegal youth access to tobacco in a manner sensitive to State
    and local interests.
        Although this bill does hold store owners responsible for illegal
    tobacco sales to children, it establishes detailed procedures to
    protect retailers who diligently require young people to show
    government-issued IDs, including procedural protections that were not
    in place between 1996 and 2000. In addition, no fines are incurred
    until repeated violations occur, and retailers are warned after the
    first violation that additional compliance checks will be conducted.
    The only retailers who will be punished will be those who repeatedly
    sell tobacco to kids illegally.
        Impact on FDA's Ability to Regulate Food, Drugs, Devices and Other
    Products Currently Under Its Jurisdiction.--We recognize that there are
    concerns about FDA's resources and whether it is successfully carrying
    out its current responsibilities. The expectation is that FDA would
    create a new office and hire additional staff to carry out the
    activities required by this legislation. The new responsibilities would
    be funded through a user fee on the tobacco industry, so it would have
    no impact on the funding provided to FDA to carry out its other
    important activities. The user fees are allocated among the
    manufacturers of tobacco products sold in the United States, based on
    the manufacturers' respective shares of the entire U.S.-
    tobacco product market. Many of the groups that support this
    legislation care deeply about the many important tasks of the FDA
    including drug and device approval and the work the agency does to
    protect our food supply. But we also believe that a key to improving
    the Nation's health is reducing the harm caused by tobacco products.
        Impact on Tobacco Companies.--Some tobacco companies have argued
    that this bill will give an advantage to one tobacco manufacturer over
    others, claiming that certain tobacco companies can more easily comply
    with stringent FDA regulations and that industry leaders will benefit
    by the bill's restriction of tobacco marketing. Neither argument has
    any merit.
        When the FDA sets safety standards for foods and drugs, its focus
    is on safety and efficacy, not the size of the manufacturer or the
    impact on market share. For those other products, the only
    manufacturers who are hurt are those who can't meet FDA's public health
    standards. This bill does the same for tobacco products and creates a
    level playing field for all manufacturers. The bill's marketing
    restrictions are also fair and balanced. Today, close to 90 percent of
    all new long-term smokers are children. It is a strength of this
    legislation, not a weakness, that it provides a comprehensive attempt
    to restrict marketing that appeals to children. The tobacco industry
    claims its marketing is about brand competition among smokers; the
    industry's own documents and Judge Kessler's decision last August
    reflects powerful evidence that the industry's advertising is a major
    contributor to tobacco use by youth. What is of paramount importance to
    public health is the size of the overall market for tobacco products,
    NOT the market share of any particular company. We believe that this
    legislation will significantly reduce the number of people who use
    tobacco and who become sick and die as a result.
        State and Local Authority.--The legislation achieves a reasonable
    balance between Federal and State or local authority over tobacco. It
    allows the States to continue to regulate the sale, distribution, and
    possession of tobacco products and would expand State authority to
    regulate tobacco product marketing. To ensure consistent product
    standards nationally, however, the legislation reserves to the Federal
    Government the right to regulate the product itself, which is
    consistent with the way the FDA regulates other products under its
    jurisdiction.
        We believe that States and localities ought to be able to control
    the time, place and manner of tobacco advertising in their communities,
    and this legislation will allow them to do that for the first time in
    almost 40 years. The bill cuts back, but does not fully eliminate, the
    exemption for the tobacco industry passed in 1969 as part of the
    Federal Cigarette Labeling and Advertising Act. That act prevented the
    States from regulating cigarette advertising, even purely local forms
    of cigarette advertising. The bill returns to State and local
    governments the ability to impose limitations on the time, place and
    manner of marketing and advertising practices, but not on the content
    of ads. The States already have this authority for smokeless tobacco
    products and other products regulated by FDA, and it has not created
    problems for the marketplace.
        The sponsors of this legislation were careful to specifically make
    clear that the legislation does not curtail any of the areas States
    have traditionally used to reduce tobacco use. Under the legislation,
    State and local governments would continue to be free to adopt measures
    regulating exposure to secondhand smoke; restricting youth access to
    tobacco products; and enacting fire safety standards for tobacco
    products. In short, the bill in no way restricts States from pursuing
    policies such as smoke-free laws, tobacco taxes, fire-safe measures,
    age requirements, identification checks, retailer licensing and fines,
    and other restrictions on the sale and distribution of tobacco products
    that have been instrumental in reducing tobacco use. States would also
    be able to impose additional reporting requirements on tobacco
    manufacturers (as Massachusetts, Texas and Minnesota have done) if
    there was any information FDA was not getting or not sharing that a
    State thought would be useful.
        The bill does give the FDA exclusive authority in such areas as
    tobacco product standards, pre-market approval, adulteration,
    misbranding, labeling, registration, good manufacturing standards, or
    modified risk products. States could not establish requirements in
    these areas. This approach is consistent with Federal law regarding FDA
    regulation of drugs, devices, and food because it provides for a
    consistent national standard.
        Permitting Cross Category Comparative Health Claims.--The bill
    permits the FDA to authorize tobacco manufacturers of one type of
    tobacco product to make health claims comparing the risks of its
    tobacco to other forms of tobacco products, but only if the
    manufacturer has presented sufficient scientific evidence that the
    advertised product is indeed safer and will reduce the user's risk of
    disease--in this regard, the bill is explicit. There has been a debate
    about whether the use of smokeless tobacco by committed, addicted
    smokers who can't or won't quit can be a useful harm reduction
    strategy. This bill sets the scientific standard for FDA making such a
    determination, but doesn't prejudge the scientific result. If a
    smokeless tobacco manufacturer provides the FDA with adequate
    scientific evidence that a specific product or group of products is
    less hazardous than a cigarette product and will reduce the risk of
    disease among certain tobacco users, FDA is authorized to permit the
    smokeless manufacturer to make an approved claim. However, in making
    such a determination, FDA is required to consider the population-wide
    impact of permitting such claims, including the impact of any claims on
    the number of smokers who would otherwise quit using tobacco altogether
    and the number of people who begin using tobacco products.
        Limitations on FDA's Authority Over Tobacco Growers and Leaf
    Tobacco.--The bill contains a number of specific prohibitions against
    the exercise of FDA authority on tobacco farms. The bill establishes
    FDA authority over tobacco manufacturers and their products and
    prohibits FDA from regulating leaf tobacco. Even FDA's standard-setting
    authority is limited to standards for manufactured tobacco products.
    Many tobacco growers believe American producers, much more easily than
    their foreign competitors, will be able to swiftly produce the quality
    tobacco leaf manufacturers require, and that consequently the
    legislation may provide American growers with a comparative advantage
    over foreign competition.
                                   conclusion
        Mr. Chairman, in summary, the Campaign strongly suports this bill,
    and we firmly believe that it will help protect our kids from tobacco
    companies and their deadly products and deceptive advertising. It will
    help more adult tobacco users to quit, and it will greatly benefit the
    public health of the Nation.

        The Chairman. Thank you. You're an old friend and I'm
    delighted to have you testifying today.
        Dr. Huerta.

    STATEMENT OF DR. ELMER HUERTA, M.D. M.P.H., PRESIDENT, AMERICAN
                     CANCER SOCIETY, WASHINGTON, DC

        Dr. Huerta. Good morning, Mr. Chairman. Good morning
    distinguished members of this committee and thank you very much
    for allowing me to testify this morning.
        I am Dr. Elmer Huerta. I am the incoming President of the
    American Cancer Society and Director of the Cancer Preventorium
    at the Washington Hospital Center here in Washington, DC.
        As a physician and researcher who specializes in cancer
    prevention and the screening among the medically underserved, I
    see firsthand the toll tobacco takes on our country and the
    benefits of prevention in combating cancer.
        On behalf of the more than 28 million volunteers and
    supporters of the American Cancer Society and its sister
    organization, the American Cancer Society Cancer Action
    Network, I thank you, Mr. Chairman, again and your committee
    for inviting me this morning.
        The need for FDA regulation of tobacco is great and its
    benefits are clear. The tobacco industry made voluntary
    promises as part of the Master Settlement Agreement that it
    would stop marketing to children. Those promises have been
    broken. Our children have been left unprotected and the tobacco
    industry is taking advantage of that loophole in sinister
    fashion.
        Indeed, the most popular cigarettes among children are the
    most heavily advertised brands--Marlboro, Camel and Newport.
        How does it happen? Here are five ways. First, the MSA did
    not place any restrictions on advertising in print media such
    as magazines. In fact, cigarette advertising in youth-oriented
    magazines actually increased in the 2 years after the MSA.
        Second, the MSA did not limit or restrict in-store tobacco
    advertising, knowing that 75 percent of teens visit a
    convenience store at least once a week. The cigarette companies
    increased their advertising and promotion in and around these
    stores.
        Third, while the MSA banned large billboards, it permitted
    outdoor signs up to 14 square feet in size, even if it is
    placed right next to schools or playgrounds.
        Fourth, the MSA lacks a quick and effective mechanism for
    identifying violations and compelling industry compliance.
        Finally and most importantly, the MSA did not establish an
    enforceable system and comprehensive set of rules to restrict
    or eliminate all the major tobacco advertising and marketing
    tools that have the greatest influence on our children.
        Because the tobacco companies remain unregulated and
    unchecked, they have circumvented the limited other tightened
    restrictions placed on them by the 1998 MSA and continue to
    target children.
        Two recent examples include Brown and Williamson's Kool
    Mixx campaign and RJ Reynolds candy-flavored cigarettes. The
    Kool Mixx campaign focused its marketing images around music
    and hip-hop, which is particularly appealing to African
    American and Latino youth. The campaign included 14 music
    concerts, a DJ competition and special themed packs of
    cigarettes. In 2004, RJ Reynolds introduced flavored cigarettes
    such as Twista Lime and Winter Mochamint, using colorful
    graphics and scratch and sniff marketing tactics in both cases.
        The State Attorney Generals asserted that tobacco companies
    had violated the MSA by targeting youth through their
    advertising and promotions.
        This legislation introduced by you, Mr. Chairman and
    Senator Cornyn, would provide FDA with the authority and
    resources to effectively regulate tobacco products. The FDA
    would be authorized to restrict tobacco advertising and
    promotions, especially those targeted at children as evidenced
    in the examples stated previously. In addition, it would
    require the tobacco companies to disclose the ingredients of
    tobacco products and smoke constituents, prohibit
    unsubstantiated health claims about so-called reduced risk
    products and require larger and more informative health
    warnings on tobacco products, among other measures.
        Last year, in a Department of Justice case against the
    tobacco companies, U.S. District Court Judge Gladys Kessler
    concluded, knowing that advertising and promotion has
    stimulated the demand for cigarettes, defendants use their
    knowledge of young people gained through tracking youth
    behavior and preferences in order to create marketing
    campaigns, including advertising, promotion and couponing that
    would appeal to youth in order to stimulate youth smoking
    initiation and to ensure that young smokers would select their
    brands.
        Just this year, RJ Reynolds introduced a new version of its
    common brand of cigarettes specifically designed to appeal to
    women and girls. These new packs are laced in hot pink and
    teal. Ads include the slogans such as Light and Luscious.
    Shockingly, the industry is targeting women and girls at a time
    when lung cancer is the No. 1 killer of women.
        Mr. Chairman, we think that these regulations in the bill
    introduced today are extremely important for the public health
    for the people and I would just say, with all due respect,
    Senator Burr, that the status quo only favors the tobacco
    industry. Thank you very much.
        [The prepared statement of Dr. Huerta follows:]
                Prepared Statement of Elmer Huerta, M.D., M.P.H.
        I am Dr. Elmer Huerta, incoming President of the American Cancer
    Society and Director of the Cancer Preventorium at the Washington
    Hospital Center. As a physician and researcher who specializes in
    cancer prevention and screening among the medically underserved, I see
    firsthand the toll tobacco takes on our country and the benefits of
    prevention in combating cancer. On behalf of the more than 28 million
    volunteers and supporters of the American Cancer Society and its sister
    advocacy organization the American Cancer Society Cancer Action
    Network, I thank you, Mr. Chairman, and your committee colleagues for
    inviting me to testify today regarding the need for providing the Food
    and Drug Administration with meaningful authority over tobacco products
    as is found in S. 625 introduced by you, Senator Kennedy, and Senator
    John Cornyn.
        As you know, the American Cancer Society is the nationwide,
    community-based voluntary health organization dedicated to eliminating
    cancer as a major health problem by preventing cancer, saving lives and
    diminishing suffering from cancer, through research, education,
    advocacy and service. In 2001, the Society created its sister
    organization, the American Cancer Society Cancer Action Network,
    referred to as ACS CAN, to more aggressively fight cancer through
    advocacy. Conquering cancer is as much a matter of public policy as
    scientific discovery, so building on the more than 90 years of
    excellence of the Society, ACS CAN serves as the lobbying arm and force
    necessary to push for legislative changes at the local, State and
    national levels.
        The Society and ACS CAN have established aggressive goals to reduce
    cancer incidence and mortality--goals that we are pursuing with the
    cooperation and collaboration of the public, private, and nonprofit
    sectors. We know from data and scientific evidence that one of the key
    steps to achieving an accelerated reduction in cancer incidence and
    mortality is tobacco control--especially when it comes to children--
    through meaningful regulation of tobacco products and effective
    cessation programs that will help those currently addicted to quit.
        The need for FDA regulation of tobacco is great. We're talking
    about an industry that sells and markets deadly products and does so
    without any accountability. In fact, tobacco products are the only
    consumable product not regulated by the FDA. This leaves consumers
    uninformed about tobacco products' ingredients and health dangers.
        The benefits of FDA regulation are clear. FDA regulation will help
    us to combat the vicious marketing practices of a deceptive industry
    that has preyed upon our children, minorities, and existing smokers who
    are desperately trying to kick their habit. FDA regulation will protect
    these groups, and in the process it will help reduce what can only be
    considered disturbing disparities in cancer rates and death rates.
    Stated simply, FDA regulation will save lives.
        We are at a huge disadvantage when it comes to combating the
    deceptive marketing practices and false health claims made by the
    tobacco industry. Mr. Chairman, over the years, the public health
    community and the public at large have worked hard at all levels of
    society to combat this Nation's deadly addiction. However, our efforts
    simply have not been strong enough. Voluntary guideline promises by
    industry have not worked and cannot be enforced. We all agree, Federal
    regulation of tobacco is absolutely necessary and now is the time for
    Congress to act.
        Under your leadership, we have come close several times to passing
    this crucial piece of legislation. In 1998, we took a small step closer
    to regulation of the tobacco companies with the Master Settlement
    Agreement. The Agreement set a promise from the tobacco industry to the
    States that marketing to children would cease. But it was just a
    promise. The restrictions on cigarette marketing to children outlined
    in the MSA do not sufficiently restrict the companies' marketing
    practices. Instead, the MSA has changed the companies' public relations
    strategies so that the deceptive practices aimed at creating a new
    generation of smokers continues. In an attempt to burnish their public
    image as ``good partners'' seriously working to implement the spirit of
    the MSA, they have even initiated ineffective and sometimes harmful
    youth anti-tobacco campaigns.
        Despite the MSA provision that the tobacco companies cannot ``take
    any action, directly or indirectly, to target youth in the advertising,
    promotion or marketing of tobacco products,'' tobacco companies'
    marketing and promotion continue to have a direct impact on children.
    There are five ways in which the MSA is not strong enough. First, the
    MSA did not place any restrictions on advertising in print media, such
    as magazines. In fact, cigarette advertising in youth-oriented
    magazines actually increased in the 2 years after the MSA. It took R.J.
    Reynolds to be found guilty of directly marketing to children in 2002
    before they decreased their magazine advertising that reached children.
    Second, the MSA did not limit or restrict in-store tobacco advertising.
    Knowing that 75 percent of teens visit a convenience store at least
    once a week, the cigarette companies increased their advertising and
    promotions in and around retail stores, such as convenience stores.
    Third, while the MSA banned large billboards, it permitted outdoor or
    outdoor-facing signs up to 14 square feet on the properties of
    businesses that sell tobacco products, even if those properties are
    right next to schools or playgrounds. Fourth, the MSA lacks a quick and
    effective mechanism for identifying violations and compelling industry
    compliance. And finally and most importantly, the MSA did not put into
    place an enforceable system and comprehensive set of rules to restrict
    or eliminate all the major tobacco advertising and marketing tools that
    have the greatest influence on our children.
        Because the tobacco companies remain unregulated and unchecked,
    they have been able to circumvent the limited advertising restrictions
    placed on them by the 1998 Master Settlement Agreement, continuing to
    target children and have even increased their marketing expenditures by
    125 percent since the MSA. Worse still, the tobacco industry is
    spending more than ever before to market its deadly products. In 2003,
    the most recent year data are available, the cigarette companies spent
    $15.1 billion, or more than $41 million a day, on marketing their
    products. Again and again, the tobacco companies have proven to us they
    will manipulate the system to encourage the uptake of smoking and keep
    current smokers from quitting by introducing new products and using
    creative marketing tactics, particularly aimed at children and other
    vulnerable populations. FDA regulation of tobacco is vital to control
    this rogue industry and to protect our most vulnerable members of
    society.
        This is an industry that cannot be trusted. Last year, in the
    Depart of Justice case against the tobacco companies, U.S. District
    Court Judge Gladys Kessler concluded:

              ``Knowing that advertising and promotion stimulated the
            demand for cigarettes, Defendants used their knowledge of young
            people, gained through tracking youth behavior and preferences,
            in order to create marketing campaigns (including advertising,
            promotion, and couponing) that would appeal to youth, in order
            to stimulate youth smoking initiation and to ensure that young
            smokers would select their brands.''

        The tobacco industry has demonstrated time and again that, if left
    to its own devices, it will falsely market its deadly products to our
    children, portraying this deadly addiction as glamorous and cool. In
    its March 2000 ruling, the U.S. Supreme Court found that tobacco use is
    ``one of the most troubling public health problems facing our Nation.''
    The industry continues to lure in new customers through its seductive
    advertising campaigns and price discounting, which has been proven to
    greatly affect the uptake of smoking by children.
        Researchers and the tobacco companies alike know how great a role
    marketing plays in children's uptake of tobacco use. Numerous studies
    have shown that children are three times more sensitive to tobacco
    advertising than adults. The most popular cigarettes among children are
    the most heavily advertised brands--Marlboro, Camel and Newport.
    Research tells us that children are more likely to be influenced to
    smoke by cigarette marketing than by peer pressure and one third of
    tobacco use experimentation by children is attributable to tobacco
    advertising and promotions. The tobacco companies know this and use
    this information to target children.
        The most recent effort by the tobacco industry to entice children
    into smoking has been the introduction of candy flavored cigarettes
    into the market in 2004. R.J. Reynolds introduced flavors such as
    Twista Lime and Winter MochaMint, using colorful graphics and ``scratch
    and sniff'' marketing tactics. In 2005, the States' Attorneys General
    asserted that R.J. Reynolds had violated the 1998 Master Settlement
    Agreement by targeting youth through its advertising and promotion of
    flavored cigarettes. As stated by Attorney General Eliot Spitzer,

              ``Selling candy, fruit and sweetened alcohol flavored
            cigarettes is downright irresponsible, given the appeal of
            these products to youth. This result reflects a recognition
            that the Attorneys General, together with the public health
            community, will not tolerate Reynolds' shameful ploys to
            introduce our children to smoking and to lure them into a
            lifetime of addiction to its deadly products.''

        This once again reminds us of the deceptive tactics the industry
    will continue to make to attract children to smoking and the desperate
    need for FDA regulation. It's a shameful reality, but it's just that--
    reality.
        The industry also specifically targets minority youth. Brown and
    Williamson introduced its own version of flavored cigarettes as part of
    its Kool Mixx campaign. The Kool Mixx campaign focused its marketing
    images around music and hip-hop, which is particularly appealing to
    African American and Latino youth. The Kool Mixx campaign included 14
    music concerts around the country and a DJ competition, as well as
    special-themed packs of cigarettes with cartoons displayed on them. In
    addition, Brown and Williamson placed advertisements in publications
    popular with Latino youth, including Latina and Cosmoplitan en Espanol.
    The slogans used in these ads included ``It's about old world class and
    new world style'' and ``It's about pursing your ambitions and staying
    connected to your roots,'' aimed at appealing to the aspirations of
    ethnic minorities. The States' Attorneys General found the industry in
    violation of the 1998 Master Settlement Agreement, by using the Kool
    Mixx campaign to target youth, proving once again that the tobacco
    industry is incapable of regulating itself.
        Brown and Williamson is not alone. Other tobacco companies have
    also specifically targeted minority populations. In 1999 and 2000,
    Philip Morris started a magazine ad campaign for Virginia Slims using
    the slogan ``Find Your Voice.'' The ads targeted women and girls,
    featuring Latinos and other ethnic women, suggesting that independence
    and allure could be found by smoking. As recent as 2 weeks ago, R.J.
    Reynolds introduced a new version of its Camel brand cigarettes,
    specifically designed to appeal to women and girls. The pack of
    cigarettes is laced in hot pink and teal and the ads include slogans
    such as ``light and luscious.'' Amazingly, the industry is increasing
    its attractiveness to women and girls at a time when lung cancer is the
    No. 1 cancer killer of women.
        FDA regulation presents our country with an historic opportunity to
    protect all Americans from tobacco addiction, especially our children.
    This legislation is a critical step toward reducing health care
    disparities, as tobacco-related cancers remain disproportionately high
    among lower-income and minority communities. Because these groups have
    been repeatedly targeted by the tobacco industry, they unfairly carry a
    greater weight of the health and economic burden tobacco has on our
    Nation. I know from my experience as a doctor that prevention is
    effective at improving the health and well-being of people, but that
    minority groups and low-income populations do not have the same access
    to health programs, such as cessation services, as others do. This once
    again gives the tobacco industry the unfair advantage. Tobacco use is
    the most preventable cause of death and disease in this country and
    granting the FDA authority over tobacco products is the key prevention
    measure that is missing in this Nation in order to reduce tobacco's
    deadly toll.
        Some minority and ethnic groups and the medically underserved
    suffer from a disproportionate burden of cancer and disease. Similarly,
    large differences in tobacco use exist in the United States. For
    example, currently, smoking prevalence is 37.5 percent among American
    Indian/Alaska Native men, 26.7 percent among African-American men, and
    24 percent among white men. This leads to marked differences in
    tobacco-related cancer deaths among different groups within the
    population. This year, it is expected that the rate of lung and
    bronchus cancer deaths for white males will be 73.8 per 100,000 while
    for African Americans it will be 98.4 per 100,000. Lung cancer death
    rates for women have increased by at least 150 percent in the last two
    decades alone and have yet to go down.
        We have made real progress on the cancer front. For the second
    straight year, we have seen a decrease in cancer deaths large enough to
    outpace the aging and growth of the U.S. population. These declines can
    be attributed in part to smoking cessation and other preventive
    efforts, such as earlier and better cancer screenings. Mortality rates
    from lung cancer in men decreased by about 1.9 percent per year from
    1991 and 2003. We have also seen a decrease in the incidence of lung
    cancer in men, from a high of 102 cases per 100,000 in 1984 to 78.5
    cases in 2003.
        Despite the significant gains we have seen in decreasing overall
    cancer incidence and mortality rates, approximately 1.4 million
    Americans still will be diagnosed with cancer this year and more than
    550,000 will lose their battle with the disease, costing more than $206
    billion in direct and indirect health care costs. While we are
    encouraged by the overall decreased mortality from cancer, we have to
    recognize that death rates from lung cancer in women have not yet
    declined.
        The health consequences from tobacco go beyond cancer and have an
    enormous health and economic impact on our Nation. Tobacco use is
    responsible for nearly one in five deaths in the United States--a
    needless and tragically preventable loss of more than 400,000 American
    lives each year. Tobacco kills more Americans than AIDS, drugs,
    alcohol, car accidents, homicides, suicides, and fires combined. More
    than 30 percent of all cancer deaths, 80 percent of chronic obstructive
    pulmonary disease deaths, 21 percent of coronary heart disease deaths
    and 18 percent of stroke deaths are attributable to smoking and tobacco
    use. And sadly, we are starting to see the progress we've made in
    reducing youth smoking initiation slip away. Overall, tobacco costs our
    Nation over $96 billion in direct health care costs annually, and an
    additional $97 billion in lost productivity.
        While we have made progress on some fronts of the fight against
    tobacco addiction, the enormous number of preventable deaths from
    tobacco tells us how important FDA regulation of these products is now.
    Deaths from tobacco can be prevented if our Nation seriously and
    comprehensively addresses tobacco and makes a long-term investment in a
    sustained campaign to prevent tobacco-related disease and death, which
    includes Federal legislation to regulate an industry that has evaded
    regulation for decades.
        This legislation introduced by you, Mr. Chairman, and Senator
    Cornyn would provide the FDA with the authority and resources to
    effectively regulate the manufacturing, marketing, labeling,
    distribution and sale of tobacco products. The FDA would then be
    authorized to restrict tobacco advertising and promotions, especially
    those targeted at children, including banning candy-flavored
    cigarettes. It would also require the tobacco companies to disclose the
    ingredients of tobacco products and smoke constituents. The FDA would
    have the authority to prohibit unsubstantiated health claims about so-
    called ``reduced risk'' products, and require larger and more
    informative health warnings on tobacco products, among other measures.
        The American Cancer Society and ACS CAN hope the introduction of
    your and Senator Cornyn's bill will encourage Congress to act now to
    grant the FDA authority to stop the tobacco industry's harmful and
    deceptive practices, before more children become addicted and more
    people die prematurely because of tobacco-caused disease. The Society
    and ACS CAN urge policymakers to take action to ensure that disparities
    in tobacco use and the associated adverse health outcomes are
    addressed. We have prioritized the reduction and elimination of the
    unequal burden of cancer as a top nationwide priority. As part of
    meeting this challenge, the Society is working at all levels of the
    organization to advance policies and programs that work to reduce
    health disparities among minority and ethnic populations and the
    underserved.
        Mr. Chairman, on behalf of the Society and ACS CAN's nationwide
    volunteers and staff, again thank you for your ongoing leadership on
    tobacco issues and for providing us this opportunity to discuss with
    you and your colleagues the importance of Federal regulation of tobacco
    products. The need for FDA authority over tobacco products has never
    been greater. The Nation's deadliest consumer product must not continue
    to be unregulated. Mr. Chairman and members of the committee, we look
    forward to working with you and your colleagues to address this issue.
    We stand ready to join with you to protect our children from tobacco
    use and to help those currently addicted to quit.

        The Chairman. Dr. Land, we want to welcome you and thank
    you very much for joining with us today and we know you've got
    an important message.

     STATEMENT OF RICHARD LAND, D.PHIL., PRESIDENT, THE ETHICS AND
         RELIGIOUS LIBERTY COMMISSION OF THE SOUTHERN BAPTIST
                       CONVENTION, NASHVILLE, TN

        Mr. Land. Thank you, Senator. Good morning, Mr. Chairman,
    Senator Enzi and members of the committee. I'm Richard Land,
    President of the Southern Baptist Convention's Ethics and
    Religious Liberty Commission. The Southern Baptist Convention
    is the Nation's largest Protestant denomination with more than
    16 million members worshiping in nearly 44,000 autonomous local
    congregations with a physical presence in 99 percent of the
    counties of the United States.
        The Ethics and Religious Liberty Commission is the official
    Southern Baptist entity charged by the Southern Baptist
    Convention to speak to our Nation's moral, cultural and
    religious liberty issues. I appreciate this opportunity to
    testify in favor of S. 625, The Family Smoking Prevention and
    Tobacco Control Act, life saving legislation to authorize the
    Food and Drug Administration to regulate tobacco products. We
    have made the enactment of this tobacco legislation one of our
    top legislative priorities for the 110th Congress. This is an
    idea whose time has come.
        Southern Baptists have strongly opposed the tobacco
    industry for a long time. We have a book containing all the
    resolutions passed by the Southern Baptist Convention in our
    offices in Nashville and Washington. I perused them before this
    testimony, Senator, and I found that--and these are just the
    resolutions that call for control, regulation, and restriction
    on the tobacco industry. There are about a dozen more that call
    upon Southern Baptist to refrain from the use of tobacco but
    the ones that actually call for action--2005, 1988, 1984, 1973,
    1969, 1964--strongly commending the Surgeon General's report,
    the first opportunity the Convention had to do so--1937, 1933,
    and 1932. Interestingly, the 1984 resolution called upon
    Southern Baptists who grew tobacco to switch to another crop if
    at all feasible, to minimize the availability of this product.
        I'm also here as a representative of a broad-based
    coalition of faith leaders known as Faith United Against
    Tobacco. Since it was founded in 2002, Faith United Against
    Tobacco has grown to include over 20 national faith
    denominations and organizations. In addition to the Ethics and
    Religious Liberty Commission of the Southern Baptist
    Convention, this coalition includes the General Board of Church
    and Society of the United Methodist Church, the National
    Council of Churches in Christ, the Presbyterian Church USA, the
    Commission on Social Action and Reform Judaism, the Seventh Day
    Adventists, the American Region of the World Seat Council and
    the Islamic Society of North America.
        Just yesterday, 24 national faith leaders from our
    coalition sent a letter to every member of the U.S. Senate and
    House of Representatives, urging support for the FDA
    legislation. As you can see, the signers of this letter
    represent very diverse groups, including Christian, Jewish,
    Muslim and Seek Faith Traditions, whose members include many
    tens of millions of Americans from every part of the country.
        We all know the terrible statistics about the toll of
    tobacco on our families. Over 400,000 Americans die every year
    from tobacco caused illnesses. Hundreds of thousands of others
    suffer every year from tobacco caused illnesses, such as lung
    cancer and heart disease.
        I have too many relatives, personally, particularly
    paternal uncles who have had their lives tragically shortened
    by their addiction to nicotine. Millions of Americans have had
    their lives snuffed out before their time, often in their
    prime, at the peak of their careers, with a spouse and children
    at home, with many other responsibilities and joys before them.
        The Southern Baptist Ethics and Religious Liberty
    Commission and the other faith groups in the coalition join
    America's public health community in viewing FDA regulation of
    tobacco as a critically needed tool to reduce tobacco use.
        This legislation would allow the FDA to prevent tobacco
    companies from adding ever more deadly and addictive
    ingredients, require larger and more informative health
    warnings, prohibit candy-flavored cigarettes, prevent tobacco
    sales to under-aged children and limit advertising and
    promotion of tobacco products that lure children into a deadly
    habit. Like many of you, we find it incredible that the FDA can
    ensure the safety of everyday items like cold medicines,
    cookies and even dog food but has no authority over tobacco, a
    product that causes more preventable deaths than any other.
        Faith leaders are not asking for a ban on tobacco products
    or even that they be treated differently than other items. We
    are simply asking that tobacco products be subject to the same
    commonsense rules that apply to other products. We want to
    level the playing field. Why should manufacturers of cessation
    products that help people quit smoking be subject to FDA
    regulation but not the products that kill over 400,000
    Americans every year? No one wants too much government
    regulation. What we are asking for is not overly burdensome. It
    would simply assure the protection of consumers, particularly
    our children. There is a broad consensus in the faith
    community, both conservative and liberal, that this product
    must be regulated and that is why we support this bill.
        We also support it for moral reasons. While each person
    bears responsibility whether he or she chooses to engage in
    tobacco use, responsibility also falls upon those in authority
    who have the power to end tobacco deception and significantly
    reduce the illness and the death that it can produce. My faith
    tradition teaches me that it is morally wrong to know the good
    that should be done and not do it. I also believe it is morally
    wrong to leave the most impressionable among us, our children,
    unprotected from the tobacco enticements that confront them. So
    I believe that those who are called to positions of leadership
    and power have a moral imperative to safeguard the men, women
    and children of our country from falling into the pitfalls of
    tobacco use.
        The members of the Faith United Against Tobacco Coalition
    believe the U.S. Congress must do a better job of protecting
    our children from tobacco addiction and the suffering of
    tobacco-caused illness and death. As political leaders, you
    have a moral obligation to act, to protect our children and
    families. You have the means to curb the cycle of allurement
    and addiction of disease and death caused by tobacco. We
    believe you owe to the families of America to do so.
        So we urge you to act quickly to enact this legislation, to
    provide the Food and Drug Administration authority to regulate
    tobacco products. I also have the copies of these resolutions
    that I'd like to have----
        The Chairman. They will be included as part of the record.
        Mr. Land. Thank you.
        [The prepared statement and resolutions submitted by Mr.
    Land follow:]
                  Prepared Statement of Richard Land, D.Phil.
        Good morning, Mr. Chairman, Senator Enzi, and members of the
    committee. I am Dr. Richard Land, President of the Southern Baptist
    Convention's Ethics & Religious Liberty Commission. As you are aware,
    the Southern Baptist Convention is the Nation's largest non-Catholic
    denomination, with more than 16 million members worshipping in nearly
    44,000 autonomous local congregations, with a presence in 99 percent of
    the counties of the United States. The Ethics & Religious Liberty
    Commission is the official Southern Baptist entity charged by the
    Southern Baptist Convention to speak to our Nation's moral, cultural,
    and religious liberty issues.
        I appreciate this opportunity to testify in favor of S. 625, the
    Family Smoking Prevention and Tobacco Control Act, life-saving
    legislation to authorize the Food and Drug Administration (FDA) to
    regulate tobacco products. We have made enactment of the tobacco
    legislation, introduced by Senators Kennedy and Cornyn and
    Representatives Waxman and Davis, one of our top legislative priorities
    for the 110th Congress. This is an idea whose time has come, and, on
    behalf of most Southern Baptists, I strongly urge you to take action
    now and enact this important legislation.
        I am also here as a representative of a broad-based coalition of
    faith leaders known as Faith United Against Tobacco. Since it was
    founded in 2002, Faith United Against Tobacco has grown to include over
    20 national faith denominations and organizations. In addition to the
    Ethics & Religious Liberty Commission of the Southern Baptist
    Convention, this coalition includes the General Board of Church and
    Society of the United Methodist Church, the National Council of
    Churches in Christ, the Presbyterian Church (USA), the Commission on
    Social Action of Reform Judaism, the Seventh-day Adventists, the
    American Region of the World Sikh Council, and the Islamic Society of
    North America. Other broad-based groups, such as Church Women United
    and the Health Ministries Association, which represents thousands of
    faith community nurses across the country, have also joined Faith
    United Against Tobacco.
        In addition to our national effort to convince Congress to enact
    the FDA regulation of tobacco legislation now before you, Faith United
    Against Tobacco has worked successfully across the country to enact
    tobacco control measures such as increased tobacco taxes, full funding
    of tobacco prevention programs, and smoke-free workplace legislation.
    In Indiana in 2005, for example, there was a very serious effort to
    dramatically cut funding for that State's landmark tobacco control
    program. A group of faith leaders, led by United Methodists, Southern
    Baptists, and faith community nurses, formed the Hoosier Faith and
    Health Coalition and took the lead in preventing these cuts from
    happening, which has saved many Hoosiers, particularly children, from
    tobacco addiction. Similar collaborations exist in other States,
    including Alabama, Kentucky, New Jersey, North Carolina, Ohio, and
    Texas. You can learn more about the history and accomplishments of
    Faith United Against Tobacco at www.faithunitedagainsttobacco.org.
        Our focus at the Federal level has always been on enacting
    legislation to give the FDA authority over tobacco products. Just
    yesterday, 24 national faith leaders from our coalition sent the
    attached letter to every Member of the U.S. Senate and House of
    Representatives, urging support for the FDA legislation. As you can
    see, the signers of this letter represent very diverse groups,
    including Christian, Jewish, Muslim, and Sikh faith denominations,
    whose members include many tens of millions of Americans from every
    part of the country. I think it is also important to note that the 24
    leaders who signed this letter are often on opposite sides of other
    very important social and political issues. But we are united in our
    desire to reduce smoking, especially among children, and in our
    commitment to the enactment of legislation authorizing the FDA to
    regulate tobacco products.
        We all know the terrible statistics about the toll of tobacco on
    our families--over 400,000 Americans die every year from tobacco-caused
    illnesses; hundreds of thousands of others suffer every year from
    tobacco-caused illnesses such as lung cancer and heart disease; and
    every day over 1,000 of our children become addicted to this deadly
    product. For us in the faith community, these statistics are especially
    tragic because every day we must bury mothers, fathers, sisters, and
    brothers who die early from preventable deaths caused by tobacco
    addiction that, more often than not, began at a young age. We, then,
    are left with the task of trying to comfort their grieving survivors. I
    speak this morning from personal experience. I have sought not only to
    bring comfort to families and individuals, but to find comfort for my
    own loss.
        I have too many relatives, particularly paternal uncles, who have
    had their lives tragically shortened by their addiction to nicotine.
    One uncle, who died in his late forties from lung disease, horribly
    exacerbated by smoking, still smoked even when reduced to carrying a
    portable oxygen supply with him wherever he went in his final months.
    He was literally a fire hazard to those around him. I am grateful that
    both my father and my mother, once heavy smokers, were able with much
    difficulty to break their tobacco habit in their late fifties. And
    thus, they are still with us at 84 and 82, respectively. If they had
    not quit smoking, they would both be long dead by now, a fact they
    readily acknowledge. They would have missed their five grandchildren's
    graduation from college, if not high school, and three of their
    grandchildren's weddings. Other children have not been as fortunate as
    I have been. They lost their parents prematurely to that ferocious
    killer, tobacco.
        Millions of Americans have had their lives snuffed out before their
    time, often in their prime--at the peak of their careers, with a spouse
    and children at home, and with many other responsibilities and joys
    before them. The families of America must not continue to be lured
    toward futures of incomplete chapters. Men and women deserve to know
    the toxic chemicals rolled into every cigarette. Young sons and
    daughters deserve to enjoy their youth without being confronted with
    tobacco marketing tailored to their age.
        Like the many Members of Congress from both parties and across the
    political spectrum who are cosponsoring this legislation, the Southern
    Baptist Ethics & Religious Liberty Commission and the other faith
    groups in the coalition join America's public health community in
    viewing FDA regulation of tobacco as a critically needed tool to reduce
    tobacco use. This legislation would allow the FDA to prevent tobacco
    companies from adding even more deadly and addictive ingredients;
    require larger and more informative health warnings; prohibit candy-
    flavored cigarettes; prevent tobacco sales to underage children; and
    limit advertising and promotion of tobacco products that lure children
    into a deadly habit. Like many of you, we find it incredible that the
    FDA can ensure the safety of everyday items like cold medicines,
    cookies, and even dog food, but has no authority over tobacco, a
    product that causes more preventable deaths than any other.
        Faith leaders are not asking for a ban on tobacco products or even
    that they be treated differently than other items. We are simply asking
    that tobacco products be subject to the same commonsense rules that
    apply to other products. We want to level the playing field. Why should
    manufacturers of cessation products that help people quit smoking be
    subject to FDA regulation but not the products that kill over 400,000
    Americans every year? No one wants too much government regulation. What
    we are asking for is not overly burdensome; it would simply assure the
    protection of consumers, particularly our children. There is broad
    consensus in the faith community, both conservative and liberal, that
    this product must be regulated, and that is why we support this bill.
        We also support this bill for moral reasons. My faith tradition
    informs me that our bodies are gifts from God and, therefore, should be
    treasured and treated with dignity. This means we should refrain from
    engaging in activities or abusing substances that pose grave threats to
    our health. Tobacco is one such substance. While each person bears
    responsibility for whether he or she chooses to engage in tobacco use,
    responsibility also falls upon those in authority, who have the power
    to end tobacco deception and significantly reduce the illness and death
    that it can produce. My faith tradition teaches me that it is morally
    wrong to know the good that should be done and not do it. I also
    believe that it is morally wrong to leave the most impressionable among
    us, our children, unprotected from the tobacco enticements that
    confront them. And so, I believe that those who are called to positions
    of leadership and power have a moral imperative to safeguard the men,
    women, and children of our country from falling into the pitfalls of
    tobacco abuse.
        I find it unconscionable that Congress, knowing the deadly effects
    of tobacco use, continues to leave tobacco companies virtually
    unchecked, left to use their own discretion to determine what
    carcinogenic chemicals to include in their products. I find it
    unconscionable that Congress, knowing that the overwhelming majority of
    adult smokers began their habit as minors, would do nothing more than
    call unfortunate the tobacco companies' marketing targeted at children.
        Almost 10 years ago, in 1998, Congress debated comprehensive
    tobacco control legislation but failed to enact anything. In 2004, the
    Senate overwhelming passed legislation virtually identical to S. 625,
    but it was killed in a conference committee. Throughout this time
    tobacco companies have continued to spend billions of dollars every
    year marketing their deadly products to children and, as a result, far
    too many high school students smoke and far too many people will die
    prematurely from tobacco-caused diseases.
        The Ethics & Religious Liberty Commission of the Southern Baptist
    Convention and all other members of Faith United Against Tobacco
    believe that the U.S. Congress must do a better job of protecting our
    children from tobacco addiction and the suffering of tobacco-caused
    illness and death. As political leaders, you have a moral obligation to
    act to protect our children and families. You have the means to curb
    the cycle of allurement and addiction, of disease and death, caused by
    tobacco. You owe it to the families of America to do so. We, therefore,
    urge you to act quickly to enact S. 625, bipartisan legislation to
    provide the Food and Drug Administration authority to regulate tobacco
    products.
        Mr. Chairman, Senator Enzi, and other members of the committee, I
    thank you for permitting me to testify this morning. I will be happy to
    entertain any questions.
                Resolution of Reducing Teen Smoking (June 2005)
        WHEREAS, Human beings are created in the image of God (Genesis
    1:26-27); and
        WHEREAS, Being created in the image of God endows humans with great
    dignity and inestimable worth; and
        WHEREAS, More than four hundred thousand Americans die every year
    from tobacco-caused diseases; and
        WHEREAS, Every day in our Nation, five thousand children under the
    age of eighteen, including adolescents of childbearing age, smoke their
    first cigarette; and
        WHEREAS, Every day in our Nation, two thousand children become
    regular daily smokers, one-third of whom will die prematurely as a
    result of tobacco-caused diseases; and
        WHEREAS, Approximately one out of five pregnant teenagers passes
    the risks of smoking on to her baby directly or through exposure to
    secondhand smoke; and
        WHEREAS, Preventing and reducing smoking and other tobacco use
    among teenagers and other children requires a strong commitment from a
    broad, diverse range of organizations and individuals concerned about
    our Nation's youth and public health; and
        WHEREAS, According to the American Cancer Society and other
    national health organizations, one of the most effective ways to reduce
    smoking and other tobacco use, particularly among adolescents, is to
    raise the price of cigarettes, smokeless tobacco, and other tobacco
    products through tax increases; now, therefore, be it
        RESOLVED, That the messengers to the Southern Baptist Convention
    meeting in Nashville, Tennessee, June 21-22, 2005, commit to add our
    efforts to those of such national organizations as the American Cancer
    Society, American Heart Association, Campaign for Tobacco-Free Kids,
    and the American Lung Association to work to reduce tobacco use,
    especially among teens; and be it further
        RESOLVED, That we encourage our churches to redouble their efforts
    to educate our youth about the dangers of tobacco use; and be it
    further
        RESOLVED, That we applaud those jurisdictions that have helped
    reduce teen smoking with substantial tax increases on tobacco products;
    and be it finally
        RESOLVED, That we commit ourselves to seek ways, through personal
    efforts and coalitions, to become more involved in our communities and
    States to prevent and reduce smoking and other tobacco use, especially
    among teens.
                                     ______

          Resolution on Exportation of Alcohol and Tobacco (June 1988)
        WHEREAS, The United States Government is actively pursuing export
    markets for alcohol and tobacco industries; and
        WHEREAS, The alcohol and tobacco industries are making profits at
    the expense of the health of those who consume their products; and
        WHEREAS, The United States Government is involved in the war
    against addictive drugs; and
        WHEREAS, Alcohol and tobacco are addictive.
        Be it RESOLVED, That we encourage the United States Government to
    cease to assist these industries via trade talks; and
        Be it finally RESOLVED, That Southern Baptists in their annual
    meeting, June 14-16, 1988, in San Antonio, Texas, declare their
    opposition to these hypocritical practices by the United States
    Government on behalf of the alcohol and tobacco industries.
                                     ______

                  Resolution on Cigarette Smoking (June 1984)
        WHEREAS, We as Christians know that our bodies are temples of the
    Holy Spirit, and that we should therefore refrain from defiling our
    bodies; and
        WHEREAS, The United States Government has for many years required
    that tobacco companies state in their advertising and on cigarette
    packages that smoking is hazardous to health; and
        WHEREAS, Cigarette smoking is habit forming and often becomes a
    physical addiction comparable to other drug addictions; and
        WHEREAS, The Surgeon General of the United States, C. Everett Koop,
    M.D., has described cigarette smoking as ``the most important health
    risk in the country''; and
        WHEREAS, Cigarette smoking is causally related to lung cancer and
    coronary heart disease, as well as other diseases, and is the leading
    cause of chronic bronchitis and emphysema; and
        WHEREAS, The Surgeon General's report blames chronic lung disease
    for more limitation of activity than any other type of disease, with
    more than 500,000 hospital admissions a year attributed to this
    disease; and
        WHEREAS, More than 62,000 Americans have died of chronic
    obstructive lung disease in 1983 with as many as ninety percent of
    these deaths blamed on cigarette smoking, and costs the Nation forty
    billion dollars a year in health expense and productivity; and
        WHEREAS, The Surgeon General's report stated that children of
    smoking parents have a higher prevalence of respiratory symptoms and
    more frequent bouts of bronchitis and pneumonia in early life; and
        WHEREAS, Mothers who smoke during their pregnancy have a higher
    incidence of congenitally deformed and low-birth weight babies.
        Therefore, be it RESOLVED, That the messengers of the Southern
    Baptist Convention meeting in Kansas City, Missouri, June 12-14, 1984,
    encourage churches to give people the facts regarding the physical harm
    involved in cigarette smoking, beginning with children of an early age;
    and
        Be it further RESOLVED, That we encourage schools to make
    information regarding the harm of cigarette smoking part of the
    curriculum for students of all ages; and
        Be it further RESOLVED, That we encourage parents by personal
    example to teach abstinence from cigarette smoking; and
        Be it further RESOLVED, That our churches, associations, State
    conventions, and the Southern Baptist Convention take leadership in
    encouraging our people, pastors, and SBC leaders to refrain from using
    tobacco in any form, including cigarettes; and
        Be it further RESOLVED, That we encourage Southern Baptists
    presently engaged in the growing of tobacco, which has no use except
    for cigarettes and related products, to cease such agriculture and,
    where feasible, to switch to another cash crop in order to make such
    products less accessible; and
        Be it finally RESOLVED, That we encourage the Congress and Senate
    to terminate all agricultural funding and subsidies to those who plant,
    grow, or sell any tobacco products.
                                     ______

               Resolution on Alcohol and Other Drugs (June 1973)
        WHEREAS, The drug problem a complex and intricately interrelated
    phenomenon in our society, now including a widespread misuse of
    valuable prescription products, a broad spectrum of unscientific self-
    medication, a deeply implanted custom of cigarette smoking, deeply
    entrenched customs of drinking alcohol beverages, and an alarmingly
    developing culture involving marijuana and other illegal drugs, and
        WHEREAS, This pervasive drug orientation of our culture is
    resulting in widespread social disruption and destruction of life by
    cancer, emphysema, coronary heart disease, accidents, alcoholism and
    other drug addiction, and is a factor in other serious social problems
    such as crime, family disruption, industrial waste, and automobile
    accidents, and
        WHEREAS, Basic factors now recognized as perpetuating the drug
    approach to life are commerical promotion of alcohol, tobacco, and
    over-the-counter drugs; glamorization of the use of alcohol and
    tobacco; social pressures for smoking, drinking, and other drug usage;
    and widespread ignorance of accurate information pertinent to personal
    usage of these drugs, and
        WHEREAS, Contemporary efforts of government, church, civic groups,
    and other independent agencies are failing to cope effectively with the
    drug orientation of our culture.
        Therefore, be it RESOLVED, that we encourage the Congress--also
    such agencies as Food and Drug Administration; Department of Health,
    Education, and Welfare; Department of Environmental Control; Federal
    Communications Commission; Office of Consumer Affairs; Federal Trade
    Commission; Office of the Attorney General; and the Office of the
    President--to take action to control advertising of alcohol, tobacco,
    and other addictive drugs which perpetuate the drug orientation of the
    culture, and
        Be it further RESOLVED, that we call for the broadcast possible
    offensive to be mounted to restrain commercial promotion of all such
    products, and
        Be it further RESOLVED, that we pledge our cooperation with others
    to neutralize social pressures and minimize glamorization of drug
    usage, and
        Be it further RESOLVED, that preventive education in the homes, the
    churches, and the schools be strongly encouraged, and
        Be it further RESOLVED, that the Christian Life Commission be
    encouraged to work diligently with appropriate agencies of the Southern
    Baptist Convention to publicize this position and to encourage
    cooperation with others seeking these same objectives.
                                     ______

          Resolution on Cigarette and Liquor Advertisement (June 1969)
        WHEREAS, There is pending legislation in the National Congress
    dealing with the regulation and possible deletion of cigarette and
    liquor advertisement from the mass media,
        Therefore, be it RESOLVED, That we give encouragement and support
    to all Congressmen who are backing this legislation.
                                     ______

       Resolution on a Request of President Lyndon B. Johnson (June 1964)
        WHEREAS, The Surgeon General's Committee appointed by President
    Kennedy rendered our Nation a much-needed service in pointing out the
    hazards of cigarette smoking, which report can have far-reaching
    benefits to human health and well-being,
        WHEREAS, The serious problem of beverage alcohol also deserves the
    same careful medical and scientific investigation,
        We go on record as a Convention as requesting President Johnson to
    appoint a similar commission to investigate and to make known to our
    American people the hazards to personal health and to society presented
    by the use of alcohol as a beverage.
                                     ______

      Amendment to Report by the Social Service Committee (adopted) (May
                                     1937)
        ``It is the sense of this Convention that the prevalence of smoking
    among Christian people, especially among preachers, church leaders and
    denominational workers, is not only detrimental to the health of those
    who participate, but is hurtful to the cause of Christ in that it
    weakens the message and lowers the influence of those who are charged
    with the preservation and spread of the Gospel.''
                                     ______

                        Resolution on Tobacco (May 1933)
        J. M. Shelburne offered the following amendment and it was adopted:
        RESOLVED, That we respectfully suggest to the ministers of our
    churches and to the teachers in the schools of our land, and to the
    fathers and mothers of our boys and girls, that they consider the
    probable ultimate effect of the growing and excessive use of tobacco by
    our boys and girls, with a view to arriving at some kind of cooperative
    measures by which at least some of our young people may hope to escape
    the experience of an habitual slavery to tobacco.
                                     ______

       Social Service Committee Recommendation Concerning Race Relations
                              (adopted) (May 1932)
        10. That we respectfully suggest to the ministers of our churches
    and to the teachers in the schools of our land that they consider the
    probable ultimate effect of the growing and excessive use of tobacco by
    our boys and girls with a view to arriving at some kind of cooperative
    measure by which some of our young people, at least, may hope to escape
    the experience of an habitual slavery to tobacco.

        The Chairman. Thank you very much.
        Senator Hatch. Mr. Chairman, could I just take 1 minute
    because I have to----
        The Chairman. OK.
        Senator Hatch.

                       Opening Statement of Senator Hatch

        Senator Hatch. I'm very interested in what all of you have
    to say and I will read all of the record. I'm really
    appreciative of the Chairman and what he is trying to do here.
        On the other hand, I'm worried sick about burdening FDA
    with more responsibilities with maybe not enough finances to
    take care of it. So I just want to express my concern because I
    have a tremendous interest in everything you're talking about
    regarding this matter. I have a tremendous interest in FDA. I'm
    just really worried about it and I want to work with other
    members of this committee to try and resolve these problems and
    get them resolved in a way that is equitable for all but will
    help to advance the cause of healthcare in our society. I just
    appreciate your letting me say that, Mr. Chairman, because I'm
    concerned about it and I appreciate the efforts that all of you
    have made and I feel guilty that I have to leave. But I just
    wanted to make that as clear as I could under the
    circumstances. Thank you, Mr. Chairman.
        The Chairman. Senator Hatch has had a long career ensuring
    that we're going to have an FDA that is going to meet its
    responsibilities in terms of oversight. This has been something
    that he has been very much involved in. So we appreciate his
    comments and involvement.
        I'll introduce now the remainder of the panel. Dr. Jack
    Henningfield is Adjunct Professor of Behavioral Biology in the
    Department of Psychiatry at the Johns Hopkins University School
    of Medicine. He is also Vice President for Research and Health
    Policy at Pinney and Associates. He is the former head of the
    laboratory of the National Institute of Drug Abuse, where he
    evaluated the addictive potential of drugs, including cocaine,
    sedatives, nicotine in various forms. He was assigned to be
    editor of the 1988 Addiction Report of the Surgeon General,
    advised the FDA on its tobacco regulations in the 1990s, and
    advised the World Health Organization on issues related to
    tobacco control.
        Greg Connolly, is an old friend from Massachusetts, now a
    Professor at Harvard School of Public Health who teaches and
    conducts research in tobacco control policies and projects. He
    has published over 70 scientific articles on smoking and health
    issues. He is the former Director of the Massachusetts
    Department of Public Health's Tobacco Control Program, one of
    the largest campaigns to curb tobacco use in the world. Over
    the 10 years that he directed the program, cigarette
    consumption fell 50 percent in Massachusetts, three times the
    national average. That is an impressive record. I don't think
    there is a State in the country that used the money from the
    Master Tobacco settlement more effectively, during this period
    to combat tobacco use, and Gregory Connolly was the head of
    that program. Under our recent governors, the money was cut out
    for that program, which is very unfortunate.
        Dr. Alan Blum is Professor and Endowed Chair in Family
    Medicine, University of Alabama. He directed the Center for the
    Study of Tobacco and Society. From 1977 to 2002, he led the
    Doctor's Ought to Care. He has written over 100 articles on
    tobacco problems. In recognition of his efforts to prevent
    smoking, Dr. Blum has received the first Surgeon General's
    Medallion from Dr. Koop, and the first public health award by
    the American Academy of Family Physicians. We very much
    appreciate your presence.
        And Ms. Lisa Shames is currently GAO Acting Director for
    Food and Agricultural Issues. Her portfolio covers issues of
    food safety, agro-terrorism, agricultural conservation and farm
    program payments.
        Let's start with Dr. Henningfield.

       STATEMENT OF JACK E. HENNINGFIELD, PH.D., VICE PRESIDENT,
     RESEARCH AND HEALTH POLICY, PINNEY AND ASSOCIATES, BETHESDA,
       MD, AND PROFESSOR OF BEHAVIORAL BIOLOGY AT JOHNS HOPKINS
              UNIVERSITY SCHOOL OF MEDICINE, BALTIMORE, MD

        Mr. Henningfield. Mr. Chairman, members of the committee,
    thank you for the opportunity to testify and to serve. I have
    studied drug addiction and health for three decades at Johns
    Hopkins Medical School, the National Institute on Drug Abuse
    and through my consulting at Pinney Associates to
    GlaxoSmithKline on smoking cessation medications.
        Many people think of tobacco products as relatively simple
    concoctions of tobacco and flavorings that people smoke for
    simply pleasure and with full awareness of the dangers and that
    smoking is a completely free choice. Nothing could be further
    from the truth.
        Tobacco products are sophisticated drug delivery systems.
    They are engineered and manufactured to increase addiction risk
    and without any meaningful regulatory oversight to draw the
    line on practices that unnecessarily increase harmful and
    addictive effects.
        FDA authority could lead to less addictive and less harmful
    products and regulation of marketing could reduce deception.
    Existing and future products need to be regulated. Existing
    products are used by more than 50 million Americans a year,
    killing more than 1,000 every single day. Setting standards for
    chemicals that can heighten addictiveness, such as ammonia and
    acetaldehyde and flavorings, such as menthol and chocolate
    could be steps toward less addictive and less attractive
    tobacco products.
        Developing performance standards for toxicants such as
    pesticide residues, tobacco specific nitrosamines, carbon
    monoxide and formaldehyde could reduce toxic exposure in those
    who continue to use tobacco. Regulation is needed to prevent
    deceptive designs that are killing Americans.
        Today, more than two-thirds of cigarette smokers smoke
    light cigarettes. My sister was one of them. As she told me,
    you can tell Marlboro Reds are worse. They felt stronger and
    left my throat raw compared to lights.
        Well, let me tell you a few things she didn't know. She
    assumed there were government standards for light cigarettes.
    She assumed that the FTC test method for tar and nicotine
    reflected health effects or at least actual intake, as is the
    case for food labeling. She assumed that cooler, smoother smoke
    meant it was weaker and less harmful. She couldn't believe the
    Government would allow such a scam.
        Cigarette ventilation is one deadly scam you can see for
    yourself. If you tear the paper from just about any cigarette
    filter and especially a light cigarette and if your cameras are
    looking for what I'm going to show you, they won't be able to
    see them. You have to look close. You tear the paper off, hold
    it up to the light, you can see tiny bands of holes. These
    holes allow air to come into the smoking machine and fool the
    machine into thinking the smoke is much weaker than it is. They
    do the same thing for the smoker. What the smoker does is
    inhale more deeply and more smoke and more deeply into the
    lungs. The holes are right where they can be easily covered by
    fingers or lips.
        Unbeknownst to most smokers, covering some of the holes can
    double or triple the amount of tar and nicotine. I did this
    demonstration a few years ago for my son's third grade class.
    They reacted with passion and clarity. They said, ``that's
    cheating.'' They can't do that. The third graders got it.
        Well, Senators, that is cheating and there is a means of
    preventing and stopping such deception for food products but
    not for tobacco, not until tobacco is regulated by the FDA.
        But light cigarettes are just the tip of the iceberg. New
    generations of products appear to be following the commercially
    effective model of light cigarettes, which is to develop highly
    addictive products with designs and marketing efforts that
    assuage fears about tobacco so as to hook more people and keep
    them using tobacco. These products will need their own
    standards. They will need their own standards so that their
    potential effects are understood before they are marketed,
    before they are allowed on the market and to make sure that
    marketing does not inappropriately promote use, including does
    not inappropriately use FDA's regulation to promote use.
        FDA is the right agency and the only agency with
    appropriate experience to develop and enforce product
    performance standards. I have heard the entire range of
    arguments about why FDA should not be granted regulatory
    authority, including that FDA was not designed to evaluate
    cigarettes or inherently dangerous products. The fact is, FDA
    was designed to assess a few ingredients and toxic exposures
    for a broad range of products. Furthermore, tobacco products
    are drug delivery systems at heart. Even the tobacco industry
    documents admit this. Moreover, tobacco products are designed
    and marketed to deceive and heighten addiction risk.
        Finally, let me emphasize that FDA's authority will not
    make tobacco products safe, will not make them nonaddictive and
    should not been seen as a substitute for comprehensive tobacco
    control efforts to reduce all forms of tobacco use and disease.
    This is not an either/or situation. In fact, FDA regulation
    should be viewed as a partner to tobacco control, finally
    bringing FDA, the most powerful health regulatory agency in the
    world, to the table alongside tobacco control professionals to
    position and be positioned to serve these efforts because it
    will restrict the ability of the industry to modify products
    and use descriptors that undermine prevention and cessation.
        I therefore urge expeditious passage and implementation of
    the bill. Thank you for the opportunity.
        [The prepared statement of Mr. Henningfield follows:]
               Prepared Statement of Jack E. Henningfield, Ph.D.
        Thank you for the opportunity to testify on S. 625, the Family
    Smoking Prevention and Tobacco Control Act, that would provide ``the
    Food and Drug Administration with effective authority to regulate
    tobacco products.'' FDA regulation is not only the right thing to do,
    it is urgent. More than 4 million Americans have died prematurely since
    FDA asserted jurisdiction and issued its Final Rule to regulate
    cigarettes and smokeless tobacco in 1996. Although we have made modest
    progress in reducing tobacco use, I believe FDA regulation would have
    made the progress significantly greater. Furthermore, the tobacco
    industry is unleashing new products, new claims, and clandestinely
    modifying conventional products at a terrifying rate, with no
    plausibly-effective regulatory mechanism in sight, except for the
    approach embodied in the Senate bill. Even the FTC has thrown in the
    towel and apparently given up on its own widely criticized and deeply
    flawed method of cigarette testing.
                              basis for testimony
        I am speaking on my own behalf and not as a representative of the
    organizations, of which I am a member, consult for, or voluntarily
    serve. I am an Adjunct Professor of Behavioral Biology (Adjunct),
    Department of Psychiatry, The Johns Hopkins University School of
    Medicine; and Vice President for Research and Health Policy, Pinney
    Associates. I was trained in behavioral science, pharmacology, and
    other disciplines relevant to understanding addictive substances. I
    have focused on tobacco-related issues for nearly three decades. From
    1980 to 1996, I conducted and led tobacco and other drug research at
    the National Institute on Drug Abuse (NIDA). While at NIDA, I was
    liaison frequently to the FDA on tobacco products and tobacco addiction
    treatment. I contributed to numerous Surgeon General's reports as well
    as reports by other agencies. I presently serve on the World Health
    Organization (WHO) Tobacco Regulation Study Group (TobReg) which
    provides scientific guidance for implementation of several articles of
    the international tobacco treaty, the WHO Framework Convention on
    Tobacco Control (FCTC); a treaty (signed by not yet ratified by the
    United States) which includes many directives in harmony with the
    proposed FDA tobacco regulation.
        By further way of disclosure and to provide you with some basis for
    my perspective, let me tell you that part of my role at Pinney
    Associates is to advise companies on how to minimize the risk of abuse,
    addiction, misuse and harmful effects of drugs with a known or
    suspected potential to cause addiction, including opioid analgesics,
    stimulants, sedatives, and many others. In many cases it is not only
    the chemical entity itself but the formulation and marketing of the
    drug that poses the challenge for risk minimization. This work includes
    advising GlaxoSmithKline Consumer Healthcare on its treatments to help
    people quit smoking. I also share two patents on a tobacco dependence
    treatment product under development which has given me additional
    perspectives on FDA regulation. On the tobacco side, I have reviewed
    thousands of pages of previously secret document and testified on
    behalf of the U.S. Department of Justice (DOJ) and other plaintiffs
    against the tobacco industry concerning the many ways by which this
    industry has been able to manipulate its products to heighten their
    addiction risk under the cover of darkness left by the regulatory
    vacuum. I have gained first hand experience in understanding the
    challenges and benefits of FDA regulation of the tobacco industry and
    its products through these activities.
     tobacco products are sophisticated drug delivery systems--engineered
       and manufactured to increase their potential to cause and sustain
                                   addiction
        Tobacco products are diverse and all are harmful and share the
    common feature of being designed to cause and sustain addiction to
    nicotine. The World Health Organization said in its 2006 World No
    Tobacco Day report, an effort to which I contributed: all tobacco
    products are deadly and addictive in any form or disguise. Products
    vary widely in their form and degree of sophistication in engineering.
    The most elaborately designed and manufactured product, the cigarette,
    accounts for the vast majority of the more than 1,000 tobacco-
    attributable deaths that occur every day in the United States.
        For most consumer products, extensive research and design expertise
    by manufacturers is often used to improve safety and reduce risk.
    However, this is not true for cigarettes: much of the research and
    engineering has been dedicated to increasing their risk of causing and
    sustaining addiction and high levels of use. In fact, many features are
    intended to make it easier to inhale the deadly poisons deep into the
    lungs where the damage is greatest. Why? Because this increases the
    addictive impact of nicotine by producing explosively fast absorption
    in the massive alveoli bed of the lung. This undoubtedly helps explain
    why lung cancer risk increased in the 1980s and 1990s even though
    machine measured tar levels declined. It also may help to explain the
    increasing proportion of the especially deadly deep airway small cell
    adenocarcinomas relative to squaemous cell lung cancer in the recent
    decade.
        Cigarette design and manufacture is extensively researched and
    engineered to control features that contribute to deceiving smokers
    into thinking they are getting less harmful exposures, to make it
    easier to take up smoking, and to cause and sustain addiction. Much of
    this was summarized in the FDA's Final Tobacco Rule (1996) and more
    recently in the 1,700-page findings by Judge Kessler in her ruling in
    the U.S. Department of Justice litigation against the tobacco industry.
    She wrote:

              ``Every aspect of a cigarette is precisely tailored to ensure
            that a cigarette smoker can pick up virtually any cigarette on
            the market and obtain an addictive dose of nicotine.''
            (Paragraph 1368).

    Further, Judge Kessler concluded:

              ``Defendants have designed their cigarettes to precisely
            control nicotine delivery levels and provide doses of nicotine
            sufficient to create and sustain addiction.'' (Paragraph 1366).

        The remarkable range of features includes control over the
    following aspects of cigarette design, delivery, and addictive impact.
    Ignition propensity and burn rate are controlled with burn accelerants
    and paper porosity to help control nicotine dosing and make cigarettes
    convenient to use. Smoke particle size is engineered to facilitate
    efficient inhalation of smoke deep into the lung. Smoke temperature and
    harshness are controlled to make it easier to take up smoking, to
    inhale deeply and provide smoother smoke that fools the smoker into
    assuming it's not as harmful. Smoke and ash color are controlled with
    chemicals in the tobacco and paper to make the process as neat and
    attractive-appearing as possible. Ingredients are further added to
    smooth, flavor and make the smoke more attractive to target
    populations, even if they yield additional carcinogens to the smoke
    (such as burned chocolate does). Still other chemicals are added that
    prolong shelf life and control humidity, which, in turn, helps control
    nicotine dosing and smoke sensations. The inclusion of some of these
    ingredients on FDA's Generally Recognized as Safe (GRAS) list is
    virtually meaningless when they are used in cigarettes. These
    ingredients have not been tested and approved for use in burned
    products. They are ``GRAS'' for use in food, not for inhalation in
    combination with burned tobacco material. Certain agricultural
    practices, storage, shipping and handling add still other questionably-
    safe chemicals, such as herbicides, pesticides, fertilizer residues,
    heavy metals, cyanide, arsenic, and insect parts. The fact that many
    American tobacco growers maintain high standards does not obviate the
    need for regulation of the substances in tobacco plant material,
    particularly since so much tobacco is imported.
        A number of chemicals used in manufacturing process further alter
    the addictiveness of the product through manipulation of the chemical
    form of nicotine (e.g., ratio of free-base or unionized nicotine to
    ionized nicotine). These compounds increase the amount of free base
    nicotine, probably increasing the addictiveness of cigarettes because
    free-base nicotine is more readily released from the cigarette and
    absorbed in the mouth. For example, ammonia compounds can alter the
    free base fraction of the smoke while also making it easier to inhale.
    The practice of manipulating the free base fraction of nicotine is not
    unique to cigarettes: smokeless tobacco products marketed as
    ``starter'' products (an industry term) are mildly alkaline to yield a
    smaller proportion of free base nicotine than the more alkaline
    maintenance products such as Copenhagen. Why? Too much nicotine
    delivered too rapidly to the novice user can cause acute nausea and
    discourage further use. By contrast, highly tolerant smokeless users
    who have ``graduated'' (another industry term) to higher levels of
    daily use seek stronger and faster doses to satisfy their addictions.
        Cigarette filter technology is also extremely sophisticated and
    reduces certain throat burning sensations but not necessarily the
    deadliest of the toxicants. Filters can help ensure that nicotine is
    readily delivered in a form that can be easily inhaled deep into the
    lung where addiction potential is maximized, and lung disease risk is
    increased by the inhalation of smoke particles that carry nicotine
    molecules into the lung. Filters also commonly include elaborate
    ventilation systems (described in greater detail below), which can
    increase the free-base fraction of nicotine and enable smokers to
    obtain addictive levels of nicotine regardless of its advertised yield.
        It is time to rein in the addictiveness and harmfulness of tobacco
    products by giving FDA the authority to enact performance standards to
    regulate and restrict levels of ingredients (added or residual) that
    are toxic, and to reduce the ability of the industry to maximize the
    addictive potential of their products.
    it is vital to give fda the authority to regulate tobacco products and
     develop product performance standards as will be accomplished through
                               senate bill s. 625
        FDA could develop performance standards that, over time, could lead
    to less addictive and less harmful products. One key feature of the
    legislation is that mere compliance with a performance standard cannot
    be used as the basis for product claims. This will help ensure that
    communications about the dangers are not weakened. After all, the
    products will still remain highly toxic and addictive by any ordinary
    standards and communications should not be used to imply anything
    contrary to these facts.
        Performance standards can and should be developed for all smoke
    constituents including those that affect addictiveness and
    attractiveness as ammonia compounds, acetaldehyde, menthol, flavorings,
    as well as substances emitted in the normal course of use of the
    products, such as carbon monoxide gas and carcinogens. In addition,
    performance standards could cover substances that may not have been
    intended for the final product but are residual from tobacco growing,
    storage and processing, such as pesticide and herbicide residues, as
    well as contaminants including heavy metal residues, cyanide, insect
    parts and other materials. Performance standards can also be developed
    for product emissions commonly known as tar but which include deadly
    carcinogens such as tobacco specific nitrosamines, and formaldehyde.
        Nicotine content and dosing need to be regulated. Nicotine is
    regulated in medicines and it must be regulated in tobacco products
    where content and delivery are often much higher than is allowable in
    medicines. For example a typical ``pinch'' of some of the most popular
    snuff products contains 10-20 mg nicotine compared to 4 mg in the
    highest dose of nicotine gum or lozenge.
        Tobacco delivered nicotine, particularly from cigarettes, is
    particularly addictive because of the various ingredients and design
    features that function to increase the addictiveness of the products.
    For example, the level of free-base nicotine allowed in cigarette smoke
    needs to be examined and considered for performance standard
    development. Other ingredients that appear to synergistically increase
    the addictiveness of the product such as acetaldehyde need to be
    examined from this perspective in performance standard development.
        Perhaps most controversial is whether performance standards should
    be developed with the intent of phasing nicotine out of cigarettes. I
    have published papers on the potential benefits (e.g., making tobacco
    products less addictive) and obstacles (e.g., precipitating increased
    use, mass withdrawal, and inadequate treatment infrastructure for
    tobacco dependence) for such an effort. However, I am in agreement with
    the World Health Organization, that at present it would be premature to
    attempt to drastically alter levels through regulation. The bill will
    give FDA the flexibility and authority to develop the additional
    science, as necessary, to set performance standards for nicotine
    content and delivery.
        Regulatory flexibility to address emerging science and evolving
    products is part of FDA's strength that will be enabled by the Senate
    bill. If we think of tobacco products as analogous to deadly globally
    spread viruses, then we must also think of them as constantly evolving,
    requiring vigilant oversight and the sort of authority to regulate that
    FDA exerts over foods and drugs. This means that performance standard
    setting and evaluation will be a continuous process as long as tobacco
    products are marketed. This is also important because we need to assume
    that in any science-based regulatory process, new science will emerge
    that requires an agency like FDA to reconsider and, if needed, modify
    previously issued regulations. By contrast, as described below, the
    light cigarette fraud emerged and persisted over several decades and
    was not even irrefutably unmasked until the 2001 publication of
    National Cancer Institute Monograph 13. But yet the fraud continues
    unabated in the regulatory vacuum!
      product misrepresentation, health and harm reduction related claims
                              need to be regulated
        With the recognition by the Surgeon General in 1964, that cancer
    risk was related to overall tobacco exposure, cigarette smokers were
    encouraged to quit. Those who did not quit were encouraged to reduce
    their exposure. The focus was on ``tar'' because this conglomerate
    smoke condensate contained many substances that separately and together
    were clearly implicated in cancer and lung disease. This gave birth to
    the Federal Trade Commission's method for tar and nicotine assessment
    and communications. Nicotine was included in part because of its
    presumed role (probably over estimated at the time) in heart disease.
    The intentions of the FTC were good but it is not a science and health
    agency, and it adopted a method that was well understood and easily
    defeated by the tobacco industry. Armed with a flawed method and little
    expertise in understanding drug delivery systems, assessing drug
    delivery, or monitoring and evaluating health effects, the FTC was no
    match for the tobacco industry. The industry co-opted the FTC's ratings
    of tar and nicotine as marketing tools to reduce smokers concerns about
    smoking. By designing cigarettes that generated lower tar and nicotine
    ratings, labeling those below certain levels ``light'' and ``reduced
    tar and nicotine'' the industry had a powerful force to prevent or at
    least delay life-saving smoking cessation by many people.
        After reviewing evidence and listening to various experts, Judge
    Kessler, in the Findings from the DOJ trial concluded as follows:

              ``They [tobacco company defendants] also knew that the [FTC]
            Method was totally unreliable for measuring actual nicotine and
            tar any real life smoker would absorb'' (Paragraph 2627).

        Further,

              ``By engaging in this deception, Defendants dramatically
            increased their sales of low tar/light cigarettes, assuaging
            fears of smokers about the health risks of smoking . . . ''
            (Paragraph 2629).
     the light cigarette fraud continues: regulation is needed to prevent
                  deceptive designs that are killing americans
        Today, more than two thirds of cigarette smokers smoke light
    cigarettes. My sister was one of them. As she told me: ``You can tell
    Reds (Marlboro Regular Cigarettes) are worse: they felt stronger and
    left my throat raw compared to Lights.'' Let me tell you a few things
    she didn't know and that angered her when she found out. She assumed
    that there were government standards for light cigarettes and that the
    FTC testing method intended to measure tar and nicotine yield reflected
    health effects or at least actual intake as is the case for food
    labeling. She assumed that cooler, smoother smoke meant that it was
    weaker and less harmful. She had no idea that a hidden ventilation
    system was diluting the poisons for smoking ventilation by allowing
    fresh air to be ``inhaled'' by smoking machines, whereas she and other
    smokers were probably taking in two to three times as much tar and
    nicotine than indicated by the ratings. She couldn't believe ``the
    government'' would allow such a scam.
        Since the light and low-tar scam began with a vengeance in the late
    1960s America has lost tens of millions of its citizens prematurely as
    they smoked light cigarettes to their graves, all the time not knowing
    that tobacco industry marketing of ``light'' and ``low'' cigarettes was
    completely misleading and that these products were not any less harmful
    than other cigarettes. In 2001, the National Cancer Institute in
    Monograph 13 finally concluded definitively: ``Epidemiological and
    other scientific evidence . . . does not indicate a benefit to public
    health from changes in cigarette design and manufacturing over the past
    50 years.''
      how did it happen? what can we learn? looking into lights--through
                                  their holes
        Most aspects of cigarette design that contribute to harm and
    addiction require sophisticated equipment and procedures to detect,
    such as CDC's approach to measuring free-base nicotine. However,
    cigarette ventilation is one deadly scam you can see for yourself. If
    you tear the filter paper from a cigarette filter and hold it up to the
    light, you can see bands of tiny vent holes about \3/8\ to \1/2\ inch
    out from the filter end. This is right where they can be easily covered
    with lips or fingers. Unbeknownst to most cigarette smokers, blocking
    of the holes with lips or fingers can easily double or triple delivered
    tar and nicotine. On most cigarettes they are difficult to see because
    the designs are intended to hide them. When the cigarettes are smoked
    according to the FTC method, the holes leak anywhere from about 20-90
    percent air into the testing apparatus, thereby contributing to the
    deceptively low advertised rating. I did this demonstration a few years
    ago for my son Vincent's third grade class and his classmates reacted
    with clarity and passion. Their comments included: ``that's cheating!''
    and ``they [the companies] can't do that.''
        By analogy, this is like punching holes in a fruit drink container,
    allowing some of the beverage to leak out, then testing the residual
    beverage for calorie and sugar content and listing those figures on the
    box even though consumers may consume several times more sugar than was
    listed on the package or in advertisements. That would be cheating, and
    there is a means of stopping and preventing it with food products, but
    not for tobacco products--not until tobacco is regulated by FDA, which
    routinely addresses such issues with food and drug products. In fact,
    for any food or beverage in America, including Kraft cheese, Miller
    Lite beer, Oreo cookies, and potato chips made by tobacco company
    affiliates, such fraudulent misrepresentation of products can result in
    the products being pulled from shelves and/or penalties. Manufacturers
    can't even claim dog food is low fat if it is not true. Companies that
    market addictive drugs for therapeutic use must formulate and market
    them to reduce risk of addiction and other adverse side-effects, or the
    drugs can be refused approval, pulled from the market, or be subject to
    new limitations on marketing, as has happened to several potentially
    addictive medications in recent years. Tobacco products are not
    therapeutic but many of the same principles apply.
        ``Light'' and ``low tar'' cigarettes can be considered the first
    generation of putative but fraudulent ``harm reduction'' products
    designed to address smokers concerns about health but not really to
    reduce their health risks. Light cigarettes may just be the tip of the
    iceberg though.
        New generations of products appear to be following the commercially
    effective model of light cigarettes, which is to ensure that new
    products are highly addictive to sustain use, with designs and
    marketing efforts to assuage fears about tobacco. There is the
    theoretical potential to reduce actual toxin exposure and an Institute
    of Medicine Report released in 2001 acknowledged this, giving the
    potential product category a new name: Potential Reduced Exposure
    Products or PREPS. It urged, however, regulation by FDA to provide a
    framework for evaluation of the products, determine what communications
    would be appropriate, and monitor their use and impact. Absent with
    such regulation, products termed PREPS by an unfettered industry could
    be the next generation of lights, further undermining prevention and
    cessation, and killing many of their users.
        Fortunately, we have learned a lot in the past decade that will arm
    FDA in its regulation of PREPS, lights, and all other tobacco products.
    Much of this information emerged thanks to the 1990s investigation by
    FDA as part of its Tobacco Rule development. More information emerged
    through litigation against tobacco companies that made public millions
    of pages of previously secret internal tobacco industry documents,
    giving birth to a new research discipline called ``tobacco document
    research,'' which involves increasingly sophisticated analysis to
    determine what the industry knew about health effects and addiction
    engineering, as well as many of its actual practices. We also have
    empirically derived knowledge from NIH and CDC research relevant to
    tobacco product design and effects. Perhaps most importantly, we have
    learned, through the tobacco industry documents, how much more the
    industry knows than it discloses, how much it knows about designs and
    ingredients to heighten addiction risk, and how much more we need to
    learn if we are to more effectively prevent continued product
    manipulation. I believe that an empowered FDA could demand and evaluate
    such information, and put it to use to serve public health.
        For example, as you have learned, the State of Massachusetts
    cigarette testing program shows nicotine levels had gradually increased
    in many brands since the late 1990s. There has been considerable debate
    as to why this was done. My opinion is that this was done to make it
    easier for cigarette smokers to get their daily addictive fix of
    nicotine when faced with restrictions on smoking and higher costs that
    drive their daily cigarette intake down. To tobacco companies, keeping
    their customers addicted and satisfied is better than allowing
    cigarette smokers to reach that point that sustaining nicotine is such
    a hassle that they are more driven to quit. However, that is my
    opinion, and in the absence of regulatory oversight there is no way to
    find out the basics: the how, what, why and when. You see, regulation
    would give FDA the authority to demand an explanation and even to ban
    the manipulation if it deemed that it was contrary to the interests of
    public health. FDA could freeze levels; it could even require reduction
    of various toxicants and nicotine over time.
        Senators, it is time that the American public be truthfully told
    what the tobacco industry knows about the ingredients, delivery, and
    effects of the products, and that the products they buy and use are
    honestly labeled regarding ingredients and maximum possible exposure
    levels. We would not tolerate such deception with food manufacturers or
    the makers of any other products consumed by Americans. It is time to
    stop protecting the tobacco companies and start making them play by the
    same rules as the manufacturers of other products consumed by
    Americans. The deception continues and is poised to worsen: tobacco
    products are mutating undeterred by regulatory oversight. Learning the
    truth and developing appropriate communications for consumers for
    existing products and the pipeline of new drugs or consumed products,
    is central to FDA's mission.
        Absent regulation, the deadly deception I have described continues.
    Cigarettes and smokeless tobacco products are designed to addict,
    designed to go beyond the addiction risk of their relatively crudely
    manufactured ancestors. Cigarettes are designed to taste smooth and
    garner misleadingly-low tar and nicotine ratings because consumers
    react to such information as meaning substantially-less harmful.
    Tobacco products are researched, designed, manufactured and marketed to
    maximize the likelihood of trial, the graduation from trial to
    addiction, and to retain their addicted users despite efforts to quit.
    Products are fine tuned to attract various populations, including the
    young, with flavors, designs, and dosing characteristics. This is far
    beyond simply satisfying existing needs and desires of adults.
        And the problem appears to be worsening: More Americans than ever
    before are concerned about smoking, and want to quit. But without
    regulation these individuals will turn to light cigarettes or new
    tobacco products that falsely claim (at least implicitly) to be less
    harmful. These products have been shown to reduce the motivation to
    quit smoking because of the false reassurance that the smoker is
    ``doing something'' that represents a healthier step in the right
    direction. But delaying tobacco cessation is deadly: disease risk is
    more strongly related to years of smoking than to the number of
    cigarettes smoked per day.
        Worse still, the pipeline of new products and claims is growing.
    Some of you may have seen advertisements in widely-circulated magazines
    such as Parade, trumpeting cigarettes such as Omni and Eclipse that are
    ``lower in carcinogens'' and ``may present less risk of cancer, chronic
    bronchitis and possibly emphysema.'' Eclipse, delivers very high levels
    of the deadly odorless gas carbon monoxide. Marketed versions were also
    reported to deliver glass fibers from its aluminum and glass inner
    chamber that can penetrate the lung.
        Philip Morris is now test marketing what many smokers might be
    truly waiting for, a Marlboro with reduced risk claims: Marlboro Ultra
    Smooth. Philip Morris has admitted that it is premature to make harm
    reduction claims for the product though they tout the product's
    potential to reduce exposure to harmful substances. In the void of
    regulation, however, Philip Morris is test marketing the product and
    creating the illusion of reduced harm through its clever name and
    descriptions of the potential of the product to reduce certain
    substances. Furthermore, it is using messaging such as ``Filter
    Select'' and ``new carbon filter'' which might be reasonably construed
    by a consumer to indicate advances in filtration of harmful elements.
        One widely-advertised cigarette, Quest from Vector, even claimed to
    be ``nicotine-free'' supporting the claim by asserting it met the
    ``standard'' of Benowitz and Henningfield. Now, without detracting from
    my own work with Dr. Benowitz, we are not FDA, and we never intended a
    recommendation for reducing the addictiveness of cigarettes to stand in
    place of FDA evaluation and regulation. This would be laughable if it
    were not deadly and still being perpetuated.
        I am not here to testify, that products such as Quest and Marlboro
    Ultra Smooth are, in fact, as deadly as conventional products. The
    problem is there is no way to know if they are potential steps in the
    right direction or as fraudulent and deadly as light cigarettes. And
    there will be no way to tell until we have an authorized and empowered
    FDA to find out.
        There is also an increase in widely advertised smokeless tobacco
    products from ``for when you can't smoke,'' implying you don't need to
    quit smoking because you can use their products when you can't smoke.
    The lure is increased by touting new products and implied benefits. One
    product is packaged to resemble a medicinal cessation product with its
    label reading ``for when you can't smoke.'' These manufacturers are
    using Americans as guinea pigs without informed consent. They are
    introducing new products; modifying products with new designs and
    ingredients; and making claims, implicit and explicit, without
    regulatory oversight from the one agency, FDA, that is charged with the
    oversight of consumable products that have health effects, and require
    consumer communications that are honest and do not mislead. These
    efforts not only are deceptive, they help the industry thwart tobacco
    prevention and cessation efforts.
                        regulation is overdue and urgent
        For several decades, the tobacco industry anticipated but fought
    FDA regulation, as illustrated by Philip Morris scientist William
    Dunn's warning to his superiors in 1969:

              ``I would be more cautious in using the pharmic-medical
            model--do we really want to tout cigarette smoke as a drug? It
            is of course, but there are dangerous FDA implications to have
            such a conceptualization go beyond these walls.''

        Dr. Dunn was right in his apparent assumption that FDA authority
    could have reined in many deceptive practices of the tobacco companies.
    fda is the right agency and the only agency with appropriate experience
              to develop and enforce product performance standards
        I have heard the entire range of arguments about why FDA should not
    be granted regulatory authority, including that FDA was not designed to
    evaluate cigarettes. The fact is that FDA was designed to assess
    safety, ingredients, and resultant exposure to a broad range of drugs
    and foods. Tobacco products are drug delivery systems at heart. They
    are sophisticated and complicated with many ingredients, just as many
    drugs are. Even the tobacco industry admits this in their documents.
    Moreover, they are designed to deceive, and designed to heighten
    addiction risk.
        Foods and drugs that are designed and/or marketed to deceive,
    whether by intent or not, can be judged as misbranded or recalled, and
    lead to various correctional actions ordered. This happens frequently
    and routinely many times each year for foods and drugs. FDA has more
    experience and sophistication in the regulation of drugs and drug
    delivery systems than any agency in the world. This is the same
    expertise that needs to be applied to tobacco.
        For any product, whether food, drug or dog food, FDA can ask and
    must be given answers to the basic questions that many consumers of
    those products undoubtedly believe are being addressed for tobacco
    products: WHO is the product for? WHAT is in it? WHY is it designed and
    manufactured as proposed or done? HOW is it manufactured? WHEN were
    changes made? FDA can require surveillance to detect unintended
    consequences of products already marketed or proposed for marketing
    approval if it has residual concerns.
        Finally, what is communicated to consumers about product content
    will be vital, so that eventually tobacco products, like other
    consumable products, are labeled in meaningful ways that do not confuse
    or obscure the truth, do not inappropriately make or imply claims, and
    do not unintentionally undermine efforts to prevent tobacco use from
    beginning and tobacco users from quitting.
        FDA's authority will not make tobacco products safe, and should not
    be seen as a substitute for comprehensive tobacco control efforts to
    reduce all forms of tobacco use and disease. In fact, FDA regulation
    should be viewed as a partner in these efforts and be positioned to
    serve these efforts because it will restrict the ability of the
    industry to modify products and descriptors to undermine prevention and
    cessation. For all of these reasons and more, FDA regulation of all
    tobacco products is vital in setting our Nation on a healthier path.
    Directing the FDA to develop its regulatory system with urgency,
    empowering it to rise to the challenge of tobacco regulation, and
    providing it with the support to get the job done can be accomplished
    through Senate bill S. 625. I therefore urge its most expeditious
    passage and implementation.

