    [House Hearing, 110 Congress]
    [From the U.S. Government Publishing Office]

              THE FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

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

                                    HEARING

                                   BEFORE THE

                             SUBCOMMITTEE ON HEALTH

                                     OF THE

                        COMMITTEE ON ENERGY AND COMMERCE
                            HOUSE OF REPRESENTATIVES

                           ONE HUNDRED TENTH CONGRESS

                                 FIRST SESSION

                                       ON

                                   H.R. 1108

                                   __________

                                 OCTOBER 3, 2007

                                   __________

                               Serial No. 110-69

          Printed for the use of the Committee on Energy and Commerce

                            energycommerce.house.gov

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                        COMMITTEE ON ENERGY AND COMMERCE

        JOHN D. DINGELL, Michigan,       JOE BARTON, Texas
                 Chairman                    Ranking Member
    HENRY A. WAXMAN, California          RALPH M. HALL, Texas
    EDWARD J. MARKEY, Massachusetts      J. DENNIS HASTERT, Illinois
    RICK BOUCHER, Virginia               FRED UPTON, Michigan
    EDOLPHUS TOWNS, New York             CLIFF STEARNS, Florida
    FRANK PALLONE, Jr., New Jersey       NATHAN DEAL, Georgia
    BART GORDON, Tennessee               ED WHITFIELD, Kentucky
    BOBBY L. RUSH, Illinois              BARBARA CUBIN, Wyoming
    ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
    BART STUPAK, Michigan                HEATHER WILSON, New Mexico
    ELIOT L. ENGEL, New York             JOHN B. SHADEGG, Arizona
    ALBERT R. WYNN, Maryland             CHARLES W. ``CHIP'' PICKERING,
    GENE GREEN, Texas                        Mississippi
    DIANA DeGETTE, Colorado              VITO FOSSELLA, New York
        Vice Chairman                    STEVE BUYER, Indiana
    LOIS CAPPS, California               GEORGE RADANOVICH, California
    MIKE DOYLE, Pennsylvania             JOSEPH R. PITTS, Pennsylvania
    JANE HARMAN, California              MARY BONO, California
    TOM ALLEN, Maine                     GREG WALDEN, Oregon
    JAN SCHAKOWSKY, Illinois             LEE TERRY, Nebraska
    HILDA L. SOLIS, California           MIKE FERGUSON, New Jersey
    CHARLES A. GONZALEZ, Texas           MIKE ROGERS, Michigan
    JAY INSLEE, Washington               SUE WILKINS MYRICK, North Carolina
    TAMMY BALDWIN, Wisconsin             JOHN SULLIVAN, Oklahoma
    MIKE ROSS, Arkansas                  TIM MURPHY, Pennsylvania
    DARLENE HOOLEY, Oregon               MICHAEL C. BURGESS, Texas
    ANTHONY D. WEINER, New York          MARSHA BLACKBURN, Tennessee
    JIM MATHESON, Utah
    G.K. BUTTERFIELD, North Carolina
    CHARLIE MELANCON, Louisiana
    JOHN BARROW, Georgia
    BARON P. HILL, Indiana

    _________________________________________________________________

                               Professional Staff

     Dennis B. Fitzgibbons, Chief of
                   Staff
    Gregg A. Rothschild, Chief Counsel
       Sharon E. Davis, Chief Clerk
     David L. Cavicke, Minority Staff
                 Director

                                      (ii)
                             Subcommittee on Health

                    FRANK PALLONE, Jr., New Jersey, Chairman
    HENRY A. WAXMAN, California          NATHAN DEAL, Georgia,
    EDOLPHUS TOWNS, New York                 Ranking Member
    BART GORDON, Tennessee               RALPH M. HALL, Texas
    ANNA G. ESHOO, California            BARBARA CUBIN, Wyoming
    GENE GREEN, Texas                    HEATHER WILSON, New Mexico
        Vice Chairman                    JOHN B. SHADEGG, Arizona
    DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
    LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
    TOM ALLEN, Maine                     MIKE FERGUSON, New Jersey
    TAMMY BALDWIN, Wisconsin             MIKE ROGERS, Michigan
    ELIOT L. ENGEL, New York             SUE WILKINS MYRICK, North Carolina
    JAN SCHAKOWSKY, Illinois             JOHN SULLIVAN, Oklahoma
    HILDA L. SOLIS, California           TIM MURPHY, Pennsylvania
    MIKE ROSS, Arkansas                  MICHAEL C. BURGESS, Texas
    DARLENE HOOLEY, Oregon               MARSHA BLACKBURN, Tennessee
    ANTHONY D. WEINER, New York          JOE BARTON, Texas (ex officio)
    JIM MATHESON, Utah
    JOHN D. DINGELL, Michigan (ex
        officio)

                                 C O N T E N T S

                                  ----------
                                                                       Page
    Hon. Frank Pallone, Jr., a Representative in Congress from the
      State of New Jersey, opening statement.........................     1
    Hon. Joe Barton, a Representative in Congress from the State of
      Texas, opening statement.......................................     3
    Hon. Henry A. Waxman, a Representative in Congress from the State
      of California, opening statement...............................     4
    Hon. John B. Shadegg, a Representative in Congress from the State
      of Arizona, opening statement..................................     6
    Hon. Gene Green, a Representative in Congress from the State of
      Texas, opening statement.......................................    17
    Hon. Michael C. Burgess, a Representative in Congress from the
      State of Texas, opening statement..............................    19
    Hon. Lois A. Capps, a Representative in Congress from the State
      of California, opening statement...............................    20
    Hon. Nathan Deal, a Representative in Congress from the State of
      Georgia, opening statement.....................................    21
    Hon. Darlene Hooley, a Representative in Congress from the State
      of Oregon, opening statement...................................    22
    Hon. Heather Wilson, a Representative in Congress from the State
      of New Mexico, opening statement...............................    23
    Hon. Tammy Baldwin, a Representative in Congress from the State
      of Wisconsin, opening statement................................    23
    Hon. Ralph M. Hall, a Representative in Congress from the State
      of Texas, opening statement....................................    24
    Hon. Diana DeGette, a Representative in Congress from the State
      of Colorado, opening statement.................................    25
    Hon. Steve Buyer, a Representative in Congress from the State of
      Indiana, opening statement.....................................    26
    Hon. Tom Allen, a Representative in Congress from the State of
      Maine, opening statement.......................................    27
    Hon. Marsha Blackburn, a Representative in Congress from the
      State of Tennessee, opening statement..........................    28
    Hon. Hilda L. Solis, a Representative in Congress from the State
      of California, opening statement...............................    29
    Hon. John D. Dingell, a Representative in Congress from the State
      of Michigan, prepared statement................................    30
    Hon. Jim Matheson, a Representative in Congress from the State of
      Utah, prepared statement.......................................    31
    Hon. Edolphus Towns, a Representative in Congress from the State
      of New York, prepared statement................................    31

                                   Witnesses

    Richard J. Bonnie, Harrison Foundation, professor of medicine and
      law; director, Institute of Law, Psychiatry, and Public Policy,
      University of Virginia.........................................    32
        Prepared statement...........................................    35
        Answers to submitted questions...............................   172
    Fred Jacobs, M.D., commissioner, New Jersey Department of Health
      and Senior Services............................................    37
        Prepared statement...........................................    39
        Answers to submitted questions...............................   201
    Alan Blum, M.D., professor, Wallace Endowed Chair and director of
      the Center for Study of Tobacco and Society, College of
      Community Health Sciences, University of Alabama...............    62
        Prepared statement...........................................    64
    Risa Lavizzo-Mourey, M.D., president and chief executive officer,
      Robert Wood Johnson Foundation, Princeton, NJ..................    66
        Prepared statement...........................................    68
        Answers to submitted questions...............................   206
    Scott Ballin, steering committee member, Alliance for Health,
      Economic, and Agriculture Development, Washington, DC..........    71
        Prepared statement...........................................    74
    James Winkler, general secretary, General Board of Church and
      Society, United Methodist Church...............................    96
        Prepared statement...........................................    97
    Henry Armour, president and chief executive officer, National
      Association of Convenience Stores..............................    99
        Prepared statement...........................................   101
    Jack E. Henningfeld, vice president, research and health policy,
      Piney Associates, Bethesda, MD.................................   105
        Prepared statement...........................................   107
        Answers to submitted questions...............................   196
    William V. Corr, executive director, Campaign for Tobacco-Free
      Kids...........................................................   113
        Prepared statement...........................................   115
        Answers to submitted questions...............................   189

                               Submitted Material

    Andrew C. von Eschenbach, M.D., Commissioner, Food and Drugs,
      Food and Drug Administration, U.S. Department of Health and
      Human Services, submitted statement............................     7
    U.S. Smokeless Tobacco Company, submitted statement..............   138
    Mike Szymanczyk, chairman and chief executive officer, Philip
      Morris USA, submitted statement................................   209

          H.R. 1108, FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

                                  ----------

                           WEDNESDAY, OCTOBER 3, 2007

                      House of Representatives,
                                Subcommittee on Health,
                              Committee on Energy and Commerce,
                                                        Washington, DC.
        The subcommittee met, pursuant to call, at 10:00 a.m., in
    room 2123 of the Rayburn House Office Building, Hon. Frank
    Pallone, Jr. (chairman) presiding.
        Members present: Representatives Pallone, Waxman, Gordon,
    Green, DeGette, Capps, Allen, Baldwin, Engel, Solis, Hooley,
    Deal, Hall, Wilson, Shadegg, Buyer, Burgess, Blackburn, and
    Barton.
        Staff present: John Ford, Ryan Long, Robert Clark, Virgil
    Miller, Chad Grant, Melissa Sidman, Erin Bzymek, and Brin
    Frazier.

    OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
                IN CONGRESS FROM THE STATE OF NEW JERSEY

        Mr. Pallone. The hearing is called to order. Today we are
    having a hearing on H.R. 1108, the Family Smoking Prevention
    and Tobacco Control Act introduced by Mr. Waxman. And I will
    recognize myself initially for an opening statement and thank
    everyone for being here today. I am also a cosponsor of the
    legislation, which aims to strengthen our Nation's regulation
    of tobacco products and restrict tobacco product marketing.
        Every day, approximately 4,000 children try a cigarette for
    the first time. According to the Center for Disease Control,
    every day 1,140 of our children become new daily smokers. And
    take a minute to just think about these statistics. According
    to my calculations, this means that since the beginning of this
    year, January 1, 2007, 313,400 children have become tobacco
    addicts, and one-third of those kids will end up dying
    prematurely because of tobacco-related illnesses.
        In fact, tobacco use is the leading cause of preventable
    death in the United States, killing more than 400,000 Americans
    every year. That is more than AIDS, alcohol, car accidents,
    murder, suicides, illegal drugs and fires combined. And tobacco
    use costs our health care system, both public and private, over
    $96 billion annually. Fourteen percent of our total Medicaid
    expenditure is spent on treatments for smoking-related
    diseases.
        With such implications, it is hard to believe that tobacco
    products are exempt from the basic health and safety
    regulations that apply to other consumer products. The FDA
    regulates toothpaste but not cigarettes. They monitor cereal
    but not chewing tobacco. And ironically the FDA regulates both
    over-the-counter and prescription medications to help people
    quit smoking yet has no authority over the cause of the
    addiction.
        In 1996, the FDA began to implement a comprehensive rule to
    prevent and reduce tobacco use by children. Only 4 years later,
    the U.S. Supreme Court ruled that under existing law, the FDA
    lacks the authority to regulate tobacco products or cigarette
    company marketing practices. It is therefore up to this
    Congress to grant the FDA the authority that they need.
        The 1996 rule identified that the best way to reduce the
    harm caused by tobacco was to reduce the number of children who
    became addicted in the first place. And we must build on this
    concept and tackle the problem on a variety of points. We must
    ensure that tobacco products are not marketed or sold to
    children. We must identify harmful elements in tobacco
    products. We must require more detailed warnings on cigarettes
    packs, and we must demand scientific proof of claims made about
    lower risk products.
        I happen to be a parent of three children who are nearing
    their teens. Actually, one just turned 14 a couple days ago.
    And the practice of targeting young people with tobacco
    advertising particularly concerns me. Since the multi-state
    tobacco settlement in 1998, tobacco companies have increased
    their advertising spending by 95 percent. And they are
    currently spending approximately $13 billion a year. They use
    imagery that appeals to youth on their billboards and in their
    print ads. They hand out free tobacco-themed merchandise and
    sponsor sports and entertainment events.
        All of these practices aim to draw children into a lifetime
    of addiction. Studies have shown that teens are twice as likely
    to remember tobacco advertising than adults, and they remain
    loyal to their brand as their addiction takes hold and they
    move into adulthood.
        Mr. Waxman has taken the initiative and proposed a
    bipartisan bill that seeks to address what has become a
    critical public health problem. I am proud to be a cosponsor,
    along with many of my colleagues on the subcommittee. The bill
    will provide the FDA with the authority to appropriately
    regulate tobacco products and restrict tobacco product
    marketing.
        The Family Smoking Prevention and Tobacco Control Act would
    allow FDA to monitor false or misleading advertising, as well
    as marketing aimed at children. It will halt tobacco sales to
    minors and will require tobacco companies to provide the FDA
    with the list of ingredients and additives in their products.
    And finally, it forces companies to substantiate their claims
    that some tobacco products are lower risk. This summer, the
    Senate Committee on Health, Education, Labor, and Pensions
    passed their version of the bill. Both the Senate bill and the
    bill before us today are vital pieces of legislation to curb
    the consumption of tobacco products, to reduce the number of
    children using tobacco products, and to ultimately save
    millions of lives.
        Encouraged by the progress of our colleagues in the Senate,
    I am convinced that in this Congress tobacco regulation
    legislation will see the light of day. We are determined that
    it will. And I want to commend Mr. Waxman again for not only
    this legislation but for so many years of attention to this
    issue. And I want to thank the witnesses for appearing before
    us today to share their experience. We look forward to your
    testimony, and I would now recognize the ranking member of the
    full committee, Mr. Barton.

       OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN
                    CONGRESS FROM THE STATE OF TEXAS

        Mr. Barton. Thank you, Mr. Chairman. This is a very
    important hearing, and I appreciate you organizing it. I wish
    all the subcommittee members were here. I think everyone in the
    room agrees that smoking is a bad habit, and for many people,
    it can lead to very serious health consequences. I don't smoke.
    I never have. I never will, and I am going to do everything I
    can possible to make sure that my 2-year-old son Jack never
    smokes either.
        I do believe that some of the provisions in the bill before
    us have merit. I am not so sure, however, that the Food and
    Drug Administration is a proper place to regulate tobacco. Even
    if it is, this legislation seems to me to overreach in its
    enthusiasm to stop smoking by giving the agency virtually
    unlimited discretion.
        The FDA is charged generally with ensuring the safety of
    products. It approves drugs and devices based on safety and
    efficacy. This legislation would require the FDA to take on
    something that is both enormous and completely outside of its
    regulatory experience. Under this legislation, the FDA is
    supposed to base its decision on the very vaguest of standards:
    ``appropriate for the protection of public health.'' I am not
    sure what that means. There is no legal definition. There is,
    as far as I know, not even a history that you could go through
    as a predicate for it.
        This is the sort of vague language that is great for
    producing headlines, but I don't think it is going to be very
    good at producing constitutionally protected regulations. And,
    with all due respect to the authors of the legislation, we got
    to take a step back and really think about it before we move
    forward.
        As of this time, the FDA doesn't even have the resources
    for what it is already supposed to do. We have just tasked the
    FDA with a new responsibility for the post-market safety of our
    Nation's drug supply. We now want the FDA to fix the infamous
    problems we are having with imported food. And this
    subcommittee and the Oversight Subcommittee have held hearings
    on that this year. It seems to me that you just can't keep
    piling more and more work on the FDA without giving them the
    additional resources and expertise to do it. Nothing in that
    bill does that.
        In 1996, the last time the FDA attempted to regulate
    tobacco, it was with the intention of regulating it as a drug
    and to ban tobacco products all together. Quite a bit has
    happened to the marketing and sale of tobacco products since
    then. In particular, in 1998, we had the master settlement
    agreement. It restricted advertising. Congress also passed the
    Synar amendment that would require States to enforce their law
    prohibiting the sale of tobacco products to minors or risk
    losing up to 40 percent of their Federal substance abuse block
    grant funding.
        Smoking rates, in general, since then are declining, and
    kids in particular are smoking quite a bit less. What hasn't
    changed is this particular legislation. In fact, it is
    basically the same legislation that we looked at back in those
    days. It was a bill as far back as 2000 referred to this
    committee that uses, as far as we can tell, the same language.
    It is hard to believe that there have been no changes, no
    improvements, no rethinking of thoughts about this particular
    issue since that time.
        I think it is appropriate that we have the hearing. I think
    it is appropriate that we listen to the witnesses before us
    today because it is an issue that needs to be at least
    discussed and debated. I am particularly looking forward to the
    testimony of Dr. Fred Jacobs of the New Jersey Department of
    Health and Senior Services.
        According to the General Accountability Office and
    testimony before the other body earlier this year, the States
    have received over $52 billion in tobacco settlement payments
    from fiscal year 2002 through the fiscal year 2005, $52.6
    billion. Of that amount, only 30 percent has gone to provide
    for health care services, and believe it or not, only 3\1/2\
    percent has gone to tobacco control by smoking cessation
    programs. Three and a half percent. That is about $1.5 billion.
    According to a report released by the Campaign for Tobacco-Free
    Kids, the States have allocated from tobacco settlement
    payments $538 million for tobacco prevention in fiscal year
    2005, which amounts to just one-third of the $1.6 billion
    annually that the CDC recommends. I think that is a very poor
    record and something that we ought to look at very closely.
        A peer-reviewed article from the July 2007 ``Preventing
    Chronic Disease'' found ``significant reductions in smoking
    prevalence among Washington residents following the
    implementation of a comprehensive tobacco control program
    funding at a level near that recommended by the Centers for
    Disease Control and Prevention indicate that the tobacco
    control programs are effective when the investment is made and
    States are committed to improving public health.''
        If we are serious about cutting the number of kids who
    smoke, shouldn't we insist that the States get serious about
    meeting the CDC's funding targets for their smoking cessation
    and education programs with money from the tobacco settlement?
        I have a little bit more, Mr. Chairman, but my time has
    expired. I yield back, and again thank you for holding this
    hearing.
        Mr. Pallone. Mr. Waxman.

    OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
                 CONGRESS FROM THE STATE OF CALIFORNIA

        Mr. Waxman. Thank you very much, Chairman Pallone, for
    holding this hearing and for your leadership on this issue. I
    am pleased to present to the committee this bill and to have
    this hearing on the legislation. I am open to hear what the
    witnesses have to say, and I know all of us here want to learn
    to see if the bill needs to be changed in any way, but I think
    we need a bill.
        Tobacco is the deadliest product on the market today when
    used as intended. It kills over 400,000 Americans every year.
    That is more than alcohol, murders, and car accidents combined,
    yet it is one of the least regulated of all consumer products.
    It is really remarkable that a cigarette is subject to less
    regulation than a lollipop.
        The price for this vacuum of regulation is paid by all of
    us, most tragically by our children. In the absence of
    comprehensive regulation, tobacco companies can market freely
    to kids; even though, kids aren't allowed to buy tobacco, but
    they certainly find ways to get it. The industry has the
    unfettered ability to engineer their products to trigger quick
    and severe addiction. And they are able to deceive the American
    public about the dangers of their products. We saw that in a
    campaign that went on for decades.
        But we have a moral obligation to do better. Chairman
    Pallone, Chairman Dingell, Representative Tom Davis, and I have
    introduced the Family Smoking Prevention and Tobacco Control
    Act, which will give FDA the authority to regulate the design,
    manufacture, marketing and distribution of tobacco products.
    Now, regulating tobacco is the single most important thing we
    can do right now to curb the deadly toll of tobacco.
        By giving FDA jurisdiction over tobacco products, this bill
    would help to prevent the marketing and sales of tobacco to
    kids, enable public health professionals to know what exactly
    is in a cigarette and to learn what the industry knows about
    their addictiveness and toxicity. It would empower the FDA to
    keep tobacco companies from making false and misleading claims
    about the safety of their products. It would allow FDA to
    require changes to the product content or design to protect the
    public health by, for example, reducing the amount of nicotine
    to make cigarettes less addictive.
        Now, some have raised concerns that FDA is not the right
    agency for this job. I disagree. No other agency shares FDA's
    strong scientific foundation, together with a public health
    mission and comprehensive regulatory authority.
        FDA also possesses institutional familiarity with tobacco
    itself. Not only does FDA currently regulate nicotine as a drug
    in smoking cessation products, but in the 1990s, FDA actually
    spent years crafting a detailed framework for regulating
    tobacco. Ultimately the Supreme Court struck down the exercise
    of regulatory authority, but the groundwork was laid for a
    sophisticated approach to tobacco regulation.
        It is true that tobacco is different from other products
    regulated by the FDA. We can't have a safe and effective
    standard. That is why the bill has a new standard appropriate
    for the protection of public health. There is no question FDA
    needs new resources to do the job, and that is why we have a
    user fee to help provide them with those resources.
        Experts in the public health community agree that this is
    the right approach. The bill is supported by the Heart
    Association, Lung Association, Cancer Society, and over 500
    other organizations. I look forward to the hearing today, and I
    think it is legislation that will help protect our children and
    grandchildren from what has been a tobacco epidemic. Thank you,
    Mr. Chairman.
        Mr. Barton. Mr. Chairman?
        Mr. Pallone. Yes.
        Mr. Barton. Parliamentary inquiry. The Republican sponsor
    of this legislation is not a member of the committee, Mr. Davis
    of Virginia. We had asked that he be allowed to sit in on this
    hearing. Has that been approved?
        Mr. Pallone. Yes, my understanding is that members from
    other committees can sit on the dais, but they don't
    participate in either opening statements or questions. But they
    can sit on the dais.
        Mr. Barton. Thank you.
        Mr. Pallone. So as soon as he comes in, he is welcome to
    join us.
        Mr. Barton. OK.
        Mr. Pallone. I recognize the gentleman from Arizona, Mr.
    Shadegg.

    OPENING STATEMENT OF HON. JOHN B. SHADEGG, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF ARIZONA

        Mr. Shadegg. I thank you, Mr. Chairman, and I thank you for
    holding this hearing. I think it is an important discussion to
    have. I want to make it clear that I share the goals of the
    authors and proponents of this legislation to reduce the use of
    tobacco in this country and particularly to reduce its use by
    children.
        My mother smoked most of her life and died of disease
    related to her use of tobacco, and I have deep concern about
    its health consequences and about its addictive qualities and
    share the goal of doing everything we can to reduce those
    incentives and that inclination in our society and to educate
    people about the potential harm of tobacco and the danger that
    it causes particularly when people become hooked on smoking at
    a young age.
        Having said that, I would like to also express my deep
    disappointment that the Majority was not able to structure this
    hearing today in a way to create a panel so that the chairman
    of the FDA, Commissioner von Eschenbach, could have testified
    and provided his testimony. I believe that would be the most
    useful testimony to elucidate us, as members of Congress, and
    the public at large as to the fundamental question here which
    is what is the best mechanism to achieve the goals this
    legislation seeks.
        I believe Commissioner von Eschenbach would, more than any
    other person, be able to provide insight regarding the FDA's
    capability and suitability to handle this task. I note that in
    his prepared testimony, he has shared his view that he supports
    the goal of the legislation to reduce tobacco use in this
    country but that the FDA has ``concerns with the bill's
    proposed means to achieve those objectives.''
        He goes on to state that they have concerns regarding
    whether or not the bill could undermine the public health role
    of the FDA. That is his first point, whether or not aspects of
    the bill may be extremely difficult for the FDA to implement.
    And third, significant concerns about the resources that will
    be provided under the bill and the expectations it might
    create.
        Mr. Chairman, I would ask unanimous consent that his
    testimony be made a part of this hearing at this point.
        Mr. Pallone. So moved.
        [The prepared statement of Dr. von Eschenbach folows:]

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        Mr. Shadegg. I share the commissioner's concerns. It seems
    to me that it is worth noting that tobacco is already regulated
    by numerous Federal and State agencies, including the Federal
    Trade Commission. I would hope the Federal Trade Commission is
    already taking action with regard to false or misleading claims
    made by tobacco companies. And if it is not, we ought to be
    doing oversight on the Federal Trade Commission and pushing
    them harder.
        I have concerns about adding the regulations of tobacco to
    an already resource and time-constrained agency and whether or
    not that will achieve the goals intended. One of my concerns is
    that the Food and Drug Administration is there to regulate food
    and drugs, and I don't view tobacco as either of those. I view
    food as being good for you and drugs as being therapeutic and
    helpful. It seems to be somewhat confusing to say to an agency,
    which is supposed to regulate things that are good for you, is
    now going to regulate a product which is inherently bad for
    you. And I hope that is not viewed as the Government condoning
    the use of tobacco or expanding it.
        I also am concerned about the lack of expertise within the
    FDA to regulate tobacco and perhaps wonder whether or not some
    other agency would be better to do this task.
        I would note that the legislation calls for additional user
    fees, which may indeed be necessary to accomplish its tasks.
    However, I am worried that the cost of those user fees will be
    imposed upon the lowest income Americans and will hit them the
    hardest and now conflicts with the funding source advocated for
    the S-CHIP Program.
        Let me simply conclude by saying I do think this is a
    worthy discussion to have. I have great concerns about whether
    or not this is the right agency, and I hope at some point we
    will be able to hear, in terms of testimony and the questioning
    and answering, from Commissioner von Eschenbach.
        Thank you, and with that, I yield back.
        Mr. Pallone. Thank you, and next recognize our vice chair,
    Mr. Green.

       OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
                    CONGRESS FROM THE STATE OF TEXAS

        Mr. Green. Thank you, Mr. Chairman, for holding the hearing
    on the legislation to grant the Food and Drug Administration
    the authority to regulate tobacco products.
        I share my colleague from Arizona's concern, and I would
    hope we could schedule a hearing so we could hear from the FDA
    particularly. And I understand the tradition that the Federal
    witnesses sit on their own panel, but it is no secret that
    cigarette smoking is the most preventable cause of death in
    this country. I imagine there isn't one person here today who
    hasn't been affected by cigarette smoking, whether personally
    or through the experience of a family member or friend.
        The need to reduce the level of cigarette smoking in this
    country is a very personal issue for my family, as my wife and
    I watched her father and two brothers suffer severely and
    eventually pass away prematurely from lung cancer and smoking-
    related illnesses. And I watched all three of them also try in
    their 40s and 50s to do everything they could to kick that
    habit. It was so difficult.
        To know that the bulk of their health problems are by and
    large preventable is a sobering realization to the devastating
    effect of smoking. According to statistics from the CDC,
    approximately 21 percent of American adults are cigarette
    smokers. Unfortunately, many of these adults become addicted as
    teenagers, just like my relatives, who tried smoking out of
    peer pressure or simple experimentation but too quickly became
    hooked.
        More than 1,100 teenagers under the age of 18 become
    regular smokers and adopt the habit that is not only deadly but
    extremely difficult to break. Seventy percent of adult smokers
    indicate they want to quit. Forty percent of smokers try to
    quit each year, but the addiction too often wins out over the
    smoker's will to quit and need to improve his or her life and
    health.
        The recognition of the health dangers that smoking poses to
    the American public, both the FDA and Congress has worked for
    10 years now to implement FDA regulations of tobacco products.
    Following the Supreme Court's 2000 ruling invalidating FDA's
    1996 rule exerting regulatory authority over tobacco, clearly
    Congress must act to explicitly give the FDA this authority.
        I am proud to be a cosponsor of the bill. The Family
    Smoking Prevention and Tobacco Control Act would subject
    tobacco products to many of the FDA's regulatory tools, such as
    premarket approval of new tobacco products and mandatory
    inspections of manufacturing facilities. The bill would also
    create a new user fee system imposed on tobacco manufacturer's
    to help the FDA absorb the cost to tobacco regulation. It
    seemed like in the first 10 months of this year, we have given
    or pointed out the FDA's lack of enforcement, whether it be the
    reform bill on the prescription drugs or with the food
    inspections that we just had a hearing last week. So we know
    they need additional funding.
        Too many Americans have switched to certain brands based on
    unsubstantiated claims that these new brands will reduce the
    health risks we all know that are associated with smoking. It
    is high time that science-based agency have the authority to
    regulate the advertising of tobacco products and manufacturers'
    claim of reduced risk or reduced exposure.
        This bill is a true compromise piece of legislation. Like
    most compromises, no stakeholder got everything it wanted.
    There are certainly still stakeholders with concerns about the
    bill. Nevertheless, I consider it victory that the American
    Lung Association, Tobacco-Free Kids, and Philip Morris are on
    the same side of the tobacco issue.
        I would like to thank our colleague, Mr. Waxman, of our
    committee, and his Republican lead Congressman Davis of
    Virginia for crafting this compromise. I look forward to
    hearing from the witnesses and yield back my time.
        Mr. Pallone. Thank you. the gentleman from Texas, Mr.
    Burgess.

    OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
                  IN CONGRESS FROM THE STATE OF TEXAS

        Mr. Burgess. Thank you, Mr. Chairman. I appreciate the
    consideration for letting me go out of order. Mr. Chairman,
    this subcommittee has spent a fair amount of time this year
    talking about the FDA could or should do a better job ensuring
    the safety of drugs and ensuring the safety of our food supply.
    Indeed we passed, just 2 weeks ago, some of the most sweeping
    legislation to affect the FDA in probably 40 years, and I was
    grateful to be a part of that process.
        We have talked about how the FDA could better inform the
    American people and about the therapeutic benefits, risks, and
    side effects of FDA-approved drugs. So, Mr. Chairman, forgive
    me. I am a little perplexed about the topic of discussion
    today. Used as directed, tobacco products in this country will
    kill 400,000 people every year when use as directed. And that
    is not even to address the number that are maimed and left
    infirm by the ravages of tobacco smoking.
        I know something about whereof I speak. I was a physician
    for 25 years down in Texas before coming to Congress. Indeed, I
    am a reformed smoker. I lost both parents to cigarette-related
    disease. Both my parents died in their 80s of lung cancer, but
    perhaps the most serious problem that I saw associated with
    cigarette smoking was my father who was always eloquent and
    loquacious was rendered aphasic from a stroke at age 67 and
    died at age 83, never being able to utter a single word during
    that time. I am no proponent of cigarette smoking.
        So memo to the American people: cigarette smoking is
    dangerous and addictive. Don't do it. If you do it, stop now.
    Your life will be better for it, and certainly your children's
    lives will be better for it. Why we need the FDA to weigh in on
    this is a mystery to me. We are going to hear a lot of
    testimony this morning, and I appreciate the witnesses who have
    given of their time to come give us the testimony.
        Dr. Hemmingfield states that tobacco products are
    sophisticated drug delivery systems, engineered and
    manufactured to increase their potentials to cause and sustain
    addiction. We all agree there is no therapeutic benefit to
    smoking cigarettes. So why are we going to waste taxpayer
    dollars to regulate a product like that? What have we got next
    in line, crystal meth?
        I know that the proponents of this bill are going to spend
    some time talking about how the Federal Trade Commission has
    failed to regulate cigarette advertisements, and maybe we could
    better spend our time to determine how the Federal Trade
    Commission could do a better job at regulating this commercial
    speech.
        Instead of doing the one thing that could benefit public
    health in this country, outlawing cigarette use, proponents of
    this legislation would enact into law an arrangement that the
    courts have perpetuated by huge legal settlements to keep the
    gravy train flowing, and we saw that just last week with the
    passage of the S-CHIP bill.
        We are addicted to tobacco money. Let us be honest about
    this. We ought to put that money where it would do some good.
    How about paying back the Medicare system for all of the money
    that tobacco has cost the Medicare system over the years? How
    about paying the money to really make aggressive anti-smoking
    cessation campaigns? But where are we going to get our tax
    dollars to fund all the things that we have now committed
    ourselves to funding with cigarette use?
        Mr. Chairman, I see my time is up. I am going to submit my
    whole statement for the record. It is full of valuable insight,
    and I encourage all members and witnesses to read it. And I
    will yield back the balance of my time.
        Mr. Pallone. Thank you. The gentlewoman from California,
    Mrs. Capps.

       OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN
                 CONGRESS FROM THE STATE OF CALIFORNIA

        Mrs. Capps. Thank you, Chairman Pallone, for holding this
    extremely important hearing, and I want to join my colleagues
    in commending Henry Waxman for his tireless work on this bill
    and tobacco issues in general over the years. Our country owes
    a debt to him, and I agree with him and others that we do need
    to see this bill passed and signed into law.
        As a nurse, I especially support this bill's approach to
    combating one of, if not the most, serious health problem
    facing our country. It is finally common knowledge that tobacco
    is unhealthy, dangerous, and deadly, but unfortunately it is
    still glamorized. Tobacco companies have purposely glamorized
    this product in order to attract new customers, especially a
    vulnerable population like young women.
        If you could all please direct your attention to the
    posters that are pink, the poster that is pink and has flowers,
    you will see immediately what I am talking about. A new
    cigarette product manufactured in hot pink packaging and the
    tag line ``light and luscious'' is undoubtedly meant to appeal
    to women.
        Newsweek columnist Anna Quindlen recently wrote on the
    deliberate effort to make Camel No. 9 cigarettes appeal to
    young women. She wrote about how her own daughter had tried
    them and described them with words like ``caramel, perfume,
    chai tea.'' And just when you thought that was bad enough,
    check out what they came up with next. ``Dressed to the
    nines.'' This ad introduces readers to stiletto style
    cigarettes, which are advertised as the newest, must-have
    fashion accessory to go along with the dress, the bracelets,
    and the lip balm.
        While we expect this kind of sleazy marketing from tobacco
    companies, I have been terribly disappointed that they found a
    new and unexpected ally in women's fashion magazines. These
    magazines have historically served as legitimate sources for
    information on women's health, fitness, and fashion. But they
    have sold out the well being of their readers to help big
    tobacco in their search for new victims.
        I was proud when 40 of my colleagues joined me in asking
    women's magazines to reject these ads. When not one of these
    magazines bothered to formally respond to our letter, we wrote
    again. This time, seven of them responded, but none will drop
    the ads. Several tried to defend themselves by pointing to
    their editorials on the dangers of smoking, and each made sure
    to emphasize that accepting the advertisements is completely
    legal. The publishing director of Vogue Tom Florio even wrote
    the following. ``The goal of Congress should be to create legal
    guidelines for the marketing, distribution, and sale of tobacco
    products.''
        Well, there is an old saying, biblical in fact, ``ask and
    ye shall receive.'' H.R. 1108 will give the FDA the authority
    to effectively regulate advertising. It would be wonderful if
    more members of the private sector would follow the lead of
    publications like Self magazine, which rejects all tobacco ads,
    but that is not the case. So we will pass a law that will
    enable us to better protect public health.
        I look forward to hearing from our witnesses today and
    would like to finish with one final thought. If the Camel No. 9
    advertising blitz that greeted our students at the start of
    school is any indication of their intentions, I shudder to
    think of the tricks or treats RJ Reynolds and its new friends
    in the magazine business have in store for our young women and
    girls this Halloween. I yield back.
        Mr. Pallone. Thank you. I recognize our ranking member, Mr.
    Deal.

      OPENING STATEMENT OF HON. NATAHN DEAL, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF GEORGIA

        Mr. Deal. Thank you, Mr. Chairman. I am glad we are taking
    this opportunity today to evaluate Mr. Waxman's contribution on
    the issue of the FDA's regulation of tobacco products.
        I think all of us have certainly been aware of the harmful
    and addictive effects of tobacco use and smoking, and I believe
    it is appropriate for us to take a look at ways to diminish the
    prevalence of smoking in our society. It contributes to disease
    and death and imposes a tremendous cost on our society as a
    whole.
        That is especially true in the health care sector. One
    study has found that if all current smokers in the Medicaid
    Program quit, our Medicaid Program could save $9.7 billion. I
    am certainly sympathetic to the goals expressed by the authors
    of this legislation to keep our children from having easy
    access to cigarettes and trying to ensure that less people are
    in fact smoking every year.
        But I do believe, however, that this issue needs the
    scrutiny of the legislative process. Many of the issues that
    require that scrutiny have been enunciated by Mr. Shadegg and
    by Dr. Burgess. There are many important considerations to be
    made in crafting the legislation, and I look forward to our
    witnesses' testimony on these issues.
        The tobacco industry is diverse, and legislation like this
    will affect each sector differently. There are also
    considerations to be made about the country's convenience
    stores, and I am glad they are going to be here today to
    provide us with their views on this proposal.
        The panels before us represent a wide range of viewpoints,
    and I believe their input will be useful as we evaluate the
    concerns that they raise and other parties have raised about
    this legislation. Overall, I think it should be a good hearing,
    and I look forward to the testimony of the witnesses. And thank
    you all for being here today, and I yield back my time.
        Mr. Pallone. Thank you. The gentlewoman from Oregon, Ms.
    Hooley.