        Senator Sanders. Mr. Chairman.
        The Chairman. Yes?
        Senator Sanders. I'm going to apologize. I have to leave as
    well. I just wanted to thank all of our guests here today and I
    would just say, Mr. Chairman, the idea that we throw drug
    pushers and heroin dealers into jail because of what they do to
    our kids and the idea that we do not regulate those people who
    are pushing cigarettes and addicting kids and killing kids,
    cause lung disease and emphysema and everything else, it's
    incomprehensible. So thank you very much for holding this
    important hearing.
        The Chairman. Thank you.
        Senator Sanders. I look forward to working with you.
        The Chairman. Dr. Connolly.

     STATEMENT OF GREGORY N. CONNOLLY, D.M.D., M.P.H., PROFESSOR,
        HARVARD SCHOOL OF PUBLIC HEALTH, FORMER DIRECTOR OF THE
      MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH'S TOBACCO CONTROL
                          PROGRAM, BOSTON, MA

        Mr. Connolly. I think it's over 20 years of coming before
    this committee and it's like watching the Red Sox. We always
    hope that next year, next year. Not only being a Red Sox fan,
    my son-in-law is from Columbus so we watch the Buckeyes every
    year very carefully.
        When I was in Massachusetts, we achieved a 50 percent
    decline but we still got stuck at 18 percent of our adults. We
    still got stuck with youth rates and not enough change. So we
    tried to fill the void with the Federal Government. We
    regulated advertising on schools and playgrounds. We acquired
    ingredients. We have a new testing protocol that the feds don't
    apply in Massachusetts but we found we lacked the resources and
    we lacked the legal authority to do so.
        Clearly we need the Federal Government to step in and fill
    this void. If we wanted to put a warning label on Marlboros, as
    a State we couldn't do it, the way they do it in Britain, the
    way they do it in Brazil, a developing country. We couldn't do
    it. So States like Massachusetts, Ohio, Wyoming, North
    Carolina--basically that's third-world states with Brazil,
    Jordan and others having much more effective warning labels.
        We looked at--and I have a slide, could we see it, please?
    We looked at nicotine through the Massachusetts testing system
    and we found that over the past 8 years, there has been a 11
    percent increase of nicotine, both in the smoke and the raw and
    you can see here, there is significant increases.
        Next slide, please, next chart, please. We looked at
    Marlboros in particular and we found that--we took into account
    random fluctuation that this was, in fact, a significant
    increase. I wish we didn't see this increase. I wish we saw
    post the MSA, nicotine levels going down.
        Why did this occur? We have no clue as a State. We don't
    have the resources. The Harvard School of Public Health doesn't
    have the resources. Why did they do it? We don't know. Did this
    increase addiction among kids or adults trying to quit? We
    don't know. But all of those questions can be answered by the
    Food and Drug Administration if this bill is passed.
        We just don't know. Is it a real increase? The industry has
    challenged us and said, ``no it is a real increase.'' We took
    into account through very good statistics, which haven't been
    applied by the tobacco industry, we found an increase. Is it
    new? It's not new. This has been occurring through decades. The
    only new issue here is that this occurred after the MSA.
        Also, the train has left the station on reduced risk
    products. There are over 38 that have been marketed, mostly
    after the MSA with claims that they reduce cancer risk, that
    they lower carcinogens.
        Next chart, please.
        We conducted research among 600 smokers and we asked the
    question, do these reduced-risk products lower your risk to
    disease versus light cigarettes and versus regular cigarettes.
    Even if you are seeing an implied claim, universally the
    smokers who looked at the advertisements for these reduced-risk
    products--Eclipse, Omni, Advance--perceive the implied claim as
    an explicit claim. They perceived it as a way to forestall
    quitting. They perceived it as a way to reduce their cancer
    risk. So it's a repetition of the failed history of light
    cigarettes.
        What we found through the Harvard research at the Nurse's
    study that light cigarettes only increase the risk of disease
    versus others. So we need FDA regulation, not to regulate only
    explicit claims but implied claims until we show it is safer.
        Are we saying we want to ban Marlboros? I don't think so. I
    think it's unrealistic. I think it's unreasonable but we maybe
    want to create Marlboros so that they are like lard. They are
    legal but we regulate the constituents, we regulate the
    toxicity, we regulate whatever--so it sits back on the shelf
    and no one uses it.
        And FDA tomorrow can give us warning labels or a ban on
    lights. They can give us restrictions on ads near schools but
    it may take some time to come up with a product where we can
    make perhaps a claim that it is safer, but it's worth waiting
    for that. It's worth that legislation.
        Next chart, please.
        Post the MSA, we looked at advertising and we scored youth
    ads versus adult ads and we found on this chart here that at
    least for two companies, that the exposure to adults and youth
    are equivalent. That is a rating of 100--100 exposures and the
    same for adults and kids. They haven't changed their marketing
    to youth. They've just gotten smarter. This is an ad for the
    new custom Kool and I've asked how many people wear running
    shoes like this into the committee room today. But this is in
    magazines like Rolling Stone, with more youth readership,
    enough for the FDA provision.
        Next, please.
        The Chairman. Could you adjust the chart. The light is
    reflecting off of it. I don't understand quite what's going
    down and what's going up.
        Mr. Connolly. OK, what we did here is we looked at pre- and
    post- the MSA and we looked at exposures to advertising among
    youth and adults. So before the MSA--1997, 1998, we had about
    160 exposures on average to adults and about the same for
    youth. That was 12 through 17. MSA came in and we saw a general
    reduction in advertising so that was good, primarily driven by
    Philip Morris and I'm not thanking them for that because they
    could still get rid of their marketing but for RJ Reynolds,
    Brown and Williams and RAI, the youth exposure equals the adult
    exposure. So there is no change. Kids are still being exposed
    to advertising at the same levels that adults are being
    exposed.
        One of the tragedies is, we went from--in the advertising,
    we went from 19 percent of the ads for menthol ads, which are
    popular with black kids--we're now at 50 percent. Half of the
    advertising is for menthol. Like this. We found the industry is
    manipulating the menthol levels, post the MSA, to make those
    products more attractive with young African Americans. And what
    happened? OK, the youth rights went down with the adolescent
    white kids, is old men wear ties. That's great. But for black
    African Americans, the young adults, rates had gone up 30
    percent from 2002 to 2005, based on the SAMSA research. Yeah,
    we've been successful with those guys. But this industry
    clearly is going after the high-risk population with
    manipulation of menthol, increased marketing and advertising
    for menthol and what is the result? It's a negative population
    impact.
        Next please and I'm going to finish up here. This is the
    candy-flavored cigarette. No one knew this was here. RJ
    Reynolds had this in the tank prior to the MSA. But after the
    MSA, they introduced this new pellet, which impart a candy-like
    flavor to the smoke. No one knew it was there, not even
    smokers. The only people who knew it was there was Philip
    Morris. We went out and we found an internal document, brought
    it and--would we allow this to be put in a food product without
    telling anyone? We then ran a gas spec and we found foreign
    constituents in that pellet and no one had a clue what those
    constituents did, either in helping youth to start or its
    toxicity and the FDA can do that with this action.
        Has the industry changed after the MSA? Yeah, but maybe not
    for the better. And I'll end by saying 40 years ago, a Senator
    from New York gave the opening address at the First World
    Conference on Smoking and Health and he prophetically warned
    that 28 million Americans will be killed by smoking unless
    urgent action was taken. Fifty million Americans have been
    killed since that date, since that Senator made that statement.
    He told the attendees at that meeting to be equal to the task,
    for the stakes are nothing less than the lives and health of
    millions all over the world. I know it is a battle which will
    be won. Our battle--that Senator's vision--will be won when
    this Congress passes this historic legislation. The States
    can't do it alone, Senator. As one who has fought in the
    trenches, pushed the envelope of the States, we can't do it
    alone. We need your help. Thank you very much.
        [The prepared statement of Mr. Connolly follows:]
           Prepared Statement of Gregory N. Connolly, D.M.D., M.P.H.
        My name is Gregory N. Connolly. I am a professor at the Harvard
    School of Public Health (HSPH) and direct the Tobacco Control Research
    Program. Prior to coming to Harvard, I served as the director of the
    Massachusetts Department of Public Health's Tobacco Control Program and
    in that capacity, oversaw one of the largest public health programs to
    curb tobacco use in the United States achieving a 50 percent decline in
    cigarette consumption from 1993 to 2003. Massachusetts was the first
    State to require warning labels on smokeless tobacco, the second for
    warnings on cigars and the first to require public disclosure of
    tobacco product additives and nicotine yield. Massachusetts has led all
    States in attempting to fill the Federal void in regulating tobacco
    products and marketing. We clearly found that States lack the resources
    and legal authority to effectively do so. FDA regulation is urgently
    needed today. My opinion is based on the following:

        1. Despite the Tobacco Industry's Admission that Nicotine is
    Addictive, Following the MSA Manufacturers Have Increased Nicotine
    Content in Cigarettes and Cigarette Smoke.
        Our research has found a significant increase in nicotine to
    cigarette tobacco and smoke from 1997 to 2005 (12 percent). Industry
    manipulation of nicotine is nothing new, what is new is that it is
    still occurring post the MSA. A statistically significant trend
    confirmed an increase in smoke nicotine yield of 0.019 mg per cigarette
    (1.1 percent) per year over the period 1997-2005 for an 11.7 percent
    increase. The increasing trend was observed within all major market
    categories (mentholated vs. nonmentholated and full flavor vs. light,
    medium (mild), or ultralight).

        Increasing smoke nicotine yield was associated with increasing
    nicotine concentration in the tobacco and number of puffs per
    cigarette, and decreasing percent filter ventilation of the cigarette.
    Such changes increased the elasticity of the cigarette making it
    potentially more addictive.

        In her August 2006 decision, Judge Kessler devoted 140 pages to
    describing the tobacco industry's long history of nicotine
    manipulation. She concluded that tobacco manufacturers:

         ``. . . have designed their cigarettes to precisely
    control nicotine delivery levels and provide doses of nicotine
    sufficient to create and sustain addiction.''
         ``. . . have extensively studied smoking intake and
    inhalation, compensation, addiction physiology, smoker psychology, the
    pharmacological aspects of nicotine, the effects of nicotine on brain
    waves, and related subjects.''
         ``. . . intentionally developed and marketed cigarettes
    which, in actuality, delivered higher levels of nicotine than those
    measured by the FTC method.''

        These studies consisted not only of consumer smoking panels but
    also large-scale human clinical trials, electrophysiological studies of
    brain waves, chemical and physical brand analyses, and other
    sophisticated techniques. Factors such as use of blends, genetic
    modification of tobacco, and in particular, ammonia or other chemical
    agents are used to alter the chemical form of nicotine delivered to the
    smoker. Detailed evidence shows that manufacturers could and did
    manipulate free nicotine delivery through product changes and that even
    ``small'' increases in free nicotine delivery could significantly
    increase their ability to deliver an ``optimum'' dose of nicotine
    capable of creating and sustaining addiction in cigarette smokers.
        Our research is not new but only shows that this historical pattern
    of nicotine manipulation has not changed. We don't know why nicotine
    has increased. The tobacco industry regulatory oversight by the FDA is
    necessary to evaluate changes in product delivery and their effects on
    smoker initiation and use; and possibly to make the product less
    addictive.
        2. Since the MSA Tobacco Manufacturers Have Greatly Increased the
    Marketing of ``Safer'' Cigarettes to Health Conscious Smokers in the
    Absence of Independent Scientific Evidence They are Actually ``Safer.''
        This Nation has already suffered immensely from the failed history
    of light cigarettes when they were presented in the 1970s as a
    ``safer'' alternative to regular brands. The Harvard School of Public
    Health's Nurses Study found that smokes of ``lights'' had the same risk
    of cardiovascular diseases as smokers of regular brands. The National
    Cancer Institute concluded in 2001 that smoking ``lights'' did not
    reduce the risk of lung cancer. In the absence of FDA regulation, the
    failed history of ``lights'' will only be repeated with the promotion
    of cigarettes today as being safe.
        Potentially Reduced (tobacco) Exposure Products (PREPS) are being
    marketed with explicit and implicit claims that they reduce health
    risks in the absence of scientific evidence to show they actually do.
    Over 35 PREPS have been marketed over the past few years (see Appendix
    A).
        In 1998, RJR claimed that there is ``No Cigarette Like Eclipse''
    based on a comparison of its smoke chemistry to a typical ultralight
    cigarette (Merit) and also claimed that Eclipse may reduce cancer risk.
    We analyzed the smoke chemistry of Eclipse versus two conventional
    ultralight cigarettes (NOW and Carlton) and found that Eclipse had up
    to five times the levels of cancer causing agents than the existing Now
    or Carlton brands. There are ``Cigarettes like Eclipse'' in the
    marketplace. A careful review of other research conducted by RJR on
    Eclipse found serious problems with the methodology that supported the
    lung cancer reduction claim.

        When sales for Eclipse faltered in the late 1990s, RJR altered the
    filter design by drilling a hole in it but not alerting consumers to
    the change. The new design resulted in an increase of 300 percent in
    two cancer causing agents called NNN and NNK. Consumers were not
    informed of the design change on increase in toxins.

        We tested two prototypes of the new carbon filtered PREP, Marlboro
    UltraSmooth (MUS), test marketed in the United States beginning in
    2005, using both standard (FTC/ISO) and intensive (Health Canada)
    machine methods to measure gas/vapor and particulate phase smoke
    constituents. When tested under the standard regimen, gas phase
    constituents of MUS prototypes were reduced compared with a
    conventional low yield cigarette. However, far smaller reductions in
    gas phase constituents were observed under the intensive regimen,
    suggesting that the carbon technology employed in MUS is less effective
    when smoked under more intense conditions. Particulate phase
    constituents were not reduced by the carbon filter under either machine
    smoking regimen. Studies of human smoking show that MUS is likely to be
    smoked intensively, thus negating its potential for toxic constituent
    reductions.
        PREPS have been marketed include nicotine hand gel, nicotine
    chewing gum, modified cigarettes (Omni, Advance and Marlboro
    UltraSmooth) and electrically heated nicotine inhalers (Accord) (see
    Appendix). All of these products have been sold with implied or
    explicit claims of reduced risk without review or approval of
    independent scientific agencies such as the FDA.
        Other research we conducted showed that consumers perceive implied
    claims for reduced levels of toxins in smoke as explicit claims for
    reduced health risks when, in fact, there is no science to support the
    claims. We studied 600 adult smokers who reviewed advertisement for
    regular and PREP cigarettes. Smokers perceived PREP products as having
    lower health risks (mean=5.4 on a scale of 1-10) and carcinogens (6.6)
    than light cigarettes (5.8 and 6.9, respectively, p < .001), and lights
    as having lower health risks and carcinogen levels than regular
    cigarettes (8.2 and 8.8, respectively, p < .001). Although no
    advertisements explicitly said that the products were healthy or safe,
    advertisements for PREP products and light cigarettes were interpreted
    as conveying positive messages about health and safety. Most smokers
    believed that claims made in cigarette advertisements must be approved
    by a government agency. The results indicate that advertisements can
    and do leave consumers with perceptions of the health and safety of
    tobacco products that are contrary to the scientific evidence. This
    supports regulating the promotion, advertising, and labeling of PREP
    tobacco products and light cigarettes. Effective FDA regulation should
    focus on consumer perceptions resulting from advertisements not just
    the explicit content of advertising text. This is needed to prevent a
    repeat of the failed history and disease burden by the marketing of
    ``lights.'' The unintended consequences of PREP marketing by youth
    initiation and deterrence of quitting can also be monitored by the FDA.

        The bill will give the FDA authority to prevent such
    unsubstantiated claims from being made. FDA will require scientific
    support and closely examine the real world performance of PREPs such as
    Eclipse and MUS. Regulation of PREPS by independent health agencies
    such as the Food and Drug Administration is needed to protect the
    public health and validate both the industry science and its claims.
        3. Advertising After the Master Settlement Agreement has Become
    More Targeted to Youth, Minorities and Other High-Risk Groups.
        Following the Master Settlement Agreement (MSA), youth and other
    high-risk groups, including low-income women and African Americans,
    have been targeted with disproportionate levels of magazine advertising
    for tobacco products. Our analysis of tobacco magazine advertising post
    the MSA found, from 1998-2005 on average, every youth in the United
    States was exposed to 559 tobacco ads, every adult female 617
    advertisements, every African American adult 892 ads, and every
    Hispanic adult 605 ads.
        Exposure to a magazine advertisement is measured as the percentage
    of a population group that reads the magazines that runs the
    advertisement in the studied time period.
        Compared to adults, youth had greater exposure to magazine
    advertising for cigarettes or major manufacturers including R.J.
    Reynolds, Brown & Williamson and Lorillard and were disproportionately
    exposed to magazine advertising for brands and varieties preferred more
    by youth including Newport and Camel, and mentholated and full flavor
    cigarettes. Philip Morris ended magazine advertising in 2003 but the
    other companies have more than made up for PM's absence. Despite the
    MSA, cigarettes were advertised in magazines with 15 percent or greater
    youth readership and in magazines with 2 million or more youth readers
    in every year from 1998 to 2005, criteria used in the 1994 FDA rule to
    define a youth magazine.

        Regulation by the FDA can eliminate cigarette advertising to youth.
        Among young, Black smokers, Newport has traditionally been the most
    popular menthol brand. Newport has the lowest menthol levels (0.24
    percent weight of tobacco filler among King-size, full flavor) compared
    to its major competitor (Kool, 0.36 percent). Between 1993 and 2005,
    Newport's market share doubled, from 4 percent of market to 8 percent,
    while Kool and Salem's share of market has remained relatively steady.
        Reynolds American Tobacco aggressively competed against Lorillard
    and recently re-designed Kool under the name Kool XL and heavily
    advertised it to compete against Newport's dominance among young
    Blacks. Kool Smooth Fusions is a candy-flavored menthol brand, promoted
    through dance clubs and hip hop music venues beginning in 2004. Philip
    Morris has followed Reynolds American promotion of Kool with Marlboro
    Smooth, a new menthol product, available in March 2007. Both brands
    employed the selling message ``smoother'' a possible connation of a
    reduction in menthol levels to target young Black smokers. Expenditures
    for magazine advertising of mentholated cigarettes has increased from
    13 percent of total ad expenditures in 1998 to 49 percent by 2005.

        Among Black young adults (age 18 to 25) menthol smoking rates
    increased significantly by 30 percent between 2002 and 2005 from 19.8
    percent (95 percent CI: 17.7-21.9 percent) to 25.8 percent (95 percent
    CI: 23.5-28.1 percent), but did not increase significantly among same-
    aged Whites and Hispanics during that time. Nonmenthol cigarette use
    decreased by 39 percent among African-American young adults, although
    this change was not significant (from 7.9 percent in 2002 to 4.8
    percent in 2005). In 2002, 19.8 percent (95 percent CI: 17.7-21.9
    percent) of African Americans age 18-25 smoked menthol cigarettes (an
    additional 7.8 percent smoked nonmen-
    thols). In 2004, 25.8 percent (95 percent CI: 23.5-28.1 percent) of
    African-American young adults smoked menthol (while an additional 4.0
    percent smoked nonmenthols). In 2005, this proportion decreased
    slightly, but remained above pre-2004 levels.
       Menthol Use in Past 30 Days Among Young Adults, by Race, 2002-2005

         The rates of menthol smoking among African Americans ages
    18-25 years have increased by 10 percent per year since 2002 (OR =
    1.10, 95 percent CI = 1.04-1.18).
         No statistically significant trends over time since 2002
    are seen in the rates of menthol smoking among Whites and Hispanics
    ages 18-25 years or among Blacks or Hispanics ages 12-17 years.
         The rates of menthol smoking among Whites ages 12-17 years
    have decreased since 2002 (OR = 0.95, 95 percent CI = 0.90-0.99).

        Following the MSA, R.J. Reynolds acquired the second largest
    smokeless company Conwood for $4.8 billion and introduced its own
    smokeless brand called Camel Snuss. Philip Morris introduced its new
    smokeless tobacco brand in Indianapolis called Taboka and acquired a
    Swedish smokeless company the same year. Lorillard has entered into an
    agreement with Swedish Match North America to produce its smokeless
    brand in 2007. The cigarette companies, rather than offering smokeless
    products as an alternative to cigarettes, have only produced and sold
    smokeless products as a temporary way to receive nicotine through
    smokeless tobacco in places where smoking is banned thus perpetuating
    smoking.
        FDA regulation is needed to prevent cigarette companies from
    marketing smokeless tobacco to perpetuate smoking. FDA authority is
    needed to require manufacturers to adopt new technologies to reduce
    toxins in all smokeless products not just the ones they make ``safer''
    claims for.
        In 2002, RJR introduced Camel ``Exotic'' Blends and Brown and
    Williamson ``Kool Fusion'' brands all with candy-like flavors in the
    product. The Exalt Camel brand used a plastic pellet in the filter to
    deliver flavors to smokers. No public health agency knew it was
    present, its toxicity or how it contributed to youth initiation. Candy-
    like flavorants mask the natural toxicity of smoke and could enhance
    initiation and addiction.
       Examples of recent candy flavored cigarettes and flavor delivery
                                    systems

        The use of flavorants to appeal to young nonsmokers is consistent
    with other research on the reformulation of Camel cigarettes in the
    1980s, a brand then popular with older men. The newly designed Camel
    was targeted to first-time young smokers by using additives that masked
    the harshness, making it smoother and easier to inhale. Market share
    for Camels rose among adolescent males three-fold post the
    reformulation from 3 to 10 percent.
                                   conclusion
        Post the MSA manufacturers have become more aggressive in targeting
    high risk groups including minorities and youth with aggressive
    advertising, re-designed products with more not less nicotine,
    introducing candy-like flavored product and aggressively marketing
    brands popular with young African Americans.
        Forty years ago, a Senator from New York gave the opening address
    at the First World Conference on Smoking and Health and prophetically
    warned that 28 million Americans would be killed prematurely by smoking
    unless urgent action was taken at that time. None was taken. The same
    Senator urged the attendees to: ``be equal to the task. For the stakes
    are nothing less than the lives and health of millions all over the
    world. I know it is a battle which will be won.'' (Robert Kennedy,
    First World Conference on Smoking or Health) Our battle will be won and
    that vision fulfilled when the Congress passes this historic
    legislation.

        The Chairman. Thank you.
        Dr. Blum.

          STATEMENT OF ALAN BLUM, M.D., DIRECTOR, UNIVERSITY
        OF ALABAMA CENTER FOR THE STUDY OF TOBACCO AND SOCIETY,
                             TUSCALOOSA, AL

        Dr. Blum. Chairman Kennedy, Senator Enzi and members of the
    committee, the public entrusts the Food and Drug Administration
    to evaluate the safety and efficacy----
        The Chairman. Do you have your button on there? Just bring
    your microphone closer, thank you. I think we're going to be
    okay.
        Dr. Blum. The public entrusts the Food and Drug
    Administration to evaluate the safety and efficacy of
    medications. Having served on an FDA advisory panel, I have
    sympathy for the over-extended staff at this beleaguered
    agency. But placing the Nation's most lethal consumer product,
    cigarettes, under the control of FDA would be unwise. And
    asking a food and drug bureau to promulgate product safety
    standards for cigarettes is an oxymoron that will perpetuate
    the myth long fostered by the tobacco industry that this
    inherently harmful product can be made safer.
        The promotion of this bill by Philip Morris USA, maker of
    Marlboro and by far the biggest of big tobacco, with 50 percent
    of the market, should prompt skepticism about the measure and
    its purported public health benefits. Although the bill will
    strictly regulate new and potentially less hazardous
    noncombustible tobacco products, it would not apply these
    standards to the most harmful form of tobacco, namely Marlboro
    and other cigarettes, which caused the deaths of nearly half a
    million Americans a year and although the bill bans candy
    flavorings and no doubt will get rid of the term lights and
    will have new, bigger and improved warning labels, it does not
    require the FDA to eliminate menthol, the mint-flavored
    anesthetic agent added to the brands most heavily targeted to
    African American and Latino American consumers.
        Nor is there a mandate for the FDA to eliminate toxic
    gases, including cyanide or the more than 40 known cancer
    causes in cigarette smoke, such as benzene, nitrosamines and
    radioactive polonium. The bill will most assuredly cause
    confusion about the difference between reduced exposure and
    reduced harm. If consumers are told that 1, 2, or even 22
    cancer causes in tobacco smoke have been reduced, they are
    going to assume that a problem has been taken care of. They are
    going to believe that cigarettes are safer and they are going
    to continue to smoke.
        This is, of course, deja vu all over again. For more than
    70 years, every report on the dangers of cigarette smoking was
    disputed by the tobacco industry, who claim more research was
    needed and who promised to identify and remove any component of
    smoke that was found to cause disease. This led to marketing
    gimmicks to allay public anxiety about smoking, such as filters
    that promised double-barreled health protection and claimed to
    be ``just what the doctor ordered'' or in at least one
    instance, was made of asbestos.
        In spite of the fact that the cigarette filter does not
    confer any reduced health risk whatsoever, more than 95 percent
    of persons who smoke buy filtered brands in the false belief
    that they are safer. Yet this bill will not ban the filter, the
    biggest and longest running scam of big tobacco.
        Similarly, when the Federal Trade Commission mandated that
    tar and nicotine levels be printed on cigarette advertisements,
    tobacco companies were only too happy to oblige. Carlton is
    lowest. It's official, confirmed by the U.S. Government, now is
    lowest. To this day, hardly a day goes by when a patient
    doesn't proudly tell me, but doc, I smoke Marlboro Lights
    because it's got only one milligram of tar. I try to tell these
    young ladies that they are being duped but they don't want to
    believe it.
        Few consumers have caught on that such numbers mean
    nothing. History has shown that the tobacco industry has
    circumvented every attempt to impose Federal regulations on
    cigarette marketing. The goal of the Cigarette Advertising and
    Labeling Act of 1970 was to remove cigarette ads from the
    broadcast media but no sooner had the commercials ended than
    televised sporting events began, such as Nascar Winston Cup
    racing and the Virginia Suns Women's Tennis Circuit, providing
    even greater cigarette brand image exposure than ever.
        We still see Marlboro logos on TV, auto racing worldwide.
    Research has documented that the kinds of marketing
    restrictions imposed by this bill are not effective in reducing
    youth exposure to cigarette advertising. The proposed FDA bill
    will simply change who is committing consumer fraud. Currently,
    it is still the tobacco companies marketing reduced tar and
    nicotine cigarettes in a way that deceives consumers into
    believing that these products are safer. If the FDA bill is
    enacted, then the Government will be doing the dirty work for
    the tobacco companies. Small wonder why Philip Morris embraces
    this bill, which will permit it to tell consumers that it is
    complying with strict product safety standards, making
    government-approved cigarettes.
        In summary, there is no evidence that this bill will save
    any lives at all. It goes from A to Z without telling us how B
    to Y are going to work. To the contrary, the bill will
    perpetuate great harm to its grandfathering of high risk
    cigarette products, its hindering of the introduction of
    reduced risk, noncombustible tobacco products and its
    eliminating litigation for consumer fraud. However well
    intended, the bill is misguided. It could well be renamed, the
    Marlboro Protection Act. It should carry its own Surgeon
    General's warning that this legislation is deceptive and it
    will prove devastating to public health.
        [The prepared statement of Dr. Blum follows:]
                     Prepared Statement of Alan Blum, M.D.
        Mr. Chairman and members of the committee, the public trusts the
    Food and Drug Administration (FDA) to safeguard the medicines and food
    products that contribute to good health and well-being. Having served
    as a member of an FDA advisory panel, I have great respect for this
    agency's work in assuring the safety of medications and medical devices
    used in the diagnosis and treatment of disease.
        As we have known for decades, cigarettes are the Nation's leading
    cause of cancers, heart disease, and emphysema. Placing our most lethal
    consumer product under the control of the Food and Drug Administration
    makes no sense. Asking this agency to promulgate ``product safety
    standards'' for this death-dealing device is an oxymoron and will
    perpetuate the myth that cigarettes can be made safer. Safer than what,
    one might ask, fresh air?
        The championing of this bill by Philip Morris USA, America's top
    cigarette manufacturer with 50 percent of the market, should prompt
    skepticism about the measure and its alleged public health benefits.
    Reading the fine print bears this out. Consider these three points:
        First, the bill would stringently regulate new and potentially less
    hazardous tobacco products but would not apply these same standards to
    the most harmful form of tobacco, namely Marlboro and other existing
    cigarettes which cause the deaths of nearly half a million Americans
    each year.
        Second, although the bill will enable the FDA to prevent the
    introduction of new cigarette brands, it seems inappropriate for the
    protection of public health that the bill permits Marlboro and the
    other most popular existing cigarette brands to remain on the market,
    even though they are far and away the leading public health threat.
        Third, although the bill specifically bans the use of strawberry,
    grape, chocolate, or similar flavoring additives in cigarettes, it does
    not require the FDA to eliminate (or even reduce the level of) toxic
    gases, including hydrogen cyanide or the more than 40 known cancer-
    causers in cigarette smoke such as benzene and radioactive polonium.
    The agency would be given the authority to take such action but there
    is no mandate to regulate these poisons.
        The only sensible and ethical action for a health agency charged
    with regulating cigarettes could be to ban them, which is an
    unrealistic prohibition.
        As Yogi Berra would say, this bill is deja vu all over again. For
    more than 70 years, every newly published scientific report on the
    countless diseases caused by cigarette smoking was disputed by the
    tobacco industry, which claimed more research was needed and which
    promised to remove any constituents of smoke that might be found to
    cause disease. This led to a proliferation of marketing gimmicks to
    allay growing public anxiety about smoking, foremost among them filters
    that promised ``Double-barrelled health protection,'' or claimed to be
    ``Just what the doctor ordered,'' or in at least one instance was made
    of asbestos.
        In spite of the fact that the cigarette filter does not confer any
    reduced health risk whatsoever, more than 95 percent of persons who
    smoke buy filtered brands in the false belief that they are safer. The
    second most sensible and ethical action for a health agency charged
    with regulating cigarettes would be to ban the filter, but this would
    hardly pass muster with Philip Morris.
        When the Federal Trade Commission mandated that tar and nicotine
    levels be printed on cigarette packs and in advertisements, tobacco
    companies were only too happy to engage in a ``tar derby.'' ``Carlton
    is lowest,'' was a long-running ad campaign. ``It's Official: U.S.
    Government proves NOW is lowest,'' was another. Few consumers caught on
    that such numbers are meaningless. It's akin to advertising Wonder
    Bread as having ``only one ounce of poison in every loaf '' or
    Campbell's touting its soups as ``low-arsenic.'' Hardly a week goes by
    when a patient doesn't proudly tell me, ``But Doc, I smoke Carlton
    'cause it's got only 1 milligram of tar.'' I try to tell these women
    they're being duped, but it's very difficult.
        History has shown that the tobacco industry has outwitted us at
    every attempt to impose Federal regulation on cigarette manufacture and
    marketing. The main goal of the Federal Cigarette Advertising and
    Labeling Act of 1970 was to remove cigarette ads from the broadcast
    media. Yet no sooner had cigarette commercials left the airwaves than
    televised sporting events such as NASCAR Winston Cup and The Virginia
    Slims Women's Tennis Circuit began airing for hours on end, providing
    even greater cigarette brand name exposure than ever before. Today we
    still see Marlboro logos on televised auto racing worldwide.
        Tobacco companies have also out-maneuvered health advocates who
    believed they had found a way to utilize the industry's money to fund
    anti-smoking education. The Master Settlement Agreement of 1998 has
    resulted in a tiny fraction of settlement funding being directed toward
    smoking prevention and cessation programs. Only four States are
    currently allocating to tobacco prevention the minimum amount
    recommended by the Centers for Disease Control and Prevention; all
    told, only 2.6 percent of tobacco revenues are being spent on tobacco
    prevention and cessation.
        Meanwhile, Philip Morris has not skipped a beat in cultivating
    financial relationships with dozens of career centers at universities
    across the country in an aggressive attempt to recruit college students
    as Marlboro sales interns and Marlboro territory sales managers. Thus
    these well-educated individuals who are least likely to smoke are being
    hired to promote cigarettes to the least educated and poorest sectors
    of our population. Bold ads in college newspapers brag about Philip
    Morris' innovative, redefined marketing strategies. When I asked one
    student why he was interviewing with Philip Morris, he told me ``It's a
    great company. They don't just sell cigarettes. They help prevent
    smoking.''
        Instead of concentrating on regulation, we should be putting most
    of our efforts into reducing demand, especially major multimedia paid
    counter-advertising campaigns that young people will see daily and
    remember. In other words, we need to fight smoke with fire.
        Research has documented that the kinds of marketing restrictions
    imposed by this bill are not effective in reducing youth exposure to
    cigarette advertising. There are simply too many venues for tobacco
    companies to market their products, and anything short of a near-total
    ban on advertising and promotion of tobacco products (which could
    violate the first amendment) is unlikely to have a substantial effect
    on youth smoking.
        There is no evidence that the system of product safety standards
    set up by the bill would result in a safer product. Essentially, the
    bill gives the FDA a mandate which it cannot carry out. The only way to
    know whether any reductions in specific constituents of tobacco smoke
    would result in a safer product would be to conduct long-term studies,
    using smokers as guinea pigs. Perhaps some would view that as
    acceptable because the product is dangerous anyway. However, the
    problem is that smokers are going to assume that these reduced exposure
    products are safer.
        There are an estimated 40 compounds in tobacco smoke that cause
    cancer. What sense does it make to require the manufacturers to take
    out 2 or 3 of them or even 25? What if smokers then believe that this
    is a safer product and start smoking more? This approach will kill
    people, not save lives.
        The bill would make it virtually impossible for modified risk
    products to enter the market, while at the same time permitting reduced
    exposure products to be falsely marketed as reduced risk products. At
    least that's how consumers are going to perceive them. How else would
    someone interpret a claim of reduced exposure?
        The bill will diminish the public's appreciation of the inherent,
    irredeemable harmfulness of cigarettes. By promulgating health
    standards, the FDA will be fostering the perception that cigarettes are
    now safer to smoke. Few of my patients who still smoke realize that
    there are 4,000 poisons and 40 cancer-causers in cigarette smoke. If
    they are told that the nitrosamines have been reduced or removed, they
    are going to assume that a problem has been taken care of. Since we
    know that smoking prevalence is directly proportional to the degree of
    perceived harm from smoking, this will lead to an increase in smoking
    prevalence, compared to what would have occurred without this bill.
        In her opinion, in the Department of Justice lawsuit against the
    tobacco companies, Judge Gladys Kessler ruled last year that decade
    after decade the defendants had engaged in fraud by marketing
    cigarettes that rated lower tar and nicotine yields via machine testing
    in a way that misled consumers to believe that these product offered a
    health benefit over higher machine-yield products. The basis of her
    decision was the body of literature demonstrating that machine-yields
    of nicotine and other tobacco smoke constituents have no direct
    relationship with actual human exposure, and thus with actual health
    risk, either on an individual or a population level.
        The bill implies that reductions in nicotine yields would be a good
    thing. But the reality is that reduced nicotine yields could be harmful
    to public health because they would likely increase cigarette
    consumption due to the smoker compensating by inhaling more deeply
    leading to increased exposure to poisons (tar and toxic gases) and
    resulting in higher rates of lung cancer and emphysema.
        The proposed FDA bill will simply change who is committing consumer
    fraud. Currently, it's still the cigarette companies, marketing reduced
    tar and nicotine cigarettes in a way that deceives consumers into
    believing that these products are known to be safer. If the FDA bill is
    enacted, then the government will be doing the dirty work. Small wonder
    why Philip Morris embraces this legislation. It completely removes the
    risk of litigation for fraud, yet allows the tobacco companies to tell
    consumers that they are complying with stringent product safety
    standards, assuring a safer product produced under the nose of the FDA.
        In summary, I regret that there is no evidence to suggest that this
    bill will save any lives at all. To the contrary, there is well-
    documented evidence to suggest that the legislation will not reduce the
    risks of cigarette smoking. The bill is likely to cause harm through
    its grandfathering of high-risk products; its hindering of the
    introduction of reduced risk products; its eliminating litigation for
    fraud; and its inhibiting tougher State and local legislative tobacco
    control efforts.
        However well-intended, the Family Smoking Prevention and Tobacco
    Control Act is misguided. While setting up an impossible standard for
    new products, it gives the most harmful (and most consumed) existing
    product a free ride. This bill could well become known as the Marlboro
    Protection Act. At the very least, it should come with its own Surgeon
    General's warning: ``This legislation is harmful to public health.''
        This submission is an extension of a commentary in the medical
    journal, The Lancet, co-authored with Michael Siegel, M.D., Professor
    of Social and Behavioral Sciences, Boston University School of Public
    Health. (Siegel M., Blum A. FDA regulation of tobacco: reprieve for the
    Marlboro man? Lancet 2006; 368: 266-68.) I also relied on additional
    critical analysis of the Family Smoking Prevention and Tobacco Control
    Act by Dr. Siegel (mbsiegel@bu.edu).

        The Chairman. Ms. Shames.

     STATEMENT OF LISA SHAMES, ACTING DIRECTOR, NATURAL RESOURCES
                   AND ENVIRONMENT TEAM, GOVERNMENT
                 ACCOUNTABILITY OFFICE, WASHINGTON, DC

        Ms. Shames. Thank you. Chairman Kennedy, Senator Enzi and
    members of the committee, I am pleased to be here today to
    present GAO's findings on the State's tobacco settlement
    payments under the Master Settlement Agreement.
        There have already been a number of references to the MSA.
    As you know, in 1998, 46 States signed what is called the
    Master Settlement Agreement, with four of the largest tobacco
    companies. The States sued these companies to be reimbursed for
    healthcare costs caused by the public's use of tobacco.
        The settlement was the largest civil settlement in U.S.
    history. It committed the tobacco companies to pay what was
    then an estimated $200 billion over the first 25 years.
    Payments are to continue in perpetuity. Congress required GAO
    to report annually on how the 46 States allocated their tobacco
    settlement payments.
        This morning, I will present our findings from these
    reports.
        First, we found collectively that States received over $52
    billion in tobacco settlement payments over fiscal years 2000-
    2005. Of the $52 billion, about $36 billion were payments from
    the tobacco companies and about $16 billion were advance
    payments that 15 States received by issuing bonds, backed by
    their future payments from the tobacco companies. Annually,
    total payments ranged from a high of $14.1 billion in 2001 to a
    low of $5.8 billion in fiscal year 2005. These total payments
    varied because they are adjusted for fluctuations in cigarette
    sales, inflation and other variables.
        Second, we found that States have allocated their payments
    to a wide variety of activities. Let me emphasize that the
    Master Settlement Agreement imposed no restrictions on how
    States could spend these payments. Some States told us that
    they viewed the tobacco settlement payments as an opportunity
    to fund those needs that they were not able to fund in the
    past, because of the high cost of healthcare.
        Many States deliberated, such as through special
    commissions, on how to allocate their payments. This chart to
    my left shows how the States allocated their payments, from
    fiscal years 2000-2005. The purple slice shows States allocated
    the largest portion of their total payments, 30 percent or
    $16.8 billion, toward healthcare activities, such as Medicaid,
    health insurance, hospitals, medical technology and research.
    The white slice shows a closely related category, tobacco
    control. States allocate about $1.9 billion or 3.5 percent of
    their total payments. Tobacco control addresses prevention,
    education enforcement and cessation activities. The red slice
    shows States allocated the second largest portion of their
    payments, about 23 percent or $12.8 billion, to help balance
    their budgets or reduce their deficits.
        In descending order, States used their tobacco settlement
    payments on general purposes and for structure projects,
    education and debt service on secure-type funds. The other tan
    slice category includes economic development for tobacco
    regions, social services reserve funds, tax reductions and
    payments to tobacco growers.
        In summary, tobacco settlement payments have varied from
    State to State and from year to year. The Master Settlement
    Agreement imposed no restrictions on how States could spend
    these settlement payments. As such, the States have allocated
    their payments to a wide variety of activities. States
    allocated the largest portion of their payments toward
    healthcare and the second largest to budget shortfalls.
        Mr. Chairman, this concludes my statement. I'd be pleased
    to respond to any questions that you or other members of the
    committee may have.
        [The prepared statement of Ms. Shames follows:]
                       Prepared Statement of Lisa Shames
       Tobacco Settlement--States' Allocations of Payments from Tobacco
                  Companies for Fiscal Years 2000 through 2005
                             why gao did this study
        In the 1990s, States sued major tobacco companies to obtain
    reimbursement for health impairments caused by the public's use of
    tobacco. In 1998, four of the Nation's largest tobacco companies signed
    a Master Settlement Agreement, agreeing to make annual payments to 46
    States in perpetuity as reimbursement for past tobacco-related health
    care costs. Some States have arranged to receive advance proceeds based
    on the amounts that tobacco companies owe by issuing bonds backed by
    future payments.
        This testimony discusses (1) the amounts of tobacco settlement
    payments that the States received from fiscal years 2000 through 2005,
    the most recent year for which GAO has actual data, and (2) the States'
    allocations of these payments. We also include States' projected fiscal
    year 2006 allocations.
        The Farm Security and Rural Investment Act of 2002 required GAO to
    report annually, through fiscal year 2006, on how States used the
    payments made by tobacco companies. GAO based this testimony on five
    annual surveys of these 46 States' Master Settlement Agreement payments
    and how they allocated these payments.
                                 what gao found
        From fiscal year 2000 through 2005, the 46 States party to the
    Master Settlement Agreement received $52.6 billion in tobacco
    settlement payments. Of the $52.6 billion total, about $36.5 billion
    were payments from the tobacco companies and about $16 billion were
    advance payments which several States had arranged to receive by
    issuing bonds backed by their future payments from the tobacco
    companies.
        The Master Settlement Agreement imposed no restrictions on how
    States could spend their payments, and as such, the States have chosen
    to allocate them to a wide variety of activities. Some States told us
    that they viewed the settlement payments as an opportunity to fund
    needs that they were not able to fund previously due to the high costs
    of health care. States allocated the largest portion of their payments
    to health care--$16.8 billion or 30 percent--which includes Medicaid,
    health insurance, hospitals, medical technology, and research. States
    allocated the second largest portion to cover budget shortfalls--about
    $12.8 billion or about 22.9 percent. This category includes allocations
    to balance State budgets or reduce deficits that resulted from lower
    than anticipated revenues, increased mandatory spending, or essential
    expenditures. Included among the next largest categories are
    allocations for infrastructure projects, education, debt service on
    securitized proceeds, and tobacco control.

        Mr. Chairman and members of the committee, I am pleased to be here
    today to contribute to your deliberation on the need for the Food and
    Drug Administration to regulate tobacco products. Tobacco use is the
    leading cause of preventable death in the United States. Most adults
    who use tobacco started using it between the ages of 10 and 18. A
    Surgeon General's report to the Congress concluded that preventing
    youth from starting to use tobacco is key to reducing tobacco-related
    deaths and disease. The Centers for Disease Control and Prevention
    reported a few years ago that, on average, more than 440,000 deaths and
    $76 billion in medical expenditures are attributable to cigarette
    smoking annually. Reducing tobacco-related deaths and the incidence of
    disease, along with their associated costs, is a significant public
    health challenge.
        Beginning in the mid-1990s, States sued the major tobacco companies
    for reimbursement of the cost of health impairments caused by the
    public's use of tobacco. The States alleged that the industry had
    violated antitrust and consumer protection laws, withheld information
    about the adverse health effects of tobacco, manipulated nicotine
    levels to keep smokers addicted, and conspired to keep less risky and
    less addictive tobacco products out of the market. Forty six States,\1\
    along with the District of Columbia and the five U.S. territories,
    negotiated and signed a settlement agreement, called the Master
    Settlement Agreement, with four of the largest tobacco companies--
    Philip Morris, USA; R.J. Reynolds Tobacco Company; Brown & Williamson
    Tobacco Corporation; and Lorillard Tobacco company. The settlement was
    the largest civil settlement in U.S. history. It committed the tobacco
    companies to pay the 46 States an estimated $200 billion \2\ over the
    first 25 years of the agreement, with payments to continue in
    perpetuity. In addition, it restricted the tobacco companies' marketing
    and advertising practices, among other things.
    ---------------------------------------------------------------------------
        \1\ The four States that are not party to the Master Settlement
    Agreement--Florida, Minnesota, Mississippi, and Texas--reached earlier,
    individual settlements with the tobacco companies.
        \2\ This original estimate does not take into account adjustments
    in tobacco companies' payments that have and will occur.
    ---------------------------------------------------------------------------
        Today, I will focus on how the 46 States party to the Master
    Settlement Agreement have allocated their settlement payments.
    Specifically, I will discuss (1) the amounts of Master Settlement
    Agreement payments that the States received from fiscal years 2000
    through 2005, the most recent year for which we have actual data, and
    (2) the States' allocations of these payments. The Farm Security and
    Rural Investment Act of 2002 (the 2002 Farm bill) required GAO to
    report annually, from fiscal years 2002 through 2006, on how these 46
    States used their Master Settlement Agreement payments.\3\ My testimony
    is based primarily on these annual reports.
    ---------------------------------------------------------------------------
        \3\ GAO, Tobacco Settlement: States' Allocations of Phase II Funds,
    GAO-03-262R (Washington, DC.: Dec. 3, 2002); GAO, Tobacco Settlement:
    States' Allocations of Fiscal Years 2002 and 2003 Master Settlement
    Agreement Payments, GAO-03-407 (Washington, DC.: Feb. 28, 2003); GAO,
    Tobacco Settlement: States' Allocations of Fiscal Year 2003 and
    Expected Fiscal Year 2004 Payments, GAO-04-518 (Washington, DC.: Mar.
    19, 2004); GAO, Tobacco Settlement: States' Allocations of Fiscal Year
    2004 and Expected Fiscal Year 2005 Payments, GAO-05-312 (Washington,
    DC.: Mar. 21, 2005); and GAO, Tobacco Settlement: States' Allocations
    of Fiscal Year 2005 and Expected Fiscal Year 2006 Payments, GAO-06-502
    (Washington, DC.: April 11, 2006).
    ---------------------------------------------------------------------------
        Our reports were based on our yearly surveys of the 46 States. Each
    year we asked the States to report (1) the amount of payments they
    received for the current State fiscal year, (2) the amount of payments
    they expected to receive for the next State fiscal year, and (3) their
    allocations of these payments among 13 spending categories. We
    independently corroborated the States' data to the extent possible by
    analyzing budget-related and legislative documents, and interviewing
    State budget officials, staff from State attorneys generals' offices
    and governors' offices and others as needed to clarify information. We
    performed our work in accordance with generally accepted government
    auditing standards.
        In summary, from fiscal year 2000 through fiscal year 2005, the
    States received $52.6 billion in Master Settlement Agreement payments
    from the tobacco companies in amounts that varied from state-to-state
    and from year to year. Of the $52.6 billion, about $36.5 billion were
    payments from the tobacco companies and about $16 billion were advance
    payments (securitized proceeds) that 15 States arranged to receive by
    issuing bonds backed by their future payments from the tobacco
    companies. The annual payments from the tobacco companies' are adjusted
    based on several factors that include fluctuations in the volume of
    cigarette sales, inflation, and other variables, such as the
    participating companies' shares of the tobacco market. Also, each
    State's share of the tobacco companies' annual payments is a fixed
    percentage based on smoking-related health care costs, which reflect
    population and smoking prevalence.
        The Master Settlement Agreement imposed no restrictions on how
    States could spend these settlement payments and, as such, the States
    have allocated their payments to a wide variety of activities. Some
    States told us that they viewed the settlement payments as an
    opportunity to fund needs that they were not able to fund previously
    due to the high costs of health care. States allocated the largest
    portion of their payments--30 percent or $16.8 billion--toward health
    care activities such as Medicaid, health insurance, hospitals, medical
    technology, and research. States allocated the second largest portion
    of their payments--about 23 percent or $12.8 billion--to help balance
    State budgets or reduce deficits that resulted from lower than
    anticipated revenues, increased mandatory spending, or essential
    expenditures.
        In descending order, the next largest categories where States used
    their tobacco settlement payments were general purposes, infrastructure
    projects, education, debt service on securitized funds, and tobacco
    control.
             States' Annual Tobacco Settlement Payments Have Varied
        The 46 States reported receiving a total of nearly $52.6 billion in
    payments in varying annual amounts from fiscal year 2000 through fiscal
    year 2005. Of the nearly $52.6 billion, about $36.5 billion were
    payments from the tobacco companies and about $16 billion were
    securitized proceeds that 15 States arranged to receive, as shown in
    table 1.

     Table 1.--Master Settlement Agreement Payments and Securitized Proceeds Received by the 46 States (Fiscal Years
                                                       2000-2005)
    ----------------------------------------------------------------------------------------------------------------
                                                                                   Securitized
                          Fiscal year                             Payments           proceeds            Total
    ----------------------------------------------------------------------------------------------------------------
    2000-2001..............................................    $13,200,000,000       $928,900,000    $14,128,900,000
    2002...................................................      6,238,393,496      3,838,376,465     10,076,769,961
    2003...................................................      6,306,329,459      6,482,764,469     12,789,093,928
    2004...................................................      5,340,128,223      4,374,698,723      9,714,826,946
    2005...................................................      5,453,132,303        389,977,667      5,843,109,970
                                                            --------------------------------------------------------
      Total................................................    $36,537,983,481    $16,014,717,324    $52,552,700,805
    ----------------------------------------------------------------------------------------------------------------
    Sources: GAO-01-851, GAO-03-407, GAO-04-518, GAO-05-312, GAO-06-502, State budget offices or their designees,
      and GAO analysis.
    Note: This table does not include payments to cities and counties in California and New York.

        The tobacco companies' annual payments are adjusted based on
    several factors contained in the Master Settlement Agreement that
    include fluctuations in the volume of cigarette sales, inflation, and
    other variables, such as the participating companies' share of the
    tobacco market. Declining tobacco consumption alone would result in
    lower Master Settlement Agreement payments than originally expected.
    Tobacco consumption has declined since the Master Settlement Agreement
    was signed in 1998--by about 6.5 percent in 1999 alone--mostly due to
    one-time increases in cigarette prices by the tobacco companies after
    the agreement took effect. Analysts project that, in the future,
    tobacco consumption will decline by an average of nearly 2 percent per
    year.\4\ As a result, tobacco consumption is estimated to decline by 33
    percent between 1999 and 2020.
    ---------------------------------------------------------------------------
        \4\ Cigarette consumption peaked in 1981 and has been declining
    since.
    ---------------------------------------------------------------------------
        However, the Master Settlement Agreement also includes an inflation
    adjustment factor that some analysts have estimated increases payments
    more than any decreases caused by reduced consumption. The inflation
    adjustment equals the actual percentage increase in the Consumer Price
    Index for the preceding year or 3 percent, whichever is greater. The
    effect of these compounding increases is potentially significant,
    especially given that the payments are made in perpetuity. Assuming a
    3-percent inflation adjustment and no decline in base payments,
    settlement amounts received by States would double every 24 years.
        Also, several tobacco companies' interpretation of the provision
    that addresses participants' market share led them to lower their
    payments in 2006. Under this provision, an independent auditor
    determined that participating tobacco companies lost a portion of their
    market share to nonparticipating companies. An economic research firm
    determined that the Master Settlement Agreement was a significant
    factor in these market share losses. Based on these findings, several
    participating companies reduced their fiscal year 2006 payments by a
    total of about $800 million. Many States have filed suit to recover
    these funds.
        Each State's share of the tobacco companies' total annual payments
    is a fixed percentage that was negotiated during the settlement. These
    percentages are based on two variables related to each State's smoking-
    related health care costs, which reflect each State's population and
    smoking prevalence. In general, the most populous States receive a
    larger share of the tobacco companies' total annual payments than the
    less populous States. For example, California and New York each receive
    about 13 percent, while Alaska and Wyoming each receive less than 1
    percent. However, these percentages are not strictly proportional to
    population.
        In addition to the annual payments States receive, the Master
    Settlement Agreement requires that a Strategic Contribution Fund
    payment begin in 2008 and continue through 2017. The base amount of
    each year's Strategic Contribution Fund payment is $861 million, which
    will be adjusted for volume and inflation and shared among the States.
    Strategic Contribution Fund payments are intended to reflect the level
    of the contribution each State made toward final resolution of their
    lawsuit against the tobacco companies. They will be allocated to the
    States based on a separate formula developed by a panel of former State
    attorneys general.
       states are exercising their flexibility to use tobacco settlement
                   payments for a wide variety of activities
        The Master Settlement Agreement imposed no restrictions on how
    States could spend their settlement payments and, as such, the States
    have allocated their payments \5\ to a wide variety of activities, with
    health-related activities the largest among them. As part of their
    decisionmaking on how to spend their payments, some States established
    planning commissions and working groups to develop recommendations and
    strategic plans for allocating their States' payments. In six States,
    voter-approved initiatives restricted use of the funds and, in 30
    States, the legislatures enacted laws restricting their use.
    ---------------------------------------------------------------------------
        \5\ When States allocate payments, they may include carry-over
    funds from prior years and interest earned; therefore, in any 1 year,
    States' payments and securitized proceeds may not equal payments
    allocated for spending.
    ---------------------------------------------------------------------------
        Overall, we identified 13 general categories to which States have
    allocated their Master Settlement Agreement payments, as shown in table
    2. Appendix I provides more details on the categories to which States
    allocated their payments.

        Table 2.--Amount and Percentage of States' Allocations of Master
       Settlement Agreement Payments and Securitized Proceeds by Category,
                             Fiscal Years 2000-2005
                        [Dollars in millions and percent]
    ------------------------------------------------------------------------
                          Category                         Dollars   Percent
    ------------------------------------------------------------------------
    Health..............................................   $16,807      30.0
    Budget shortfalls...................................    12,806      22.9
    Unallocated.........................................     6,639      11.9
    General purposes....................................     3,955       7.1
    Infrastructure......................................     3,350       6.0
    Education...........................................     3,078       5.5
    Debt service on securitized funds...................     3,005       5.4
    Tobacco control.....................................     1,943       3.5
    Economic development for tobacco regions............     1,490       2.7
    Social services.....................................       961       1.7
    Reserves/rainy day funds............................       810       1.4
    Tax reductions......................................       616       1.1
    Payments to tobacco growers.........................       521       0.9
                                                         -------------------
      Total.............................................   $55,981     100.1
    ------------------------------------------------------------------------
    Source: GAO analysis of data from State budget offices and their
      designees.
    Note: Percentages do not total to 100 due to rounding. Also, States'
      allocations do not match the payment amounts on an annual basis
      because States have carried over funds from 1 year to the next and
      earned interest on their payments.

        States allocated the largest portion of their payments--about $16.8
    billion, or 30 percent of the total payments--to health-related
    activities. To a closely related category--tobacco control--States
    allocated $1.9 billion, or 3.5 percent of their total payments. States
    allocated the second largest portion of their payments--about $12.8
    billion or 22.9 percent--to cover budget shortfalls. Some States told
    us that they viewed the settlement payments as an opportunity to fund
    needs that they were not able to fund previously due to the high cost
    of health care. Figure 1 illustrates the relative magnitude of the
    categories receiving allocations.

        The seven largest categories of allocations, in descending order,
    are health, budget shortfalls, general purposes, infrastructure,
    education, debt service on securitized funds, and tobacco control.
    States' allocations to these categories have varied considerably from
    year to year--with some categories showing wide fluctuations. For
    example, for budget shortfalls, the States allocated from 2 to 44
    percent of the total payments. On the other hand, for health care, the
    States allocated from 20 to 38 percent of the total payments. Figure 2
    shows these annual changes for these seven categories.

        Information about how States have allocated their Master Settlement
    Agreement payments follows.
        Health.--From fiscal years 2000 through 2005, States allocated
    about $16.8 billion of their Master Settlement Agreement payments to a
    variety of health care programs, including Medicaid; health insurance;
    cancer prevention, screening, and treatment; heart and lung disease;
    and drug addiction. Over this period, the amounts States allocated to
    health care ranged from about $1.9 billion in fiscal year 2005 to
    nearly $4.8 billion in fiscal years 2000-2001 combined.
        In fiscal year 2005, the most recent year for which we collected
    actual data, 36 of the 46 States allocated some of their Master
    Settlement Agreement payments to health care. Of the 36 States, 5
    States allocated two-thirds or more of their payments to health care;
    19 States allocated one-third to two-thirds; and 12 States allocated
    less than one-third. Ten States did not allocate any of their payments
    to health care activities. In fiscal year 2005, Pennsylvania, Illinois,
    Michigan, and Maryland allocated larger amounts to health care than the
    other States. Pennsylvania allocated over $326 million of its payments
    to health care programs for adult health insurance, uncompensated care,
    medical assistance for workers with disabilities, and community medical
    assistance. Illinois allocated nearly $204 million of its payments to
    health care, citing Medicaid drugs as a key program that would receive
    funds. Michigan allocated over $185 million of its payments to areas
    such as elder pharmaceutical assistance and Medicaid support programs.
    Maryland allocated nearly $100 million of its payments to areas such as
    Medicaid; cancer prevention, screening, and treatment; heart and lung
    disease; and drug addiction.
        Budget Shortfalls.--From fiscal years 2000 through 2005, States
    allocated about $12.8 billion of their Master Settlement Agreement
    payments to budget shortfalls. Over this period, the amounts the States
    allocated to budget shortfalls ranged from a high of about $5.1
    billion, or 44 percent of the total payments in fiscal year 2004, to
    $261 million, or 4 percent in fiscal year 2005. In fiscal year 2005,
    only 4 of the 46 States allocated some of their Master Settlement
    Agreement payments to budget shortfalls. Of these States, only Missouri
    allocated more than one-third of its total payments--about $72
    million--to budget shortfalls.
        General Purposes.--From fiscal years 2000 through 2005, States
    allocated about $4 billion of their Master Settlement Agreement
    payments to general purposes, including law enforcement, community
    development activities, technology development, emergency reserve
    funds, and legal expenses for enforcement of the Master Settlement
    Agreement. Over this period, the amounts States allocated to general
    purposes ranged from $623 million, or about 5 percent of the total
    payments they allocated in fiscal years 2000-2001 combined, to about
    $1.1 billion, or 8 percent in fiscal year 2003.
        In fiscal year 2005, 27 of the 46 States allocated some of their
    Master Settlement Agreement payments to general purposes. Of these 27
    States, 4 States allocated two-thirds or more of their total payments
    to general purposes; 2 States allocated one-third to two-thirds; and 21
    States allocated less than one-third. Nineteen States did not allocate
    any of their payments to general purposes. Massachusetts, Tennessee,
    Connecticut, and Colorado allocated the largest amounts to general
    purposes in fiscal year 2005. Massachusetts allocated nearly $255
    million of its payments to general purposes for its General Fund,
    Tennessee allocated nearly $157 million of its payments to its General
    Fund, and Connecticut allocated about $113 million of its payments to
    its General Fund. Colorado allocated about $64.5 million of its
    payments to general purposes, but did not specify which programs would
    receive funds.
        Infrastructure.--From fiscal years 2000 through 2005, States
    allocated about $3.4 billion of their Master Settlement Agreement
    payments to infrastructure-related activities, including capital
    maintenance on State-owned facilities, regional facility construction,
    and water projects. Over this period, the amounts States allocated to
    infrastructure have ranged from $31 million, or about 1 percent of the
    total payments in fiscal year 2005, to about $1.2 billion, or 10
    percent in fiscal year 2002.
        In fiscal year 2005, 5 of the 46 States allocated some of their
    Master Settlement Agreement payments to infrastructure. Of these 5
    States, North Dakota was the only State that allocated more than one-
    third of its total payments to infrastructure. North Dakota, Hawaii,
    and Kentucky allocated the largest amounts to infrastructure in fiscal
    year 2005. North Dakota allocated about $10.5 million of its payments
    to infrastructure for work on water projects. Hawaii allocated
    approximately $10 million of its payments to infrastructure, citing
    debt service on University of Hawaii revenue bonds issued for the new
    Health and Wellness Center as a primary program that would receive
    funds. Kentucky allocated $6.1 million of its payments to service debt
    on such things as water resource development and a Rural Development
    Bond Fund.
        Education.--From fiscal years 2000 through 2005, States allocated
    about $3 billion of their Master Settlement Agreement payments to
    education programs, including early childhood development; special
    education; scholarships; after-school services; and reading programs.
    Over this period, the amounts States allocated to education ranged from
    between $280 million or 2 percent of the total payments in fiscal year
    2004, to over $1.1 billion, or 9 percent, in fiscal year 2002.
        In fiscal year 2005, 16 of the 46 States allocated some of the
    Master Settlement Agreement payments to education. Of the 16 States,
    only New Hampshire allocated more than two-thirds of its total payments
    to education; 4 States allocated between one-third and two-thirds to
    education; and 11 States allocated less than one-third. Thirty States
    did not allocate any of their payments to education-related activities.
    Michigan, New Hampshire, Nevada, and Colorado allocated the largest
    amounts to education in fiscal year 2005. Michigan allocated over $99
    million of its payments to education for Merit Award scholarships and
    tuition incentive grants for higher education students; the Michigan
    Educational Assessment Program testing for K-12 students, nursing
    scholarships, the Michigan Education Savings Plan, and general higher
    education support. New Hampshire allocated $40 million of its payments
    to areas such as an Education Trust Fund, which distributes grants to
    school districts in the State. Nevada allocated about $33 million of
    its payments to education programs, citing a scholarship program for
    Nevada students attending Nevada's higher education institutions as a
    key recipient. Colorado allocated over $16 million of its payments to
    education, including its Read to Achieve program.
        Debt Service on Securitized Funds.--From fiscal years 2000 through
    2005, States allocated about $3 billion of their Master Settlement
    Agreement payments to servicing debt on securitized funds. This
    category consists of amounts allocated to servicing the debt issued
    when a State securitizes all or a portion of its Master Settlement
    Agreement payments. Over this period, the amounts States allocated for
    this purpose have ranged from $271 million, or about 2 percent of the
    total payments in fiscal year 2002, to about $1.4 billion, or about 24
    percent, in fiscal year 2005. In fiscal year 2005, four States--
    California, Rhode Island, South Carolina, and Wisconsin--allocated 100
    percent of their Master Settlement Agreement payments to servicing debt
    on securitized funds, while New Jersey allocated just under 100
    percent. In addition, Alaska, Louisiana, and South Dakota, allocated
    more than half of their payments for this purpose. In fiscal year 2005,
    California and New York allocated the largest amounts to servicing debt
    on securitized funds.
        Tobacco Control.--From fiscal years 2000 through 2005, States
    allocated about $1.9 billion of their Master Settlement Agreement
    payments to tobacco control programs, including prevention, cessation,
    and counter marketing. Over this period, the amounts States allocated
    to tobacco control ranged from $790 million, or about 6 percent of the
    total payments in fiscal years 2000-2001 combined, to $223 million, or
    about 2 percent, in fiscal year 2004.
        In fiscal year 2005, 34 of the 46 States allocated some of their
    Master Settlement Agreement payments to tobacco control programs. Of
    the 34 States, Wyoming allocated more than one-third of its payments to
    tobacco control, while 33 States allocated less than one-third. Twelve
    States did not allocate any of their payments to tobacco control-
    related programs.
        Pennsylvania and Ohio allocated more than the other States to
    tobacco control--about $44 million and $37 million, respectively--in
    fiscal year 2005.
        Mr. Chairman, this concludes my prepared statement. I would be
    pleased to respond to any questions that you or other members of the
    committee may have.
                                     ______

                 Appendix I: Categories of States' Allocations
        To standardize the information reported by the 46 States, we
    developed the following categories and definitions for the program
    areas to which States allocated their payments.
        Budget Shortfalls.--This category is comprised of amounts allocated
    to balance State budgets and close gaps or reduce deficits resulting
    from lower than anticipated revenues or increased mandatory or
    essential expenditures.
        Debt Service on Securitized Funds.--This category consists of
    amounts allocated to service the debt on bonds issued when the State
    securitized all or a portion of its Master Settlement Agreement
    payments.
        Economic Development for Tobacco Regions.--This category is
    comprised of amounts allocated for economic development projects in
    tobacco States such as infrastructure projects, education and job
    training programs, and research on alternative uses of tobacco and
    alternative crops. This category includes projects specifically
    designed to benefit tobacco growers as well as economic development
    that may serve a larger population within a tobacco State.
        Education.--This category is comprised of amounts allocated for
    education programs such as day care, preschool, Head Start, early
    childhood education, elementary and secondary education, after-school
    programs, and higher education. This category does not include money
    for capital projects such as construction of school buildings.
        General Purposes.--This category is comprised of amounts allocated
    for attorneys' fees and other items, such as law enforcement or
    community development, which could not be placed into a more precise
    category. This category also includes amounts allocated to a State's
    general fund that were not earmarked for any particular purpose.
    Amounts used to balance State budgets and close gaps or reduce deficits
    should be categorized as budget shortfalls rather than general
    purposes.
        Health.--This category is comprised of amounts allocated for direct
    health care services; health insurance, including Medicaid and the
    State Children's Health Insurance Program (SCHIP); hospitals; medical
    technology; public health services; and health research. This category
    does not include money for capital projects such as construction of
    health facilities.
        Infrastructure.--This category is comprised of amounts allocated
    for capital projects such as construction and renovation of health
    care, education, and social services facilities; water and
    transportation projects; and municipal and State government buildings.
    This category includes retirement of debt owed on capital projects.
        Payments to Tobacco Growers.--This category is comprised of amounts
    allocated for direct payments to tobacco growers, including subsidies
    and crop conversion programs.
        Reserves/Rainy Day Funds.--This category is comprised of amounts
    allocated to State budget reserves such as rainy day and budget
    stabilization funds not earmarked for specific programs. Amounts
    allocated to reserves that are earmarked for specific areas are
    categorized under those areas--e.g., reserve amounts earmarked for
    economic development purposes should be categorized in the economic
    development category.
        Social Services.--This category is comprised of amounts allocated
    for social services such as programs for the aging, assisted living,
    Meals on Wheels, drug courts, child welfare, and foster care. This
    category also includes amounts allocated to special funds established
    for children's programs.
        Tax Reductions.--This category is comprised of amounts allocated
    for tax reductions such as property tax rebates and earned income tax
    credits.
        Tobacco Control.--This category is comprised of amounts allocated
    for tobacco control programs such as prevention, including youth
    education, enforcement, and cessation services.
        Unallocated.--This category is comprised of amounts not allocated
    for any specific purpose, such as amounts allocated to dedicated funds
    that have no specified purpose; amounts States chose not to allocate in
    the year Master Settlement Agreement payments were received that will
    be available for allocation in a subsequent fiscal year; interest
    earned from dedicated funds not yet allocated; and amounts that have
    not been allocated because the State had not made a decision on the use
    of the Master Settlement Agreement payments.

        The Chairman. Thank you very much. We'll have a 5-minute
    time limit on questioning. Dr. Land, let me ask you this--you
    must represent a part of the country where smoking is widely
    used, or perhaps used more frequently than in other parts of
    the country. What do your parishioners say about your
    involvement on this issue, when they've got a range of
    different kinds of moral issues that they're concerned about.
    Do they say, why are you interested in this smoking issue when
    there are many other negative activities that are going on in
    their communities or in the country or the world?
        Mr. Land. No, sir. They expect us to be able to walk and
    chew gum at the same time. They think our attention span is up
    to the task. As I pointed out at the beginning of my testimony,
    Southern Baptists have long had concern about tobacco use and
    indeed, we do have a lot of constituents in parts of the
    country where tobacco has been an important product but those
    resolutions are passed by majority vote of the constituents who
    elect their representatives. The Southern Baptist Convention,
    when it meets every June and passes these resolutions, is the
    largest deliberative parliamentary body in the world. Those
    44,000 autonomous churches elect messengers who go to the
    convention and conduct business and they vote on these issues.
    They also voted to elect the trustees that elected me. I serve
    at the pleasure of the Southern Baptist Convention. There is
    somewhat of a generation gap. People older than myself tend to
    have somewhat different views toward tobacco than people
    younger than myself and since I'm now 60, a lot of the people
    who would be more ambivalent about this are older or have--you
    know, tobacco smokers tend to be a declining constituency
    because they die. When I first came to the Commission in 1988,
    we have several Sundays on the Denominations Calendar where we
    are charged to produce materials to help them observe these
    Sundays and one of those Sundays is Alcohol and Drug Abuse
    Sunday. The first one that I had the opportunity to choose the
    issue we were going to deal with, I chose nicotine for 1990 and
    this raised some eyebrows in 1988. They said, ``Wow, you're
    going to take on tobacco?'' And I said, ``We absolutely are.''
    We were braced for a large response, negative and we got very,
    very little. I would remind you that in 1984, the Southern
    Baptist Convention, in session, passed a resolution,
    overwhelmingly, that called for government to end subsidies to
    tobacco growth and to encourage individual Southern Baptists
    who were tobacco farmers, to find alternative means and
    alternative crops and to no longer grow tobacco. That was in
    1984 and it was passed by the elected messenger to the
    Convention overwhelmingly.
        The Chairman. OK. This is primarily because of the dangers
    to children. Am I right?
        Mr. Land. Well, we are particularly concerned about these
    deceptive advertising messages to children who do not have the
    maturity and the responsibility to make these decisions but
    it's also because it has obviously seeped into the conscious of
    people in the faith community as it has other people in this
    society, that this is a very dangerous product and I don't
    think there is any American who has reached maturity, who
    doesn't know people personally who have died from the use of
    this product. It really has seeped into the conscious. I smiled
    when I heard the reference to lard. I mean, it really is--
    people do understand that this is really a destructive product.
        The Chairman. Thank you. Mr. Myers, let me come back to you
    for a quick response to Dr. Blum, who says there is no evidence
    that this bill will save lives. He says, it's deceptive, it's
    harmful to the public health, it's a Marlboro Protection Act.
    It should carry its own warning label. Pretty strong indictment
    of the legislation. Your response?
        Mr. Myers. I have great respect for Dr. Blum but I think it
    is not an accurate factual representation of what is in the
    bill. He said that the bill would strictly regulate new
    products but not apply the same standards to existing products.
    That's just wrong. Section 907 gives the FDA broad authority to
    regulate existing products as well as new products; in fact,
    it's the strongest regulatory standard ever proposed for any
    regulatory agency whatsoever.
        He said it will inhibit the introduction of new products.
    That too, is wrong. What it will do is inhibit manufacturers
    from making health claims for new products before they have the
    scientific evidence from doing so. As we know, our experience
    shows that if you allow tobacco companies to make claims for
    products, not only will they mislead the public but they won't
    have any incentive to make actually less hazardous products. If
    anything, this bill will, for the first time, give tobacco
    companies and others, the incentives to make serious changes to
    those products.
        He said it has no mandates to eliminate toxic gases. That's
    wrong. It provides the FDA with full authority to require
    changes in toxic materials, including gases, in them. We have
    to understand what the status quo is. The status quo is nobody
    has any authority to require any tobacco company to make any
    change in its product and as a result of that, the status quo
    is that the changes the tobacco companies make are more
    accurately what Dr. Henningfield described--those that make the
    product more addictive, more attractive without regard to its
    health hazards. He spoke about the past failed efforts. The
    problem is, we have relied on voluntary action in the past. So
    when he talks about advertisements about Carlton is the lowest,
    he ignores the fact that this bill would allow the FDA--a
    matter of fact, it would mandate that the FDA prevent exactly
    those kinds of claims, absent scientific evidence. Not only
    that the claim is truthful but that the claim is being made in
    such a way so that it won't discourage millions of people from
    smoking. He claims that it doesn't mandate the elimination of
    menthol. Well, that's one of those half-truth statements that
    is very important. It gives FDA authority to regulate menthol
    but to do it in a way based on sound science as opposed to
    making a political decision without knowing what the impact
    would be automatically today of eliminating it.
        Dr. Blum's experience in this field is unparalleled in
    terms of its length. But when you look at the terms of this
    legislation, it presents a very different picture when you look
    at its details than what was presented as the underpinning of
    his testimony.
        The Chairman. Dr. Blum, my time is up, but I will give you
    an opportunity to respond if you don't get that opportunity
    with other questioners.
        Senator Enzi.
        Senator Enzi. Mr. Chairman, I won't be able to pass up the
    opportunity on that but I've got to tell you, I've got hundreds
    of questions--no, I started with hundreds of questions. Now
    I've got a lot more and I do appreciate that all of you
    volunteered to testify. I hope you also volunteered to answer
    questions that we won't have time to put in, in just 5 minutes.
        Mr. Myers, to follow up just a little bit on what you said,
    before I give Mr. Blum a chance to unload----
        [Laughter.]
        Even if it is a new product and the FDA says that it's okay
    to sell it, isn't that putting an FDA stamp of approval on a
    product that is going to kill them? Or is it going to be made
    safe enough that it won't?
        Mr. Myers. You raise a very thoughtful and important
    question. The bill was carefully crafted; in fact, there are at
    least five different sections of the legislation that would
    authorize FDA to prohibit a manufacturer from saying that a
    product is FDA approved. If FDA found that that was necessary
    to protect the public health because the drafters of this
    legislation were concerned about the same issue. In fact, FDA
    doesn't approve most products. What FDA does is approve--well,
    whether or not there is adequate scientific evidence to make a
    claim so that will prevent the tobacco companies from
    misleading the public the way they currently do. And the only
    time the FDA actually gets in the process of approving whether
    a new product comes on the market, is when it is not
    substantially equivalent. So the issue you raise is a very
    important one. This legislation has tried in a very thoughtful
    way----
        Senator Enzi. My time is pretty limited. I think you've
    made your point.
        Mr. Myers. To prevent the tobacco companies from doing
    exactly what you're----
        Senator Enzi. Actually, from the FDA hearings that we've
    had, they can't control labeling, they can't control
    advertising. They can suggest.
        Mr. Myers. But this is----
        Senator Enzi. Now, on a reform bill that we have, there
    would be some additional criteria on that, but any way you look
    at it, they'll be able to say, the constituents were approved
    or looked at. I wish I had time to ask Mr. Henningfield some
    more questions about some things like that. Another thing that
    will come into it, is who is going to pay the fees on this?
    We're looking at the medical device and drug user fee programs
    and trying to figure out how to get all of the pay for that
    sort of thing. Can we get the companies to pay for all of the
    testing? And I do suggest that we would have to back up to the
    very beginning on the testing and test every single ingredient
    every time there is a change. Mr. Blum, you looked like you had
    a few comments you wanted to make on those, too.
        Dr. Blum. Part of the unloading process here, thank you,
    Senator Enzi. I think this bill creates a bridge on the River
    Kwai for the tobacco industry. It's what they want, at least
    Philip Morris does, because it will have government sanctioned
    cigarettes. We already know what Marlboro does. Marlboro kills.
    Whatever the market share is, it's 40 percent of the market--
    Marlboro is taking the lives of 40 percent of those 400,000
    that die from tobacco smoke every year. What more is there to
    know? The definition of--research that we need to know more on
    is the definition of infinity. There are always going to be
    curious questions. But we already know what cigarettes do to
    you. All the other tobacco products put together do not cause
    the harm that cigarettes do and this regulation largely
    grandfathers in Marlboro. Sure, as Matt Myers said, it does
    grant the authority of the FDA to do certain things, to maybe
    consider these things and modify the product but it doesn't
    mandate. The only thing the bill mandates is candy flavorings,
    bigger warning labels or new and improved warning labels so if
    the deaf person can't hear you, you've got to yell louder. And
    it has more of the kinds of reliance on machine measurements,
    which Dr. Connolly, in his recent article in Tobacco Control,
    has said is bogus. So the science that the FDA is going be
    relying on is by those who study what kinds of statistics we're
    relying on anyway, through machine measurements of tar and
    nicotine are already unreliable. Where is the science standard
    going to come from? I don't think anybody knows that.
        There is also the matter of ethics. If you were to conduct
    research to show whether or not a product is going to cause
    reduced harm, I don't know of any institutional review board at
    any university that would approve those subjects to take
    Cigarette A or Cigarette B or tobacco product A and tobacco
    product B and study those over the 20 and 30 years that it will
    take to see whether one product reduces harm over another.
        This cigarette bill will not affect the sale of cigarettes
    in pharmacies. We're the only country in the world where
    cigarettes are sold alongside medications. As Paul Harvey said,
    ``America is the only place where the sick people have to walk
    all the way in the back to get their medicines and healthy
    people get their cigarettes right up front.''
        Senator Enzi. I thank you and as I mentioned, I've got
    questions for everybody. I have particularly some numbered
    questions as the only accountant, I'm always fascinated by the
    numbers, so I apologize for not having an opportunity to ask
    them right now but I will put those in writing and would
    suggest that maybe the Federal Trade Commission ought to be
    involved in this, maybe as opposed to the FDA. They are the
    ones that really control false advertising or I hope control
    false advertising. And that's what we're talking about here,
    besides the need to do more testing and have more disclosure.
    But I just worry a lot about this FDA seal of approval, whether
    implied or actual, that's going to come about through this
    process. We've got to find some way. The oncologist that worked
    with my wife had the hospital attorney visit him because he
    said that he wasn't going to treat people that smoked anymore
    for cancer because they were working against themselves and
    there's a little bit of a brouhaha going on over that. But we
    know that cigarettes kill. Now we've got to figure out how we
    can keep it from killing as many people.
        The Chairman. Senator Brown.
        Senator Brown. Thank you, Mr. Chairman. As we know, smoking
    kills some 400,000-plus Americans a year and we also know the
    tobacco companies know they have to replace those customers
    with young smokers and that's sort of been the thrust, it seems
    in all of this. We've sat through hearings for years, many of
    us and seen the sort of growing sophistication of the tobacco
    industry. It used to be Joe Camel. It used to be billboards
    near schoolyards, clever mailings, free samples, all the things
    they do. Dr. Huerta mentioned Camel No. 9 and I have a mailing
    here that this is--those of you that buy perfume can see that
    this looks a lot like it could be a perfume package, Camel No.
    9. And you open this up, Camel No. 9 introducing our smoothest
    smoke sensation. Light and luscious. Are you ready to flaunt
    it? No. 9, take your No. 9 experience to the next level. This
    stylish, sexy cigarette case. If you look in really small
    print--and because I'm way older than the people they are
    appealing to, I have to use these cheap $6 glasses--an offer is
    on a Web site restricted to legal and tobacco consumers. But it
    says, just your smokes to the nines with a complimentary
    cigarette case. Take a pack at Camelsmokes.com and you'll be
    smoking in style in no time. Then again, light and luscious.
    You pull this out. I believe they can't actually send you a
    pack of cigarettes. That's the DMSA, I believe, but you open
    this up and it looks a lot like it. Then you strike gold with
    four coupons, $2 off, $2 off. Buy one pack, get one free, buy
    one pack, get one free. This is the kind of--and it's strains
    the imagination to think that this campaign is aimed at anybody
    other than 15, 16, 17-year-old girls, something that is a
    violation of the MSA, to be sure but maybe more importantly,
    pretty morally repugnant and a violation of what I think Dr.
    Land with his values and what all the public health people, all
    of whom find this pretty repugnant. Dr. Huerta, my question for
    you is about price. As you know, the 10 percent is pretty
    elastic--elastic economics, if you will, to the pricing of
    cigarettes. Ten percent increase in price generally brings a 7
    percent decline in youth consumption. They are still finding
    ways, obviously, to make tobacco, the introduction of smoking
    to young people, they're finding a way to make it less and less
    expensive and more and more appealing until they're addicted
    and they may go beyond that.
        The tobacco industry, I understand, spends about $10
    billion on promotion, price promotion, obviously much of it to
    children, to recruit new people as the 400,000 people a year
    die. How should FDA, if this bill passes, how should FDA
    address things like this? How should FDA especially, more
    pointedly, address the whole issue of price and the kinds of
    price deals that the tobacco industry offers?
        Dr. Huerta. Thank you for the question. What the FDA, in my
    opinion, should do is base all their opinions on signs. And if
    the signs say that the tobacco companies are not allowed to
    make any claim, then FDA should not allow the companies to make
    that particular claim regarding marketing. Marketing--it's a
    whole chapter in the FDA regulation now, even we see that every
    day with the pharmaceutical companies that are doing this
    direct to consumer marketing practices on television and we are
    seeing that FDA is now taking a very active approach to these
    marketing techniques. So I would say that's a chapter that
    needs to be discussed among the experts of marketing but my
    feeling is that if the claim that the tobacco companies want to
    do is not based on science, they shouldn't be allowed to do it.
        The Chairman. Thank you very much.
        Senator Burr.
        Senator Burr. Thank you, Mr. Chairman. I have listened
    intently to everybody's testimony and I want to applaud you for
    bringing a lot to the table. There is only one major difference
    I have, it is that I am not yet convinced that all the things
    that you pointed out have to happen at the FDA. I have very few
    disagreements with some of the items that were highlighted by
    each of you and I'll try to go through some of those but let me
    ask first, just so I know.
        If given the authority, would you outlaw tobacco today?
    Just a quick yes or no.
        Matt.
        Mr. Myers. No, sir.
        Senator Burr. Dr. Huerta.
        Dr. Huerta. No.
        Senator Burr. Dr. Land.
        Mr. Land. No, sir.
        Senator Burr. Right down the line.
        Mr. Henningfield. No.
        Mr. Connolly. No.
        Dr. Blum. No. I'm not in favor of prohibition.
        Senator Burr. I'm not going to ask you.
        Ms. Shames. I can't----
        Senator Burr. Dr. Huerta, you mentioned five things and I
    only got four of them but I think the four really do encompass
    what your message was. Magazine advertising--still going on,
    still affects children. In-store advertising--it certainly goes
    on, affects children. Outdoor signage, billboards gone but
    outdoor signage based upon the agreement in the MSA still
    exists, could influence children's decisions. Let me just
    simply ask you--and you mentioned no compliance. If we could
    address that in a way that you and I and Matt Myers and others
    said, you know, we have eliminated the ability to advertise to
    children. Can you live with that authority, staying at the
    Federal Trade Commission and the Department of Justice?
        Dr. Huerta. It seems to me that--of course, I'm a profound
    respectful person of the first amendment but there are limits
    for what you can--the way you can promote your products.
        Senator Burr. Clearly to accomplish this without a
    constitutional challenge would require an agreement by the
    industry as well, to ban certain things. If we could accomplish
    that, are you comfortable that the Federal Trade Commission and
    the Department of Justice can, in fact, bring that degree of
    compliance and assurance to you and to me and to everybody
    else?
        Dr. Huerta. It's going to be difficult and would probably
    require a lot of discussion.
        Senator Burr. Difficult to believe that they could bring
    that level of regulation? To enforce it?
        Dr. Huerta. Well, they are different forces playing here. I
    mean, the tobacco industry, obviously they want to sell their
    products and we want to protect the public so we meet you----
        Senator Burr. Dr. Huerta, let me stop you. I'm talking
    about a direct, specific ban. Are you comfortable with a direct
    specific ban being administered by the Federal Trade Commission
    and the Department of Justice?
        Dr. Huerta. No. Bans are not good for society. That's what
    I can tell you.
        Senator Burr. OK. Matt, are Phase 4 clinical trials
    important at the FDA for the safety and efficacy of drugs?
        Mr. Myers. For drugs?
        Senator Burr. Yes, sir.
        Mr. Myers. We're not talking about--and I apologize to you.
    I'm not an expert on drug clinical trials so I need to be
    careful with regard to those issues.
        Senator Burr. Sure.
        Mr. Myers. And that's not what we're talking about with
    regard to this legislation.
        Senator Burr. Well, I appreciate you acknowledging that,
    but that's exactly my point--there are some that are very
    engaged in this but have absolutely no idea what the FDA is
    faced with, day in and day out. And Phase 4 clinical trials
    determine dosage. The safety and efficacy is already determined
    long before then but yes, Phase 4 trials are extremely
    important to the outcome for a patient.
        Dr. Connolly, you went--put your props back up there, would
    you? I mean, I appreciate the fact that you brought something
    that visualizes the challenge. And the challenge is that we're
    way behind the curve from the standpoint of the degree that we
    make adults aware of the risk. Now, let's assume for a second
    that whether it was the half a pack size warning or whether it
    was the full back of the pack size warning, which I think is
    Brazil. If we codified that into law, would you feel
    comfortable if, in fact, the enforcement for that was part of
    the FTC and the Department of Justice versus the FDA?
        Mr. Connolly. No. I think the thing that you're forgetting
    is the product is linked with the marketing. Now, let me just--
    let me finish my point--you asked a question, sir. When you saw
    that blue pellet up there in Camel--that blue pellet is in the
    product. It's unregulated by FTC but that blue pellet, in part,
    is a very specific flavor that is tied to a Web site that is
    tied to a marketing claim that is tied to----
        Senator Burr. Dr. Connolly, I appreciate your point but I'm
    asking specifically about the warning label. I don't disagree
    with you. I don't disagree.
        Mr. Connolly. We don't know. We're testing these--we're
    testing warning labels among children in Crete to determine if
    this is better than this and we think among the children, this
    is better. I wish we could test it----
        Senator Burr. Dr. Connolly, my colleagues----
        Mr. Connolly. Back to the FDA with data and then let them
    make a reasoned choice on what works best--pictorials versus
    verbals. My impression would be, the FDA could make that
    decision, not the FTC. The FTC's most recent smokers report--
    the most recent one is 2001.
        Senator Burr. Dr. Connolly, I know where we are today.
        Mr. Connolly. Right.
        Senator Burr. Legally. I'm talking about if we codify in
    law, exactly what it has to say, are you comfortable with the
    FTC and the Department of Justice, in fact, enforcing it
    because I've got problems--Senator Kennedy has a bill right now
    that's addressing drug safety and labeling deficiencies at the
    FDA.
        Mr. Connolly. I'm very uncomfortable. You need joint
    regulation between FDA to regulate the product and regulate the
    marketing. Right now, we've got one arm tied behind our back.
    We're leaving the attorney generals to deal with consumer
    protection issues and the FTC but we're not dealing with public
    health issues in the product. What they're adding to the
    product can make this the most popular product with kids. We
    need combined regulation with both the FDA and with the
    consumer protection actions by the FTC and by attorney generals
    to address the issue of smoking among youth. If we let the blue
    pellets sit in the product, if we let them manipulate menthol
    levels, all the work and effort we do to restrain the claims,
    the marketing are for naught.
        Senator Burr. Dr. Connolly----
        Mr. Connolly. We have to have a comprehensive approach in
    this Nation. It's about time we had a comprehensive approach,
    worried about our children and not about the economic interest
    of this industry.
        Senator Burr. Dr. Connolly, I appreciate your passion on
    this.
        Mr. Connolly. Thank you very much, sir.
        Senator Burr. And I'm not proposing or suggesting that
    there not be a comprehensive approach to this. You, as others,
    seem to connect all the pieces and they only end up at one
    place. I'm trying to determine whether, in fact, there are
    other places where those pieces can be done. In no way am I
    trying to diminish the scope of what we could sit at a table
    and talk about. I've got to tell you, though. It disturbs me--
    concerns me--as to what type of rational conversation we might
    be able to have if we got down to talk about where is the best
    fit. If, in fact, just the warning label has to be tied to
    everything else that you can't comprehend the--the warning
    label could be enforced at the Federal Trade Commission or the
    Department of Justice, yet you could have an agreement that the
    FDA looks at the toxicity of a product and that we've got an
    agreement that says, here's the epidemiology study that we're
    going to look at to determine whether something is reduced
    risk. I think there are agreements we can come to on that but I
    think there are also areas that you have highlighted, Dr.
    Huerta has highlighted that really don't fit in the FDA.
        I thank the Chairman who has been very kind and I
    appreciate it.
        The Chairman. OK.
        Senator Murkowski.
        Senator Murkowski. Thank you, Mr. Chairman. Thank you and
    good morning to all of you. I appreciate the testimony. I'm
    sorry that I wasn't present for all of it but I have read the
    testimony that has been provided.
        My interest in this issue is really coming from the
    perspective of our kids. As much as I worry about the adults
    that make decisions, those are adults that are making decisions
    but I worry about the fact that every day, we've got some 4,000
    American kids that are trying cigarettes for the first time and
    of those 4,000, how many of them go on to become the customers
    that we deal with later on in life. So I want to speak
    specifically to the issue of the children and why, after all
    that has been worked out through the MSA agreements, all that
    we have been trying to do in terms of education and getting
    into the classrooms, tell me--this is directed to you, Mr.
    Myers and Dr. Huerta--what else do we need to do? This
    legislation you obviously support. What else can we be doing to
    make sure that we're not growing new numbers of tobacco smokers
    through our children? Is there more that needs to be done,
    either within this legislation or elsewhere, to make a
    difference?
        Mr. Myers. Thank you and thank you for your longtime
    commitment to this issue, Senator Murkowski. One needs a
    comprehensive approach to this problem if we're going to really
    dramatically reduce tobacco use among our children. This bill
    provides key tools for that comprehensive approach but no one
    should kid themselves. It's not the panacea by itself. By
    eliminating the forms of marketing that have been identified as
    having a great impact on children, even after the Master
    Settlement Agreement, that allows a mother and father to sit
    down across the table with them and talk about tobacco with a
    much more even playing field. That's a critically important
    step.
        By preventing the tobacco industry from implying that
    certain products are safer and therefore may be safer to start
    smoking--you can delude yourself as a young person into
    thinking that there is a safe way to start smoking. It gives us
    another tool to prevent the tobacco industry from luring our
    children. By doing this, Dr. Henningfield suggested looking at
    what the tobacco industry does with regard to nicotine and the
    impact of nicotine. We take into account the fact that most
    kids--literally 90 percent of all smokers--become long-term
    smokers before they're old enough to purchase the product
    legally. Many of them are addicted to the product and
    therefore, having a hard time to quit. We have not known how
    the tobacco industry has altered or controlled nicotine's
    impact. This bill would give us that tool at the same time to
    do so, which is vitally important as we move forward.
        Ease of smoking is another area that Dr. Henningfield has
    talked about in his testimony that impacts how quickly kids
    start because if it's not to brusque, if it's not too hard when
    you start, when your lungs are still pure, what we have
    discovered is that more kids will move from that quick,
    experimental stage to becoming regular smokers. This bill would
    give FDA the authority to look at that issue and address that
    issue as well. So this bill has a number of key link tools that
    only by bringing those things together can you have a
    meaningful approach to kids.
        And most importantly, it also, for the first time, gives a
    Federal agency the authority to look at what the tobacco
    industry is doing with its marketing and if they introduce new
    things that are not specifically covered, it gives us an
    administrative framework for addressing those issues up to the
    limit of the first amendment. It's as far as we can go in our
    Nation.
        Senator Murkowski. Let me ask you, Dr. Blum, you do not
    support this legislation but I understand that you are equally
    passionate about making sure that our kids are not the next
    customers. How do we address the kids? If this isn't the
    answer, what is the answer from the children's perspective?
        Dr. Blum. Thank you, Senator. I think that the Master
    Settlement Agreement had a hope as Ms. Shames alluded to that
    we would have had the resources to provide major multimedia
    counter advertising campaigns, such as Senator Kennedy proposed
    years ago and I justified before this committee. It's a shame
    that that money has been squandered and misused. So I also
    would see the possibility of perhaps a separate agency. But the
    reason why I oppose this bill is that literally from day one,
    if this bill is enacted, you would have the product that kills
    more people than all other drugs, food, medications--whatever
    else there is that the FDA regulates combined--and that product
    would be dithered with and torqued with and regulated when the
    elephant in the room would be Marlboro, would be sitting there,
    doing its damage every day. I think that it makes no sense
    whatsoever. It's good to talk about children but I think that
    it's the definition of infinity if we're going to try to
    regulate every single brand that comes out. They're going to
    come up with everything in the world to keep us on our toes, to
    constantly keep regulating. I think that the reason that we
    need to be here is to consider how do we reduce demand for this
    product, not how we regulate the product.
        Senator Murkowski. Thank you.
        Mr. Connolly. If I could add, Senator, we could research
    about 10 years ago, looking at the internal documents on a
    reformulation of Camel. At the time, Camel was smoked by old
    men. RJ Reynolds intentionally affected the nicotine level.
    They added more flavorings to make it more sugar-like and also
    affected the smoothness and they did rankings against Marlboro
    cigarettes. This was among 18-year-olds but in fact, it's what
    they did. They affected the smoothness of the product, they
    affected the nicotine yield, they added sugars so it would make
    it easier for a youngster to inhale. Now, the whole public
    health community is worrying about cartoon advertising when
    they were worrying about the product. I think if you want to
    address kids' use, we have to say, if you're going to
    reformulate and change the product, then tell us what you're
    doing with it. Why are you adding these sugars? Why are you
    affecting nicotine yield? And just to sit back and say, go
    ahead and have our children, with your product, and ban
    advertising. It's just a flawed public health strategy.
        The Chairman. Senator Coburn.
        Senator Coburn. Thank you, Mr. Chairman. Dr. Land, I
    remember as a young boy hearing an Evangelist by the name of
    Angel Martinez and his famous statement was, ``as a believer,
    you wouldn't go to hell for smoking. You'd just get to heaven
    sooner and smell like you'd been there.''
        [Laughter.]
        And that has stuck with me through a number of years. I'm
    somewhat perplexed at where we find ourselves. I'm a big
    believer in prevention. As a matter of fact, I'm getting
    ready--March 15, to introduce a large prevention bill in this
    country. We spend almost $7 billion a year on prevention
    through 21 different agencies. We don't get much for it because
    it's not been focused properly, and I'm highly disturbed that
    less than $1.5 billion out of $50 billion has gone to fund
    prevention. The question I have for you is, why not pass a bill
    (rather than the FDA and all this other stuff) that says you'll
    get all the carcinogens out of your product by 9 years from
    now. You will be decreasing the nicotine level by ``X'' percent
    every year for the next 10 years. Why not go after it? We can't
    ban advertising without consent, based on the first amendment,
    but we certainly can say what you can and can't produce when it
    is such a great health hazard. So my question is--I know where
    Senator Kennedy wants to eventually go with this and I'm not
    necessarily opposed to getting rid of the addictive potential
    of cigarettes--but why not do it directly? Why don't we set it
    up? We know what to do. We know how to do it. Why are we not
    doing that? Why are we going through this? You know, the No. 1
    reason for the Food and Cosmetic Act was for determining safety
    and efficacy. There is no safety in tobacco products of any
    type and the only thing they are efficacious at is addiction.
    And we're going to put that through an agency? Why not go for
    the gold. Why don't we go for the meat? Why don't we say,
    you've got this many years to get all 60 carcinogens out and
    you've got this many years by which you'll reduce the
    percentage and in the meantime, let's do some Federal
    tinkering, in terms of mandates, through incentives to States.
    If you don't spend some of your tobacco money, a larger
    percentage, on prevention and anti-smoking campaigns, then this
    will cost you this. And why don't we spend some of the $7
    billion a year that we're now spending on prevention, to
    directly go after this? We can win this fight. Answer those
    questions for me. I don't care who answers them.
        Mr. Connolly. I think what you're doing is applying a
    scientific agency to make those very decisions. There is no
    reason why, under this legislation, that the FDA couldn't ramp
    the levels of nicotine down in 30 years to the levels in
    tomatoes.
        Senator Coburn. We don't need FDA to do that. We can do it
    right here.
        Mr. Connolly. Well, I would argue that you've got a complex
    issue that takes time to weigh. Do you take the toxins out, the
    nicotine out, you take both and you give them----
        Senator Coburn. You set up a separate commission. You say,
    here's your charge. Here's the 10-year goal. Go do it. We're
    going to compliment----
        Mr. Connolly. I think the bill adequately does that,
    Senator.
        Dr. Blum. Senator, I'd like to answer. One specific comment
    you made that might be in error and that relates to this bill,
    which talks about nicotine. We all know that's the addictive
    component--of nicotine but this bill only mandates that
    nicotine be adjusted in one level and that is downward, yet the
    experience of the individuals who smoke is to compensate by
    inhaling more deeply and thus, we could regulate nicotine all
    we want but the fact is, not even to acknowledge that what
    science has found is that people who smoke are inhaling more
    deeply, putting themselves at far greater risk for emphysema,
    heart disease and lung cancer by smoking the low nicotine
    cigarettes is mind-boggling to me.
        Senator Coburn. Well----
        Mr. Myers. Senator, could I just----
        Senator Coburn. Let me make one point. There is wonderful
    new research about drugs that are coming out that hinder the
    addictive components of nicotine in the brain. So, the new
    treatments that are on the market for addiction, in combination
    with lowered carcinogens, this can help solve this problem.
        Matt.
        Mr. Myers. Just quickly, Senator. Several years ago, we
    actually proposed that States be given incentives to spend more
    money on tobacco prevention. We don't see that it is an either/
    or. We think it is vitally important that we do everything we
    can to encourage States to do so. So if that's something you
    would like to work on, we would be delighted to work on it with
    you because we do think that more should be done to encourage
    States to do so.
        And your notion is an intriguing notion about setting a 10-
    year goal for doing these sorts of things and a number of
    people have talked about that very idea in the past. The more
    experts you talk to who really look at this product, the more
    they tell you, just as Dr. Blum just did, is there are things
    that we don't know the answer to, which is one of the reasons
    for trying to give this to an agency with real scientific
    expertise, hold their feet to the fire, for them to come up
    with the kind of rigorous standards that can make a difference
    and I don't think anybody here today can tell you what they
    are. But in the past, when legislative bodies--not just in the
    United States but elsewhere, have thought they understood the
    issue without knowing all the detailed science and you know it
    better than most do, what we have found is that all it does is
    lead the tobacco industry into a pathway around it. So it is
    the reason that many of us have come to the conclusion that the
    best thing we can do is give it to an agency, give them a
    mandate, watch over them to make sure they do it and they do it
    in a way that, in the end, has the kind of public health,
    scrutinize them in the way you're talking about doing over the
    long-term.
        Senator Coburn. The only problem with that theory is the
    Bureaucrats' Law of Washington--never do what is right when you
    can do what is safe. And that will mess up all your plans, I
    promise you, as I've seen many great plans messed up at the
    FDA. So that's a nice utopian goal but I'm here to tell you,
    that ain't going to work. The FDA is like a balloon. You push
    in one place, it goes out somewhere else. They are smart enough
    to get around anything--and they'll move around that, too. So
    the goal has to be everybody recognizing what the problem is.
    There's no question. We need to work on that end in terms of
    supply but the No. 1 thing is prevention. Prevention is the No.
    1 thing and how do we counter what Senator Burr was talking
    about? If you could get an agreement where the first amendment
    rights were limited by agreement and then we poured the money
    into prevention, we could make a big impact in this country, a
    big impact. We're not going to make any kind of impact with
    this for 5, 10, or 15 years. We could do that tomorrow. We
    could start saving 40,000 lives a year tomorrow if we would go
    with prevention and some type of agreement where we limited
    first amendment rights in terms of tobacco products.
        Mr. Chairman, thank you. I've gone over my time.
        The Chairman. Could I just ask Dr. Henningfield, who is an
    expert on this whole issue of addiction. Maybe you could make a
    comment?
        Mr. Henningfield. I'd appreciate it. Being from Minnesota,
    I tend to wait and then you don't get in line.
        The Chairman. You don't get any time, any floor time.
        Mr. Henningfield. Prevention is vital. Prevention won't pay
    off in terms of death reduction for 20 to 30 years in a big
    way. We've got 50 million-plus tobacco users that we need to
    help earlier. The idea is intriguing of setting a standard and
    say 10 years or 9 years, to take all the carcinogens out. That
    sounds like a 10-year clock to prohibition. It's a legitimate
    thing to discuss. That really is a political/social discussion.
    But FDA does not design foods, drugs. Congress doesn't design
    foods, drugs. I work with WHO--they don't design foods, drugs.
    They say, these are the standards that you must achieve in
    light of today's science. As the science evolves, as the
    products evolve, you evolve the standards and hopefully,
    tighten up the standards. That, I think, is the regulatory
    approach to----
        Senator Coburn. Let me respond to that, if I might. So
    we're going to tighten up the standards. There is no difference
    in that and in going to abolition. You're going to trust an
    agency to do what we don't have the courage to do as a
    Congress. That's what you're really saying to me. We don't have
    the guts to stand up and say, here's where we need to go. We
    can create a small commission and we can fund it and we can
    figure out a way to do that. We don't have the courage to do
    what is really necessary--take a combination of our ideas for
    an agreement on both advertising and warnings, and really
    invest in prevention. We don't have the courage to do that.
    We're going to shuffle this over and in 10 years, we're going
    to be back here talking about the same thing, because Marlboro
    will be Marlboro tomorrow.
        Mr. Henningfield. Senator, I hope you will have the courage
    to stand up and argue for much more funding for prevention. I
    think it is atrocious that States haven't spent more money on
    prevention. I think we all agree with that. But you can give us
    the work in prevention too, an asset, so companies can't come
    out with Camel No. 9 or if they try to, we can say, what, when,
    how, why.
        Senator Coburn. That's what Senator Burr is offering you.
        Mr. Henningfield. The FTC is clueless. It can't----
        Senator Coburn. But they are now. What makes you think the
    FDA is any better?
        Mr. Henningfield. The FDA is----
        Senator Coburn. On these same issues?
        Mr. Henningfield. Well, the FDA's entire authority and
    history is health regulation, toxic regulation.
        Senator Coburn. No, it's safety and efficacy. There is
    nothing safe and there is nothing efficacious about tobacco
    products and we're going to ask an agency whose whole goal is
    safety and efficacy to approve our grandfather, what is
    obviously not safe and not efficacious.
        Mr. Henningfield. Neither FTC nor DOJ nor anyone else
    discovered that light cigarettes were a sham. NCI, NIH, CDC and
    FDA discovered that. These are health organizations. The FTC is
    not a health organization. It doesn't have the culture, the
    experience to assess ingredients----
        Senator Coburn. I want you to think bigger. I'm talking
    about doing the whole thing. I'm not talking about a little
    piece here and there. I'm talking about thinking outside of the
    box. Let's go after it. Let's create true prevention. Let's--
    sorry, Mr. Chairman.
        The Chairman. Senator Reed.
        Senator Reed. Thank you, Mr. Chairman. Thank you for your
    testimony. One of the presumptions of an effective market is
    perfect information by buyers and sellers. So Dr. Henningfield,
    do you think buyers of cigarettes have perfect information
    about what's in the cigarette?
        Mr. Henningfield. Not even close. I don't think they
    understand the vent holes. I don't think probably anyone here
    understands that the vent holes do something else. They
    increase the free-base nicotine fraction. CDC discovered that.
    It took CDC to jump in and say they not only are a sham but
    they increase free-base nicotine. So in order, if this is a
    product in the marketplace, in order to make it--the market--
    better, consumers need more information, like what's inside the
    cigarette, how is it designed to produce nicotine in higher
    effects? Wouldn't that sort of be a principle of an effective
    market? At least they know what they're getting into when they
    start smoking?
        Senator Reed. I think it is core and it's what we rely on
    the Food and Drug Administration to do, whether it's dog food,
    potato chips or anything else, to ask what, when, how, why--
    what are the effects?
        Mr. Henningfield. Except for cigarettes.
        Senator Reed. Except for cigarettes. So the FDA--these
    arguments about they don't have the capacity and they can't be
    effective in terms of dog food seems to be disputed by--they
    actually do things like that. Is that true?
        Mr. Henningfield. This is what they do on a routine, daily
    basis. One of the sad things about the data that Dr. Connolly
    showed about trends in nicotine is, all of us that are expert
    in this area are not sure why it's being done, how it's being
    done, what the effect is. FDA could do all of that. They could
    say why, what, when, how.
        Dr. Blum. Senator, could I add something? I'm Dr. Alan
    Blum.
        Senator Reed. Please, doctor.
        Dr. Blum. I served on an FDA advisory committee and again,
    I have great respect for the staff and it breaks my heart and I
    wasn't prepared to do this, to catalogue the list of abject
    failures of the FDA over the last 10 years. We all know about
    them, from antibiotics in animal feed that have resulted in
    resistance and contamination to women's hormones to
    antidepressants in children, cash donations to doctors from
    drug companies--it's all been botched and this is an agency
    that is now going to take over a product that has no redeemable
    health value. It strikes me as an exercise in absurdity for
    this agency to be the one that the proponents of this bill want
    to entrust with the most irredeemably harmful consumer product
    in our society. I would love to see a separate agency or a
    separate Congress as Senator Coburn said, with the courage to
    tackle the elephant in the room, which is Marlboro. That's
    what's killing people. It's not little Camel No. 9's or
    whatever new little product come on the market that will be the
    definition of infinity.
        Mr. Connolly. Senator, let me----
        Senator Reed. Dr. Connolly, go ahead, please.
        Mr. Connolly. I disagree totally with what he said. I mean,
    if you read the history of the FDA, it's probably one of the
    most--greatest public health institutions known to our country.
    It prevented the adulteration of meat by throwing sugar in it.
    It stepped in and it stopped that in the early part of the last
    century. RJ Reynolds throwing sugar into tobacco products, to
    me is no different. It's adulteration of a very harmful product
    to make it even more attractive to kids. FDA dealt with HIV,
    fast tracking the research, did a wonderful job. FDA has done
    food labeling so our Nation's consumers are much, much more
    knowledgeable about foods. When Massachusetts--post the MSA,
    tried to get the ingredients in cigarettes, we were sued by a
    big tobacco--by six companies, by 4 p.m. and spent 6 years in
    Federal court, $20 million of their litigation, just trying
    tell adult consumers what's in their products so they could
    make a choice between one that could be more addictive and less
    addictive. If this industry has changed, they wouldn't be suing
    us to give adult consumers information about quitting. FDA has
    got a wonderful history and I can recommend some very excellent
    books to my close friend, Alan, to read about the history of
    FDA and I think this agency can do a miraculous job on an issue
    that this Congress, this Nation, has failed to address.
        Senator Reed. Dr. Henningfield.
        Mr. Henningfield. Just to add to that, what FDA does is
    find the balance, it tries to find the balance. People,
    including Dr. Blum, have criticized the bill that will be too
    restrictive on new products, not restrictive enough--well,
    that's FDA's job to find the balance and it will make mistakes
    at times, as it has made in the past. Then it has mechanisms to
    be flexible and corrective. If you just say, Congress orders--
    this is the new label. This is the way it should be, that will
    be wrong in a while and you won't have a flexible way to
    address it. That's what FDA does every day.
        Senator Reed. Well, my presumption is that it is a process
    involving several institutions. No. 1, Congress lays out
    guidelines and an agency like FDA, when it comes to
    advertising, perhaps FTC, will implement those, subject to our
    approval, appeal, criticism, and changes. What I sense is that
    finding fault with the FDA is a way of stopping any type of
    progress with respect to regulating what is in cigarettes, the
    information consumers might have because I think, again, it's
    the classic situation of the perfect becomes the enemy of at
    least the barely adequate. And around here, barely adequate
    might mean progress. Mr. Myers, do you have any comments?
        Mr. Myers. Let me echo what Dr. Henningfield said. There is
    no simple solution, as much as we'd all like a simple solution.
    This bill gives the FDA the authority to deal with Marlboro as
    well as with Camel 9. We're all going to have be vigilant to be
    sure that FDA does its job to protect the public to the extent
    possible but there simply hasn't been a more thoughtful,
    balanced approach presented to Congress to address this problem
    in the past. Otherwise, we have the status quo where it's
    Philip Morris who controls what goes in Marlboro. It's Philip
    Morris who controls what goes in the advertising to young
    people today. We need a Federal agency with a mandate to do it
    day in and day out and then all of us need to remain vigilant
    to make sure they do their job.
        Senator Reed. Thank you. Thank you, Mr. Chairman.
        The Chairman. This has been enormously interesting and
    worthwhile discussion. Now let me ask the panel, what we have
    basically underlined in the legislation--we know that it is the
    tar and the chemicals that kill. But we know it's the nicotine
    that's addictive. So we know that people smoke and they get the
    nicotine because that is what is the addictive substance. We've
    given the FDA the authority to bring that nicotine level down.
    Some will say, ``Well, by bringing it down, smokers are going
    to smoke a lot more and they're going to inhale a lot more tar
    and chemicals. Therefore, it's going to be just as dangerous
    for them.'' Are we saying that medically we don't know whether
    you can get nicotine down so low where, from a medical point of
    view, it is nonaddictive. These are all scientific questions.
    But aren't we all trying to get to the point where we're
    reducing the tar and the chemicals, which are the most
    dangerous and where we get the nicotine, which is the addictive
    substance. In this general kind of discussion, are we getting
    mixed up between these different subject matters in terms of
    what the legislation is attempting to do?
        Mr. Myers. I think you said it very well. The goal is to
    reduce the toxic substances with a real goal of reducing the
    number of people who die. That's the end measurement in this.
    The bill doesn't make a judgment about whether it's good or bad
    to raise or lower nicotine levels. What it does is say to the
    FDA, you need to take a look at the best available science and
    what its impact will be, with the ultimate goal of taking steps
    that will reduce the number of people who will die. It doesn't
    pre-judge whether that number goes up or goes down or what that
    number does and it defers to Congress to make that final
    decision in that respect. But the key here is it gives the
    agency the authority to take the steps to reduce the things
    that are killing people today.
        The Chairman. What is the answer to the question that
    Senator Enzi mentioned, that the FDA regulation could give the
    appearance of an FDA seal of approval on the cigarettes that
    they allow to be sold?
        Mr. Myers. There are at least five provisions in this bill
    that give FDA the authority to prevent a tobacco company from
    explicitly or implicitly doing that. If that needs to be made
    clear, then we should make that clearer in that respect, I
    think everybody agrees. Equally important, there is a standard
    in the bill that addresses that issue and that is that FDA must
    look at the impact of any action, not just based on an
    individual smoker but on the population as a whole so that if
    an action has the impact, either by tobacco companies finding a
    way to give the impression that it's FDA approved or some other
    mechanism, to actually increase tobacco use by encouraging
    starters, discouraging quitters, then FDA has the power to step
    in to prevent that. It's broadly based on the notion that the
    agency should have broad-based flexibility. Dr. Henningfield
    may want to add to that.
        The Chairman. Please address that, and then address the
    point that, since the advertising budgets of the companies are
    virtually unlimited, no matter what the FDA has actually done,
    the companies' ads will distort it.
        Mr. Henningfield. Well, the first thing is, what FDA is
    already good at, for better and for worse, is sitting back and
    letting the companies spend the money and say, ``Prove it.''
    And with this, Camel No. 9, it says it's new. FDA could sit
    back and say, ``Is it new? Does that mean we need prior
    approval?'' They can get into issues like that. They can look
    at--they can ask the company to do focus group testing on the
    intent of the marketing and the effect of the marketing and sit
    back and say, ``We're not happy. Go do more.'' So the FDA has a
    lot of tools at its disposal that are embodied within the
    regulation. If I can just touch nicotine?
        The Chairman. Go ahead.
        Mr. Henningfield. Nicotine, like cocaine, like sedatives,
    like stimulants, it's not just the drug. It's how it's
    delivered. The National Institute on Drug Abuse that I used to
    be a part of made enormous progress. You look at the nicotine
    patch. It's minimally addictive. Same chemical. What Marlboro
    does is increase the free-base fraction, have other chemicals
    along with nicotine. They did research that showed that
    acetaldehyde worked synergistically with nicotine. So can we
    make a cigarette nonaddictive? Probably not, as long as there
    is nicotine. Can we make it less readily addicting? I believe
    we can.
        Dr. Blum. Senator, it took 10 years to get rid of Joe
    Camel. Everyone was jumping around with their necks cut off
    about the cartoon character and cigarettes. That did not even
    end as a regulatory measure. It was voluntarily withdrawn by RJ
    Reynolds. Meanwhile, Marlboro sales soared. You're all upset
    about Camel No. 9 but how many days, months, weeks or years
    will it take for more regulators to engage our taxpayer money
    in looking at each variation of a brand name that comes along?
    The most dynamic, creative expert marketing force in this
    country is Philip Morris. They have done wonders with any
    regulation. They have outwitted us. You know, three quick
    examples. This ad ran in the University of Alabama student
    newspaper last week. They know all about--the public knows all
    about what has been happening about smoking but that doesn't
    seem to block Philip Morris from coming into universities--over
    35 universities and talking about how they have redefined not
    just cigarette marketing but marketing in general, to a one-on-
    one experience. And the job interviews are being held all this
    week. They are mailing to physicians. That's right--the Philip
    Morris Tobacco Company is mailing its Quit Assist booklet to
    physicians and asking them if they want more copies for their
    waiting room. They are promoting a youth anti-smoking--I call
    it anti-youth smoking program and we don't really--we say this
    is nonsense and of course, it is but this bill will not prevent
    this company from being as dynamic and creative as ever. I
    asked a college student, why would you want to work for Philip
    Morris? He was interviewing for it and he said, ``Oh, they
    don't just sell cigarettes. They help prevent smoking.''
        Mr. Connolly. Senator, I would say that--two points. We
    don't know the answer. Is it toxicity or nicotine--which to
    take out. And I think the FDA is empowered to look at both
    issues. Tomatoes have .3 milligrams per gram of nicotine in
    them but no one is outside the building today eating bags of
    tomatoes. And maybe we want to go down that route but we have
    to look at it very, very carefully. If we go down that route,
    maybe bring in close products that reduce harm to replace the
    nicotine in Marlboros and turn Marlboros into lard. I think
    that's conceivable.
        I brought some research we did on the safest cigarettes. We
    also asked consumers about the advertising claims. Do you think
    these claims are approved by government? Eighty percent of our
    respondents said, ``Yeah, the Government has approved those
    claims.'' So the train has already left the station here. The
    Government--I mean the consumers think the Government is
    approving those claims so why not put them into--to look at
    those claims and regulate claims? I don't think this is going
    to impact whatsoever on the litigation front. If the industry
    continues to behave the way they have behaved, it will be
    continued action within the courts and FDA regulations are not
    going to impact on that.
        Senator Coburn. Just one short answer. What would be wrong
    with the Federal Government having an advertising program
    saying that they didn't approve those claims? And that there is
    no government endorsement of the product? There is none. So
    we've not done that. So we've allowed that kind of response
    because we've failed to do what we should be doing.
        Mr. Connolly. If you pass this bill, Senator, you will ban
    those claims that are being made today for those 38 safer
    products. Their claims are being made today. We need this bill
    out there today to ban those unfounded, unsubstantiated claims.
    And then, based on science, if they do come up with a product
    that actually does reduce harm to the consumer, then the
    Federal Government should allow those claims. They shouldn't
    deny the consumer that information.
        Senator Burr. Mr. Chairman, I have found this discussion to
    be fascinating and the reality is, the way the bill is written,
    there can't be higher nicotine because it bans it. As a matter
    of fact, it sets the ceiling at the current product and no
    product more harmful, which is the way it should be. More
    harmful should be considered, much less approved and yes, there
    is an FDA approval but somehow we suggest nobody in America
    will realize that when that new product comes out that suggests
    less harm, that they will consider that it has the stamp of
    approval from the U.S. Government because they are much smarter
    than we are, let me assure you. As a matter of fact, in 1938,
    when the FDA was created, there were drugs on the market then.
    Do you realize all of those drugs that were on the market then
    were never required to go through FDA approval? They are
    marketed today. They are not FDA approved. But to use your
    analogy, we would have to go out as a Federal Government and
    force those manufacturers of those compounds to now advertise
    that they're not FDA approved. Well, we know, what in fact,
    that would do to a compound that might be very useful to a lot
    of people, that passed safety and efficacy a long time ago but
    when you put, ``it has not been approved,'' boy, you kill the
    market for it. So part of the challenge that I've got is that I
    have to pick, choose from everything you're trying to do to
    figure out--just like the tobacco industry, which ones are they
    structuring so they can do this? Which ones are you structuring
    so that the outcome is predetermined? Because I think we have
    the--we're the only ones that have the challenge of balance,
    Dr. Henningfield.
        Hold on. I mean, you guys have gotten a lot more time than
    I have and I'll ask a few questions. You said that the FDA's
    role is fair and balanced. It is not the FDA's role. The FDA's
    role is to make sure that the hurdle is never lowered and that
    the threshold for safety and efficacy is, in fact, something
    that every product that comes through has to meet. So I'm not
    sure where, in fact, there is balance on the part of the FDA.
    As a matter of fact, Dr. Coburn and I have worked for 13 years,
    as has Senator Kennedy and we've seen kids that came in--many
    of them cancer victims, patients. And you know what? Picking up
    the phone and trying to get the FDA to fast track something 10
    years ago was unheard of, even if that was the only choice--the
    only option for that child to have a hope of overcoming cancer
    and the FDA said, ``No, we don't do that. We have a threshold--
    a drug, a biologic, a device must meet that threshold and if it
    doesn't, it doesn't go through here. We don't approve it.'' And
    you know what? That's the standard that should be maintained.
    Now, let me say this. Can you create a new area of FDA that has
    limited responsibilities, authority, very well prescribed as to
    what it is we want them to look at, what it is that we want
    them to regulate? Sure, we can do that. We're the Congress of
    the United States. That may be what we need to do. But we've
    tried to go through a process today to determine, is this the
    most appropriate agency for everything that we're trying to do?
    And I would challenge you that it's not. That there are areas
    that can do it more effectively, with greater assurance that
    it's being done and there may be some things that at the end of
    the day, we need to sit down and say, maybe this is something
    only the FDA can do. But you know, even for some of the
    toxicology studies--I'd challenge you that probably CDC is a
    more appropriate place to do that. They do it every day. They
    respond in a different fashion. It doesn't encompass everything
    in one agency, which is what many want to do in this. But it
    can be just as effective.
        Now, Dr. Henningfield, I've got to ask two real quick
    questions. Do you support granting sovereign control of the
    tobacco industry to an international organization and
    relinquish American control of the product?
        Mr. Henningfield. No.
        Senator Burr. Do you support sending taxpayer dollars to
    developing countries in order to subsidize their tobacco
    production?
        Mr. Henningfield. Their tobacco production?
        Senator Burr. Production, yes sir.
        Mr. Henningfield. I think that's a question with complexity
    beyond my ability.
        Senator Burr. Well, I've read the World Health Organization
    bill that you signed and I think it does exactly those two
    things. So I would ask you to go back and look at that. And Dr.
    Connolly again, I want to--I really want to comment on your
    passion. There is no substitute for that and I appreciate it.
        Mr. Connolly. Senator, could I just respond?
        Senator Burr. Yes.
        Mr. Connolly. By saying, I'd like to----
        Senator Burr. But let me make my last point first and then
    I'll let you talk all you want to.
        Mr. Connolly. No, I don't want to--I just want to just
    correct the record, that's all, Senator.
        Senator Burr. You know, I expected when I pulled the
    numbers up, that I'd find Massachusetts having used all their
    tobacco money for health and education. In fact, I found
    Massachusetts ranked No. 31. They used 23.4 percent for tobacco
    and education. North Carolina is the tobacco State. Our
    livelihood is in it--manufacturing, growth. We used 40.2
    percent of the MSA money for education and for healthcare. We
    were No. 21. There were 20 States that did better than we did.
        You know, in large part, I hope you--and I'm sure you
    have--displayed some of that passion back in Massachusetts as I
    will in North Carolina, to see if we can't use money that was
    targeted for this specific thing and to get it out of budget
    deficits and transportation dollars and everything else States
    love to spend it on.
        Mr. Connolly. Well, I didn't have the action but our
    Governor Romny, who wasn't a Democratic by the way, cut the
    budget. He maintained that--Governor DeVaugn--Patrick has
    increased the budget by $18 million 2 days--actually Wednesday,
    today, in his budget. So we will be ahead of North Carolina. We
    should be much higher. Just as acting as a Senate historian,
    the FDA bill was passed in 1906. What the FDA bill is
    grandfathered in from the homeopathic pharmacopoeia--all those
    substances that were either approved or not approved--nicotine
    was one of those substances. Purportedly for passage of the
    bill by the Senate in 1906, nicotine was withdrawn from the
    homeopathic pharmacopoeia so basically, unregulated by FDA.
    Cocaine was in the original 1906 FDA bill. It was in Coca-Cola.
    And what happened is FDA then took it out of Coca-Cola, put it
    into a schedule so a physician could still prescribe cocaine
    and then finally prohibited it. So I think it's a wonderful
    Senate--of this chamber and I think when one only has to go
    back to 1906 and empower the FDA to do what they've done for
    cocaine, to do for tobacco products and this Nation will be
    healthier for it. Thank you, Senator.
        The Chairman. OK, well.
        [Laughter.]
        Dr. Land, did you have any final comments?
        Mr. Land. Well, I must confess, I experienced some
    frustration with the latter part of this process. It seems to
    me that we're trying to make the perfect enemy of the good
    here. The FDA, like all Federal agencies, like all man-made
    creations, has flaws but it has done an enormous amount to
    protect the American people over the years and I don't think--I
    would not want to be charged with the argument of trying to
    make the argument that this bill will not retard the ability of
    the tobacco companies to run their scam on the American people.
    Are there other things that can be done? Of course. And all of
    them together--the end product, the sum--the end product will
    be more than the sum of the parts but this bill, we believe,
    will help protect the American people and will help to regulate
    what is too unregulated an industry. I will go back to what I
    said in my testimony--it just seems to me to be irrational that
    the FDA controls--has control over products that help people
    quit smoking but has no control over the product that they are
    trying to quit.
        The Chairman. OK. We're running out of time here but I'll
    just give 30 seconds to anybody that wants a final comment.
        Dr. Huerta. Thank you, Mr. Chairman. When I do my radio
    talk shows on a daily basis, we talk about tobacco. Some
    listeners, they say, ``Why don't you ban tobacco being so
    bad?'' Well, nobody is in agreement with that in this room. So
    I see this bill as a positive way to change the environment and
    when you change the environment in a Nation, that is the first
    step for change for good. Remember our long fight against this
    industry. We fought this in the fifties and the sixties and the
    seventies, eighties and nineties--well, 2007 now and this will
    do the right thing to change the environment.
        The Chairman. Thank you.
        Dr. Blum.
        Dr. Blum. Thank you again, Mr. Chairman, for this hearing.
    I have to really claim to be the longest running person in this
    field in this room and I believe, unfortunately, that the bill
    is the wrong policy for the wrong agency at the wrong time.
    Tinkering with a product, with ingredients is the most resource
    and labor-intensive and the least effective, least proven,
    least relevant and biggest waste of time, money, attention and
    focus we can do.
        The Chairman. You can see that we don't hear just one side
    at these hearings.
        [Laughter.]
        Senator Coburn. While we're at it, I'd just throw out one
    other drug that we ought to consider for FDA control. The FDA
    doesn't control alcohol but they control all the drug
    treatments for alcohol withdrawal and treatment. This
    rationalization--I'm not against the purposes that everybody in
    this room is trying to go for. But let's apply the same
    standard everywhere. You all have a lot more faith in the FDA
    than I have in the FDA and I have a law since January 2000,
    signed by Bill Clinton, that said the FDA will label condoms as
    to their efficacy. The science is proven on that. But, for the
    political correctness, the FDA has kept the information for
    that to themselves. So we consequently have no law and we have
    no label on condoms that are 80 percent ineffective--and this
    can cause cancer in women. Eighty percent ineffective. But yet
    we don't have it. So this is the same FDA that you are
    entrusting to do everything that you hope to do, but they don't
    control alcohol sales. They don't control advertising for
    alcohol and I would put forward to you, alcohol consumption in
    this country might be a larger problem, or equal, in terms of
    the illness and associated morbidities that Americans
    experience. Thank you, Mr. Chairman.
        The Chairman. We're winding up but I really have to add my
    commendation of the Food and Drug Administration. I've been on
    this committee for a number of years, 45 years on it, and
    I've--particularly Senator Hatch and I--have spent a lot of
    time dealing with the FDA. We've been very much involved in the
    re-authorization. There are a lot of challenges that are out
    there but we are the gold standard in the world, in terms of
    the Food and Drug Administration. Just while we're meeting
    here, the Chinese are in the process of adapting a Food and
    Drug Administration virtually identical to what we have here.
    It's been modeled in terms of the countries in Western Europe.
    We haven't always had the right answers, but we are in the life
    science century and the changes that have been brought on in
    terms of products that have made a difference in the lives,
    particularly of our senior citizens, have been close to
    miraculous. So I can also give my observations about some of
    the shortcomings of FDA and we're going to try and address some
    of those in the Enzi/Kennedy legislation; but we need to keep
    those shortcomings in perspective.
        I want to thank all of our panel. We're going to keep the
    record open and we're going to keep you all busy with written
    questions. There will be more questions, but this has been
    very, very helpful to our committee. We're enormously grateful
    to all of you and we will stand in recess. Thank you.
        [Additional material follows:]

                              ADDITIONAL MATERIAL

                     Prepared Statement of Senator Clinton

        I would like to thank Chairman Kennedy and Ranking Member
    Enzi for convening today's hearing on the importance of
    providing the FDA with the authority to regulate tobacco.
        We have a duty to safeguard our Nation's health and fight
    efforts to target tobacco products to women and children. I am
    proud to be an original cosponsor of The Family Smoking
    Prevention and Tobacco Control Act, and I am delighted that
    this bill has garnered such strong bipartisan support.
        I'm also pleased to announce that today, Senator Hagel and
    I are reintroducing our lung cancer resolution, which seeks to
    draw attention to this terrible, smoking-related disease. This
    resolution passed the Senate last year, and I'm hopeful that
    the Senate will take quick action again.
        It's hard to believe that it's been 7 years since the
    Supreme Court ruled that the FDA does not have authority over
    tobacco products.
        I am fortunate to represent a State where tobacco control
    laws are amongst the best in the Nation. This past January, the
    American Lung Association ranked New York as the second highest
    in the Nation for its efforts. New York particularly received
    praise for its exceptional smoking prevention and cessation
    programs.
        But, despite these laudable efforts, there has been a
    troubling increase in smoking-related diseases among women in
    New York in the last 30 years. Female smokers are 13-times more
    likely to develop lung cancer than women who don't smoke. And
    between 1983 and 2003, the annual number of cases of lung
    cancer and bronchus among women nearly doubled, increasing from
    3,852 to over 6,000 in New York State in that 20-year period.
        In fact, lung cancer is the leading cause of cancer deaths
    in our Nation, causing more deaths than breast cancer, prostate
    cancer, and colon cancer combined.
        Each year, 178,000 women die annually from smoking-related
    diseases in this country, and over 35 million Americans--male
    and female--suffer from chronic lung diseases such as asthma,
    emphysema and chronic bronchitis.
        Risk of infertility is greater among female smokers
    compared to nonsmokers, and there is a higher risk of pregnancy
    complications, premature birth, low-birth-weight infants,
    stillbirth, and infant death if a woman smokes during
    pregnancy.
        There is strong evidence that tobacco advertisements
    cynically target advertising to adult and adolescent women.
    According to an analysis published by the Journal of the
    American Medical Association in 1994 and a 2001 report by the
    Surgeon General, the tobacco industry has targeted women with
    some form of this dangerous promotional strategy for almost a
    century, beginning in the 1920s. The latest example of this is
    chronicled in a recent New York Times editorial, entitled
    ``Don't Fall for Hot Pink Camels,'' which discusses R.J.
    Reynolds's $25 million to $50 million investment in an
    advertising campaign behind the new female-friendly Camel No.
    9.
        In addition to targeting women, tobacco advertisements are
    also designed to appeal to our youth. This is unconscionable.
        According to the 2004 Surgeon General's report on the
    Health Consequences of Smoking, there is a higher incidence of
    respiratory illness in children and adolescents who smoke
    compared to their nonsmoking peers. This report also concluded
    that the overall health of kids who smoke is worse than their
    nonsmoking peers.
        I believe that tobacco use constitutes one of the largest
    threats to public health, a conclusion that is also expressed
    in the 2000 Supreme Court ruling.
        In States such as New York, we've seen evidence that
    tobacco control efforts can help lower rates of smoking and
    tobacco use among kids. Between 2000 and 2004 in New York
    State, there was a widespread reduction in use of cigarettes
    and other tobacco products by students in both middle and high
    school. Frequent use of cigarettes among middle school students
    dropped by 55 percent, while high school students' frequent use
    decreased by 36 percent.
        However, given the damaging effects of tobacco products on
    kids, I am still concerned that over 20 percent of high school
    students in my State smoke. And that nationally, 25 percent of
    children smoke by the time they finish high school.
        The United States spends more on health care than any other
    industrialized nation and yet we struggle to provide adequate
    health care for all our citizens. We literally cannot afford
    the myriad of health problems that we know result from tobacco
    use: bladder, esophageal, laryngeal, lung, oral, and throat
    cancers, chronic lung diseases, coronary heart and
    cardiovascular diseases, as well as reproductive effects and
    sudden infant death syndrome.
        That's why I support S. 625. This important legislation
    gives FDA the legal authority necessary to accomplish a
    collection of crucial tasks: preventing tobacco advertising
    aimed at children--preventing tobacco product sales to minors--
    and making tobacco products less toxic. These efforts are
    critical in improving our Nation's health and reducing the
    burden of health care costs.
        I look forward to hearing the expert opinions from our
    panelists today, and I hope that with their input, we will
    remove any doubts that passing this legislation is critical to
    our Nation's health.
        Again, I would like to thank both Chairman Kennedy and
    Ranking Member Enzi for holding this hearing and I look forward
    to working with my colleagues on the committee to ensure
    passage of this bill. Thank you.
                       STATEMENTS AND LETTERS OF SUPPORT
      Statement of Matthew L. Myers, President, Campaign for Tobacco-Free
                                      Kids
        Washington, DC. (February 15, 2007)--The bipartisan legislation
    introduced today to grant the U.S. Food and Drug Administration (FDA)
    authority over tobacco products presents the new Congress with a truly
    historic opportunity to protect our children, improve the Nation's
    health and save countless lives. There are few steps Congress can take
    that would make a bigger difference for our Nation's health. It is
    truly inexcusable that the most deadly product sold in America today is
    one of the least regulated products sold in America. By passing this
    legislation this year, the new Congress can end the special protection
    the tobacco industry has enjoyed for far too long and at such terrible
    cost in health, lives and money.
        Along with our many public health, faith and other partners that
    have endorsed this legislation, the Campaign for Tobacco-Free Kids
    applauds U.S. Senators Edward Kennedy and John Cornyn and U.S.
    Representatives Henry Waxman and Tom Davis for their leadership in
    introducing this bipartisan legislation. The large number of original
    cosponsors in both houses of Congress and from both parties underscores
    the strong, bipartisan support for this legislation.
        Throughout the coming debate, we should never forget what this
    legislation is all about: Reducing tobacco's devastating toll on our
    families. Tobacco use is the leading preventable cause of death in the
    United States. It kills more than 400,000 Americans and costs the
    Nation more than $96 billion in health care bills every year. Tobacco
    use kills more of our citizens annually than AIDS, alcohol, car
    accidents, murders, suicides and fires combined. Every day, another
    1,200 Americans die from tobacco use and more than 1,000 kids become
    regular smokers. This deadly toll will continue to mount so long as the
    tobacco industry remains unregulated and free to engage in marketing
    that appeals to children, to deceive consumers and to resist even the
    most minimal steps to make their products less harmful.
        Congress has debated the issue of FDA authority over tobacco for
    nearly a decade. It is time to finish the debate and take action to
    protect children and save lives.
         Statement of John Kirkwood, President and CEO, American Lung
                           Association, New York, NY
        Washington, DC. (February 15, 2007)--The American Lung Association
    commends Senator Ted Kennedy (D-MA), Senator John Cornyn (R-TX),
    Representative Henry Waxman (D-CA) and Representative Tom Davis (R-VA)
    for the introduction of the Family Smoking Prevention and Tobacco
    Control Act, strong, bipartisan legislation that would give the U.S.
    Food and Drug Administration authority over tobacco products. Once
    enacted into law, this measure will end the special protection enjoyed
    by the tobacco companies for decades and seriously reduce the
    devastating impact of tobacco use in the United States.
        Tobacco-related diseases are the leading preventable cause of death
    in the United States, causing more than 438,000 deaths each year. Each
    day, more than 1,140 kids become regular smokers--and one-third of them
    will ultimately die from their habit. The tobacco companies spend more
    than $15.15 billion a year marketing their deadly products--preying on
    our children, who make up the ``replacement generation'' of smokers.
        In August 2006, U.S. District Court Judge Gladys Kessler correctly
    concluded that tobacco companies have engaged in a long-term,
    fraudulent scheme to mislead the American people about the health risks
    of smoking, the addictiveness of their products, and their tactics for
    marketing their products to children. In her decision, Judge Kessler
    wrote that the tobacco companies have ``marketed and sold their lethal
    products with zeal, with deception, with a single-minded focus on their
    financial success, and without regard for the human tragedy or social
    costs that success exacted.'' Unless this important legislation becomes
    law, the tobacco companies will continue to aggressively market their
    products to children and lie about the health consequences of smoking.
        The American Lung Association is committed to working with Congress
    to ensure that the legislation becomes law in 2007.
                      about the american lung association
        Beginning our second century, the American Lung Association is the
    leading organization working to prevent lung disease and promote lung
    health. Lung disease death rates continue to increase while other
    leading causes of death have declined. The American Lung Association
    funds vital research on the causes of and treatments for lung disease.
    With the generous support of the public, the American Lung Association
    is ``Improving life, one breath at a time.'' For more information about
    the American Lung Association or to support the work it does, call 1-
    800-LUNG-USA (1-800-586-4872) or log on to www.lungusa.org.
                                     ______

                          American Medical Association,
                                                    February, 15, 2007.

      ama applauds legislation to give fda authority over tobacco products

        The American Medical Association strongly supports the regulation
    of tobacco products by the Food and Drug Administration (FDA). We
    applaud Representatives Henry Waxman (D-CA) and Tom Davis (R-VA) and
    Senators Ted Kennedy (D-MA) and John Cornyn (R-TX) for their bipartisan
    leadership in introducing the ``Family Smoking Prevention and Tobacco
    Control Act'' to give the FDA authority to regulate the manufacture,
    sale, distribution, and marketing of tobacco products. Passage of this
    legislation will end the cruel irony that cigarettes are the most
    important preventable cause of death and disease in the United States
    and one of the least regulated products in our society.
        Every year, 440,000 Americans die from diseases caused by tobacco
    use, which kills more Americans than heroin, PCP, cocaine, alcohol and
    every other drug combined. Tobacco is responsible for more than $75
    billion in health care costs and $92 billion in productivity losses
    each year.
        Tobacco addiction usually begins in childhood or adolescence. Each
    day, 2,000 kids become addicted smokers and one-third will die
    prematurely as a result. Some of the provisions in this legislation
    would stop illegal sales of tobacco products to children; restrict
    tobacco marketing, especially to children; ban fruit and candy
    flavorings in cigarettes; and require more informative health warnings.
    The AMA urges Congress to protect the public health of Americans by
    passing legislation to authorize effective FDA regulation of tobacco
    products.
                                               Ron Davis, M.D.,
                                                   AMA President-Elect.
                                     ______

                 Statement of the American Medical Association
        The American Medical Association (AMA) is pleased to submit this
    statement for the record of the Senate Committee on Health, Education,
    Labor, and Pensions (HELP) hearing on ``The Need for FDA [Food and Drug
    Administration] Regulation of Tobacco Products.'' On behalf of our
    physician and medical student members, we applaud Senators Ted Kennedy
    (D-MA) and John Cornyn (R-TX) for their bipartisan leadership in
    introducing S. 625, the ``Family Smoking Prevention and Tobacco Control
    Act,'' to give the FDA authority to regulate the manufacture, sale,
    distribution, and marketing of tobacco products. The AMA has a long
    history of supporting strong and effective FDA regulation of tobacco
    products. We firmly believe that Congress should act this year to
    protect the public's health by passing S. 625 and its House companion
    bill, H.R. 1108, introduced by Representatives Henry Waxman (D-CA) and
    Tom Davis (R-VA).
        Cigarettes are one of the least regulated products in our society
    but cigarette smoking remains the leading preventable cause of death
    and disease in the United States. Passage of this legislation would
    address the lack of regulation of this product. We expect the FDA to
    carefully monitor and regulate thousands of products that we consume on
    a daily basis. There are recent examples of such oversight with peanut
    butter, spinach, eye drops and similar products. Our government should
    apply the same diligence to the monitoring of tobacco products that it
    currently dedicates to ensuring the safety of the food and drug supply.
    It is unconscionable that cigarettes remain virtually unregulated with
    their ingredients undisclosed a full 43 years after the first Surgeon
    General's report on smoking and health.
        As physicians, we see daily the devastating consequences of tobacco
    use on our patients' health. Patients suffer from preventable diseases
    including cancer, heart disease, and emphysema that develop as a result
    of a single product--tobacco. The evidence is overwhelming concerning
    the health risks of using tobacco products, particularly when used over
    decades. Each year, 440,000 Americans die from diseases caused by
    tobacco use, including at least 38,000 who die from secondhand smoke.
    Smoking kills more people than alcohol, AIDS, car accidents, illegal
    drugs, murders, and suicides combined, with thousands more dying from
    chewing tobacco use. Millions more suffer from illnesses caused by
    smoking. In fact, former Surgeon General Richard Carmona, in releasing
    his office's 2004 report on ``The Health Consequences of Smoking,''
    stated that ``smoking causes disease in nearly every organ in the body,
    at every stage of life.''
        In addition to the human toll, the financial consequences of
    tobacco use are enormous. The Centers for Disease Control and
    Prevention estimates that tobacco use causes over $96 billion in annual
    health care expenditures. This includes over $30 billion in total
    annual Medicaid costs (Federal and State), or 14 percent of all
    Medicaid costs.
        Tobacco addiction usually begins in adolescence. Each day,
    approximately 4,000 kids will try a cigarette for the first time, and
    another 1,000 will become new, regular, daily smokers. As a result,
    one-third of these kids will die prematurely. Despite their assertions
    to the contrary, the tobacco companies continue to market their
    products aggressively and effectively to reach kids. Cigarette
    marketing and promotional expenditures have increased dramatically
    since the 1998 State tobacco settlement, reaching over $15 billion per
    year. Much of this increase was particularly focused on kid-friendly
    venues, such as convenience stores where kids hang out and from
    magazines that they read. Such marketing has also included fruit and
    candy flavorings in cigarettes. Research has shown that kids are three
    times more sensitive to tobacco advertising than adults and are more
    likely to be influenced by cigarette marketing than by peer pressure.
        Although there has been progress in recent years to treat tobacco-
    related diseases and encourage all smokers to quit, more needs to be
    done to preserve and protect the health of Americans. Congressional
    action to grant FDA authority to regulate tobacco products is long
    overdue. The AMA strongly supports S. 625/H.R. 1108, which we believe
    would finally end special protection for the tobacco industry and
    protect our children and the Nation's health instead. In particular, we
    believe the following provisions in the legislation are essential to
    ensure the effectiveness of the FDA in reducing the number of
    individuals who begin using tobacco.
        Youth Access and Marketing. The bill would require the FDA, within
    1 month after enactment, to republish the 1996 Rule, which was struck
    down by the U.S. Supreme Court in 2000. This rule would significantly
    restrict access to tobacco products by targeting marketing to children.
    The legislation would:

         ban all outdoor tobacco advertising within 1,000 feet of
    schools and playgrounds;
         ban all remaining tobacco brand sponsorships of sports and
    entertainment events;
         ban free giveaways of any nontobacco items with the
    purchase of a tobacco product or in exchange for coupons or proof of
    purchase;
         ban free samples and the sale of cigarettes in packages
    that contain fewer than 20 cigarettes;
         require retailers to verify age for all over the counter
    sales and provide for Federal enforcement and penalties against
    retailers who sell to minors;
         restrict vending machines and self-service displays to
    adult-only facilities;
         limit advertising in publications with significant teen
    readership to black and white text only; and
         limit any outdoor and all point-of-sale tobacco
    advertising to black and white text only.

        The FDA would have authority to take additional regulatory steps to
    restrict tobacco marketing and to prevent tobacco sales to children
    under the age of 18.
        Health Information Disclosure. The bill would require detailed
    disclosure of ingredients and harmful smoke constituents by tobacco
    companies. It would also require that all documents relating to health,
    toxicological behavioral or physiological effects of current or future
    tobacco products be listed. FDA would have to publish a brand-specific
    list of harmful and potentially harmful constituents. These disclosure
    requirements would give the FDA the information it needs to require
    changes to tobacco products to reduce the harm they cause and to better
    educate the public about the dangerous chemicals in tobacco products
    and the health effects of tobacco use. It would also provide the public
    with much needed information in order to fully understand the toxic
    nature of the product. With tobacco companies offering their own
    version of smoking cessation programs, the public is misled about the
    inherent harm in this product which if used as intended causes
    disabling diseases and death.
        Authority to Order Removal of Hazardous Ingredients. The FDA would
    have the power to establish performance standards, including reduction
    or elimination of ingredients, additives, constituents, including smoke
    constituents, or reduction in nicotine yields to any level other than
    zero. Thus, FDA could reduce nicotine to minimal levels, including
    nonaddictive levels, to protect the public health. This is especially
    important in light of a recent study conducted by the Harvard School of
    Public Health showing that tobacco manufacturers have intensified the
    concentration of nicotine in their tobacco and modified cigarette
    designs to increase the number of puffs per cigarette. As a result, the
    amount of nicotine that smokers typically inhale per cigarette rose by
    11 percent from 1998 to 2005, making it much harder for smokers to
    quit.
        This regulatory authority is also critical in protecting nonsmokers
    from secondhand smoke. The scientific evidence on the health risks
    associated with exposure to secondhand smoke is overwhelming.
    Secondhand smoke is a known cause of lung cancer, heart disease,
    chronic lung diseases such as bronchitis and asthma, and results in
    thousands of deaths annually in the United States. Sadly, secondhand
    smoke also contributes to over 1 million illnesses in children per
    year. As the Surgeon General concluded in his recent 2006 report, ``The
    Health Consequences of Involuntary Exposure to Tobacco Smoke,'' ``The
    scientific evidence indicates that there is no risk-free level of
    exposure to secondhand smoke.''
        Health Warnings. The FDA would be granted the authority to revise
    the health warnings on both cigarettes and smokeless tobacco products,
    and in print advertisements, to make them more prominent and explicit.
    The warning labels on cigarette packages could be increased from 30
    percent up to 50 percent of the front and rear panels.
        Standards for Reduced Risk Products. Any so-called ``reduced risk''
    products could not be sold or distributed without prior FDA approval.
    In order to receive FDA approval manufacturers would be required to
    submit data and a sample product to the FDA. They would also have to
    demonstrate that the scientific evidence is adequate to conclude that
    the product, as actually used by consumers, will significantly reduce
    the risk of tobacco-related disease to individuals and that the product
    as marketed will benefit the health of the population as a whole. In
    addition, tobacco companies would be required to conduct and report to
    the FDA postmarket surveillance of approved products' actual usage.
    Providing the FDA with review and approval authority of ``reduced-
    risk'' claims is a critical safeguard in preventing deceptive industry
    marketing campaigns. It is ironic that on the same day that S. 625 was
    introduced, the New York Times reported on a new marketing campaign
    announced by a major tobacco manufacturer targeting women. The
    advertisements describe the product as ``light and luscious,'' and show
    flowers surrounding packs of cigarettes, which are in hot pink fuchsia
    and minty green teal colors. This legislation would prevent such claims
    and advertisements without prior FDA approval, thereby protecting the
    health of our Nation's women.
        In conclusion, congressional action to provide FDA with strong and
    effective regulatory authority over tobacco products is long overdue.
    Congress should act now to protect the public's health and save
    millions of lives by passing S. 625/H.R. 1108 this year. The AMA is
    committed to working with Congress to accomplish this goal.
       Statement of John R. Seffrin, Ph.D., CEO, American Cancer Society
                     Cancer Action Network, Washington, DC
        The American Cancer Society Cancer Action NetworkSM (ACS
    CAN) applauds the introduction today of ``The Family Smoking Prevention
    Tobacco Control Act'', bipartisan legislation in the House and Senate
    that would grant the U.S. Food and Drug Administration (FDA) the
    authority to regulate the sale, distribution and advertising of tobacco
    products. Tobacco, which kills more than 400,000 Americans each year
    and remains the leading cause of preventable death in the country, is
    the only consumable product the FDA does not regulate.
        ``Congress has the opportunity to take a monumental step and grant
    the Food and Drug Administration the meaningful and long-overdue
    authority to regulate tobacco, which kills 440,000 people and costs our
    Nation $96.7 billion in health care bills every year,'' said John R.
    Seffrin, Ph.D. chief executive officer of the American Cancer Society
    and ACS CAN.
        ``The tobacco industry has demonstrated time and again that, if
    left to its own devices, it will falsely market its deadly products to
    our children, portraying this deadly addiction as glamorous and cool
    and luring 4,000 kids to try their first cigarette every day.
        ``The FDA has the scientific expertise necessary to effectively
    regulate tobacco products and the health-related claims made by the
    tobacco companies. As a science-based organization committed to
    decreasing the toll tobacco takes on our country, ACS CAN will continue
    to fight for American's right to know the contents of a product that
    when taken as directed, kills.''
        A joint statement from ACS CAN and its public health partners, the
    American Heart Association, American Lung Association and Campaign for
    Tobacco-Free Kids is also being released today.
              Statement of American Cancer Society Cancer Action
    NetworkSM, American Heart Association, Campaign for Tobacco-
                  Free Kids, and the American Lung Association
        Washington, DC. (February 15, 2007)--Our public health
    organizations strongly support the bipartisan legislation introduced
    today in Congress to provide the U.S. Food and Drug Administration
    (FDA) with effective authority to regulate tobacco products. This
    legislation presents Congress with a truly historic opportunity to
    protect our children from tobacco addiction and save lives by
    addressing the Nation's No. 1 preventable cause of death. We applaud
    U.S. Senators Edward Kennedy (D-MA) and John Cornyn (R-TX) and U.S.
    Representatives Henry Waxman (D-CA) and Tom Davis (R-VA) for their
    leadership in producing strong bills that would end special protection
    for the tobacco industry and protect our children and the Nation's
    health instead.
        We urge both the Senate and the House to quickly enact this long-
    overdue legislation into law and to reject all efforts to weaken it.
    Every day Congress fails to act, another 1,200 Americans die from
    tobacco use and more than 1,000 children become new regular smokers.
    Each year in the United States, tobacco use kills more than 400,000
    people and costs the Nation more than $96 billion in health care bills.
    The legislation introduced today would save countless lives and improve
    health for generations to come by reducing tobacco use and its
    devastating consequences, which include cancer, heart disease, chronic
    obstructive pulmonary disease (COPD) and diseases that affect virtually
    every organ in the human body.
        Unbelievably, despite all the harm they cause, tobacco products are
    exempt from basic health and safety regulations that apply to other
    products, such as food, drugs, cosmetics and even dog food. The tobacco
    companies continue to take advantage of this lack of regulation to
    market their deadly and addictive products to our children, deceive
    consumers about the harm their products cause, make changes to their
    products without disclosing them (such as secretly increasing nicotine
    levels in cigarette smoke, as recent studies have shown), and resist
    any meaningful change to make their products less harmful. Until
    Congress grants the FDA authority over tobacco products, the tobacco
    companies will continue to get away with their harmful practices that
    addict children and make it difficult for smokers to quit.
        The proposed legislation would grant the FDA the authority and
    resources to effectively regulate the manufacturing, marketing,
    labeling, distribution and sale of tobacco products. The FDA would have
    authority to:

         Restrict tobacco advertising and promotions, especially to
    children.
         Stop illegal sales of tobacco products to children.
         Ban candy-flavored cigarettes, which clearly are starter
    products for young new smokers.
         Require changes in tobacco products, such as the removal
    of harmful ingredients or the reduction of nicotine levels.
         Prohibit health claims about so-called ``reduced risk''
    products that are not scientifically proven or that would discourage
    current tobacco users from quitting or encourage new users to start.
         Require tobacco companies to disclose the contents of
    tobacco products, changes to their products and research about the
    health effects of their products.
         Require larger and more informative health warnings on
    tobacco products.
         Prohibit terms such as ``light,'' ``mild'' and ``low-tar''
    that have mislead consumers into believing that certain cigarettes are
    safer than others.

        These are common-sense measures that should have been enacted into
    law long ago. In 2004, the U.S. Senate voted 78-15 to pass FDA tobacco
    legislation as an amendment to a corporate tax bill, but it was killed
    in the conference committee.
        Despite the tobacco companies' claims of reform, recent events
    underscore that their harmful practices continue today and show why the
    FDA tobacco legislation is so critical:

         On August 17, 2006, U.S. District Judge Gladys Kessler
    issued a final opinion in the U.S. Government's landmark tobacco
    lawsuit that found the major tobacco companies have violated civil
    racketeering laws and defrauded the American people by lying for
    decades about the health risks of smoking and their marketing to
    children. Judge Kessler also found that the tobacco companies'
    wrongdoing, including their marketing to children, continues today:
    ``The evidence in this case clearly establishes that Defendants have
    not ceased engaging in unlawful activity.'' However, Judge Kessler felt
    constrained by law in the remedies she could order and put the
    responsibility on Congress to take additional action: ``In a democracy,
    it is the body elected by the people, namely Congress, that should step
    up to the plate and address national issues with such enormous
    economic, public health, commercial and social ramifications.''
         Since Judge Kessler's ruling, two studies--one by the
    Massachusetts Department of Health and the other by the Harvard School
    of Public Health--have found that the tobacco companies have secretly
    and significantly increased the levels of nicotine in cigarette smoke
    since 1998. These findings indicate that as smoking rates decline, and
    more smokers try to quit, tobacco companies have sought to maintain
    addiction among smokers and to addict a new generation of replacement
    smokers. The tobacco companies can secretly increase nicotine levels
    because no Federal agency has regulatory authority over what they put
    in cigarettes.
         The tobacco companies have taken advantage of their
    unregulated status to introduce so-called ``reduced risk'' cigarettes
    with claims like ``all of the taste . . . less of the toxins'' and
    ``reduced carcinogens, premium taste.'' However, no government agency
    currently has the authority to make sure these claims are
    scientifically proven and the products are marketed responsibly. These
    new products risk a repeat of the public health disaster caused by the
    marketing of ``light'' and ``low-tar'' cigarettes. Millions of smokers
    switched to these brands thinking they were safer or would help them
    quit only to find out decades later that neither is true and the
    tobacco companies knew this all along (as the National Cancer Institute
    concluded in a November 2001 report).
         The major cigarette companies have easily circumvented the
    minimal restrictions placed on their marketing by the 1998 State
    tobacco settlement and have since more than doubled their marketing to
    at least $15.1 billion a year--more than $41 billion every day,
    according to the Federal Trade Commission. Much of this marketing
    continues to appeal to children. A study published in the December 2006
    issue of the peer-reviewed journal Archives of Pediatrics and
    Adolescent Medicine found that exposure to tobacco marketing and pro-
    tobacco depictions in movies, television and videos more than doubles
    the odds that children under 18 will become tobacco users.
                                     ______

                           American Dental Association,
                                              January 29, 2007.
    Hon. Ted Kennedy,
    Chairman,
    Health, Education, Labor, and Pensions Committee,
    SD-428 Dirksen Office Building,
    Washington, DC. 20510.
        Dear Mr. Chairman: We are writing to support your efforts to
    introduce and pass legislation to make Federal regulation of tobacco
    products an urgent priority for the first session of the 110th
    Congress. As associations and organizations involved in improving the
    Nation's oral health, we are committed to reducing and preventing oral
    cancer and other diseases that are related to tobacco use, especially
    spit tobacco. Approximately 30,000 new cases of oral cancer are
    diagnosed each year in the United States. According to the American
    Cancer Society, oral cancer occurs almost as frequently as leukemia and
    claims almost as many lives as melanoma cancer. When detected late, the
    overall 5-year survival rate is 50 percent.
        Legislation providing the Food and Drug Administration (FDA) with
    the authority to regulate the manufacture, distribution, and sale of
    tobacco products is critically needed to protect the public health. FDA
    oversight is especially required to crack down on illegal sales of
    tobacco products to children and to restrict advertising and marketing
    that appeal to children. The tobacco industry is aggressively marketing
    as well a new generation of products with unproven claims that they are
    less harmful. This continued deception of consumers makes ever more
    urgent the need for FDA restrictions on advertising and marketing,
    especially to children.
        Our organizations are especially supportive of legislative efforts
    to amend current law to strengthen and highlight spit tobacco warning
    labels. We were pleased to see that in previous legislation sponsored
    by you, you added a requirement for a new warning label to read,
    ``Warning: This product is not a safe alternative to cigarettes.'' Our
    organizations are opposed to the use of smokeless tobacco as an
    alternative to cigarettes or as a smoking cessation technique. We
    encourage you to include this provision in your new legislation.
        While virtually every other consumer product is regulated, tobacco
    products continue to be exempt from the most basic oversight. Tobacco
    companies are not required to test additives for safety, prevent
    misleading or inaccurate health claims, inform consumers what is in
    their products, or take any other action to make their products less
    harmful or addictive. In fact, besides containing 28 carcinogens, the
    level of addictive nicotine available in smokeless tobacco products is
    manipulated to increase the user's dependence on such products.
    Congress affords no other industry this degree of special protection,
    costing taxpayers billions of dollars each year to treat tobacco-caused
    disease through federally funded health programs including Medicare and
    Medicaid.
        We applaud your efforts to address this situation legislatively and
    will work with you for its enactment.
                Sincerely,

        Academy of General Dentistry; Alabama Dental Association; Alliance
    of the American Dental Association; American Academy of Pediatric
    Dentistry; American Academy of Periodontology; American Association of
    Dental Editors; American Association of Dental Examiners; American
    Association for Dental Research; American Association of Oral and
    Maxillofacial Surgeons; American Association of Orthodontists; American
    Association of Public Health Dentistry; American College of Dentists;
    American College of Prosthodontists; American Dental Association;
    American Dental Education Association; American Student Dental
    Association; Arizona Dental Association; Arkansas State Dental
    Association; Association of State and Territorial Dental Directors;
    California Dental Association; Colorado Dental Association; Connecticut
    State Dental Association; District of Columbia Dental Society; Florida
    Dental Association; Georgia Dental Association; Hawaii Dental
    Association; Hispanic Dental Association; Illinois State Dental
    Society; Indiana Dental Association; International College of Dentists,
    USA Section; Iowa Dental Association; Kansas Dental Association;
    Kentucky Dental Association; Loma Linda University School of Dentistry;
    Loma Linda University School of Public Health; Louisiana Dental
    Association; Maine Dental Association; Massachusetts Dental Society;
    Michigan Dental Association; Minnesota Dental Association; Mississippi
    Dental Association; Missouri Dental Association; Montana Dental
    Association; National Dental Association; Nevada Dental Association;
    New Hampshire Dental Society; New Jersey Dental Association; New Mexico
    Dental Association; North Carolina Dental Society; Ohio Dental
    Association; Oklahoma Dental Association; Oregon Dental Association;
    Pennsylvania Dental Association; Pierre Fauchard Academy; Rhode Island
    Dental Association; School of Nursing at Loma Linda University; South
    Dakota Dental Association; Tennessee Dental Association; Texas Dental
    Association; Utah Dental Association; Virginia Dental Association;
    Washington State Dental Association; West Virginia Dental Association;
    Wisconsin Dental Association; Wyoming Dental Association.
                                     ______

                 Partners for Effective Tobacco Policy,
                                             February 15, 2007.

        Dear Senator/Representative: As members of Partners for Effective
    Tobacco Policy (PARTNERS), we are writing to strongly urge you to
    support the Kennedy-Cornyn and Waxman-Davis bills that would regulate
    tobacco products. PARTNERS is a coalition of more than 60 national
    organizations committed to reducing and preventing the staggering death
    and disease caused by tobacco use. Tobacco use kills more than 400,000
    Americans annually and is the leading cause of preventable death in the
    United States.
        Congress has failed to complete action on the strong legislation to
    address this epidemic that has been introduced in the last two
    Congresses. Moreover, there is overwhelming support of Americans for
    regulation of tobacco products by the Federal Food and Drug
    Administration (FDA). This support crosses all party, ideological,
    regional, State, income and educational lines--even a majority of
    smokers support FDA regulation of tobacco products.
        Reflecting that support, FDA legislation in the last Congress
    enjoyed a broad, bipartisan group of 122 cosponsors in the House of
    Representatives and 28 in the Senate. It has the robust support of
    every major national health organization and of a broad cross-section
    of American faith leaders and organizations. In 2004, this legislation
    passed the Senate twice--once overwhelmingly; the second time by
    unanimous consent--but year, after year, it has languished in the House
    of Representatives.
        Legislation providing FDA the authority to regulate the
    manufacture, distribution, and sale of tobacco products is critically
    needed to protect the public health. FDA oversight is especially
    required to crack down on illegal sales of tobacco products to children
    and to restrict advertising and marketing that appeal to children. The
    tobacco industry is aggressively marketing as well a new generation of
    products with unproven claims that they are less harmful. This
    continued deception of consumers makes ever more urgent the need for
    FDA restrictions on advertising and marketing, especially to children.
        While virtually every other consumer product is regulated, tobacco
    products continue to be exempt from the most basic oversight. Tobacco
    companies are not required to test additives for safety, prevent
    misleading or inaccurate health claims, inform consumers what is in
    their products, or take any other action to make their products less
    harmful or addictive. Congress affords no other industry this degree of
    special protection, costing taxpayers billions of dollars each year to
    treat tobacco-caused disease through federally funded health programs
    including Medicare and Medicaid.
        Now that strong, effective FDA legislation supported by the public
    health community has been reintroduced, we ask that you cosponsor it
    and work for its speedy enactment into law during the first session of
    the new Congress.
                Sincerely,

        American Cancer Society; American Heart Association; American Lung
    Association; Campaign for Tobacco-Free Kids; AARP; Alliance of the
    American Dental Association; American Academy of Child and Adolescent
    Psychiatry; American Academy of Family Physicians; American Academy of
    Nurse Practitioners; American Academy of Pediatrics; American
    Association for Respiratory Care; American College of Cardiology;
    American College of Chest Physicians; American College of Clinical
    Oncology; American College of Obstetricians and Gynecologists; American
    College of Occupational and Environmental Medicine; American College of
    Physicians; American College of Preventative Medicine; American Dental
    Association; American Dental Hygienists' Association; American Medical
    Association; American Psychological Association; American Public Health
    Association; American Society of Addiction Medicine; American Society
    of Clinical Oncology; American Thoracic Society; Association of
    Maternal and Child Health Programs; Children's Defense Fund; Community
    Anti-Drug Coalitions of America; General Board of Church & Society of
    the United Methodist Church; Hadassah--the Women's Zionist Organization
    of America; Interreligious Coalition on Smoking or Health; March of
    Dimes; National African American Tobacco Prevention Network; National
    Association of County & City Health Officials; National Association of
    Local Boards of Health; National Education Association; National
    Hispanic Medical Association; National Latino Council on Alcohol and
    Tobacco Prevention; National Partnership for Women & Families; National
    Women's Law Center; Oncology Nursing Society; Oral Health America;
    Partnership for Prevention; Seventh-day Adventist Church; Society for
    Public Health Education; Trust for America's Health; United Church of
    Christ.
                                     ______

                         American Heart Association and
                           American Stroke Association,
                                             February 26, 2007.

        Dear Senator Kennedy: The American Heart Association, on behalf of
    its more than 22 million volunteers and supporters, is pleased to
    endorse the provisions of the Family Smoking Prevention and Tobacco
    Control Act of 2007. If enacted into law, this legislation will finally
    ensure that the tobacco industry is properly regulated, that Americans
    are better informed about the dangers of smoking, and that our children
    are appropriately protected from this vigorously marketed product.
        Smoking is a major cause of cardiovascular disease and stroke--the
    Nation's No. 1 and No. 3 killers. An estimated 180,000 Americans die
    each year from cardiovascular diseases caused by smoking. And it's not
    just smokers who are at risk: an estimated 35,000 people die from
    coronary heart disease every year caused by breathing secondhand smoke.
        When the chemical cocktail created from smoking tobacco or
    breathing secondhand smoke hits the bloodstream, it can damage arteries
    throughout the body: the heart, brain, and other major blood vessels
    such as in the legs. Clots in arteries are more likely to form as a
    result, causing heart attack or stroke, and the capacity for routine
    physical activities markedly declines. Smoking also lowers the level of
    HDL or ``good'' cholesterol, raises heart rate and blood pressure, and
    replaces oxygen in the blood with carbon monoxide. In short, smoking
    wreaks havoc on the cardiovascular system, causing preventable
    disability and death for many Americans.
        The health risks associated with smoking tobacco are undisputed. It
    is therefore alarming that tobacco products remain totally unregulated
    in America today. It is vital that Congress pass this legislation of
    the tobacco industry and its deadly products. We thank you for your
    leadership on this important health issue and look forward to working
    with you to advance this important legislation.
                Very truly yours,
                        Raymond J. Gibbons, M.D., FAHA,
                                                     President.

                               Andrew B. Buroker, Esq.,
                                                      Chairman.
                                     ______

                      American Osteopathic Association,
                                             February 16, 2007.
    Hon. Edward Kennedy,
    U.S. Senate,
    317 Russell Senate Office Building,
    Washington, DC. 20510.
    Hon. John Cornyn,
    U.S. Senate,
    517 Hart Senate Office Building,
    Washington, DC. 20510.
        Dear Senators Kennedy and Cornyn: As President of the American
    Osteopathic Association (AOA), I write to express our strong support
    for the ``Family Smoking Prevention and Tobacco Control Act'' (S. 625).
    The AOA, which represents the Nation's 59,000 osteopathic physicians,
    applauds your efforts to improve the health and wellness of your fellow
    citizens, especially children, by reducing their exposure to the
    dangers of tobacco products. The AOA advocates greater oversight of the
    tobacco industry and a more focused effort on preventing children from
    starting smoking in their formative years.
        In 1990, the AOA House of Delegates adopted a policy that states,

              ``The AOA strongly recommends that all Federal and State
            health agencies continue to take positive action to discourage
            the American public from using cigarettes and other tobacco
            products.''

        This policy was revised and reaffirmed in 2002. Additionally, the
    AOA has adopted and ratified policies that ``endorse a ban on all
    advertising of tobacco.''
        By granting oversight authority of tobacco to the Food and Drug
    Administration (FDA), your legislation proposes important steps towards
    reducing the number of people who smoke or use other tobacco products.
    Additionally, if enacted, your legislation will contribute to a
    reduction in the number of children and teenagers who smoke by limiting
    their access and exposure to tobacco products. Ultimately, this will
    lead to a healthier population, a decrease in smoking related illnesses
    and diseases, and lower health care costs.
        This important legislation has fallen short in previous Congresses.
    We are hopeful that it will receive a fair evaluation and once again be
    approved by the Senate during the 110th Congress. We look forward to
    seeing it enacted into law. Please do not hesitate to call upon the AOA
    or our members for assistance with this important issue. We stand ready
    to help. For additional information, please contact the AOA's
    Department of Government Relations at (202) 414-0140.
                Sincerely,
                              John A. Strosnider, D.O.,
                                                     President.
                                     ______

                          Faith United Against Tobacco,
                                             February 26, 2007.

        Dear Senator/Representative: We are writing to you as leaders of
    Faith United Against Tobacco, a faith coalition comprised of clergy and
    lay members throughout the country, to strongly urge you to support S.
    625 and H.R. 1108, the Kennedy-Cornyn and Waxman-Davis bills that would
    authorize the U.S. Food and Drug Administration (FDA) to regulate
    tobacco. We in the faith community believe that our Nation's leaders,
    and particularly our Members of Congress, have a moral obligation to do
    all they can to protect Americans, particularly children, from tobacco
    addiction and disease. We are united on this issue.
        Granting FDA authority to regulate tobacco products would prevent
    tobacco companies from adding even more deadly and addictive
    ingredients, prohibit candy-
    flavored cigarettes, prevent tobacco sales to underage children and
    limit advertising and promotion of tobacco products that lure children
    into a deadly habit. We find it incredible that the FDA can ensure the
    safety of everyday items like macaroni and cheese, but has no authority
    over tobacco, a product that kills over 400,000 Americans every year.
    No one wants too much government regulation, but FDA authority to
    regulate tobacco products will simply treat tobacco manufacturers like
    the manufacturers of other products--it will level the playing field
    and assure the protection of consumers and our children.
        Over the last few years, Faith United Against Tobacco has been
    working with the public health community to draw attention to the need
    for FDA oversight of tobacco products. We have spoken out on this issue
    because we have spent too much time burying mothers, fathers, sisters
    and brothers who die because they became addicted to tobacco products
    when they were young. We know that the tobacco companies continue to
    spend billions of dollars marketing their deadly products to children
    and far too many high school students smoke.
        Moreover, the evidence about tobacco industry's misdeeds and the
    harm caused by this unregulated product keeps mounting. On August 17,
    2006, Federal Judge Gladys Kessler found the major tobacco companies to
    be racketeers who have lied--and continue to lie--to the American
    people about the health risks of their products and their marketing to
    children. Then, on the heels of this court decision, a report by the
    Massachusetts Department of Public Health found that tobacco companies
    have secretly and significantly increased the levels of nicotine in
    cigarette smoke between 1998 and 2004.
        Now that strong, effective FDA legislation, S. 625 and H.R. 1108,
    has been reintroduced, we ask that you cosponsor it and work for its
    speedy enactment into law during the first session of the new Congress
    It is time to protect our children and families.
        If you have any questions or would like to reply to this request,
    please contact Vincent DeMarco, Coordinator for Faith United Against
    Tobacco at 410-591-9162 or demarco@mdinitiative.org.