     OPENING STATEMENT OF HON. DARLENE HOOLEY, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF OREGON

        Ms. Hooley. Thank you, Mr. Chairman, for holding this
    hearing. And like many of my colleagues before me, I want to
    recognize Mr. Waxman for his extraordinary leadership on this
    issue. You have truly been a champion for protecting our
    children from the dangers of smoking.
        I am a proud cosponsor of H.R. 1108 because I believe this
    bill takes important steps to improve public health. I have
    seen the toll on family and friends of what a lifetime of
    smoking can do. As a former smoker, I think it is past time
    that we take responsible steps to allow the FDA to regulate
    tobacco, like it does nearly every other product that we put
    into our bodies.
        It is nearly inconceivable to think that the FDA has
    considerable authority to regulate the vegetables and fruit
    that we serve to our families but cannot regulate cigarettes,
    which are known to cause cancer and other serious health
    complications.
        Smoking and its health effects have serious impact on
    women. The Center for Disease Control and Prevention estimates
    that more than 178,000 American women die from smoking-related
    diseases each year. The risk of developing lung cancer is about
    13 times higher in female smokers than in non-smokers. Although
    we rightly put tremendous resources into treating breast
    cancer, lung cancer surpassed breast cancer in 1987 as the
    leading cause of cancer death among women.
        Smoking is also associated with an increased incidence of
    cervical cancer and osteoporosis in women. Moreover, smoking is
    linked to cardiovascular disease, the No. 1 killer among women.
    This bill is not only beneficial for women's health, but it is
    also important for the well being of our children.
        Every day, more than 1,100 young people under the age of 18
    become regular smokers. When young people smoke, they are much
    more likely to become lifelong smokers than those who start
    smoking at a later age.
        This legislation will save lives. This legislation will
    help reduce the incidence of teenage smoking and result in
    fewer lifelong smokers. Studies show that nonsmokers will have
    healthier adulthoods than their smoking counterparts. If we can
    take common sense steps to help reduce teenage smoking and
    ultimately improve young people's lives, then we must do so.
    This legislation takes those steps.
        I also want to note that this legislation prohibits the FDA
    from banning tobacco products or reducing nicotine levels to
    zero. We should not and will not prohibit adults from smoking.
    Those who make the personal decision to smoke may continue to
    make that choice. This legislation simply ensures that the FDA
    will have authority to regulate tobacco just like it has the
    authority to regulate all our other food and drugs we consume.
        In other words, H.R. 1108 takes common sense steps to
    regulate a product that is known to cause harmful health
    effects. Thank you, Mr. Chairman, for having this hearing.
        Mr. Pallone. Thank you. The gentlewoman from New Mexico,
    Mrs. Wilson.

     OPENING STATEMENT OF HON. HEATHER WILSON, A REPRESENTATIVE IN
                 CONGRESS FROM THE STATE OF NEW MEXICO

        Mrs. Wilson. Thank you, Mr. Chairman. I will be very brief.
    I wanted to thank you for holding this hearing. Like my
    colleagues on this committee, I want to see us reduce the use
    of tobacco. But I am not sure yet and what I want to learn
    about today is whether this bill will help or hurt in that
    effort.
        And I am particularly concerned about overlapping
    responsibilities or muddying the water with respect to clarity
    of responsibilities in making sure that agencies have the right
    resources to do the tasks that we give to them.
        There are a number of agencies involved in the regulation
    of tobacco now. This would shift those responsibilities, but it
    is unclear to me at this point how much or what the result
    would be in the ultimate goal, which is to reduce the use of
    tobacco.
        So I look forward to the hearing today and learning more
    about these issues. Thank you, Mr. Chairman.
        Mr. Pallone. Thank you. The gentlewoman from Wisconsin, Ms.
    Baldwin.

     OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF WISCONSIN

        Ms. Baldwin. Thank you, Mr. Chairman. I appreciate the fact
    that you are holding this hearing, and I appreciate our
    witnesses that will join us momentarily. We have heard some of
    the statistics this morning, but I think that many of them bear
    repeating. Cigarette smoking is the leading preventable cause
    of death in the United States, and it is responsible for about
    one in five deaths annually or about 438,000 deaths per year.
        Smoking-related deaths account for more deaths than AIDS,
    alcohol, cocaine, heroin, homicide, suicide, and motor vehicle
    crashes and fires combined. And yet 21 percent of all U.S.
    adults, approximately 45.1 million people are smokers.
        I am sure we could have a fascinating discussion about why
    people continue to smoke, knowing the serious harm that
    cigarettes do to their health. And while that is a conversation
    I think we should have, we are here today to discuss steps that
    we can take right now at the Federal level that will better
    educate Americans about the dangers of smoking and regulate the
    marketing and distribution of tobacco products.
        I am proud to be an original cosponsor of H.R. 1108, and I
    thank Congressman Waxman for his tremendous leadership on this
    issue. I am especially pleased that H.R. 1108 will focus and
    prohibit cigarettes from containing any artificial or natural
    flavors. I am concerned about these products. Sometimes they
    are strawberry flavored or other candy-like flavors. And it
    seems to me that these are blatantly aimed at getting children
    to smoke, and it is really truly appalling. And I am glad that
    this bill puts an end to these candy-flavored cigarettes.
        Additionally, I am pleased that the bill requires tobacco
    companies to disclose the contents of their products. Just like
    every other company that produces an ingestible consumer
    product, tobacco companies will have to submit a listing by
    quantity of all ingredients and additives to tobacco, paper,
    and filters for each brand they manufacture. This is the right
    thing to do. We do it for drugs. We do it for food. We should
    require it of cigarettes.
        Again thank you, Mr. Chairman, for holding this hearing. I
    look forward to our discussion today.
        Mr. Pallone. Thank you. Next is the gentleman from Texas,
    Mr. Hall.

     OPENING STATEMENT OF HON. RALPH M. HALL, A REPRESENTATIVE IN
                    CONGRESS FROM THE STATE OF TEXAS

        Mr. Hall. Thank you, Mr. Chairman. And I thank Mr. Waxman
    for his work in this area. You know I am of a generation that
    remembers how the Federal Government encouraged our members and
    our people in the armed services to smoke by giving them
    cigarettes free, enticing them into the tobacco industry.
        And now I see that generation that are dying out by 1,000
    or 1,500 a day, and I have a hospital up in northeast Texas,
    the Sam Rayburn Memorial Hospital, where these old fellows are
    put outside the air conditioning in the heat of the summer in
    100 degree weather several days in a row to smoke their
    cigarettes. In the winter, put out of the warmth and the care
    of the same area, out in the cold to do that.
        I had a place built for them to smoke their cigarettes, and
    I got some criticism for it. But I felt as they were enticed
    into the situation back in the time of stress when they were
    thousands of miles away from home fighting for all of our
    freedom that they had some rights.
        And I still see a gleam of that that people think they have
    a right to smoke and abuse their bodies, and that is a hard
    thing to reconcile either way. I wish we could do away with
    every cigarette in the world. I think we would be better off.
    And, of course, the world would be better off. We would have
    more money to spend on other health pursuits. I just appreciate
    you holding the hearing, and I think it will spark some
    continued congressional debate over the proper way to regulate
    tobacco.
        And I would also like to thank the panelists for joining
    us. Your insight and your expertise will certainly guide the
    continued examination of the issue. Smoking-related disease is
    a real serious problem in the country, which deserves a fair
    and honest debate. And I firmly believe that we need to be
    doing more to reduce smoke-related diseases as we can be. I
    have some problems about taxing it out of existence, though I
    am not totally against that if that is what it takes.
        My primary concern over the legislation before us today,
    though, is the cost of further Federal Government expansion and
    whether the user fees contained in the bill are just a tax
    increase by another name. There are many parts of the
    legislation I could support, but I want to make sure we think
    carefully about what we are doing and how we are doing it.
        For example, the legislation appears to treat all tobacco
    products the same when it seems clear that it is a matter of
    common sense and science that smokeless tobacco products are
    different than cigarettes. They may be dangerous in themselves,
    but different than cigarettes. They ought to be treated a
    little bit differently. We are also concerned for the tobacco
    retailers with over 300,000 in this country. How will the FDA
    regulate and enforce and adjudicate them, and how much
    additional staff will the FDA need? How much will this cost?
        It appears Internet retailers, Native American retailers,
    and adult facilities are favored by the legislation. These
    groups share a large percent of tobacco sales and should have
    the same regulations as all other retailers. I hope to work
    with the committee on these concerns and make sure this
    legislation is both fair and addresses public health concerns.
    And, Mr. Chairman, I thank you, and I yield back the balance of
    my time.
        Mr. Pallone. Thank you. The gentlewoman from Colorado, Ms.
    DeGette.

     OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF COLORADO

        Ms. DeGette. Thank you very much, Mr. Chairman. In 1982,
    then-Surgeon General C. Everett Coop said ``cigarette smoking
    is the chief single avoidable cause of death in our society and
    the most important public health issue of our time.''
    Unfortunately, that statement is just as true today as it was
    when he said it 25 years ago.
        Tens of millions of Americans remain addicted to smoking,
    and almost all of them started smoking when they were young.
    Also true is that most smokers today would like to quit, but
    they are unable to break this highly addictive habit.
        I want to give a hallelujah to you, Mr. Chairman, for
    having this hearing and even more to Mr. Waxman for having
    drafted such a great comprehensive piece of legislation which I
    too am a proud cosponsor of.
        Smoking prevention and tobacco control are issues that have
    been missing in action for quite some time, at least as far as
    Congress is concerned. I am in my sixth term on this committee,
    and we have a lot of hand-wringing in this committee over the
    years about what we do about tobacco use and smoking cessation.
        When I first came to Congress, I had a mock congressional
    hearing in my district on teen tobacco use, and there were some
    low-income kids, Hispanic kids from a high school in my
    district, who took it upon themselves to do a study. And they
    did a scientific study in which they found that tobacco
    companies targeted advertising, billboards and other types of
    advertising, to low-income neighborhoods and to communities of
    color. These kids were so unbelievable then-Chairman Bilirakis
    had them come here to testify in a real congressional hearing,
    and they talked about their findings.
        What happened after that hearing? Nothing. And then
    Congresswoman Bono and I introduced legislation, which we
    worked on for many years, on smoking cessation to add that to
    Medicare because it is estimated, of course, that Medicare will
    pay billions of dollars over the next few decades to treat
    tobacco-related diseases. What happened to that bill? We were
    told by the then chairman of the committee that we couldn't
    pass that legislation because it cost too much to pay for
    smoking cessation programs and services, which I find
    incredibly ironic, given the amount that we are spending to
    treat lung cancer, emphysema, heart disease, and other smoking-
    related diseases.
        In my early years in Congress, I also introduced
    legislation to raise the smoking age from 18 to 21 just as we
    had done with alcohol, and, of course, you can imagine how that
    went over with the committee at that time.
        And then I tried to get rid of crop insurance for tobacco,
    which met with about the same result. And so, Mr. Chairman, I
    think it is really great that we are having a hearing on this
    bill, but I think it is even greater that we actually might do
    something about this problem, that we actually might pass Mr.
    Waxman's bill, that we actually might give the FDA the ability
    to regulate tobacco, which to my mind, is a no brainer.
        So, Mr. Chairman, I look forward to working with you and
    Mr. Waxman and everybody else so that we can truly prevent
    teens from starting to use tobacco and prevent millions of
    deaths. Thank you.
        Mr. Pallone. Thank you. Next is the gentleman from Indiana,
    Mr. Buyer.

      OPENING STATEMENT OF HON. STEVE BUYER, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF INDIANA

        Mr. Buyer. Thank you. When it comes to making decisions on
    behalf of a country, I utilize principle-oriented decision-
    making. So what I do is I put any issue through a paradigm. The
    paradigm goes like this. I say what is its impact upon
    individual liberty? Does it promote personal responsibility and
    accountability? Does it promote economic opportunity? Is the
    marketplace open, fair, and competitive? And does it protect
    American citizens at home and abroad. Whatever the issue, I put
    it in that paradigm.
        So now let us take the issue that is before us. I ask the
    question of is what we are trying to do is regulate human
    behavior? I think that is what we are trying to do here. So as,
    I guess, we look out across the spectrum, there are a lot of
    things out there with regard to products that have an impact
    upon the human physiology. And if we are going to regulate one
    product, what about all these other products?
        Now, if the real goal here is education and harm reduction,
    that is what we should be focusing on because I assure you my
    wife, God bless her, is driving me crazy because she goes
    through all the series of foods, all the bad foods, which I
    eat, and here are the good foods. So, let us see, she has a
    list. She has salt. She has refined sugar, caffeine, nicotine,
    alcohol, go through all that list of things that are bad for
    you.
        Now, are we going to go down the road of saying OK, let us
    start regulating all of these other things? Because when I look
    at this, let us see, we could regulate trans fats, refined
    sugar, salts, alcohol, supplements, caffeine. All of these
    things are having an impact upon human physiology. But no, let
    us go ahead and let us go after nicotine.
        As a matter of fact, are we really going after nicotine?
    Because it is really cigarettes. Because if we really wanted to
    have a harm reduction strategy, we would talk about moving
    people from cigarettes to smokeless tobacco as a harm reduction
    strategy. No, that is not even taken into account in this. And
    with regard to advertising, yes, OK, right. They use Joe Camel
    and all of that. They should not have been targeting cigarettes
    to children, but what is the difference between McDonald's
    using Ronald McDonald and promoting trans fats to children. And
    now we are dealing with childhood obesity.
        And let us go ahead and take it to the extreme. Let us see.
    What about all the advertising by the candy industry for the
    Easter bunny that also adds to what, tooth decay and childhood
    obesity. So then what are we going to do? We are going to
    outlaw Halloween, Valentine's Day, the Easter bunny. We can do
    a lot of things out there to regulate human behavior. Now that
    gets pretty ridiculous when you think about all of that.
        Going back to it, the focus, I believe, what we should have
    is on education and harm reduction strategy. That is exactly
    what my wife is doing to me: taking me away from refined sugar
    products to Splenda. Taking me off of my Diet Dr. Pepper, which
    I love, and move me then to non-caffinated drinks. So I picked
    up Gatorade. Then she shows me how much salt is in Gatorade,
    and now she has me on Propel. My son calls it Gatorade for
    girls. That is what I drink today.
        So I am on this harm reduction strategy by my wife, and
    that is what we should be focusing on, Mr. Chairman. I yield
    back.
        Mr. Pallone. I was going to ask you if your wife was a
    Democrat. I am sorry. I yield to the gentleman from Maine, Mr.
    Allen.

       OPENING STATEMENT OF HON. TOM ALLEN, A REPRESENTATIVE IN
                    CONGRESS FROM THE STATE OF MAINE

        Mr. Allen. Thank you, Mr. Chairman. This is a tough act to
    follow. I will come back to tobacco here. I want to thank you
    for holding this hearing. The use of tobacco products kills
    over 400,000 people and costs our Nation more than $167 billion
    a year, based on lost productivity of $92 billion and health
    care expenditures of $75 billion a year.
        For decades, tobacco companies have mislead the American
    public and Congress about the health consequences of smoking,
    the addictive nature of smoking, and their manipulation of
    nicotine levels. Perhaps of greatest concern, the tobacco
    companies have targeted substantial marketing efforts toward
    children in order to boost their profits and hook future
    generations on their products. An estimated 4\1/2\ million
    children and adolescents smoke, and another 1 million use
    smokeless tobacco; 15\1/2\ million kids are exposed to second
    hand smoke at home.
        According to HHS, 1 million children will start smoking
    each year. One-third of those children will eventually die of a
    smoking-related illness. Regrettably, Maine has one of the
    highest teenage smoking rates in the country, despite the fact
    that we have reduced by 60 percent teen smoking in Maine over
    the last 10 years. And even though Maine leads the Nation in
    its commitment to dedicating tobacco settlement money to
    tobacco prevention and treatment, Maine still has more than one
    out of every five high school students smoking. That figure is
    unacceptably high. It is extremely difficult to get young
    adults to quit smoking once they have started.
        The continued efforts by the tobacco industry to market
    their product to young people is further evidence that despite
    the master settlement restrictions, this industry continues to
    recruit replacement smokers to keep businesses going.
        I am proud to be an original cosponsor of Representative
    Waxman's bill, which grants the FDA the same authority over
    cigarettes and other tobacco products that it already has over
    countless other consumer products. The bill would allow the FDA
    to discourage children from starting smoking and encourage
    adults to quit in part by reigning in advertising, bolstering
    existing sales restrictions, and strengthening warning labels.
        It would also allow the FDA to order the elimination or
    reduction of harmful and addictive ingredients in tobacco.
    Significantly the bill would require tobacco companies to
    disclose what tobacco products and their smoke contain.
    Secondhand smoke, for example, contains 250 chemicals known to
    be toxic or carcinogenic, according to the Center for Disease
    Control. Giving the FDA the power and authority to regulate
    tobacco products will protect our children, improve the public
    health, and ensure that consumers have more information about
    tobacco products to make better decisions.
        I look forward to the testimony of our distinguished panel
    and yield back the balance of my time.
        Mr. Pallone. Thank you. The gentlewoman from Tennessee,
    Mrs. Blackburn.

    OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF TENNESSEE

        Mrs. Blackburn. Thank you, Mr. Chairman. I appreciate your
    calling the hearing today, and I am looking forward to hearing
    from our witnesses.
        Back in the mid 1980s, I was president of the Middle
    Tennessee Board of the American Lung Association, and I was
    very involved in our smoking cessation programs, in education
    and awareness, asthma programs and training programs for
    parents. I am allergic to cigarette smoke, I have a child that
    is allergic to cigarette smoke, and very well aware of the
    harmful effects that come from cigarette smoke.
        However, I think that the policy that is set forth in this
    bill has some serious flaws, and I do think that it misses the
    mark on protecting the public from tobacco. And I make these as
    somebody who has read the bill and just disagrees with it,
    disagrees with the premise on it.
        We all know that the FDA is responsible for ensuring the
    safety of all domestic and imported food, drugs, medical
    devices, biologics, cosmetics. The list goes on and on, and as
    we have heard from countless hearings, the FDA does not have
    the resources to handle additional product regulation. They
    struggle with the intra-agency communication, and they
    struggled with even giving us a list of what their best
    practices are.
        The bill grants the FDA unlimited authority to impose new,
    undefined tobacco restrictions and places burdensome standards
    on tobacco manufacturers, farmers, sellers. The FDA is not
    prepared to regulate and enforce the bill's provision for the
    300,000 retailers that are selling tobacco products nationwide.
        Always there are two sides to every issue, and I am also
    concerned about the impact the bill would have on Tennessee
    tobacco farmers. U.S. Smokeless Tobacco Manufacturing Company
    has called Tennessee home for more than 75 years and employs
    close to 600 people through the State. The company purchase
    about half of all the dark tobacco grown in Tennessee from
    approximately 200 growers.
        Many of those are in my district, and while the bill's
    provisions are not directed at tobacco farmers, these
    constituents would be negatively impacted by broad regulations
    that place no limits on FDA authority to regulate tobacco leaf.
    It is only fair to consider the impact that this bill would
    have on those individuals.
        In 1992, Congress passed the Synar Amendment, which
    withheld Federal funds until States met an 80 percent
    compliance rate for preventing tobacco sales to minors. All 50
    States are now in compliance. Since implementation, this
    approach has been to prevent youth usage, and those rates have
    declined. We should be working with our States, with
    manufacturers, producers, packagers, distributors, and
    retailers on new initiatives versus implementing an unworkable
    Federal layer that has no proven track record.
        As you all know, we are in the midst of a debate on
    expansion of the SCHIP program. Many of my colleagues have
    voted to fund SCHIP with an increase in the Federal excise tax
    on tobacco. If H.R. 1108 attempts to eradicate smoking, how
    much would Congress have to increase the tobacco tax in order
    to pay for the SCHIP expansion bill?
        Consumers believe that if the FDA approves a product, then
    it is safe. So why would we give tobacco the FDA stamp of
    approval? Thank you, Mr. Chairman. I appreciate the hearing,
    and I am looking forward to our witnesses. I yield back.
        Mr. Pallone. Thank you. The gentlewoman from California,
    Ms. Solis.