        James Winkler, General Secretary, General Board of Church and
    Society, United Methodist Church; Bishop Henry Williamson, Christian
    Methodist Episcopal Church; Dr. DeWitt Williams, Director, Health
    Ministries, North American Division, Seventh-day Adventists; Julie
    Taylor, Executive Secretary for Children, Youth and Family Advocacy,
    Women's Division, GBGM, United Methodist Church; Dr. Sayyid M. Syeed,
    National Director, Islamic Society of North America; Reverend William
    G. Sinkford, President, Unitarian Universalist Association of
    Congregations; Manmohan Singh, General Secretary, World Sikh Council--
    America Region; Rabbi David Saperstein, Director and Counsel Religious
    Action Center of Reform Judaism; Reverend Deborah L. Patterson,
    Executive Director, International Parish Nurse Resource Center; Dr.
    Walter L. Parrish, II, Executive Minister, American Baptist Churches of
    the South; Rev. Dr. A Roy Medley, General Secretary, American Baptist
    Churches USA; Peggy Matteson, President, Health Ministries Association;
    Dr. Richard D. Land, President, Ethics & Religious Liberty Commission,
    Southern Baptist Convention; Phil Jones, Director, Brethren Witness/
    Washington Office; Rev. Elenora Giddings Ivory, Director, Washington
    Office, Presbyterian Church (USA); Andrew Genszler, Director for
    Domestic Policy, Evangelical Lutheran Church in America; Matthew Ellis,
    Executive Director, National Episcopal Health Ministries; Reverend Bob
    Edgar, General Secretary, National Council of Churches of Christ in the
    USA; Reverend Ruben Cruz, Church Finance Council, Christian Church
    (Disciples of Christ) Reverend Michael H. Crosby, OFMCap., Coordinator
    Tobacco Program, Interfaith Center on Corporate Responsibility;
    Patricia G. Burkhardt, Legislative Officer, Church Women United;
    Barbara Baylor, M.P.H., Minister for Health and Wellness, United Church
    of Christ; Rev. David Adams, General Secretary, General Commission on
    United Methodist Men.
                                     ______

                        American Academy of Pediatrics,
                                                 March 6, 2007.
    Hon. Ted Kennedy,
    317 Russell Office Building,
    Washington, DC. 20510.
    Hon. John Cornyn,
    517 Hart Office Building,
    Washington, DC. 20510.
        Dear Senators Kennedy and Cornyn: On behalf of the 60,000
    pediatricians, pediatric medical subspecialists and pediatric surgical
    specialists of the American Academy of Pediatrics, I would like to
    express our support for H.R. 1108, legislation to protect the public
    health by providing the Food and Drug Administration (FDA) with certain
    authority to regulate tobacco products. This legislation is a good
    first step at curbing the devastating effects tobacco has on
    adolescents and young adults.
        It is estimated that more than 3 million U.S. adolescents are
    cigarette smokers and more than 2,000 children under the age of 18
    start smoking each day. If current tobacco use patterns persist, an
    estimated 6.4 million children will die prematurely from a smoking-
    related disease. Smoking and exposure to secondhand smoke among
    pregnant women cause low-birth weight babies, pre-term delivery,
    perinatal deaths and sudden infant death syndrome. Other effects may
    include childhood cancer, childhood leukemia, childhood lymphomas and
    childhood brain tumors. Well over 30,000 births per year in the United
    States are affected by one or more of these problems.
        H.R. 1108 will lower tobacco use by restricting sales of tobacco
    products to children, regulating tobacco marketing, prohibiting
    unsubstantiated health claims about tobacco products, requiring
    disclosure of harmful ingredients in tobacco products, and mandating
    larger and more informative health warnings. By giving FDA this new
    authority to regulate tobacco products, we can lower tobacco use by our
    adolescents and young adults and reduce the life-threatening risks
    tobacco poses to our Nation's youth.
        We look forward to working with you to move this legislation
    through Congress.
                Sincerely,
                        Jay E. Berkelhamer, M.D., FAAP,
                                                     President.
                                     ______

         University of California San Francisco (UCSF),
                                                March 12, 2007.
    Hon. Edward M. Kennedy,
    Chairman,
    Committee on Health, Education, Labor, and Pensions,
    317 Russell Senate Building,
    Washington, DC. 20510.
        Dear Senator Kennedy: I am writing to compliment you on the
    introduction of S. 625, the ``Family Smoking Prevention and Tobacco
    Control Act.'' This legislation marks a critical point in our Nation's
    long effort to reduce the damage caused by tobacco and to protect our
    children and public health.
        It has been 13 years since the Food and Drug Administration (FDA)
    announced its investigation into whether the evidences warranted FDA's
    assertion of jurisdiction over tobacco. That investigation was followed
    by regulations that would have addressed the serious problem of youth
    tobacco use. Unfortunately, those regulations never went into effect.
        During the past 13 years, more than 5.2 million Americans have died
    from tobacco-related diseases and over 5 million kids became regular,
    daily smokers. The need for FDA jurisdiction over tobacco has never
    been stronger. This legislation as introduced would address the goals
    that the Food and Drug Administration sought to achieve during the time
    I was Commissioner, including reinstating the 1996 FDA rule, and would
    make a major contribution to the effort to reduce the number of people
    who die from using tobacco.
        This is a strong bill and would significantly advance the public
    health.
                Sincerely yours,
                                         David A. Kessler, M.D.
                                     ______

                                     Philip Morris USA,
                                             February 26, 2007.
    Hon. Edward M. Kennedy,
    U.S. Senate,
    Washington, DC. 20510.
    Hon. Michael B. Enzi,
    U.S. Senate,
    Washington, DC. 20510.
        Dear Chairman Kennedy and Senator Enzi: Attached hereto is written
    testimony that I respectfully request be made part of the record of the
    hearing entitled ``The Need for FDA Regulation of Tobacco Products''
    scheduled for February 27, 2007 before the Senate Committee on Health,
    Education, Labor, and Pensions.
        As you know, Philip Morris USA strongly supports enactment of S.
    625, The Family Smoking Prevention and Tobacco Control Act. Thank you
    for your consideration of these views.

        cc. Senator Christopher Dodd, Senator Tom Harkin, Senator Barbara
    A. Mikulski, Senator Jeff Bingaman, Senator Patty Murray, Senator Jack
    Reed, Senator Hillary Rodham Clinton, Senator Barack Obama, Senator
    Bernard Sanders, Senator Sherrod Brown, Senator Judd Gregg, Senator
    Lamar Alexander, Senator Richard Burr, Senator Johnny Isakson, Senator
    Lisa Murkowski, Senator Orrin Hatch, Senator Pat Roberts, Senator Wayne
    Allard, and Senator Tom Coburn.
    Prepared Statement of Mike Szymanczyk, Chairman and CEO, Philip Morris
                               USA, Richmond, VA
                                  introduction
        On behalf of the nearly 12,000 employees of PM USA I am very
    pleased to submit these remarks, and to express our strong support for
    S. 625, legislation that would give the Food and Drug Administration
    (FDA) authority to regulate tobacco products. More than 4 years after
    we announced our full support for FDA regulation, Philip Morris USA
    remains committed to passage of comprehensive regulation of tobacco
    products. S. 625 can serve to create a uniform set of Federal standards
    for the manufacture and marketing of tobacco products. In addition,
    regulations promulgated pursuant to this legislation should provide
    clear guidelines and oversight of products that could potentially
    reduce the harm caused by tobacco use.
        The Family Smoking Prevention and Tobacco Control Act is the result
    of many difficult choices and compromises by all those who have been
    involved in this process over the last several years. Nevertheless, the
    bill clearly provides the framework for comprehensive FDA regulatory
    authority over tobacco products. We commend you for moving forward with
    this bipartisan legislation that provides important policy solutions to
    many of the complex issues involving tobacco products.
        We applaud Chairman Kennedy and Senator Cornyn for the leadership
    they have shown on this issue. Likewise, we appreciate the leadership
    shown by Congressman Waxman and Congressman Davis in introducing
    identical legislation in the House of Representatives. We look forward
    to working with you and your colleagues in the House to enact this
    legislation that is intended to benefit adult consumers by reducing the
    harm caused by tobacco consumption, and to establish clear rules that
    will be applied to, and hopefully enforced uniformly, throughout the
    tobacco industry. Uniform enforcement of such rules by the FDA will be
    critical to reducing the harm for adult tobacco product consumers.
                       harm reduction--first and foremost
        We believe that adult consumers should be and will be a primary
    beneficiary of FDA regulation. S. 625 will serve to accomplish this
    goal by providing a new framework within which manufacturers can re-
    focus their efforts in reducing the harm of their products. As in many
    other industries, the companies that do the best job of exceeding their
    consumers' expectations, while meeting regulatory standards, will both
    benefit their consumers and achieve the best business results.
        In spite of the controversy that continues to surround our industry
    and our company, we at Philip Morris USA spend most of our time running
    our factories, working with our suppliers, making our payroll and
    paying our taxes and continuing to look for ways to reduce the harm
    caused by smoking. We believe that comprehensive regulation of the
    tobacco industry makes sense for a number of reasons.
        One of our highest priorities at PM USA is the development of
    cigarettes and other products that have the potential to reduce the
    harm caused by smoking. Of the thousands of compounds present in
    tobacco smoke, the public health community has identified a number of
    them that are harmful or potentially harmful to smokers. Accordingly,
    our basic strategy is to reduce smokers' exposure to as many of these
    compounds as we can by developing products that will also provide
    continued enjoyment to our adult consumers. It will take some time, but
    if we are successful in finding ways of both reducing potentially
    harmful compounds and reducing smokers' actual exposure to them under
    real-world conditions, we believe that the FDA under this legislation
    will be in a position to evaluate whether our product development
    efforts are actually reducing the risk of tobacco-related diseases
    among current smokers. Our goal, which we believe would ultimately
    provide both societal and shareholder value, is to design the best
    products we can, and then, ideally under the full regulatory oversight
    of the FDA, make them available to adult smokers who do not quit. It
    seems clear to us that we will not be able to make progress in this
    area unless two critical conditions are met: first, that manufacturers
    such as ourselves develop successfully and make available products that
    reduce smokers' exposure to harmful compounds compared to conventional
    cigarettes, and second, that current smokers are given a reason--
    through communication of truthful, nonmisleading information that
    avoids unintended consequences--to switch to these products. For people
    who continue to smoke, we believe that this is the best way to
    meaningfully reduce the overall harm caused by smoking.
        We have extensive external and internal research programs that are
    focused on advancing our knowledge about tobacco smoke to support our
    efforts to develop new product designs. This includes work involving
    the compounds of smoke and smokers' actual exposure to them. We are
    continuing to devote substantial research and development efforts to
    develop and launch products that significantly reduce smokers' exposure
    to compounds that have been identified by public health authorities as
    harmful or potentially harmful.
        We believe these product technologies show promise for the future,
    and that the FDA should be empowered as quickly as possible by
    enactment of this legislation to evaluate products and their potential
    for reducing the risk of contracting smoking-related diseases.
        We respectfully urge our future regulators at the FDA to keep in
    mind that innovation in developing new products is crucial to the
    ultimate success of this legislation. In order to have any real impact,
    reduced exposure products must be acceptable to adult smokers. We see
    little benefit to consumers or society if harm reduction is not pursued
    in the context of cigarettes that adult consumers will enjoy smoking.
    As the 1998 Canadian Experts' Committee on this subject concluded,
    ``[i]f smokers would not buy these products, product modification
    initiatives would fail.''
        Importantly, once the FDA concludes as a matter of science that a
    new product has the potential to offer reduced exposure or reduced
    risk, S. 625 grants the agency an essential role in approving and
    overseeing any claims, explicit or implied, made about the product by
    the manufacturer regarding exposure or risk-reduction. Crafting
    appropriate claims regarding these products requires great care and
    attention. We are mindful of the critical need for manufacturers to
    work closely with the FDA on consumer messages.
        Once again, as with determinations regarding the scientific issues
    of potential exposure and risk reduction, we believe S. 625 correctly
    charges FDA with deciding what communications to consumers are
    appropriate on this subject. On the one hand, in terms of public
    health, future FDA regulations should ensure that consumers are not
    mistakenly led to believe that a particular tobacco product may be an
    acceptable alternative to quitting. On the other hand, we do not
    believe future regulations should be utilized as a tool to suppress
    legitimate, accurate and objective information about product
    developments that individuals may find beneficial or important. The key
    here is for all FDA-approved communications to consumers to be truthful
    and not misleading, all within the context that there is no safe
    cigarette.
        We are keenly aware that some members of the public health
    community are opposed to the very concept of developing and offering
    ``reduced exposure'' or ``reduced risk'' tobacco products. They are
    concerned that the availability of such products might discourage
    smokers from quitting or encourage people to start smoking. These
    advocates appear to believe that the only acceptable message for the
    government to communicate, irrespective of potential alternatives, is a
    directive not to consume tobacco products at all. Philip Morris USA
    strongly believes if products that could ultimately reduce the harm
    caused by smoking are developed, it would be wrong to deny adult
    smokers access to information about the potential benefits of such
    products. The ``modified risk tobacco products'' section of S. 625 sets
    out rigorous requirements that must be met before manufacturers could
    communicate about these types of products. We agree fully with the need
    for such rigorous requirements while urging future FDA regulators to
    take note of the Institute of Medicine admonition that ``[the]
    regulatory process should not discourage or impede scientifically
    grounded claims of reduced exposure, so long as steps are taken to
    ensure that consumers are not misled. . . .''
                  reducing youth smoking--a critical priority
        In 1998 PM USA created a Youth Smoking Prevention department with
    the objective of helping to prevent kids from smoking cigarettes. We
    are committed to this effort because we firmly believe that kids should
    not smoke.
        S. 625 aims to help reduce youth smoking. Among other things, it
    would prohibit self-service transactions (except in adult-only
    facilities), establish a national minimum age of 18, require age
    verification for anyone younger than 27 years of age, and prohibit the
    sale of unpackaged cigarettes (so-called ``loosies''). We commend the
    cosponsors of this legislation for taking these steps. We believe that
    by working together, we can all contribute to continuing the reduction
    in youth smoking rates that has occurred over the past decade.
        A number of other provisions in the legislation deserve further
    discussion and comment.
                 sec. 901--fda authority over tobacco products
        S. 625 creates a new chapter within the Food, Drug, and Cosmetic
    Act to regulate tobacco products. Importantly, tobacco products will
    not be regulated as a drug or device. Moreover, the bill explicitly
    states that one of ``the purposes of this Act'' will be ``to continue
    to permit the sale of tobacco products to adults in conjunction with
    measures to ensure that they are not sold or accessible to underage
    purchasers.'' The bill limits the scope of FDA's authority to
    manufacturers of tobacco products, making clear that FDA does not have
    the authority to regulate tobacco growers. FDA will not be on the farm.
                     sec. 903--misbranded tobacco products
        Pursuant to the legislation, tobacco products will be deemed
    misbranded if their label is false or misleading or they are not
    correctly labeled. Of real significance to America's tobacco growers
    and their families and communities, a tobacco product will be
    misbranded if the label does not contain an accurate statement of the
    percentage of the tobacco used in the product that is domestically
    grown and the percentage that is foreign grown.
                   sec. 904--submission of health information
        The bill requires, within 6 months of passage, submission to the
    Secretary of documents any information concerning ingredients,
    compounds, paper, filter and other components of tobacco products as
    well as content, delivery and form of nicotine. Philip Morris USA fully
    supports this requirement with appropriate safeguards to protect our
    trade secrets, which this bill provides. We think the FDA should be
    able to give smokers confidence that the ingredients added to
    cigarettes do not increase the inherent health risks of smoking,
    including increasing the addictiveness. Further, we have no objection
    to disclosing the results of our own ingredients testing to the FDA so
    it can assess every ingredient we use. The same is true for other
    information that may be requested by the Secretary under this section
    including information related to research activities and findings,
    scientific information on reduced risk products and technology and
    marketing research.
                         sec. 905--annual registration
        S. 625 requires the registration of every entity that owns or
    operates any establishment in any State engaged in the manufacture,
    preparation, compounding, or processing of tobacco products. While
    these same requirements extend to foreign manufacturers of tobacco
    products, it will be critical for FDA to ensure the even-handed
    application of the legislation to these foreign manufacturers,
    including through appropriate inspections.
      sec. 906--general provisions respecting control of tobacco products
        The section allows for regulations requiring good manufacturing
    practices (GMPs) with input from the public and interested parties and
    provides for a 3-year delay for compliance to ensure that manufacturers
    have ample opportunity to comply.
                          sec. 907--product standards
        S. 625 grants the Secretary the authority to adopt performance
    standards for tobacco products if ``appropriate for the protection of
    the public health.'' Although broad, the delegation of authority to the
    FDA to issue product standards is fully supported by PM USA. It will
    allow FDA to reduce harm by imposing mandatory design changes on
    tobacco products. These standards could include provisions to regulate
    nicotine yields and other constituents and components of cigarettes. It
    also will ban the sale of candy or fruit-flavored cigarettes.
        We believe future FDA regulators should be very cautious and avoid
    doing what no one should want: to impose changes that are so radical
    that tobacco products are effectively banned, or consumers are driven
    away from the legitimate market toward illicit, completely unregulated
    products. In fact, the legislation explicitly directs FDA to consider
    whether a standard would create a significant new demand for
    contraband, including counterfeit, products, in determining what would,
    and would not, be ``appropriate to protect public health.'' We urge
    future FDA regulators to fully consider the warning voiced by the FDA
    in the 1996 tobacco rule regarding this subject:

              Black market and smuggling would develop to supply smokers
            with these products . . . [which] would be even more dangerous
            than those currently marketed, in that they could contain even
            higher levels of tar, nicotine, and toxic additives.

        In addition, a product standard may not have the effect of
    ``banning all cigarettes'' or reducing nicotine yields ``to zero'';
    this power is explicitly reserved to Congress.
        A word about nicotine is appropriate at this point. A recent
    Harvard University report asserts that Philip Morris USA and other
    tobacco companies have deliberately increased the amount of nicotine
    that smokers get from cigarettes over the past 7 years. The conclusion
    from the report, that there was a trend of more and more nicotine in
    cigarettes between 1997 and 2005, and that the cigarettes were designed
    to yield greater amounts year after year, is not true for Philip Morris
    USA. We have not changed the design of our cigarettes with the
    intention to increase nicotine yields in order to make the product more
    addictive. The data we submitted to Massachusetts shows that nicotine
    yields in Marlboro cigarettes were the same in 1997 as in 2006.
        While current skepticism may stand in the way of arriving at a
    consensus on these data, we believe that enacting S. 625 will create a
    framework to address any public concerns.
                    sec. 911--modified risk tobacco products
        Much of my earlier testimony is focused on the importance of harm
    reduction. These provisions are essential to that goal and must be
    implemented by FDA in a careful, thoughtful manner in order to be
    successful in achieving everyone's goal of reducing the harm caused by
    tobacco products. In its report, the IOM committee made two important,
    fundamental recommendations: (i) determinations about what is, and what
    is not, a reduced-risk or reduced-exposure product should be made by
    the government on a purely scientific basis and (ii) any claims made
    about such products should be strictly regulated to ensure that
    consumers are not misled. We believe S. 625 gives FDA the necessary
    level of authority and discretion to achieve both.
        Significantly, the bill creates a special rule for certain products
    where the label, labeling or advertising contains an explicit or
    implied statement that the product contains a reduced level of a
    substance, or presents a reduced exposure to a substance if the
    Secretary makes such a finding based on a number of criteria. We
    believe the bill appropriately and reasonably empowers FDA to approve
    applications for products that make exposure-reduction claims for 5-
    year periods, utilizing criteria that appear to have been substantially
    derived from the Institute of Medicine Report.
                              sec. 920--user fees
        S. 625 requires the Secretary to require tobacco product
    manufacturers and importers to pay for providing, equipping and
    maintaining adequate service for regulating tobacco products. Philip
    Morris USA believes the collection of such user fees is reasonable, but
    again strict enforcement by the agency will be essential.
               sec. 102--repromulgation of fda's 1996 final rule
        Within 30 days of enactment of S. 625 the Secretary is required to
    publish a final rule on the advertising of, and access to, tobacco
    products, which shall become effective no later than 1 year after the
    date of enactment. The rule will be identical in its provisions to the
    advertising and access regulations promulgated by the FDA in 1996.
    Prior to making any amendments to the rule, the Secretary would be
    required to publish a proposed rule.
        In addition, under section 906(d) of the legislation, FDA would
    have authority to impose additional restrictions on the sale,
    distribution, advertising and promotion of tobacco products if the
    Secretary determines that the regulation would protect the public
    health. The bill specifies that marketing and advertising restrictions
    must be consistent with the first amendment.
        The bill explicitly provides that FDA will not be permitted to
    prohibit the sale of any tobacco product to adults age 18 and over.
    Further, it does not permit the Secretary to require that tobacco
    products be available only by prescription.
        The timing of these requirements raises a broader point. At the
    same time that we will be making the transition into the new regulatory
    environment, we understand that FDA will also be transitioning into its
    new role, including putting the necessary regulatory structures and
    resources into place.
        As such, it will be critically important for FDA and the industry
    to work closely together in order to provide for a smooth transitional
    period, such as was accomplished with the State Attorneys General with
    respect to the transition into the MSA and with other government
    agencies that have been granted new or additional authority over
    tobacco products. For example, it will be important to work out
    reasonable timelines for the substantial new requirements that are
    contemplated by the legislation.
               sec. 201--cigarette label and advertising warnings
        This section of S. 625 specifies nine new warning labels required
    to appear on cigarette packages and advertisements. The warnings must
    comprise at least the top 30-percent of the front and rear panels of
    the package, and at least 20-percent of the related advertisements. It
    will be unlawful for a manufacturer, importer, distributor or retailer
    to advertise any cigarette unless its advertising bears one of the
    required warning labels. Philip Morris USA fully supports these
    provisions.
                                   conclusion
        I will conclude by reiterating a point made earlier: a
    comprehensive national tobacco policy should bring more, not less,
    beneficial competition to the U.S. tobacco industry. Viewed another
    way, none of the measures that would be advanced by enactment of S. 625
    would give any one tobacco company a commercial advantage,
    notwithstanding the assertions of some manufacturers. Tobacco companies
    know very well that the first amendment of the Constitution guarantees
    that the FDA could not impose a total ban on tobacco product
    advertising, which effectively ensures the continuation of vigorous
    competition in the market place.
        The most significant restrictions placed on the tobacco industry in
    recent history were those contained in the Master Settlement Agreement
    (``MSA''). Those changes, which restrict billboard and transit
    advertising among other things, did not lock in any single company's
    market share. In fact, since the adoption of the MSA, there are
    examples of both new brands and pre-existing ones that have increased
    their market share.
        History and the facts simply do not support the contention that the
    additional access, advertising or marketing restrictions contained in
    S. 625 will lessen competition, create a monopoly or lock in market
    share. Indeed, we believe that, with clear guidelines and oversight,
    there should be an opportunity for increased competition as both new
    and existing manufacturers work to develop and commercialize products
    that could potentially reduce the harm caused by tobacco use.
        Thank you for allowing us to submit these views to the committee.
    Thank you for your leadership and commitment to this issue. Please know
    that we will work tirelessly to secure enactment of S. 625, which
    represents a truly historic opportunity to establish a comprehensive
    and coherent national tobacco policy.
                      STATEMENTS AND LETTER OF OPPOSITION
      Prepared Statement of Henry O. Armour, President and CEO, National
            Association of Convenience Stores (NACS), Alexandria, VA
        Good morning, Mr. Chairman and members of the committee. My name is
    Hank Armour and I am President and CEO of the National Association of
    Convenience Stores (NACS). NACS is an international trade association
    representing the convenience store industry. The industry as a whole
    includes about 140,000 stores in the United States, sold 143.5 billion
    gallons of motor fuel in 2005, and employs about 1.5 million workers
    across the Nation. It is truly an industry of small businesses; 60
    percent of convenience stores are owned by one-store operators.
        I know the industry not only from my time running the trade
    association, but prior to my tenure at NACS I owned a convenience store
    chain that operated primarily in the State of Washington. This topic is
    of great interest to our industry because more than one-third of in-
    store sales at convenience stores are tobacco products. Customers who
    come into our stores to buy tobacco also purchase other items that
    often have higher profit margins. Given that the annual per store
    profits in the industry average less than $40,000.00, it is not an
    exaggeration to say that if convenience stores are put at a competitive
    disadvantage in the sale of tobacco, it would threaten many of these
    businesses.
        Before I relay the concerns we have with the way that the current
    legislation grants the Food and Drug Administration (FDA) the authority
    to regulate tobacco, I want to make our interest in this issue clear.
    NACS is not taking a position regarding whether or how the
    manufacturing of tobacco should be regulated. Our industry sells legal
    products and goes to great lengths to sell them responsibly. We spend
    millions of dollars each year in our industry on training and
    compliance programs, including efforts like the We Card program,
    internal stings to gauge our compliance, and the like. Selling tobacco
    products to minors is both against the law and bad for business. We are
    members of the communities where we have stores. We care about these
    communities and we make a large financial investment in trying to make
    sure we sell tobacco products responsibly.
        Our concerns are limited to the parts of the legislation before the
    committee that directly impact the retail sale of tobacco products. It
    is, in fact, our view that these portions of the bill can be made more
    equitable and more effective. With that in mind, we have three main
    concerns about this legislation. First, the legislation does not create
    incentives for the behavior it is trying to promote or put
    responsibilities on the individuals who are best able to affect these
    behaviors--all of this undermines the effectiveness of the proposal.
    Second, the legislation federalizes an area of regulation where the
    States have already demonstrated effectiveness and is already guided by
    Federal performance standards. We believe this regime will be less
    effective than the current system. Third, the legislation treats
    different types of retailers inequitably, which will both create
    competitive imbalances and allow for loopholes that undermine the
    purposes of the bill. I will address each of these issues in turn.
     legislation should place incentives and responsibilities in the right
                                     places
        It is a fundamental, equitable precept that an entity should be
    held accountable for behavior and acts which it can control and should
    not be penalized for actions over which it cannot exert effective
    control. NACS believes that everyone involved in the distribution of
    tobacco should do everything that can be reasonably expected of them to
    avoid the unlawful transfer of these products to minors. However, it is
    irrational and counterproductive to penalize any entity for things it
    cannot control.
        The current legislation makes retailers responsible for things they
    cannot control. Socially responsible retailers can train employees
    regarding the laws prohibiting sales to minors, have a policy in place
    requiring compliance with the law, and take action if an employee does
    not follow the policy. Legislation ought to recognize these limits on
    the ability of retailers to prevent violations and ought to have
    incentives for retailers to take these steps and use best compliance
    practices. The current legislation does not do that. Instead, it makes
    retailers liable for every violation no matter how extensive the
    efforts they take to prevent violations. Legislation ought to provide
    socially responsible retailers with a ``safe harbor'' so that a
    violation would not cause a retailer to lose its right to sell tobacco
    if it has taken the steps it can to prevent a violation. The defense in
    the current legislation is inadequate because it is limited to
    situations in which the clerk relies upon a fake identification card
    and does not cover other errors made by the clerk (intentional or not),
    nor does it apply to situations when a minor uses a valid
    identification that belongs to someone else. The language in the
    legislation also requires the retailer to prove good faith on the part
    of the clerk, which introduces a complex and difficult-to-prove legal
    standard (particularly in light of the adjudication process).
        The legislation also falls short by not having potential penalties
    for all of the individuals involved in an illegal transaction. A clerk
    who has been trained, for example, should face a penalty if he or she
    makes an illegal sale. The only defense for a clerk who has been
    trained should be that the clerk relied upon an identification which
    appeared to be valid.
        Any legislation should also address the minor who makes an illegal
    purchase or illegally possesses tobacco products. Minors need to face a
    potential penalty for inducing an illegal transaction or they will have
    no incentive to stop them from trying to buy tobacco at every retailer
    who carries it--until they are successful. Some States have passed
    penalties for minors making illegal purchases and these laws have been
    quite successful. We do this for alcohol and other products. It makes
    no sense to allow teenagers to try to induce violations of law with
    impunity and face no countervailing incentive.
        Without such a sanction this legislation will not be as effective
    in meeting its stated goals as it should be. Some socially responsible
    retailers may literally lose their businesses even if they have made
    substantial efforts to comply with the law--while teenagers will be
    able to smoke in public and attempt to buy cigarettes in the presence
    of FDA officials without any fear of sanction.
        Similarly, the bill's provisions relating to labeling and
    advertising violate the principle of holding people accountable for
    only those things over which they can effectively exert control.
    Specifically, these provisions would hold retailers strictly liable for
    labeling violations, even if the retailer had nothing to do with the
    label.
        In sum, the current system of retailer regulation in the
    legislation looks more closely calculated to move gradually and
    surreptitiously toward a system of prohibition of the product than to
    reducing consumption of tobacco products by minors.
            state regulation makes sense and will be more effective
        States have traditionally regulated the sale of tobacco products to
    make sure those products are not sold to people under the legal age.
    The same is true for alcoholic beverages and other products that are
    intended only for adults. In 1992, with the passage of the Synar
    Amendment, the Congress set performance standards to ensure that every
    State was effectively regulating retail tobacco sales. If States do not
    meet Federal performance measures, they can lose the funding they
    receive from the Substance Abuse and Mental Health Services
    Administration (SAMHSA).
        Since passage of the Synar Amendment, youth smoking by high school
    students has declined from 31.9 percent to 23 percent among boys and
    from 29.8 to 22.9 percent among girls. This basic model is the right
    one to follow. There is room for the Congress to set standards for
    States to meet in their regulation of tobacco sales. But duplicating
    the extensive system of State regulation that already exists--and has
    shown results--does not make sense.
        There are 300,000 retailers of tobacco products in the United
    States. The Food and Drug Administration does not have the resources to
    regulate these retailers in an even-handed manner. They may be able to
    contract with States to enforce the law--though if that is the answer
    it is very difficult to understand why such a system would be
    preferable to setting standards for States--but it also ignores that
    much of the cost of regulating lies not in enforcement but in
    adjudication. Any system of regulation and enforcement needs to meet
    basic standards for due process. States already do this with respect to
    tobacco retailers and have an extensive infrastructure in place to try
    to ensure fairness. It would be exceedingly difficult for the FDA to
    provide due process for tobacco retailers. The financial burdens of
    hiring and deploying the necessary administrative law judges alone
    would be staggering.
        Another due process problem with FDA regulation is geography. When
    FDA implemented a similar system in the 1990s, before it was struck
    down by the U.S. Supreme Court, retailers that wanted to challenge a
    violation had the choice of traveling to FDA's headquarters in
    Rockville, Maryland, for the hearing or participating by phone.
    Obviously, it is far more effective to appear in person than to
    participate by phone--we recognize this in the operation of our courts
    just as Congress does in the conduct of hearings like this one. But for
    many retailers around the country traveling to Rockville not only would
    mean a large expense, but it would be significant time away from
    running the business. For the 60 percent of the industry who are one-
    store operators, this is particularly burdensome.
        There is also a long list of logistical issues with which the FDA
    would need to grapple in order to duplicate the State system of
    regulating retailers. The States have years of experience working with
    retailers and have a sense of who buys the products, who owns what
    outlet, where notices of violation should be provided, and the like.
    The FDA would have to recreate all of this information under the
    current legislation. Doing that would be costly and unnecessary.
                  legislation should treat retailers equitably
        The legislation, as currently drafted, would have adverse effects
    and loopholes that may not be readily apparent. With respect to
    prohibitions on sales to minors, for example, mail order and Internet
    sales are exempted. While such sales were a relatively small part of
    the market in the mid-1990s, when the FDA drafted its regulations on
    this topic, that is not true now. Internet sales of cigarettes, in
    particular, have exploded in the last decade. These sales constituted
    14 percent of the market in 2005. A brief exploration of some of the
    more than 500 Web sites that sell cigarettes demonstrates that
    exempting these sales from age verification requirements would be a
    problem. Typically, these sites do nothing more than ask a customer
    whether he or she is 18 years of age and relies entirely on that
    representation to establish the customer's age. In fact, many sites
    give only one box to click in response to the question of whether the
    customer is 18--and that box says ``yes.'' Even if a customer answers
    no, however, many sites still allow that individual to continue to
    purchase cigarettes.
        Multiple delivery services offer their customers the option of
    having the delivery person check and verify identification upon
    delivery. There is no reason or justification, then, for treating
    Internet and mail order sellers any differently than other tobacco
    retailers with respect to age verification.
        Native American tribes and reservation retailers also sell a large
    volume of tobacco products. We have been concerned about these sales
    for many years because the sales are often made without applying the
    legally required State taxes. The U.S. Supreme Court has weighed in on
    this issue many times and confirmed that States can impose taxes on
    reservation sales to everyone other than an enrolled member of the
    tribe. Yet many tribes across the Nation continue to illegally evade
    these taxes. This is also an age verification loophole. States are
    hindered in their efforts to enforce their laws against reservation
    retailers because of the tribes' assertion of sovereign immunity--
    notwithstanding the fact that the Congress through the Foreign
    Sovereign Immunities Act did away with immunity for every other
    sovereign in the world when it acts in a commercial, rather than
    governmental, capacity. If the Congress is going to pass legislation
    regulating the sale of tobacco, it cannot leave this gaping loophole in
    the law. It must make clear that Native American tribes and retailers
    are fully covered by the law and include a way for the law to be
    enforced against those retailers. Any other outcome leaves a gaping
    loophole in the law. There is nothing inherently safer about a
    cigarette sold by a Native American retailer than one sold at the local
    convenience store.
        The signage and marketing restrictions in the legislation are also
    inequitable. The legislation would not allow for any signage, including
    simple displays of brands, if it could be viewed from outside the
    store. That restriction will disproportionately impact convenience
    stores. NACS has performed extensive studies of store security and
    published guidelines for its members recommending that convenience
    stores keep the entire store visible from outside. That visibility is
    the best deterrent to crime. The result, however, is that while
    competitors such as grocery stores and drug stores may be able to place
    signage and other advertising inside their stores to let customers know
    they carry tobacco products, convenience stores will not. That creates
    a competitive imbalance in the marketplace and does not make sense in
    light of the stated goals of the legislation. These rules should be
    modified to cover all establishments in the same way.
        Adult stores (other than tobacco shops), including bars and
    restaurants are also advantaged by this legislation. These businesses
    would be able to use color advertising in their stores while others
    would not have that opportunity. The assumption underlying this
    differential treatment--that minors do not enter these adult
    establishments--is factually wrong. Minors do enter these
    establishments and, if this legislation passes, more businesses will
    become ``adult only'' in name though not necessarily in practice.
    Again, this inequity should be remedied.
                                   *  *  *
        There are many other details in this legislation (and missing from
    it) that are of concern to NACS. If the FDA is going to regulate
    retailing of tobacco products and do it the right way, issues as
    diverse as where to send notices and how burdensome the recordkeeping
    requirements will be must be addressed. But the three principles I have
    laid out in this testimony are the primary problems we see and should
    be dealt with for this legislation to be fair and effective. We look
    forward to working with the members of this committee to address these
    issues.
              Prepared Statement of Laurie Comstock, Elk Grove, CA
        I am opposing the above S. 625--FDA Regulation of Tobacco Products.
        I would like to tell you a little about my family's experience with
    tobacco products.
        I am forwarding you a photo of my beautiful younger sister, Lois.
    She started smoking at the age of 13 (in 1968), and died on Oct. 16,
    1999 at age 44 from lung cancer. She was my best friend. I miss her
    with all my heart and so does my entire family. She leaves behind her
    husband and two sons, who were 14 and 17 when she died. She suffered
    from lung cancer for 3 long years. She went through several surgeries,
    chemotherapy and radiation. In the end her cancer spread throughout her
    whole body and she was in excruciating pain. I was with her the last
    few weeks of her life. I promised her I would do everything I could to
    keep kids from starting to use tobacco and that I would spread the word
    about the dangers of tobacco and smoking. This bill is not the answer
    to keeping kids safe and would not help people to quit smoking.
        We also lost our father to a tobacco-related disease when he was
    39. I was 13 when he died, my two brothers were 9 and 11 and my sister
    was only 8. He died on Nov. 6, 1963, approximately 2 weeks before
    President John Kennedy was assassinated. In those days the public did
    not know as much about the dangers of tobacco and smoking cigarettes
    and cigars as we do now. Of course the tobacco industry knew even in
    those days how deadly their products were as is reflected in the
    Legacy.library.ucsf.edu tobacco documents that are online. Our dad
    started smoking in his teens.
        We have lost many other family members, related both by blood as
    well as by marriage, to tobacco-related diseases. My mother is
    currently suffering from emphysema and my stepdad has heart problems,
    both because of their smoking.
        In July 2001, I lost my favorite aunt to lung cancer, caused by
    smoking. I was staying at her house, taking care of her property and
    taking care of her dogs. I was sitting at her table and reading her San
    Diego Union Tribune Newspaper on July 18, 2001. The article I read, I
    could not believe. The title of the article was ``Smoking Deaths an
    Economic Boon, Philip Morris study says.'' It goes on to say, ``Sick
    smokers may burden a country's healthcare system, but dead smokers save
    governments money.'' That's the conclusion of a study on the financial
    cost of smoking that was commissioned by tobacco giant Philip Morris.''
        Even though this study was about the Czech Republic, this just is
    unacceptable and unbelievable. Every country and every family deserves
    to be protected from this despicable company and the tobacco industry.
    Yes, Philip Morris apologized, but I do not accept their apology. I
    have lost far too many loved ones because of the tobacco industry's
    deadly products. My family has been devastated and so have thousands of
    other families, thanks to the tobacco industry.
        Philip Morris is the very company that is pushing for FDA
    Regulation. Philip Morris may have changed their name to Altria, but
    they certainly have not changed their ways. They claim that they don't
    want kids to start smoking, that it's an ``Adult Decision'' but that
    just causes kids to want to be adults and smoke even more. They think
    by smoking that they will be more mature and look more adult. Don't
    believe the tobacco industry when they say they don't want kids to
    smoke. That is their future. The present smokers will either quit or
    die and without kids or young adults taking up smoking, this industry
    would no longer exist.
        I used to be naive enough to believe that FDA Regulation was the
    most important thing. I now realize just how wrong I was. By having
    weak FDA regulations, it gives the appearance that the Government is
    endorsing smoking by ``regulating it.'' The tobacco industry will be
    able to say that cigarettes and tobacco smoking is now regulated by the
    Government, implying that smoking is somehow safer or the Government
    wouldn't be allowing it. They would also be able to use this as
    protection from punitive damages in lawsuits if they were allowed to
    bring FDA regulation to the jury's attention.
        The Government should not be protecting the tobacco industry and
    their rights but should be protecting families from the devastation
    that this industry and their addictive and deadly products cause.
        I ask this committee to really look long and hard at this bill and
    see why Philip Morris, a tobacco company, is pushing for this bill.
    There should be many red flags and it should be viewed with strong
    suspicion.
        I ask this committee to look at the findings and orders of U.S.
    District Judge Kessler, after her finding the tobacco industry had
    violated the Federal Racketeering laws after the lengthy trial last
    year. Her orders really make sense. She found this industry had lied
    and deceived the public for over 50 years.
        I ask you to disregard anything that Philip Morris (Altria) says or
    at least look at it with serious skepticism.
        I believe that the big health agencies, American Cancer Society,
    American Lung Association and American Heart Association feel that even
    a weak bill is better than no bill at all. I strongly disagree with
    them.
        We should not be negotiating with the tobacco industry on a bill to
    regulate them. That's like allowing the fox to guard the henhouse. The
    only thing that Philip Morris wants is the ability to continue to sell
    their addictive and deadly products. They definitely don't care about
    public health or they would get out of the tobacco business.
        I ask this committee to look deep into your hearts and souls and do
    what's best for the public. Look at my sister's photo and think what if
    that were my child or grandchild or wife or mother. Please do not let
    my sister or father or the other smokers die in vain. Think of your own
    families.
        Thank you for your time.
                            Smoking out Big Tobacco
                                laurie comstock
        Re: ``Camel No. 9 smells of killer marketing,'' commentary, Feb.
    21: No matter how much you dress it up, flavor it, decorate the
    packages with pink, fuchsia and teal flowers and designs, the truth is
    smoking all cigarettes, and using other tobacco products, addicts and
    kills people.
        The words ``light and luscious'' should be ``black and deadly''
    when used in advertising tobacco.
        My younger sister started smoking when she was 13. She died from
    lung cancer at age 44. I miss her with all my heart and so does my
    entire family. She leaves behind her husband and two sons who were 14
    and 17 when she died.
        I have lost many other family members, related both by blood as
    well as marriage, to tobacco-related diseases. All of them started
    smoking as teens.
        How many other people will die and how many more families will be
    devastated before this despicable industry is stopped?
        The answer is not weak FDA regulation that Philip Morris (now part
    of Altria Inc.) approves of, but implementation of U.S. District Judge
    Gladys Kessler's orders when she found the tobacco industry had
    violated Federal racketeering laws after a lengthy trial last year.
        The tobacco racketeers need to be held accountable for their
    crimes. Too bad prison is not an option.
        Prepared Statement of K.H. Ginzel, M.D., Professor Emeritus of
        Pharmacology and Toxicology, University of Arkansas for Medical
                           Sciences, Westhampton, MA
        I am opposed to any Federal regulatory action that implies formal
    approval and indefinite continuation of the commercial trade of tobacco
    products (see Attachment 1 and 2). The mission of the FDA is to
    oversee, among others, drugs used for the treatment of diseases and to
    make sure they are effective and safe.
        The inclusion of tobacco products by whatever classification would
    pervert this fundamental role of the FDA, especially as nicotine is
    increasingly recognized as an extremely harmful substance in addition
    to its addictiveness (see Attachment 3).
        Age 18 as the age for the legal purchase of tobacco is unacceptable
    for the following reasons:

        (1) The proposed regulation specifically prohibits the FDA from
    raising the legal minimum sale age for tobacco beyond age 18, as
    obviously demanded by Altria/PM to retain access to high school
    seniors, many of whom are over 18 and would therefore be able to
    legally buy tobacco products and pass them on to peers under 18.
        (2) Although the majority of adult smokers started smoking under
    18, 15 percent to 20 percent may start between 18 and 21. Hence,
    smoking would still be perpetuated at a significant level.
        (3) Tobacco use, smoked or chewed, imposes a carcinogenic burden
    that is more dangerous for the growing organism than for the adult.
    Physical growth does not stop at 18 but continues at least until 21.
        (4) The age at which the psychological maturity is attained for
    making an informed decision about using legal drugs with a high
    potential for addiction is at least 21, the age adopted for legal
    purchase of alcoholic beverages.

        I am attaching the following documents:

        (1) My position on tobacco as expressed in a letter to then-
    President Clinton and a Memo to the Presidential Task Force on National
    Tobacco Policy.
        (2) BMJ posting on ``The Future of Tobacco.''
        (3) Critical Review on Nicotine, just appeared as electronic
    version (publication in print early March).
                                     ______

        The following two documents express my judgment as to how, in a
    civilized society, the true reality of the tobacco issue ought to be
    confronted and resolved.
        Although they were created in 1997, they are as timely today as
    they were then.
                                     ______

                                                     September 8, 1997.
    Hon. William Jefferson Clinton,
    President of the United States,
    The White House, 1600 Pennsylvania Ave. NW.,
    Washington, DC 20500.
        Dear Mr. President: It is puzzling beyond comprehension that not a
    single argument among those raised in recent weeks against the
    ``tobacco settlement'' or in favor of alternative solutions to the
    leading preventable public health scourge of our time, has truly
    confronted reality and proposed the obvious, the obvious being the
    phasing out of commercial production and sale of tobacco products.
    Tobacco farmers should be assisted in harvesting tobacco for the
    commercialization of a high-quality protein that could feed a protein-
    starved third world. Smokers who want to quit should be given help,
    while those who don't should be allowed to grow their own tobacco
    plants strictly for personal use. This is NOT PROHIBITION.
        Are we so totally mired in the morass of ideological and political
    absurdities that we have lost the ability to think straight and act
    responsibly? For more than four decades American scientists have been
    at the forefront of accumulating incontrovertible evidence for the
    immense harm smoking inflicts on smokers as well as nonsmokers. At the
    same time U.S.-based tobacco corporations have occupied the field,
    deceived the public, and unashamedly pushed their deadly merchandise in
    the domestic and foreign marketplace. And essentially all we are
    laboring and fussing about now is how we can let them continue selling
    death with impunity, albeit in diminishing numbers. If this type of
    mindset had prevailed at the end of the second World War, we would
    probably have stopped our advance on the beachhead at Normandy, made
    peace with Hitler, and argued about the least offensive way to keep the
    concentration camps operating.
        Mr. President, circumstances have now granted us one of those rare
    opportunities when politics must end and moral courage command our
    actions. If you can seize this unique moment, cut through all the sham
    to the bedrock of truth, and start the world on the path of liberation
    from the lethal addiction to tobacco and to the profits garnered from
    the suffering of its victims, you will have a place in history among
    the greatest benefactors of humankind.
                Respectfully yours,
                                             K.H. Ginzel, M.D.,
                     Professor of Pharmacology and Toxicology Emeritus,
                           University of Arkansas for Medical Sciences.
                                     ______

                                                       August 27, 1997.
                                      MEMO
    To:  Presidential Task Force on National Tobacco Policy
    From:  K. H. Ginzel, M.D.

    (The tobacco industry is an economic tyrannosaurus rex: enormous,
    ferocious, and destined for extinction. The world, and its economies,
    will survive the industry's gradual demise quite handsomely.--Kenneth
    Warner, The Global War, Seventh World Conference on Tobacco & Health,
    Australia, 1990.)

        Ever since the first Surgeon General's Report on Smoking and Health
    appeared in 1964, the Federal Government has taken a duplicitous stance
    vis-a-vis tobacco use and its disastrous consequences for public
    health. Up till now one could euphemistically argue that the Government
    simply ``condoned'' the death of millions of Americans who succumbed to
    tobacco-related diseases during the past 33 years.
        However, by adopting the proposed tobacco ``settlement,'' the
    Government would formally endorse the continued sacrifice of old and
    new lives to the ravages of nicotine addiction. A case in point is the
    fact that a negotiated compromise intended to cut teens' smoking in
    half in a given number of years inescapably condemns the other half to
    the risk of disease and premature death. Hence, if there ever was
    pretense of innocence, from that moment on innocence would
    irretrievably be lost and liability for inflicted injury would no
    longer be limited to industry alone.
        Thanks to many years of untiring tobacco control advocacy,
    activism, and litigation, we have finally arrived at a juncture of
    profound significance and unparalleled opportunity. Numerous compelling
    reasons converge to mandate that the Federal Government, empowered by
    the Commerce Clause of Article 1, Section 8 of the Constitution, act
    responsibly and ban the commercial manufacture and worldwide marketing
    of tobacco products by U.S.-based corporations. Sales would have to be
    phased out over a specified period of time, during which current
    consumers can either seek help for quitting tobacco use or be permitted
    to start growing their own tobacco plants for strictly personal use
    (This would NOT be PROHIBITION. Tobacco farmers should be assisted in
    changing to alternative crops or in harvesting tobacco for the
    extraction and commercialization of a high-quality protein that is only
    found in tobacco plants. Tobacco giants, which are already highly
    diversified, will be able to switch to non-tobacco commodities without
    undue hardship. According to Kenneth Warner, the total economic impact
    of changing to a non-smoking society would be negligible, if not
    beneficial.
        If this prescription sounds too Utopian, a reality check may be in
    order.
        Let everyone try to invoke cogent and logically impeccable
    arguments as to why the industrial manufacture and global marketing of
    tobacco products by U.S. corporations must continue.

        (1) Is it to continue because 50 million Americans still smoke and
    need to be provided with cigarettes? (After all nicotine replacement
    medication can be purchased over the counter and smokers could still
    grow their own tobacco).
        (2) Is it because smokers' alleged freedom of choice to continue
    smoking--they surely did not exercise choice when they started smoking
    as teens--deserves greater protection than their health, as well as the
    health of those involuntarily exposed to their smoke?
        (3) Or is it because tobacco sales at home and abroad not only
    yield huge profits for the tobacco industry and substantial tax
    revenues for governments, but also make possible generous corporate
    donations to influential Members of Congress?
        (4) Or, finally, is it because the premature death of smokers could
    help reduce payments from pension funds, and Social Security and
    Medicare expenditures?

        The issue of a black market for cigarettes, now faced especially by
    countries like Canada with high taxes on cigarettes, would largely
    disappear once U.S. production has ceased. Europe is now looking at
    America's evolving tobacco policy and is likely to follow its example.
        If any of the reasons considered above are deemed sufficient to
    justify the continued marketing of such a deadly product, this would
    suggest that our society places a higher priority on corporate profit
    than on the health and happiness of people. If, however, the converse
    is true and no valid arguments can be found in support of the status
    quo, the time for action has clearly arrived. This is a propitious
    moment in history that, if not seized upon now, will probably not
    return until tobacco has claimed many more millions of victims.
                                     ______

                             The Future of Tobacco
        In addressing ``The Future of Tobacco,'' Nigel Gray suggests two
    alternative approaches. One is the prohibition of tobacco, the other
    concentrates on finding other nicotine delivery systems to compete with
    tobacco. He dismisses the first option because of the notorious failure
    of the alcohol prohibition in the United States in the 1920s. Indeed, a
    ``Prohibition'' patterned after the former would not be a practicable
    solution.
        However, a fundamentally different kind of ``prohibition'' not only
    deserves serious consideration but also follows compellingly from the
    extraordinary new stance Philip Morris, the most successful U.S.-based
    multinational cigarette maker, has recently adopted. After more than
    half a century of blatant denial, PM is suddenly fully embracing the
    death and destruction its products inflict (philipmorris.com Web site).
    Yet, despite PM's agreement with ``the overwhelming medical and
    scientific consensus that cigarette smoking causes lung cancer, heart
    disease, emphysema and other serious diseases in smokers,'' it still
    conducts ``business as usual,'' continues to advertise and sell its
    cigarettes at home and abroad. * The
    perfunctory warning labels about the risks of smoking can in no way
    compete with the massive pictorial impact of insidious advertising
    imagery that uniquely affects the young mind.  I am not aware of any product other than cigarettes that,
    after being found defective and endangering life, was not withdrawn
    from the market, either voluntarily by the manufacturer or by
    regulatory or legal fiat of government.
    ---------------------------------------------------------------------------
        * (Note: The two statements added here between < and > in the above
    paragraph had been eliminated by the BMJ Editor from the published
    version of my RESPONSE).
    ---------------------------------------------------------------------------
        The stage appears to be set to examine if the sale of a product
    that kills half of its long-term users and whose manufacturer now
    unreservedly endorses its multiple risks and dangers can any longer be
    tolerated by society. As one ponders the realities of the free
    enterprise system, one is inevitably led to appreciate the role that
    Government must play on behalf of its people. In their wisdom, the
    Framers of the Constitution granted Congress the right to regulate
    commerce, empowering the U.S. Government in the ``Commerce Clause'' of
    Article 1, Section 8, of the Constitution to stop the interstate trade
    of dangerous merchandise, an authority that could conceivably be
    exercised in the case of tobacco. Such action must be clearly
    distinguished from prohibition, since individuals would still be able
    to grow tobacco strictly for personal use.
        The second alternative considered by Nigel Gray aims at a nicotine
    delivery device not based on tobacco. Although this would greatly
    reduce the burden of toxic and carcinogenic exposure of the user, the
    fact that nicotine itself is a tumor promoter and can be converted in
    the body to the tobacco-specific nitrosamine, NNK, one of the most
    potent lung carcinogens known, would argue against its extended use as
    a substitute for tobacco. However, sebacylcholine, an agent that is
    chemically different from nicotine but duplicates certain effects of
    nicotine, should be tested as a potential substitute (K.H. Ginzel, A
    hypothesis on the peripheral origin of smoking satisfaction and its
    implication for nicotine replacement. Proc. 7th World Conference on
    Tobacco and Health, Perth, Western Australia, 1990, pp. 426-427).
                                     ______

                          Journal of Health Psychology
    Critical Review: Nicotine for the Fetus, the Infant and the Adolescent?
    k.h. ginzel, gert s. maritz, david f. marks, manfred neuberger, jim. r.
      pauly, john r. polito, rolf schulte-hermann and theodore a. slotkin)
                                    abstract
        The recent expansion of Nicotine Replacement Therapy to pregnant
    women and children ignores the fact that nicotine impairs, disrupts,
    duplicates and/or interacts with essential physiological functions and
    is involved in tobacco-related carcinogenesis. The main concerns in the
    present context are its fetotoxicity and neuroteratogenicity that can
    cause cognitive, affective and behavioral disorders in children born to
    mothers exposed to nicotine during pregnancy, and the detrimental
    effects of nicotine on the growing organism. Hence, the use of
    nicotine, whose efficacy in treating nicotine addiction is
    controversial even in adults, must be strictly avoided in pregnancy,
    breastfeeding, childhood and adolescence.

        Keywords: adolescence; carcinogenesis; fetotoxicity; Nicotine
    Replacement Therapy; pregnancy; teratogenicity
                                  introduction
        With the prospect of causing one billion deaths in the 21st
    century, cigarette smoking has entrapped the planet in a pandemic of
    tobacco-related morbidity and mortality of unprecedented proportion
    (Ginzel, 2001). Since addiction to nicotine is at its core, one should
    expect that efforts be focused on helping smokers to overcome their
    addiction to nicotine. Instead, nicotine, as in ``Nicotine Replacement
    Therapy'' (NRT), is becoming a more and more heavily promoted tool for
    smoking cessation.
        In support of NRT, it is claimed that the main cause of the health
    damage inflicted by smoking is the cigarette smoke with its contingent
    of over 4,000 substances, many of which are toxic or carcinogenic, but
    not the nicotine to which the smoker is addicted. Therefore, it is
    argued, if the addiction to cigarette smoking is too powerful to
    respond to treatment, providing nicotine via NRT or even smokeless
    tobacco in place of cigarettes is the correct course of action. This
    argument is then further strengthened by portraying nicotine as largely
    innocent, on par with caffeine, thereby ignoring the abundant evidence
    that nicotine itself can imperil health due to a host of adverse
    effects independent of its addictiveness.
        But even if the toxicity of nicotine were accepted as a given,
    would medicinal nicotine from NRT not be preferable to nicotine
    contaminated with the bulk of poisons in cigarette smoke? Although this
    question may suggest an affirmative answer, it actually hides the need
    for uncompromised quitting as the only truly lasting solution. There
    are at least two points to consider. For one, the satisfying experience
    of a deep inhalation of cigarette smoke correlates with a sudden, steep
    spike of the blood nicotine level. The generally much gentler and more
    protracted rise following ingestion of NRT or smokeless tobacco can
    neutralize the unpleasantness of withdrawal symptoms during quitting
    attempts but it fails to eliminate the urge to smoke, prompting a
    relapse to smoking. The unsuccessful quitter then smokes either in
    alternation or even concurrently with NRT. Despite the inevitable
    increase in nicotine exposure that this practice entails, it was
    officially endorsed by the ``the new rules'' (see later). Second, for
    both the addict and the counselor, the true labor of quitting is
    comfortably postponed or suspended by resorting to a simple pill or
    patch. By making ``quitting'' look so effortless, the health concerns
    and attitudes toward smoking will have lost their urgency.
        When the concept of treating nicotine addiction with nicotine first
    emerged in the early 1980s, pharmaceutical companies seized upon the
    opportunity to develop and market several nicotine preparations for
    this purpose. Available today are nicotine chewing gum, transdermal
    patch, lozenges, nasal spray and inhaler, which enjoy increasing
    popularity among cessation specialists and smokers who are trying to
    quit. However, a critical commentary questions the overall utility and
    success rate of NRT as an aid to smoking cessation (Polito, 2006).
    Also, according to a new meta-analysis, the long-term benefit of NRT is
    modest, while existing treatment guidelines, based on only 6-12 months
    of followup, overestimate the lifetime benefit and cost-efficacy of NRT
    (Etter & Stapleton, 2006).
        Despite the lack of evidence for long-term effectiveness, NRT use
    continues to grow. In the United Kingdom the Committee on Safety of
    Medicines (CSM) and the Medicines and Healthcare Regulatory Authority
    (MHRA) have issued new rules, extending the use of nicotine in smoking
    cessation to the most vulnerable recipients, the unborn child, the
    neonate and children as young as 12 (Action on Smoking and Health,
    2005). Yet, in the only two trials conducted in pregnancy, NRT patches
    had no greater effect on smoking cessation than placebo (Coleman et
    al., 2004). Neither did NRT prove effective in a study of 120
    adolescent smokers (Moolchan et al., 2005).
        Whether or not successful in achieving quitting, the recommendation
    to use NRT in pregnancy and childhood raises the most serious concerns
    because of potential long-term consequences of nicotine action for this
    target group. In addressing these concerns, we first review the current
    state of the science on nicotine's pharmacological profile with its
    diverse impact on body functions, in particular its implication in
    carcinogenesis, and then zero in on those effects of nicotine that
    specifically impinge upon the developing and growing organism, the
    primary objective of this article.
                      a brief synopsis of nicotine action
        More than 100 years ago nicotine was first used as a tool in
    physiological research. When nicotine was found to duplicate several
    effects of acetylcholine (ACh), one of the principal neurotransmitters
    in the central and peripheral nervous systems, this type of
    ``cholinergic'' transmission was designated ``nicotinic.''
        The transmission occurs across a synapse between a presynaptic
    nerve ending from which ACh is released and the adjacent postsynaptic
    neuronal cell body or effector cell that carries specialized receptors
    normally stimulated by ACh but also responsive to nicotine. Nicotinic
    cholinergic transmission via nicotinic cholinergic receptors (nAChRs)
    is a vital process indispensable for the normal functioning of the
    living organism but vulnerable to impairment by nicotine. This is one
    target for nicotine in the mature nervous system. Yet in the developing
    nervous system, very early in gestation, nAChRs are expressed prior to
    the formation of the neurons, which later establish synaptic contact
    with the nAChRs. By modifying the function of these receptors, nicotine
    can interfere with the normal developmental role of ACh (Falk,
    Nordberg, Seiger, Kjaeldgaard, & Hellstrom-Lindahl, 2005). These
    effects occur in the range of amounts of nicotine derived from smoking
    or equivalent sources.
        Nicotine also exerts multiple effects on the afferent portion of
    the nervous system. In lowest effective doses it stimulates vagal
    sensory nerve endings in the lungs, producing reflexly a generalized
    relaxation of the skeletal musculature and an activation of the
    electroencephalogram (EEG) correlated with mental alertness. This
    intriguing combination, experienced and valued by the smoker, is likely
    to contribute to nicotine's addictive property (Ginzel, 1987).
        Recently an entirely new dimension was added to the wide spectrum
    of nicotine action. Neuronal nicotinic acetylcholine receptors, nAChRs,
    expressed on many different nonneuronal cell types throughout the body,
    including lymphocytes, macrophages, dendritic cells, adipocytes,
    keratinocytes, endothelial cells and epithelial cells of the intestine
    and lung, appear to be implicated in inflammatory conditions and
    diseases as diverse as ulcerative colitis, chronic pulmonary
    obstructive disease, Parkinson's and Alzheimer's disease (Gahring &
    Rogers, 2006).
        Among the classical effects of nicotine are those on heart and
    blood vessels mediated via nAChRs in the peripheral autonomic nervous
    system. Nicotine affects adult heart rate and rhythm and accelerates
    fetal heart rate. More recently, a key role of the inner lining of
    blood vessels, the endothelium, in maintaining adequate blood flow to
    organs was discovered. In the human brachial artery, the endothelium-
    dependent dilatation was found to be impaired by nicotine from
    cigarette smoke as well as from NRT nasal spray (Neunteufl et al.,
    2002). After a mere 30-minute exposure to environmental tobacco smoke
    (ETS), a substantial reduction in the coronary flow velocity reserve,
    indistinguishable from that seen in habitual smokers, was observed in
    healthy young nonsmokers (Otsuka et al., 2001). The underlying
    mechanism was found to be the inhibition by nicotine of the self-
    regulatory coronary vasodilatation in response to nitric oxide released
    by endothelial cells. Since this effect of nicotine reaches its maximum
    already in the small amounts present in ETS, the difference between
    passive and active smoking as to their effects on blood vessels is
    greatly narrowed. Heart disease from smoking only one to four
    cigarettes per day is probably due to this mechanism (Bjartveit &
    Tverdal, 2005). By increasing platelet aggregation and low density
    cholesterol (LDL) while lowering high density cholesterol (HDL),
    nicotine favors clot formation that may lead to heart attacks and
    strokes. Nicotine, especially in the presence of a high cholesterol
    diet, stimulates the growth of vascular smooth muscle cells and
    promotes plaque formation and atherosclerosis (Jeremy, Mikhailidis, &
    Pittilo, 1995). The American Heart Association (2006) has questioned
    the suitability of NRT for patients with heart disease and for pregnant
    smokers.
        Nicotine has a whole spectrum of other effects at different stages
    of fetal and adult development, which should not be ignored by those
    administering or receiving NRT. Some of these are: an increase in
    airway resistance; a decrease in fetal respiratory movements; a
    decrease in alphal-antitrypsin associated with an increase in elastase
    favoring the development of emphysema; gastrointestinal
    vasoconstriction combined with a reduction in prostacyclin leading to
    stomach ulcers; a depression of the immune response; and multiple
    effects on hormones, especially a lowering of estrogen due to an
    increase in its metabolism leading to an earlier onset of menopause,
    osteoporosis and cardiac problems (U.S. Department of Health and Human
    Services, 1988).
                          nicotine and carcinogenesis
        One of the reasons for protecting the developing and growing
    organism from exposure to nicotine is the prominent role nicotine plays
    in both ``initiation'' and ``promotion,'' the two cardinal stages in
    carcinogenesis. Nicotine can be transformed to one of the most potent
    lung carcinogens, the tobacco-specific nitrosamine, NNK. As an
    initiator, NNK is a prime candidate among the many carcinogens in
    cigarette smoke responsible for starting the process toward cancer in
    active and passive smokers (Hecht, 2004; Hecht, Hochalter, Villalta, &
    Murphy, 2000). NNK and its metabolites are found in the first urine of
    infants born to smoking mothers, supporting the hypothesis that in
    utero exposure to tobacco carcinogens could be carcinogenic later in
    life (Lackmann et al., 1999). Transplacental carcinogenesis associated
    with smoking during pregnancy may involve, in addition to nicotine and
    NNK, other carcinogens from cigarette smoke. Reduced detoxification
    capabilities and increased susceptibility to DNA damage render the
    fetus especially vulnerable to carcinogenic risk (Whyatt et al., 2001).
    NNK and metabolites have also been recovered from elementary school
    children and adults exposed to ETS (Hecht et al., 2001), attesting to
    the fact that even the relatively small amounts of nicotine in ETS can
    be transformed to NNK in the recipient. Added to this are the minute
    concentrations of NNK in ETS that had been formed earlier in stored and
    burning tobacco. Nicotine ingested from NRT can also undergo
    transformation to NNK (Hatsukami et al., 2004). Fetal pulmonary
    neuroendocrine cells as well as lung cancer cells express nAChRs that
    bind NNK and nicotine which, in turn, stimulate the growth of these
    cells (Minna, 2003). The fact that human lung cancer cells of all
    histological types carry nAChRs suggests that nicotine itself may also
    play a direct role in the pathogenesis of lung cancer (Minna, 1993).
        Tumor growth occurs when the critical balance between cell
    proliferation and programmed cell death (apoptosis) in normal healthy
    tissues is disturbed. At blood concentrations achieved by smoking, ETS
    exposure, or NRT, nicotine activates via nAChRs the cellular signalling
    pathway Akt, a protein kinase, which stimulates cell proliferation and
    inhibits apoptosis (Tsurutami et al., 2005). Activated Akt has been
    identified in all lung cancer samples taken from smokers. By this
    mechanism nicotine promotes unregulated growth and tumor formation, an
    effect that is not limited to the lungs but can also occur in cancers
    of other organs. Nicotine in NRT can be expected to act in a similar
    way (Heusch & Maneckjee, 1998).
        Nicotine from cigarettes or NRT might also confer a proliferative
    advantage to already existing tumors. At concentrations even lower than
    those in smokers' blood, nicotine stimulates proliferation of
    endothelial cells and the formation of new blood vessels
    (angiogenesis), a basic requirement for tumor growth and metastasis
    (Villablanca, 1998). Furthermore, through activation of protein kinase
    C, nicotine accelerates migration and invasion of human lung cancer
    cells (Xu & Deng, 2006). All these actions define nicotine as an
    effective tumor promoter. As smoking-related promotion is now being
    recognized as the primary etiologic mechanism in carcinogenesis
    dominating over smoking-related initiation (Hazelton, Clements, &
    Moolgavkar, 2005), nicotine, implicated in both processes, ought to be
    a major aim for intervention instead of a tool advocated for use in
    smoking cessation.
        New research using human tissues raised the question whether
    nicotine is ``potentially a multifunctional carcinogen'' (Campain,
    2004), since it produces concomitant genotoxic and antiapoptotic
    effects, first steps in the neoplastic process. In human gingival
    fibroblasts nicotine induced rapid DNA damage at in vitro
    concentrations equivalent to those found to occur in the plasma of
    tobacco users (Argentin & Cicchetti, 2004). Genotoxicity observed in
    human tonsillar tissue and lymphocytes as well as in upper
    aerodigestive tract epithelia also suggests a direct tumor-initiating
    effect of nicotine (Kleinsasser et al., 2005; Sassen et al., 2005).
        Smoking is now recognized as the second most significant cause of
    cervical cancer after human papilloma virus (International Agency for
    Research on Cancer, 2003). Nicotine which accumulates in cervical mucus
    after active and passive smoking and smokeless tobacco use (McCann et
    al., 1992), and which is also highly concentrated in the cervical mucus
    of women who use nicotine patches (Cancer Weekly, 1995), was found not
    only to promote rapid tumor growth and its lympho-angiogenic spread but
    also to inhibit an anti-proliferative factor (Lane, Gray, Mathur, &
    Mathur, 2005).
        Although the preceding experimental data focus largely on adult
    cancer incidence implicating nicotine as a causative factor, similar
    scenarios can be expected to play out over time following fetal or
    childhood exposure to nicotine. Transplacental carcinogenesis
    associated with smoking during pregnancy may also involve, in addition
    to nicotine, other carcinogens found in cigarette smoke.
                      nicotine in pregnancy and childhood
        Nicotine also acts as a neuroteratogen. There is now abundant
    evidence that normal fetal development can be disrupted more
    specifically by nicotine than by any other component of cigarette
    smoke. Nicotine, which impacts the brain during critical stages of its
    intrauterine development in experimental animals, is in the offspring
    of smoking mothers also the most likely cause of the deficits in
    learning and memory, and the emotional and behavioral problems seen in
    childhood and later in life (Levin & Slotkin, 1998; Slikker, Xu, Levin,
    & Slotkin, 2005; Slotkin, 1998). In this context, a higher incidence of
    attention deficit hyperactivity disorder (ADHD), lower adult
    intelligence and mental retardation have been reported (Drews, Murphy,
    Yeargin-Allsopp, & Decoufle, 1996). Higher order sensory function
    depends in part on the activation of nAChRs in the sensory cortex by
    its natural transmitter acetylcholine. When nicotine, even if only
    transiently, usurps these receptors in the developing sensory cortex
    during a critical period, it can permanently alter sensory-cognitive
    function (Metherate, 2004). Just published new findings provide
    experimental evidence that nicotine exposure in pregnancy is
    responsible for auditory-
    cognitive deficits in the offspring. Children with cognitive hearing
    deficits have difficulty in understanding speech and verbally presented
    information in noisy settings, and may be unable to tell the difference
    between similar sounds (Liang et al., 2006). Prenatal nicotine also
    primes the adolescent brain for depression (Law et al., 2003), and for
    nicotine addiction in future years (Abreu-Villaa, Seidler, Tate,
    Cousins, & Slotkin, 2004; Kandel & Davies, 1994; O'Callaghan et al.,
    2006).
        Significantly lowered levels of catecholamines found in umbilical
    cord blood in response to hypoxemia during parturition may explain the
    increased perinatal morbidity and mortality associated with smoking
    during pregnancy (Oncken et al., 2002). A blunted catecholamine
    response to hypoxic stress with a greater risk of death to offspring
    was also observed in rats receiving nicotine throughout gestation.
    Prenatal nicotine exposure can also have a permanent impact on lung
    development and function with potential long-term health consequences
    (Fauroux, 2003). Nicotine crosses the placenta and activates nicotinic
    receptors located at a wide range of lung cells. In rat experiments, in
    doses equivalent to those ingested by smoking mothers, nicotine causes
    what appears to be a faster aging of the lungs in the offspring,
    characterized by enlarged alveoli, fewer alveoli, a smaller surface
    area for gas exchange and microscopic emphysema (Maritz & Windvogel,
    2003). NRT use during pregnancy and breast-feeding when the neonate
    lungs are still developing should be avoided (Alm, Lagercrantz, &
    Wennergren, 2006). Prenatal nicotine exposure can permanently alter
    lung development and airway function (Sandberg, Poole, Hamdan,
    Arbogast, & Sundell, 2004). Prenatal and postnatal nicotine exposure
    have been causally implicated in Sudden Infant Death Syndrome (SIDS)
    (Cohen et al., 2002; Huang, Wang, Dergacheva, & Mendelowitz, 2005;
    McMartin et al., 2002; Milerad, Vege, Opdal, & Rognum, 1998; U.S.
    Department of Health and Human Services, 2006). NRT use during the
    first 12 weeks of pregnancy increased the risk of congenital
    malformations (Morales-Surez-Varela, Bille, Christensen, & Olsen,
    2006).
        A well-known consequence of smoking during pregnancy is the
    incidence of low birth weight (LBW) babies, but even in the absence of
    LBW, nicotine that reaches some 15 percent higher levels on the fetal
    side of the placenta than on the maternal side, affects fetal brain
    development and newborn neurobehavior (Lambers & Clark, 1996). Nicotine
    concentrates in fetal blood, amniotic fluid and breastmilk. Breast-
    feeding by smoking or ETS exposed mothers continues the delivery of
    nicotine to the baby (Dahlstrom, Ebersjo, & Lundell, 2004). Postnatal
    exposure to cigarette smoke also appears to act through nicotine: in a
    study of 4,399 children aged 6 to 17 years, even the lowest exposure,
    as monitored by the levels of cotinine, the main metabolite of
    nicotine, in blood, urine, saliva and hair, was found to significantly
    impair, in a dose-related manner, the children's reading, math and
    reasoning scores (Yolton, Dietrich, Auinger, Lanphear, & Hornung,
    2005).
                            nicotine in adolescence
        According to recent human and animal research, adolescents are more
    susceptible to developing nicotine dependence than adults, because a
    single drug exposure can lead to lasting neuronal changes associated
    with learning and memory (Fagen, Mansfelder, Keath, & McGehee, 2003).
    The earlier the exposure to nicotine, the greater is the impact on the
    neuronal circuitry of the still developing brain causing irreversible
    effects on hippocampal structure, function, learning and memory
    (Slotkin, 2002). This experimental finding was borne out of a study of
    5,863 students, where a single experience with cigarettes reported at
    age 11 was found to significantly increase the risk of becoming a
    smoker as an adolescent even after 3 intervening years of nonsmoking.
    This dormant vulnerability, termed ``sleeper effect'' (Fidler, Wardle,
    Brodersen, Jarvis, & West, 2006), must be made widely known to help
    prevent preteens from early experimentation with cigarettes or other
    tobacco products. Early exposure to nicotine can also make children
    more vulnerable later to stress or depression, prompting them to try
    some form of nicotine again.
        Adolescent smokers have only recently started to receive NRT. Some
    of them reported simultaneous use of NRT and cigarettes. Nonsmoking
    teens have also tried NRT and some have even indulged in regular use
    (Klesges, Johnson, Somes, Zbikowski, & Robinson, 2003). The easy
    availability of NRT poses a special risk for the curious and
    adventurous young. Like smoking, NRT has the potential of priming the
    brain for nicotine addiction and leading to illegal drug use.
        A review of teen smoking cessation approaches reveals their
    complexity and the lack of an effective solution (Mermelstein, 2003).
    What appears to be missing from the majority of interactions with young
    people is a totally honest confrontation and a truthful dissection of
    the tobacco problem in its entirety (Ginzel, 2002).
                                 the new rules
        Against this background, it is with much concern that we confront
    the recently proposed rules issued by the Committee on Safety of
    Medicines (CSM) and by the Medicines and Healthcare Regulatory
    Authority (MHRA) for the use of NRT in the UK (Action on Smoking and
    Health, 2005), likely to set a precedent for other countries to follow.
    According to these new rules, all forms of NRT can be used by pregnant
    smokers; different forms of NRT can be used alternatively or
    concurrently; NRT can be used while still smoking (!) and can be
    prescribed for up to 9 months if needed; and all forms of NRT can be
    used by young smokers aged 12 to 17 years as well as by patients with
    cardiovascular disease if so advised.
        These new rules differ fundamentally from past recommendations.
    Molyneux (2004) states that the effectiveness of NRT in adolescents and
    children who smoke has not been established, and he also urges smokers
    not to smoke while using NRT. NRT, especially by transdermal patch,
    delivers more nicotine to the fetus than smoking does. Nicotine
    concentrations in fetal rat brain are 2.5 times higher than the
    mother's blood nicotine level when on continuous nicotine feed; a
    similar ratio can be expected in pregnant women using the patch
    (Sarasin et al., 2003). Smokers who use NRT may have nicotine
    concentrations up to three times higher than the approved dose (Chan,
    Jeremy, Stansby, & Shukla, 2004). The U.S. Surgeon General's Report of
    2001 on Women and Smoking states: Because of uncertainties over the
    safety of nicotine replacement during pregnancy, FDA has assigned a
    Pregnancy Category C warning to nicotine gum (``Risk cannot be ruled
    out'') and a Pregnancy D warning to transdermal nicotine (``Positive
    evidence of risk'') (U.S. Department of Health and Human Services,
    2001, p. 557). Since many of tobacco smoke's harmful effects on the
    unborn baby can be attributed to nicotine, NRT or smokeless tobacco
    products are not a safe alternative to smoking during pregnancy (Cohen
    et al., 2005). No data are available on long-term effects of NRT use on
    fetal outcomes (Oncken, Bert, Ockene, Zapka, & Stoddard, 2000). The
    uncertainty of benefit and the risk of NRT use in pregnancy and by
    teens are echoed throughout the literature dealing with this topic. The
    risk of oral NRT use also received new emphasis by the recent finding
    that nicotine causes concomitant genotoxic and antiapoptotic effects in
    human gingival fibroblasts, potentially the first step in the
    neoplastic process (Argentin & Cicchetti, 2004).
        It is obvious that the smoker whose body is busy dealing with the
    nicotine contingent in inhaled smoke ought not to be burdened with
    additional amounts of nicotine delivered from NRT but should be
    resolutely supported to overcome the addiction to nicotine altogether.
    This cannot be achieved by recommending or prescribing nicotine through
    NRT. The ultimate goal must be total cessation of smoking and nicotine
    intake in any form. NRT simply substitutes one form of nicotine for
    another but is neither safe nor as effective as other cessation aids
    (Hutter, Moshammer, & Neuberger, 2006; Marks, 2005, 2006; Moshammer &
    Neuberger, 2006). Originally, the tobacco industry opposed the makers
    of NRT, but now both industrial enterprises seem to be finding common
    ground as tobacco and NRT have begun reinforcing each other and keeping
    the addiction to nicotine alive.
                              concluding comments
        Prescribing or simply recommending an over-the-counter purchase of
    one form or another of NRT is unquestionably quicker and less engaging
    for the health professional than any in depth one-to-one counsel that
    tries to inspire mind and heart of the mother-to-be so as to make her
    cherish and protect the new life she has been entrusted with; it is
    also easier than a straight talk with a teen or preteen about a future
    eclipsed by addiction, disease and premature death, exploring the real
    reasons that made them light up in the first place (Ginzel, 2002). It
    is easy not only for the counselors to prescribe NRT, it is also easy
    for the clients to receive it: they may conveniently assume that this
    is all that needs to be done, and the urge to smoke may go away in due
    course. While there is compelling experimental and clinical evidence
    that nicotine harms the developing fetus in several ways, evidence is
    lacking that NRT aids smoking cessation in pregnancy. There are
    pregnant women today who would have quit but are wearing nicotine
    patches, persuaded by the safety assurances about NRT use. Moreover,
    new evidence reveals that offering a remedy for a risky behavior
    inadvertently promotes it by suggesting that the risk is manageable
    (Bolton, Cohen, & Bloom, 2006).
        If the new UK rules, which extend and multiply a regimen ill-
    conceived from the start were followed and also adopted by other
    countries, they would perpetuate nicotine addiction rather than
    diminish it. And so would a recently proposed policy of extended, or
    even indefinitely continuing (!), use of the so-called ``clean
    nicotine'' of NRT (Gray et al., 2005). This could actually set us on a
    path eventually leading to the end of tobacco control as we know it.
    Tobacco control must be nicotine control. Without nicotine control,
    nicotine addiction and nicotine's multifarious and insidious impact on
    the user would persist and spread at the peril of the unborn, the next
    generation and public health in general.
        Some 4,000 years ago the code of Hammurabi decreed the penalty of
    death for anyone who would harm a child. In an editorial in the New
    York Times in March 1985, William G. Cahan of the Memorial Sloan
    Kettering Cancer Center identified smoking as the most prevalent form
    of child abuse. Will nicotine now join this deplorable distinction?
                                 abbreviations
        ACh, acetylcholine; ADHD, attention deficit hyper activity
    disorder; CSM, Committee on Safety of Medicines; ETS, environmental
    tobacco smoke; FDA, Food and Drug Administration; MHRA, Medicines and
    Healthcare Regulatory Authority; nAChRs, nicotinic cholinergic
    receptors; NNK, tobacco specific lung carcinogen 4-(methylnitrosamino)-
    1-(3-pyridyl)-1-butanone; NRT, nicotine replacement therapy; SIDS,
    sudden infant death syndrome.
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                       Comment of Stephen L. Hansen, M.D.
         Prof. Ginzel has it just right. This is a politically achievable
    goal of tremendous public health import. Polls support de-legalization
    of the sort envisioned here. Let's unify around this approach for the
    long run--people are ready for tobacco to go.
     Prepared Statement of Michael S. Givel, Ph.D., Professor of Political
                  Science, University of Oklahoma, Norman, OK
       fda legislation requires significant changes to curb cigarette use
        Mr. Chairman and distinguished members of the committee, thank you
    for the opportunity to allow me to submit this written testimony with
    respect to proposed Food and Drug Administration legislation and
    regulation of tobacco. I respectfully request that my written statement
    be included as part of the committee's official record.
        My name is Michael Steven Givel and I am an associate professor of
    political science at the University of Oklahoma. My area of research
    expertise includes public policy, health policy and tobacco policy. I
    have been involved in tobacco policy research for about 10 years and
    prior to that was involved for 2 years with Synar youth enforcement
    program administration in the State of Missouri. I have published
    extensively in scientific peer-reviewed journals with respect to the
    issue of Federal tobacco policymaking, including two recent scientific
    articles on the Global Settlement and past attempts by the U.S. Food
    and Drug Administration (FDA) to regulate tobacco products. I will
    preface my written testimony today with comments regarding the adequacy
    of the proposed FDA legislation to actually reverse the use of the
    Nation's consumption of tobacco products.
        The very long title I of this bill with the various requirements
    for cigarette product performance, labeling, and monitoring standards
    represents a long-term goal by some for an alleged ``safer'' cigarette.
    Unfortunately, there is no wide scientific consensus or proof that has
    definitively and conclusively shown that a reduction of some
    ingredients or product modifications will make a lit cigarette safer.
    In fact current scientific evidence and research has provided little
    conclusive evidence as to what tobacco ingredients and in what
    combination and in what levels is specifically linked to particular
    morbidities and mortalities.
        For example, even if the FDA were to lower nicotine levels as is
    proposed for title I of this bill, this will not make cigarettes, as
    some claim, non-addictive or ``safer.'' In fact, lowering of nicotine
    levels will lead smokers to compensate to maintain their current level
    of nicotine consumption. This will result in these smokers consuming
    higher levels of harmful ingredients including tar leading to
    continuing high levels of disease and death.
        Supposedly safer cigarettes coming on to the market with FDA
    approval will also maintain the current market brands of cigarettes
    that cause significant disease and death. Given that there is no
    scientific evidence conclusively linking varying amounts of ingredients
    with specific morbidities and mortalities, testing of the new brands,
    which would be very long-term lasting numerous years would be highly
    problematic and questionable. In the meantime, the current market would
    be maintained.
        Another glaring example of the problem with this idea of supposedly
    safer cigarettes in title I is the provision to ban all additives
    except menthol. Why is there this significant disparity in standards in
    banning additives that are all known to unduly entice smokers to smoke
    particular brands? This is illustrative of how uncertain actual
    agreement is on what constitutes a supposedly safer cigarette.
        In fact, if there were such a thing as a safer cigarette, the
    shorter title II of this proposed bill requiring stronger warning
    labels would not be necessary. Either a cigarette is safer or there is
    no need for larger warning labels, but not both. While much of title I
    can not currently be justified, at a minimum, in order to mitigate one
    very severe problem with title I, I would recommend that this committee
    remove by amendment the provision that allows the use of menthol as an
    additive.
        This legislation also provides a significant litigation shield
    (along with provisions of title II, discussed below) that can be
    presented to future juries that there are now supposedly stricter
    product standards (along with larger and clearer warning labels). With
    this litigation shield consumers would have lesser basis to obtain
    monetary damages, particularly punitive damages. Thus this bill, which
    is based on a far from settled notion that cigarettes can supposedly be
    made safer stymies the lawful right of plaintiffs to obtain full
    justice in lawsuits. I recommend that this committee ensure that clear
    language in this law require that this legislation can not be used to
    justify undue lesser legal damages, particularly punitive damages, in
    product liability and tort lawsuits.
        Title II of this bill does approximate current scientific public
    health recommendations for warning labels, except the strongest
    labeling requirements also require graphic color pictures depicting
    four major diseases due to smoking. These diseases include: heart
    disease, stroke, lung cancer in smokers, and lung cancer in non-
    smokers. The current legislation makes this a discretionary
    requirement. This is an important public health consideration as recent
    research indicates that the strongest approach to cause smoker
    cessation or smoker consideration of cessation occurs when all diseases
    are graphically shown on large warning labels. I recommend that this
    committee make color graphics tied to the four major diseases related
    to smoking a mandatory and not discretionary requirement.
        The legislation also substantially preempts State and local control
    in the following areas: tobacco product standards, pre-market approval,
    adulteration, misbranding, labeling, registration, good manufacturing
    standards, and modified risk tobacco products. In addition, section 906
    (3) (ii), of this bill preempts State authority to restrict the minimum
    age of sale of tobacco products to no one older than 18. This is an
    unprecedented advance of Federal power at the expense of State and
    local governments. Several States, which have enacted innovative
    regulatory requirements in such areas as adulteration of cigarette
    products would have their legislative autonomy and authority
    significantly superceded by this legislation. I recommend to this
    committee that the clause preempting State and local rights be removed.
        Title III addresses another important issue with respect to
    smuggling calling for stronger labeling and tracking of tobacco
    products. However, this can be easily circumvented with counterfeit
    labels and packaging as has been done in the past so this is a very
    weak provision. This provision needs to be reconsidered with respect to
    more aggressive anti-smuggling policies such as stepped up border
    enforcement efforts and equivalence in tobacco tax policies and rates
    that do not encourage smuggling from the United States to bordering
    countries like Canada or visa versa.
        Finally, due to the glaring deficiencies in various key premises of
    this legislation, unfortunately this proposed law will not
    significantly reduce tobacco use in the United States. Instead, it will
    ironically create a stable and thriving adult tobacco market through
    the FDA regulatory framework into the far future that unduly sanctions
    tobacco products as ``safe'' while removing greater legal liability and
    State and local authority to pass more stringent legislation. There is
    no conclusive evidence that this legislation will significantly save
    lives or reduce disease. What this legislation will do is convince
    current and new smokers into believing that cigarettes are supposedly
    safer with a likelihood of even stabilizing or increasing consumption
    to the detriment of the public health.
        I strongly urge this committee to either defeat this bill or in the
    alternative significantly amend and correct this bill so that true
    progress can be made in reducing tobacco consumption.
        Thank you for this opportunity to allow me to present my written
    testimony to this committee.
    Prepared Statement of William T. Godshall, M.P.H., Executive Director,
                     Smokefree Pennsylvania, Pittsburgh, PA

        Smokefree Pennsylvania is a nonprofit organization founded in 1990
    whose goals include protecting people from the involuntary exposure to
    tobacco smoke pollution, reducing tobacco marketing to youth,
    increasing cigarette prices, preserving civil justice remedies for
    injured tobacco victims, and increasing tobacco prevention and
    cessation services.
        Smokefree Pennsylvania strongly opposes the introduced version of
    S. 625, the ``Family Smoking Prevention and Tobacco Control Act'' that
    would authorize the U.S. Food and Drug Administration (FDA) limited
    regulatory jurisdiction over tobacco products.
        In sum, Smokefree Pennsylvania opposes the current text of S. 625
    because it would:

         mislead the public into believing FDA regulation reduces
    tobacco products risks,
         protect cigarettes from market competition by less harmful
    smokeless tobacco products,
         increase Philip Morris' 51 percent cigarette market share,
    as well as Marlboro's market share,
         increase inaccurate public beliefs that smokeless products
    are as hazardous as cigarettes,
         encourage FDA to set cigarette emission standards based
    upon inaccurate machine tests,
         increase inaccurate public beliefs that certain cigarettes
    are less hazardous than others,
         mandate counterproductive and/or ineffective warning
    labels on tobacco products,
         fail to adequately inform consumers of comparable risks of
    different tobacco products,
         prohibit harm reduction marketing of lower risk smokeless
    products to smokers,
         do very little, if anything, to reduce cigarette-caused
    disease, disability and death,
         allow tobacco manufacturers and others to promote
    cigarettes as FDA approved,
         severely limit the FDA's authority to issue effective
    tobacco product regulations, and
         reduce cigarette manufacturer liability by misleading
    potential jury pools.
                reducing health risks of future tobacco products
        Effective regulations gradually phase out the most hazardous
    products, and encourage the development of and transition to lower risk
    products. Effective product regulations also adequately inform
    consumers of relative and comparable product risks. In sharp contrast,
    S. 625 protects the most hazardous tobacco product (cigarettes), the
    largest cigarette company (Philip Morris) and the largest cigarette
    brand (Marlboro) from market competition from far less hazardous
    noncombustible tobacco products by misleading consumers to incorrectly
    believe that smokeless tobacco products are just as hazardous as
    cigarettes, and by prohibiting truthful harm reduction marketing claims
    by smokeless tobacco products that are directed towards already
    addicted cigarette smokers.
        Cigarettes kill 50 percent of addicted smokers, and up to 63,000
    American nonsmokers annually (from secondhand smoke and fires). In
    contrast, smokeless tobacco kills about 1 percent of addicted users,
    and ZERO nonusers. Swedish smokeless (snus) and other new low
    nitrosamine noncombustible tobacco products pose even fewer risks.
    Smokers who switch to smokeless products can sharply reduce their
    disease and death risks.
        But S. 625 perpetuates the myth/fraud that noncombustible tobacco
    products are just as hazardous as cigarettes by requiring larger labels
    on smokeless packs and advertisements that state: ``This product is not
    a safe alternative to cigarettes,'' and by failing to inform smokers
    (e.g., via labels on cigarette packs and advertisements) that smokeless
    tobacco products pose fewer morbidity and mortality risks than
    cigarettes. If U.S. Congress is sincere about truthfully informing
    consumers about the health risks of different tobacco products, this
    misleading warning MUST be removed from smokeless tobacco products.
        S. 625 also could be improved if FDA was encouraged to approve
    clean nicotine products (e.g., skin patches, gum, lozenges, inhalers)
    for nicotine maintenance instead of just for temporary use as a smoking
    cessation aid. Shiffman et al. found that 36.6 percent of nicotine gum
    users consumed the product for longer than 6 months, despite the
    product warning urging discontinued use after 12 weeks. Clean nicotine
    products are far less hazardous than relapsing to cigarettes, and
    should be approved for nicotine maintenance.
        Although Section 911 of S. 625 includes provisions for FDA to
    approve the marketing of ``modified risk tobacco products,'' it is
    highly unlikely that any product would be approved since any
    manufacturer applying for FDA approval for a modified risk product
    would need to demonstrate that the product wouldn't discourage smokers
    from quitting tobacco use and wouldn't result in use by nontobacco
    users. Besides, the Campaign for Tobacco Free Kids, American Cancer
    Society and other proponents of S. 625 have repeatedly alleged that the
    marketing of smokeless tobacco products for harm reduction discourages
    smokers from quitting and encourages youth to begin using those
    products.
        In contrast, Section 911(g)(2) of S. 625 would allow a cigarette
    manufacturer to apply for and receive FDA approval for ``an explicit or
    implicit representation that such tobacco product or its smoke contains
    or is free of a substance or contains a reduced level of a substance,
    or presents a reduced exposure to a substance in tobacco smoke.'' This
    clause could very likely result in the FDA approving the marketing of a
    ``reduced exposure'' cigarette even if the cigarette is as hazardous as
    other cigarettes. Even worse, the marketing of an FDA approved
    ``reduced exposure'' cigarette is likely to confuse smokers into
    believing that the product is less hazardous than other cigarettes.
       cigarette machine testing methods are inaccurate, and only serve
                                  to misinform
        Effective product regulations also protect consumers from health
    frauds. Although S. 625 eliminates cigarette brand descriptors
    ``Light,'' ``Low-Tar'' and ``Mild,'' (which arguably is the deadliest
    consumer fraud of the 20th century), consumers of these products would
    barely notice this change because these brands would remain on the
    market in their easily recognized package designs and colors (minus one
    word). Marlboro Lights, which has the largest market share of any
    cigarette, would simply become known as Marlboro Gold, while Marlboro
    Ultralights would simply become known as Marlboro Ultras or Marlboro
    Silver. Meanwhile, S. 625 does nothing to warn smokers that the brands
    previously named ``Lights'' and ``Ultralights'' are just as hazardous
    as other cigarettes.
        But far more troublesome, S. 625 authorizes the FDA to establish
    cigarette emission standards for various smoke constituents based upon
    inaccurate smoking machine testing methods similar to the notorious FTC
    smoking machine tests that were partly responsible for creating the 35-
    year-old consumer fraud that duped smokers into believing that Low-Tar,
    Light and Ultralight cigarette brands were less hazardous than other
    cigarettes.
        Although a recent study by the Harvard School of Public Health
    concluded that cigarette companies have increased the nicotine yields
    of cigarettes by about 10 percent during the past decade leading some
    news reports to claim that cigarettes are now more addictive, that same
    study also concluded that (during the past decade) nicotine yields of
    Light brands were about 25 percent less than those of Full Flavor
    brands, and that nicotine yields of Ultralight brands were about 30
    percent less than those of Light brands. But in fact, all cigarettes
    are similarly and quite adequately addictive. The fundamental problem
    with the Harvard study is that it relied upon another inaccurate
    smoking machine testing method somewhat similar to the defective FTC
    testing method.
        Hammond et al. recently evaluated the accuracy of the International
    and Canadian cigarette machine testing methods, and concluded that
    neither of those machine testing methods are accurate, and that NO
    machine testing method should be relied upon for establishing
    government regulatory standards for cigarette smoke emissions.
        Besides, cigarette smoke contains more than 50 carcinogens and
    3,000 other constituents. So even if an accurate FDA machine testing
    method is devised (which doesn't appear viable), an FDA product
    standard that reduces or removes one, two or a few chemicals or
    carcinogens from cigarette smoke would not reduce the overall health
    risks of cigarettes.
        Any FDA product standard for cigarettes almost certainly would be
    perceived by smokers and the public as making cigarettes less
    hazardous, which could discourage smokers from quitting and could
    encourage youth and ex-smokers to begin smoking.
        S. 625 also authorizes the FDA to reduce nicotine levels in
    cigarettes, and some supporters of S. 625 have advocated mandatory
    nicotine levels reductions in cigarettes. Yet, there is broad
    scientific consensus that smokers of cigarettes with purportedly lower
    nicotine yields simply puff more intensely, take more puffs and/or
    smoke more cigarettes in order to obtain a similar level of nicotine
    that they are accustomed to receiving, which is known as ``nicotine
    compensation.'' As such, smokers of purportedly lower nicotine yield
    cigarettes inhale greater quantities of smoke, which increases their
    disease risks.
        Thus, it would be counterproductive for public health if the FDA
    mandated reductions in nicotine, because doing so could make cigarettes
    even more hazardous. If the FDA were to require any changes in nicotine
    content (assuming that an accurate machine testing method could be
    developed), it would be better for public health to require higher
    levels of nicotine in cigarettes, because smokers would inhale less
    cigarette smoke.
                      constitutional concerns about s. 625
        Another concern with S. 625 is that some of its tobacco advertising
    restrictions are virtually certain to be struck down by the Supreme
    Court for violating a manufacturer's first amendment right to advertise
    to its adult customers. That is precisely why in 2001 the Supreme Court
    (in Lorillard Tobacco Co. v. Reilly) struck down a Massachusetts
    regulation that prohibited outdoor tobacco advertisements within 1,000
    feet of a school or playground. And yet, a similar 1,000 foot outdoor
    advertising restriction is contained in S. 625.
         denying fda authority to effectively regulate tobacco products
        Effective product regulations also allow regulatory agencies
    unfettered authority to issue regulations that reduce use of and access
    to the most hazardous products. But S. 625 prohibits the FDA from
    issuing many of the most effective regulations that could reduce
    cigarette usage, especially among youth, including prohibiting the FDA
    from:

         increasing the minimum age to purchase cigarettes beyond
    18 years;
         eliminating cigarette sales from any type of retail
    outlet;
         requiring prescriptions to buy cigarettes (as FDA requires
    for other hazardous drugs);
         removing nicotine from cigarettes; and
         eventually removing cigarettes from the market.