     OPENING STATEMENT OF HON. HILDA L. SOLIS, A REPRESENTATIVE IN
                 CONGRESS FROM THE STATE OF CALIFORNIA

        Ms. Solis. Thank you, Mr. Chairman, and good morning. And
    thank you to our witnesses for being here. In my opinion, the
    bill that we have before us, H.R. 1108, Family Smoking
    Prevention and Tobacco Control Act, I think is a bill going in
    the right direction and especially as it affects hundreds of
    thousands of Latinos. I am talking in particular about the
    youthful age of our community because we see a higher incidents
    of smoking rates amongst young Latinos and Latinas. And that is
    alarming for me because you think with all the money that we
    have spent to try to inform our community about the devastating
    health effects and consequences of smoking that you would see
    that there would be a downturn. That is not the case.
        And part of it is because the tobacco industry has become
    very clever in targeting their message. While other
    corporations ignore our community and don't expand outreach in
    many ways to them, the tobacco companies have done a great job,
    in my opinion, of targeting Latino youth. And what they have
    done is they are running ads in Spanish and English. They put
    up Spanish speaking role models, and they make it sound as
    though it is cool. And they actually say that, cool cigarettes.
    It is good to have this image of smoking the cool cigarettes
    while saying that somehow this is part of our culture and part
    of our morals or mores, put more appropriately.
        And I find that rather insulting because I know that that
    is not the case, and it is just like the alcohol and other
    groups that also go way out of their way to focus narrowly to a
    community that is underserved in so many ways by health care
    insurance and has very high rates of cancer, in particular
    among Latinos, young males as well as Latinas.
        And the statistics are there. I won't repeat them, but I do
    want to enter my statement into the record and just say that I
    am not pleased with the manner in which our corporations, in
    particular in this case the tobacco industry, is treating my
    community.
        I also say that about young teens because I know
    Congresswomen Capps, Schakowsky, and I have sent letters to
    magazines that target young women and glamorizing, more or
    less, smoking. That somehow that is in style, and that is the
    way you should be if you want to be accepted by society.
        So I know that there are a lot of Members of Congress that
    would like to see more regulation, more science, more research
    done, on the ill effects of tobacco and what it has on all of
    our community. So I yield back the balance of my time and would
    ask that my statement be placed in the record.
        Mr. Pallone. Thank you. I think that concludes our opening
    statements from the members. Additional statements for the
    record will be accepted at this time.
        [The prepared statements follow:]

        Prepared Statement of Hon. John D. Dingell, a Representative in
                      Congress from the State of Michigan

         Mr. Chairman, thank you for holding this hearing on a very
    critical public health issue, tobacco use, and, more
    specifically, on H.R. 1108, the Family Smoking Prevention and
    Tobacco Control Act.
         The harmful effects of tobacco products and its toll on
    human lives have been known for decades. In spite of efforts to
    decrease the number of smokers, cigarette smoking remains the
    leading preventable cause of death in the United States.
    Cigarette smoking is responsible for about 1 in 5 deaths
    annually, or about 435,000 deaths per year. In addition to the
    45.1 million U.S. adult smokers, it is estimated that each day
    more than 1,000 persons younger than 18 years of age become
    addicted to tobacco products. Not only has tobacco use claimed
    lives, but it also has caused serious financial losses. The use
    of tobacco costs the United States more than $167 billion
    annually in terms of lost productivity and healthcare
    expenditures.
         In 1996, the Food and Drug Administration attempted to
    address this problem by issuing a final rule asserting
    regulatory authority over tobacco products. This rule would
    have made great strides in reducing the prevalence of underage
    smoking and use of smokeless tobacco products through strict
    distribution, marketing, and labeling provisions.
         Unfortunately, in 2000, after several court challenges,
    the U.S. Supreme Court ruled that FDA did not have the
    authority to regulate tobacco products. Since then, there have
    been numerous attempts to pass legislation granting the FDA
    this authority.
         States have done their part to address this issue. In
    1998, the attorneys general of 46 States signed the Master
    Settlement Agreement with the four largest U.S. tobacco
    companies to recover billions of dollars in costs associated
    with treating smoking-related illnesses. These funds have been
    used to pay for tobacco-control programs. Now is the time for
    the Federal Government to do its part.
         H.R. 1108 has broad support from the public health
    community. We will look closely at this legislation and engage
    in a fair process that is inclusive of the public health
    community, industry, and other interested stakeholders.
         I appreciate this hearing, Mr. Chairman. I thank
    Representative Waxman for his leadership on this issue. I look
    forward to the testimony of our witnesses and the input of our
    Members.
                                  ----------

     Prepared Statement of Hon. Jim Matheson, a Representative in Congress
                             from the State of Utah

        Thank you, Mr. Chairman, for holding this hearing today on
    the Family Smoking Prevention and Tobacco Control Act, H.R.
    1108.
        I am a cosponsor of this legislation, as I have been of
    similar legislation since I first came to the House in the
    107th Congress.
        I represent the second district of Utah, where an estimated
    of 7.4 percent of our high schoolers smoke and an estimated 2.4
    million packs of cigarettes are bought or smoked by kids in
    Utah each year. Not surprisingly, helping our kids to become
    far less likely to start smoking, we can instill in them these
    good habits to carry into adulthood. Indeed, only 10 percent of
    smokers begin after age 18. Slightly less than one-in-10 adults
    in Utah smoke, and that's better than half the national average
    of 21 percent. But we still want to do better, and we can with
    this legislation with its restrictions on advertising to kids,
    improved warning labels, and for the first time, product
    standards to reduce the harm of tobacco products.
        In my State of Utah, the State and Federal tax burden for
    each Utah household to cover smoking costs is $537 each year,
    while the average American household is spending $630 each year
    for that same purpose. That's nearly $100 for each Utah family.
    And even that figure does not include the private health care
    expenditures or lost productivity caused by smoking.
        Mr. Chairman, I am glad that we are moving this legislation
    forward--for the kids in Utah--and kids, who without this
    legislation, may be on their way to becoming addicted to
    tobacco products. There are far too many in this country.
        I believe we can give the FDA the tools it needs to make
    cigarettes less addictive, to ban products marketed to kids
    such as candy-flavored cigarettes, to stop those who repeatedly
    and illegally sell these products to our kids, and to stop the
    marketing of these products to the next generation of smokers.
        Thank you.
                                  ----------

    Prepared Statement of Hon. Edolphus Towns, a Representative in Congress
                           from the State of New York

         Mr. Chairman, I am very concerned about the slowing down
    of the decline of tobacco use and the potential use of tobacco
    among adolescents, particularly those from homes without access
    to either health insurance, or adequate health care. However,
    while I am generally in favor of the underlying principles of
    H.R. 1108, I believe that we have to be careful about giving
    the Food and Drug Administration authority that it has
    demonstrated it cannot handle. By that I mean the provisions in
    the bill that would put the FDA in the position of inspecting
    and regulating hundreds of thousands of sellers of tobacco
    across the Nation.
         I am a co-sponsor of the bill because I want to ensure
    that the manufacture of tobacco is appropriately regulated.
    However, I believe that the Synar amendment, which has been
    aimed at decreasing youth access to tobacco, has been working.
    I don't think we should willy nilly overstep State authority to
    regulate this aspect of tobacco when we have gotten substantial
    results. Under the 1992 Synar amendment, States have the
    authority to conduct unannounced inspections and over the past
    10 years all States and the District of Columbia have reached
    the goal of achieving retailer violation rates of no more than
    20 percent--that's sales of cigarettes to minors. That's not
    enough. We would like zero sales to minors, however, studies
    cited by the U.S. substance abuse and mental health
    administration show that the retailed violation rates were in
    the 60-90 percent range prior to the Synar amendment, so we
    have seen great progress.
         Conversely the continued squeeze on FDA funding has
    prompted the agency to shut down regional offices and some
    field facilities to make more efficient use of limited
    resources. How will this streamlining by the FDA affect the
    proposed inspection programs in this bill? My concern is that
    the FDA will not have the trained inspector workforce needed to
    do frequent oversight. Reductions in FDA inspection operations
    have caused problems in areas like food safety. There are 12
    percent fewer FDA employees in field offices who concentrate on
    food issues and safety tests for U.S.-produced food have
    dropped nearly 75 percent. Downsizing at FDA has also resulted
    in cuts in budget and staff and the FDA's field force has
    dropped from 4,000 in 2003 to some 3,400 today. What makes us
    think that added additional inspection burdens on the FDA will
    be successful?
         Every State regulates tobacco sellers now and the States
    have shown the ability to reduce illegal tobacco sales. I
    believe that a continued partnership with States in terms of
    retail tobacco sales will be fruitful. I look forward to
    exploring whether FDA should become involved in regulation of
    retail tobacco sales or whether another approach that does not
    place the entire burden on the FDA can be workable. Thank you,
    Mr. Chairman and I yield back the balance of my time.
                                  ----------