        While these restrictions limiting the FDA's authority to regulate
    tobacco in S. 625 are not necessarily opposed by Smokefree
    Pennsylvania, our organization is nevertheless concerned that their
    inclusion in S. 625, along with the many truly counterproductive
    provisions that were previously cited, have severely compromised this
    legislation.
        The following report compares the health risks of different tobacco
    products and recommends the only viable tobacco product and policy harm
    reduction strategy for smokers who are not ready or willing to quit
    tobacco use; providing truthful comparable product risk information,
    and encouraging switching to a smokeless tobacco product. http://
    www.harmreductionjournal.com/content/3/1/37.
         Tobacco Harm Reduction: An Alternative Cessation Strategy for
                               Inveterate Smokers
                   brad rodu \1\ and william t. godshall \2\
                         (harm reduction journal 2006)
                                    abstract
        According to the Centers for Disease Control and Prevention, about
    45 million Americans continue to smoke, even after one of the most
    intense public health campaigns in history, now over 40 years old. Each
    year some 438,000 smokers die from smoking-related diseases, including
    lung and other cancers, cardiovascular disorders and pulmonary
    diseases.
    ---------------------------------------------------------------------------
        \1\ Professor of Medicine and Endowed Chair, Tobacco Harm Reduction
    Research, School of Medicine, University of Louisville, KY, USA.
        \2\ Founder and Executive Director, Smokefree Pennsylvania,
    Pittsburgh, PA, USA.
    ---------------------------------------------------------------------------
        Many smokers are unable--or at least unwilling--to achieve
    cessation through complete nicotine and tobacco abstinence; they
    continue smoking despite the very real and obvious adverse health
    consequences. Conventional smoking cessation policies and programs
    generally present smokers with two unpleasant alternatives: quit, or
    die.
        A third approach to smoking cessation, tobacco-harm reduction,
    involves the use of alternative sources of nicotine, including modern
    smokeless tobacco products. A substantial body of research, much of it
    produced over the past decade, establishes the scientific and medical
    foundation for tobacco-harm reduction using smokeless tobacco products.
        This report provides a description of traditional and modern
    smokeless tobacco products, and of the prevalence of their use in the
    United States and Sweden. It reviews the epidemiologic evidence for low
    health risks associated with smokeless use, both in absolute terms and
    in comparison to the much higher risks of smoking. The report also
    describes evidence that smokeless tobacco has served as an effective
    substitute for cigarettes among Swedish men, who consequently have
    among the lowest smoking-related mortality rates in the developed
    world. The report documents the fact that extensive misinformation
    about ST products is widely available from ostensibly reputable
    sources, including governmental health agencies and major health
    organizations.
        The American Council on Science and Health believes that strong
    support of tobacco-harm reduction is fully consistent with its mission
    to promote sound science in regulation and in public policy, and to
    assist consumers in distinguishing real health threats from spurious
    health claims. As this report documents, there is a strong scientific
    and medical foundation for tobacco-harm reduction, and it shows great
    potential as a public health strategy to help millions of smokers.
                                 i. background
        According to the Centers for Disease Control and Prevention (CDC),
    about 45 million Americans continue to smoke [1], even after one of the
    most intense public health campaigns in history, now over 40 years old.
    Some 438,000 smokers die from smoking-related diseases each year,
    including lung and other cancers, cardiovascular disorders and
    pulmonary diseases [2].
        There is clear evidence that smokers of any age can reap
    substantial health benefits by quitting. In fact, no other single
    public health effort is likely to achieve a benefit comparable to
    large-scale smoking cessation. Surveys document that most smokers would
    like to quit, and many have made repeated efforts to do so. However,
    conventional smoking cessation approaches require nicotine-addicted
    smokers to abstain from tobacco and nicotine entirely (as discussed
    later, use of nicotine replacement medications is limited to 10-12
    weeks, per labels required by Federal regulations). Many smokers are
    unable--or at least unwilling--to achieve this goal, and so they
    continue smoking in the face of impending adverse health consequences.
    In effect, the status quo in smoking cessation presents smokers with
    just two unpleasant alternatives: quit or die.
        There is a third choice for smokers: tobacco-harm reduction. It
    involves the use of alternative sources of nicotine, including modern
    smokeless tobacco (ST) products, by those smokers who are unable or
    unwilling to quit tobacco and nicotine entirely. The history of
    tobacco-harm reduction may be traced back to 1974, with the publication
    of a special article in the Lancet by British tobacco addiction
    research expert Michael A.H. Russell [3]. Citing the ``high dependence-
    producing potency and the universal appeal of the effects of nicotine''
    on smokers, Russell likened ``harsher restrictive measures'' and
    ``intensification'' of anti-smoking efforts to ``flogging a dead horse
    harder.'' Russell believed that ``the goal of abstinence and the
    abolition of all smoking is unrealistic and doomed to fail.''
        Six years later Russell's research group compared nicotine
    absorption rates from various tobacco products, which led them to
    suggest that nasal snuff use could serve as an effective substitute for
    cigarette smoking [4]. This article was cited shortly thereafter by a
    short letter in a leading American medical journal [5]. Russell et al.,
    published followup studies on nasal snuff in 1981 [6] and on an oral ST
    product in 1985 [7]. Lynn Kozlowski, a prominent American smoking and
    nicotine addiction expert at Penn State University, noted in 1984 and
    1989 that ST products conferred fewer risks to users and therefore
    might serve as effective substitutes for cigarettes [8, 9]. In 1994
    oral pathologist Brad Rodu and epidemiologist Philip Cole from the
    University of Alabama at Birmingham made quantitative comparisons of
    the risks from oral ST use and smoking in a series of studies [10-13].
    Some of that work was summarized in a 1995 ACSH publication [14].
        A substantial body of research over the past decade has been
    transformed into the scientific and medical foundation for tobacco-harm
    reduction, the substitution of safer sources of nicotine, including
    tobacco products, by those smokers who are unable or unwilling to
    achieve nicotine and tobacco abstinence. In 2001 the Institute of
    Medicine, a subsidiary of the National Academy of Sciences, provided a
    now widely accepted definition of a harm reduction product as ``harm
    reducing if it lowers total tobacco-related mortality and morbidity
    even though use of that product may involve continued exposure to
    tobacco-related toxicants'' [15]. The purpose of this report is to
    review the evidence for tobacco-harm reduction.
                     ii. the status quo: cigarette smoking
    A. Prevalence
        At first glance, the United States (U.S.) appears to be the
    quintessential example of the slow but substantial decline of cigarette
    smoking in the developed world. Smoking prevalence in the United States
    has decreased since at least the mid-1960s, following landmark reports
    from the Royal College of Physicians of London in 1962 and the U.S.
    Surgeon General in 1964. Smoking among men was 52 percent in 1965 [16],
    dropping to 23 percent by 2004 [1]. Prevalence among women declined
    from 34 percent in 1965 to 19 percent in 2004. In 1965, only 44 percent
    of American adults had never smoked and 14 percent were former smokers;
    by 2004, those percentages had increased to 58 percent and 21 percent
    respectively.
        But declining prevalence overshadows the fact that, with population
    growth, the absolute number of smokers in the United States remained
    relatively constant at 45 to 50 million over the entire period.
    Heavily-addicted, or inveterate, smokers are resistant to conventional
    cessation strategies emphasizing tobacco and nicotine abstinence.
    Today's smoking population has a higher proportion of heavy smokers
    than in the past, and the National Cancer Institute (NCI)-funded
    Community Intervention Trial for Smoking Cessation underscores the
    challenges facing them [17]. Perhaps the most intensive cessation trial
    ever conducted, this 4-year effort had no effect on cessation among
    heavy smokers. The published report called the intervention
    ``disappointing but consistent with the findings of most other
    community studies . . .'', and it described heavy smokers as ``more
    resistant to change. Reaching these smokers may require new clinical
    programs and public policy changes.''
    B. Health effects
        Cigarette smoking remains the single most important avoidable cause
    of death in the developed world. The CDC reports that smoking is
    responsible for 438,000 deaths in the United States annually [2], a
    figure which has changed little over the last 15 years.
        Cigarette smoking was responsible for a large proportion of the
    increase in cancer mortality in the second half of the 20th Century, a
    trend with important social consequences, including the widespread
    misperception that the United States was being consumed by a ``cancer
    epidemic'' caused by environmental pollution and industrial chemicals.
    In fact, the ``epidemic'' consisted almost exclusively of one disease,
    lung cancer, and was due to one lifestyle factor, cigarette smoking. A
    retrospective analysis of mortality statistics revealed that, if lung
    cancer is excluded, the mortality rate from all other forms of cancer
    combined has declined continuously since 1950 [18].
        The first reports linking lung cancer to cigarette smoking were
    published over 50 years ago [19, 20]. In 2006 there will be 175,000 new
    cases of lung cancer in the United States, with a 5-year survival rate
    of just 15 percent [21]. The CDC estimates that smoking causes 142,000
    deaths per year from lung cancer [2]. Smoking is a risk factor for
    other malignancies, including cancers of the oral cavity and pharynx,
    larynx, esophagus, stomach, bladder, kidney, pancreas, uterine cervix
    and leukemia [2].
        According to the CDC, smoking causes 132,000 deaths per year from
    cardiovascular diseases, including heart attacks, strokes,
    atherosclerosis and aortic aneurysms [2]. Smoking also causes 103,000
    deaths per year from pulmonary diseases such as pneumonia, influenza,
    bronchitis and chronic airway obstruction [2].
        While many Americans are aware that cigarette smoking causes
    cancer, cardiovascular and respiratory diseases, most are not aware
    that it also increases risks for neurological disorders, reproductive
    complications, cataracts and other eye diseases, premature aging of the
    skin, osteoporosis and other orthopedic and rheumatologic problems,
    psychiatric disorders and surgical complications [22]. Recent studies
    have also linked smoking to the development of type 2 diabetes [23-25].
    C. Stagnation
        As Russell noted 30 years ago, ``There is little doubt that if it
    were not for the nicotine . . . people would be little more inclined to
    smoke than they are to blow bubbles or light sparklers'' [3]. Nicotine
    fulfills all the criteria of an addictive agent, including psychoactive
    effects, drug-reinforced behavior, compulsive use, relapse after
    abstinence, physical dependence, and tolerance. Nicotine stimulates
    specialized receptors in the brain which produce both euphoric and
    sedative effects. It has been known for many years that nicotine shares
    many features of drug dependence with opioids, alcohol and cocaine.
    This includes similar disappointing patterns of relapse [26].
        It is for this reason that most attempts at smoking cessation are
    not successful, despite the fact that the majority of smokers are aware
    that smoking is harmful to their health, and so would like to quit. It
    is clear that most smokers would rather quit on their own, and 90
    percent of successful quitters use self-help methods because of limited
    access to and cost of formal cessation programs [27].
        Formal cessation programs have existed for decades and have grown
    more complex and sophisticated, but relapse rates remain very high.
    According to a 2006 National Institutes of Health (NIH) Consensus
    Conference on Tobacco Use, ``70 percent [of smokers] want to quit and
    40 percent make a serious quit attempt each year, but fewer than 5
    percent succeed in any given year'' [28]. The conference press release
    went on to make an astounding admission, ``Effective tobacco cessation
    interventions are available and could double or triple quit rates . .
    .'' This means that fewer than 15 percent of existing smokers, no more
    than 7 million, would be successful with maximum application of
    existing cessation strategies. The consensus statement failed to answer
    a vital question: What can be done for the remaining 40 million adult
    smokers? The rest of this report will review the scientific rationale
    and evidence for tobacco-harm reduction as an alternative for these
    smokers.
                           iii. smokeless tobacco use
    A. Introduction
        The tobacco plant is native to the Western hemisphere, and the use
    of tobacco in smokeless forms (placed in the mouth or inhaled as a
    powder through the nose) predates the arrival and exploration of the
    West by Europeans. According to the historian Jan Rogozinski, the most
    common manufactured tobacco product in Europe until the early 1800s was
    a compressed plug or cake [29]. This product was relatively simple to
    produce and was amenable to transport and storage. The plug could be
    cut into large pieces for chewing, grated into smaller pieces for
    smoking, or ground into a fine powder for nasal inhalation. Smokeless
    forms were the favored method of use because a day's supply could be
    carried and conveniently used in industrial and agricultural work
    settings.
        ST was the dominant form of tobacco used in the United States until
    early in the 20th century [29]. Developments in tobacco cultivation,
    curing and manufacturing, along with the invention of the safety match,
    resulted in the increased popularity of cigarettes. In addition, at the
    beginning of the 20th century tobacco spit inaccurately was believed to
    transmit tuberculosis, so bans on public spitting and spittoons
    resulted in a decline in ST use. The transmission of tuberculosis now
    has been understood for decades, and it does not include expectoration
    [30].
        Use of all types of ST traditionally has been most prevalent in
    Southern States and in rural areas throughout the United States.
    B. Types of ST
        As described below, ST is currently used by only a small proportion
    of American tobacco users. This is one reason that most Americans,
    including smokers, know almost nothing about ST products, or--even
    worse--are completely misinformed about even basic product
    characteristics. Thus, it is important to understand what these
    products are and how they are used.
        ST products are not burned but instead are placed in the cheek or
    between the lip and gum. ST is used in many countries around the world,
    including those in the Middle East and on the Indian subcontinent.
    However, ST products in those regions are considerably different from
    those used in the West. For example, in India ST products are made by
    individual farmers and small companies with little control over
    fermentation and curing, which affects the production of potential
    carcinogens called tobacco-specific nitrosamines (TSNAs) [31]. In India
    ST is often combined with betel leaf (Piper betle), sliced areca nut
    (Areca catechu) and/or powdered agricultural lime [32], additives that
    enhance the toxicity as well as the psychotropic effect of tobacco [33,
    34]. In addition, Indian ST users often smoke concurrently, which
    complicates efforts to assess the health effects of ST use [35, 36].
        This report will focus on ST products used in Western societies,
    mainly the United States and Sweden. But ST is not a homogeneous
    category, even in these countries. Three traditional types of ST are
    used in the United States: powdered dry snuff, loose leaf chewing
    tobacco and moist snuff, and it is important to understand the
    differences among them with respect to their manufacturing and
    characteristics, the populations that consume them, and the
    consequential health risks, especially mouth cancer.
                               Powdered Dry Snuff
        Dry snuff is made from fermented, fire-cured tobacco that is
    pulverized into powder. Nasal inhalation of dry snuff was widely
    practiced in Europe in the 17th and 18th centuries but declined
    thereafter [37]. Manufacturers in Germany and the United Kingdom still
    provide an array of flavored dry snuff products for a small number of
    contemporary users in those countries. In the United States powdered
    dry snuff, also called dental or Scotch snuff, is sold in small
    canisters. Since the early 1800s it has been used primarily by women in
    Southern States [29,38], who place the powder on the gum or between the
    gum and cheek. However, use of dry snuff is declining, and sales have
    fallen 67 percent in the past 15 years [39].

                           Loose Leaf Chewing Tobacco
        Loose-leaf chewing tobacco consists of air-cured leaf tobacco from
    Pennsylvania and Wisconsin that is shredded, coated with sweet
    flavoring solutions and packaged in foil-lined pouches. It is consumed
    primarily by men in the United States, commonly in conjunction with
    outdoor activities. Chewing tobacco is typically used in large volumes,
    resulting in the archetypical golf ball-sized bulge in the user's cheek
    and large quantities of saliva that users usually expectorate.
    Consequently, the popularity of this product has waned, with
    consumption declining gradually over the past century, dropping by
    about 44 percent in just the last 15 years [39].

                                  Moist Snuff
        Moist snuff consists of fire- and air-cured dark tobaccos that are
    finely cut or ground. It is packaged in round containers, and the user
    compresses a ``pinch'' between the thumb and forefinger and places it
    inside the lip. Much less bulky than loose leaf chewing tobacco, moist
    snuff produces less saliva, but expectoration is still common. It is
    now the most popular form of ST in the United States; sales of this
    product increased by 66 percent over the past 15 years [39].
        In addition to the United States, there is a long tradition of
    moist snuff use in Scandinavia, especially in Sweden, where ``snus''
    (the generic term for moist snuff in Swedish, pronounced ``snoose'') is
    essentially the only type of ST product in use [40]. There are
    differences in how American and Swedish moist snuff products are
    manufactured. Traditional American products undergo fermentation, which
    imparts characteristic flavors but in the past resulted in higher
    concentrations of unwanted bacterially mediated by-products, especially
    TSNAs and nitrite. In Sweden, moist snuff is subjected during
    manufacturing to a heat treatment akin to pasteurization, yielding
    virtually sterile products containing very low levels of TSNAs.
    However, manufacturing refinements over the past 25 years have resulted
    in lower TSNAs in both Swedish and American products. A 1997 report by
    the Swedish National Board of Health and Welfare reported that TSNA
    concentrations in both Swedish and American ST brands had declined
    substantially [41]. The report concluded:

              ``Recent data suggest that the differences [in TSNA levels
            reported in American and Swedish ST] have grown smaller, and
            that it is now questionable to make a sharp distinction between
            use of American and Swedish moist snuff when assessing risks--
            at least where TSNA content is concerned.''

        A separate section of this report will discuss how the high
    prevalence of snus use in Sweden has played an important role in the
    low prevalence of smoking, especially among men.

                               Modern ST Products
        Over the past few years several ST products have emerged that are
    not easily classified into one of the previous groups. In fact, one
    reason for the popularity of moist snuff is that manufacturers have
    gradually refined the products in this category to be more user-
    friendly. The traditional pinch of moist snuff is difficult to keep in
    place, and the resultant migration is esthetically displeasing. Modern
    moist snuff products are sold in pre-portioned pouches similar to
    teabags, but much smaller. Because these products remain stationary in
    the mouth and generate very little juice, they can be used discreetly
    with no expectoration. There is a recent trend among manufacturers to
    offer even smaller pouches that are dry, with a wide range of non-
    tobacco flavors. Other products in this category consist of small
    pieces of leaf tobacco and pellets of compressed tobacco that dissolve
    completely. These products all share one important characteristic: they
    are of sufficiently small size that can be used invisibly, and without
    expectoration.

                                 c. prevalence
        The prevalence of ST use has not received nearly as much attention
    as that of smoking, but adult prevalence has been documented by the
    National Health Interview Survey (NHIS). For adults, NHIS defines
    current ST users as those individuals who have used ST at least 20
    times in their lives and are using ST every day or some days. In 1991
    the prevalence of current ST use among adult men in the United States
    was about 5.6 percent (4.8 million), which declined to 4.4 percent (4.4
    million) in 2000. In 1991 about 0.6 percent (533,000) of adult women in
    the United States were current users, and prevalence declined to 0.3
    percent (324,000) by 2000 [42, 43].
        In 2000 the prevalence of ST use was higher among men age 18-44
    years (6 percent) than among those age 45+ years (3 percent). Men in
    the Southern United States had the highest prevalence (7 percent) and
    those in the Northeast had the lowest (2 percent). As with smoking,
    prevalence of ST use was higher among men with a high school education
    or less. Finally, higher male prevalence was seen in rural areas (9
    percent), compared with urban areas (3 percent) [43].
        In the United States the number of male smokers is tenfold higher
    than the number of ST users, so it follows that concurrent use of both
    products is common among ST users, but rare among smokers. About 25
    percent of men who use ST report concurrent smoking, whereas concurrent
    use occurs in fewer than 5 percent of men who smoke [44]. Cigarette
    consumption is considerably lower in combined users compared with
    exclusive smokers [45-47].
                               d. health effects
    1. Oral leukoplakia
        Oral leukoplakia is an ominous sounding term used frequently in
    discussions about ST use. The term literally means ``white plaque,''
    and it is used to describe areas of the mouth lining that become
    thickened by ST use or smoking. The World Health Organization has
    determined that leukoplakias resulting from ST use are considerably
    different from those resulting from smoking. The distinctions are based
    on the frequency of occurrence, the location in the mouth, and how
    often these leukoplakias result in mouth cancer [48, 49].
        The condition is rare, occurring in less than 1 percent of the
    general population, primarily in long-time smokers 40 to 60 years old
    [50, 51]. Smoking-related leukoplakias most commonly involve the
    undersurface of the tongue and throat area, locations that account for
    75 percent of oral cancer in the United States [51, 52].
        Oral leukoplakias occur in up to 60 percent of ST users [53, 54],
    within 6 months to 3 years of starting ST use [55, 56]. They primarily
    occur at the site of ST use and are largely a result of local
    irritation [55, 57]. The frequency of appearance depends on the type of
    ST that is used. Moist snuff, which is more alkaline than chewing
    tobacco, more often leads to leukoplakia [56]. However, moist snuff in
    pre-portioned pouches causes fewer cases of leukoplakia than does the
    loose form [58].
        There are distinct differences in how often ST and smoking
    leukoplakias show pre-cancerous changes called dysplasia. Dysplasia is
    seen infrequently in ST leukoplakias (less than 3 percent) [49, 59-61].
    Furthermore, even when dysplasia is present in ST leukoplakia, it
    usually is found in earlier stages than in leukoplakias due to smoking
    [62, 63] where it is seen in about 20 percent of cases [64].
        ST leukoplakias only rarely progress to cancer. For example, one
    prospective study found no case of cancer in 1,550 ST users with
    leukoplakia who were followed for 10 years [65], and a second study
    reported no case of oral cancer among 500 regular ST users followed for
    6 years [66]. A retrospective study of 200,000 male snuff users in
    Sweden found only one case of oral cancer per year, an extremely low
    frequency [67]. In comparison, a followup study reported that 17
    percent of smoking leukoplakias transformed into cancer within 7 years
    [68].
        In conclusion, oral leukoplakia occurs commonly in ST users, but it
    primarily represents irritation and only very rarely progresses to oral
    cancer.
    2. Oral cancer
        ST use has been associated with oral cancer for many decades. It is
    widely perceived--both by laypersons and medical professionals--that
    the association is strong and applies to all ST products. However,
    epidemiologic studies dating back to the 1950s provide convincing
    evidence that most ST products increase oral cancer risks only
    minimally.
        Rodu and Cole reviewed 21 epidemiologic studies published from 1957
    to 1998 [69]. Unlike previous reviewers, these authors derived relative
    risk (RR) estimates for cancers of the mouth and associated upper
    respiratory sites related to use of chewing tobacco, moist snuff, dry
    snuff and a fourth category in which the type of ST was unclear or
    undetermined (ST unspecified). This study found that use of chewing
    tobacco and moist snuff were associated with only minimally elevated
    risks, while use of dry snuff conferred somewhat higher risks.
        Chewing tobacco has been studied at least once in each of four
    decades from the 1960s to the 1990s. The data clearly show that chewing
    tobacco use is associated with only slightly elevated cancer risks; RRs
    for all anatomic sites are under 2 with confidence intervals including
    1 (i.e. the risk elevation was not statistically significant) (Table
    1). The first study evaluating the risk of chewing tobacco appeared in
    1962 [70]. There were two studies in 1977 [71, 72], two in 1988 [73,
    74], and four studies from 1993 to 1998 [75-78].

                      Table 1.--Chewing Tobacco and Cancer of the Mouth and Upper Respiratory Sites
    ----------------------------------------------------------------------------------------------------------------
                                                                         RR (95 percent
                               Anatomic Site                                   CI)         Studies   Cases/Controls
    ----------------------------------------------------------------------------------------------------------------
    Oral cavity.......................................................     0.6 (0.3-1.3)         2           283/296
    Pharynx...........................................................
    Oral cavity + pharynx.............................................     1.1 (0.8-1.6)         4         2113/4454
    Larynx............................................................     1.3 (0.9-1.8)         1          387/2560
    Oral + pharynx + larynx...........................................     1.7 (1.2-2.4)         2           362/457
    All sites.........................................................     1.2 (1.0-1.4)         8         3145/5245
    ----------------------------------------------------------------------------------------------------------------

        As with chewing tobacco, summary RRs are only slightly elevated for
    moist snuff, with three RRs at or below 1 and the highest RR at 1.2
    (Table 2). RRs for moist snuff were reported first in 1977 [71].
    Another study appeared in 1988 [74], and five additional studies were
    published from 1993 to 1998, as this ST type came under intense
    scrutiny [75-79].

                        Table 2.--Moist Snuff and Cancer of the Mouth and Upper Respiratory Sites
    ----------------------------------------------------------------------------------------------------------------
                                                                         RR (95 percent
                               Anatomic Site                                   CI)         Studies   Cases/Controls
    ----------------------------------------------------------------------------------------------------------------
    Oral cavity.......................................................     1.1 (0.8-1.6)         2           482/995
    Pharynx...........................................................     0.7 (0.4-1.4)         1           138/641
    Oral cavity + pharynx.............................................     0.7 (0.4-1.2)         3         1682/3931
    Larynx............................................................     1.2 (0.9-1.7)         2          544/3201
    Oral + pharynx + larynx...........................................
    All sites.........................................................     1.0 (0.8-1.2)         5         2846/4926
    ----------------------------------------------------------------------------------------------------------------

        Two of the seven studies on moist snuff were Swedish, both
    appearing in 1998 [78, 79]. These studies have received considerable
    attention among tobacco researchers, particularly in Europe, because
    they are viewed as showing no oral cancer risk for Swedish products.
    They formed the basis for the Swedish government's decision in 1999 to
    recommend that the European Union (EU) oral cancer warning labels be
    removed from ST products. An EU directive in 2001 accomplished that
    objective and specified a new warning, ``This tobacco product can
    damage your health and is addictive'' [80]. Notably, the other five
    studies contributing to the summary RRs for moist snuff were American,
    and they reported RRs very similar to those of the Swedish studies.
        Summary RRs for dry snuff use are higher, ranging from 4 to 13,
    although the confidence intervals for these estimates are wide (Table
    3). The first study appeared in 1962 [70], followed by studies in 1981
    [81], 1988 [73], and 1994 [76], spanning a period of 32 years.

                         Table 3.--Dry Snuff and Cancer of the Mouth and Upper Respiratory Sites
    ----------------------------------------------------------------------------------------------------------------
                                                                         RR (95 percent
                               Anatomic Site                                   CI)         Studies   Cases/Controls
    ----------------------------------------------------------------------------------------------------------------
    Oral cavity.......................................................
    Pharynx...........................................................
    Oral cavity + pharynx.............................................     4.0 (2.7-5.9)         3           298/947
    Larynx............................................................
    Oral + pharynx +larynx                                                   13 (8.0-20)         1            93/393
    All sites.........................................................      5.9 (1.7-20)         4          391/1340
    ----------------------------------------------------------------------------------------------------------------

        RRs for ST-unspecified range from 1.5 to 2.8, and most are
    statistically significant. For all sites the summary RR is 1.9 (CI =
    1.5-2.3), which is intermediate between the low risks reported for
    chewing tobacco (1.2, 1.0-1.4) or moist snuff (1.0, 0.8-1.2) and the
    higher risk for dry snuff (5.9, 1.7-20) (Table 4). The intermediate
    risks for this ST category probably reflect the use of either the
    lower- or higher-risk products among different groups within the
    studies. Eight studies provided RRs for ST-unspecified, five of which
    appeared between 1957 and 1969 [82-86]. Additional studies appeared in
    1992 [87], 1993 [75] and 1998 [88].

                      Table 4.--ST-Unspecified and Cancer of the Mouth and Upper Respiratory Sites
    ----------------------------------------------------------------------------------------------------------------
                                                                         RR (95 percent
                               Anatomic Site                                   CI)         Studies   Cases/Controls
    ----------------------------------------------------------------------------------------------------------------
    Oral cavity.......................................................     2.8 (1.9-4.1)         4           581/798
    Pharynx...........................................................     2.3 (1.2-4.4)         3           169/472
    Oral cavity + pharynx.............................................     1.5 (1.1-2.0)         3          655/2718
    Larynx............................................................      1.8 (0.3-9.3         1            23/100
    Oral + pharynx +larynx
    All sites.........................................................     1.9 (1.5-2.3)         7         1428/3681
    ----------------------------------------------------------------------------------------------------------------
    Tables 1 to 4 are adapted from [69].

        Prior to the 2002 analysis by Rodu and Cole, the distinctive risk
    profiles of moist snuff and chewing tobacco on one hand, and dry snuff
    on the other, had gone unnoticed. In fact, the low oral cancer risk
    associated with chewing tobacco had been discussed briefly in only one
    article [89]. No distinction in risks had been made previously between
    dry snuff and moist snuff, even though these products are considerably
    different with regard to tobacco content and processing, as noted
    earlier.
        The majority of epidemiologic studies regarding ST and oral cancer
    have limitations, many of which are typical for case-control studies,
    and some important for understanding unique oral cancer risks. Most of
    them did not control for confounding by two strong determinants of oral
    cancer, cigarette smoking and alcohol use. Positive confounding by
    smoking would occur if ST users smoke more than do nonusers of ST. This
    would result in artificially high-risk estimates for oral cancer among
    ST users. On the other hand, negative confounding is plausible and
    would occur if smoking rates are lower among ST users than among
    nonusers of ST. This would result in artificially low risks for oral
    cancer among ST users.
        Only three studies [78, 79, 81] controlled for alcohol use, where
    only positive confounding is likely. Thus, control for alcohol
    consumption in all studies probably would have reduced, somewhat, many
    of the estimates of mouth cancer risk associated with ST use.
        However, even with these limitations, the results of these studies
    are reasonably consistent with regard to mouth cancer risks from long-
    term use of moist snuff and chewing tobacco. In their review Rodu and
    Cole concluded that ``the abundance of data now available indicates
    that commonly used ST products increase the risk of oral and upper
    respiratory tract cancers only minimally.''
        Since the 2002 review four epidemiologic studies, one from Sweden
    and three from the United States, have been published [90-93]. In all
    of these studies ST use was not associated with a significant increase
    in mouth cancer risk. In 2004 a group of epidemiologists concluded that
    the evidence linking ST use and oral cancer was ``not decisive'' [94].
    These investigators commented that many claims in the media
    ``overemphasize the risk of oral cavity cancer [from ST use], reaching
    beyond the scientific data.''
        In 2005 the American Cancer Society (ACS) reported that ST users
    did not have significantly increased risks for oral and pharyngeal
    cancer in either the first or the second Cancer Prevention Study [92].
    Despite this finding, the ACS Web site continues to focus on ST as a
    cause of mouth cancer, erroneously stating that ``risk of cancer of the
    cheek and gums may increase nearly 50-fold among long-term snuff
    users'' [95]. A later section of this report will discuss this type of
    misinformation.
    3. Other cancers
        As noted above, cigarette smoking is associated with increased risk
    for several cancers in locations not in contact with cigarette smoke.
    In comparison, numerous epidemiologic studies have not demonstrated
    that ST use is associated with risk of cancer at any site outside the
    mouth. In 2004 Waterbor et al. assessed the epidemiologic research
    literature and summarized the evidence regarding ST use and cancers in
    various locations [94]. Table 5 shows the conclusions of Waterbor et
    al. with respect to cancer risks associated with ST use, compared with
    the established risks for smoking.

      Table 5.--Risk of Cancer in Various Sites Associated with ST Use and
                                     Smoking
    ------------------------------------------------------------------------
                                                              Risks from
               Cancer Site            Risks from ST Use*       Smoking**
    ------------------------------------------------------------------------
    Pharynx.........................  No relationship...  RR = 5-11
    Larynx..........................  No relationship...  13-15
    Lung............................  Inadequate........  13-23
    Stomach.........................  Not persuasive....  1.4-2.0
    Kidney..........................  No association....  1.3-3.7
    Esophagus.......................  Not persuasive....  7-8
    Pancreatic cancer...............  Inconclusive......  2.3
    Bladder cancer..................  None..............  2.2-3.3
    ------------------------------------------------------------------------
    * From [94].
    ** Among current smokers (men and women), used by the CDC for national
      estimates of smoking-attributable mortality [96].

    4. Cardiovascular diseases
        Over the past 15 years, eight epidemiologic studies have examined
    the risk of cardiovascular diseases among ST users. Six of the studies
    found that ST users had no increased risk for heart attacks or strokes
    [47, 90, 97-100]. The other two reported modestly positive
    associations, with ST users having RRs of 1.2 and 1.4 [92, 101], which
    are lower than those of smokers. In 2003, Asplund completed a
    comprehensive review of the cardiovascular effects of ST use [102]. He
    concluded that, in distinct contrast to smokers, ST users do not
    exhibit any significant differences from nonusers of tobacco with
    regard to the following measures of cardiovascular health: heart rate,
    blood pressure, cardiac output and maximal working capacity, levels of
    hemoglobin and hematocrit, leukocytes, antioxidant vitamins,
    fibrinogen, components of the fibrinolytic system, C-reactive protein
    and thromboxane A2 production. In addition, ST users did not show
    important smoking-associated vascular changes, including increased
    thickness of blood vessels and atherosclerotic plaque development. In
    summary, most of the medical and epidemiologic evidence documents that
    ST users do not have elevated risks for cardiovascular diseases.
        Two studies based in Sweden have examined the impact of ST use as a
    risk factor for adult-onset diabetes. One of these studies found that
    current ST users had a slightly elevated risk (Odds ratio = 1.5, CI =
    0.8-30) [103], while the other reported that the risk of diabetes in ST
    users was not significantly increased [104].
              iv. scientific rationale for harm reduction with st
    A. Nicotine maintenance
                             1. Nicotine background
        Nicotine has been characterized as powerfully addictive. But
    nicotine itself poses little or no health hazard. For example, it does
    not cause emphysema or cancer [105, 106], and there is no evidence that
    it plays a direct role in the development of cardiovascular diseases
    [106, 107]. A report from a meeting at the United Nations Focal Point
    on Tobacco or Health concluded that ``long-term nicotine use is not of
    demonstrated harm, with the possible exception of use during
    pregnancy'' [108].
        The U.S. Food and Drug Administration (FDA) has acknowledged the
    safety of nicotine replacement therapy (NRT) by allowing its sale
    without prescription. Long-term use of NRT has not been associated with
    any medical risks and is considered far less hazardous than relapsing
    to smoking cigarettes [109, 110], prompting authorities in the United
    Kingdom (U.K.) to liberalize NRT regulations there recently. The new
    guidelines allow NRT use by patients with cardiovascular disease, by
    confirmed smokers ages 12 to 17, by pregnant smokers, and concurrently
    by those who continue to smoke [111].
        Nicotine gum was introduced in the United States in 1984 as a
    prescription product to assist in smoking cessation. The gum is
    considered to pose no consequential health hazard, and it was granted
    over-the-counter status by the FDA in 1996. The gum gives the user only
    a limited degree of control over the amount of nicotine absorbed
    because its nicotine content is low and only slowly released [112].
    Depending on State and local excise taxes and cigarette consumption,
    the gum may be competitive on a per-unit basis for the smoker. However,
    it is available only in large quantities, making the purchase price far
    more expensive than that for cigarettes, a major economic disincentive.
    In fact, cost is the reason most frequently cited by smokers for never
    using NRT [113].
        The nicotine patch was introduced in the United States in 1992 and
    was available without prescription by 1996. It continuously delivers
    nicotine through the skin for up to 24 hours. Although the patch is
    intended to preclude smoking, the rate of nicotine delivery is so low
    that smoking while wearing the patch is not uncommon. The patch's major
    limitation is its inadequate nicotine delivery, but it is not a
    technical problem. A high-dose nicotine patch has been evaluated and
    may provide complete nicotine replacement even for heavy smokers [114].
        Many smokers overestimate the health risks of NRT products. A 2001
    survey of 1,046 adult smokers found that 53 percent incorrectly
    believed nicotine causes cancer and 14 percent didn't know [115], and a
    2002 survey found that half of all smokers are concerned about negative
    side effects of using NRT [116]. A similar problem exists in the United
    Kingdom, where recent research found that 69 percent of smokers believe
    NRT is as harmful as cigarettes.
        Misconceptions are not limited to persons without medical training.
    Twenty-two percent of general medical practitioners in the United
    Kingdom are concerned that NRT is just as harmful as cigarettes, 40
    percent believe that nicotine may cause cardiovascular disease and
    stroke, and one-quarter believe it may cause lung cancer [117].
        In summary, poor nicotine delivery, high cost and misconceptions
    about health risks are the principal reasons that the long-term quit
    rate among users of non-
    prescription nicotine medications is only 7 percent, according to a
    recent meta-
    analysis [118].
                    2. Long-term use of nicotine medications
        The FDA specifies that nicotine medications should not be used for
    more than 10 to 12 weeks. This restriction is based not on health
    considerations, but on a concern about prolonging nicotine addiction.
    Considering the limitations of nicotine medications, it is remarkable
    that some smokers continue to use the products beyond the 3-month
    period specified by the FDA. About 20 percent of those who quit smoking
    with nicotine gum used it for more than 1 year when it was available
    only by prescription [112]. A cessation study that provided free gum
    but encouraged weaning after 2 months use reported that 37 percent of
    smoke-free subjects at 1 year were still using nicotine gum [119].
    Using a liberal definition of continuous use, a recent study found that
    as many as one-third of current nicotine gum users have used the
    product for longer than 6 months [120]. That study also reported that,
    among persons who start to use nicotine gum, 7 percent will use it for
    longer than 6 months and 1 percent will continue use for over 2 years.
    The equivalent figures for nicotine patch were 1.7 percent and 0.05
    percent respectively.
          3. Nicotine concentration and availability from ST products
        ST products contain nicotine at far higher concentrations than
    nicotine medications, and at levels that are generally acknowledged to
    be addictive [121, 122]. Bioavailability of nicotine from ST products
    is dependent on the pH of the product, since unprotonated nicotine (in
    more alkaline products) is absorbed more efficiently and more rapidly
    across the mucous membranes of the mouth than protonated forms of the
    drug from more acidic products. The pH-dependent absorption kinetics of
    nicotine is a very important reason why ST is not consumed like foods.
    The pH of stomach contents is very acidic, which strongly inhibits the
    absorption of nicotine [122]
        The nicotine absorption profiles of ST products, which have been
    known for many years [105, 123], show both advantages and disadvantages
    when compared with those from smoking. Nicotine absorption from ST is
    somewhat slower than that from cigarettes, although the peak nicotine
    levels obtained in venous blood are similar [105]. In addition,
    elevated serum nicotine from ST use persists for much longer than that
    from smoking [105]. This may explain the observation that unit
    consumption of ST products among former smokers was much lower than
    prior unit consumption of cigarettes [124, 125]. In the end, ST users
    and smokers consume similar quantities of nicotine daily [126].
    B. Comparison of risks from ST use and smoking
        The established health risks associated with ST use are vastly
    lower than those of smoking. In the past 25 years, almost 80 peer-
    reviewed scientific and medical publications have acknowledged the
    differential risks between the two tobacco products (see Additional
    File 1).
        In 1980 Michael A.H. Russell and co-workers proposed that powdered
    nasal snuff might serve as an effective substitute for cigarettes
    because it delivers nicotine effectively without the risks of tobacco
    combustion [4]. This article was cited shortly thereafter in a brief
    letter in the New England Journal of Medicine [5]. Russell et al.
    published followup studies on nasal snuff in 1981 [6] and on an oral ST
    product in 1985 [7]. Lynn Kozlowski, a prominent American smoking and
    nicotine addiction expert at Penn State University, noted in 1984 and
    1989 that smokeless forms of tobacco conferred fewer risks to users and
    therefore might serve as effective substitutes for cigarettes [8, 9,
    127]. Starting in 1994, University of Alabama at Birmingham researchers
    Brad Rodu and Philip Cole provided a quantitative assessment of the
    difference in risks for the two products. Using established risk
    estimates from accepted sources, Rodu and Cole documented that ST use
    confers only about 2 percent of the health risks of smoking [10-12]. In
    addition, they established that the average reduction in life
    expectancy from long-term ST use was about 15 days, compared with a
    reduction of about 8 years from smoking [11].
        In 1994 Rodu noted that ST use posed a lower risk for mouth cancer
    than smoking [10]. In 2001 this was confirmed by a comprehensive report
    on tobacco-harm reduction by the Institute of Medicine, which stated
    that ``the overall [oral cancer] risk [for ST use] is lower than for
    cigarette smoking, and some products such as Swedish snus may have no
    increased risk'' [15].
        By the late 1990s some influential organizations acknowledged the
    differential risks of ST use and smoking. For example, in 1997 experts
    meeting at the United Nations Focal Point on Tobacco or Health
    concluded that ``it is now evident that the risk of death and disease
    is related to not only the amount but also the nature of tobacco
    exposure; for example, daily cigarette smoking is far more dangerous
    than occasional use of Swedish snuff'' [108]. That same year a
    scientific panel convened by the Swedish National Board of Health and
    Welfare concluded that ``the health risks related to smokeless tobacco
    are with great probability lower than those related to smoking'' [41].
        In 2002 the Royal College of Physicians of London, one of the
    oldest and most prestigious medical societies in the world, issued a
    report called ``Protecting Smokers, Saving Lives,'' which stated,

              ``As a way of using nicotine, the consumption of non-
            combustible [smokeless] tobacco is on the order of 10-1,000
            times less hazardous than smoking, depending on the product.''

        The report continued with an even bolder statement, acknowledging
    that some smokeless tobacco manufacturers may want to market their
    products ``as a `harm reduction' option for nicotine users, and they
    may find support for that in the public health community'' [128].
        In 2004 a study funded by the NCI assembled an international panel
    of experts (including epidemiologists from the NIH and the ACS) to
    compare the risks of ST use with those of smoking. The study authors
    reported that, ``In comparison with smoking, experts perceive at least
    a 90 percent reduction in the relative risk of low-nitrosamine
    smokeless tobacco use.'' The authors concluded that ``This finding
    raises ethical questions concerning whether it is inappropriate and
    misleading for government officials or public health experts to
    characterize smokeless tobacco products as comparably dangerous with
    cigarette smoking'' [129].
        Phillips et al. have provided perhaps the most detailed and direct
    comparison of risks from use of Swedish or American ST products and
    from smoking, using a spectrum of risk estimates for ST use ranging
    from well-substantiated and plausible to highly speculative and
    implausible [130]. They estimated that, compared with smoking, ST risks
    ``in the range of 1 percent or 2 percent, and possibly less, are most
    consistent with the epidemiologic evidence. Perhaps most important, our
    calculation shows that comparative risk estimates as high as 5 percent,
    let alone 10 percent or more, cannot be justified based on the
    evidence.''
    C. Evidence that ST is an effective substitute for cigarettes
                                 1. Survey data
        There is limited evidence from governmental and other surveys that
    some smokers have quit by substituting ST products for cigarettes, and
    most of the published information on this subject is dated. The 1991
    NHIS survey revealed that 33.3 percent (about 1.8 million) of adult
    current ST users were former cigarette smokers [42].
        The 1986 national Adult Use of Tobacco Survey, conducted by the CDC
    Office on Smoking and Health, found that 7 percent (1.7 million) of
    male ex-smokers had used ST to help them quit smoking cigarettes. That
    same survey found that only 1.7 percent of male ex-smokers (404,600)
    had used organized programs to help them quit smoking [131].
        The 1998 NHIS survey revealed that 5.8 percent of daily snuff users
    reported quitting smoking cigarettes within the past year, that daily
    snuff users were three times more likely to report being former
    cigarette smokers than never snuff users, and that daily snuff users
    were four times more likely to have quit smoking in the past year than
    never snuff users [132].
        According to the 1987 NHIS survey, 23- to 34-year-old U.S. men who
    had smoked cigarettes and subsequently used snuff were twice as likely
    to have quit smoking (95 percent CI 1.2-3.5) than were cigarette-only
    users [133].
        Cohen-Smith and Severson surveyed 51 female and 59 male ST users in
    the Northwestern United States, 98 percent and 90 percent of whom
    respectively were either current or former cigarette smokers. They
    found that 52 percent of women and 59 percent of men used ST in place
    of cigarettes while quitting smoking [134].
                             2. Clinical trial data
        One clinical trial, an open-label, nonrandomized pilot study, has
    been conducted assessing the efficacy of an ST product in helping
    cigarette smokers become smoke-free. The investigators used a low-
    intensity approach, consisting of a 20-minute lecture about the health
    effects of all forms of tobacco use, followed by information about and
    samples of pre-portioned single-dose tobacco packets available
    throughout the United States. The investigators used exhaled carbon
    monoxide levels to validate participant self-reports regarding smoke-
    free status at the conclusion of the original study after 1 year [125]
    and after 7 years of followup [135].
        Of 63 subjects starting the study, 16 had successfully quit smoking
    by switching to ST after 1 year, and 12 were still smoke-free after 7
    years. At enrollment, the average cigarette consumption of the
    successful participants had been 1.5 packs per day. One year later
    average consumption of ST was 2.3 packages per week among the 13
    successful quitters using ST (3 were tobacco-free). Four additional
    participants had used ST to reduce their cigarette consumption by at
    least 50 percent.
                       3. The Swedish tobacco experience
        For the past 100 years, cigarette smoking has been the dominant
    form of tobacco consumption in almost all developed countries. One
    notable exception is Sweden, where smoking rates, especially among men,
    have been considerably lower than those of comparable countries for
    decades. (An ACSH article provides historical background on Swedish
    snus [136]). Over the past 50 years Swedish men have had the lowest
    rates of smoking-related cancers of the lung, larynx, mouth and bladder
    in Europe [137], and the lowest percentage of male deaths related to
    smoking of all developed countries [138, 139].
        A 2004 study revealed that if men in the (15-country) EU had the
    smoking prevalence of Sweden, almost 200,000 deaths attributable to
    smoking would be avoided each year [140]. In contrast, women in Sweden
    smoke at rates much more similar to women in other European countries,
    and this is reflected in similar rates of smoking-related illnesses.
    The 2004 study found that only 1,100 deaths would be avoided in the EU
    at Swedish women's smoking rates.
        As Fagerstrom pointed out in a recent study, per capita consumption
    of nicotine from tobacco in Sweden is quite high and on par with other
    countries such as Denmark, the United States and Austria [141]. The
    difference between Sweden and the other countries is how nicotine is
    consumed. In Denmark, the United States and Austria, almost all
    nicotine consumption is derived from tobacco combustion. In contrast,
    ST use, in the form of snus, accounts for almost 50 percent of all
    contemporary nicotine consumption in Sweden. Snus use in Sweden is much
    more common among men than among women; over 60 percent of nicotine
    consumption among Swedish men is from snus. This is not a new
    phenomenon; for over a century, Swedish men have had among the world's
    highest per capita consumption of ST [142].
        Beginning in 2002, an American-Swedish research group used a World
    Health Organization database to describe in detail the impact of snus
    use on smoking among the population in northern Sweden during the
    period 1986-2004 [46, 143, 144].
        Among men, the prevalence of all tobacco use was stable during the
    study period, at about 40 percent. However, there were striking, and
    opposite, changes in prevalence of smoking and snus use. Smoking
    prevalence was 19 percent in 1986, and it was lower in all subsequent
    surveys, reaching 9 percent in 2004. The prevalence of exclusive snus
    use increased from 18 percent in 1986 to 27 percent by 2004. Snus use
    was the dominant factor in the higher prevalence of ex-smoking among
    men compared to women (prevalence ratio 6.18, 95 percent CI 4.96-7.70).
        Among women, the prevalence of all tobacco use also was steady at
    27 to 28 percent, and women smoked at higher rates than men in all
    surveys. But these studies showed that snus use was associated with
    lower smoking rates among women in 1999 and 2004. Smoking prevalence
    was about 25 to 27 percent in 1986, 1990 and 1994, but declined to 21
    percent in 1999, and 16 percent in 2004. The prevalence of snus use was
    0.5 percent in 1986 and increased to 1.9 percent in 1990, 2.0 percent
    in 1994, 5.1 percent in 1999 and 8.9 percent in 2004.
        In these reports snus use was not associated with smoking
    initiation, as the prevalence of smoking among former snus users was
    low in all survey years (3-4 percent). The evidence showed that among
    adult men in northern Sweden the dominant transition is from smoking to
    snus, not vice versa.
        In 2003 Foulds et al. reviewed the evidence relating to the effects
    of snus use on smoking and concluded, ``Snus availability in Sweden
    appears to have contributed to the unusually low rates of smoking among
    Swedish men by helping them transfer to a notably less harmful form of
    nicotine dependence.'' The investigators noted that ``in Sweden we have
    a concrete example in which availability of a less harmful tobacco
    product has probably worked to produce a net improvement in health in
    that country'' [145].
        In 2005 Furberg, et al. examined tobacco use data from the Swedish
    Twin Registry, finding that regular snus use was associated with
    smoking cessation, not initiation, among almost 15,000 male
    participants. Both regular and occasional snus use were protective
    against having ever smoked [146].
        In 2006 Ramstrom and Foulds examined data from a 2001-02 nationally
    representative Swedish social survey. They found that snus use among
    men was significantly protective against smoking initiation (OR = 0.3,
    CI 0.2-0.4). They also found that snus was the most commonly used
    cessation aid among men (used by 24 percent of men on their most recent
    quit attempt). Men who used snus as a quit-smoking aid were more likely
    to quit successfully than those using nicotine gum (OR = 2.2, CI = 1.3-
    3.7) or the patch (OR = 4.2, CI = 2.1-8.6), which was also true for
    women [147].
                                v. policy issues
    A. ST use: gateway to smoking cessation, not smoking initiation
        Data from research studies in Sweden and the United States do not
    support the allegation that widespread use of ST serves as a gateway to
    smoking, especially among youth. A 2003 policy statement published in
    Tobacco Control, coauthored by Clive Bates, former director of Action
    on Smoking and Health (U.K.) and five other eminent tobacco research
    and policy experts, dismissed the notion that ST use led to smoking in
    Sweden: ``To the extent there is a `gateway' it appears not to lead to
    smoking, but away from it and is an important reason why Sweden has the
    lowest rates of tobacco-related disease in Europe'' [148]. Foulds
    reached a similar conclusion: ``This review suggests . . . that in
    Sweden snus has served as a pathway from smoking, rather than a gateway
    to smoking among Swedish men'' [145].
        A 2005 study examined tobacco use among 15- to 16-year-old
    schoolchildren over a 15-year period, from 1989 to 2003 [149]. The
    investigators found that the prevalence of regular snus use among
    Swedish boys increased from about 10 percent to 13 percent from 1989 to
    2003, but the prevalence of regular smoking was very low and declined,
    from about 10 percent to under 4 percent. The prevalence of snus use
    among girls was very low, and the prevalence of smoking was about
    double that of boys over the entire period. The authors concluded that
    snus use did not appear to be a gateway to smoking among Swedish youth
    but instead was associated with low-smoking prevalence among boys.
        In the United States investigators have not found credible evidence
    that ST use is a gateway to smoking among American youth. In 2003
    Kozlowski et al. analyzed data from the 1987 INHIS survey and concluded
    that there was little evidence that ST use was a gateway to smoking,
    because the majority of ST users had never smoked or had smoked
    cigarettes prior to using ST [133]. The investigators noted that their
    results coincided with earlier work from Sweden and with a tobacco
    industry-sponsored survey from 1984 [150].
        In 2003 O'Connor et al. examined data from the 2000 National
    Household Survey on Drug Abuse [151]. They described the impact of ST
    use on subsequent cigarette smoking initiation as ``minimal at best.''
    O'Connor et al. also examined data from the CDC's Teenage Attitudes and
    Practices Survey for evidence that ST use served as a gateway to
    smoking among youth [152]. They concluded that ST use was not
    associated with smoking initiation after appropriate control for
    confounding by well-recognized psychosocial predictors of smoking. This
    is in contrast to an earlier report that did not control for
    confounding and found a positive association [153].
        Claims of a gateway effect persist, even with lack of credible
    evidence, prompting O'Connor et al. to note in 2005, ``Continued
    evasion of the [harm reduction] issue based on claims that ST can cause
    smoking seems, to us, to be an unethical violation of the human right
    to honest, health-relevant information'' [154]. That quote introduces
    the next topic, information and misinformation about ST and tobacco-
    harm reduction.
    B. Information and misinformation about ST and tobacco-harm reduction
        Kozlowski et al. have argued persuasively that smokers have a
    fundamental right to accurate information about safer forms of tobacco
    use [155-157]. The research group established the underlying rationale
    for the provision of this information, citing principles of the
    Universal Declaration of Human Rights, the doctrine of informed
    consent, and business ethics contract theory, under which companies
    have a moral obligation to inform customers about important information
    regarding their products.
        In 2001 the U.S. Supreme Court may have provided a legal basis for
    holding tobacco manufacturers responsible for providing truthful
    information about the differential risks of ST use and smoking. Writing
    the majority opinion in Lorillard v. Reilly, in which a 5-4 majority of
    the Court ruled that broad advertising restrictions by the Commonwealth
    of Massachusetts violated the commercial free-speech rights of tobacco
    manufacturers, Justice Sandra Day O'Connor wrote that,

              ``The State's interest in preventing underage tobacco use is
            substantial, and even compelling, but it is no less true that
            the sale and use of tobacco products by adults is a legal
            activity. We must consider that tobacco retailers and
            manufacturers have an interest in conveying truthful
            information about their products to adults, and adults have a
            corresponding interest in receiving truthful information about
            tobacco products'' [158].
                      1. Fundamental right to information
        Over the past 20 years, many public health and tobacco policy
    experts have argued that smokers have a fundamental right to accurate
    information about less hazardous products so that they can make
    informed choices if they are unable or unwilling to quit tobacco
    altogether. In 1984 Kozlowski commented on both the challenges and the
    potential of tobacco-harm reduction, writing that ``the use of less-
    hazardous tobacco, if prohibitionist impulses can be put aside, may
    have an important role in the treatment of the smoking and health
    problem . . .'' [9].
        In 1994 Rodu proposed that a ``public health policy that recognizes
    ST as an alternative to smoking would benefit individuals confronted
    with the unsatisfactory options of abstinence or continuing to smoke''
    [10]. In a 1995 book, Rodu told smokers that ``ST products allow you,
    the hard-core and long-term smoker, to take back a measure of control
    over your health by indulging in a far safer form of tobacco use''
    [13].
        One concern about tobacco-harm reduction is that dissemination of
    information about less hazardous tobacco products might adversely
    affect public health if it creates new users. However, the risk/use
    equilibrium addresses this issue [159]. If ST use is 50 to 100 times
    less hazardous than smoking, it would require 50 to 100 more ST users
    to reach the level of public harm produced by smoking. In other words,
    it would take 2.3 to 4.5 billion ST users to have the same death toll
    as 45 million American smokers do today, an impossible scenario in the
    U.S. population of 290 million people.
        Kozlowski's message in 2002 was clear:

              ``Cigarettes kill about half of those who smoke them . . . It
            is urgent to inform smokers about options they have to reduce
            risk . . . public health policy in this instance lacks
            compelling justification to override the human rights of the
            individual. Individuals have the right to such relevant
            information [on tobacco risks]'' [155].

        That same year, the prestigious Royal College of Physicians of
    London made its hopeful statement that ``some manufacturers may want to
    market ST as a `harm reduction' option for nicotine users, and they may
    find support for that in the public health community'' [128].
        Since then a growing number of experts have weighed in on the case
    for providing smokers relevant risk information and safer tobacco
    options. In 2002 Cummings argued for a market approach involving risk
    information:

              ``Until smokers are given enough information to allow them to
            choose products because of lower health risks, then the status
            quo will remain. Capitalism, and not government regulation, has
            the greatest potential to alter the world-wide epidemic of
            tobacco-related disease'' [160].

        In 2003 Kozlowski et al. expanded on the rationale that smokers are
    entitled to information about safer products, addressing concerns that
    provision of risk information might adversely affect public health:
    ``Public health concerns should trump individual rights only when there
    is clear and convincing evidence of harm to society. Lacking that
    evidence, individual rights should prevail'' [161].
          2. Misinformation from governmental and other organizations
        Americans are badly misinformed about the risks of ST use,
    especially in comparison with smoking. In 2005 a survey of 2,028 adult
    U.S. smokers found that only 10.7 percent correctly believed that ST
    products are less hazardous than cigarettes [154]. In another survey,
    82 percent of U.S. smokers incorrectly believed that chewing tobacco is
    just as likely to cause cancer as smoking cigarettes [162].
        A 1999-2000 survey of 36,012 young adults entering the U.S. Air
    Force found that 75 percent of males and 81 percent of females
    incorrectly believed that switching from cigarettes to ST would not
    result in any risk reduction, while another 16 percent of males and 13
    percent of females incorrectly believed that only a small risk
    reduction would occur. Only 2 percent of males and 1 percent of females
    correctly understood that a large risk reduction would occur by
    switching from cigarettes to ST [163]. That survey also found that the
    overwhelming majority of subjects believed that switching from regular
    to low-tar cigarettes conferred greater reduction in risks than
    switching from cigarettes to ST.
        It is not clear how Americans have become so confused about tobacco
    risks. But it is clear that misinformation about ST products is
    available in copious quantities from ostensibly reputable sources,
    including governmental health agencies and health-oriented
    organizations. Phillips et al. have made some of the most pointed
    comments about this phenomenon:

              ``Certain health advocates believe it is acceptable to
            mislead people into making choices they would not otherwise
            make . . . Through the use of various tactics, advocates who
            oppose the use of ST as a harm reduction tool have managed to
            convince most people that the health risk from ST is several
            orders of magnitude greater than it really is. The primary
            tactic they use is making false or misleading scientific claims
            that suggest that all tobacco use is the same. . . . Apparently
            motivated by their hatred of all things tobacco, they are
            trying to convince people to not switch from an extremely
            unhealthy behavior to an alternative behavior that eliminates
            almost all of their risk'' [164].

        The tactic has worked in the United States, as Americans, almost
    without exception and regardless of general and health education
    levels, believe that the risks from ST are similar to those from
    smoking. In particular, Americans incorrectly believe that switching
    from smoking to ST use will create a large increased risk for oral
    cancer. Phillips has characterized this popular misinformation as the
    ``you might as well smoke'' message, since it tells people that if they
    are using ST, they could switch to smoking with no increase in risk,
    while smokers considering switching to ST should not bother [165].
        Phillips et al. systematically reviewed content about ST use on the
    Web in 2003 and found that the risks of ST use are almost always
    conflated with those of smoking [165]. Roughly one-third of the time,
    there are explicit claims that ST is as bad as or worse than smoking.
    Most of the rest of the time the information is arranged to imply
    similar risks, though there is no such explicit statement. There are
    also a variety of specific claims that are not supported by the
    literature.
        Government agencies, other organizations and members of the public
    health community have a moral obligation not to misinform smokers about
    products that have fewer risks than cigarettes. Nevertheless,
    researchers have exposed numerous cases of misinformation from
    governmental sources. For example, in 2003 Kozlowski and O'Connor
    criticized Web sites of the CDC and the Substance Abuse and Mental
    Health Services Administration for erroneously reporting that ST
    products were not safer than cigarettes, pointing out that ``the
    misleading health information on ST fails to meet the government
    criteria against deception in research'' [156].
        At a 2003 U.S. House subcommittee hearing, U.S. Surgeon General
    Richard Carmona testified:

              ``I cannot conclude that the use of any tobacco product is a
            safer alternative to smoking . . . There is no significant
            evidence that suggests ST is a safer alternative to
            cigarettes'' [166]. Scott Leischow, Chief of the Tobacco
            Control Research Branch at the NCI, presented similar testimony
            at a concurrent hearing [167]. Carmona's statement prompted
            Rodu, who also presented testimony at that hearing [168], to
            comment that the Surgeon General was ``sadly ill-informed about
            the Nation's No. 1 health problem, cigarette smoking.'' Rodu
            strongly criticized Carmona, writing that he should be
            compelled to ``tell American smokers the truth about all
            available options for quitting. After all, the 10 million
            smokers who will die over the next two decades are, in a very
            tangible way, his responsibility and his legacy'' [169].

        In March 2004, Ken Boehm of the National Legal & Policy Center
    (NLPC), a non-profit organization committed to promoting open,
    accountable and ethical practices in government, filed a request under
    the Data Quality Act (DQA) for correction of a document from the
    National Institute of Aging (NIA) that contained misinformation
    regarding the relative risks of ST versus cigarettes. (The other DQA
    requests on ST can be seen at the U.S. Department of Health and Human
    Services Web site [170]) The request resulted in a change of wording
    from the original text: ``Some people think ST (chewing tobacco and
    snuff), pipes, and cigars are safer than cigarettes. They are not.''
        The revised wording from NIA was: ``Some people think ST (chewing
    tobacco and snuff), pipes, and cigars are safe. They are not.''
        The claim that ST products are not ``safe'' is a tactic that can be
    traced back to the 1986 Comprehensive Smokeless Tobacco Education Act,
    which required as one of three warnings on all ST products: ``This
    product is not a safe alternative to cigarettes.''
        In 1995 Rodu criticized this warning as ludicrous and suggested
    that other consumer products like automobiles, lawnmowers, aspirin and
    red meat don't meet absolute criteria for safety [13]. A decade later,
    Kozlowski and Edwards criticized this type of uninformative warning in
    a study entitled, `` `Not safe' is not enough: smokers have a right to
    know more than there is no safe tobacco product'' [157]. These authors
    believe that smokers deserve more information:

              ``The `not safe' or `not harmless' messages don't address the
            reality that some tobacco products are substantially safer than
            others . . . Saying tobacco `isn't safe' isn't incorrect, but
            it isn't saying enough. Going beyond the no safe tobacco
            message to provide better information on the nature of risks
            from tobacco products and nicotine delivery systems is
            necessary to respect individual rights to health relevant
            information.''

        Ken Boehm from NLPC summarized the arguments against
    misinformation:

              ``This is the kind of evidence Americans should be able to
            review and make their own decisions. Despite the best efforts
            of the largest government bureaucracy in the history of the
            Republic, Americans still prefer to do their own thinking. And
            as we do our own thinking on the merits of reduced-risk
            products such as ST, none of us needs misinformation supplied
            by our own government'' [171].

        With regard to a policy as ``credible, logical and eminently do-
    able'' as tobacco-harm reduction [172], it is unfortunate that
    arguments against deception are actually necessary.
                       vi. conclusion and recommendations
        The past 40 years have brought ever more assertive public health
    campaigns against cigarette smoking. A coalition of well-funded public
    and private agencies has as its goal a reduction in the prevalence of
    cigarette smoking. The coalition's influence has resulted in pervasive
    health warnings, ever more intensive quit-smoking programs, and
    recently the social ostracism of smokers and the industry that supplies
    them. Yet 45 million Americans continue to smoke, and far too many die
    from smoking-related diseases.
        The American Council on Science and Health has been part of this
    anti-smoking coalition for several decades. Throughout its history ACSH
    has published many articles about the health risks of smoking. And it
    has held the tobacco industry accountable for its part of the
    devastating toll from tobacco. ACSH founder Elizabeth Whelan published
    a landmark anti-smoking book, A Smoking Gun?: How the Tobacco Industry
    Gets Away with Murder [173].
        ACSH was founded in 1978 by a group of scientists who had become
    concerned that many important public policies related to health and the
    environment did not have a sound scientific basis. These scientists
    created the organization to add reason and balance to debates about
    public health issues and bring commonsense views to the public.
        The mission of the ACSH is to promote sound science in regulation,
    in public policy, and in the courtroom and to assist consumers, via the
    media, in distinguishing real health threats from purely hypothetical
    ones. ACSH believes that strong support of tobacco-harm reduction is
    fully consistent with this mission; as this report documents, there is
    a strong scientific and medical foundation for tobacco-harm reduction,
    and it shows great potential as a public health strategy to help
    millions of smokers.
        Tobacco-harm reduction empowers smokers to gain control over the
    consequences of their nicotine addiction. At its simplest it is
    nonintrusive and solely educational, and therefore has a strong moral
    rationale. The strategy is cost-effective and accessible today to
    almost all smokers. But its implementation will require rethinking of
    conventional tobacco control policies and their premises.
        The ACSH believes that the following actions will benefit smokers:
        1. Agencies of the Federal Government (most notably the Office of
    the Surgeon General) and health promotion organizations (such as the
    American Cancer Society and the Mayo Clinic) should discontinue the
    campaign of misinformation that irresponsibly misrepresents the
    scientific information about and use of ST products. They endanger
    their reputations as sources of trusted health information by providing
    messages about ST products that are neither accurate nor credible. The
    campaign of misinformation should be replaced with an educational
    program that emphasizes the differential risks of all forms of tobacco
    use.
        2. Regulatory restrictions on the manufacture and sale of nicotine
    replacement medications should be revised. Nicotine is addictive, but
    it plays little or no role in the development of most smoking-related
    diseases. Manufacturers of nicotine replacement medications should be
    permitted to sell higher doses of the drug within flavor/delivery
    systems that are satisfying and enjoyable for smokers at costs that are
    competitive with cigarettes. In addition, smokers should be informed
    that permanent use of NRT is vastly safer than continuing to smoke.
    This could be accomplished by new labels on NRT packaging and
    additional labels on cigarette packs: ``Notice: Nicotine does not cause
    cancer, heart diseases or emphysema.''
        3. Manufacturers of tobacco products should follow the lead of
    British American Tobacco (BAT) and acknowledge that ST use is vastly
    safer than smoking. BAT has openly admitted that oral ST products are
    safer than cigarettes, and this company is actively engaged in test-
    marketing Swedish snus in Sweden, Norway and South Africa [174]. At the
    press date of this report, cigarette manufacturers in the United States
    have introduced ST products in limited test markets, but they have made
    no statements regarding differential health risks. This is
    unacceptable, given the state of the science documented in this report.
        4. Any Federal legislation that addresses the regulation of tobacco
    should include provisions that adequately reflect the differences in
    risks between combustible tobacco products and ST products or NRT. This
    includes careful review of current proposals before Congress to ensure
    that the legislation is written to regulate the labeling and marketing
    of products based on their risks. The goal should be to give users of
    tobacco the necessary information they need to understand the
    differences between various tobacco and nicotine products so they can
    make the appropriate health choices and decisions.
        5. Pending enactment of more comprehensive regulation, the U.S.
    Congress should repeal the federally-mandated warning that now appears
    on ST products: ``This product is not a safe alternative to
    cigarettes.'' This warning not only misleads smokers; it may send a
    message to ST users that they might as well smoke. The warning should
    be replaced with the following, which would appear as an onsert with
    cigarette packages--``Warning: Smokeless tobacco use has risks, but
    cigarette smoking is far more dangerous. Quitting tobacco entirely is
    ideal, but switching from cigarettes to ST can reduce greatly the
    health risks to smokers and those around them.'' Placement of this
    warning with cigarettes ensures that it reaches the target audience,
    continuing smokers.
        6. State legislatures should follow the lead of Kentucky and
    establish rational risk-based tax policies for tobacco products. In
    2005 the Commonwealth of Kentucky enacted an excise tax structure for
    cigarettes and ST products that was based on differential risks. The
    final bill stated:

              ``The General Assembly recognizes that increasing taxes on
            tobacco products should reduce consumption, and therefore
            result in healthier lifestyles for Kentuckians. The relative
            taxes on tobacco products proposed in this section reflect the
            growing data from scientific studies suggesting that although
            smokeless tobacco poses some risks, those health risks are
            significantly less than the risks posed by other forms of
            tobacco products. Moreover, the General Assembly acknowledges
            that some in the public health community recognize that
            tobacco-harm reduction should be a complementary public health
            strategy regarding tobacco products. Taxing tobacco products
            according to relative risk is a rational tax policy and may
            well serve the public health goal of reducing smoking-related
            mortality and morbidity and lowering healthcare costs
            associated with tobacco-related disease.''
        Abbreviations: ACS--American Cancer Society; ACSH--American Council
    on Science and Health; BAT--British American Tobacco; CDC--Centers for
    Disease Control and Prevention; DQA--Data Quality Act; EU--European
    Union; FDA--Food and Drug Administration NCI--National Cancer
    Institute; NHIS--National Health Interview Survey NIA--National
    Institute on Aging NIH--National Institutes of Health NLPC--National
    Legal Policy Center NRT--Nicotine replacement therapy RR--Relative
    risk; ST--Smokeless tobacco; TSNA--Tobacco specific nitrosamine U.K.--
    United Kingdom; U.S.--United States.

    Competing interests

        Dr. Rodu is supported by unrestricted grants from the US Smokeless
    Tobacco Company and Swedish Match AB to the University of Louisville.
    The sponsors are unaware of this work, and thus had no scientific input
    or other influence with respect to its design, analysis, interpretation
    or preparation of the manuscript. Dr. Rodu has no other financial or
    other personal conflict of interest with respect to tobacco use or
    cessation.
        Mr. Godshall declares that he has no competing interests.

    Authors' contributions

        Both authors participated in the literature review and drafting of
    the manuscript.

    Acknowledgements

        This manuscript is a position statement of the American Council on
    Science and Health. The authors gratefully acknowledge the assistance
    of the following ACSH staff who provided critical reviews of content
    and perspective, especially with regard to the policy sections of the
    report.
        Elizabeth M. Whelan, ScD, MPH President and Founder; Gilbert Ross,
    MD, Medical/Executive Director.
        The authors gratefully acknowledge the following individuals, who
    provided peer reviews, critical analysis, commentary and suggestions
    during the development of this review, and whose names have been listed
    with their permission:
        Scott D. Bailin, JD, Tobacco and Health Policy Consultant
    Washington DC; Clive Bates, Former Director (1997-2003), Action on
    Smoking and Health, UK London, United Kingdom; Ronald W. Brecher,
    Ph.D., DABT, C Chem, Principal, Globaltox: Toxicology Focused Solutions
    Guelph, ON, Canada; Emil William Chynn, MD, FACS, MBA Medical Director,
    IWANT2020.com, Inc. New York, NY; Michael Dubick, Ph.D., Senior
    Research Pharmacologist, U.S. Army Institute of Surgical Research San
    Antonio, TX; Dwight B. Heath, Ph.D., Department of Anthropology Brown
    University, Providence, RI; Rudolph J. Jaeger, Ph.D., DABT, REA
    (California) Consulting Toxicologist, Environmental Medicine Inc.,
    Westwood, NJ; Michael Kunze, Dr Med, Professor, Institute of Social
    Medicine, Center for Public Health, Medical University of Vienna,
    Vienna,, Austria; Carl V. Phillips, Ph.D., Associate Professor,
    University of Alberta School of Public Health, Director, Alberta
    Smokeless Tobacco Education and Research Group Edmonton, AB, Canada;
    Lars M. Ramstrom, Ph.D., Director, Institute for Tobacco Studies
    Stockholm, Sweden; William O. Robertson, MD, Medical Director,
    Washington Poison Center, Emeritus Professor of Pediatrics, University
    of Washington School of Medicine Seattle, WA; David Schottenfeld, MD,
    John G. Searle Professor Emeritus of Epidemiology, Professor Emeritus
    of Internal Medicine, School of Public Health, University of Michigan,
    Ann Arbor, MI; Peter G. Shields, MD, Professor of Medicine and
    Oncology, Director, Cancer Genetics and Epidemiology, Lombardi
    Comprehensive Cancer Center, Georgetown University Medical Center
    Washington, DC; Robert B. Sklaroff, MD, Elkins Park, PA; Jacob Sullum,
    Senior Editor, Reason, Dallas, TX; David T. Sweanor, BA (Hon), LLB,
    Adjunct Professor of Law and Medicine, University of Ottawa, Ottawa,
    ON, Canada; John W. Waterbor, MD, DrPH, Associate Professor of
    Epidemiology, School of Public Health, University of Alabama at
    Birmingham, Birmingham, AL.
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    BSR?opendocument&SID=&DTC=&TMP=1] British American Tobacco News
    Release. June 28, 2006.
       Prepared Statement of Anne Landman, Tobacco Document Research and
                           Consulting, Glade Park, CO
        I have been a tobacco document researcher since 1998. After almost
    a decade of reading tobacco industry documents, I have become acutely
    aware of the industry's strategies and tactics for undermining public
    health. Documents show that Philip Morris is at least 10 years ahead of
    the rest of society in anticipating future scenarios to regulate
    cigarettes, advertising, etc. For example, they had the basic tenets of
    the 1998 Master Settlement Agreement (MSA) drawn up in 1991, in
    anticipation that Congress would try to pass a total ban on cigarette
    advertising.
        It is my belief that legislation to regulate tobacco products
    should be thoroughly vetted by highly experienced tobacco control
    advocates and public health-sided tobacco industry strategists and that
    all loopholes in the existing proposed legislation bill be completely
    eliminated. Regulation of tobacco products, should, in fact ideally be
    drafted with, or by, experienced public health authorities with the
    sole purpose of protecting public health. Tobacco companies should be
    permitted input, but they should not be permitted to be the driving
    force behind such legislation. Documents show that Philip Morris has
    maintained an internal program since 1999 specifically to drive the
    enactment of FDA regulations in its favor. Reading the existing
    legislation, and knowing of PM's internally devised 5 core principles
    (the company's requirements of what it requires in FDA regulations) I
    fear Philip Morris has had a hand in drafting, and is currently
    driving, the passage of the existing proposed measure.
        Realizing that the eventual regulation of cigarettes was
    inevitable, in 1999 PM started an internal project to enact Food and
    Drug Administration (FDA) regulations on its own terms. The plan was
    called the Regulatory Strategy Project. The goal was to enact FDA
    regulations according to 5 core principles that would assure the
    company retained a measure of control over advertising and marketing,
    and assure a future market for cigarettes. The core principles, if
    achieved, would have the effect of safeguarding the company's ability
    to market cigarettes with a minimum of restrictions, transfer
    responsibility for fully informing the public about the dangers of
    tobacco use onto the FDA and take it off the manufacturers, and
    transfer legal liability for the safety of tobacco products onto the
    FDA, while allowing cigarette companies the ability to continue to
    design and market cigarettes as they see fit.
        A 2001 PM strategy memo shows that pursuit of FDA regulations would
    help complicate tobacco issues for the public. This constitutes a
    positive for PM, since it would blur the ``black and white'' divisions
    between public health and tobacco companies). Pursuit of FDA
    regulations would provide a positive public relations benefit for PM.
    The memo states,

              ``Unfortunately for the industry, the tobacco debate in
            recent years suffered from oversimplification, perpetuated by
            media coverage that depicts tobacco-
            related issues as `black and white,' with tobacco companies
            playing the predictable role as evil corporate giant . . .''

        It continues,

              ``The debate over FDA reform has the potential to complicate
            this portrayal in a manner that will specifically benefit
            Philip Morris. The simple fact that other tobacco companies
            will likely come out on the opposite side of the issue--against
            FDA regulation--provides Philip Morris a chance to distinguish
            itself from its competitors as a good corporate citizen.
            Positioned appropriately, the campaign can actually serve two
            purposes: achieving Philip Morris's goal of instituting
            regulation of the tobacco industry while also realizing
            significant public affairs benefits.''

    (Campaign to Achieve FDA Regulation of Tobacco, Philip Morris memo from
    22 March 2001, Bates No. 2085235845/5847.)
                 specific comments on the proposed legislation
        The proposed legislation spends more time listing what FDA cannot
    do to regulate tobacco than what it can do. It effectively ties FDA's
    hands in responding to current research, science and health threats
    posed by tobacco. For example, section 906 of the current legislation
    ``cements'' the age of sale of tobacco at 18 years. This is despite the
    understanding that raising the age of purchase of tobacco products to
    19 would make significant inroads in getting cigarettes out of high
    schools. However, under the current bill, such a change would be
    prohibited nationwide. A measure like this, that limits peoples'
    ability to enact stricter legislation, is called Preemption. Philip
    Morris has long had an internal program (called its ``Accomodation/
    Preemption Program'') to pass preemptive laws benefiting the company in
    all 50 States. PM's preemptive programs in my opinion have set back the
    progress of public health smoking laws by at least a decade. Preemption
    of local ordinances by state-level legislation has long been considered
    a ``deal breaker'' by health advocates when clean indoor air
    legislation have been introduced. To explicitly avoid preemption,
    Congress should pass a bill that sets minimum standards for the FDA,
    but that does not preempt the FDA's ability to do more.
        The proposed legislation also takes a strong product/ingredient-
    focused approach to regulating tobacco. In fact, the tobacco control
    community has moved beyond this approach. The tobacco companies
    themselves have spent 40-50 years on research and development of their
    products without releasing information about their research or
    activities for public scrutiny. Current tobacco control theory focuses
    less on the product and much more on eliminating the harm done to
    nonsmokers from secondhand smoke and denormalizing use of the product.
    This approach is not mentioned anywhere in the bill, and should be a
    central focus of any FDA effort to regulate tobacco.
        The proposed legislation also fails to address or preclude the
    likely occurrence that tobacco companies will start including language
    on their labels and in advertisements to the effect of ``This product
    manufactured in accordance with FDA standards.'' Such messages would
    have the effect of seriously misleading the public into believing that
    cigarettes have been somehow made safer or less harmful, or that the
    Government sanctions their use.
        Since the beginning of its existence, the FDA has been charged with
    assuring that products under its scrutiny are safe. This bill would
    represent the first time the agency would be charged with managing a
    product that is inherently unsafe. The appropriateness of this should
    be seriously questioned, to the extent that Congress should consider
    whether some different and separate agency should be established to
    manage the Government's efforts to regulate cigarettes. FDA's
    management of a deadly product could seriously erode and undermine the
    public's remaining confidence in the agency.
        I am also concerned that the current bill will have the effect of
    transferring liability for the manufacture of a deadly product onto the
    Government, and take liability off the tobacco companies. There is no
    provision in the bill that specifically protects the Government from
    charges of complicity in the manufacture and distribution of a known
    harmful product.
        The proposed legislation in many places conflates the pursuit of
    public health with avoiding disruption of the tobacco trade, as in an
    excerpt from p. 60 that says,

              ``Such date . . . [of establishing a tobacco product
            standard] shall be established so as to minimize, consistent
            with the public health, economic loss to, and disruption or
            dislocation of, domestic and international trade.''

        You simply cannot have it both ways. The fact is that a healthy
    tobacco trade is antithetical to public health, within and outside the
    United States. This clause is another indication that the bill was
    drafted with the tobacco industry's needs in mind, rather than the
    public's best interests.
        The bill assumes that tobacco use is primarily a problem of youth,
    and thus relies heavily on a youth-focused approach to advancing the
    public health. The youth-focused view has largely lost favor with
    serious tobacco control advocates, since tobacco document research
    revealed that a youth-focused approach to tobacco control plays
    directly into the hands of tobacco companies. The companies have used
    the over-emphasis on youth smoking to deflect the attention of
    legislators and rulemakers away from the fact that smoking is a
    society-wide problem, not simply a youth problem. Congress should not
    lose focus on the fact that the issue is not one simply of youth
    smoking (the preferred focus of the tobacco industry); it is the
    ongoing promotion and sale of a deadly product.
        Congress need also be aware of some very problematic loopholes in
    the bill as it is written. In one clause from sec. 908, the bill
    states:

              (c) Recall Authority.--(1) In General.--If the Secretary
            finds that there is a reasonable probability that a tobacco
            product contains a manufacturing or other defect not ordinarily
            contained in tobacco products on the market that would cause
            serious, adverse health consequences or death, the Secretary
            shall issue an order requiring the appropriate person
            (including the manufacturers, importers, distributors, or
            retailers of the tobacco product) to immediately cease
            distribution of such tobacco product.

        My interpretation is that this clause has the effect of sanctioning
    the already-
    existing defects in tobacco products that cause illness and death. If a
    tobacco product is determined to have a WORSE manufacturing defect that
    makes it even MORE deadly, THEN the onus would be on FDA to issue a
    cease and desist order for sales of the product. But if the product is
    just at its normally deadly level, FDA's hands are tied--no cease and
    desist order, no recalls. This simply is bad policy.
        There are no provisions in the current bill that address ongoing
    problems of contamination that are inherent in the manufacture of
    cigarettes, specifically the contamination of cigarettes with bugs and
    bug larvae, bits of rubber and lubricating oils from conveyor belts in
    manufacturing facilities, pieces of foam from tobacco drying barns,
    blood, bits of metal, and other contaminants like ink from printing on
    cigarette paper and the off-gassing of plastics used in packaging that
    are revealed as ongoing problems in tobacco industry quality control
    documents.
        FDA should be given full and unfettered authority to act on any and
    all current science and research regarding tobacco, and to take
    whatever actions are necessary to reduce the problem of society
    smoking. FDA should have complete authority to regulate all areas of
    nicotine administration, as well as other constituents and ingredients,
    and that authority should be made completely explicit.
        Taken as a whole, Philip Morris internal documents indicate that
    PM's goals in pushing for FDA regulation are:

        (1) To assure a future market for cigarettes,
        (2) To preserve the company's ability to make cigarettes that
    appeal to their market,
        (3) To safeguard the company's ability to market cigarettes without
    restrictions,
        (4) To prevent FDA from obtaining any real authority to restrict
    the marketing and promotion of cigarettes,
        (5) To give FDA the responsibility of fully informing the public
    about the dangers of tobacco use, and take this responsibility off of
    the manufacturers,
        (6) To transfer legal liability for the safety of tobacco products
    onto the FDA, while allowing cigarette companies to continue to design
    and market cigarettes as they see fit.

        It seems to me that the current bill allows the tobacco industry to
    achieve all this.
        I urge Congress to carefully go through the bill and re-craft so
    that it allows public health authorities to make real progress against
    tobacco use in this country. Do not lose this chance to do what is best
    for society for a change, instead of what is best for Philip Morris.
      Prepared Statement of John R. Polito, Esq., Editor, WhyQuit, Mount
                                  Pleasant, SC
        Dear Chairman Kennedy, WhyQuit is the Internet's oldest and largest
    quit smoking forum devoted exclusively to abrupt nicotine cessation,
    the quitting method employed by 80 percent to 90 percent of all long-
    term successful ex-smokers. As an all volunteer forum we dream of the
    day when the need for our free education, counseling and support
    services is at end and the team can turn their energies and passions to
    new causes. But, sadly, the bill before you would better be titled
    ``The Nicotine Addiction Industry Protection Act.''
        It seeks to grant the Food and Drug Administration (FDA) limited
    authority to regulate cigarettes and tobacco. At first blush the idea
    sounds great. In fact, an initial reading of the full bill will likely
    reinforce that opinion. But don't we want America's 9,000 FDA food and
    medicine watchdogs ringing alarms when any product is found responsible
    for even a single death? How can we not pollute their mission and minds
    by commanding them to accept regulatory oversight and thus some degree
    of responsibility for hundreds of thousands of smoking-related deaths
    annually?
        The FDA's full mission statement reads as follows:

              ``The FDA is responsible for protecting the public health by
            assuring the safety, efficacy, and security of human and
            veterinary drugs, biological products, medical devices, our
            Nation's food supply, cosmetics, and products that emit
            radiation. The FDA is also responsible for advancing the public
            health by helping to speed innovations that make medicines and
            foods more effective, safer, and more affordable; and helping
            the public get the accurate, science-based information they
            need to use medicines and foods to improve their health.''

        Key Congressional ``findings'' from the bill assert that ``tobacco
    products are inherently dangerous and cause cancer, heart disease, and
    other serious adverse health effects,'' ``nicotine is an addictive
    drug,'' ``virtually all new users of tobacco products are under the
    minimum legal age to purchase such products,'' and ``tobacco use is the
    foremost preventable cause of premature death in America. It causes
    over 400,000 deaths in the United States each year and approximately
    8,600,000 Americans have chronic illnesses related to smoking.''
        Clearly, America's leading cause of preventable death isn't a
    medicine or food but by the bill's own findings an inherently dangerous
    and highly addictive killer. Isn't it obvious that the Federal Trade
    Commission (FTC), pursuant to the Federal Cigarette Labeling and
    Advertising Act of 1966 (15 U.S.C. Sec. Sec. 1331-1340, as amended) is
    the proper Federal agency for addressing what are primarily tobacco
    advertising, marketing and sales oversight responsibilities.
        But instead, the bills language, which clearly had strong input
    from Philip Morris USA, is loaded with provisions that tie the FDA's
    hands. It prohibits the FDA from removing all nicotine from cigarettes,
    from banning their sale, from requiring that tobacco be removed from
    neighborhood convenience stores (what to youth is the neighborhood
    candy, chip, ice cream and soda store), and from raising the age of
    purchase above age 18.
        Philip Morris USA's Web site notes the February 15, 2007
    introduction of the bill and states, ``PM USA strongly supports this
    bipartisan legislation and urges Congress to take quick action'' on the
    bills. Philip Morris asserts that the bill will bring
    ``predictability'' to the tobacco industry in the United States.
    Predictability?
        This bill is a tobacco industry dream come true--an official
    government birth certificate that guarantees the right to sell a
    chemical that the Surgeon General claims is at least as addictive as
    heroin to 18-year-old high school students across the Nation, 18-year-
    olds who want to be liked. Try to find any convenience store without a
    buy 1 get 1 free or buy 1 get 2 free deal. They make captivating gifts
    that all but guarantee that underage recipients will become new friends
    who'll soon return begging for more.
        Although the bill is well intended, it plays smack dab into the
    tobacco industry's hand. The industry always seems two moves ahead of
    health policymakers but considering that its economic survival is at
    stake it must stay ahead. When the 1998 Master Settlement Agreement
    with the States ended tobacco product advertising in high youth
    readership magazines they simply shifted those dollars into
    neighborhood convenience stores--into what is now ``nicotine addiction
    central.''
        We beg committee members to think like a tobacco company. Imagine
    watching horror as smoke-free workplace laws sweep the Nation and
    nearly all States raise cigarette taxes in an attempt to price nicotine
    products beyond the disposable income of most youth. But what's now
    just starting to sweep the tobacco control community is a realization
    that cigarettes, by far the dirtiest drug delivery device ever devised,
    are no longer needed.
        In November 2003 GlaxoSmithKline consultants reported that nearly
    37 percent of all nicotine gum users were engaged in chronic long-term
    use of at least 6 months. We have no reason to believe that nicotine
    lozenges, releasing 25 percent more nicotine than gum, won't be just as
    high. Although nicotine replacement therapy products have shown 1.5- to
    2-fold efficacy over placebo in randomized clinical trials, once
    outside the door and going head-to-head against cold turkey they fall
    flat on their face. But replacement nicotine's true value to society
    isn't in cessation but as an ongoing daily dependency alternative to
    cigarettes.
        Which city in America would have been the first to ban the sale of
    all cigarettes and have a city-wide transfer campaign to help smokers
    adapt to cleaner forms of nicotine delivery? What would have happened
    to youth and adult smoking rates in that community? Like smoke-free
    workplace air, could such a movement quickly sweep the entire Nation?
    Under this bill we'll never know.
        Section 907(b)(3) of the bill, entitled ``POWER RESERVED TO
    CONGRESS,'' ``expressly reserves'' to Congress the power to ban all
    cigarettes. If we were thinking ahead, instead of another aspect of
    Federal preemption why couldn't this reservation have expressly shared
    such power with the States or their political subdivisions?
        As for tasking the FDA with determining which of 4,000 cigarette
    smoke constituents are the most deadly and then battling the industry
    to have one or more removed, picture for a moment the marketing
    representations that would be made in association with selling this
    reduced risk product that's still extremely deadly. In fact, as soon as
    this bill is passed all cigarette advertisements will instantly be able
    to honestly proclaim that they are in full accord with all Food and
    Drug Administration safety requirements. Imagine how that message will
    play inside a 15-year-old's mind.
        We encourage the committee to amend the bill to task all sales,
    marketing and advertising provisions to the FTC while including a
    strong preemption disclaimer that makes it clear that the States are
    free to regulate all aspects of advertising, marketing and sales,
    including the power to ban any or all forms of nicotine delivery, with
    the exception of altering required tobacco product health warnings if
    tobacco products are sold.
        If the committee insists on going forward with this ill-advised
    bill it should be amended to:

         Make it clear that, as with alcohol, the States and their
    political subdivisions have full authority to ban the sale of any or
    all classes of nicotine delivery devices, including all forms of
    nicotine replacement therapy.
         Authorize the FDA to raise the smoking age to 21.
         Authorize the FDA authority to limit the sale of any class
    of nicotine delivery device to stores to which those who are underage
    are denied access. Responsible stores need to make a choice. They
    either want to market and sell what many consider earth's most
    captivating chemical or cater to children but they cannot do both.
         Authorize the FDA to both remove all nicotine from tobacco
    products and ban the sale of any class of nicotine delivery device.
         Include an express provision that any reference to FDA
    regulation of tobacco during any products liability jury trial will
    result in a mistrial and a statutory penalty of $100,000.
         Amend the warnings to require that alternating nicotine
    addiction warnings appear on one side of each cigarette pack sold, with
    a health warning appearing on the other side. For example, Canada's
    addiction warning reads, ``Warning Cigarettes are Highly Addictive--
    Studies have shown that tobacco can be harder to quit than heroin or
    cocaine.'' Canadian youth smoking rates have fallen dramatically since
    the warning first appeared in 2000. Relative risk information is
    critical if youth are to make informed decisions. Youth also need to
    know how quickly dependency can occur, the warning signs, and the truth
    about how ineffective over-the-counter quitting aids such as the
    nicotine patch and gum actually are with a 93 percent 6-month smoking
    relapse rate as determined by GlaxoSmithKline consultants. Otherwise we
    provide them a false belief that quitting is easy when in fact 50
    percent of adult U.S. smokers are losing 13 to 14 years of life. As for
    giving dependency warnings equal weight with health warning, it is
    nearly impossible to experience most health risks unless the user first
    becomes dependent, the greatest risk of all.
        Provide clearer language that the Secretary is not only free to
    amend existing warnings but to create new warnings.
        If this were any other consumer product the FDA would instantly
    battle to have it removed from the market. The bill attempts to pound a
    square peg into roundness. It cannot be done. Although all sponsoring
    this bill are well intended they should put themselves in the shoes of
    the average FDA employee and reflect upon how this bill will
    fundamentally alter their mission and thinking in regard to product
    risk analysis. Is that really what's best for America? We're making
    great strides. Give the States full authority to regulate sales and
    then, like smoke-free workplace laws, watch the magic unfold.
    Prepared Statement of Vicki Voldal Rosenau, Barnes County Tobacco-Free
                            Network, Valley City, ND
        For many years, I have been reading and re-reading expert analyses
    and conclusions (both pro and con) regarding the provisions that are
    now included in this year's version of so-called ``FDA Regulation of
    Tobacco'': the Kennedy-Cornyn bill.
        I've probably studied this issue more thoroughly than any other
    person in the state of North Dakota. This careful consideration has
    brought me to the inescapable conclusion that, if enacted, this
    legislation would do significant, serious harm to the public's health.
    Because the 155 pages are so fraught with pitfalls and loopholes and
    blatant sellouts, it is not feasible to ``amend'' it to a state of
    wholesomeness. Therefore, the bill should be abandoned.
        As if the compelling negative evidence that has been piling up for
    years were not enough, the recent arrival-on-scene of R.J. Reynolds'
    cunning ``Camel No. 9'' promotion offers just one final ounce of proof
    that the Kennedy-Cornyn bill is a sham. Why? Because, even though this
    brand-new, slick, hot-pink fuchsia campaign makes a blatant appeal to
    young girls, the proposed ``FDA bill'' would do absolutely nothing to
    prohibit this powerful exploitation of youthful vulnerability.
     Prepared Statement of Michael Siegel, M.D., M.P.H., Professor, Social
    and Behavioral Sciences Department, Boston University School of Public
                               Health, Boston, MA
        I am a Professor in the Social and Behavioral Sciences Department
    at the Boston University School of Public Health and as a physician
    trained in preventive medicine and public health, I have been a tobacco
    control researcher, practitioner, and teacher for the past 21 years. I
    spent 2 years at the Office on Smoking and Health at the Centers for
    Disease Control and Prevention (CDC), and I am quite familiar with the
    issues involved in Federal tobacco control regulation and policy. I was
    at CDC during Dr. David Kessler's original investigation into the
    possibility of FDA claiming jurisdiction over tobacco products, and
    helped advise FDA at that time. I have published more than 60 peer-
    reviewed articles in the medical and public health literature, most
    concerning tobacco policy. I have testified as a witness for the
    plaintiffs in seven tobacco-related lawsuits, including the Engle case
    which resulted in an unprecedented $145 billion verdict in favor of the
    plaintiffs. I have testified in more than 50 local and State hearings
    in support of smoke-free bar and restaurant laws. In summary, I am
    about as anti-smoking as one can be.
        Proponents of the proposed FDA tobacco legislation have argued that
    this bill would end special protections for the tobacco industry,
    protect the public's health, reduce tobacco use, make cigarettes safer,
    and save lives. However, a detailed analysis of the actual provisions
    of the legislation makes it clear that quite the opposite is true. The
    bill would provide unprecedented special protections for Big Tobacco--
    protections not enjoyed by any other industry whose products are
    regulated by the FDA. The bill would harm the public's health at the
    expense of protecting the financial interests of the largest tobacco
    companies. The bill would likely increase tobacco use, create a false
    impression that cigarettes are safer, end the prospects for a truly
    safer cigarette, and in the long run, result in an increased number of
    deaths from tobacco use. Supporters of the bill are full of rhetoric,
    but when you take the time to actually examine the bill and the
    regulatory framework it establishes, you see that this legislation is
    in the best interests of the Nation's leading tobacco company--Philip
    Morris; it is not in the best interests of protecting the public's
    health.
     1. the regulatory scheme established by the legislation is pure lunacy
    The Bill Would Create the Illusion of Safer Cigarettes Without Any
            Evidence That the Product Is, or Can be Made Safer
        The system of tobacco product safety standards set up by the bill
    is pure lunacy. Although the rhetoric by groups like the Campaign for
    Tobacco-Free Kids sounds great, the truth is that there is no evidence
    that these standards would actually result in a safer product.
        The problem is that we simply do not know which of the constituents
    in tobacco smoke, and at what quantities, are responsible for what
    diseases. So the Campaign for Tobacco-Free Kids can talk all they want
    about how FDA will be able to reduce levels of certain toxins and
    produce a safer cigarette, but that's a pipe dream. It would be
    difficult to conduct, long-term epidemiologic studies, where you'd have
    to follow smokers of conventional vs. new products for 10-20 years,
    before you could have an answer to this question. But in the mean time,
    we wouldn't know what the risks are--or even if the risk could be
    decreased.
        Essentially, the bill gives the FDA a mandate which it cannot carry
    out. The only way to know whether any particular reductions in specific
    smoke constituents would result in a safer product would be to carry
    out long-term epidemiologic studies, using smokers as guinea pigs.
    Perhaps some would view that as acceptable because the product is
    dangerous anyway. However, the problem is that smokers are going to
    naturally assume that these products are safer--and we won't know that
    is true. This legislation would greatly deceive smokers into thinking
    that the product is safer, when it may well not be any safer at all,
    and could potentially be more hazardous.
        Unfortunately, we simply do not have any idea whether it is even
    possible to reduce the toxicity of cigarettes by reducing the levels of
    specified components.
        The entire approach is flawed, because if you want safer
    cigarettes, you need to use the free-market approach to set up
    competition between the companies for a safer product. This legislation
    does the opposite. It takes away the free market completely and puts
    all decisions into the hands of FDA. But it gives the FDA a mandate
    which sets up impossible standards that could never be met for new
    products. What it really does is ensure that existing products will be
    institutionalized and protected from competition. This, indeed, is the
    reason why Philip Morris supports the bill, and all the smaller
    companies oppose the bill. What the smaller companies despise is the
    removal of any serious chance to compete in the market--and largely,
    the market we are talking about is potentially safer products.
        Philip Morris wants to freeze the market as is, so that Marlboro--
    one of the highest risk products imaginable--will be able to dominate
    the market, without any serious competition from potentially safer
    products which could advertise themselves as being safer than Marlboro
    and thus gain market share among the ``health-conscious'' segment of
    smokers who are looking to reduce their risks while still satisfying
    their demand for cigarettes.
        If you really think about it, you'll see that the approach of
    trying to reduce the levels of specific smoke constituents is complete
    lunacy. When you have no idea which constituents, in what combination,
    and at what concentrations, cause which diseases that are associated
    with smoking, then it is impossible to produce a cigarette that you
    know will be safer simply by mandating a reduction in the levels of
    various smoke constituents.
        The one thing you will never hear the supporters of this
    legislation do is estimate the number of lives they think this
    legislation will save. All they can do is talk about ``countless''
    lives being saved. And they are quite correct. The lives are countless.
    You cannot count them because they do not exist.
        It is estimated, for example, that there are over 60 compounds in
    tobacco smoke which cause cancer. So what sense does it make to require
    the companies to take out two or three of them? What if they take out
    the wrong ones? What if the actual compound which causes most of the
    cancer is not one of those chosen to be removed? What if smokers
    believe that this is a safer product and start smoking more? This
    approach could actually kill people, rather than save lives.
        And it could also kill people by reducing youths' perceptions of
    the hazards of cigarette smoking. If youths are led to believe--
    correctly--that the FDA now regulates every ingredient of the cigarette
    and that--incorrectly--because of this, countless lives will be saved,
    does it not make sense for these kids to infer that cigarettes are not
    as bad as they used to be? We know for a fact that any decline in the
    perceived harm of cigarettes results in an increase in youth smoking.
    So the proposed FDA legislation could well kill more people than it
    saves.
        The bottom line is that there is no point in giving the FDA
    regulatory authority over cigarettes unless there is evidence that
    there is something that the FDA could do to regulate cigarettes to
    unequivocally make the products safer. To start the FDA on a crapshoot
    where they would choose random smoke constituents to reduce or
    eliminate in cigarettes makes no public health sense. It will give an
    FDA stamp of approval to tobacco products, but without actually making
    them any safer.
    2. the legislation would be a death knell for the development of truly
                             safer tobacco products
    The Bill Would Make it Impossible for Tobacco Companies to Market Truly
            Reduced Risk Cigarettes and Would Eliminate Any Incentive to
            Develop Such Products
        The bill puts a death knell to harm reduction as a strategy. It
    prohibits the marketing of any newer, safer cigarette, unless it meets
    FDA approval. But here's the catch--in order to meet FDA approval, you
    would have to prove that the product improves health, both on an
    individual and a population level. To do that, you'd have to conduct
    epidemiologic studies in which smokers were followed for 10-20 years.
    And you'd have to hope that they stuck with their products
    (conventional vs. new), without switching, for the entire period. In
    short, this is impossible. Thus, this legislation would make it
    impossible to produce and market safer cigarettes. It essentially takes
    all the incentive away. No cigarette company is going to want to spend
    millions of dollars on testing and producing a safer cigarette when
    they know it is going to be virtually impossible for them to ever
    market it.
        And this is precisely why Philip Morris favors this legislation.
    Philip Morris realizes that the bill sets up an impossible standard for
    new products. Thus, it ensures that the existing market is basically
    frozen--obviously, this is a dream come true for the company with the
    largest current market share, because it stifles competition.
        The only way to get safer cigarettes would be to allow the free
    market to produce them--not by creating this elaborate regulatory
    scheme.
        In fact, if you actually read the legislation [see section
    901(g)(1)], you'll see that it is not just virtually impossible to meet
    the standards required to market a reduced risk product, it is actually
    impossible. In order to prove that a product reduces health risks as it
    is actually used, both on an individual and population basis, you'd
    have to demonstrate the results of a study in which the product is
    marketed the way it would be marketed in real life--that is, as a
    reduced risk product. But you can't market it as a reduced risk product
    until you've proven that it reduced risks.
        This is truly a catch-22. You cannot market a product as reduced
    risk until you've proven it reduces risk, but you cannot possibly prove
    that it reduces risk until you've marketed it as such.
        Thus, the proposed legislation not only represents a de facto end
    to the prospect of truly safer products--it represents an actual death
    knell for any meaningful harm reduction strategy.
        The critical flaw in the proposed legislation is section 911(g)(1).
    This is the Modified Risk Product section of the bill.
        The Modified Risk Product section of the proposed FDA legislation
    would make it virtually impossible for modified risk products to enter
    the market, while at the same time, allowing reduced exposure products
    to essentially be falsely marketed as reduced risk products (thus
    institutionalizing the very problem that the health organizations have
    expressed so much concern about).
        Here are the specific problems:

        1. The legislation lists several criteria for achieving approval of
    a modified risk product. The most important are the following: ``the
    Secretary shall approve an application for a modified risk tobacco
    product filed under this section only if the Secretary determines that
    the applicant has demonstrated that such product, as it is actually
    used by consumers, will: (A) significantly reduce harm and the risk of
    tobacco-related disease to individual tobacco users; and (B) benefit
    the health of the population as a whole taking into account both users
    of tobacco products and persons who do not currently use tobacco
    products.
        Section 911(g)(1)(A), the (A) clause above places an insurmountable
    obstacle in the path of approval of modified risk products. In order to
    demonstrate that the product, as actually used by consumers, will
    significantly reduce the risk of tobacco-related disease to individual
    users, large-scale, long-term epidemiologic studies are necessary. Even
    ignoring the requirement under 911(g)(1)(B), the (B) clause above
    (which itself appears to introduce an insurmountable obstacle), the
    bill as currently written precludes any harm reduction approach to
    tobacco control both by making it impossible for such products to meet
    the conditions for approval and by eliminating any incentive
    (especially economic) to develop such products. Thus, the bill may have
    the exact opposite effect that many believe it should have. It protects
    the existing high-risk products on the market.
        It is critical for the public and policymakers to understand the
    ramifications of section 911(g)(1). In order to market a reduced risk
    product, a cigarette company would have to demonstrate that the
    product, as actually used by smokers, would substantially reduce the
    actual risk of disease among individual tobacco users.
        There is only one way to do this. And that is to conduct a long-
    term epidemiologic study in which one compares the disease risk of the
    modified product with that of a comparison product over a long time
    period and among a large population of smokers.
        There are all kinds of complications with conducting such a study.
    First, it would be tremendously expensive. Second, it would take, at a
    minimum, 10-20 years to follow the smokers long enough to monitor
    changes in disease. For cancer risks in particular, you would have to
    follow smokers for about 20 years before you would be able to draw
    definitive conclusions regarding any reductions in risk.
        Third, there are all kinds of research complications that would
    make it difficult to draw accurate conclusions. The only way to
    credibly demonstrate a reduction in risk would be to conduct a
    randomized clinical trial, where smokers were randomized to either
    smoke conventional cigarettes or the putative reduced risk cigarettes.
    But conducting a randomized trial of smoking would be unethical; such a
    study is impossible.
        The best that could be hoped for is a natural experiment type of
    study in which a product is ``test-marketed'' and that population of
    smokers (i.e., guinea pigs) are monitored for 10-20 years. But this is
    a catch-22. How can you test-market the product if you need to obtain
    FDA approval before you can test-market it? The only way you could do
    this would be to market the product as a conventional cigarette (not
    let anyone know that it is a potentially reduced risk product). But to
    do that, you would destroy the study, because it is your obligation to
    demonstrate that as actually used by consumers, the product would
    reduce risk. Smokers might use the product very differently if they
    believe it is a reduced risk product than if they don't.
        In other words, the legislation does not merely make it difficult
    to market a reduced risk product. It makes it literally impossible.
        2. The bill contains a special rule that would allow FDA to approve
    certain modified risk products that cannot meet the criteria listed
    under (A) and (B) above. Such products must only claim to be reducing
    exposure to, or reducing levels of, or being free of a particular
    constituent. Specifically, such products can be approved if
    ``scientific evidence is not available and, using the best available
    scientific methods, cannot be made available without conducting long-
    term epidemiological studies for an application to meet the standards
    set forth in paragraph (1).'' In such cases, the major criterion that
    must be met is as follows: ``the scientific evidence that is available
    without conducting long-term epidemiological studies demonstrates that
    a measurable and substantial reduction in morbidity or mortality among
    individual tobacco users is anticipated in subsequent studies.''
        Thus, section 901(g)(2)(A) essentially allows products that do not
    claim to reduce risk but merely claim to reduce exposure to or levels
    of a particular constituent to be approved by simply showing that a
    reduction in risk is anticipated in subsequent studies. This is a very
    weak standard. As long as there is any promising preliminary evidence,
    one could argue that reduced risk is expected if it were to be studied
    (this is a far cry from demonstrating reduced risk, especially given
    the many uncertainties including the actual use of the product by
    consumers and unintended side effects or consequences).
        The effect of 901(g)(2)(A), then, is essentially to allow the
    approval of reduced exposure products and to allow these products to be
    marketed as such, even though there is shoddy scientific evidence of
    any health benefit. This institutionalizes the very problem
    (unsubstantiated health claims) that health groups supporting this
    legislation have expressed so much concern about. The fact that the
    bill does not allow these products to represent themselves as reducing
    health risk is largely irrelevant, because consumers are going to
    perceive them as reducing risk. How else would someone interpret a
    claim of reduced exposure?
        Of note, the bill does require that there be testing of consumer
    perception which shows that as the product is proposed to be labeled
    and advertised, it will not mislead consumers into thinking that the
    product reduces health risk. However, there are no restrictions on who
    must do the consumer testing and what the conditions or protocols must
    be. It would be relatively easy for a company to do consumer testing in
    such a way that they obtain the result they want to show. Anyone
    familiar with survey research, focus group studies, or other types of
    formative research knows that the way questions are asked and the
    specific protocols used can shape consumer responses substantially.
    Similarly, post-market surveillance protocols are left to the
    companies.
        The proposed FDA legislation is thus the worst of both worlds. On
    the one hand, it allows companies to gain a government sanction to
    market products under the guise of reduced risk by merely calling their
    product reduced exposure. On the other hand, it prevents companies from
    marketing products that may truly be reduced risk products by putting
    an impossible regulatory burden in the path of such products.
        Despite all the rhetoric, the proposed FDA legislation would do
    nothing to save lives, but would instead ensure that the highest risk
    products remain firmly entrenched in the marketplace, without any
    competition from what could be life-saving alternatives. Of course,
    this lack of effective competition is why Philip Morris adores this
    legislation.
        What it comes down to is protecting the profits of the Nation's
    largest tobacco company at the expense of the public's health. That
    Philip Morris is lobbying for this legislation makes perfect sense, and
    it is the company's fiduciary responsibility to do nothing less. That
    the Campaign for Tobacco-Free Kids and other major anti-smoking groups
    are joining alongside Philip Morris in promoting this legislation is
    nothing less than a travesty.
      3. the legislation makes a public health blunder--asking the fda to
        prevent the addiction of kids by lowering nicotine levels, but
              preventing the agency from eliminating the nicotine
    Due to a Mechanism Known as Compensation, Reducing Nicotine Levels
            Would be a Public Health Disaster; Smokers Would Smoke More,
            Increasing Tar Delivery and Deaths from Cancer and Chronic Lung
            Disease
        According to a recent report released by the Harvard School of
    Public Health,\1\ cigarette companies steadily increased the nicotine
    yield of their cigarettes during the period 1997-2005. The report
    describes the increase as being a total of 11 percent over the 7-year
    period 1998-2005, or an average increase of 1.6 percent each year
    during that period.
        Major anti-smoking groups also hailed the study and told the public
    that it shows the need for FDA regulation of tobacco products. The
    Campaign for Tobacco-Free Kids used the study results to call for
    passage of legislation that would grant the Food and Drug
    Administration (FDA) authority to regulate tobacco products \2\:

              ``A new study released today by the Harvard School of Public
            Health shows the critical need for Congress to enact
            legislation granting the U.S. Food and Drug Administration
            (FDA) authority over tobacco products. The Harvard study
            expands on and confirms an August 2006 study released by the
            Massachusetts Department of Public Health that found that
            tobacco companies have deliberately increased the levels of
            nicotine in cigarette smoke since 1998. The FDA legislation
            would require tobacco companies to disclose to the FDA changes
            in their products and provide FDA the authority to require them
            to reduce levels of constituents, like nicotine that make them
            more harmful or more addictive. . . . The fact that the tobacco
            companies have been able to secretly increase nicotine levels
            in tobacco smoke occurred only because no Federal or State
            agency currently has regulatory authority over cigarettes or
            what tobacco companies put in cigarettes. . . . The proposed
            legislation would grant the FDA the authority and resources to
            stop harmful tobacco company practices that continue to addict
            children . . . .''

        The steady and significant increase in nicotine yields cigarettes
    over the past 8 years or so sounds like a concerning finding. It sounds
    like cigarette companies are increasing the addictive potential of
    their cigarettes and harming the public's health in a way that demands
    passage of the proposed FDA tobacco legislation. At least this is what
    the major anti-smoking groups want the public to think.
        There are, however, two major problems with this.
        First, an increase in nicotine yields does not necessarily mean
    that the public's health has been harmed. It is well documented that
    smokers compensate in response to changes in nicotine yields to
    maintain exposure to a relatively constant nicotine dose. This is why
    ``light'' cigarettes are not safer products. While the nicotine levels
    are lower, smokers compensate by simply smoking more; this negates the
    potential benefits of reduced nicotine and tar levels.
        In a similar way, smokers might be expected to compensate by
    smoking slightly less if nicotine yields increase. This could actually
    have a marginally positive health benefit if it reduces overall
    cigarette consumption.
        In fact, the report \1\ acknowledges this important point:

              ``The increase in smoke nicotine yield does not necessarily
            signify any change in exposure within the population of
            smokers, particularly as human smoking behavior is compensatory
            and will adjust for differences in smoke yield.''

        If anything, the proposed legislation would actually harm efforts
    to protect the public's health. By focusing on increases in nicotine
    yields as if they are necessarily harmful to public health, the
    legislation implies that decreases in nicotine yields would be a good
    thing. But the truth is that reduced nicotine yields could be harmful
    to public health because they would likely increase cigarette
    consumption (due to compensation), leading to increased tar delivery
    and higher rates of lung and other cancers as well as chronic lung
    disease.
        If lawmakers are disturbed by the addictiveness of cigarettes, then
    there's only one thing that can be done--and that's to require the
    elimination of the nicotine. Short of that, there's nothing that can be
    done. At least not anything beneficial. Requiring reductions in
    nicotine levels would be the worst thing we could do, because cigarette
    consumption would rise due to compensation, causing increased tar
    delivery and increased disease and death.
        Regulating the levels of nicotine to make sure that they don't
    increase would be absolutely useless. Forcing the levels to come down
    would be absolutely disastrous for the public's health. There is no
    point in using the addictiveness of cigarettes to argue for the need
    for FDA regulation unless what you are calling for is granting the FDA
    the power to eventually eliminate the nicotine from cigarettes.
        If the Campaign for Tobacco-Free Kids and other anti-smoking and
    public health groups were truly sincere in their public statements that
    we need to do something to protect kids from cigarette company attempts
    to addict them through the manipulation of nicotine in cigarettes, then
    the only viable option is to remove the nicotine. Nothing else would
    work--and in fact, merely lowering the levels of nicotine would
    actually harm the public's health.
        Let's face it. This legislation represents a purely political
    compromise to protect the financial interests of the tobacco companies.
    Maybe that is the right thing to do, but let's cut out the rhetoric and
    simply admit that this is all about politics and not about protecting
    our children from the addictive nicotine in cigarettes.
        On January 17, Senator Edward Kennedy released a statement \3\ in
    response to the Harvard University School of Public Health report which
    concluded that nicotine yields of cigarettes have increased steadily
    over the past 8 years. In the statement, Senator Kennedy condemned Big
    Tobacco for addicting millions of young smokers due to these rising
    nicotine levels and called it a travesty for Congress to be an
    accomplice to this addiction by failing to enact legislation that would
    allow the Food and Drug Administration (FDA) to prevent this from
    happening.
        Senator Kennedy said \3\:

              ``This study is an extraordinary public service by Harvard's
            School of Public Health. It's dramatic new proof that Big
            Tobacco is addicted to addicting millions of young smokers into
            lifetimes of illness and early death. Congress has been an
            accomplice in the travesty because of the success of the
            tobacco lobby in blocking real reform. Hopefully, the study
            will be a wake-up call to persuade Republicans and Democrats
            alike to enact long overdue legislation allowing the FDA to
            regulate cigarettes and deal with their enormous risks.''

        Unfortunately, Senator Kennedy's statement deceives the American
    public into believing that the legislation which Senator Kennedy has
    introduced would actually do something to protect our Nation's youths
    from the addictive nature of nicotine in cigarettes.
        It turns out that the legislation that is proposed would not do
    anything to address the problem of the nicotine addiction of our
    Nation's children.
        In contrast, the proposed legislation would actually
    institutionalize the addiction of our Nation's children into law,
    ensuring that the Food and Drug Administration could never address the
    problem of nicotine addiction of our children by requiring the
    elimination of nicotine from cigarettes. The legislation would ensure
    that cigarettes always contain nicotine, and thus always maintain the
    potential to addict our children, regardless of whether we ever reach a
    point where social norms change in a way that would otherwise make
    feasible the FDA's gradual phasing out of nicotine from cigarettes.
        Ironically, if you want to give the FDA the power to possibly
    reduce the harms of cigarettes, the one thing that might actually work
    would be to mandate very high levels of nicotine in cigarettes.
        This would have two beneficial effects: first, it would
    substantially reduce the intensity of smoking and levels of
    consumption, reducing tar delivery and lowering cancer and chronic lung
    disease risks.
        Second, it would make cigarettes all but ``unpalatable'' for kids,
    ensuring that fewer young people would take up the habit and have it
    turn into an addiction. But established smokers would still be able to
    obtain their nicotine.
        This proposed legislation would not allow the FDA to mandate
    increases in nicotine levels in cigarettes. According to section
    907(a)(4)(a)(i) of the legislation, the FDA could only require
    reductions of certain constituents in cigarettes.
    4. the legislation would preclude the single most effective regulatory
       action to protect health that is politically and technologically
                                    feasible
    By Precluding the FDA from Requiring an Increase in the Nicotine Yields
            of Cigarettes, the Bill Eliminates a Regulatory Option
            Recommended by the Institute of Medicine that Could Produce a
            Safer Cigarette
        It honestly seems disingenuous to me to condemn the cigarette
    companies for addicting our Nation's youths with the nicotine in their
    cigarettes and then to support legislation that would institutionalize
    the addiction of our Nation's youths by precluding the FDA from
    removing the nicotine. It seems disingenuous to me to suggest to the
    public that we need FDA legislation to address the problem of the
    nicotine in cigarettes, but then support legislation that precludes FDA
    from doing anything other than reducing the nicotine levels.
        The reason? Reducing nicotine levels will not make cigarettes non-
    addictive. Reducing nicotine levels will not stop kids from smoking.
    Reducing nicotine levels will not end the problem of the addiction of
    our Nation's youths.
        What will reducing nicotine levels do? It will create a public
    health disaster by deceiving the public into thinking cigarettes are
    safer. It will lead to compensation by smokers, who will smoke more to
    maintain their dosage of nicotine. These smokers will therefore be
    exposed to higher levels of tar, which will lead to more cancer and
    emphysema. In short, reducing nicotine levels, without eliminating the
    nicotine, will kill people.
        I think it is most reasonable to argue that removing the nicotine
    from cigarettes is not a feasible solution to the problem of addiction.
    I would never criticize someone for suggesting that the FDA should not
    be given the authority to require the elimination of nicotine from
    cigarettes. However, I find it inappropriate to mislead people by
    suggesting that the increased nicotine yields in cigarettes demands
    enactment of the FDA legislation that has been introduced in Congress.
    If the fact that cigarette companies are using nicotine to addict
    youths is a travesty and it needs to be stopped, then the only way to
    do that is to get rid of the nicotine. You can't bemoan the presence of
    nicotine in cigarettes, suggest that we need legislation to take care
    of the problem, and then deceive the American people by supporting
    legislation whose fine print actually precludes the FDA from taking
    care of the problem.
        I can't over-emphasize this fact: reducing the nicotine yields of
    cigarettes will not take care of the problem.
        What is so disturbing about this story is that we, as tobacco
    control advocates, have condemned the tobacco industry for doing
    precisely this: reducing the nicotine yields of their cigarettes.
        In fact, we have taken the tobacco companies to court and helped to
    convict them of racketeering and fraud by virtue of the fact that they
    chose to decrease the nicotine yields of their cigarettes and market
    the cigarettes as having lower nicotine yields and therefore being
    ``lighter.'' We have argued, apparently successfully, that marketing
    low-nicotine-yield cigarettes is fraudulent, because it deceives the
    American people into thinking that the product is somehow safer when
    the truth is that it is not any safer.
        So why in the world would we propose a regulatory scheme in which
    we will do to the public exactly what the tobacco companies have done
    and been convicted of a crime for doing?
        Tobacco control groups and advocates who are supporting this FDA
    legislation are essentially calling on the Government to do exactly
    what the tobacco companies tried to do, but for which they were accused
    and convicted of racketeering and fraud: to reduce nicotine yields of
    cigarettes.
        Such an action by the FDA would certainly mislead smokers into
    thinking that the product is safer. The truth, however, is that the
    product would not be any safer. And it might actually be more
    dangerous.
        The truth is that, short of removing the nicotine, the only
    effective regulatory action that could actually protect the public's
    health would be to require increases in the nicotine yields of
    cigarettes. Greatly increasing the nicotine/tar ratio of cigarettes
    would allow smokers to obtain the same amount of nicotine dosage while
    inhaling substantially lower amounts of tar. This could potentially
    reduce cancer and chronic lung disease rates.
        However, the proposed legislation precludes the FDA not only from
    eliminating the nicotine, but also from requiring such increases in
    nicotine.
        According to section 907(a)(4)(A)(i) of the proposed legislation:
    ``A tobacco product standard established under this section for a
    tobacco product--(A) shall include provisions that are appropriate for
    the protection of the public health, including provisions, where
    appropriate--(i) for the reduction of nicotine yields of the product.''
        So the FDA cannot do the one thing that might actually produce some
    health benefits from regulation of the nicotine content of cigarettes.
    5. the legislation would essentially transfer the misrepresentation of
     the safety of cigarettes from the tobacco companies to the government
    By Establishing Product Safety Standards for Which There is Not
            Adequate Evidence of a Health Benefit, the Government Would Be
            Making Precisely the Same Type of Fraudulent Health Claims for
            Which Judge Kessler Found the Tobacco Companies Guilty
        In her final opinion in the Department of Justice tobacco lawsuit
    against the tobacco companies, Judge Gladys Kessler ruled that the
    defendants had engaged in fraud by marketing cigarettes that rated
    lower yields via machine testing in a way that falsely led consumers to
    believe that these products offered a health benefit over higher
    machine-yield products.
        A major part of the basis for this decision was a body of
    literature demonstrating that machine-yields of nicotine and other
    tobacco constituents have no direct relationship with actual human
    exposure, and thus with actual health risk, either on an individual or
    a population level. Machine yields, for example, do not adequately
    account for changes in human smoking behavior (e.g., compensation)
    which accompany any change in the yields of cigarettes.
        A report published recently in the journal Tobacco Control and
    written by a group of tobacco control experts confirmed not only that
    machine-measured toxin yield information is virtually meaningless, but
    that newer advances in the way in which these yields are measured--
    which attempt to more closely simulate actual smoking behavior--are
    inadequate, and even these new methods do not yield information that is
    of any consumer value.\4\

              ``Although each of the testing regimes will help to
            ``characterise'' how a product performs under a given set of
            smoking conditions, none of the smoking regimes ``represent''
            human behaviour in terms of compensatory smoking and none is
            likely to produce emissions that will be markedly associated
            with human exposure or risk, either for individual smokers or
            for population-level differences between brands.'' . . .
              ``After nearly 40 years--and after great cost to public
            health--the public health community is now coming around to the
            realisation that lower ISO emission cigarettes are not lower-
            risk products. Unfortunately, many regulators fail to
            understand the distinction between ``product characterisation''
            and predicting human exposure. At the same time as they insist
            that cigarette emissions are not measures of risk, various
            regulators continue to use cigarette emissions in ways that
            assume a link between the machine emissions and human exposure.
            Many jurisdictions continue to require that quantitative levels
            of tar, nicotine and carbon monoxide appear on packages. These
            numbers continue to be misunderstood and misused by smokers,
            including smokers in the most affluent and highly educated
            countries in the world. To date, there is no evidence that
            quantitative emissions constitute effective consumer
            information, and several scientific bodies have rightly called
            for the removal of these emissions from packages. . . . the
            tobacco industry should be prohibited from using machine
            emissions in any of its labelling, advertising or marketing
            directed at consumers, even if accompanied by ``warnings'' or
            disclaimers, such as those that currently appear in the United
            States and Europe.'' . . .
              ``Patterns of use must be examined to understand the
            interaction between product design and smoking behaviour in
            humans, and to identify systematic differences across products.
            Products that deliver fewer toxins for a fixed volume of smoke
            and also promote greater smoke intake when used by consumers
            are not lower-risk products. Likewise, products that deliver
            higher amounts of toxins, but discourage repeated use might
            potentially be seen as harm reducing compared with conventional
            cigarettes.''

        This is the flawed logic that underlies the proposed FDA
    legislation: We know that measurements of the amounts of various
    constituents in cigarettes have no demonstrable relationship with
    actual human exposure or with actual human health risk, so we propose a
    system to regulate the safety of cigarettes that relies upon reducing
    the measured levels of various smoke constituents. What an absurd idea.
        We attack the tobacco companies for relying upon cigarette
    constituent measurements in making implied health claims, take them to
    court, get them convicted for fraud, and then proceed to go ahead and
    propose to set our own cigarette constituent level regulations, thereby
    making our own unsubstantiated implied health claims.
        Unfortunately, the idea isn't just absurd. It's also damaging. The
    reason? Because like the machine-measured nicotine yields that we
    blasted the tobacco companies for relying upon in their communications,
    these FDA-sanctioned tobacco constituent levels will have no
    demonstrable relationship to the public's health, yet they will most
    certainly be interpreted by consumers as conveying an improved degree
    of safety.
        There is no question that by virtue of cigarettes being placed
    under the regulatory jurisdiction of the FDA and by virtue of FDA
    promulgating ``product safety standards,'' the public is going to
    assume that cigarettes have been made to be a safer product. However,
    those product safety standards are none other than specified reductions
    in a number of specifically chosen tobacco constituents, whose levels
    have not been shown to correlate directly with human health risk.
        Essentially, what the proposed FDA legislation would do is simply
    change who is committing the fraud. Right now, it's the cigarette
    companies doing the dirty work, marketing reduced tar and reduced
    nicotine cigarettes in a way that deceives consumers into believing
    that these products are known to be safer. If the FDA legislation is
    enacted, then it will be the Government who is doing the dirty work,
    implying to the public that reduced X and Y cigarettes are known to be
    safer, when there is absolutely no evidence that such a product would,
    in fact, be safer.
        No wonder why Philip Morris loves this legislation so much. It
    completely takes away the risk of litigation for fraud, yet allows the
    tobacco companies to tell consumers that they are complying with
    stringent product safety standards, assuring a safer product that is
    produced under the strict scrutiny of the Food and Drug Administration.
        This whole thing has the potential to institutionalize the fraud
    that the tobacco companies have committed, but to put it into the hands
    of our own Government.
        The Tobacco Control review article \4\ points out many reasons why
    regulation of tobacco smoke constituent levels would not necessarily
    produce a safer product:

              ``Not all constituents change to the same extent or even in
            the same direction under different testing regimes--for
            example, the NNK and benzo[a]pyrene:
            nicotine ratios decrease under more intense puffing conditions,
            whereas the nicotine ratio for carbon monoxide increases, as
            does the overall tar:nicotine ratio. It is unclear to what
            extent certain emissions can be reduced independently of
            others. Manufacturers have also shown their skill in
            substantially reducing machine emission levels through subtle
            design changes. Recent evidence from the United Kingdom
            suggests that tobacco manufacturers have adhered to the `10-1-
            10' limits on ISO emissions simply by increasing the level of
            filter ventilation so that brands provide deceptively low
            readings under machine conditions. Filter ventilation is the
            most prominent, but by no means the only design change
            available to manipulate yields. . . . Emission limits will
            require considerable resources to implement and monitor,
            resources that may exceed the current capacity of regulators.
            There are also concerns that emission limits would exempt
            tobacco manufacturers from liability. Most important, it is
            uncertain how consumers will respond to emission regulation.
            Despite clear scientific statements to the contrary, consumers
            may interpret emission limits as an indication that cigarettes
            are less harmful--much in the same way that they have
            interpreted emission reductions in the past. In fact, future
            emission limits may be even more likely to undermine
            perceptions of risk than in the past: ``new'' emission
            reductions would be based on a ``superior'' machine method,
            would be more comprehensive in scope, and may have the formal
            endorsement of the [FDA]. . . . one can also envision how
            manufacturers might shape consumer response through packaging
            and marketing. Overall, regulations that achieve modest
            reductions in smoke toxicity but result in fewer quitters or
            more initiators are not effective policy measures.''

        But the most important reason why the product safety standard
    approach taken in the proposed FDA legislation is a potential disaster
    is that there is simply no evidence that cigarettes can be made to be a
    safer product, in actual human practice, simply by mandating a
    reduction in levels of specified smoke constituents.
        We simply do not know which constituents, at what levels, and in
    what combination, result in what degree of risk of what diseases that
    are caused by smoking.
        Anyone who promises you that they are going to ``save countless
    lives'' via these product safety standards (precisely what the Campaign
    for Tobacco-Free Kids is telling its constituents) would probably also
    be effective in selling you a bridge in Brooklyn.
        In one respect, the Campaign for Tobacco-Free Kids is precisely
    correct in stating that this legislation is going to save countless
    lives. It is so unclear that product safety standards will do anything
    to reduce overall health risks and that it is impossible to count any
    lives that will be saved. Perhaps that's why the Campaign is having
    trouble counting them.
        Ultimately, there's only one way that I think even has the
    potential to be successful in developing safer cigarettes or other
    tobacco products. And that's to allow the free-market system to work.
    Free-market competition could, possibly, result in a race to see which
    company could come up with safer products. The proposed FDA
    legislation, however, destroys the possibility of this free-market
    competition by making it impossible for any tobacco company to market a
    truly reduced risk product.
        What the bill does, on the other hand, is set up a competition to
    see who can market a reduced exposure product, which, just like
    reduced-nicotine or reduced-tar cigarettes, is likely to be just as
    effective in killing people, but which would most certainly be
    interpreted by the public as implying a reduced health risk.
        Essentially, what the proposed legislation does is set up a system
    of government-administered public fraud in order to benefit the tobacco
    companies.
      6. rather than set up a meaningful scheme for regulation of tobacco
           products, the legislation merely provides window dressing
        The legislation that some health groups have been claiming creates
    an effective public health policy that actually does the following:

         It bans the presence of strawberry, grape, orange, clove,
    cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate,
    cherry, or coffee in cigarettes, but does not inherently disallow the
    presence of hydrogen cyanide, carbon monoxide, N-nitrosodimethylamine,
    benzene, radioactive polonium 210, or nitrogen dioxide.
         It requires FDA to ban any tobacco product that contains a
    severely harmful chemical defect, but explicitly prevents FDA from
    doing the same with tobacco products that contain thousands of severely
    harmful chemicals, so long as those chemicals are ordinarily contained
    in tobacco products.
         It provides for stringent regulation to prevent
    adulterated or misbranded products, but leaves the ``pure'' and
    ``properly branded'' deadly products largely unregulated.
         It requires that manufacturers report any adverse health
    effects of its products that are unexpected, but the expected 450,000
    or so deaths per year due to these products require no special
    attention.
         It expresses grave concern for the tremendous harm to the
    public health caused by tobacco products that falsely purport to reduce
    disease risk, but does not seem to find the harm caused by the high-
    dose products to be of much alarm.
         It strictly regulates new tobacco products introduced to
    the market for safety and health, but allows existing products to
    continue killing hundreds of thousands of Americans each year.
         It expresses grave concern over youth access to tobacco
    products and calls for comprehensive restrictions on the sale of
    tobacco products to minors, but it explicitly prevents FDA from
    regulating the sale of cigarettes in any specific retail establishments
    (including malls, grocery stores, restaurants, gas stations,
    convenience stores, bowling alleys, and even pharmacies).
         It provides for extremely rigorous and comprehensive (and
    probably impossible) tobacco company reporting of brand-specific levels
    of tobacco smoke constituents, but does not require any particular
    action concerning the more than 4,000 constituents that are already
    known to be harmful.
         It requires the FDA to establish a series of health
    standards regarding the nicotine and harmful constituents of tobacco
    smoke (and no health standard other than finding the cigarette itself
    to be inherently and unacceptably toxic is rational or defensible), but
    then prevents FDA from requiring even the gradual elimination of
    nicotine from cigarettes, or from requiring the gradual shift to a
    system of prescription-only cigarette access, or from ever requiring
    even a gradual elimination of cigarette products from the market.
         It requires the FDA to prescribe labeling requirements for
    the proper use of the tobacco product. How does one properly inhale
    thousands of dangerous chemicals and scores of deadly carcinogens?
         It requires FDA to consider periodically new medical data
    on cigarette risks, but the existing evidence on the established risks
    of cigarettes can be largely ignored.
         It requires notification to all tobacco product users of
    the substantial health risks of any new tobacco products, but no
    special notification procedures for the existing deadly products.
         It requires FDA to recall and ban any tobacco product that
    contains a manufacturing defect that is not ordinarily present in
    tobacco products, but a serious defect--such as producing death in one
    out of every two long-term users--is fine, so long as the deaths are
    caused by an ordinary constituent of the product rather than a new
    manufacturing defect.
         It allows the FDA to prescribe strict regulations to
    protect the public's health from sub-standard packing and storage, but
    the fact that what is being packed and stored is inherently dangerous
    is of little concern. The FDA may prescribe stringent regulations to
    eliminate any pesticide residues on the tobacco, but the rest of the
    toxins inside the tobacco are not necessarily regulated.

        The fatal flaw of the legislation is the unacceptable degree of
    restriction of FDA's potential actions which makes it impossible for
    FDA to act appropriately within the legislative mandate it is given.
        Although this legislation eliminates the chocolate in cigarettes
    and prevents cigarette companies from misrepresenting their new
    products as being safe, the latter has been happening for more than
    half a decade, and the dangers of existing ``normal risk'' products are
    far more important than anything else. We should be focusing our
    efforts on addressing the Nation's current tobacco-use epidemic, which
    is killing more than 400,000 Americans each year.
     7. the proposed legislation will be detrimental to the public's health
    By Giving Tobacco Products an FDA Stamp of Approval, the Legislation
            Will Undermine the Public's Appreciation of the Dangers of
            Cigarettes, but Without Actually Ensuring that These Products
            are Significantly Safer
        This legislation is severely detrimental to the best interests of
    the public's health. While the health groups supporting the bill are
    arguing that although it's not perfect, it's better than the status
    quo, a careful analysis reveals that it is not better than the status
    quo, but instead, would represent a substantial loss for public health.
        The three major reasons why this is the case are:

        (1) The overall regulatory framework of the bill is counter-
    intuitive to basic public health principles. The bill would protect
    existing cigarette products by making it nearly impossible for
    potentially reduced risk products to enter the market. At the same
    time, it would allow tobacco companies to market products as having
    reduced levels of certain toxins without having to provide any
    substantial evidence of a health benefit. Thus, the basic regulatory
    framework established by the bill as relates to reduced risk products
    would do two disastrous things. First, it would make it virtually
    impossible for reduced risk products to enter the market. It would take
    away any economic incentive for companies to do meaningful research and
    development of potentially significantly safer products. Second, it
    would actually institutionalize the problem of misleading health claims
    regarding reduced exposure products--the very problem that the health
    organizations keep emphasizing is so unacceptable. But the bill itself
    creates a regulatory framework by which companies can market their
    products as being reduced exposure products without any solid
    scientific substantiation of a health benefit. The public does not
    consist of scientists. The public is going to interpret a reduced
    exposure claim as being a reduced risk claim. Thus, the problem of
    unsubstantiated (implied) health claims about tobacco products will not
    only remain, it will now be sanctioned and operated through FDA.
        (2) The bill would essentially put an end to the prospect of any
    meaningful punishment of the industry, receipt of punitive damages for
    victims of classes of victims of tobacco-caused death, disease, and
    personal suffering, or achievement of real industry changes through
    litigation. In previous litigation, the tobacco companies have
    successfully used the argument that they are already regulated so there
    is no need for further steps to deter future bad behavior. They gained
    tremendous mileage from the tobacco settlement in this regard. But they
    would gain even greater mileage from FDA regulation. They would then be
    able to claim that the Federal Government has assumed jurisdiction over
    all aspects of tobacco operations, including manufacture, new product
    introductions, health claims, health standards, ingredients, additives,
    and smoke constituents, nicotine, advertising, access, and marketing
    (which would be true), and that there is therefore no need for any
    further injunctive relief or punitive damages to deter future bad
    activity--it is all under FDA's control now. And from a public
    perception standpoint they would be right.
        It is important to understand that the important point is not
    whether the legislation actually gives the companies any immunity or
    protection from litigation. The important point is simply whether or
    not the companies can use the fact of being regulated by FDA to achieve
    de facto immunity by taking advantage of the public perception that the
    problem is basically taken care of.
        (3) This legislation is likely to result in increased, not
    decreased deaths from tobacco products, for the following reasons:

        (a) It will make it virtually impossible to research, develop,
    introduce, and market new potentially less hazardous tobacco products.
    It essentially freezes the market as it is and entrenches existing
    high-risk products into the market. It puts an end to any meaningful
    possibility of harm reduction as a tobacco control approach.
        (b) It will undermine current and future litigation: the companies
    will be able to successfully use the argument that they are already
    regulated to stave off injunctive relief and substantial punitive
    damages in litigation by appealing to jurors' perceptions that the
    problem is ``taken care of.'' The highly exaggerated claims of the
    positive public health impacts of this legislation that the health
    organizations are making are only contributing to this perception.
        (c) It will reduce the public's perception of the inherent harms of
    cigarettes. By promulgating health standards, FDA will be giving the
    public the perception that cigarettes are now safer to smoke. The
    public is not necessarily aware of the 4,000 toxins and 50+ carcinogens
    in the smoke, nor are they epidemiologists--if they are told that the
    nitrosamines have been removed, they are naturally going to perceive
    that the problem is being taken care of, or at least largely taken care
    of. Since we know that smoking prevalence is directly proportional to
    the degree of perceived harm from smoking, this will lead to an
    increase in smoking prevalence (at least compared to what would have
    occurred in the absence of the legislation).
        (d) Most importantly, there are no documented mechanisms by which
    the legislation will save lives. Health groups supporting this
    legislation have not produced a single solid, evidence-based argument
    of how this bill will save lives.

        There are really only three ways in which this could occur:
        First, the bill could save lives if the performance standards
    reduced the relative risk of smoking-related diseases. There is
    absolutely no evidence that this is the case--we simply do not know the
    specific constituents that are responsible for the diseases as well as
    the relative contribution of each, alone and in combination, nor do we
    have any evidence for there being a decreased relative risk associated
    with product changes that eliminate or reduce a single or a few
    components.
        Second, the bill could save lives if it encouraged the research,
    development and marketing of actual reduced risk products. But in fact,
    the bill does the opposite. It puts an almost impossible barrier in
    front of the development and marketing of these potential products. It
    also puts a virtually insurmountable barrier over other potential harm
    reduction efforts--such as promoting the use of snus or other less
    hazardous nicotine-delivery devices.
        Third, the bill could save lives if it reduced youth smoking. It
    has been well documented that youth access restrictions, implemented in
    actual widespread practice, do nothing to reduce youth smoking. So the
    access regulations are essentially meaningless. And the three access
    restrictions that could potentially reduce youth smoking have been
    precluded (raising the legal age of purchase, restricting the types of
    establishments that sell tobacco, and phasing in some sort of
    prescription-access system).
        Research has also documented that the kinds of marketing
    restrictions imposed by the bill are not effective in reducing youth
    smoking, or even in reducing youth exposure to cigarette advertising.
    There are simply too many avenues for the tobacco companies to market
    their products, and anything short of a near total ban on advertising
    and promotion of tobacco products (which clearly would violate the
    First Amendment based on the Supreme Court's interpretation) is
    unlikely to have a substantial effect on youth smoking. A number of
    articles document that even major changes in policy, such as removing
    ads completely from youth-oriented publications, does not reduce youth
    exposure to this advertising to any meaningful (from a public health
    perspective) degree.
        In fact, Central Hudson provides a perhaps insurmountable obstacle
    to the advertising restriction approach to tobacco control, because of
    two basically conflicting prongs. First, the restrictions would need to
    be comprehensive enough so that they have a substantial impact on
    smoking behavior. Second, the restrictions would have to be crafted as
    narrowly as is possible to address the relevant government interest. It
    remains to be seen whether this can be done and if it can result in
    regulations that have a substantial public health effect. We simply
    don't have evidence yet that it can be done, and there is no
    justification for highly touting this bill as being the ultimate answer
    to curtailing cigarette advertising.
        Finally, the bill could save lives if it reduced adult smoking (or
    youth smoking) by reducing cigarette demand. It won't do that by
    increasing the competition in the marketplace and it won't do that by
    increasing the public's perceptions of the inherent risks of smoking.
        In summary, there simply is no documented evidence to suggest that
    (or how) the proposed legislation will save lives. In contrast, there
    is well-documented evidence (including substantial literature in the
    fields of tobacco product chemistry, tobacco epidemiology, psychology
    and public opinion research, framing theory, and mass communications
    [including marketing and advertising] research) to suggest that the
    legislation is unlikely to provide any public health benefits in terms
    of reducing the relative risk of smoking or increasing the use of
    lower-risk tobacco products, but that it is likely to produce public
    health harm through its institutionalization of high-risk products, its
    barriers to the introduction of reduced risk products, its probable
    effects on litigation, its probable effects on public opinion and
    attitudes towards tobacco products and towards the tobacco industry,
    and its probable effects on slowing down the pace of other tobacco
    control legislative efforts (including what will be a chilling effect
    on State and local tobacco control legislation).
                                   References
        1. Connolly GN, Alpert HR, Wayne GF, Koh H. Trends in Smoke
    Nicotine Yield and Relationship to Design Characteristics Among Popular
    U.S. Cigarette Brands. Boston, MA: Tobacco Research Program, Division
    of Public Health Practice, Harvard School of Public Health, January,
    2007. (http://www.hsph.harvard.edu/nicotine/trends.pdf).
        2. Campaign for Tobacco-Free Kids. Harvard Study Confirms Tobacco
    Companies Increased Nicotine Levels In Cigarettes, Highlights Need For
    FDA Regulation of Tobacco. Statement of Matthew L. Myers, President,
    Campaign for Tobacco-Free Kids (press release). Washington, DC.:
    January 18, 2007. (http://tobaccofreekids.org/Script/
    DisplayPressRelease.php3?Display=962).
        3. Office of Senator Edward M. Kennedy. Statement By Senator Edward
    M. Kennedy On Harvard Study Revealing Big Tobacco Efforts To Keep
    Smokers Hooked (press release). Washington, DC.: Office of Senator
    Edward M. Kennedy, January 17, 2007. (http://kennedy.senate.gov/
    newsroom/press_release.cfm?id=0d0ec94c-312c-40d3-9761-0822f6864ef2).
        4. Hammond D, Wiebel F, Kozlowski LT, Borland R, Cummings KM,
    O'Connor RJ, McNeill A, Connolly GN, Arnott D, Fong GT. Revising the
    machine smoking regime for cigarette emissions: implications for
    tobacco control policy. Tobacco Control 2007; 16:8-14.
    Prepared Statement of Elizabeth Whelan, M.P.H., Sc.D., Gilbert L. Ross,
      M.D., and Jeff Stier, Esq., The American Council on Science Health
                              (ACSH), New York, NY
        Mr. Chairman, the mission of the American Council on Science and
    Health (ACSH) is to promote sound science and to inform policy debates
    about public health, providing independent scientific evidence and
    analysis to clarify the scientific record in order to educate the
    public and assist policymaking. As such, we are writing on behalf of
    ACSH to lend our voice to others who have criticized S. 625, a bill
    recently introduced in the Senate and referred to your committee. We
    believe, as experts in the field of tobacco-related health effects and
    public health policy, that this bill would unnecessarily disregard a
    large and growing body of scientific evidence pertaining to the
    relative dangers posed by smoking and smokeless tobacco.
        As you know, there has been a 50-year public health campaign
    against smoking cigarettes in the United States. Evidence has mounted,
    and indeed continues to mount, about the health risks associated with
    smoking cigarettes. And yet, despite widespread awareness of the
    general risks, cigarette smoking remains by far the greatest
    preventable cause of death in the United States, claiming more than
    400,000 lives every year. While we can hardly say the public health
    campaign has failed--indeed, the ubiquitous acknowledgement of
    smoking's risks can be considered a major accomplishment of public
    health consumer education--the campaign has long offered what should
    now be considered a false dichotomy to smokers: quit or die, instead of
    fostering awareness of harm-reducing alternatives to cigarettes for
    those who cannot quit nicotine altogether.
        Indeed, after all these years, there is no reason to doubt that
    smokers know that cigarettes are unhealthful, yet they continue to
    smoke, in large part because of the difficulty of quitting.
    Unfortunately, quit rates with traditional methods are abysmal. This is
    where research published by ACSH might prove useful in this particular
    debate, and in the crafting of an improved, more beneficial version of
    S. 625.
        The conventional wisdom, perpetuated not only by cigarette
    companies but by otherwise reliable sources, including the U.S. Surgeon
    General, includes the fallacy that all tobacco products are equally
    harmful to public health. That is, smokeless tobacco, cigars,
    cigarettes, and pipe tobacco are, from a public health perspective, the
    same thing. Scientific studies have proven that they are not, and a
    rapidly-
    growing body of evidence confirms that they are not. Any effort to
    regulate tobacco products must explicitly acknowledge the differences
    in health risks between types of tobacco.
        The fact is that modern smokeless tobacco products are considerably
    less harmful than cigarettes. No one should start using any form of
    tobacco if they can avoid it, of course, but for those who are already
    inveterate smokers and unable to quit nicotine altogether, smokeless
    tobacco at least provides a far, far safer (albeit not completely risk-
    free) way of receiving nicotine. Public policies that ignore this fact
    undermine public health, especially the health of those specifically
    designated to be in the protected, vulnerable group. Unfounded,
    unscientific pronouncements that lump all tobacco products and their
    risks together ultimately undermine the basic purpose of tobacco-
    regulatory policies. S. 625 does not distinguish between harmful smoked
    tobacco and the demonstrably less harmful smokeless tobacco, to the
    detriment of millions of nicotine addicts. ACSH supports the announced
    goals of S. 625--the reduction of smoking and smoking-related
    illnesses, clearer and streamlined regulation of tobacco, and the
    protection of children--but we strongly disagree with the bill's
    failure to appreciate the opportunity presented by the scientific
    evidence distinguishing smoking and smokeless tobacco.
        Consider a limited but informative case in Sweden. ACSH recently
    reported on a study to gauge the efficacy of a program that encourages
    smokers to switch to smokeless tobacco products as an alternative both
    to smoking (which they know is harmful to them) and complete tobacco
    abstinence (which they have found extremely difficult). The results of
    the study are extremely positive. The program works. It works so well,
    in fact, that Sweden now has the lowest smoking-related mortality rates
    in the world. A similar program in the United States, where smoking is
    a bona fide public health disaster, could save thousands of lives and
    vast amounts of health-related expenditures. Harm reduction programs
    using smokeless tobacco as an option, even small programs, would seem
    to be a welcome opportunity to build on the successes and learn from
    the failures of our decades-old public health campaign against smoking.
    Smokeless tobacco is demonstrably less harmful than cigarettes, while
    making it much easier for some smokers to quit cigarettes. A transition
    from smoking to smokeless tobacco--and for many, from smokeless to
    abstinence--could produce great benefits for public health. It seems
    clear that it ought to at least be allowed a chance to work.
        With even the U.S. Surgeon General failing in some public
    statements to rank the profoundly different health risks from different
    forms of tobacco--differences that, if known to the general public,
    might save lives by means of harm reduction--we must take care not to
    perpetuate the myth of smoking and smokeless tobacco equality. Part of
    what S. 625 ought to do is to correct the public record regarding that
    myth, and until it does so, ACSH urges that the bill be modified or
    amended to allow lower-exposure products, such as smokeless tobacco,
    easy or at least equal access to the tobacco marketplace.
                                     ______

                         American Association of Public
                             Health Physicians (AAPHP),
                                Rolling Meadows, IL 60008-1842,
                                                     February 26, 2007.
                                   Memorandum
    To: Senator Mike Enzi, c/o Amy Muhlberg

    From:  Joel L. Nitzkin, M.D., M.P.H., DPA, Chairman, AAPHP Tobacco
    Control Task Force

    Subject:  Statement for the Record re. S. 625--FDA Regulation of
    Tobacco Products; ref 2/27/07 Committee Hearing

        Hon. Senator Enzi: I am writing this note in my capacity as a
    public health physician with over 30 years of experience dealing with
    tobacco-related legislation, and on behalf of the American Association
    of Public Health Physicians (AAPHP), as Chair of the AAPHP Tobacco-
    Control Task Force.
        On behalf of AAPHP, I am urging that the ``fast track'' for this
    legislation be temporarily derailed to allow in-depth consideration of
    the full text of S. 625/H.R. 1180 by Senators, Representatives, and
    national organizations who have endorsed this legislation on the basis
    of one or more widely circulated summary descriptions of this bill.
        AAPHP endorses FDA regulation of tobacco products in accordance
    with Koop-Kessler guidelines (the Report of the Koop-Kessler Advisory
    Committee on Tobacco Policy and Public Health (December 18, 2003)
    http://repositories.cdlib.org/tc/reports/koop). Unfortunately, this
    bill, with its current text, has the potential to do significant harm
    in terms of increasing illness, death and other costs to society from
    tobacco products. Our reading of this bill, in its current form, leads
    us to believe that it offers no possibility of any public health or
    other community benefit.
        This bill has the enthusiastic endorsement of many prominent
    health-related national organizations, apparently on the basis of a
    brief description of its contents developed and distributed by the
    Center for Tobacco Free Kids (CTFK). Their summary hypes this bill as
    enabling FDA to eliminate advertising of tobacco products to children,
    disclose the ingredients of their products and require them to remove
    or reduce harmful ingredients.
        The bill has wording which, if taken out of context, leads to these
    impressions. Unfortunately, in the opinion of AAPHP, other wording
    included within this 155 page bill totally eliminates any possibility
    of public health benefit--and reasonably assures the opposite result.
        The text begins with an accurate description of the illness, death
    and cost-related burdens now imposed on our society by tobacco
    products. It then proceeds to enshrine in law the concept that this
    burden is fully acceptable to Congress and the FDA--with the major
    purpose of the FDA regulation to prevent misbranding and adulteration
    of tobacco products that might threaten even higher risk of illness and
    death.
        Our huge toll of illness and death from current tobacco products is
    not due to adulteration and misbranding. It is due to the inherent
    toxicity of the tobacco itself. Framing the problem in terms of
    misbranding and adulteration will invite current tobacco manufacturers
    to advertise and prominently label their products as ``FDA Approved.''
    If this bill, in its current form, is passed into law.
        The provisions in the bill to allow FDA to reduce harmful
    components of tobacco smoke are more than totally neutralized by a
    series of provisions that require FDA to carry a technically impossible
    burden of proof (that reduction of that single component will reduce
    the health impact), by provisions that give the politically appointed
    secretary of the agency veto power over any proposed regulation, by
    requiring (rather than passively allowing) congressional action before
    any regulation is implemented, and by requiring FDA to ``consider''
    whether any proposed regulation would increase the demand for
    contraband tobacco products. This last provision stands as an open
    invitation to tobacco companies to assert in court that any proposed
    change in the composition of its tobacco products that change the
    taste, reduce the attraction to nicotine addicts or significantly
    increase the cost of manufacture could increase the demand for
    contraband.
        In addition, the bill prohibits FDA action to ban any tobacco
    products, to require reduction of nicotine levels to zero or to raise
    the allowable age to purchase tobacco products above 18.
        The bill does prohibit marketing directly to children. It does
    nothing, however, to inhibit advertising ``directed'' at young adults
    to suggest initiation of tobacco use as a rite of passage to adulthood.
    The provision of the bill, referencing the tobacco industry's ``first
    amendment rights'' imposes on FDA the burden to demonstrate that such
    advertising, is, in fact, intended for underage potential smokers.
        Both Altria and the public health community have written guidelines
    defining what each would consider appropriate FDA regulatory authority.
    The tobacco industry guidelines specify the ability to manufacture and
    market its products to adults without governmental interference. S. 625
    fully meets all of the tobacco industry specifications. The public
    health specifications, known as the ``Koop/Kessler Guidelines'' were
    originally developed in the mid-1990's, then republished in 2003. They
    specify authority by FDA to take whatever action is needed relative to
    manufacture, advertising and distribution of tobacco products to
    protect the health of the public. S. 625 violates Koop-Kessler
    guidelines by virtue of major limitations imposed on FDA authority.
        The current regulatory and reporting requirements strongly favor
    the current market leader and impose substantial costs and time delays
    relative to the introduction of new tobacco products into the
    marketplace, while allowing ``minor'' alterations of currently marketed
    products with little FDA interference. They specify studies and reports
    easily provided by Altria, but prohibitively costly to smaller firms--
    thus the strong endorsement by Altria, but opposition from other
    tobacco companies.
        AAPHP is recommending that S. 625 be temporarily derailed from it's
    current fast-track to allow due consideration of the issues noted
    above, based on a careful reading of the entire bill rather than brief
    and possibly biased summary descriptions.
        For easy reference--the full bill, our analysis with page and line-
    number specifications of key provisions, and the Koop-Kessler
    guidelines have been posted on www.aaphp.org.
     Response to Questions of Senator Kennedy, Senator Enzi, Senator Burr,
             Senator Hatch, and Senator Coburn by Matthew L. Myers
                          questions of senator kennedy
        Question 1. Does the Federal Trade Commission have the expertise to
    effectively regulate tobacco industry marketing? How does the expertise
    of the FDA to regulate tobacco industry marketing, as well as tobacco
    products, compare with that of the FTC?
        Answer 1. The Federal Trade Commission (FTC) does not have the
    requisite expertise to effectively regulate tobacco industry marketing
    or tobacco products upon which marketing and claims are based. The FTC,
    by its own admission, is ``an agency of lawyers and economists'' and is
    not a science-based agency and does not have the necessary scientific,
    medical and public health expertise to evaluate scientific claims and
    data regarding tobacco products.\1\ The FDA is the only science-based,
    public health agency with the expertise required to evaluate cigarette
    design and content and scientific claims of reduced harm that will
    ultimately protect consumers.
    ---------------------------------------------------------------------------
        \1\ Testimony by Timothy Muris, FTC Chairman, June 3, 2003, before
    the Committee on Energy and Commerce Subcommittee on Commerce, Trade,
    and Consumer Protection, U.S. House of Representatives.
    ---------------------------------------------------------------------------
        Furthermore, the FTC is a law enforcement agency whose primary task
    is to enforce the law--such as the Federal Trade Commission Act's
    Section 5 prohibition against false and deceptive advertising--not
    protect the public's health. In most instances, the FTC acts
    retrospectively against one bad actor once a violation has occurred. In
    contrast, FDA is charged with protecting the public's health and as a
    public health agency routinely acts prospectively to address problems.
    Through the rulemaking process, FDA sets regulation standards for an
    entire industry and addresses problems comprehensively. The FTC's
    rulemaking authority is extremely limited and rarely used. (maybe
    elaborate)
        The FTC's track record provides ample evidence of its inability to
    carry out the functions that are assigned to FDA in this legislation.
    The type of ``light'' and ``low tar'' marketing that has resulted in
    millions of Americans switching to these products falsely thinking they
    are safer has been allowed to continue by the FTC for decades without
    challenge.\2\ The only time the FTC has gone after a manufacturer in
    the last 20 years with regard to ``light'' and ``low tar'' marketing
    are in the few cases where there is evidence that a company's reports
    do not even accurately report tar and nicotine levels according to the
    FTC testing system.
    ---------------------------------------------------------------------------
        \2\ National Cancer Institute. Risks Associated with Smoking
    Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
    Chapter One: Public Health Implications of Changes in Cigarette Design
    and Marketing Smoking and Tobacco Control Monograph No. 13. Bethesda,
    MD: U.S. Department of Health and Human Services, National Institutes
    of Health, National Cancer Institute, NIH Pub. No. 02-5074, October
    2001; Tobacco Control Legal Consortium, The Verdict Is In: Findings
    from United States v. Philip Morris, Light Cigarettes (2006).
    ---------------------------------------------------------------------------
        Furthermore, the only case the FTC has brought with regard to
    tobacco marketing is a case challenging the use of a cartoon character
    to sell Camels and the FTC did not act for more than 4 years after the
    Camel cartoon character was introduced. Despite the overwhelming
    evidence linking tobacco marketing to youth tobacco use, a virtual
    flood of ads that others have identified as impacting youth tobacco
    use, findings by the National Academy of Sciences in 1994,\3\ the
    exhaustive findings by the FDA as part of the documentation issued in
    support of its Proposed Rule \4\ and other studies linking tobacco
    marketing to youth tobacco use, the FTC has taken no action to curtail
    or stop any of these campaigns.
    ---------------------------------------------------------------------------
        \3\ Institute of Medicine, National Academy of Sciences, Growing Up
    Tobacco Free (1994).
        \4\ August 1995.
    ---------------------------------------------------------------------------
        The capability of talented and skilled scientists and researchers
    currently employed by FDA, who are able to conduct sophisticated
    analyses and evaluate complex scientific data, including an analysis of
    the impact of different products on the human body, is the best example
    of why FDA is the right agency to regulate tobacco products. The FDA's
    scientists regularly evaluate the impact of foods, drugs, cosmetics and
    medical devices, the same expertise and skills that are needed to carry
    out the functions given to the FDA in the pending legislation. For
    example, analysis of toxicity data for tobacco products and/or various
    constituents (including smoke constituents) could be conducted by the
    FDA's National Center for Toxicological Research, whose mission
    ``involves fundamental and applied research specifically designed to
    define biological mechanisms of action underlying the toxicity of
    products regulated by the FDA.'' \5\
    ---------------------------------------------------------------------------
        \5\ National Center for Toxicological Research, http://www.fda.gov/
    oc/oms/ofm/accounting/cfo/2002/NCTR.htm (Web site accessed March 15,
    2007).
    ---------------------------------------------------------------------------
        FDA's various centers that oversee foods, drugs, medical devices,
    and biologics are home to career chemists, toxicologists,
    statisticians, epidemiologists, and surveillance and consumer marketing
    experts with the relevant skills needed to assume regulatory oversight
    of tobacco products. These are the types of functions and skills that
    will be critical to building an effective, science-based regulatory
    regime for tobacco products. In addition to evaluating complex
    scientific data, the FDA applies this knowledge toward the marketing
    and advertising associated with any approved product to ensure that it
    is consistent with the evidence for that product and delivered to
    consumers in an understandable and truthful manner that does not
    exaggerate the benefits or misrepresent the risks associated with the
    use of that product--key skills and expertise that will be critical in
    FDA's oversight of tobacco product marketing and claims.

        Question 2. Concern was expressed at the hearing that FDA
    regulation of tobacco products would create the public perception that
    cigarettes had the FDA ``seal of approval,'' misleading consumers into
    believing that the products were less harmful. What provisions are
    contained in S. 625 to make clear to the public that the FDA has not
    approved the use of cigarettes or other tobacco products? Are there
    additional safeguards that could be included in the legislation to make
    this even more clear?
        Answer 2. The real problem is that today consumers mistakenly
    believe that tobacco products are regulated by the Government for
    health and safety purposes, not that consumers will be misled about the
    relative safety of tobacco products and the Government's role if this
    legislation is enacted. This legislation will ensure that consumers are
    not misled by the tobacco industry about the relative safety of their
    products, and it provides FDA the authority to make sure the tobacco
    industry does not misuse the legislation to give the public the false
    impression that FDA has concluded that tobacco products are safe.
        Many consumers already believe that cigarettes and other tobacco
    products--and the claims being made in their advertising--are already
    regulated and approved by the Federal Government.\6\ When consumer
    misperceptions about government approval are combined with the current
    marketing practices of the tobacco companies which are not regulated in
    terms of their scientific accuracy, merit, or truthfulness, we have a
    recipe for a public health disaster--a disaster we have already seen
    take place in the form of light and low tar cigarettes--and a disaster
    that this legislation will prevent in the future.
    ---------------------------------------------------------------------------
        \6\ ``Smokers' responses to advertisements for regular and light
    cigarettes and potential reduced-exposure tobacco products,'' Nicotine
    & Tobacco Research, Volume 6, Supplement 3 (December 2004) S353-S362.
    ---------------------------------------------------------------------------
        The history of light and low tar is a poignant and tragic example
    that it is the status quo that is misleading consumers about the
    relative safety of tobacco products. In its historic report on light
    and low tar cigarettes, the National Cancer Institute \7\ concluded
    that:
    ---------------------------------------------------------------------------
        \7\ National Cancer Institute. Risks Associated with Smoking
    Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
    Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S.
    Department of Health and Human Services, National Institutes of Health,
    National Cancer Institute, NIH Pub. No. 02-5074, October 2001, http://
    cancercontrol.cancer.gov/tcrb/monographs/13/.

        1. Many consumers use the terms ``Light'' and ``Ultra-Light'' as a
    guide to the riskiness of particular brands of cigarettes.
        2. Many smokers choose Light and Ultra-Light brands because they
    believe that such cigarettes are less likely to cause health problems.
        3. Individuals who are most concerned about smoking risks and most
    interested in quitting adopt low-yield brands.

        These types of misleading actions would be corrected by the current
    legislation. In addition to consumer misperceptions about light and low
    tar, the NCI found, regarding the marketing of these products by the
    tobacco companies, that:

        1. Advertisements of filtered and low-tar cigarettes were intended
    to reassure smokers (who were worried about the health risks of
    smoking) and were meant to prevent smokers from quitting based on those
    same concerns.
        2. Advertising and promotional efforts were successful in getting
    smokers to use filtered and low-yield cigarette brands.
        3. Internal tobacco company documents demonstrate that the
    cigarette manufacturers recognized the inherent deception of
    advertising that offered cigarettes as ``Light'' or ``Ultra-Light,'' or
    as having the lowest tar and nicotine yields.

        Furthermore, as found by Judge Kessler in her August 2006 ruling
    against the tobacco company defendants in the Department of Justice
    tobacco lawsuit (for more details on Judge Kessler's findings for the
    entire case, see Tobacco Control Legal Consortium, The Verdict Is In:
    Findings From United States v. Philip Morris (2006), http://
    www.tobaccolawcenter.org/dojlitigation.html),

            ``Contrary to their internal documents, Defendants also
            continue to deny that low tar cigarettes are just as hazardous
            to smokers as full-flavor cigarettes, in part because of smoker
            compensation. In 1998, Philip Morris, RJR, B&W, and Lorillard
            jointly stated to the FTC that compensation was so ``weakly
            documented'' that the FTC should not require disclosure
            warnings to alert consumers, and that they were ``unaware of
            evidence,'' other than that presented in Monograph 7,
            520842199-2295 at 2243, 2289 (US 88618), that consumers viewed
            low-tar cigarettes as safer. Defendants are well aware from
            their own research that a majority of smokers believe that low-
            tar cigarettes are healthier, are willing to buy them for
            precisely that reason, and are willing to sacrifice taste for
            what they believe to be less harmful cigarettes. Nonetheless,
            to this day, Defendants still deny that, as Monograph 13 found,
            low-tar cigarettes are just as dangerous as full-flavor
            cigarettes. These RICO violations are likely to continue.''
            [Judge Kessler's Final Opinion, page 1609].
        Several sections in this legislation give the FDA authority to
    prohibit a tobacco company from advertising or asserting that its
    product has received ``FDA Approval'' or from making some other similar
    affirmative statement in its labeling or advertising from being made.
    Sections 903, 906(d), 907 and 910 give FDA specific authority over the
    content of labels, labeling and advertising. These sections provide FDA
    clear authority to prohibit these types of claims on the basis that
    they will mislead consumers about the harmfulness of tobacco products.
    Specifically, if the FDA determines that such a statement would result
    in increased individual risk and/or population level harm, the
    authority FDA is granted over the labeling of the product is sufficient
    to allow FDA to prevent such ``seal of approval'' statements from ever
    taking place.

        Question 3. S. 625 creates an entirely new section of FDA law for
    the regulation of tobacco products, with standards that were
    specifically designed to deal with the unique issues raised by the use
    of tobacco. Contrary to what some have claimed, under the legislation
    the FDA would not be regulating tobacco products the same way it
    regulates drugs and medical devices. Would you explain the key
    differences in the tobacco regulatory process?
        Answer 3. S. 625 recognizes that tobacco products are uniquely
    lethal \8\ and cannot be ``safe and effective,'' the standard that FDA
    applies to many products under its jurisdiction and, therefore, the
    bill adopts a different standard that is appropriate for tobacco
    products and consistent with the agency's overall mission of protecting
    the health of the American public. Instead of maintaining the status
    quo under which we do nothing to reduce the harm of tobacco products,
    the standard in the bill is based on what actions are ``appropriate to
    protect the public health,'' taking into account the impact of any
    proposal on the health of the ``population as a whole, including users
    and non-users'' of tobacco products. Thus, the bill gives the FDA the
    authority to take actions it believes will reduce the number of people
    who die from tobacco.
    ---------------------------------------------------------------------------
        \8\ U.S. Department of Health and Human Services. The Health
    Consequences of Smoking: A Report of the Surgeon General. Executive
    Summary. U.S. Department of Health and Human Services, Centers for
    Disease Control and Prevention, National Center for Chronic Disease
    Prevention and Health Promotion, Office on Smoking and Health, 2004.
    ---------------------------------------------------------------------------
        It gives the FDA the authority to use its skills and expertise to
    evaluate the health impact of different products on consumers to
    reduce, to the extent possible, the harm caused by tobacco products,
    using a standard that recognizes that tobacco products are currently
    used by approximately 50 million consumers, are not safe and are
    addictive. It recognizes that a different standard is needed in this
    situation and includes a standard that will allow FDA to save lives.
        The bill puts in place measures to prevent kids from starting to
    smoke and to ensure that smokers are not dissuaded from quitting by
    misleading claims, and it establishes a process to reduce the harm from
    tobacco products to those who are unable to quit. The goal of this
    legislation is to reduce the number of people who needlessly die
    prematurely from tobacco use.
        Although the legislation uses a different standard for the
    regulation of tobacco products, the agency will apply the same basic
    set of skills that it has used for decades. The core competencies of
    the FDA can and should be applied to the regulation of tobacco
    products. FDA's various centers that oversee foods, drugs, medical
    devices, and biologics are home to career chemists, toxicologists,
    statisticians, epidemiologists, and surveillance and consumer marketing
    experts with the skills required to assume regulatory oversight of
    tobacco products. In fact, FDA is the only agency with the scientific
    and health expertise, as well as regulatory experience required, to
    adequately evaluate tobacco products.

        Question 4. Under S. 625, the entire cost of FDA regulating tobacco
    products would be paid for by a user fee imposed on the tobacco
    companies based on their market share. Therefore, there would be no
    impact on the existing resources that FDA receives to discharge its
    current regulatory responsibilities. Would you describe how this
    funding for tobacco regulation would work?
        Answer 4. This legislation creates a new, separate funding
    mechanism for FDA's new tobacco product-related responsibilities. The
    legislation allows FDA to determine the best way to structure its staff
    to carry out the functions assigned to FDA, but funds are provided to
    allow FDA to hire the additional staff it will need to carry out the
    activities required by this legislation. The new responsibilities would
    be funded through a user fee on the tobacco industry, so it would have
    no impact on the funding provided to FDA to carry out its other
    important activities. The user fees are allocated among the
    manufacturers of tobacco products sold in the United States, based on
    the manufacturers' respective shares of the entire U.S. tobacco product
    market. It should be noted that many of the groups that support this
    legislation care deeply about the many current important tasks
    conducted by the FDA.
        Furthermore, the estimated funding levels provided for in the
    legislation, which ramp up to $300 million annually in year three, are
    based on FDA's prior experience regulating tobacco from 1996-2000,
    along with previous budget estimates provided by FDA to Members of
    Congress drafting legislation to provide the agency with authority over
    tobacco products.

        Question 5. What impact would the user fee paid to the FDA by the
    tobacco companies have on the price of a pack of cigarettes?
        Answer 5. The user fee would have minimal impact on the price of a
    pack of cigarettes. In 2006, 18.1 billion packs of cigarettes were
    sold.\9\ If pack sales continue to decline by about 1.5 percent per
    year, 17.56 billion packs of cigarettes would be sold in 2008. In 2008,
    the cost of the program is estimated to be $85 million. Therefore, it
    would take less than half a cent per pack to raise this amount. In
    2009, pack sales would be about 17.29 billion and the cost of the
    program is estimated to be $175 million. It would take about 1 cent per
    pack to raise this amount. When the program is fully funded at $300
    million a year, the cost would still be less than 2 cents per pack.
    ---------------------------------------------------------------------------
        \9\ Orzechowski & Walker, Tax Burden on Tobacco, 2006.

        Question 6. Some have claimed that FDA regulation of tobacco
    products would provide a liability shield for tobacco companies. Does
    FDA regulation as set forth in S. 625 provide any liability protection
    for tobacco companies that are sued by the victims of tobacco-induced
    disease?
        Answer 6. The bill will not change the rules applicable to product
    liability litigation brought by citizens against the tobacco industry.
    The bill states explicitly that it does not provide any liability
    protection for tobacco companies. There are two specific provisions of
    the legislation that address this issue:

         Sec. 4(a) of the legislation (p. 15 of S. 625) states,

              ``Nothing in this Act (or an amendment made by this Act)
            should be construed to . . . affect any action pending in
            Federal, State or Tribal court, or any agreement, consent
            decree, or contract of any kind.''

         Sec. 917(b) of the legislation (p. 109 of S. 625) states,

              ``No provision of this chapter relating to a tobacco product
            should be construed to modify or otherwise affect any action or
            the liability of any person under the product liability law of
            any State.''

        In addition to these provisions, it is important to note that just
    because an industry is regulated does not mean it is shielded from
    legal action for violating State tort laws.

        Question 7. In his testimony, Dr. Blum claims that the bill will
    ``inhibit tougher State and local tobacco control efforts.'' This is
    inaccurate. In fact, S. 625 removes certain existing preemptions so
    that States and localities will have much greater authority to
    regulate, particularly in the area of tobacco advertising and
    marketing, than they do under current law. Would you explain what
    authority States and local governments will have under this bill to
    regulate tobacco products?
        Answer 7. The bill allows the States to continue to do all that
    they are currently doing or have done to prevent tobacco use, limit
    youth access to tobacco, assist and encourage tobacco users to quit and
    to protect individuals from secondhand smoke. The legislation also
    expands State authority to regulate tobacco product marketing. Under
    the legislation, State and local governments would continue to be free
    to adopt measures regulating the sale, distribution, and possession of
    tobacco products (regardless of age); to limit exposure to secondhand
    smoke; to restrict youth access to tobacco products; and to enact fire
    safety standards for tobacco products. In short, the bill does not
    restrict States from pursuing policies such as smoke-free workplace
    laws, tobacco taxes, fire-safety standards, age requirements,
    identification checks, retailer licensing and fines, and other
    restrictions on the sale and distribution of tobacco products that have
    been instrumental in reducing tobacco use. States would also be able to
    impose additional reporting requirements on tobacco manufacturers (as
    Massachusetts, Texas and Minnesota have done) if there was any
    meaningful information FDA was not getting or not sharing that a State
    thought would be useful.
        Today, States have no authority to regulate cigarette marketing.
    The legislation alters the existing preemption of State authority over
    cigarette marketing in the Federal Cigarette Labeling and Advertising
    Act (FCLAA), so that States will for the first time since 1969 have the
    ability to regulate cigarette marketing. As a result, States and
    localities could impose bans or restrictions on the time, place and
    manner, but not content, of the advertising or promotion of cigarettes,
    to the full extent permitted under the first amendment. (States already
    have this authority for smokeless tobacco products.) For example, if
    permitted under the first amendment, a State could ban or restrict in-
    store advertising or limit in-store advertising to locations away from
    the checkout counter or near products kids buy or limit the number of
    in-store ads.
        FDA would have exclusive authority in such areas as tobacco product
    standards, pre-market approval, adulteration, misbranding, labeling,
    registration, good manufacturing standards, and modified risk products.
    This is consistent with the way the FDA regulates other products under
    its jurisdiction. This is an area of regulation that the States have
    not undertaken in the past and one that would require significant
    resources and technical/scientific capability given the complexity of
    the issues to be addressed. The FDA is unique in possessing the
    combination of scientific expertise and regulatory experience that is
    necessary.
        In addition to preserving and in some ways expanding State and
    local authority, this legislation will also significantly enhance the
    impact of State tobacco prevention and cessation initiatives by
    curtailing tobacco marketing that encourages children to start using
    tobacco and discourages current tobacco users from quitting. The more
    than $15 billion a year the tobacco companies spend on marketing \10\
    dwarfs the $597.5 million a year the States currently spend on
    prevention and cessation.\11\ The bill will enhance State prevention
    efforts by giving the FDA authority to restrict marketing that appeals
    to children.\12\ It will enhance cessation efforts by banning deceptive
    terms like ``light'' and ``low-tar'' and giving the FDA authority to
    strictly regulate reduced risk claims that are intended to encourage
    smokers to switch rather than quit.\13\ In addition, there is
    considerable evidence that the stronger health warnings mandated by the
    bill will enhance prevention and cessation campaigns.\14\
    ---------------------------------------------------------------------------
        \10\ U.S. Federal Trade Commission (FTC), Cigarette Report for 2003
    (2005), data for top six manufacturers only.
        \11\ Campaign for Tobacco Free Kids, ``A Broken Promise to Our
    Children: The 1998 State Tobacco Settlement Eight Years Later,'' http:/
    /www.tobaccofreekids.org/reports/settlements/2007/execsum.pdf.
        \12\ National Cancer Institute. Changing Adolescent Smoking
    Prevalence `` Where it is and Why. Smoking and Tobacco Control
    Monograph No. 14. Chapter 13 ``The Role of Tobacco Advertising and
    Promotion in Smoking Initiation''; Tobacco Control Legal Consortium,
    The Verdict Is In: Findings From United States v. Philip Morris,
    Marketing to Youth (2006); Giovino, G. et al. ``Use of Flavored
    Cigarettes Among Older Adolescent and Adult Smokers: United States
    2004.'' PowerPoint Presentation; Carpenter, C., et al. ``New Cigarette
    Brands with Flavors That Appeal to Youth: Tobacco Marketing Strategies;
    Health Affairs, November/December 2005, Volume 24, number 6.
        \13\ U.S. Department of Health and Human Services. Reducing Tobacco
    Use: A Report of the Surgeon General--Chapter 5: Regulatory Efforts.
    Atlanta, Georgia: U.S. Department of Health and Human Services, Centers
    for Disease Control and Prevention, National Center for Chronic Disease
    Prevention and Health Promotion, Office on Smoking and Health, 2000.
        \14\ Campaign For Tobacco-Free Kids Factsheet, ``U.S. Cigarette
    Warning Labels Don't Work Well--FDA Legislation Would Fix That.''

        Question 8. In his testimony, Dr. Blum claims the legislation is
    ``grandfathering in high risk products.'' That is inaccurate. Under S.
    625, FDA will have the authority to set standards for existing
    products, ordering the removal or reduction of toxins and ingredients
    that make cigarettes more addictive. Would you explain the process by
    which FDA could require changes to be made in the composition of
    cigarettes that are already on the market?
        Answer 8. The bill gives the FDA broad authority to regulate the
    manufacturing, marketing and sale of both existing and new tobacco
    products.
        More specifically, under section 907 of the legislation, cigarettes
    (new or existing products) may not have candy or fruit flavorings--such
    as vanilla, chocolate, strawberry, cinnamon, or many other flavors--as
    a characterizing flavor.\15\ Section 907 also empowers FDA to require
    changes in new and existing products. Section 907 for the first time
    gives the FDA the authority to require tobacco companies to make
    changes to existing products such as Marlboro, Camel and Newport, the
    brands most popular with young people. S. 625 provides FDA the
    authority to require changes to tobacco products to protect the public
    health through the issuance of product standards. Such changes could
    include the reduction or elimination of ingredients, additives,
    constituents, including smoke constituents, or reduction in nicotine
    yields, or changes to the construction and components of products.\16\
    ---------------------------------------------------------------------------
        \15\ Giovino, G. et al., ``Use of Flavored Cigarettes Among Older
    Adolescent and Adult Smokers: United States 2004.'' PowerPoint
    Presentation; Carpenter, C., et al., ``New Cigarette Brands with
    Flavors That Appeal to Youth: Tobacco Marketing Strategies; Health
    Affairs,'' November/December 2005, Volume 24, number 6.
        \16\ Ashley D. et al., ``Tobacco-specific nitrosamines in tobacco
    from U.S. brand and non-U.S. brand cigarettes,'' Nicotine & Tobacco
    Research, (2003) 5, 323-331; U.S. Department of Health and Human
    Services. Reducing Tobacco Use: A Report of the Surgeon General--
    Chapter 5: Regulatory Efforts. Atlanta, Georgia: U.S. Department of
    Health and Human Services, Centers for Disease Control and Prevention,
    National Center for Chronic Disease Prevention and Health Promotion,
    Office on Smoking and Health, 2000; National Toxicology Program, Public
    Health Service, U.S. Department of Health and Human Services (HHS),
    Report on Carcinogens, Eleventh Edition, January 2005 http://
    ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s176toba.pdf.
    ---------------------------------------------------------------------------
        In addition, under section 904 of the bill, each tobacco
    manufacturer is required to submit to the Secretary a listing of all
    ingredients in each tobacco product; a description of the content,
    delivery, and form of nicotine in each tobacco product; a listing of
    all constituents, including smoke constituents, in each tobacco
    product; and all documents that relate to the health effects of their
    products, their constituents (including smoke constituents),
    ingredients, components, and additives. Further, if at any time a
    tobacco product manufacturer changes its products--by adding a new
    tobacco additive, increasing the quantity of an existing tobacco
    additive, eliminating or decreasing an existing additive, or adding or
    increasing an additive--it must notify the HHS Secretary of the
    changes. The Secretary will publish a list of the harmful and
    potentially harmful constituents by brand and quantity annually.

        Question 9. S. 625 authorizes the FDA to ``impose restrictions on
    the advertising and promotion of a tobacco product consistent with and
    to the full extent permitted by the first amendment to the
    Constitution.'' The legislation does not set particular restrictions,
    but authorizes the FDA to determine the most effective restrictions by
    regulation. This will allow the FDA to respond by regulation to changes
    in the marketplace so that the restrictions remain effective over time
    in deterring youth smoking and in preventing misleading advertising.
    The bill procedurally reinstates the regulation that the FDA adopted in
    1996 after an exhaustive fact finding process. However, FDA retains
    full authority to modify those regulations going forward. Would you
    comment on how this process is structured in the legislation and how it
    will operate?
        Answer 9. This legislation both adopts specific marketing
    restrictions that FDA has found have a significant impact on young
    people and gives FDA the authority to restrict tobacco marketing
    further ``to protect the public health'' to the extent permitted by the
    first amendment. The legislation is carefully crafted to comply with
    the requirements of the first amendment.
        The bill requires the FDA to reinstate the specific marketing
    restrictions previously adopted by the FDA. This allows the FDA to
    adjust those regulations without further congressional action if the
    situation warrants.
        If ever there is a justification for restricting commercial speech,
    this is such a case. Tobacco is this Nation's No. 1 preventable cause
    of death and disease.\17\ It is illegal to sell tobacco products to
    minors, and it has been the legitimate goal of the Government to do
    what it can to curtail marketing that encourages young people to start
    using tobacco, that misleads adults about the hazards of tobacco and
    different tobacco products, and to reduce the number of people who die
    from tobacco use.
    ---------------------------------------------------------------------------
        \17\ U.S. Department of Health and Human Services. The Health
    Consequences of Smoking: A Report of the Surgeon General. Executive
    Summary. U.S. Department of Health and Human Services, Centers for
    Disease Control and Prevention, National Center for Chronic Disease
    Prevention and Health Promotion, Office on Smoking and Health, 2004.
    ---------------------------------------------------------------------------
        Time and time again the evidence has shown that tobacco marketing
    plays a role in contributing to youth tobacco use, that tobacco
    marketing has mislead millions of consumers, that the marketing of
    light and low tar products has misled consumers to switch to these
    products rather than quit smoking, and that the marketing of these
    products has undermined efforts to educate the public effectively about
    the heath hazards of these products.\18\
    ---------------------------------------------------------------------------
        \18\ Hamilton, W.L., Norton, G. Ouellette, K., Rhodes, W.M., Kling,
    R., Connolly, G.N., Smokers' responses to advertisements for regular
    and light cigarettes and potential reduced-exposure tobacco products.
    Nicotine & Tobacco Research 2004; 6: (Suppl 3) S353-362; Slade, J.,
    Connolly G. and Lymperis, D. Eclipse: does it live up to its health
    claims? Tobacco Control 2002; 11 (64-70); Harvard School of Public
    Health, Tobacco Research Program, Division of Public Health Practice,
    Trends in Smoke Nicotine Yield and Relationship to Design
    Characteristics Among Popular U.S. Cigarette Brands 1997-2005, December
    2006.
    ---------------------------------------------------------------------------
        For over 40 years, attempts have been made to address these
    problems through restrictions--both mandatory and voluntary--that are
    less restrictive than those imposed by this legislation, but none of
    these prior efforts have been successful because of the tobacco
    industry's behavior. In the 1960s Congress added a small health warning
    to tobacco products and banned cigarette advertising on TV and radio
    and the tobacco industry dissuaded Congress from going further by
    promising not to market to young people and not to mislead the public
    through its own so-called Voluntary Advertising Code. These actions
    were not enough to stop the tobacco companies from continuing the same
    behavior.
        After Congress enacted the TV ad ban, the tobacco companies
    promised not to undermine its effectiveness by sponsoring sporting
    events on TV, a promise they almost immediately violated by sponsoring
    the Virginia Slims tennis tour and later violated again and again by
    their sponsorship of motor racing (e.g., NASCAR's Winston Cup). After
    the staff of the FTC found in 1981 that tobacco industry marketing
    continued to focus on themes that appealed to children and undermined
    the existing health warnings, the tobacco industry once again went
    before Congress to argue that further regulation was not needed because
    they were serious about enforcing their own advertising code. Thus,
    while Congress imposed new health warnings on tobacco products, it did
    not adopt further marketing regulations.
        But in the 1990s, investigations of tobacco marketing revealed once
    again that tobacco marketing continued to appeal to and impact
    children, deceive adults and minimize the health effects of tobacco
    products. In the mid-1990s the FDA conducted an exhaustive study of
    tobacco industry marketing, as did the Institute of Medicine of the
    National Academy of Sciences and the Surgeon General.\19\ All reached
    the same conclusions.
    ---------------------------------------------------------------------------
        \19\ National Academy of Sciences, Institute of Medicine, ``Taking
    Action to Reduce Tobacco Use'' (1998), http://books.nap.edu/
    catalog.php?record_id=6060#toc; National Academy of Sciences, Institute
    of Medicine, ``Growing Up Tobacco Free: Preventing Nicotine Addiction
    in Children and Youths, (1994), http://books.nap.edu/
    catalog.php?record_id=4757/; 1994 Report of the Surgeon General:
    Preventing Tobacco Use Among Young People, http://www.cdc.gov/tobacco/
    data_statistics/sgr/sgr_1994/index.htm; 2000 Report of the Surgeon
    General: Reducing Tobacco Use, http://www.cdc.gov/tobacco/
    data_statistics/sgr/sgr_2000/index.htm; Federal Register: August 28,
    1996 (Volume 61, Number 168)], Page 44395-44618, Department of Health
    and Human Services, Food and Drug Administration, Regulations
    Restricting the Sale and Distribution of Cigarettes and Smokeless
    Tobacco to Protect Children and Adolescents; Final Rule August 11, 1995
    FDA Proposed Rule.
    ---------------------------------------------------------------------------
        In 1998 the State Attorneys General attempted to curtail deceptive
    tobacco industry marketing and tobacco industry marketing that impacted
    children. Yet, Judge Gladys Kessler of the U.S. District Court for the
    District of Columbia found last August, despite all of these prior
    efforts, the tobacco industry continues to engage in marketing
    practices that put our children at risk, that mislead consumers and
    that wrongfully minimize the health effects of tobacco and tobacco use.
        Last August's (2006) ruling by Judge Kessler in the Department of
    Justice tobacco lawsuit (USA v. Philip Morris, USA), represents the
    most comprehensive and detailed accounting of the tobacco industries
    historical and ongoing predatory marketing practices and gives
    additional, compelling and strong evidence in support of the rules set
    forth in the legislation. Amongst her many findings against the tobacco
    company defendants, Judge Kessler found that:

         ``There is a reasonable likelihood that Defendants' RICO
    violations will continue in most of the areas in which they have
    committed violations in the past. Defendants' practices have not
    materially changed in most of the Enterprise's activities, including:
    denial that ETS causes disease, denial that Defendants market to youth,
    denial of the addictiveness of nicotine, denial of manipulation of the
    design and content of cigarettes, suppression of information and
    research, and claims that light and low tar cigarettes are less
    hazardous than full-flavor cigarettes.'' [Judge Kessler's Final
    Opinion, pages 1606-1607]
         ``Defendants continue to engage in many practices which
    target youth, and deny that they do so. Despite the provisions of the
    MSA, Defendants continue to track youth behavior and preferences and
    market to youth using imagery which appeals to the needs and desires of
    adolescents. Defendants are well aware that over 80 percent of adult
    smokers began smoking before the age of 18, and therefore know that
    securing the youth market is critical to their survival. There is
    therefore no reason, especially given their long history of denial and
    deceit, to trust their assurances that they will not continue
    committing RICO violations denying their marketing to youth.'' [Judge
    Kessler's Final Opinion, pages 1607-1608]
         ``Although Defendants recently began to finally admit that
    smoking is addictive, no Defendant publicly informs consumers that
    nicotine is addictive, much less that smoking is a nicotine-driven
    addiction. See Findings of Fact Section V(B)(4). Defendants minimize
    the issue as a ``quibble over the precise wording of the addictiveness
    of smoking.'' JD Br. at 39. To the contrary, the issue is Defendants'
    refusal to admit publicly that nicotine is physiologically addictive,
    that smoking is a nicotine-driven addiction, and that, therefore,
    quitting is not a simple act of willpower. At trial, the General
    Counsel for Philip Morris, Denise Keane, admitted that the ``Smoking is
    Addictive'' statement that Philip Morris removed from cigarette packs
    after buying three Liggett cigarette brands in 1999 was both correct
    and material. She also agreed that it is material for people to know
    that Philip Morris agrees that the nicotine delivered in cigarette
    smoking is addictive, but it does not say so publicly. Keane TT, 1/18/
    05, 10458:6-17. The deliberate mission of admittedly material
    information about nicotine addiction is not a mere ``quibble.'' It is
    fraudulent, with consequences for those who smoke and those, especially
    young people, who are considering whether to start smoking. Defendants
    have thus made clear that, despite their internal research to the
    contrary, they remain unwilling to admit publicly that nicotine is
    addictive and that smoking is an addiction driven by nicotine. Such
    RICO violations are reasonably likely to continue.'' [Judge Kessler's
    Final Opinion, page 1608]

        The FDA Rule and the marketing restrictions in this legislation on
    tobacco advertising and marketing were carefully tailored to reduce
    underage exposure only to the types of tobacco marketing that has the
    greatest impact on children, while still leaving numerous ways for
    tobacco advertising to reach adult customers. Judge Kessler's decision
    demonstrates that there remains a strong factual basis for these
    restrictions today even though FDA's investigation was conducted 10
    years ago. For example, the FDA Rule's restrictions on outdoor and
    point-of-sale tobacco-product advertising to black print on white
    background do not restrict what can be said about tobacco products or
    otherwise block the communication of truthful information about tobacco
    products to adult consumers but only make the ads less attractive or
    alluring to kids (and these restrictions do not even apply to tobacco
    ads in adult-only locations). In fact, the advertising of financial
    investments has long been limited to black and white text-only ads
    without any constitutional objections.
        After 40 years of attempting to address the Government's legitimate
    interests with all of these less restrictive efforts, the specific
    marketing restrictions in the pending legislation are amply justified
    as a reasonable next step.
        Prior to Judge Kessler's ruling in the DOJ trial, there was already
    strong and ample legal precedent to support the advertising
    restrictions proposed in the legislation. These restrictions are
    consistent with the standards set forth by the Supreme Court in
    Lorillard Tobacco Co. v. Reilly. The bill's restrictions address a
    legitimate government interest; there is significant evidence that they
    will advance these interests; and given the prior history and current
    tobacco industry marketing practices, there is overwhelming evidence
    that these restrictions are necessary to protect the Government's
    legitimate interests.
        The Court has firmly established that reducing underage use of
    tobacco products is a substantial and legitimate government interest
    that can justify time, place and manner restrictions on commercial
    speech, and that restrictions on tobacco-product advertising practices
    that have been documented to impact youth, mislead adults and
    wrongfully distort the health effects of tobacco properly advance those
    interests.

        Question 10. Some have claimed that it will be difficult for
    convenience stores and other retailers to comply with the
    responsibilities that the legislation places on them to prevent the
    sale of tobacco products to minors. Would you explain what the
    responsibilities of retail sellers of tobacco products will be, and
    what safeguards have been included in the bill to protect retailers who
    are attempting to comply in good faith with the regulations?
        Answer 10. S. 625 addresses the problem of illegal sales of tobacco
    products to children in the manner that has been proven most effective.
    When FDA implemented the youth-access provisions of the FDA Tobacco
    Rule \20\ between 1996 and 2000, there were no significant problems
    with its administration or with retailer compliance, and that should
    hold true when the pending legislation passes and the Rule's youth
    access provisions are re-implemented. Put simply, the FDA Rule youth-
    access provisions require retailers to check the ID of any young person
    seeking to purchase tobacco products to prevent and reduce illegal
    sales to children. When in place previously, FDA enforced these youth
    access restrictions, not by employing Federal agents, but by
    contracting with State and local officials, such as health departments
    and police departments. By 2000 FDA had contracts with every State to
    conduct compliance checks and had an extensive outreach program that
    provided resources and information to retailers. FDA tried to ensure
    that retailers fully understood their responsibilities under the youth-
    access provisions, as well as the penalties associated with
    noncompliance. In addition, FDA provided retailers with a mediation
    procedure to resolve complaints and avoid litigation.
    ---------------------------------------------------------------------------
        \20\ Federal Register: August 28, 1996 (Volume 61, Number 168)],
    Page 44395-44618, Department of Health and Human Services, Food and
    Drug Administration, Regulations Restricting the Sale and Distribution
    of Cigarettes and Smokeless Tobacco to Protect Children and
    Adolescents; Final Rule August 11, 1995 FDA Proposed Rule.
    ---------------------------------------------------------------------------
        The National Association of Convenience Stores (NACS) has been the
    most active entity complaining about the re-implementation of the FDA
    Rule regarding youth access to tobacco products. It should be noted,
    however, that NACS did not oppose similar legislation introduced by
    Senator John McCain in 1998. The 1998 McCain legislation fully adopted
    the 1996 FDA rule that applied to retailers, but did not contain the
    provisions that have been added to the pending legislation to address
    concerns that have subsequently been raised by NACS.
        The current legislation directly addresses previously voiced
    retailer concerns.

         The pending FDA legislation says that retailers shall not
    be held liable for an employee making a sale to a minor who presents a
    false government issued ID if the retailer has adopted and enforced a
    written policy against sales to youth, and informed its employees of
    applicable laws. [Sec. 103(l)(1)(F)].
         Section 103(e) provides that ``to the extent feasible, the
    Secretary shall contract with the States . . . to carry out inspections
    of retailers within that State in connection with the enforcement of
    this Act.'' At the same time, it is clear that Federal involvement is
    necessary. The so-called ``Synar Amendment,'' currently requires States
    to enact and enforce youth tobacco access laws but studies by the State
    attorneys general, FDA and others have found that Synar has failed to
    curtail illegal tobacco sales to kids effectively. Similarly, a 2001
    GAO study found that ``State implementation of Synar and [HHS]
    oversight raise concern about the quality of State estimates of the
    percentage of retailers that sell tobacco products to minors.'' \21\
    The data is clear: current law helps, but has not solved, the youth
    sales problem. On the other hand, the implementation of the FDA Tobacco
    Rule's youth access provisions from 1996 to 2000 dramatically improved
    the situation, and can do so again.
    ---------------------------------------------------------------------------
        \21\ U.S. General Accounting Office, Report to the Ranking Minority
    Member, Committee on Government Reform, House of Representatives,
    ``Synar Amendment Implementation: Quality of State Data on Reducing
    Youth Access to Tobacco Could Be Improved'' (November 2001).
    ---------------------------------------------------------------------------
         The FDA legislation actually states that no retailer shall
    be required ``to maintain records relating to individual purchasers of
    tobacco products for personal consumption.'' [Title III, Sec.
    921(b)(5)]
         Some complained that between 1996 and 2000 FDA played ``a
    `gotcha' game'' with retailers collecting violations against a retailer
    and then dumping them on a retailer all at once, without prior notice,
    to get massive fines. According to FDA, that did not happen. In any
    case, additional protections to address these complaints have already
    been added to the FDA legislation, requiring ``timely and effective
    notice to the retailer of each alleged violation at a particular retail
    outlet,'' ``an expedited procedure for the administrative appeal of an
    alleged violation,'' and numerous other specified procedural rights and
    protections for retailers. [Title I. Sec. 103(l)(1)] The bill also
    requires clear guidance from FDA as to what constitutes a ``repeated
    violation'' and how long a period free of violations would produce a
    clean slate. [Sec.103(l)(1)(A&E)]
         A provision has been added to the legislation ``providing
    for an expedited procedure for the administration of alleged
    violations.'' [Section 103(l)(1)(C).]
         The FDA legislation has a graduated series of penalties
    and does not subject any retailer to higher-level fines or forbid their
    sale of tobacco products unless the retailer has repeatedly sold
    tobacco products to kids at a specific outlet, repeatedly been caught,
    and repeatedly failed to remedy the situation. [Title I. Sec. 103(f)]
    The legislation also specifically provides that violators that do not
    engage in a new violation for a period of time after their initial
    violation get a clean record and cannot be subjected to the penalties
    that apply to repeat violators. [Title I. Sec. 103(l)(1)(E)].
         The FDA legislation appropriately focuses on the retailers
    because they not only directly profit from illegal sales to kids but
    also have the most power to stop such illegal sales from occurring.
    Moreover, FDA's authority extends to manufacturers, importers,
    distributors, and retailers, but not to clerks and end users. The
    States already have the authority to pass the kinds of laws NACS
    proposes and the FDA legislation does nothing to preempt or weaken any
    such State laws. In fact, the vast majority of the States already have
    laws on the books that penalize youth who try to purchase tobacco
    products.
        State attorneys general and other experts have recommended that any
    effort to reduce youth access to tobacco products include an agency
    designated with clear responsibility for enforcement, frequent and
    realistic compliance checks, and meaningful penalties including
    graduated fines and ultimately, prohibiting sales of tobacco products
    to minors. The provisions of this legislation are based on these solid
    research findings and are designed to curtail illegal tobacco sales to
    minors.
        Other issues that have been raised by retailers that either are
    addressed or were corrected previously:

        1. The FDA legislation does not establish Federal licensing of all
    tobacco product retailers. There is no language in the FDA legislation
    or the FDA Tobacco Rule implemented by the legislation that establishes
    Federal retailer licensing.
        2. This legislation is still needed despite the declines in youth
    tobacco use. In fact, recent declines in youth smoking rates have
    stagnated and youth smoking remains at unacceptably high levels. Close
    to one out of every four high school youth is a current smoker. While
    progress has been made, every single day 4,000 additional new kids try
    their first cigarette, and another additional 1,000 kids become new
    daily smokers.
        3. The legislation goes out of its way to treat all retailers
    fairly. Many of the restrictions on retailers in the FDA Tobacco Rule
    apply to ``any person, who sells cigarettes or smokeless tobacco to
    individuals for personal consumption,'' which includes Internet and
    other mail-order sellers. [Rule Sec. 897.3(h); 897.14]. Internet and
    other mail-order sellers of tobacco products are also specifically
    prohibited from redeeming coupons or sending free samples through the
    mail. [Rule Sec. 897.16(c)(2)(i)]. Also, FDA has full authority to
    establish additional rules that would also apply specifically to
    Internet sellers, such as onsite age and identity verification and the
    like, as needed. [See, e.g., Title I, Sec. 906(d)(1)] NACS also fails
    to acknowledge that separate Federal legislation to place requirements
    on Internet and other mail-order tobacco product sellers has been
    introduced in a past session of Congress and will be introduced again
    soon. In addition, the State attorneys general have already taken steps
    toward reducing the Internet tobacco product sales problem.
        4. The bill does not give tobacco product retailers in adult-only
    facilities an unfair advantage. The vast majority of the provisions
    relating to retailers in the FDA legislation and the FDA Rule apply to
    all retailers. While certain ad restrictions in the Rule do not
    currently apply to some ads in adult-only facilities, Sec. 913 of the
    FDA bill orders FDA to apply all advertising restrictions that apply to
    retailers in youth-accessible facilities to retailers primarily engaged
    in tobacco product sales that are located in adult-only facilities, as
    well.
        5. Nothing in the FDA tobacco legislation restricts the sales of
    such cessation products in convenience stores.
        6. Some oppose the FDA bill's provision prohibiting any outdoor
    advertising within 1,000 feet of a school or playground because they
    say it will prohibit convenience stores located within any such 1,000
    feet perimeter from having any indoor tobacco product advertising, In
    fact, the provision that establishes the 1,000 feet restriction
    specifically prohibits only ``outdoor advertising'' described as
    ``including billboards, posters, or placards,'' and does not make any
    mention of either retail outlets or ads located inside retail outlets.
    [Rule Sec. 897.30(b)].
        7. The requirement holding retailers liable for selling tobacco
    products that do not have the warning labels on them is meant to
    curtail the sale of counterfeit tobacco products, parallels provisions
    currently in Federal and State law that hold retailers liable for
    selling cigarettes without required tax stamps on them (and retailers
    could check for proper warning labels at the same time that they are
    checking for valid tax stamps). The only tobacco products that would
    not have the required labeling (or tax stamps) would be contraband and
    counterfeit tobacco products, and retailers should not be allowed to
    sell such illegal products. At the same time, to reduce the label-
    checking requirements on retailers, the FDA legislation was already
    revised to clarify that retailers are not responsible for checking to
    see whether warning labels comply with the requirements governing when
    warnings need to be rotated.

        Question 11. Have there been significant differences in enforcement
    of youth sales restrictions under the FDA rule between 1996 and 2000
    and under subsequent State efforts pursuant to the Synar Amendment?
    Which system has been more effective?
        Answer 11. In 1992, Congress passed the Synar Amendment, which
    requires States and territories to enact laws prohibiting the sale of
    tobacco to minors and to enforce these laws effectively. Study after
    study has found that the Synar requirements alone are inadequate and
    that it has failed to curtail illegal sales of tobacco to kids. The
    State Attorneys General produced such a study in the 1990s,\22\ as did
    the FDA in 1995. A 2001 GAO study found weaknesses in State
    implementation of Synar provisions and the U.S. Department of Health
    and Human Services (or SAMHSA, the agency responsible for overseeing
    Synar implementation) oversight of State activity.\23\ Specifically,
    GAO found that some States used inaccurate and incomplete lists of
    tobacco retailers from which to select samples for inspection. Second,
    States did not use a standardized protocol to conduct inspections; as a
    result, most States used minors younger than 16 to conduct inspections
    and told minors not to carry identification on inspections. Research
    suggests that these protocols artificially lower violation rates.
    Third, HHS approved some States' reported violation rates even though
    the rates were calculated incorrectly. Finally, HHS relied on States to
    verify their own inspection results and did little to verify the
    accuracy of the State data. This is a particular problem since a
    State's substance abuse block grant could be reduced for failing to
    meet annual violation rate goals, giving States an incentive to report
    artificially low violation rates. Also, there was great variability in
    how States enforced the law. Some States did an excellent job enforcing
    the law, while many were non-compliant.\24\ More recent data that
    suggest that over time, more States have begun to effectively enforce
    the Synar requirements, don't take into account the fact that States
    measure enforcement differently and the impact of FDA's enforcement
    program.
    ---------------------------------------------------------------------------
        \22\ No Sale: Youth, Tobacco and Responsible Retailing. Findings
    and Recommendations of a Working Group of State Attorneys General.
    December 1994.
        \23\ U.S. General Accounting Office, Report to the Ranking Minority
    Member, Committee on Government Reform, House of Representatives,
    ``Synar Amendment Implementation: Quality of State Data on Reducing
    Youth Access to Tobacco Could Be Improved'' (November 2001).
        \24\ DiFranza JR. ``Are the Federal and State Governments complying
    with the Synar Amendment?'' Archives of Pediatric and Adolescent
    Medicine 153(10): 1089-97, October 1999.
    ---------------------------------------------------------------------------
        Another weakness of the Synar Amendment is that it does not require
    States to use penalties to enforce the law; States are only required to
    report evidence of actions taken to enforce State laws. Research shows
    that enforcing existing laws against cigarette sales to kids through
    regular retailer compliance checks and issuing civil penalties to
    retailers can significantly reduce youth smoking.\25\ The data are
    clear: the Synar Amendment helps but does not solve the problem.
    ---------------------------------------------------------------------------
        \25\ DiFranza JR and Dussalt GF. ``The Federal Initiative to Halt
    the Sale of Tobacco to Children--the Synar Amendment, 1992-2000:
    Lessons Learned.'' Tobacco Control 14:93-98, 2005.
    ---------------------------------------------------------------------------
        In contrast, as a regulatory agency, FDA took a different approach
    to limit youth access to tobacco products. FDA's program focused on
    enforcement and assessed penalties against retailers who repeatedly
    sold tobacco products to youth. The youth access provisions of the
    original FDA regulations in place from 1996 to 2000 were effective in
    reducing illegal sales to youth. Congress appropriated funding for this
    program, and FDA enforced the youth access restrictions, not by
    employing Federal agents, but by contracting with State and local
    officials, such as health departments and police departments. By 2000,
    the FDA had contracts with every State to conduct the compliance checks
    and had an extensive outreach program that provided resources and
    information to retailers.

        Question 12. Several witnesses alluded to the inadequacy of the
    Master Settlement Agreement between the States and the tobacco
    companies as a means of regulating industry advertising and marketing
    practices. Please describe the types of advertising and marketing that
    are not covered by the MSA, and explain the limitations on enforcement
    of the restrictions that are contained in the Agreement when a company
    violates them.
        Answer 12. Although a constructive step in the right direction, the
    multistate settlement agreement with the cigarette companies (MSA) does
    not adequately address the problem of tobacco use in the United States.
    According to the cigarette companies, the MSA dramatically changed the
    way they market their cigarettes. The cigarette companies also say that
    they are no longer trying to increase the number of smokers and no
    longer market their deadly products to kids. In fact, studies show that
    tobacco-industry marketing has reached record levels since the
    settlement, with much of the increase in strategies that reach and
    influence kids. From 1998 to 2003, cigarette company marketing
    increased by 125 percent nationwide, with cigarette company marketing
    in 2003 totaling at least $15.1 billion (or more than $40 million per
    day), a record high.\26\ These tobacco industry marketing increases
    have overwhelmed any public health benefits from the marketing
    restrictions that were put into place in late 1998 by the Master
    Settlement Agreement (MSA) between the States and the tobacco
    companies. Other examples of cigarette company marketing after the
    settlement include:
    ---------------------------------------------------------------------------
        \26\ U.S. Federal Trade Commission (FTC), Cigarette Report for
    2003, 2005 [data for top six manufacturers only].

         This month, R.J. Reynolds launched Camel No. 9, a
    cigarette clearly aimed at girls and young women. Camel No. 9 has sleek
    packaging, flowery ads and the slogan ``light and luscious.'' News
    reports have estimated that RJR is spending between $25 and $50 million
    to launch its new product. Full-page ads are running in women's
    magazines that have high youth readership such as Glamour,
    Cosmopolitan, Marie Claire, InStyle and Vogue. Point-of-sale marketing
    is expected to be heavy and is already saturating stores and bodegas in
    New York City.
         In 2005, R.J. Reynolds launched a music-themed Kool
    marketing campaign, aimed at both African-American and Latino youth.
    This Kool Be True advertising campaign featured young, hip, multi-
    ethnic models, often with musical instruments, and appeared in
    magazines popular with young African-Americans and Latinos, including
    Jet, Essence, Latina and Cosmopolitan En Espanol.
         In 2004, R.J. Reynolds introduced a pineapple and coconut-
    flavored cigarette called ``Kauai Kolada'' and a citrus-flavored
    cigarette called ``Twista Lime.'' RJR also introduced Camel ``Winter
    Blends'' with flavors including ``Warm Winter Toffee'' and ``Winter
    MochaMint.'' Ads for these cigarettes appeared in magazines with
    significant youth readership such as Rolling Stone, Glamour,
    Cosmopolitan and Elle. The U.S. Smokeless Tobacco Company is marketing
    spit tobacco with flavors including berry blend, mint, wintergreen,
    apple blend, vanilla and cherry. The marketing of candy-flavored
    cigarettes has been condemned by public health experts as being aimed
    at trying to get kids to experiment with smoking. A study by the
    Roswell Park Cancer Institute found that 17-year-old smokers (23
    percent) were more than twice as likely to use flavored cigarettes as
    24-26-year-old smokers (9 percent).\27\
    ---------------------------------------------------------------------------
        \27\ Giovino, G. et al., ``Use of Flavored Cigarettes Among Older
    Adolescent and Adult Smokers: United States 2004.'' PowerPoint
    Presentation.
    ---------------------------------------------------------------------------
         Also in 2004, Brown & Williamson implemented the Kool Mixx
    cigarette marketing campaign clearly aimed at youth, and African-
    American youth, in particular. The Kool Mixx campaign featured images
    of young rappers, disc jockeys and dancers on cigarette packs and in
    advertising. The campaign also included radio giveaways with cigarette
    purchases and a Hip-Hop disc jockey competition in major cities around
    the country.
         In 1999, the first year after the multistate settlement
    agreement (MSA), the cigarette companies spent a record $8.2 billion on
    advertising and promotions, an increase of $1.5 billion, or 22.3
    percent--and the largest 1-year increase since the U.S. Federal Trade
    Commission (FTC) began tracking tobacco-industry marketing expenditures
    in 1970.\28\
    ---------------------------------------------------------------------------
        \28\ U.S. Federal Trade Commission (FTC), Cigarette Report for
    2003, 2005 [data for top six manufacturers only].
    ---------------------------------------------------------------------------
         A July 2000 study found that after a settlement-mandated
    ban on tobacco billboard advertising went into effect, tobacco-company
    advertising and promotions increased significantly at retail outlets--
    and 75 percent of teens visit a convenience store at least once a
    week.\29\
    ---------------------------------------------------------------------------
        \29\ Wakefield, M, et al., ``Changes at the point of purchase for
    tobacco following the 1999 tobacco billboard advertising ban.''
    University of Illinois at Chicago. Research Paper Series, No. 4, July
    2000.
    ---------------------------------------------------------------------------
         In May 2000, The Wall Street Journal and a new study by
    the Massachusetts Department of Public Health separately reported that
    cigarette company advertising in magazines with large youth readerships
    had increased by 33 percent since the MSA was signed.\30\
    ---------------------------------------------------------------------------
        \30\ Turner-Barker, D. & W. Hamilton, Cigarette Advertising
    Expenditures Before and After Master Settlement Agreement: Preliminary
    Findings, Massachusetts Department of Public Health (May 15, 2000),
    http://www.state.ma.us/dph/mtcp/report/mag.htm; Fairclough, G., ``Are
    Cigarette Ads in Magazines Angling for Teens?,'' The Wall Street
    Journal (May 15, 2000).

        It is critical that we address tobacco product marketing because
    there is compelling evidence that much of this advertising and
    promotion is directed at kids and successfully recruits new tobacco
    users. A 2002 monograph by the National Cancer Institute, which
    reviewed the research on tobacco advertising and promotion and its
    impact on youth smoking, found that tobacco advertising and promotional
    activities are important catalysts in the smoking initiation process.
    The NCI report also found, based on a review of the extant research,
    that ``the conclusion that there is a causal relationship between
    tobacco marketing and smoking initiation seems unassailable.'' \31\ The
    MSA's restrictions on cigarette marketing do not meaningfully restrict
    cigarette company marketing practices, including many that reach and
    influence kids.
    ---------------------------------------------------------------------------
        \31\ National Cancer Institute, Changing Adolescent Smoking
    Prevalence, Smoking and Tobacco Control Monograph No. 14, NH Pub. No.
    02-5086, November 2001.

        The MSA Allows the Following Cigarette Company Marketing Practices
    ---------------------------------------------------------------------------
    to Continue:

         Permits outdoor advertising for cigarettes and other
    tobacco products with signs of 14 square feet or smaller on the
    buildings or property of any business where tobacco products are sold
    (including at stores next to schools and playgrounds) and at any events
    sponsored by the tobacco industry.
         Places no limits or restrictions on any cigarette or
    tobacco product advertising inside the more than half a million
    businesses where tobacco products are sold.
         Places no limits or restrictions on cigarette or other
    tobacco advertisements in newspapers and magazines, even if they have
    large numbers of underage readers.
         Places no limits or restrictions on advertising or selling
    cigarettes or other tobacco products on the Internet. See specific
    provisions of FDA Rule.
         Places no limits or restrictions on direct-mail
    advertising of tobacco products;
         Permits each tobacco company to continue a single tobacco-
    product brand-name sponsorship of an event not specifically prohibited
    (see above), such as auto racing or rodeo events, with the limit of a
    ``single'' sponsorship defined to allow the companies to sponsor an
    entire single series of auto races, rodeos, or other events (such as
    all NASCAR races);
         Places no restrictions on the televising of tobacco brand-
    name sponsored events.

        S. 625 addresses each of these areas. It also recognizes that the
    tobacco industry has often circumvented rules designed to curtail both
    marketing to children and misleading of the public and provides FDA the
    needed authority to adopt new rules to address new conditions as they
    arise.
        The need for this legislation, despite the Master Settlement
    Agreement, is further demonstrated by the findings of Judge Kessler
    last August. Judge Kessler's Opinion included 238 pages that recite
    both the tobacco industry's long time marketing to children and
    continued marketing that reaches and impacts young people. It is a
    devastating indictment of both the efforts and the ability of the
    tobacco companies to continue to use marketing to reach and appeal to
    our youth despite the MSA and all prior efforts to retrain their
    behavior. As Judge Kessler concluded,

              ``. . . Defendants continue to engage in many practices which
            target youth, and deny that they do so. Despite the provisions
            of the MSA, Defendants continue to track youth behavior and
            preferences and market to youth using imagery which appeals to
            the needs and desires of adolescents. Defendants are well aware
            that over 80 percent of adult smokers began smoking before the
            age of 18, and therefore know that securing the youth market is
            critical to their survival. There is therefore no reason,
            especially given their long history of denial and deceit, to
            trust their assurances that they will not continue committing
            RICO violations denying their marketing to youth.'' [Judge
            Kessler's Final Opinion, pgs. 1607-1608]

        S. 625 is much needed legislation that would grant FDA the
    authority necessary to crack down on marketing and sales to children.
                           questions of senator enzi
        Question 1. The real question here is not whether the Federal
    Government should regulate tobacco--it should, and it does already.
    Given that numerous Federal and State agencies, including the Federal
    Trade Commission, the Federal Communications Commission, the Department
    of Justice and many others, already regulate tobacco, why do you
    believe involving FDA will have a greater impact?
        Answer 1. Despite the fact that there are several Federal agencies
    with extremely limited authority over very narrow aspects of the
    tobacco issue, tobacco and tobacco marketing remain unregulated for
    health purposes. There is no agency with a mandate to regulate tobacco
    for the purpose of protecting the public health and/or reducing the
    number of people who die from tobacco use. There is no agency with any
    regulatory authority that also possesses essential scientific expertise
    to protect public health. Overall, there exists a gaping hole in the
    Federal safety net as it relates to tobacco.
        The FCC's role is limited to monitoring compliance with the decades
    old ban on television and radio prohibitions on tobacco advertising.
    The DOJ's role is limited to enforcing potential violations of the
    congressionally mandated labeling requirements on cigarettes. The FTC's
    role is equally limited. It enforces the specific congressionally
    mandated labeling requirements for smokeless tobacco products, is
    supposed to collect data on total tobacco industry marketing
    expenditures and issue a report containing that information. In
    addition, section 5 of the FTCA gives the FTC the law enforcement
    responsibility over false and deceptive marketing, as that term has
    been traditionally defined that includes but is not limited to tobacco.
    As the former Chairman and the former Director of the FTC's advertising
    division have testified before Congress, the FTC lacks the scientific
    expertise and public health mandate to carry out these tasks, even the
    tasks related to marketing, that are assigned to the FDA in this
    legislation. By its own admission the FTC is ``an agency of lawyers and
    economists'' and is not a science-based agency and does not have the
    necessary scientific, medical and public health expertise to evaluate
    scientific claims and data regarding tobacco products.\32\ Furthermore,
    FTC is a law enforcement agency whose primary task is to enforce the
    law against false and deceptive advertisements without regard for
    whether technically accurate statements have a major adverse impact on
    public health and result in consumers making health decisions based on
    incomplete information. The FTC's ability to craft industrywide
    solutions is extremely narrow. As a result, in almost every instance
    the FTC acts retrospectively against one bad actor once a violation has
    occurred.
    ---------------------------------------------------------------------------
        \32\ Testimony by Timothy Muris, FTC Chairman, June 3, 2003, before
    the Committee on Energy and Commerce Subcommittee on Commerce, Trade,
    and Consumer Protection, U.S. House of Representatives.
    ---------------------------------------------------------------------------
        In contrast, FDA is charged with protecting the public's health and
    as a public health agency acts prospectively to address problems. The
    FDA possesses talented and skilled scientists and researchers who are
    able to conduct sophisticated analyses and evaluate complex scientific
    data of the impact of different products on the health of consumers.
    For example, the FDA's National Center for Toxicological Research
    mission ``involves fundamental and applied research specifically
    designed to define biological mechanisms of action underlying the
    toxicity of products regulated by the FDA.'' FDA's various centers that
    oversee foods, drugs, medical devices, and biologics are home to career
    chemists, toxicologists, statisticians, epidemiologists, and
    surveillance and consumer marketing experts with very relevant skills
    to begin the process of assuming regulatory oversight of tobacco
    products. These are the types of functions and skills that will be
    critical to building an effective, science-based regulatory regime for
    tobacco products. These are the skills we need to employ in the pursuit
    of ensuring that all scientific avenues are explored to lower the
    toxicity and reduce the morbidity and mortality associated with tobacco
    products and their marketing and claims.
        FDA is unique in that it is the one agency that combines scientific
    expertise with experience in exercising regulatory authority.

        Question 2. Dr. Blum included a number of old cigarette ads with
    his testimony. In ad after ad, the tobacco companies have co-opted
    existing science and regulation as an advantage to their products over
    others. For example, in the Carlton ad, it says ``U.S. Government
    testing confirms--Carlton is lowest!'' Is there anything in this bill
    that precludes a tobacco company from including on its cigarette
    package label or in its advertisements a statement that says ``This
    product was made in accordance with FDA standards?''
        Answer 2. Every ad that Dr. Blum showed would be prohibited by the
    current legislation. Dr. Blum correctly used these ads to show how the
    tobacco industry has deceived millions of consumers. What he did not
    note was that the current bill prohibits these tactics by eliminating
    the terms ``light,'' ``low tar'' and claims like ``Carlton is lowest''
    because the public incorrectly perceives these types of claims as
    indicating that Carlton exposes consumers to lower levels of toxic
    substances.
        It is also important to note that while Dr. Blum correctly cited a
    number of ads as being deceptive and harmful to public health, these
    ads were permitted to continue by the Federal Trade Commission. It is a
    good example of the limitations of the FTC. FTC does not have the
    expertise or the authority to protect the public against this type of
    advertising. Dr. Blum's testimony illustrates that currently, no
    Federal agency has the authority to review health claims or stop
    tobacco companies from misrepresenting the facts and misleading
    consumers. The legislation would address this problem in a manner
    consistent with sound scientific standards.
        In addition, S. 625 gives FDA the authority to preclude a tobacco
    company from including on its cigarette package or in its
    advertisements a statement that says this product is ``FDA Approved''
    or is ``made in accordance with FDA standards.'' Five separate sections
    of the bill give the FDA full authority to control what a manufacturer
    says in its label, labeling and advertising, authority sufficient to
    permit the FDA to ban the kind of statements that are the subject of
    this question.
        In addition, the bill explicitly prohibits any person from
    labeling, advertising or taking any other action directed to consumers
    that states or implies that the product is less hazardous than other
    tobacco products or reduces exposure to substances in tobacco products
    without first having sought and obtained FDA approval according to the
    standards set forth in the legislation.
        Finally, if the committee believes that the legislation should
    contain an express prohibition of the type of statements that are the
    subject of this question, the public health supporters of this
    legislation would not object.

        Question 3. The drug industry user fees pay for more than half of
    the FDA drug review program. This has caused a lot of consternation
    among some patient and consumer groups who are concerned about
    potential industry influence on the agency. Do you have concerns about
    the tobacco industry paying for 100 percent of the tobacco review
    program?
        Answer 3. We would be concerned if this legislation or the fee
    structure gave the tobacco industry influence over how the FDA would
    implement this legislation. It does not. Under this legislation, the
    tobacco industry does not have any authority over how the money is
    spent, how FDA sets its priorities, or how much FDA receives. The user
    fee system in this bill provides FDA with adequate resources to
    effectively regulate tobacco products. Another strength of the user fee
    system is that, unlike the MSA, funding for FDA is not dependent upon
    the amount of tobacco used, but rather on manufacturers' share of the
    entire U.S. market.

        Question 4. The bill says a tobacco product cannot be labeled with
    the term ``light'' or ``low tar'' unless it has been shown to actually
    reduce the risk of harm or disease. However, the legislation does not
    demand that existing light or low tar products be removed from the
    market or even modified, unless a complicated and lengthy process for
    determining a product standard is set. Just the labeling has to be
    changed. If we already know that these products are not in fact better
    for consumers, why wouldn't we directly try and get them off the
    market?
        Answer 4. This provision will have an immediate and substantial
    benefit to the public health. It is the marketing of these products in
    ways that have misled consumers into believing that they are less
    hazardous that has caused millions of smokers to switch rather than
    quit. Preventing the tobacco companies from continuing to mislead the
    American public about the relative harm of these products will
    represent a major step forward. However, unless this legislation is
    enacted, consumers will continue to be misled by the tobacco industry
    on the issue of light and low tar cigarettes--a point highlighted by
    Judge Kessler in her August 2006 ruling against the tobacco company
    defendants in the Department of Justice tobacco lawsuit,

            ``Contrary to their internal documents, Defendants also
            continue to deny that low tar cigarettes are just as hazardous
            to smokers as full-flavor cigarettes, in part because of smoker
            compensation. In 1998, Philip Morris, RJR, B&W, and Lorillard
            jointly stated to the FTC that compensation was so ``weakly
            documented'' that the FTC should not require disclosure
            warnings to alert consumers, and that they were ``unaware of
            evidence,'' other than that presented in Monograph 7,
            520842199-2295 at 2243, 2289 (US 88618), that consumers viewed
            low-tar cigarettes as safer. Defendants are well aware from
            their own research that a majority of smokers believe that low-
            tar cigarettes are healthier, are willing to buy them for
            precisely that reason, and are willing to sacrifice taste for
            what they believe to be less harmful cigarettes. Nonetheless,
            to this day, Defendants still deny that, as Monograph 13 found,
            low-tar cigarettes are just as dangerous as full-flavor
            cigarettes. These RICO violations are likely to continue.''
            [Judge Kessler's Final Opinion, page 1609]

        Today, in the absence of this legislation, we are left with a
    situation described by the National Cancer Institute \33\ in which:
    ---------------------------------------------------------------------------
        \33\ National Cancer Institute. Risks Associated with Smoking
    Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
    Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S.
    Department of Health and Human Services, National Institutes of Health,
    National Cancer Institute, NIH Pub. No. 02-5074, October 2001, http://
    cancercontrol.cancer.gov/tcrb/monographs/13/.

        1. Many consumers use the terms ``Light'' and ``Ultra-Light'' as a
    guide to the riskiness of particular brands of cigarettes.
        2. Many smokers choose Light and Ultra-Light brands because they
    believe that such cigarettes are less likely to cause health problems.
        3. Individuals who are most concerned about smoking risks and most
    interested in quitting adopt low-yield brands.

        Once enacted this legislation will give the FDA the authority--for
    the first time--to also look at whether the establishment of product
    standards related to these products can further add to the public
    health benefit, but that decision is properly left to the FDA and is to
    be based on the best available science. Decisions about the content of
    tobacco products and what changes should be ordered in the content of
    tobacco products should be made by scientists based on an evaluation of
    what changes will best protect the public health and this bill gives
    precisely that authority to the FDA.
                            question of senator burr
        Question. How is keeping tobacco products on the market in the best
    interest of the public's health? Please provide a direct answer to this
    question.
        Answer. Without this legislation tobacco products not only remain
    on the market, they continue to be unregulated for health purposes. The
    status quo is a situation in which no Federal agency has the authority
    to require the tobacco companies to disclose what they know about their
    product or to require any tobacco company to make any change in any
    tobacco product to make it less harmful or less addictive.
        Under this legislation, for the first time ever, a science-based
    agency will be able to evaluate tobacco products, review health claims,
    and assess the risks associated with these products, and require
    changes in tobacco products in order to reduce the number of toxins in
    them and/or to require changes in nicotine levels based on a scientific
    assessment of what will best protect the public health and reduce the
    number of people who die from tobacco use. It is long past due that
    tobacco products be placed under the jurisdiction of an experienced,
    credible, science-based public health agency with the skills and
    expertise necessary to evaluate tobacco products and require changes to
    protect the public health.
        The important issue is whether the legislation provides the most
    effective tools to protect the public health and reduce the number of
    people who die prematurely from tobacco use. We believe it does. Using
    sound scientific techniques, FDA can work to lower the harms associated
    with the use of tobacco products and can do so in the most responsible
    and effective way possible.
        This legislation recognizes that there are approximately 50 million
    Americans addicted to tobacco today. Given this situation, the soundest
    public policy is one that seeks to reduce the number of those people
    who die from tobacco use, positively impacts the efforts of those who
    want to quit and prevents the tobacco companies from addicting another
    generation of our children. This bill does precisely that.
                           questions of senator hatch
        Question 1. In your testimony, you talk about the surveys that your
    organization conducted on tobacco advertising. One of the findings
    found that children are almost twice as likely as adults to remember
    tobacco advertising. Did your survey go into how many of these children
    actually take up smoking? Hasn't the youth smoking trend started to
    decline?
        Answer 1. There is compelling evidence that much of tobacco
    industry advertising and promotion impacts kids and contributes to the
    number of children who become tobacco users. A 2002 monograph by the
    National Cancer Institute, which reviewed the research on tobacco
    advertising and promotion and its impact on youth smoking, found that
    tobacco advertising and promotional activities are important catalysts
    in the smoking initiation process and concluded ``. . . that there is a
    causal relationship between tobacco marketing and smoking initiation
    seems unassailable.'' \34\ A study published in the December 2006 issue
    of the peer-reviewed journal Archives of Pediatrics and Adolescent
    Medicine found that exposure to tobacco marketing, which includes
    advertising, promotions and cigarette samples, and to pro-tobacco
    depictions in films, television, and videos more than doubles the odds
    that children under 18 will become tobacco users. The researchers also
    found that pro-tobacco marketing and media depictions lead children who
    already smoke to smoke more heavily, increasing the odds of progression
    to heavier use by 42 percent.\35\ These data are disturbing because
    kids continue to be exposed to tobacco advertising at high rates.
    ---------------------------------------------------------------------------
        \34\ National Cancer Institute, Changing Adolescent Smoking
    Prevalence, Smoking and Tobacco Control Monograph No. 14, NH Pub. No.
    02-5086, November 2001.
        \35\ Wellman RJ, et al., ``The extent to Which Tobacco Marketing
    and Tobacco Use in Films Contribute to Children's Use of Tobacco: A
    Meta-Analysis.'' Archives of Pediatrics and Adolescent Medicine 2006
    Dec;160(12):1285-96.
    ---------------------------------------------------------------------------
        Tobacco use among young people did decline between 1998 and 2003.
    The best available science indicates that these reductions were
    prompted by a number of actions, including increases in cigarette
    excise taxes, enactment of comprehensive smoke-free workplace laws, and
    State tobacco prevention and cessation programs. The national truth
    sm campaign, conducted by the American Legacy Foundation,
    which is targeted at youth and includes television and radio
    advertising, grassroots efforts, and an interactive Web site, has also
    contributed to declines in smoking prevalence among high school
    students.\36\ While we have made much progress, results from recent
    national surveys indicate that the Nation's progress in reducing youth
    smoking has stalled or slowed to a crawl.
    ---------------------------------------------------------------------------
        \36\ American Legacy Foundation. ``Getting to the Truth: Assessing
    Youths' Reactions to the Truth sm and `Think. Don't Smoke'
    Tobacco Countermarketing Campaigns,'' First Look report 9, June 2002.
    ---------------------------------------------------------------------------
        What is also important to note is that since the Master Settlement
    Agreement was adopted in 1998 there has been a dramatic increase in
    tobacco industry marketing, including in areas that have been proven to
    impact children. Thus, it is no surprise that not a single published
    study has attributed any of the decline in youth tobacco use to any
    change in the tobacco industry's marketing. In fact, the CDC has
    concluded that one possible reason for the fact that the decline in
    youth tobacco use has stalled is the dramatic increase in tobacco
    marketing. Data from the most recent FTC report show that tobacco
    industry spending on marketing and promotion increased by 125 percent
    from 1998 to 2005. It also shows that major tobacco companies have
    sharply increased their marketing expenditures in categories known to
    lead to increased use among youth.\37\
    ---------------------------------------------------------------------------
        \37\ U.S. Federal Trade Commission (FTC), Cigarette Report for
    2003, 2005 [data for top six manufacturers only].
    ---------------------------------------------------------------------------
        It is a fair question to ask: Where would tobacco use rates be, had
    the tobacco industry not doubled its marketing efforts and spent its
    marketing expenditures in ways known to reach youth? There is consensus
    in the public health community that rates would have been lower, and
    ultimately fewer youth would die prematurely from smoking-caused
    disease. The marketing restrictions in this legislation are based on
    the best available science that documents the impact of current tobacco
    marketing practices and takes into consideration the evidence of the
    tobacco industry's continued marketing practices.

        Question 2. I also noted in your testimony that while you
    understand why there are concerns about the FDA's resources, you
    believe that a new user fee imposed on the tobacco industry will take
    care of the resource issue. Mr. Myers, how do you know that the user
    fee imposed on the tobacco companies is the appropriate amount of
    money? What if it is too little? I would be interested in your thoughts
    on this issue.
        Answer 2. The goal of this legislation is to insure that FDA is
    given adequate resources to do its job well and without taking any
    resources from other FDA activities. Thus, this legislation provides
    for a new and independent funding mechanism for FDA's new tobacco
    product-related responsibilities. The new responsibilities would be
    funded through a user fee on the tobacco industry, so it would have no
    impact on the funding provided to FDA to carry out its other important
    activities. The user fees are allocated among the manufacturers of
    tobacco products sold in the United States, based on the manufacturers'
    respective shares of the entire U.S. tobacco-product market. The groups
    that support this legislation care deeply about the many important
    tasks of the FDA including drug and device approval and the work the
    agency does to protect our food supply.
        The estimated funding levels provided for in the legislation, which
    ramp up to $300 million annually in year three, are based on FDA's
    prior experience regulating tobacco from 1996-2000 along with budget
    documents and estimates provided by FDA during previous congressional
    debates on legislation to provide FDA with authority over tobacco
    products.

        Question 3. There has been a growing tendency both at the Federal
    and at the State level to use monies generated from tobacco taxes for a
    variety of legislative purposes that are not directly connected to
    anti-smoking campaigns, some of which are very legitimate initiatives.
    Let's assume two scenarios. First, Congress bans cigarettes tomorrow
    and the ban works. We are no longer able to rely upon any revenues,
    either at the Federal or the State level, from the sale of tobacco. If
    such a ban took place, what would be the budgetary shortfall that we
    would have to make up? Second, let's assume the legislation before the
    committee is enacted, which is intended, among other things, to result
    in a reduction of the sale of cigarettes. What is the budgetary
    shortfall we can expect if the current bill is enacted at both the
    Federal and State level?
        Answer 3. First, nothing in this legislation will lead to a ban on
    cigarettes tomorrow and no one who supports this legislation supports
    such an action.
        Second, the concerns expressed by these questions don't take into
    account the fact that tobacco does not just generate revenue for
    government, it imposes enormous costs on society and government.
    Studies demonstrate that tobacco use is a significant net drain on
    State governments, the American government and the economy. In monetary
    terms alone, tobacco costs the American economy nearly $97 billion
    every year in excess health care expenditures and nearly $98 billion
    every year in additional productivity losses.\38\ In human terms,
    tobacco results in the annual, preventable deaths of more than 400,000
    Americans and more than 8 times that figure in people living with a
    tobacco-caused illness or disease.\39\ Clearly, a decline in tobacco
    use and a decline in tobacco-related disease will have a positive
    impact on the American economy, Federal budget, State budgets and, most
    importantly, on American families. If this legislation results in fewer
    children smoking and fewer people dying from tobacco, then any modest
    impact on tax receipts will be more than offset by gains in
    productivity and lower health care costs.
    ---------------------------------------------------------------------------
        \38\ Toll of Tobacco in the United States of America, Campaign for
    Tobacco Free Kids, http://www.tobaccofreekids.org/research/factsheets/
    pdf/0072.pdf (Web site accessed March 9, 2007).
        \39\ Toll of Tobacco in the United States of America, Campaign for
    Tobacco Free Kids, http://www.tobaccofreekids.org/research/factsheets/
    pdf/0072.pdf (Web site accessed March 9, 2007).
    ---------------------------------------------------------------------------
        If this bill is enacted and rigorously implemented, it will produce
    a benefit for the Government and the public--both in economic terms and
    in the health of American families.

        Question 4. Unfortunately, one of the consequences of the increased
    regulation of cigarettes, as well as an increase in the cost, has been
    a burgeoning black market in cigarettes. Again, the legislation is
    intended, among other things, to discourage smoking, as well as the
    smoking of cigarettes at current levels of nicotine. What provisions
    are included in the bill that will enable the FDA to combat not only
    the illegal sale of cigarettes in general but the possibility of a rise
    in the illegal shipment of cigarettes into this country?
        Answer 4. The FDA legislation has a specific section relating to
    contraband tobacco products, Title III--Prevention of Illicit Trade in
    Tobacco Products. That section requires all packaging of tobacco
    products meant for sale in the United States to be labeled with the
    statement ``Sale Only Allowed in the United States,'' which will make
    illegal diversions of such products more difficult. [Sec. 921(a)] In
    addition, that section requires the Secretary, within 9 months of the
    enactment of the legislation, to issue regulations regarding the
    establishment and maintenance of records by any person who
    manufactures, distributes, exports or imports tobacco products in order
    to make it easier for the Secretary to track and trace the paths taken
    by tobacco products through legal distribution channels and block their
    diversion into contraband trafficking. To enhance the Secretary's
    abilities in this regard, this section also provides the Secretary with
    authority to inspect records and to establish special codes, labels,
    and designs on the labels of tobacco products that facilitate tracking
    and tracing. [Sec. 921(b)]
        Title III also requires manufacturers, importers, and distributors
    of tobacco products to report to the Attorney General whenever they
    have knowledge indicating that any tobacco product they have
    manufactured, imported, or distributed has been diverted from legal
    channels and become contraband. [Sec. 921(d)] Pursuant to title III,
    the Comptroller General must also conduct a study of cross-border trade
    in tobacco products, including illicit trade and trade of counterfeit
    products, and issue a related report to Congress no later than 18
    months after the enactment of the legislation. [Sec. 302].
        Each of these provisions in title III should help to strengthen
    existing efforts to prevent and reduce contraband trafficking in
    tobacco products both within the United States and across its borders.
        At the same time, the FDA legislation does not allow FDA to ban any
    class of tobacco products or eliminate nicotine in any tobacco
    products, which could prompt contraband trafficking and black market
    sales of the prohibited tobacco products or of nicotine-full versions
    of the tobacco products with no nicotine. [Sec. 907(b)(3)] In addition,
    FDA is directed to take into consideration the possible impact on
    contraband trafficking when requiring any changes to existing products
    or issuing any new product standards. [Sec. 907(b)(1)(E)].
        It is also worth noting that the FDA legislation will not
    significantly increase tobacco product prices in the United States; so
    it should not promote any price-based increase in contraband
    trafficking. On the other hand, to the extent that the FDA legislation
    changes the appearance of tobacco product packaging and labeling and
    requires new anti-trafficking product codes or markings it will make
    tobacco products that are legally made in the United States even more
    distinguishable to enforcement officials and even harder to
    counterfeit.
                          questions of senator coburn
        Question 1. What constituents would you recommend that the FDA
    require to be eliminated or reduced in cigarettes, and by how much
    would that reduction or elimination reduce the relative risk of
    tobacco-related diseases?
        Answer 1. One of the strengths of the pending legislation is that
    it properly recognizes that the answer to a question like this should
    ultimately be made by individuals with complete information based upon
    the best available science with the authority to monitor the impact of
    any such decision and the breadth of authority to make adjustments as
    new information emerges and the impact of different choices is better
    and better evaluated.
        The danger of making such a determination based on incomplete
    information in the absence of a comprehensive regulatory mechanism,
    such as that proposed by S. 625, is seen by what happened with
    ``light'' and ``low tar'' and by the even more recent experience in the
    European Union. When the FTC permitted tobacco companies to include tar
    and nicotine figures in their marketing as a result of the very simple
    testing system that produced those numbers, it was believed that there
    would be a benefit to consumers if they smoked products that reduced
    their exposure to toxic substances and ``tar'' was selected as the
    measure. It failed for a number of reasons. No agency controlled how
    tobacco companies altered ``tar'' levels so the tobacco companies were
    able to design their cigarettes to produce a level of ``tar'' on the
    FTC machine method that bore no relationship to the actual level of
    ``tar'' that consumers received. Further, the overly simple system did
    not recognize that not all ``tar'' is equal. Later research showed that
    even as ``tar'' levels went down on the machine test, levels of certain
    toxic substances in the ``tar'' actually went up. In addition, the
    simple machine test did not look at other variables such as the impact
    of the particle size of the constituents that make up ``tar,'' the
    ability of the tobacco companies through chemical manipulation to alter
    the impact of the different components of the constituents of ``tar''
    and ``nicotine'' or even technology that altered where the different
    constituents found in tobacco smoke lodged in the lungs of
    consumers.\40\
    ---------------------------------------------------------------------------
        \40\ National Cancer Institute. Risks Associated with Smoking
    Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
    Chapter One: Public Health Implications of Changes in Cigarette Design
    and Marketing Smoking and Tobacco Control Monograph No. 13. Bethesda,
    MD: U.S. Department of Health and Human Services, National Institutes
    of Health, National Cancer Institute, NIH Pub. No. 02-5074, October
    2001; Tobacco Control Legal Consortium, The Verdict Is In: Findings
    From United States v. Philip Morris, Light Cigarettes (2006).
    ---------------------------------------------------------------------------
        Even more recently, the European Union sought to reduce the harm
    caused by tobacco products based on very incomplete information and
    without any kind of meaningful regulatory controls over the product.
    The EU set standards for ``tar'' and ``nicotine'' levels in cigarettes.
    Yet, already research has shown that the tobacco companies were able to
    design their cigarettes in such a way that consumers of products that
    met these standards were actually not getting less ``tar'' or
    ``nicotine.'' \41\
    ---------------------------------------------------------------------------
        \41\ O'Connor RJ and Cummings MK et al., ``How did UK cigarette
    makers reduce tar to 10 mg or less? British Medical Journal,
    2006;332:302 (4 February), doi:10.1136/bmj.332.7536.302.
    ---------------------------------------------------------------------------
        We must be careful not to misinterpret these experiences. As NCI
    Monograph 13 in 2001 concluded, our experience to date does not
    demonstrate that if cigarettes actually deliver fewer and lower levels
    of toxic substances, they are not likely to produce less disease. The
    experience to date is that in the absence of a comprehensive regulatory
    system able to base decisions on sound science and monitor cigarette
    design, the impact of prior efforts have not produced meaningful
    differences of actual exposure by consumers. There continues to be
    widespread belief among the best available independent scientists that
    if tobacco companies could be compelled to produce products with
    dramatically lower levels of toxic substances in ways that resulted in
    a major reduction of exposure to consumers, those products would still
    remain deadly but would be likely to produce less disease.
        This should not be surprising. Tobacco smoke contains over 4,000
    chemicals, more than 200 of which are toxic and nearly 70 of which are
    known or suspected human carcinogens. \42\ However, today, there is no
    Federal agency that has authority to require tobacco companies to
    identify what toxic chemicals appear in what products or brands or in
    what quantity. Nor is there any requirement of the tobacco companies to
    detail the testing they have conducted to test the health impact of
    different toxic substances in different brands/products. This
    legislation will give the FDA the authority to get this information,
    marry it with the best available science, and then determine the most
    appropriate action to take regarding these harmful substances both in
    terms of recommending changes to the product (e.g., performance
    standards) and informing consumers of the contents of these products
    and the risks associated with their use.
    ---------------------------------------------------------------------------
        \42\ National Cancer Institute. Risks Associated with Smoking
    Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
    Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S.
    Department of Health and Human Services, National Institutes of Health,
    National Cancer Institute, NIH Pub. No. 02-5074, October 2001.
    ---------------------------------------------------------------------------
        Therefore, any decision about what constituents should be lowered
    or eliminated needs to be made by an agency: able to control how the
    tobacco companies redesign their cigarettes to adjust to the new
    standard; able to monitor the impact of any such decision on the other
    components of the tobacco product and should be made with more
    information about current cigarette technology. FDA will be able to do
    that if this legislation is enacted and rigorously enforced. The
    attempt to simply identify specific components to be eliminated in the
    absence of the kind of authority to be given to FDA is far less likely
    to produce a meaningful public health impact.

        Question 2. How will smokers alter their behavior in response to
    the introduction of cigarettes with new tobacco product standards? That
    is, what will be the effect on cigarette consumption of smokers now
    knowing that the FDA is tightly regulating all the constituents and
    ingredients in cigarettes?
        Answer 2. Tobacco products are among the most unregulated consumer
    products on the market today and are exempt from important consumer
    protections such as ingredient disclosure and product testing. In this
    unregulated environment, tobacco companies are free to manipulate their
    products in ways that can make them more addictive and/or more harmful.
    Consumers have absolutely no knowledge of these changes, although these
    changes have been shown to impact consumer behavior. As the recent
    study from the Harvard School of Public Health demonstrates, tobacco
    companies have secretly and significantly increased the levels of
    nicotine in cigarette smoke over time.\43\ We have no idea how this
    change has impacted consumers. We also know too little about other
    changes the tobacco industry has made (and continues to make) to their
    products to make them more appealing to current users, easier to use,
    and harder to quit. Regulatory oversight is essential if we are ever
    going to fully understand tobacco products and how changes to these
    products effects initiation and use.
    ---------------------------------------------------------------------------
        \43\ Connolly, Gregory N., et al., ``Trends in Smoke Nicotine Yield
    and Relationship to Design Characteristics Among Popular U.S. Cigarette
    Brands 1997-2005.'' Tobacco Research Program, Harvard School of Public
    Health, January, 2007.
    ---------------------------------------------------------------------------
        A few other examples of what happens in the absence of regulation
    of the type proposed by this legislation also helps put this
    legislation in context. After the 1964 Report of the Surgeon General,
    millions of people switched to light and low tar cigarettes believing
    that such cigarettes exposed them to lower levels of toxic substances
    and reduced their risk of disease. As the National Cancer Institute
    Monograph 13 in 2001 found, these perceptions turned out to be
    inaccurate, in part because in the absence of regulation the tobacco
    companies were able to make design changes to cigarettes so that they
    produced low test results on the FTC testing machine that bore no
    relationship to the actual exposure consumers received.\44\
    ---------------------------------------------------------------------------
        \44\ National Cancer Institute. Risks Associated with Smoking
    Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
    Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S.
    Department of Health and Human Services, National Institutes of Health,
    National Cancer Institute, NIH Pub. No. 02-5074, October 2001, http://
    cancercontrol.cancer.gov/tcrb/monographs/13/.
    ---------------------------------------------------------------------------
        Another good example is what happened with nitrosamine levels in
    cigarettes after the introduction of light and low tar products.
    Nitrosamines are one of the potent carcinogens that have been
    identified in the smoke of tobacco products. Much to the surprise of
    many scientists, research conducted many years after the introduction
    of light and low tar tobacco products demonstrated that even as tar
    ratings on the FTC testing machine dropped, nitrosamine levels in
    cigarettes rose dramatically. In the absence of regulation, consumers
    did not know this potentially important fact. Indeed, the Government
    did not know this fact and as a result, government was not in a
    position to prevent the tobacco companies from allowing nitrosamine
    levels to rise.
        Later after at least one major tobacco company said publicly that
    it was reducing nitrosamine levels, research demonstrated that
    nitrosamine levels in the products of this manufacturer as well as
    others remained high. Once again consumers were misinformed because no
    governmental agency regulated these products or had this information
    and no one was in a position to require the tobacco companies to lower
    the level of this carcinogen as well as others.
        Other studies have subsequently shown that design changes in
    tobacco products have increased the potency of the nicotine in these
    products without the knowledge of either consumers or the Government
    and other studies have shown that design changes have altered levels of
    nicotine in other ways that the Federal Government did not know about.
    With a product almost always first used by children, there is good
    scientific reason to be concerned that changes to these products that
    increase the potency or level of the prime addiction causing agent
    increase the speed with which children become addicted and make it
    harder for tobacco users to quit.
        S. 625 gives the FDA the clear authority to prevent these types of
    abuses by requiring tobacco companies to disclose for the first time
    the type of information that would prevent the tobacco companies from
    hiding this kind of information from consumers and to prevent a tobacco
    company from making product changes in secret that could make the
    product more harmful and more addictive. By helping to create a market
    place where consumers and the Government are better informed, we give
    consumers new tools to take steps to protect their own health and give
    government new tools to prevent the tobacco industry from continuing
    its current harmful practices.
        Your question is: How will consumers respond? The evidence from our
    experience after the Surgeon General's 1964 is clear. Faced with new
    information about the health hazards of tobacco products, consumers in
    very large numbers quit or switched to products that they believed
    reduced their risk of disease. The problem was that those products did
    not actually reduce their risk of disease, tobacco marketing misled
    those consumers and no Federal agency had the power to intervene to
    make sure that the market place was filled with truthful and complete
    information. Unfortunately, many consumers already believe that
    cigarettes and other tobacco products--and the claims being made in
    their advertising--are already regulated and approved by the Federal
    Government.\45\ The evidence is strong that consumers will benefit and
    be better able to take steps to alter their behavior if this
    legislation passes, even before FDA is able to initiate the processes
    that could lead to the elimination and/or reduction of toxic substances
    in tobacco products or changes in nicotine delivery.
    ---------------------------------------------------------------------------
        \45\ ``Smokers' responses to advertisements for regular and light
    cigarettes and potential reduced-exposure tobacco products,'' Nicotine
    & Tobacco, Volume 6, Supplement 3 (December 2004) S353-S362.
    ---------------------------------------------------------------------------
        S. 625 also gives FDA, for the first time, authority to require
    companies to make changes in existing products, including the removal
    of harmful ingredients. Under this legislation, FDA would determine
    whether an action regarding a tobacco product will ``protect the public
    health.'' This standard would require consideration of whether a
    product change would reduce the overall harm caused by tobacco use,
    including the harm caused to individual tobacco users and the impact on
    the population as a whole.
        Importantly, the legislation enables FDA to require changes in
    nicotine based on the best available science for the purpose of
    reducing the number of people who die from tobacco. The key is that the
    science will dictate the best approach. In evaluating the impact of
    different possible changes in the levels of nicotine, FDA will be able
    to assess the impact on current smokers, smokers trying to quit and
    non-
    tobacco users and make its decision about what steps will be most
    effective in reducing the number of people who die from tobacco. It
    will be a broad multi-focused analysis that only an agency with broad
    authority, adequate information, significant scientific expertise and a
    focus on public health can achieve.

        Question 3. In what way will reducing the nicotine levels in
    cigarettes improve the public's health, since we know that when
    nicotine levels are reduced, smokers compensate by smoking more? Won't
    this approach in fact hurt the public's health?
        Answer 3. This legislation does not prejudge the best way to
    control nicotine to reduce the death and disease caused by tobacco.
    Instead, it gives the FDA the authority to examine what to do about
    nicotine based upon the best available science taking into account the
    impact of any such change on both individual smokers and the population
    as a whole. Thus, this legislation recognizes the important role played
    by nicotine, but also recognizes that what changes should be made
    require the FDA to look broadly and to examine carefully the best and
    newest science on the impact of different proposed changes.
        In the absence of effective legislation to regulate the tobacco
    industry and their products and marketing, nicotine levels in tobacco
    products have been intentionally changed by the tobacco companies
    (unbeknownst to consumers or the Government) to make them more
    addictive and to deliver more rapid doses of nicotine. As concluded by
    Judge Kessler in her August 2006 ruling in the Department of Justice
    lawsuit against the tobacco industry:

              ``The Defendants have repeatedly made vigorous and
            impassioned public denials--before congressional committees, in
            advertisements in the national print media, and on television--
            that neither smoking nor nicotine is addictive, and that they
            do not manipulate, alter, or control the amount of nicotine
            contained in the cigarettes they manufacture. The Findings of
            Fact contained in this section and section V(B), supra, provide
            overwhelming evidence that those statements are false.'' [Judge
            Kessler's Final Opinion, page 653]
              ``In sum, the evidence as presented in these Findings of Fact
            is overwhelming that Defendants have, over the course of many
            years, time and again--and with great self-righteousness--
            denied that they manipulated the nicotine in cigarettes so as
            to increase the addiction and dependence of smokers. Those
            denials were false.'' [Judge Kessler's Final Opinion, page 654]

        The legislation before the committee would provide FDA with the
    authority to evaluate the nicotine content of all tobacco products
    (along with other chemical and design features of tobacco products that
    may impact addiction). Through this grant of authority, FDA would be
    able to determine, based on the best available science, what decision
    is in the best interest of public health, weighing both the individual
    risks and the population-level impact, that changes in the nicotine
    yields of tobacco products, up or down (but not down to ``zero''),
    would generate.
        As crafted, this legislation's approach maximizes the likelihood
    that any change in nicotine levels prompted by the FDA will in fact
    improve the public health because it will be able to force the tobacco
    companies to control other changes in the tobacco product, monitor
    closely the impact of any proposed change after it takes effect, take
    into consideration the impact of any proposed change on non-smokers, as
    well as on smokers attempting to quit or interested in quitting.
        Tobacco smoke contains over 4,000 chemicals, more than 200 of which
    are toxic and nearly 70 of which are known or suspected human
    carcinogens.\46\ However, today, there is no Federal agency that has
    authority to require tobacco companies to identify what toxic chemicals
    appear in what products or brands or in what quantity. Nor is there any
    requirement of the tobacco companies to detail the testing they have
    conducted to test the health impact of different toxic substances in
    different brands/products. One of the central goals of this legislation
    is to give the FDA the authority to get this information, marry it with
    the best available science, and then determine the most appropriate
    action to take regarding these harmful substances both in terms of
    recommending changes to the product (e.g., performance standards) and
    informing consumers of the contents of these products and the risks
    associated with their use.
    ---------------------------------------------------------------------------
        \46\ National Cancer Institute. Risks Associated with Smoking
    Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
    Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S.
    Department of Health and Human Services, National Institutes of Health,
    National Cancer Institute, NIH Pub. No. 02-5074, October 2001.
    ---------------------------------------------------------------------------
    Response to Questions of Senator Enzi, Senator Burr, Senator Hatch, and
                  Senator Coburn by Elmer Huerta, M.D., M.P.H.
                           questions of senator enzi
        Question 1. FDA is the gold standard amongst public health
    regulators. I worry that under this bill, the public would interpret
    FDA regulation as an endorsement that the product was safe for
    consumption, when we know that tobacco is unsafe. I think tobacco
    companies, not public health, would benefit from the FDA ``stamp of
    approval.'' How can you ensure that FDA regulation of tobacco will not
    lead to greater consumer acceptance of tobacco?
        Answer 1. Meaningful FDA regulation of tobacco is not an
    endorsement that a tobacco product is safe for consumption. It is
    important that no tobacco company be permitted to claim that a product
    is in any way approved or endorsed by the FDA. To the contrary, the FDA
    regulatory process will ensure that the public finally has access to
    information about the harmful ingredients in tobacco products,
    including cigarette smoke constituents, and the horrendous impact they
    have on public health. Under the proposed legislation, the FDA would be
    granted the authority to stop tobacco companies from lying to and
    misleading the public with its false advertising and unsubstantiated
    health claims. FDA regulation of tobacco would also include direct
    reminders to the public about the dangers of smoking with significantly
    larger health warnings that tobacco products cause death and disease.
    As you put it so well, FDA is the gold standard and with its scientific
    expertise, it is the best agency to inform the public about the harms
    of tobacco products.

        Question 2. This bill sets a very high bar for the introduction of
    reduced-risk products. In fact, I read it as possibly requiring
    randomized, controlled clinical trials before a product can be
    approved. In addition, the use of the ``public health'' standard makes
    showing evidence of an improved product more difficult than the normal
    Food, Drug and Cosmetic Act standard of ``safe and effective.'' I worry
    that this means we will ossify the makeup of tobacco products on the
    market where they are, and make it harder to market a safer product. I
    assume this is not what you intended. Why do you believe that this bill
    will favor the introduction of safer products?
        Answer 2. First, tobacco products can never be ``safe or
    effective,'' and that is why a new public health standard is
    established in the proposed legislation to regulate tobacco products.
    FDA regulation of tobacco would allow tobacco companies to continue to
    develop new products, but would require that any health claim attached
    to a product is based on sound science. The tobacco companies already
    market products as less hazardous or safer without having to verify
    these claims. We need only look at the experience of ``light'' and
    ``low tar'' to see how the tobacco industry developed a new product and
    then used false and deceptive labeling and advertising to mislead
    smokers into thinking they were consuming a safer product. Existing
    products and new products would both have to conform to the FDA
    performance standards. Tobacco companies that want to create products
    that are actually less hazardous should welcome this standard.

        Question 3. Philip Morris supports the bill. Philip Morris
    management has an obligation to its shareholders to maximize profits.
    These two things together mean that the company believes it can sell
    more cigarettes for a longer time under this bill than if there were
    not a bill. How can you then be confident that the bill, as written,
    really will serve the public health in the long run?
        Answer 3. We have conducted a thorough and independent analysis of
    the proposed legislation. The American Cancer Society is an evidence-
    based organization and a nationally trusted source of information on
    cancer and its causes and the American Cancer Society Cancer Action
    Network bases its legislative work on the evidence-based judgments of
    the Society. We have concluded that the proposed legislation will
    protect the public health and ultimately, save lives. The proposed
    legislation would provide the FDA with the authority and resources to
    effectively regulate the manufacturing, marketing, labeling,
    distribution and sale of tobacco products. The FDA would be authorized
    to restrict tobacco advertising and marketing, especially those aimed
    at children, including banning candy-flavored cigarettes. It would also
    require the tobacco companies to disclose the ingredients of tobacco
    products and cigarette smoke constituents. The FDA would have the
    authority to prohibit unsubstantiated health claims, and require
    larger, more informative health warnings on tobacco products. The
    proposed legislation would also grant the FDA the authority to take
    further action to ensure that tobacco products are not illegally sold
    to children. The public health would be much better protected with FDA
    regulation of tobacco than the status quo.

        Question 4. Shouldn't we focus on better enforcing the dozens of
    tobacco regulations already on the books instead of burdening an
    overworked and underfunded FDA?
        Answer 4. Despite the fact that tobacco kills more than 400,000
    Americans each year, tobacco is the least regulated consumer product on
    the market today. The FDA is the only government regulatory agency that
    combines the public health mission with the scientific and health
    expertise needed to effectively regulate the tobacco industry. The
    manufacturing and marketing restrictions currently in place are
    completely inadequate, and there are no restrictions on additives or
    other ingredients that tobacco companies can add to the content of
    tobacco products. The tobacco companies market their products with
    unsubstantiated health claims, and mislead the public using terms such
    as ``light'' and ``low tar.'' Furthermore, there is no mechanism for
    identifying misleading or fraudulent labeling or advertising claims or
    holding tobacco product manufacturers accountable. The proposed
    legislation effectively places tobacco companies under the same
    regulatory rubric of every other consumer product. Finally, the
    proposed legislation would provide funding to the FDA through a user
    fee paid by the tobacco industry, and will not negatively impact the
    other critical functions of the FDA.
                            question of senator burr
        Question. How is keeping tobacco products on the market in the best
    interest of the public's health? Please provide a direct answer to this
    question.
        Answer. Keeping tobacco products on the market clearly is not in
    the best interest of the public health. Unfortunately, there is no
    effective way to eliminate these products. As we learned during
    Prohibition, an outright ban would lead to the creation of a black
    market and all of the undesirable social side effects that black
    markets create. The fact is 45 million Americans are currently addicted
    to tobacco. The critical effort is to stop new smokers, who are mostly
    kids, from starting, to increase the access and affordability of
    cessation services and to give the public objectively-reviewed, factual
    information about tobacco products. We also must stop the tobacco
    industry's misleading labeling and advertising, unsubstantiated health
    claims, and manipulation of their product in order to keep smokers
    smoking and getting new users to start. The proposed legislation is
    critically needed to protect the public health from the harms of
    tobacco.
                           questions of senator hatch
        Question 1. Dr. Huerta, what percentage of lung cancer is caused by
    tobacco usage? The reason I ask is that I am aware of a few cases where
    someone has been diagnosed with terminal lung cancer and never smoked a
    cigarette in his or her life. I was very interested in your statistics
    about the decrease in cancer deaths and the decrease in mortality rates
    and incidence from lung cancer in men. Could you please talk about this
    in more detail? These numbers are very encouraging news to those who
    have loved ones suffering from lung cancer.
        Answer 1. Approximately 87 percent of all lung cancer deaths are
    attributable to tobacco use and smoking accounts for at least 30
    percent of all cancer deaths. So while there are cases of lung cancer
    in nonsmokers, the vast majority are associated with tobacco use. The
    risk of developing lung cancer is about 23 times higher in male smokers
    and 13 times higher in female smokers compared to lifelong non-smokers.
    Lung cancer accounts for the most cancer-related deaths in both men and
    women. Death rates from lung cancer for men have declined significantly
    from 1991 to 2003, although there is still great variation between
    racial and ethnic groups. After increasing for several decades, lung
    cancer death rates for women are approaching a plateau, but still have
    yet to decline. Women lagged behind men in picking up smoking, so it is
    not surprising we see the same lag with disease. Since 1987, more women
    have died each year from lung cancer than from breast cancer. This is
    an extremely deadly type of cancer with only a 16 percent 5-year
    survival rate. In 2007, an estimated 213,380 new cases of lung cancer
    and 160,390 deaths from lung cancer are expected.
        In addition to lung cancer, smoking is associated with an increased
    risk of at least 14 types of cancer, including nasopharynx, nasal
    cavity and paranasal sinuses, lip, oral cavity, pharynx, larynx,
    esophagus, pancreas, uterine cervix, kidney, bladder, stomach, and
    acute myeloid leukemia. Smoking is a major cause of other diseases too,
    including heart disease, cerebrovascular disease, chronic bronchitis,
    and emphysema, and is associated with gastric ulcers. The health care
    costs associated with smoking-related diseases and deaths are
    astronomical. The CDC estimates that over $96 billion in direct medical
    expenditures are caused by tobacco each year, with an additional $97
    billion lost in productivity.

        Question 2. Why do you believe that the Food and Drug
    Administration is the proper agency to regulate tobacco? I am just not
    convinced that the FDA is the appropriate agency to regulate tobacco.
    Personally, I believe that the FDA, currently, has tremendous
    responsibilities imposed upon it compared to other health agencies and
    adding another major responsibility like the regulation of tobacco is
    just too much. We hear complaints all the time about the FDA not being
    able to do its current job and here we are, through this legislation,
    imposing additional responsibilities on the agency. So I'd be
    interested in your opinion--why is the FDA the best agency to oversee
    the regulation of tobacco? And please know, I do not disagree with you
    about the need for tobacco to be better regulated--I just don't know if
    the FDA is the right agency to do the job.
        Answer 2. The FDA is the only government agency with the scientific
    expertise and enforcement power necessary to effectively regulate
    tobacco products and health-related claims made by the tobacco
    companies. The FDA can evaluate the veracity of tobacco industry claims
    about their products and has the ability to swiftly modify its
    regulations to respond to new scientific information or changes in the
    tobacco industry's tactics. I agree that resources for the FDA have
    struggled to keep pace with its critical functions. The proposed
    legislation ensures that the FDA regulatory functions for tobacco will
    be paid for by means of a user fee levied on the tobacco industry. The
    proposed legislation places tobacco on the same regulatory level of
    food and drugs, and is critically important to protect the public
    health.

        Question 3. There has been a growing tendency both at the Federal
    and at the State level to use monies generated from tobacco taxes for a
    variety of legislative purposes that are not directly connected to
    anti-smoking campaigns, some of which are very legitimate initiatives.
    Let's assume two scenarios. First, Congress bans cigarettes tomorrow
    and the ban works. We are no longer able to rely upon any revenues,
    either at the Federal or the State level, from the sale of tobacco. If
    such a ban took place, what would be the budgetary shortfall that we
    would have to make up? Second, let's assume the legislation before the
    committee is enacted, which is intended, among other things, to result
    in a reduction of the sale of cigarettes. What is the budgetary
    shortfall we can expect if the current bill is enacted at both the
    Federal and State level?
        Answer 3. Tobacco use costs our Nation over $96 billion each year
    on direct health care costs and over $97 billion each year in lost
    productivity, not to mention the over 400,000 lives lost. In the
    unlikely scenario that a complete ban was to be enacted, the billions
    of dollars in public health savings would offset any loss of tax
    revenue by many orders of magnitude.

        Question 4. Unfortunately, one of the consequences of the increased
    regulation of cigarettes, as well as an increase in the cost, has been
    a burgeoning black market in cigarettes. Again, the legislation is
    intended, among other things, to discourage smoking, as well as the
    smoking of cigarettes at current levels of nicotine. What provisions
    are included in the bill that will enable the FDA to combat not only
    the illegal sale of cigarettes in general but the possibility of a rise
    in the illegal shipment of cigarettes into this country?
        Answer 4. The proposed legislation imposes strong, new requirements
    regarding the prevention and monitoring of potential black market sales
    and provides for a congressionally mandated study of illicit trade
    issues, the biggest black market threat. In addition, the user fee
    imposed on the tobacco companies to fund FDA regulation would amount to
    less than 1\1/2\ cents per pack of cigarettes, a virtually
    inconsequential increase. Black market sales are driven by price across
    State and national boundaries. The proposed legislation places
    restrictions on the advertising, marketing, promotion, labeling and
    sale of tobacco products, which should not impact the price of tobacco
    products.
                          questions of senator coburn
        Question 1. What constituents would you recommend that the FDA
    require to be eliminated or reduced in cigarettes, and by how much
    would that reduction or elimination reduce the relative risk of
    tobacco-related diseases?
        Answer 1. This is exactly what we want to give the FDA authority to
    determine. The proposed legislation would allow the FDA to use existing
    science and new science to identify changes to existing and new
    products that would reduce their harm. The tobacco companies would
    still be prohibited from making any unsubstantiated health claims based
    on any change to their product. We know the tobacco companies
    manipulate their products in order to keep their customers addicted and
    to encourage new ones to start, and we see variations in the same brand
    sold in different countries. The FDA is the only government agency with
    the resources and scientific expertise to determine what ingredients in
    tobacco products or cigarette smoke constituents should be reduced or
    eliminated in order to protect the public health.

        Question 2. How will smokers alter their behavior in response to
    the introduction of cigarettes with new tobacco product standards? That
    is, what will be the effect on cigarette consumption of smokers now
    knowing that the FDA is tightly regulating all the constituents and
    ingredients in cigarettes?
        Answer 2. First of all, the new marketing and advertising
    restrictions would stop allowing the tobacco companies to target our
    youth and other vulnerable populations. These restrictions would
    decrease the number of new tobacco users, particularly children, since
    the vast majority of smokers start before they turn 18. In addition,
    the larger health warnings, as have been used in other countries, and
    the elimination of false and misleading health claims would encourage
    more people to quit. Product disclosure would allow the public, for the
    first time, to understand how tobacco companies manipulate the
    ingredients and additives in their product in order to increase
    addiction without regard for the harm of the user. Overall, the
    proposed legislation will help discourage new users, encourage quitting
    and ultimately save lives. Tobacco use is the most preventable cause of
    death and disease in this country and granting the FDA the authority to
    regulate tobacco is the key prevention measure missing in order to
    reduce tobacco's deadly toll on our Nation.

        Question 3. In what way will reducing the nicotine levels in
    cigarettes improve the public's health, since we know that when
    nicotine levels are reduced, smokers compensate by smoking more? Won't
    this approach in fact hurt the public's health?
        Answer 3. Most tobacco cessation products rely on the principle of
    weaning the tobacco user away from nicotine addiction by reducing the
    dosage level over time, and therefore have been effective for so many
    people. Reducing the addictive nicotine levels in cigarettes improves
    an individual's chance at stopping smoking. We know that tobacco
    companies have purposefully manipulated nicotine levels in order to
    prevent smokers from quitting. The proposed legislation would permit
    the FDA to determine the level of and way nicotine is introduced in
    tobacco products, as well as create new standards, based on the overall
    impact on public health. These performance standards would be the
    primary way in which the FDA would require tobacco products to be less
    harmful and less addictive. Without the proposed legislation, the
    tobacco companies will continue to manipulate nicotine levels to
    encourage new, young smokers to start and keep current smokers from
    quitting.
      Response to Questions of Senator Enzi, Senator Burr, Senator Hatch,
                  and Senator Coburn by Richard Land, D.Phil.
                           questions of senator enzi
        Question 1. The content of the bill before us has seen little if
    any change over the years, and I think we can do better. Do you have
    any suggestions for how the bill could be made even more effective in
    preventing youth smoking and helping current smokers to quit?
        Answer 1. We believe S. 625, in its present form, includes the
    necessary tools to significantly reduce tobacco consumption among our
    youth and help addicted smokers break their habit. The fact that the
    bill has few substantive changes from versions introduced in previous
    Congresses does not necessitate that it be modified. Congress simply
    has not given the FDA opportunity to prove the effectiveness of the
    bill. If the bill had been enacted into law several years ago and
    little progress had been made in efforts to prevent or curb the use of
    tobacco among Americans, particularly our youth, then Congress would
    have legitimate reason to revisit the legislation and determine what
    provisions need to be strengthened, added, or removed. While probably
    every member of Congress would like to reduce tobacco use among
    children, we cannot fall prey to the trap of making the perfect enemy
    of the good. We believe the current provisions would provide sufficient
    means to scale back tobacco use significantly, especially among youth.

        Question 2. Certain brands are especially preferred by youth
    smokers, even though most advertising to children is prohibited. I can
    imagine that even with further restrictions on advertising as proposed
    in this bill, kids will still prefer certain brands, because that's the
    nature of fads and trends. This could further consolidate the market in
    the hands of the biggest players, who would then be even more well-
    known among youth, perpetuating the brand preferences. How does this
    bill address that market consolidation and youth smoking spiral?
        Answer 2. While the companies that signed the Master Settlement
    Agreement agreed not to market to kids, there are actually few
    restrictions on advertising to children or anyone else in the MSA.
    Analysis of the MSA reveals that less than 20 percent of the marketing
    and promotional expenditures of the tobacco companies were affected at
    all. The major cigarette companies have more than doubled their
    marketing and promotional expenditures in the years since the MSA to an
    annual total of more than $15 billion,\47\ or more than $40 million
    each day, and much of it still reaches kids. Tobacco advertising in
    youth-oriented magazines actually increased by more than 30 percent in
    the year after the MSA was signed,\48\ and tobacco companies continue
    to reach kids through magazines, retail point-of-sale marketing, sports
    sponsorship, and other venues. It's no wonder that kids are almost
    twice as likely as adults to recall tobacco advertising.\49\ Even the
    so-called youth prevention campaigns by tobacco companies have been
    shown to encourage kids to smoke.\50\
    ---------------------------------------------------------------------------
        \47\ U.S. Federal Trade Commission (FTC), Cigarette Report for
    2003, 2005 [data for top six manufacturers only].
        \48\ Bowker, D & M Hamilton, ``Cigarette Advertising Expenditures
    Before and After the Master Settlement Agreement: Preliminary
    Findings.'' May 15, 2000; and Fairclough, G., ``Are Cigarette Ads in
    Magazines Angling for Teens?'' The Wall Street Journal (May 15, 2000).
        \49\ National telephone survey of 510 teens aged 12 to 17 and 1,012
    adults conducted by International Communications Research (ICR), March
    2007.
        \50\ Wakefield, M., et al., ``Effect of Televised, Tobacco Company-
    Funded Smoking Prevention Advertising on Youth Smoking-Related Beliefs,
    Intentions, and Behavior,'' American Journal of Public Health
    96(12):2154-2164, December 2006.
    ---------------------------------------------------------------------------
        S. 625 will actually subject all tobacco companies and all brands
    to the same marketing restrictions, whereas that is not the case under
    the MSA, as not all companies are parties to the agreement. While this
    should create a level playing field across all manufacturers, our real
    concern should not be what brands kids smoke but how many kids smoke at
    all. Twenty-three percent of high school kids still smoke.\51\ While
    this represents more than a 35 percent decline in high school smoking
    since 1997, largely brought about by price increases (due to increased
    tobacco taxes and MSA costs passed on to smokers) and the impact of
    State tobacco prevention programs, this decline has slowed or stalled
    in recent years, and the most recent data show a small increase in
    youth smoking. This stalled progress no doubt reflects the aggressive
    marketing by the tobacco companies.
    ---------------------------------------------------------------------------
        \51\ U.S. Centers for Disease Control and Prevention (CDC), ``Youth
    Risk Behavior Surveillance, United States, 2005,'' Morbidity and
    Mortality Weekly Report (MMWR), June 9, 2006 55 SS-5.
    ---------------------------------------------------------------------------
        The evidence is very clear, despite industry claims to the
    contrary, that tobacco marketing affects not only brand choice but
    initiation of smoking. A 2002 monograph by the National Cancer
    Institute, which reviewed the research on tobacco advertising and
    promotion and its impact on youth smoking, found that tobacco
    advertising and promotional activities are important catalysts in the
    smoking initiation process. The NCI report also found, based on a
    review of the extant research, that ``the conclusion that there is a
    causal relationship between tobacco marketing and smoking initiation
    seems unassailable.'' \52\ The marketing restrictions in S. 625 are
    designed to reduce youth exposure to the kind of marketing that leads
    to increased smoking among kids.
    ---------------------------------------------------------------------------
        \52\ National Cancer Institute, Changing Adolescent Smoking
    Prevalence, Smoking and Tobacco Control Monograph No. 14, NH Pub. No.
    02-5086, November 2001.

        Question 3. You indicate that your support for this bill comes from
    a desire to treat tobacco no differently than other consumer products.
    Yet this bill sets up a radically different set of standards and
    regulations for FDA authorities over tobacco. Can you explain to me how
    you believe the proposed standards for tobacco regulation are the same
    as for other consumer products?
        Answer 3. The Southern Baptist Ethics & Religious Liberty
    Commission believes FDA regulation of tobacco products is long overdue.
    Astonishingly, tobacco products remain the most deadly but least
    regulated of all consumer products. The FDA can ensure the safety of
    everyday items, but has no authority over tobacco, a product that
    causes more preventable deaths than any other. Tobacco products are the
    only consumer products that, when used as directed by the manufacturer,
    kill half of their users. Thus, the standard used by the FDA to
    evaluate tobacco products cannot be the same standard it uses to
    evaluate other consumer products. S. 625 recognizes the uniquely lethal
    nature of tobacco products and that these products can never be ``safe
    and effective.'' Instead, S. 625 appropriately applies a ``public
    health'' standard, which allows the Secretary to take actions it
    believes will protect the public health and reduce the number of people
    who suffer and die from tobacco.
        Although the FDA will apply a different standard to evaluate
    tobacco products, it will rely on the same procedures, staff expertise,
    and experience to analyze and evaluate tobacco products that it uses to
    evaluate the health impact of other products on consumers.
        The ``public health'' standard used in this legislation will
    protect consumers. It will reduce smoking, especially among children,
    and reduce the tremendous toll of tobacco on our families. We fully
    support these goals.
                            question of senator burr
        Question. How is keeping tobacco products on the market in the best
    interest of the public's health? Please provide a direct answer to this
    question.
        Answer. We do not advocate removal of tobacco from the market, but
    instead believe FDA regulation is the most significant means to protect
    public health. A tobacco ban could prompt contraband trafficking and
    black market sales of the prohibited tobacco products. Additionally, a
    tobacco ban lacks sufficient congressional and public support, partly
    due to our Nation's experience with a ban on alcohol. History shows
    that Prohibition in the 1920s and early 1930s was not sustainable
    largely because alcohol consumption was a personal habit very
    widespread among adults. Outlawing tobacco, also a widely used product,
    would receive a similar negative reaction from a minority of the
    public. Additionally, while tobacco is an incredibly destructive
    product, it does not debilitate the user in the same way that illicit
    drugs do. A person can still perform his or her job and function safely
    while using tobacco. Instead, we want to find ways for people who
    choose to use tobacco to experience less harm from and less
    dependability on the product. We also want to help safeguard children
    from being targeted by tobacco marketing.
                           questions of senator hatch
        Question 1. There has been a growing tendency both at the Federal
    and at the State level to use monies generated from tobacco taxes for a
    variety of legislative purposes that are not directly connected to
    anti-smoking campaigns, some of which are very legitimate initiatives.
    Let's assume two scenarios. First, Congress bans cigarettes tomorrow
    and the ban works. We are no longer able to rely upon any revenues,
    either at the Federal or the State level, from the sale of tobacco. If
    such a ban took place, what would be the budgetary shortfall that we
    would have to make up? Second, let's assume the legislation before the
    committee is enacted, which is intended, among other things, to result
    in a reduction of the sale of cigarettes. What is the budgetary
    shortfall we can expect if the current bill is enacted at both the
    Federal and State level?
        Answer 1. The Southern Baptist Ethics & Religious Liberty
    Commission does not possess the expertise to answer the question of
    revenue effects as a result of FDA regulation of tobacco. We feel
    confident, however, that the loss of revenue would be offset to some
    extent by a reduction in demand for State-funded public health and
    other services. Healthier people will cost the State less to care for.
    A healthier workforce will also lead to greater productivity, which
    will generate more tax revenue for the State. Additionally, families
    will be strengthened. More children will experience the positive
    benefit of having two healthy parents over the entire course of their
    childhood. More children in single-parent homes will experience the
    positive benefit of living with that parent their entire childhood.
    These healthier parents will have greater opportunity to provide for
    the financial wellbeing of their families, reducing the demand on the
    public welfare system. Children raised in these more stable
    environments will be less likely to live in poverty, and will
    subsequently be less likely to exhibit the effects of poverty, such as
    crime, poor health, lack of education, and substance abuse. It is less
    likely that these children, and the adults they will become, will
    require the same degree of care by government as a result, thereby
    reducing the need for tax revenue.

        Question 2. Unfortunately, one of the consequences of the increased
    regulation of cigarettes, as well as an increase in the cost, has been
    a burgeoning black market in cigarettes. Again, the legislation is
    intended, among other things, to discourage smoking, as well as the
    smoking of cigarettes at current levels of nicotine. What provisions
    are included in the bill that will enable the FDA to combat not only
    the illegal sale of cigarettes in general but the possibility of a rise
    in the illegal shipment of cigarettes into this country?
        Answer 2. This legislation will not contribute to the sale of
    tobacco products on the black market. Indeed, it contains provisions
    expressly designed to curtail illegal tobacco product sales, including
    the sale of contraband tobacco products. There is no reason to believe
    that this bill will result in additional illegal sales. Further, the
    legislation gives the FDA the authority to evaluate the overall impact
    of any action it takes on the public health based on a population-based
    analysis. Thus, it is broad enough to allow the FDA to evaluate all
    factors, including black market sales, that impact the number of people
    who will die from using tobacco.
        What is clear is that in the absence of this legislation and
    stringent regulation of tobacco products, more than 400,000 Americans
    continue to die each year from tobacco use. This bill provides a
    critical additional tool in the battle to reduce that number.
                          questions of senator coburn
        Question 1. What constituents would you recommend that the FDA
    require to be eliminated or reduced in cigarettes, and by how much
    would that reduction or elimination reduce the relative risk of
    tobacco-related diseases?
        Answer 1. The Southern Baptist Ethics & Religious Liberty
    Commission does not possess the expertise to recommend elimination or
    reduction of the various components in cigarettes. We believe the FDA
    needs to make those determinations.

        Question 2. How will smokers alter their behavior in response to
    the introduction of cigarettes with new tobacco product standards? That
    is, what will be the effect on cigarette consumption of smokers now
    knowing that the FDA is tightly regulating all the constituents and
    ingredients in cigarettes?
        Answer 2. FDA regulation of tobacco would likely cause smokers to
    more closely evaluate their decision to smoke and prompt many of them
    to abandon the habit. Most smokers have little idea of the number of
    carcinogens and additives within tobacco products. Disclosure of these
    substances and the addition of meaningful warning labels, however,
    would awaken many people to the dangers of tobacco use. Further, the
    legislation would allow the FDA to require manufacturers to adopt
    feasible technologies to reduce or eliminate harmful ingredients,
    thereby scaling back the health risks to those who continue to smoke.
    Reductions of nicotine levels would make it easier for millions of
    Americans who have tried unsuccessfully to quit smoking to actually
    drop the habit. Possibly most important, the legislation would help
    produce future generations of adults that are not addicted to
    cigarettes. By limiting marketing and sales of tobacco to children,
    countless young people will never try cigarettes and so will never
    begin lives of nicotine addiction.

        Question 3. In what way will reducing the nicotine levels in
    cigarettes improve the public's health, since we know that when
    nicotine levels are reduced, smokers compensate by smoking more? Won't
    this approach in fact hurt the public's health?
        Answer 3. While nicotine consumption is obviously the principle
    reason that people smoke, and we are concerned about addiction to
    nicotine in the same way we are concerned about any other addictions,
    we believe the more important issue relates to the chemicals,
    additives, and processes involved in delivering nicotine through
    tobacco use. We think it should be the responsibility of the FDA to
    determine the type and degree of danger to which smokers are exposed by
    the various components and additives in tobacco as they try to reach a
    particular level of nicotine intake.
     Response to Questions of Senator Kennedy, Senator Enzi, Senator Burr,
         Senator Hatch, and Senator Coburn by Jack Henningfield, Ph.D.
                          questions of senator kennedy
        Question 1. In your testimony, you emphasize that ``FDA is the
    right agency and the only agency'' with appropriate experience ``to
    regulate tobacco products since cigarettes are drug delivery products
    at heart.''
        You contrast this with the lack of appropriate expertise at the
    Federal Trade Commission that led to its adoption of a misleading
    system for measuring the level of tar and other toxins in cigarettes.
    Please elaborate on how FDA's expertise can be used to help protect the
    public from the dangers of smoking.
        Answer 1. The FDA was established for the primary purpose of
    protecting the public health through regulation of a broad range of
    products on the basis of their contents, designs, delivery of
    substances and on health effects. Its regulation through product
    performance standards, allowable ingredients, claims, branding
    representations (e.g., ``fresh orange juice'') and other communications
    are intended to serve public health. Major staffing of the FDA are the
    many scientists and public health experts whose mission is to
    contribute to the improvement of public health through science-based
    product regulation. They work with communications experts, legal
    counsel and others to ensure that products are appropriately labeled,
    advertised and regulated so as to serve public health interests
    including minimizing hazardous exposures.
        In fact, historically, for most food products, FDA's role was
    primarily to prevent adulterated products and reduce toxic exposures
    whether or not a specific health benefit was intended. For the last 20
    years, however, FDA has conducted pre-
    market evaluations of proposed health claims for foods. In the case of
    drug products the additional burden of beneficial health effect is
    required. In virtually all cases, some level of risk is allowed to
    enable benefits and/or accommodate what is feasible from a practical
    and commercial perspective (e.g., level of ``purity'' or maximum
    allowable standards for insect parts, pesticide residues and other
    contaminants such as formaldehyde in flour). In the case of drugs, most
    can incur serious adverse health consequence and are not considered
    absolutely safe (e.g., OTC pain relievers may cause more than 15,000
    deaths per year) but their allowance for marketing is considered on the
    basis of their overall public health impact.
        In sharp contrast, the FTC was established, initially as the
    ``Bureau of Corporations'' with a core mission--the regulation and
    protection of free and fair commercial trade through support of
    competitive markets and restrictions. This of course, includes
    advertising, branding and product claims. Moreover, FTC regulates
    marketing of many products which are also or primarily regulated by FDA
    but it generally defers to FDA on aspects of those products pertaining
    to health effects. In contrast to FDA's staffing by scientists and
    public health experts, major staffing of FTC are economists and lawyers
    who focus largely on issues such as compliance with the law and serving
    to enhance free, fair, and competitive trade--not public health.
        With its focus on health protection, through regulation of tobacco
    products FDA will have its extensive history, expertise of its many
    scientists and regulators, and decades of precedents in regulation of
    foods, drugs, cosmetics and other substances that can be brought to
    bear in regulating tobacco products in such a way as to lead to
    decrease adverse health effects (including, in principle, addiction)
    and even to decrease use of some or all products.

        Question 2. Even though cigarettes will never be safe to smoke and
    our primary goal is to stop people from smoking, you believe that it's
    important for the FDA to have the power to set ``performance
    standards'' regulating the ingredients in cigarettes and how they are
    made. Over time, FDA could require many changes in the design and
    contents of cigarettes currently on the market and of new brands to
    make them less toxic and/or less addictive by issuing performance
    standards. Please explain how these performance standards would benefit
    those who do smoke, and those exposed to secondhand smoke. Give us a
    few concrete examples of the type of standards that FDA might adopt.
        Answer 2. The principle value of product performance standards will
    be to reduce or prohibit the use of added ingredients (e.g., ammonia,
    menthol, chocolate), materials in composition (e.g., glass fibers), and
    design features (e.g., hidden ventilation systems) which may increase
    toxicity and/or addiction. Standards may be set for ingredients in the
    product as well as its emissions such as constituents of ``tar,'' and
    toxic gases such as carbon monoxide.
        Standards that lead to decreased smoke exposure and or toxicity
    have the potential to reduce secondhand smoke exposure and/or the toxic
    consequences of secondhand smoke exposure. For example, if FDA
    determines that chocolate is not necessary for cigarette manufacture
    and consumption but may contribute to carcinogenicity and or risk of
    becoming addicted it could limit or ban chocolate. Similarly, if FDA
    determined that menthol increased toxic exposures by virtue of its own
    effects or by enabling deeper lung exposure of other toxins, and/or
    increased liability to addiction it could restrict or ban menthol. If
    FDA determined that hidden ventilation holes contributed to consume
    deception and/or adverse health effects it could ban their use or
    require clear demarcation and warnings. FDA could restrict nicotine
    content and/or form of delivery (e.g., free-base fraction). Setting
    standards for maximum allowable nicotine, perhaps based on current
    product levels is consistent with other efforts to prevent products
    from becoming even more toxic and/or addictive. In all of these cases,
    FDA actions would be based upon its science-based assessment of the
    potential for the standards to contribute to public health through
    reduction of toxic exposures.
        Please note two additional clarifications regarding nicotine
    regulation: (1) Although it is true that nicotine is not the primary
    ingredient in tobacco that causes adverse health effects (other than
    addiction), nicotine is not without risk, and this is why nicotine in
    medicines such as nicotine gum is carefully regulated to ensure that
    levels do not exceed acceptable standards for safety. Thus, the maximum
    allowable dose of nicotine in nicotine gum is 4 mg of which about 2 mg
    is typically delivered. This is in contrast with a conventional
    cigarette that contains about 10 mg nicotine and can easily deliver 2-3
    mg of nicotine; a ``pinch'' of the most popular brands of snuff can
    contain and deliver 10 mg or more of nicotine. (2) Although it is
    theoretically possible to reduce tobacco and tobacco toxin exposure by
    increasing nicotine levels, it is not known how much nicotine
    supplementation in tobacco would be required to reduce tobacco intake
    sufficiently to reduce adverse health effects of contaminants. Whether
    reducing nicotine would contribute to public health has not been
    determined; therefore, the bill does not compel FDA to reduce nicotine
    levels but appropriately gives FDA the power to regulate nicotine
    levels based on public health considerations.

        Question 3. In your testimony you emphasize that ``One key feature
    of the legislation is that mere compliance with a performance standard
    cannot be used as the basis for product claims.'' This is extremely
    important to prevent the public from being misled. What safeguards can
    be implemented to prevent tobacco companies from making claims based on
    compliance with these standards.
        Answer 3. The FDA has a long history of preventing products from
    being misbranded and marketed (including labeling and advertising) with
    implicit or explicit claims that can foster inappropriate use. For
    example how cholesterol levels of food are communicated, the definition
    of ``cholesterol free'' and what communications are allowed in
    marketing (including labeling, branding, and implicit and explicit
    claims) has been extensively evaluated by FDA and is regulated so as
    not to contribute to excess exposure even if a product meets the
    standard for ``cholesterol free.'' To achieve these goals, FDA has a
    variety of tools and precedents at its disposal: it can require
    sponsors to conduct studies and present data on consumer reactions and
    actual patterns of use, FDA can conduct its own consumer research to
    determine how consumers interpret communications, and FDA can require
    companies to collect and report findings after the product is marketed
    and/or collects its own data.
        Thus, for example, FDA may develop its own mandatory warning
    stipulating that its allowance of the product to be marketed does not
    imply safety and in fact that the product carries a very high risk of
    addiction, lung cancer and heart attacks. Such a statement combined
    with powerful new health warnings (that will also be regulated and
    changed as necessary by FDA) should lead to appropriately increased
    consumer concerns about tobacco use, not to diminished concerns. To
    assure that these goals were achieved and were not undermined by
    unintended consequences, FDA could obtain post-market surveillance data
    through a variety of mechanisms at its disposal. This is all consistent
    with FDA's increasing requirements for risk management programs, which
    involve assessing potential risks, requiring marketing to be developed
    so as to minimize risks, and requiring that marketing efforts be
    designed to minimize the risks. Furthermore, post-marketing
    surveillance could be used to detect unintended consequences in a
    timely fashion so as to guide corrections in regulatory approach and
    marketing.

        Question 4. In your testimony, you say that without FDA regulation,
    smokers who want to quit will increasingly turn to ``new tobacco
    products that falsely claim (at least implicitly) to be less harmful.''
    We are seeing more and more of these products making unproven claims
    entering the market today. Under S. 625, no such reduced risk claims
    could be made unless the FDA verified the accuracy of the claim, and
    determined that it would not be misleading to consumers. That is a very
    important safeguard for the public, is it not? Describe the type of
    process FDA scientists would go through to determine whether a new
    product really reduced the risk in a meaningful way?
        Answer 4. This is among the most vital safeguards. Even though
    conventional cigarettes remain the most important cause of death and
    disease among all tobacco products, all of the major companies are
    investigating and test marketing products that could replace
    conventional cigarettes in the future. We must avoid the mistake made
    with ``light'' and ``reduced tar and nicotine'' cigarettes, as well as
    filters. These so-called innovations falsely reassured smokers,
    undermined prevention and cessation, and ultimately escalated annual
    tobacco attributed mortality, including lung cancer, in the latter
    quarter of the 20th century. All of this happened even as advertised
    tar levels declined. Preventing such a public health disaster from
    recurring is more likely with FDA regulation than with a perpetuation
    of the unregulated tobacco marketplace. This role of FDA becomes more
    vital with each passing day, as new products and product claims from
    the implicit (e.g. ``Marlboro Ultra Smooth'' with its ``Filter Select''
    banner) to the more explicit (e.g. Eclipse, claiming that ``compared to
    other cigarettes Eclipse may present smokers with less risk of cancer,
    chronic bronchitis and possibly emphysema.'')
        FDA can require full disclosure of data regarding ingredients and
    can require both testing by sponsors and post-marketing data collection
    to ensure that claims are not allowed until the agency is satisfied
    that they are appropriate and justified. Equally important, if allowed
    claims lead to unintended consequences the agency has a variety of
    tools at its disposal such as communications to address the problem,
    prohibiting sales, or immediate recall of products in the marketplace.
                           Questions of Senator Enzi
        Question 1. You state over and over in your testimony that whatever
    tests or standards there are, companies will use this as a marketing
    tool. Why will FDA regulation be any different?
        Answer 1. The Food and Drug Administration is charged with
    protecting the public health. In its day to day regulation of a broad
    range of consumable products and drugs, it does this through
    coordinated regulation of both product contents, often through
    performance standards, and allowable labeling and marketing. FDA can
    take a wide range of actions when companies label and/or market
    inappropriately. For example, FDA has recalled and taken action against
    orange juice that was made from frozen concentrate but advertised as
    ``fresh'' and apple juice for infants that was actually artificially
    flavored and colored sugar water. These are but two of thousands of
    examples of FDA actions over the years to ensure that products are not
    labeled, marketed or branded in misleading ways.
        The examples posed by Dr. Blum of misleading advertisements using
    FTC tar and nicotine ratings and descriptors such as ``lights'' are
    examples of practices that occur in the absence of effective product
    regulation. Under the legislation, FDA would have the power to prohibit
    these practices. As this bill makes clear, FDA's regulatory tools will
    include regulation of marketing, labeling, claims, and warnings to
    ensure that appropriate messages are communicated. FDA can also require
    post-marketing research and surveillance when it has concerns; it can
    inspect production facilities, and obtain company product manufacturing
    documents. Furthermore, other organizations and individuals undoubtedly
    will conduct post-marketing research to determine the effectiveness and
    appropriateness of messages and whether unintended consequences are
    occurring. Such data can be brought to the FDA's attention in the form
    of additional comments to a rulemaking record or petitions for policy
    change that the agency must consider.

        Question 2. You said in your testimony that performance standards
    should be developed for all smoke constituents. I have heard figures
    for the number of constituents that range from dozens to hundreds. That
    seems like a lot of performance standards just for smoke constituents,
    never mind for nicotine, filters and additives. Would the result of all
    these regulations really be a safer cigarette?
        Answer 2. The Food and Drug Administration has many tools at its
    disposal including the establishment of advisory committees to
    prioritize targets for performance standard setting, even as the World
    Health Organization is presently undertaking to assist nations which
    are implementing the International Framework Convention on Tobacco
    Control (``Tobacco Treaty''). Performance standards are not designed to
    produce a safer cigarette but to reduce the delivery of toxins in
    existing and new products.

        Question 3. You mention the importance of stopping tobacco sales to
    children. Every State already prohibits the sale of tobacco products to
    anyone under the age of 18. These laws have been effective--reducing by
    half the number of children purchasing these products in the past
    decade. Why is FDA the appropriate agency to enforce these laws and
    what is gained by doing so? Don't we run the risk of derailing
    regulations that are already working?
        Answer 3. Model approaches to reduce access to tobacco products by
    persons under 18 years of age were developed by FDA in the process of
    its 1990s Tobacco Rule development and initial phases of
    implementation. I would submit that FDA understands, better than any
    agency, how to best achieve these goals, building on limited success in
    recent years to achieving the level of reduction of access that is
    needed in the future. An FDA program would also ensure uniform and
    consistent enforcement of youth access restrictions. In the past,
    consistent enforcement among States has been a problem.

        Question 4. I think the bill sets an extremely high bar for the
    approval of a reduced risk product. In fact, I think it might call for
    clinical trials. Do you think it will be possible to get Institutional
    Review Board (IRB) approval for studies to determine if a tobacco
    product really represents a reduced risk? If that is not possible, how
    else might an application for the approval of a reduced risk product be
    supported with data?
        Answer 4. Approval of a new product for marketing and/or claims for
    a reduced risk product (be they new products or modifications of
    existing products) should be in accordance to high standards to prevent
    debacles such as occurred with so-called ``light'' and ``reduced tar''
    cigarettes and the ongoing ``snake'' oil type of marketing that is
    occurring with some new products absent FDA regulation.
        Evaluation of such products will presumably be done on the basis of
    review of actual ingredients (all ingredients and not just substances
    that the tobacco industry calls ``additives'' and ingredients) as well
    as emissions from the product to which the person is actually exposed
    when using the product. Therefore, this will also require chemical
    laboratory testing, in-vitro testing, and probably animal testing.
    Actual claims should be evaluated to the greatest extent possible in
    clinical trials involving human volunteers. At present, all over
    America, people are volunteering for and participating in studies
    involving tobacco self-administration. The studies include NIH
    supported studies at universities and organizations such as Battelle,
    and are subject to review and approval by human subjects review boards.
    The tobacco industry has a long history of such testing and presently
    supports some testing that is conducted at universities under IRB
    review, at Battelle, and probably in its own laboratories, although I
    have no way of knowing what sorts of human subjects protections are
    being followed in their own laboratories.

        Question 5. You indicate that machine testing of factors such as
    nicotine yield is not an accurate indicator of what happens when a
    human being smokes. If that is the case, what would a product standard
    for tobacco be based upon? Or are you proposing these standards be
    based on technology you believe to be flawed?
        Answer 5. I concur with leading investigators and the World Health
    Organization that the FTC Method and its similar international variant,
    the ISO or International Standards Organization method (which was based
    largely on the FTC method), are seriously flawed and should be
    abandoned. Even a preliminary examination of the method by the FDA
    during its Tobacco Rule development led it to the conclusion that the
    FTC method was flawed but at the time it issued the Proposed and Final
    Rules, the FTC had announced that it was taking actions to study the
    problem and resolve it. It was not until after the FDA lost its
    regulatory authority that the FTC essentially walked away from the
    method with an announcement on its Web site--I believe in 2001--that it
    would no longer disseminate the results. Yet, absent regulation, the
    tests are still done by the tobacco industry and provided in
    advertising.
        New standards are under evaluation through a consortium of
    approximately 30 laboratories throughout the world, including the
    Centers for Disease Control and several NIH funded laboratories in the
    United States. FDA, with its extensive history in performance standard
    development could help ensure that new standards are accurate, fair and
    viable.
                           Questions of Senator Burr
        Question 1. How is keeping tobacco products on the market in the
    best interest of the public's health? Please provide a direct answer to
    this question.
        Answer 1. Although few in public health would probably disagree
    with the premise that the world would be better without tobacco
    products as they have been made, marketed and used, we have them and
    there is few viable ways to remove them in the near future. Most would
    probably also agree that the status quo is unacceptable. These are my
    positions as well, but what is embodied in your question is what we
    must do. Here my position is clear and is consistent with other leading
    health organizations in the United States and the World Health
    Organization: namely to institute science-based health-focused tobacco
    product regulation.
        This is an effort to address the reality that at least for the
    foreseeable future, I do not believe that banning tobacco is viable.
    FDA came to this conclusion itself in the development of its Tobacco
    Rule in the mid-1990s. These conclusions recognize that approximately
    50 million Americans are current cigarette smokers. By some estimates,
    nearly 40 percent of all cigarettes may be smoked by people with other
    psychiatric problems including depression, anxiety, thought disorder,
    and other substance dependence disorders and science-based medical
    interventions for addressing their tobacco use in the context of these
    other problems is in its infancy. Furthermore, for many people nicotine
    withdrawal is debilitating and is not compatible with their meeting
    occupational, social and family demands. This includes our military
    troops and many people in sensitive occupational positions that involve
    public safety. I believe that many of these people could be treated
    with existing pharmacological and behavioral treatments, but
    limitations in access to treatment prevent many in need of treatment
    from getting it.
        Many health care plans do not provide adequate coverage for
    existing treatment and tobacco addiction rates are highest among the
    lower income individuals who are least likely to have any health care
    coverage whether they are working or not (roughly 80 percent of the
    approximately 47 million person without health care do not work). For
    many of those with co-occurring psychiatric disorder, there are still
    unresolved questions as to how best to treat their tobacco addiction
    along with other disorders. These are just the scientific, medical, and
    health care delivery obstacles to attempting to ban tobacco product in
    the near future. The social, political, and potential contraband market
    issues that would arise are additional issues. Much of this was
    discussed in a paper that was commissioned by the American Medical
    Association and that I co-authored a few years ago (Henningfield, J.E.,
    Benowitz, N.L., Slade, J., Houston, T.P., Davis, R.M., Deitchman, S.
    Reducing the addictiveness of cigarettes. Tobacco Control, 7: 281-293,
    1998). I note that the FDA, in its Tobacco Rule development came to a
    similar conclusion about banning tobacco products. Further into the
    future, I believe and hope that within a few decades, the cigarette as
    we know it today will be a relic of the past and that we will be on our
    way to seeing lung cancer rates at the end of the 21st century become
    what they were at the end of the 19th century: a medical rarity.

        Question 2. Did you or did you not participate in the crafting of
    the World Health Organization's Framework Convention on Tobacco
    Control?
        Answer 2. No. I served on the World Health Organization (WHO) study
    groups that provided scientific evaluation of tobacco and health issues
    in the late 1990s, and I served on the WHO Scientific Advisory
    Committee on Tobacco Product Regulation (SACTob) from 2000 until 2004
    that was charged with providing WHO with scientific guidance on various
    issues that arose over the several year process of developing the
    Framework Convention on Tobacco Control (FCTC or ``Tobacco Treaty'').
    After the treaty was adopted, the SACTob was reconvened with a more
    substantial structure as the WHO Tobacco Regulation Study Group or
    TobReg, and I have served since that occurred in 2004. All of my
    participation has been in an advisory capacity. I played no role in
    crafting the FCTC.

        Question 3. Do you or do you not support the WHO's Framework
    Convention on Tobacco Control?
        Answer 3. Yes. I was encouraged that former Health and Human
    Services Secretary Tommy Thompson signed the treaty on behalf of the
    United States of American in 2004, and I hope that the President will
    request that the Senate ratify the treaty so that the United States can
    join the nearly 150 other nations, representing nearly 80 percent of
    the world population, which have ratified the treaty.

        Question 4. Is one of the main tenants of the WHO's Framework
    Convention on Tobacco Control to create an international, secretariat
    level, body that would control tobacco manufacturing, cessation
    programs, and production for all participating countries?
        Answer 4. No.

        Question 5. During the hearing, when I asked you did you support
    granting sovereign control of U.S. tobacco regulation to an
    international body, what was your answer?
        Answer 5. I have not seen the transcript, but I frankly did not
    understand the question because it seemed that you were questioning my
    support of the FCTC with a question about how the treaty operates. I do
    support the treaty, but it does not ``grant sovereign control of U.S.
    tobacco regulation to an international body,'' as I understand those
    terms. The treaty sets goals and develops standards as appropriate but
    recognizes that the more than 150 nations expected to ratify it will
    each need to find ways to comply that are consistent with their own
    systems of governance, commerce and regulation.
                           Questions of Senator Hatch
        Question 1. In your testimony, you say that we have made modest
    progress in reducing tobacco use and that FDA regulation of the tobacco
    industry have made the ``progress significantly greater.'' Could you
    elaborate on that statement?
        Answer 1. I will support my position with just a few examples.
        Youth access: The FDA initiated a national program to reduce
    tobacco sales to minors. The program effectively coupled enforcement
    with penalties for repeat violators. At its peak, I understand that
    200,000 compliance checks had been conducted and in excess of $1
    million collected from retailers who repeatedly and illegally sold
    cigarettes to minors. This entire system was discontinued after the
    2000 Supreme Court decision to remove tobacco from FDA's regulatory
    authority. I do not know how many children and adolescents who could
    have been prevented from developing addiction, but I believe that
    smoking and other tobacco among our young would be substantially less
    today had FDA been able to sustain its program.
        Warning labels: Many nations, including Canada and Australia, have
    adopted and evaluated much more aggressive health warnings that have
    been proven more effective in discouraging use and encouraging
    cessation among users than the decades-old approach that the United
    States still uses.
        FTC testing and the ``Light'' cigarette scam: The FTC never
    discovered, on its own, that its testing method was seriously flawed.
    FDA quickly determined that it was flawed in the course of its
    regulation development. Furthermore it was not until the 2001
    publication of National Cancer Institute Monograph 13 (Risks Associated
    with Smoking Cigarettes with Low Machine-Measured Yields of Tar and
    Nicotine) that our Nation formally recognized that light cigarettes
    were a deadly scam today accounting for the majority of tobacco-caused
    deaths. Yet nothing has been done to resolve this issue. FDA could act
    as other nations are to ban descriptors such as ``lights'' and provide
    strong and effective warnings.

        Question 2. Why does the FDA need to be the agency to regulate
    tobacco?
        Answer 2. If you review my answer to your first question, and my
    answers to all of Senator Kennedy's and Senator Enzi's questions, you
    will see why I believe that the Food and Drug Administration is the
    only agency with the technical, scientific, regulatory, and legal
    experience for regulating products that deliver biological active
    substances to the body and which has the improvement of health as its
    primary mission. Of course it would need to coordinate various parts of
    the effort with other agencies, including the Federal Trade Commission,
    Centers for Disease Control, Department of Agriculture, Environmental
    Protection Agency, and the National Institutes of Health. But this type
    of interagency collaboration has existed for decades when it comes to
    FDA's regulation of foods and drugs.

        Question 3. There has been a growing tendency both at the Federal
    and at the State level to use monies generated from tobacco taxes for a
    variety of legislative purposes that are not directly connected to
    anti-smoking campaigns, some of which are very legitimate initiatives.
    Let's assume two scenarios. First, Congress bans cigarettes tomorrow
    and the ban works. We are no longer able to rely upon any revenues,
    either at the Federal or the State level, from the sale of tobacco. If
    such a ban took place, what would be the budgetary shortfall that we
    would have to make up? Second, let's assume the legislation before the
    committee is enacted, which is intended, among other things, to result
    in a reduction of the sale of cigarettes. That is the budgetary
    shortfall we can expect if the current bill is enacted at both the
    Federal and State level?
        Answer 3. I have addressed why I do not believe banning cigarettes
    is right or feasible in my response to Senator Burr's first question.
    As to issues concerning budgetary shortfall and revenues, I simply am
    not qualified to answer whether the bill is passed or not and whether
    Congress attempts to ban cigarettes or not.

        Question 4. Unfortunately, one of the consequences of the increased
    regulation of cigarettes, as well as an increase in the cost, has been
    a burgeoning black market in cigarettes. Again, the legislation is
    intended, among other things, to discourage smoking, as well as the
    smoking of cigarettes at current levels of nicotine. What provisions
    are included in the bill that will enable the FDA to combat not only
    the illegal sale of cigarettes in general but the possibility of a rise
    in the illegal shipment of cigarettes into this country?
        Answer 4. I will address the elements of this question where I feel
    my expertise is relevant and defer to others on law enforcement and
    trade monitoring where I feel I have little to offer. As I mentioned in
    my explanation of why I do not support banning cigarettes and other
    forms of tobacco, I am concerned that this would foster contraband or
    ``black market'' sales (we also discussed this in the American Medical
    Association report cited above). Factors that fuel such markets are
    reduced access and substantially increased cost in the open market,
    while demand remains high. FDA regulation is expected to contribute to
    reduced demand and reduced consumption of tobacco products because its
    efforts should support prevention of initiation of use and encourage
    more users to quit. This should reduce pressures that foster contraband
    markets.
                          Questions of Senator Coburn
        Question 1. What constituents would you recommend that the FDA
    require to be eliminated or reduced in cigarettes, and by how much
    would that reduction or elimination reduce the relative risk of
    tobacco-related diseases?
        Answer 1. I believe that it would be premature to make specific
    recommendations for ingredient elimination, although I believe that
    many toxicants should be reduced if not eliminated. In fact, today's
    marketed products deliver highly toxic substances in quantities that
    vary widely across cigarettes, and includes carbon monoxide gas,
    tobacco specific nitrosamines, heavy metals, nitrosamines, agricultural
    residues (e.g., from pesticides and fertilizers). I believe that
    standards could be developed based on what the market place has already
    shown to be feasible. Under FDA's direction advisory committees could
    supplement internal evaluations to examine a wide range of substances.
    For example, added ingredients (e.g., ammonia, menthol, chocolate),
    materials in composition (e.g., glass fibers), and design features
    (e.g., hidden ventilation systems) which may increase toxicity and/or
    addiction should be considered. Standards may be set for ingredients in
    the product as well as its emissions such as constituents of ``tar,''
    and toxic gases such as carbon monoxide. Standards that lead to
    decreased smoke exposure and or toxicity have the potential to reduce
    secondhand smoke exposure and/or the toxic consequences of secondhand
    smoke exposure. For example, if FDA determines that chocolate is not
    necessary for cigarette manufacture and consumption but may contribute
    to carcinogenicity and or risk of becoming addicted it could limit or
    ban chocolate.
        In the first few years, I would not expect to see disease risk fall
    substantially, if at all, due simply to performance standards on
    ingredients, and that is why this aspect of regulation should be seen
    as simply one of my elements of comprehensive tobacco control that are
    needed short run and long run to reduce tobacco use and associated
    disease.

        Question 2. How will smokers alter their behavior in response to
    the introduction of cigarettes with new tobacco product standards? That
    is, what will be the effect on cigarette consumption of smokers now
    knowing that the FDA is tightly regulating all the constituents and
    ingredients in cigarettes?
        Answer 2. The effects will depend at least in part on how radically
    and how quickly products are changed and the nature and effectiveness
    of accompanying communications. The mid-century wholesale adoption of
    the niche market for cigarettes with filters is a powerful lesson in
    how quickly and massively tobacco users can adjust their behavior when
    there appears to be a health benefit. Unfortunately, in that case, lack
    of oversight of the health consequences (as FDA would have) meant that
    the filters provided reassurance to smokers but not necessarily actual
    health benefit. Fortunately the FDA has considerable experience in
    health communications and marketing regulation. However, many aspects
    of consumer behavior will be affected by the behavior of the tobacco
    industry itself as well as other factors such as increasing adoption of
    clean air laws by communities, cities and States.

        Question 3. In what way will reducing the nicotine levels in
    cigarettes improve the public's health, since we know that when
    nicotine levels are reduced, smokers compensate by smoking more? Won't
    this approach in fact hurt the public's health?
        Answer 3. As discussed in the American Medical Association
    commissioned paper cited above, and my testimony, I concur with the WHO
    and the FDA's own conclusion, in its 1990s Tobacco Rule which does not
    support near-term reduction of nicotine in cigarettes. We do not yet
    have the science base, the treatment infrastructure, the education or
    other elements in place to enable such action. Furthermore, with FDA
    regulation AND increased commitment to comprehensive tobacco control as
    outlined in reports by the Centers for Disease Control and Prevention
    and the WHO, it may not be necessary to eliminate nicotine from tobacco
    products. However, I believe it is vital that FDA have the power to
    reduce nicotine levels to below a threshold level of addiction as one
    of its regulatory approaches. But the agency will need to be in a
    position to help drive the science and to monitor progress and effect
    of regulation--intended and unintended--and to thereby determine if
    such an approach would be warranted.
     Response to Questions of Senator Kennedy, Senator Enzi, Senator Burr,
     Senator Hatch, and Senator Coburn by Gregory Connolly, D.M.D., M.P.H.
                          question of senator kennedy
        Question. You conducted a study into how consumers perceived the
    implied claims tobacco companies are making about the reduced health
    risks of their products. Can you elaborate on what the public
    understanding is when they see these claims, and would you give use a
    few examples of the types of claims currently being made.
        Answer. We examined smokers' responses to advertisements for
    potentially reduced exposure tobacco products (PREP), light cigarettes,
    and regular cigarettes. A convenience sample of 600 adult smokers
    reviewed one actual advertisement for each type of product. Smokers
    ranked the products on health risk, amount of tar, and carcinogenicity,
    and identified the messages they perceived the advertisements to
    convey. Smokers perceived PREP products as having lower health risks
    and carcinogens than Light or regular cigarettes.
        Although no advertisements explicitly said that the products were
    healthy or safe, advertisements for PREP products and light cigarettes
    were interpreted as conveying positive messages about health and
    safety. Most smokers believed that claims made in cigarette
    advertisements must be approved by a government agency. The results
    indicate that advertisements can and do leave consumers with
    perceptions of the health and safety of tobacco products that are
    contrary to the scientific evidence. Explicit and implicit advertising
    messages may be strengthened by the perceived government endorsement.
    This supports the Institute of Medicine's recommendation to regulate
    the promotion, advertising, and labeling of PREP tobacco products and
    light cigarettes. Effective regulation should focus on consumer
    perceptions resulting from advertisements rather than the explicit
    content of advertising text.
        Example of PREP advertising we studied include Eclipse. It used the
    slogan ``The best choice for smokers who worry about their health is to
    quit. Here's the next best choice.'' Although this was not an explicit
    claim smokers perceived it to equate with a claim for reducing their
    risk of disease.
        A second ad was for Omni. The slogan for this brand was ``There's
    only one brand that significantly reduces carcinogens. Made you look!''
    Although this ad only referenced a reduction in cancer causing agents
    and not a reduction in actual cancer risk it still was perceived by
    smokers as a claim of reduced cancer risk.
                           questions of senator enzi
        Question 1. The bill assumes tobacco industry user fees will pay
    for the regulation of the tobacco industry. The prescription drug user
    fee program also housed at FDA levies over $300 million per year in
    user fees to support over 1,500 employees. This is on top of hundreds
    of millions in appropriations and appropriations-funded employees for
    the drug center. A standard drug review takes 10 months. In contrast,,
    this bill would require the review of a reduced risk product, with an
    entirely different standard for approval, in 6 months. In addition,
    there are over 5,000 brand styles on the market today. The ``health
    information'' required for each brand or sub-brand under section 904 is
    extensive. I think it would take a lot of FDA employees to go through
    that data, never mind to do reviews of new products, otherwise it would
    just get warehoused and not be of much use to anyone. What is the basis
    for the user fee levels set in the bill, and how do we know if that is
    enough to support what the bill requires?
        Answer 1. The user fees in the bill would be used among other
    things to conduct needed independent research on conventional tobacco
    products and potentially reduced (tobacco) exposure products (PREPS).
    The bill would ramp up user fees from the initial amount to $300
    million per year, equal to the drug user fee program housed at the FDA.
    This level of funding appears adequate to carry out the provisions of
    the bill. This level of funding is not far different from what tobacco
    manufacturers are expending for research they conduct on PREPS. If FDA
    did regulate PREPs, the industry research would most likely be made
    available to the FDA and complement FDA funded research. The bill would
    also require the industry to conduct the bulk of testing on the design
    and emissions of conventional brand styles that are in the marketplace.
    There may be 5,000 brand styles in the market but realistically only
    1,000 are actually sold based on certifications by the New York Fire
    Prevention Office of Reduced Ignition Propensity Cigarettes in New
    York.
        Also, Canada requires extensive testing of toxic constituents in
    the tobacco and in smoke and CDC already receives ingredient lists for
    the companies as does Texas by brand. If these jurisdictions already
    receive this information, it should not be burdensome for FDA.

        Question 2. The data in your testimony regarding the targeting and
    uptake of menthol cigarettes to African-Americans, particularly young
    people, is amazing. This practice is abhorrent. However, section 909 of
    the bill that you support permits menthol to remain on the market. Why
    shouldn't menthol also be banned along with the rest of the flavored
    additives? Would you support changing the legislation to disallow
    menthol along with other flavorings? If not, why not?
        Answer 2. The bill will not include menthol in the list of banned
    ``candy'' flavors given the long history of menthol use in tobacco
    products. However, the FDA could reduce or ban menthol through a
    performance standard. Menthol is in all cigarettes at some level but
    only at high levels in brands that are advertised as mentholated. If
    FDA found menthol alone or high levels had an adverse effect on the
    public health, the Agency could reduce or ban it.

        Question 3. FDA's role is to assure the safety and effectiveness of
    medical products, not to tinker at the margins of regulating a product
    known to be harmful. What kind of public health message would we send
    if we directed FDA to regulate the tobacco industry and approve tobacco
    products?
        Answer 3. In our research we conducted among a panel of 600
    smokers, the vast majority believed a governmental agency approved the
    content of advertisements, including data on levels of toxins on PREPs.
    The FDA bill would protect consumers from current applied claims for
    reduced harm which they believe are explicit claims and approved by a
    governmental agency. FDA regulation will be an end to such claims.

        Question 4. In your testimony, you suggest that States lack the
    resources to aggressively counter tobacco use. How can that be possible
    given the levels of funding provided by the MSA?
        Answer 4. In my testimony, I stated that States lacked the
    resources and legal reach to regulate tobacco products. The resources
    would be both the scientific expertise as well as financial resources.
    If other States as Massachusetts did, assert FDA-like jurisdiction on
    tobacco products, the industry would likely litigate. Also, it may not
    be in the national interest to have 50 different approaches to tobacco
    product regulation.
                            question of senator burr
        Question. How is keeping tobacco products on the market in the best
    interest of the public's health? Please provide a direct answer to this
    question.
        Answer. The United States banned the sale of alcohol in the early
    part of the last century. The action did have a positive public health
    impact but also created unintended consequences of increased crime and
    other social problems. Given the fact that 45 million Americans smoke,
    this history would argue against an immediate, total ban of cigarettes.
    The legislation would allow FDA to gradually ``wean'' smokers off
    conventional tobacco products while providing alternate nicotine
    delivery devices that do not cause significant harm. This would be
    considered as a possible approach for the FDA.
                           questions of senator hatch
        Question 1. You have been repeatedly quoted as saying that the
    legislation would initially give ``Philip Morris a market advantage
    over its business rivals'' but eventually the bill ``could turn
    Marlboro into lard: legal but no one uses it.'' (Quotes are from a
    story in the Richmond-Times Dispatch, February 26, 2006.) Would you
    explain what this initial, if temporary, market advantage would be?
        Answer 1. The legislation empowers the FDA to curtail aggressive
    marketing of tobacco products to youth. After the Master Settlement
    Agreement, R.J. Reynolds Tobacco continued to advertise in magazines
    popular with youth, introduced candy flavored brands popular with young
    people, targeted black youth with new menthol brands and most recently
    young females with brands like Camel No. 9. To the extent the FDA bill
    restricts such reckless marketing, RJRT would lose market ``advantage''
    to Philip Morris. However, in the long term, the FDA bill should result
    in reduced sales of all brands regardless of the company and improve
    the public health.

        Question 2. There has been a growing tendency both at the Federal
    and at the State level to use monies generated from tobacco taxes from
    a variety of legislative purposes that are not directly connected to
    anti-smoking campaigns, some of which are very legitimate initiatives.
    Let's assume two scenarios. First, Congress bans cigarettes tomorrow
    and the ban works. We are no longer able to rely upon any revenues,
    either at the Federal or the State level, from the sale of tobacco. If
    such a ban took place, what would be the budgetary shortfall that we
    would have to make up? Second, let's assume the legislation before the
    committee is enacted, which is intended, among other things, to result
    in a reduction of the sale of cigarettes. What is the budgetary
    shortfall we can expect if the current bill is enacted at both the
    Federal and State level?
        Answer 2. First, no one is advocating a ban on cigarettes tomorrow
    and passage of such a law is extremely unlikely if not totally
    unrealistic. Making a projection on the State budgetary impact of a ban
    is equally unrealistic. If the current bill is enacted, the bill will
    result in a reduction of cigarettes sales and there is no doubt that
    the economic benefit in health or savings far out weight tax losses. We
    do not know what the reduction would be until the final bill is enacted
    and implemented. Cigarette consumption fell 50 percent between 1993-
    2004 in Massachusetts. The decline in Massachusetts taxes was offset
    with increases in the State tax rate and a redirection of consumer
    resources from cigarettes to healthy goods and services.
        Combined current Federal and State taxes are small in comparison to
    the economic burden that smoking has on the U.S. economy.

        Question 3. Unfortunately, one of the consequences of the increased
    regulation of cigarettes, as well as an increase in the cost, has been
    a burgeoning black market in cigarettes. Again, the legislation is
    intended, among other things, to discourage smoking, as well as the
    smoking of cigarettes at current levels of nicotine. What provisions
    are included in the bill that will enable the FDA to combat not only
    the illegal sale of cigarettes in general but the possibility of a rise
    in the illegal shipment of cigarettes into this country?
        Answer 3. There is a general provision in the bill for the FDA to
    seize mis-branded cigarettes which one would assume to be smuggled
    cigarettes not in compliance with standards established by the FDA. The
    provision of this law could be used to address contraband cigarette
    sales if the FDA law resulted in an increase in contraband sales. In
    1978, Congress passed the Contraband Cigarette Act which has been
    effective in reducing contraband cigarette sales. This law could be
    used to address any smuggling possibly created by the bill.
                          Questions of Senator Coburn
        Question 1. What constituents would you recommend that the FDA
    require to be eliminated or reduced in cigarettes, and by how much
    would that reduction or elimination reduce the relative risk of
    tobacco-related diseases?
        Answer 1. According to the Surgeon General's 2000 Report, tobacco
    manufacturers should eliminate or reduce a toxic constituent to the
    lowest level technically feasible but not make a claim that such
    reductions reduce health risks unless scientific study shows this. One
    example is the removal of tobacco specific nitrosamines (TSNAs) which
    cause cancer. Currently, smokeless tobacco manufacturers have reduced
    TSNA levels in smokeless tobacco that they promote as PREPs but don't
    do so for conventional brands which have up to 20 times the level of
    TSNAs than PREPs. The FDA could require them to do so for all products.
    Removing or reduction in toxins could take into account a fixed
    timetable for smokers to adapt to the changes.

        Question 2. How will smokers alter their behavior in response to
    the introduction of cigarettes with new tobacco product standards? That
    is, what will be the effect on cigarette consumption of smokers now
    knowing that the FDA is tightly regulating all the constituents and
    ingredients in cigarettes?
        Answer 2. Based on the New York experience with reduced ignition
    propensity Cigarettes (fire safer cigarettes) which were the only
    cigarette allowed for sale in the State as of July 2004, there will
    likely be little or no effect on smoker behavior if product design is
    changed. We examined cigarette consumption before and after the RIP
    requirement in New York and found no difference in consumption
    indicating product acceptance. FDA could take the same approach with
    requirements on other design features and allow time to phase in such
    changes so that consumers could adapt to the products.

        Question 3. In what way will reducing the nicotine levels in
    cigarettes improve the public's health, since we know that when
    nicotine levels are reduced, smokers compensate by smoking more? Won't
    this approach in fact hurt the public's health?
        Answer 3. We do not know how increasing or decreasing nicotine will
    affect the public health. As part of FDA regulation, research will be
    conducted to find this answer before nicotine levels are changed.
    Increasing nicotine and decreasing toxins in smoke or in the body
    doesn't necessarily correlate with a reduction in disease outcomes. For
    example, cardiovascular disease may be induced at very low doses of
    toxins.
        On the other hand, nicotine could be reduced to a level that is
    non-addictive (.3mg/g of tobacco), a level found in tomatoes. This
    could result in complete cessation of conventional cigarettes and a
    switch to nicotine products that have been shown not to cause harm.
     Response to Questions of Senator Enzi and Senator Hatch by Lisa Shames
                 U.S. Government Accountability Office,
                                         Washington, DC. 20548,
                                                        March 15, 2007.
    Hon. Edward M. Kennedy,
    Chairman,
    Committee on Health, Education, Labor, and Pensions,
    U.S. Senate,
    Washington, DC. 20510.

    Hon. Michael B. Enzi,
    Ranking Member,
    Committee on Health, Education, Labor, and Pensions,
    U.S. Senate,
    Washington, DC. 20510.

    Re: Posthearing Questions Related to the Regulation of Tobacco Products

        Dear Senators: On February 27, I testified before this committee at
    a hearing addressing the regulation of tobacco products. This letter
    responds to your request that I provide answers to followup questions
    asked after the hearing. Senator Enzi's and Senator Hatch's questions,
    along with my responses, follow.
                           questions of senator enzi
        Question 1. In 1998, as the Senate debated a major tobacco bill, I
    offered an amendment that would have directed the money paid into the
    National Tobacco Trust Fund by manufacturers and importers to Medicare,
    Medicaid and tobacco control and prevention. Half the money would have
    gone to Medicare, 25 percent to Medicaid, and 25 percent to tobacco
    control and prevention activities. Although the legislation eventually
    failed, I wonder what would have happened if we had applied that
    breakdown to the Master Settlement Agreement (MSA) funds. Are any
    States spending 25 percent of their MSA money on tobacco control and
    prevention activities?
        Answer 1. For fiscal year 2006, five States--Wyoming, Maine,
    Arkansas, Oklahoma, and Montana--reported that they planned to allocate
    over 25 percent of their MSA funds on tobacco control and prevention,
    with Wyoming reporting 35.9 percent of their funds, Montana reporting
    26.1 percent, and the others falling in between.

        Question 2. I'm interested in determining what portion of
    ``health'' spending by the States under the MSA is going toward the
    care of smokers and former smokers, and what portion is going to other
    health priorities. Can you discuss the breakdown of the ``health''
    category of State spending?
        Answer 2. While States provided examples of health programs, they
    generally did not provide a further breakdown of the percentages
    allocated to each specific example. However, Medicaid and insurance-
    related programs were two commonly-cited examples.

        Question 3. I learned a lot about the MSA and how States are
    spending the funds from your testimony, and much of what I learned
    worries me. Can it really be true that States would actually receive a
    decrease in MSA money if smoking goes down? It seems to me that is a
    perverse disincentive for States to do right with this money.
        Answer 3. The tobacco companies' annual payments are adjusted based
    on several factors contained in the MSA, including fluctuations in the
    volume of cigarette sales, inflation, and other variables, such as the
    participating companies' share of the tobacco market. Declining tobacco
    consumption alone would result in lower MSA payments than originally
    expected. Tobacco consumption has declined since the MSA was signed in
    1998--by about 6.5 percent in 1999 alone--mostly attributed to one-time
    increases in cigarette prices by the tobacco companies after the
    agreement took effect. Analysts project that, in the future, tobacco
    consumption will decline by an average of nearly 2 percent per
    year.\53\ As a result, tobacco consumption is estimated to decline by
    33 percent between 1999 and 2020.
    ---------------------------------------------------------------------------
        \53\ Cigarette consumption peaked in 1981 and has been declining
    since.
    ---------------------------------------------------------------------------
        However, the MSA also includes an inflation adjustment factor that
    some analysts have estimated increases payments more than any decreases
    caused by reduced consumption. The inflation adjustment equals the
    actual percentage increase in the Consumer Price Index for the
    preceding year or 3 percent, whichever is greater. The effect of these
    compounding increases is potentially significant, especially given that
    the payments are made in perpetuity. Assuming a 3-percent inflation
    adjustment and no decline in base payments, settlement amounts States
    receive would double every 24 years.
        Also, several tobacco companies' interpretation of the provision
    that addresses participants' market share led them to lower their
    payments in 2006. Under this provision, an independent auditor
    determined that participating tobacco companies lost a portion of their
    market share to non-participating companies. An economic research firm
    determined that the MSA was a significant factor in these market share
    losses. Based on these findings, several participating companies
    reduced their fiscal year 2006 payments by a total of about $800
    million. Many States have filed suit to recover these funds.
        In addition to the annual payments States receive, the MSA requires
    that a Strategic Contribution Fund payment begin in 2008 and continue
    through 2017. The base amount of each year's Strategic Contribution
    Fund payment is $861 million, which will be adjusted for volume and
    inflation and shared among the States. Strategic Contribution Fund
    payments are intended to reflect the level of the contribution each
    State made toward final resolution of their lawsuit against the tobacco
    companies. They will be allocated to the States based on a separate
    formula developed by a panel of former State Attorneys General.
                           questions of senator hatch
        Question 1. There has been a growing tendency both at the Federal
    and at the State level to use monies generated from tobacco taxes for a
    variety of legislative purposes that are not directly connected to
    anti-smoking campaigns, some of which are very legitimate initiatives.
    Let's assume two scenarios. First, Congress bans cigarettes tomorrow
    and the ban works. We are no longer able to rely upon any revenues,
    either at the Federal or the State level, from the sale of tobacco. If
    such a ban took place, what would be the budgetary shortfall that we
    would have to make up? Second, let's assume the legislation before the
    committee is enacted, which is intended, among other things, to result
    in a reduction of the sale of cigarettes. What is the budgetary
    shortfall we can expect if the current bill is enacted at both the
    Federal and State level?
        Answer 1. While we have not conducted an analysis of the economic
    effects of a cigarette ban or of the current bill on tax revenues and
    MSA payments, the revenue stream from the MSA, excluding securitized
    proceeds, has been over $5 billion annually for several years.

        Question 2. Unfortunately, one of the consequences of the increased
    regulation of cigarettes, as well as an increase in the cost, has been
    a burgeoning black market in cigarettes. Again, the legislation is
    intended, among other things, to discourage smoking, as well as the
    smoking of cigarettes at current levels of nicotine. What provisions
    are included in the bill that will enable the FDA to combat not only
    the illegal sale of cigarettes in general but the possibility of a rise
    in the illegal shipment of cigarettes into this country?
        Answer 2. We have not studied the provisions in this bill. However,
    we reported in 2004 that cigarette smuggling, particularly of
    counterfeit cigarettes, is a significant problem. However, because of
    the clandestine nature, the extent of cigarette smuggling into the
    United States is impossible to measure with any certainty.\54\
    ---------------------------------------------------------------------------
        \54\ GAO, Cigarette Smuggling: Federal Law Enforcement Efforts and
    Seizures Increasing GAO-04-641, (Washington, DC.: May 28, 2004).
    Counterfeit cigarettes are those produced without the authorization of
    the trademark holder.

        We appreciate the opportunity to comment and hope that these
    responses are of assistance. If you have any additional questions,
    please do not hesitate to call me at (202) 512-3841.
                                                   Lisa Shames,
                                                       Acting Director,
                                     Natural Resources and Environment.
                                     ______

    Response to Questions of Senator Enzi, Senator Burr, and Senator Hatch
                               by Alan Blum, M.D.
                           questions of senator enzi
        Question 1. Do you think FDA regulation of tobacco lends legitimacy
    to the [tobacco] industry?
        Answer 1. The tobacco industry should be fully expected to take
    advantage of this bill to remind all Americans through television,
    radio, the print media, package inserts, the U.S. Mail, and the
    internet that cigarettes are now regulated by the same agency that
    ensures that food and medicines are safe.
        Philip Morris is already testing the waters, and setting a new
    standard for chutzpah, by attempting to enlist physicians in the
    distribution of the company's propaganda to their patients. For the
    first time in more than half a century, Philip Morris is communicating
    directly to doctors by means of personal letters (example attached)
    offering to supply unlimited copies of a booklet on stopping smoking.
    If you decide to quit smoking . . . (cover attached) does not mention
    the word ``addiction,'' contains a total of three sentences in its 52
    pages that mention diseases caused by smoking, and is illustrated with
    17 color photographs, all of healthy, smiling people and none of
    persons made ill from smoking or of tobaccogenic diseases.
        Philip Morris' Youth Smoking Prevention advertisements on
    television and in booklets directed to parents (Raising Kids Who Don't
    Smoke, cover attached) have been reviled by health organizations such
    as the Campaign for Tobacco Free Kids as both ineffective and
    inappropriate. The company touts this program to college students at
    job fairs on university campuses across the country (as well as on its
    Web site (www.cantbeattheexperience.com), even though there are no
    entry-level Youth Smoking Prevention positions. To the contrary, the
    jobs offered to college students are exclusively summer internships and
    territory sales managerships that involve the distribution of
    cigarettes to upwards of 150 convenience stores, supermarkets,
    pharmacies, bars, and other retail outlets.
        In half-page color advertisements in college newspapers urging
    students to meet with company recruiters at career fairs, Philip Morris
    boasts that it is ``unique in how we face our particular challenges and
    responsibilities'' (copy of advertisement attached, from The Crimson
    White, University of Alabama, February 9, 2007, page 5: `` `I want a
    MARKET LEADER. An INNOVATOR. Someone who'll stretch my limits. And
    you're telling me TOBACCO?' YES. And we're telling you United States.
    We not only lead a major consumer products category in this country--we
    do it with a brand that's recognized as one of the 10 most valuable in
    the world. We're also unique in how we face our particular challenges
    and responsibilities. That's why we've helped redefine how products are
    marketed . . . with innovative, experiential and one-to-one programs
    for our adult consumers. So now--how about telling us more about you?
    See us on campus at the Career Fair Wednesday, February 14th, 9am-3pm
    Bryant Conference Center.'' CANTBEATTHEEXPERIENCE.COM. PHILIP MORRIS
    USA)
        Such practices aimed at burnishing the company's nicotine-stained
    image among physicians and parents and increasing the size of its
    youthful sales force--direct mail to the medical profession, propaganda
    campaigns aimed at parents, and recruitment advertisements in college
    newspapers--would remain unregulated by this bill and protected by the
    first amendment.
        FDA regulation of tobacco products would provide an unprecedented,
    unmerited, health-related legitimacy to manufacturers of cigarettes and
    would send a misleading message to consumers, namely that cigarettes,
    however unsafe, are government-sanctioned.
        By promulgating health standards, FDA will be fostering the
    perception that cigarettes are now safer to smoke. The public is not
    generally aware that there are more than 4,000 solid and gaseous
    poisons in tobacco smoke, including more than 40 cancer-causers. Nor
    are most consumers of cigarettes likely to understand epidemiology. If
    consumers are informed that nitrosamines (powerful carcinogens) have
    been reduced or removed from cigarettes, then they are going to infer
    that the problem is being taken care of or even solved. This ignores
    the dozens of other cancer-causers. Neither the technology to remove
    carcinogens from cigarette smoke nor the science to prove that the
    removal of any toxin from cigarette smoke reduces mortality yet exists.
    Such studies would take decades to detect any reduction of harm from
    tobacco use, and the ethics of conducting such ongoing research on
    persons who smoke without providing frequent cessation interventions
    would be called into question. Having served as a member of the
    Institutional Review Board (IRB) of the University of Alabama
    (overseeing research protocols to ensure the protection of human
    subjects), I cannot imagine that prospective comparison studies of
    different tobacco products would be permitted by any scientific body.
        Since smoking prevalence is directly proportional to the degree of
    perceived harm from smoking, FDA sanction of cigarettes will lead to an
    increase in smoking prevalence, compared to what would have occurred in
    the absence of this legislation.

        Question 2. Do you believe that getting FDA regulation of tobacco
    up and running will take substantial time and commitment from HHS and
    FDA leadership? What is FDA's track record when they are asked to
    produce many new complex regulations simultaneously?
        Answer 2. I agree with Senator Kennedy that the Food and Drug
    Administration has been a model for the world to follow in ensuring the
    safety and efficacy of medications. I greatly admire his longstanding
    efforts, as well as those of Representative Waxman, the late Senator
    Kefauver, and other legislators, to strengthen the watchdog powers of
    the FDA over the pharmaceutical industry.
        By all accounts, however, the FDA is in a state of turmoil.
    Unprecedented bipartisan criticism has rained down on the agency for
    several years, as its failings and foul-ups have mounted. These
    troubles culminated in the sentencing of the most recent former FDA
    Commissioner for his conviction on ethical conflict-of-interest
    violations on the very day of the HELP Committee's hearing on this
    bill.
        The current FDA Commissioner, Dr. Andrew von Eschenbach, has
    publicly questioned the wisdom of giving the FDA the power to regulate
    tobacco. ``When a product, when used as intended, results in death,
    it's hard for me to say how to regulate that as being safe and
    effective,'' he told Bloomberg News on March 6, 2007. In an interview
    on the same day with the Associated Press, Dr. von Eschenbach warned
    that if the FDA were to accept the mandate of the bill to reduce
    nicotine levels in cigarettes, consumers would tailor their smoking
    habits to maintain current levels of the addictive drug:

            ``We could find ourselves in the conundrum of having made a
            decision about nicotine only to have made the public health
            radically worse. And that is not the position the FDA is in; we
            approve products that enhance health, not destroy it,'' said
            Dr. von Eschenbach, a cancer surgeon . . . ``What I don't want
            to see happen is that we are in a position where we are
            determining that a cigarette is safe.''

        For his candor, Dr. von Eschenbach has been criticized as
    ``misinformed'' by the chairman/ceo of the Campaign for Tobacco-Free
    Kids in a March 6, 2007 press release.
        Senator Kennedy's earlier bill, The Tobacco Product Education and
    Health Protection Act of 1990 (S. 2795), which I was privileged to
    testify in favor of, was closer to the mark in establishing a separate
    Center for Tobacco Products.
        The FDA has a disappointing and alarming recent history of
    compromised consumer safety. For instance, considerable shortcomings
    have been exposed in the FDA's regulation of medical devices, including
    artificial heart valves, coronary artery stents, heart defibrillators,
    and artificial joints. FDA policy is to permit brands to be marketed
    that are ``substantially equivalent'' to other models that have been
    approved. As a result, failures of these less-tested brands--and
    resultant fatalities--are more likely to occur. This has been the case
    with defibrillators, and since only health facilities (among all sorts
    of public places in which a host of cheap, shoddy models are installed)
    must regularly test devices and report failures, the FDA does not even
    know the magnitude of the problem.
        In contrast to the time when the FDA prevented drugs like
    thalidomide from reaching the market for the treatment of nausea of
    pregnancy, today the pharmaceutical industry has regained the upper
    hand through aggressive marketing and ineffective regulation. For
    example, in 2006 two separate congressional committees examined the
    FDA's handling of antidepressant medications in pediatric patients
    because of an increased association between these drugs and suicide
    attempts. The FDA had failed to make public the recommendation of its
    own scientific reviewer that there be an intensive risk management
    strategy if these drugs were to continue to be prescribed to
    adolescents and children. Similarly, although some medications used for
    hyperactivity in children have been removed from the market in Canada,
    the FDA has been slow to restrict the use of these drugs.
        In several recent instances, the failure of the FDA to obtain
    complete and accurate data from companies on the incidence of adverse
    effects of top-selling medications has undermined public confidence in
    the impartiality of the agency. After one manufacturer, AstraZeneca,
    was found to have withheld information that its cholesterol-lowering
    medication Crestor may have caused a higher incidence of muscle damage,
    liver damage, and kidney failure than similar drugs, the company
    purchased full-page ads in major newspapers that claimed, ``The FDA has
    confidence in the safety and efficacy of Crestor,'' In response,
    Representative Henry Waxman wrote in a letter to the FDA, ``Either
    AstraZeneca is misleading the public about Crestor's safety, or the FDA
    is giving the company private assessments that conflict with the
    agency's public position'' (``Crestor Ads Draw Fire; FDA Could Act.''
    USA Today, December 8, 2004).
        Such failures by the FDA to obtain and act on reports of adverse
    drug effects may be the tip of the iceberg. The FDA's latest annual
    report on mandatory monitoring of drugs approved for the market found
    that 899 of 1,259 post-approval studies had not even been started.
    (``Many Drug Studies Not Begun, FDA says.'' Los Angeles Times, February
    2, 2007, page A20).
        Similar serious post-marketing safety concerns have been raised
    about medications for weight-loss (Meridia), acne (Accutane), and
    asthma (Serevent).
        Perhaps the most thorough failure of the FDA occurred with the COX-
    2 inhibitor drugs for arthritis (Vioxx, Celebrex, Bextra), which became
    the most promoted, prescribed, and consumed class of medications in
    spite of the fact that they were no more effective and were far less
    expensive than older, over-the-counter drugs, and in spite of the
    manufacturers' knowledge of an increased incidence of cardiovascular
    problems attributed to these new drugs. In this instance, in 2004 a
    glaring conflict-of-interest was revealed to have occurred in the
    agency, wherein an FDA scientist who worked with pharmaceutical
    companies on drug approvals also had authority over FDA's drug safety
    office.
        Other allegations of problems at the FDA in recent years have
    included rampant conflict-of-interest and pro-pharmaceutical industry
    bias among scientific advisory panel members; the lack of checks on
    bovine hormone and antibiotic use in cattle that has led to bacterial
    contamination of meat; the failure to prevent contamination of animal
    feed and the resultant increased risk of mad cow disease and Jacob-
    Creutzfeld disease in humans; inadequate inspections of produce and
    other food; the failure to end the practice of gifts to prescribing
    physicians by pharmaceutical companies; insufficient attention to
    questions about the safety of dietary supplements, sleep medications,
    and hormone replacement therapy in women, among other classes of drugs;
    influenza vaccine shortages due to the failure to plan for the
    replacement of a contaminated facility in the United Kingdom; mixed
    messages on the safety of breast implants; the relative ease with which
    certain prescription drugs with potentially harmful consequences have
    been able to receive over-the-counter status; and the failure to limit
    off-label uses of drugs or to enforce its own rules on prescription
    drug advertising.
        To its credit, during the brouhaha over the COX-2 drugs, the FDA
    commissioned the Institute of Medicine (IOM) to assess the drug safety
    system. On the basis of its investigation, in September 2006 an IOM
    committee reported on numerous serious problems at the FDA, including
    the scarcity of post-approval data. Earlier in 2006, the Government
    Accountability Office also found that the FDA lacks a clear and
    effective process for oversight of post-market safety issues. The IOM
    proposed 25 recommendations for overhauling the agency. Although the
    FDA pledged to adopt the necessary reforms, the Wall Street Journal
    reported on March 3, 2007 that a study commissioned by the agency
    itself found that its new system for detecting adverse effects of
    medications has failed. (``Report Blasts FDA's System to Track Drugs.
    Wall Street Journal, March 3-4, 2007, page A1-A2).
        Senator Enzi's observation that the FDA is struggling with the
    challenges of regulating an expanded universe of products and threats
    is accurate. The FDA is already tasked with duties related to public
    health, drug importation, food safety, and bioterrorism, any of which
    could ramp up demands for FDA resources. It makes no sense to give this
    overextended agency yet another huge mission. I also agree that getting
    FDA regulation of tobacco up and running will take substantial time.
    Given its present inability to solve its own myriad problems, the FDA
    would be the wrong agency at the wrong time to undertake oversight of
    tobacco products.
        William Godshall, a public health professional and founder of
    Smokefree Pennsylvania, is a leading advocate of the harm reduction
    approach to tobacco control, whereby consumers of cigarettes are
    encouraged to switch to noncombustible tobacco products if they cannot
    otherwise stop smoking. He sees a parallel between the hundreds of
    medications overseen by the FDA and the more than 400 different brand
    variations of cigarettes on the U.S. market, each containing differing
    amounts of scores of chemical additives and thousands of smoke
    constituents; and he therefore questions the feasibility of correlating
    tobacco-related deaths and diseases with the brands of cigarettes
    consumed, which the FDA would have to do if it is to make any valid
    assessments and recommendations about individual tobacco products.
        FDA's track record in dealing with complex and controversial
    regulations is problematic at best. But this reason should not, per se,
    rule out FDA regulation of tobacco if such regulation would likely
    result in major reductions of tobacco-related illness and death.
    Regrettably, S. 625, if enacted, would not provide this public health
    benefit.
        Addendum: As a former member of an FDA advisory panel (on
    immunologic devices), I support the mission of this agency and
    appreciate the dedication of its staff. However, a personal experience
    may help to illustrate the disappointment and frustration I anticipate
    would result were the FDA to undertake the regulation of tobacco
    products.
        In the April 3, 1981 edition of the Journal of the American Medical
    Association, I wrote an editorial that was the first to state the case
    for the removal from the market of phenylpropanolamine (PPA), a
    stimulant with actions similar to ephedrine and the amphetamines that
    was an ingredient in heavily advertised over-the-counter weight loss
    remedies and cold pills (Phenylpropanolamine: An over-the-counter
    amphetamine? JAMA 1981;246:1347-48). Several medical journal articles
    had reported individual cases of hypertension and hemorrhagic stroke
    attributed to PPA (even in small doses and even among young persons) in
    Australia and the United Kingdom.
        In October 1981 the Center for Science in the Public Interest, a
    Washington-based nutrition education group, petitioned the FDA to ban
    dietary aids containing PPA. In the mid-1980s, The Medical Letter, an
    independent review of medications, joined in the call for a ban on PPA.
    Ubiquitous advertising for the diet pills (e.g., Dexatrim) and
    decongestants continued unabated. Not until 1991, by which time a total
    of 44 cases of stroke in PPA users had been reported to the FDA, did
    the agency convene a public hearing on the drug, but pressure from the
    manufacturers of PPA-containing OTC products prevented any action from
    being taken.
        In October 2000 Public Citizen's Health Research Group, which
    estimated that as many as 510 to 1,020 cases of hemorrhagic strokes had
    occurred in persons using PPA-containing products, petitioned the FDA
    for an immediate ban on all uses of PPA in OTC products, including
    appetite suppressants and cough and cold preparations. Finally, on
    December 22, 2005 the FDA reclassified PPA as not safe or effective and
    ordered the removal of PPA from all drug products.
        Cigarettes are already known to be responsible for an estimated
    500,000 deaths each year in the United States. Yet, as Senator Coburn
    points out, with enactment of this bill Congress would be sidestepping
    its responsibility to take direct action against cigarettes by not
    granting the FDA the authority either to remove them from the market or
    otherwise seriously limit their sale. Cigarette manufacturers have far
    greater financial resources and influence than makers of PPA. If it
    took nearly 25 years for the FDA to heed calls for a ban on this
    dangerous drug, then can we truly expect the agency to take any
    immediate and decisive actions that will significantly inhibit
    cigarette sales?

        Question 3. [C]ould this bill serve to create a significant legal
    defense by the industry to counter product liability and tort lawsuits
    by plaintiffs?
        Answer 3. The bill would serve to create a significant legal
    defense by the tobacco industry to counter product liability and tort
    lawsuits by plaintiffs. In court, the industry would remind jurors and
    judges alike that tobacco products are now regulated by the same agency
    that ensures the safety of food and medicines.
        The bill would end the prospect of meaningful punishment of the
    tobacco industry and the achievement of reform through litigation.
    Punitive damages for victims, or classes of victims, of tobacco-caused
    death, disease, and suffering would end due to the shield provided by
    the FDA.
        In previous tobacco litigation, cigarette manufacturers have
    successfully argued that they are sufficiently regulated and thus there
    is no need for further steps to deter future misconduct. The industry
    gained considerable public relations value from the Master Settlement
    Agreement (MSA) and would gain additional mileage from FDA regulation.
    Analogous to its having cited the MSA numerous times in court over the
    past decade, including the Department of Justice case, the industry
    would claim that the Federal Government has assumed jurisdiction over
    all aspects of tobacco operations, including manufacture, new product
    introductions, health claims, health standards, ingredients, additives,
    constituents of smoke, nicotine, advertising, access, and marketing
    (which would be true) and that there is thus no need for any further
    injunctive relief or punitive damages to deter future bad behavior: it
    is now all under FDA's control. And from a public perception, cigarette
    manufacturers would be right.
        The important point is not whether the bill actually gives the
    tobacco companies immunity or protection from litigation. Rather, it is
    whether or not the companies can use the fact of being regulated by FDA
    to achieve de facto immunity by exploiting the public perception that
    the problem is being solved.
        Tobacco industry investment analyst Bonnie Herzog wrote in her
    March 5, 2007 report that the bill could ``prevent future litigation.''
    Tobacco industry investment analyst David Adelman wrote in his February
    15, 2007 report that the bill gives the industry, ``an additional and
    potentially effective legal defense.'' Analysis of internal Philip
    Morris documents (e.g., Bates numbers 207573345/3346 and 2081523647,
    accessible at University of California, San Francisco Legacy Tobacco
    Documents Library) suggests that this is a key goal the company hopes
    to achieve with FDA regulation.

        Question 4. Does anything in the proposed legislation address anti-
    smoking programs? Does anything in the proposed legislation help
    smokers quit?
        Answer 4. Nothing in this legislation addresses anti-smoking
    programs or encourages these programs to be offered to the public. In
    fact, the bill will likely have a chilling effect on State and local
    anti-smoking programs because it will shift the entire focus to the
    Federal regulatory level. It will create a perception that the problem
    is being handled by the Federal Government, which will deter many State
    and local legislatures from taking on this issue.
        In addition, there is nothing in the proposed legislation that will
    help current smokers quit. In fact, the legislation will likely make it
    much more difficult for smokers to quit because it will create a false
    sense of security. Knowing that cigarettes are now stringently
    regulated by the FDA and that the products now have an FDA seal of
    approval, many smokers will be under the illusion that the product is
    now somehow safer. This will result in many consumers continuing to
    smoke, rather than quit. Tobacco companies have long been able to
    accomplish this by marketing filtered cigarettes, then ``low-tar''
    cigarettes, then ``light'' and ``ultralight'' cigarettes. These much-
    touted innovations did not confer any reduction in the risk of disease.
    Yet they successfully addressed the health concerns of many if not most
    smokers, who would otherwise have attempted to stop smoking but who
    decided to continue because of the false inference that such products
    were safer.
        Indeed, according to Professor Michael Siegel of Boston University
    School of Public Health (personal communication, March 3, 2007), this
    legislation is likely to result in increased, not decreased, deaths
    from tobacco products for the following reasons:

        a. The bill will make it virtually impossible to research, develop,
    introduce, and market new potentially less hazardous tobacco products.
    It essentially freezes the market as it is and entrenches existing
    high-risk products into the market. It puts an end to any meaningful
    possibility of harm reduction as a tobacco control approach.
        b. It will undermine current and future litigation: the companies
    will be able to argue successfully that they are already regulated to
    stave off injunctive relief and substantial punitive damages in
    litigation by appealing to jurors' perceptions that the problem is
    being solved. The grossly exaggerated claims by health organizations
    supporting this bill of the bill's positive impact on public health are
    only contributing to this perception.
        c. It will reduce the public's perception of the inherent
    harmfulness of cigarettes. By promulgating health standards, FDA will
    be giving the public the perception that cigarettes are now safer to
    smoke.
        d. Most importantly, there are no documented mechanisms by which
    the legislation will save lives. Health groups supporting this bill
    have not produced a single evidence-based argument of how it will save
    lives.

        Dr. Siegel points out that there are only three ways that this
    could occur:

        First, the bill could save lives if the performance standards
    reduced the relative risk of smoking-related diseases. There is no
    evidence whatsoever that this is the case.
        Second, the bill could save lives if it encouraged the research,
    development, and marketing of actual reduced risk products. But the
    bill does the opposite by setting up an almost impossible barrier to
    the creation of such products.
        Third, the bill could save lives if it reduced youth smoking. It
    has been well-documented that youth access restrictions, implemented in
    actual widespread practice, do not reduce youth smoking. The very
    access restrictions that could potentially reduce youth smoking have
    been precluded by the bill (namely, raising the legal age of purchase
    and restricting the types of establishments, such as pharmacies, that
    sell cigarettes).
        [Research has also documented that the kinds of marketing
    restrictions imposed by the bill are not effective in reducing youth
    exposure to cigarette advertising. There are too many avenues for the
    tobacco companies to market their products, and anything short of a
    near-total ban on advertising and promotion of tobacco products (which
    would violate the first amendment) is unlikely to have a substantial
    effect on youth smoking. Even major changes in policy, such as removing
    advertisements completely from youth-oriented publications, would not
    reduce youth exposure to advertising to any meaningful extent.]
        Fourth, the bill could save lives if it reduced adult smoking by
    reducing demand for cigarettes. The bill won't do that by increasing
    competition in the marketplace, and it won't do that by increasing the
    public's perception of the inherent risks of cigarettes.

        Question 5. I believe that people shouldn't smoke. I also believe
    that the best way to achieve this is by reducing demand, not tinkering
    with the supply. We reduce demand by preventing people from smoking in
    the first place, and helping current smokers quit. Do you agree with
    this approach?
        Answer 5. The best approach to address the smoking pandemic is to
    do all we can to reduce the demand for cigarettes. The supply-side
    approach makes little sense because cigarettes are an inherently
    dangerous product, and there is no evidence that tinkering with the
    levels of various constituents of tobacco smoke will result in a safer
    product. We simply do not know the specific constituents that are
    responsible for the diseases or the relative contribution of each
    constituent, alone and in combination. Nor do we have any evidence for
    a decreased relative risk associated with product changes that either
    eliminate or reduce one or several components of tobacco smoke.
                            question of senator burr
        Question. How is keeping tobacco products on the market in the best
    interest of the public's health? Please provide a direct answer to this
    question.
        Answer. As former FDA Commissioner David Kessler has noted, as long
    as there are 50 million Americans addicted to nicotine, taking tobacco
    products off the market would not be prudent. Among other adverse
    effects, such a prohibition would dramatically exacerbate the black
    market.
        Prevention is universally agreed upon as the answer to end the
    devastating health toll caused by smoking. Reducing demand through paid
    mass media education campaigns is the cornerstone of primary
    prevention. Regrettably, this bill is by no means likely to reduce
    consumption, since it will normalize cigarettes and create the illusion
    of safety.
                           questions of senator hatch
        Question 1. What provisions are included in the bill that will
    enable the FDA to combat not only the illegal sale of cigarettes in
    general but the possibility of a rise in the illegal shipment of
    cigarettes into this country?
        Answer 1. With regard to contraband, Professor David Sweanor of the
    Faculties of Law and Medicine of the University of Ottawa notes
    (personal communication, March 11, 2007) that section 921 of the bill
    institutes a form of ``track and trace'' for tobacco products. Had such
    a system been in place, the major tobacco companies would not have been
    able to develop the infamous ``transit trade'' that allowed cigarettes
    to get ``lost'' and show up untaxed in various jurisdictions. He
    commends this aspect of the bill but believes this is addressing the
    last war.
        According to Professor Sweanor, the problem now is not cigarettes
    that originate from the major cigarette manufacturers but rather from
    counterfeiters and Native American reservations who can produce fake
    branded cigarettes for a few cents a pack. Although the legal authority
    exists to stop such practices, the bill does nothing to address these
    alternative sources of contraband. Thus the growing problem of fake
    Marlboros from Asia or Mexico, or anything else that enters the
    pipeline other than from the major manufacturers, is not addressed. The
    goal should be to anticipate where the contraband will originate and to
    take measures to stop it. This bill does not do that.

        Question 2. If such a ban took place, what would be the budgetary
    shortfall we would have to make up? What is the budgetary shortfall we
    can expect if the current bill is enacted at both the Federal and State
    level?
        Answer 2. Since the bill would have a negligible effect at most in
    reducing smoking, the budgetary shortfall would be little to none.
        A ban on cigarettes would reduce annual Federal cigarette tax
    revenue by about $7.5 billion* (calculated at the Federal excise tax
    rate of 39 cents a pack for 19 billion packs sold), annual State and
    local cigarette tax revenue by about $13 billion, and annual tobacco
    settlement payments to States by about $8 billion. Thus cigarette
    prohibition could reduce Federal and State revenue by about $28.5
    billion a year.
    ---------------------------------------------------------------------------
        * Since Federal cigarette tax revenue is a small fraction of 1
    percent of total Federal Government taxes ($2.5 trillion a year), it
    does not have a meaningful impact on the Federal revenue situation.
    ---------------------------------------------------------------------------
        It is possible that reduced health costs for tobaccogenic diseases
    and fires might offset such lost revenue. However, since this bill is
    unlikely to reduce cigarette consumption, its enactment is certain to
    increase the already massive amounts of Federal and State Government
    expenditures spent on the treatment of cigarette-caused disease and
    disability.

        [Whereupon, at 12:10 p.m., the hearing was adjourned.]