        Mr. Pallone. We will now turn to our witnesses.
        I want to welcome you all, and let me indicate who we do
    have. First of all, on my left is Richard J. Bonnie, who is
    John S. Baddle professor of law and director of the Institute
    of Law Psychiatry and Public Policy at the University of
    Virginia. And second, from my home State is Dr. Fred Jacobs who
    is our commissioner for the New Jersey Department of Health and
    Senior Services, and I want to particularly welcome him not
    only for being here today to discuss the tobacco issue but also
    because of all you do on health care. And I know I have had
    some conversations with you about New Jersey's efforts to
    expand health insurance and try to provide universal health
    care. And just want to commend you for all that you do, Dr.
    Jacobs. Thank you for being here today.
        And I think I already indicated that we had submitted into
    the record, at Mr. Shadegg's request, the statement from the
    FDA. So let me just mention your statements, of course, are
    part of the hearing record. And each of the witnesses may, in
    the discretion of the committee, submit additional brief and
    pertinent statements in writing for inclusion in the record.
    And so I will begin by recognizing Dr. Bonnie for 5 minutes.
    Thank you.

    STATEMENT OF RICHARD J. BONNIE, HARRISON FOUNDATION, PROFESSOR
     OF MEDICINE AND LAW; DIRECTOR, INSTITUTE OF LAW, PSYCHIATRY,
               AND PUBLIC POLICY, UNIVERSITY OF VIRGINIA

        Mr. Bonnie. Good morning, Mr. Chairman, Mr. Deal, and other
    members of the subcommittee. I am, as the chairman said, on the
    faculties of medicine and law at the University of Virginia,
    and I recently served as chair of the committee on reducing
    tobacco use of the Institute of Medicine, a component of the
    National Academies.
        The committee's work was funded by the American Legacy
    Foundation, and I am here today to testify about the
    committee's report entitled ``Ending the Tobacco Problem: A
    Blueprint for the Nation'' a copy of which should be at your
    side. A summary of the report also has been submitted for the
    record.
        As everyone here knows and has been indicated by the
    members, tobacco use, especially cigarette smoking, has been
    one of the Nation's major public health problems for most of
    the 20th century and continues at an unacceptable level in the
    21st century. Indeed, it has become one of the world's major
    public health challenges.
        Even though the tobacco leaf grows naturally, the tobacco
    problem is fundamentally a man-made problem. Cigarettes became
    one of the most successful consumer products in history in only
    a few decades and became an ever-present icon of American life,
    embedded in the culture and promoted by a powerful industry.
        Unfortunately, cigarettes are one of the most dangerous
    consumer products ever marketed. They are highly addictive and
    deadly, as even the tobacco companies now concede. If tobacco
    cigarettes were being introduced into the marketplace for the
    first time, there can be no doubt that they would be banned
    under any one of several consumer protection statutes.
        Of course, banning tobacco products is not feasible or
    wise. The challenge the country faces today is to develop a
    feasible strategy for rooting out a problem that has become
    deeply entrenched in our economic and cultural life. There are
    still 45 million cigarette smokers, and another 9.7 million
    users of other tobacco products. Most of them regret taking up
    the habit and struggle to quit.
        The title of the committee's report probably got your
    attention. Let me explain what the committee means by ending
    the tobacco problem. In the committee's view, the Nation's
    long-term goal should be to reduce tobacco use so substantially
    that it is no longer a significant public health problem. That
    doesn't necessarily mean eliminating tobacco use. The blueprint
    outlined in the report aims to set the Nation irreversibly on a
    course for achieving this objective.
        Optimists might say that we are already well on our way to
    ending the problem. After all, the prevalence of smoking among
    adults has been cut in half from 42 percent to 21 percent since
    1965. The prevalence of daily smoking among high school
    students is now at its lowest level since annual monitoring
    began 30 years ago. An increasing proportion of the indoor
    environment around the country is now smoke-free.
        The tobacco companies are defending themselves in an
    increasing number of lawsuits, and State juries outraged by the
    industry's deceptive conduct have imposed very large punitive
    damage awards. Why not just keep doing what we are doing and
    wait for these historical currents to bring the problem to an
    end?
        The IOM committee concluded that maintaining our present
    course will not end the tobacco problem. There are already
    signs that the prevalence of smoking among adults is flattening
    instead of decreasing, and the rate of youth initiation has
    hovered around 20 percent for most of the past two decades even
    though it is down at the moment.
        The high rate of youth smoking is especially troubling
    because at least 80 percent of people who smoke begin to do so
    as adolescents when they cannot fully appreciate the grip of
    addiction and the future risk to their health.
        Moreover, quitting after decades of use is difficult.
    Despite the fact that 70 percent of smokers say they want to
    quit and 40 percent have a specific intention to do so within
    the next month or so, the annual rate of cessation among people
    younger than 65 is low and remains low.
        Meanwhile, the tobacco industry is spending more than $15
    billion annually marketing its product to smokers and potential
    smokers in ever more creative ways, as we have just seen, while
    public and private resources devoted to preventing smoking and
    helping people quit are dwindling. It will probably come as a
    surprise to most Americans, but the States use very little of
    the billions of dollars they are receiving under the Master
    Settlement Agreement to reduce tobacco use, as Congressman
    Barton noted earlier.
        Taking these realities into account, the committee believes
    that the annual toll of more than 400,000 smoking-related
    deaths will continue well into the 21st century. It is time to
    change course. For four decades, the tobacco industry
    successfully framed a public debate around the health
    consequences of smoking and the illegitimacy of governmental
    efforts to prevent or discourage people from smoking whenever
    and wherever they wanted.
        But that debate as I think is entirely clear from the
    comments made by the members, is over. The dangerous properties
    of tobacco and its impact on the public health are now beyond
    dispute. And, as our report shows, aggressive measures to
    reduce smoking rest on a solid scientific and ethical
    foundation.
        The only debate now should be about how best to accommodate
    the legitimate interests of addicted smokers within a
    comprehensive national policy designed explicitly to reduce
    smoking and other forms of tobacco use.
        In its blueprint for the Nation, the committee offers a
    two-pronged strategy for putting the Nation on an irreversible
    course toward ending the tobacco problem. This strategy
    involves strengthening current tobacco control measures while
    transforming the regulatory environment for tobacco products.
    This is not an either/or question. This is both.
        First, we have to invest in traditional tobacco control
    measures. The evidence is in. These interventions do work. The
    report contains almost 100 pages documenting the effectiveness
    of traditional tools of tobacco control, such as excise tax
    increases, indoor smoking restrictions, comprehensive State-
    based programs, media-based prevention campaigns, school-based
    programs, and cessation therapies and services.
        Specifically the committee urges States to fund tobacco
    control programs at the level that has been recommended by the
    CDC, to license all retail establishments that sell tobacco,
    and to ban the sale or shipment of tobacco products directly to
    consumers through mail order or the Internet.
        The committee also urges Congress to help fund State
    tobacco control activities and to fund a national youth-
    oriented media campaign. Further, the committee recommends that
    all insurance managed care and employee benefits plans,
    including Medicaid and Medicare, cover reimbursement for
    effective smoking cessation programs as a lifetime benefit.
        Mr. Pallone. Mr. Bonnie, you are 2 minutes over, so I am
    going to ask you to summarize the rest if you don't mind.
        Mr. Bonnie. I am sorry, Mr. Chairman.
        Mr. Pallone. That is all right.
        Mr. Bonnie. All right, well if I might refer specifically
    then to the second part of the committee's strategy with regard
    to the change of the legal structure of tobacco control.
    Tobacco products, as the committee knows, are not ordinary
    consumer products. And for no other lawful consumer product can
    it be said that the acknowledged aim of national policy is to
    suppress consumption altogether rather than to promote safe or
    responsible use.
        And as has been noted, these products are essentially
    unregulated. So Congress should enact a Federal regulatory
    statute that is suited to the unique history and
    characteristics of tobacco products. There are many elements of
    the bill, of course, the committee did not and the national
    academies would not endorse any particular piece of
    legislation. And I am speaking on behalf of the committee.
        But the elements of the bill and the goal of the bill, are
    fully compatible with all the recommendations that appear in
    the committee's report. Thank you, Mr. Chairman.
        [The prepared statement of Mr. Bonnie follows:]

                         Statement of Richard J. Bonnie

         Good morning, Mr. Chairman and members of the committee.
    My name is Richard Bonnie. I am Harrison Foundation Professor
    of Medicine and Law, Professor of Psychiatry and
    Neurobehavioral Sciences, and Director, Institute of Law,
    Psychiatry and Public Policy at the University of Virginia. I
    recently served as Chair of the Committee on Reducing Tobacco
    Use of the Institute of Medicine, a component of the National
    Academies, chartered by Congress in 1863 to advise the
    government on matters of science and technology. The
    committee's work was funded by the American Legacy Foundation.
    Thank you for inviting me to testify today about the
    committee's report entitled Ending the Tobacco Problem: A
    Blueprint for the Nation. A summary of the report is included
    with my statement and submitted for the record.
         As everyone here knows, tobacco use--especially cigarette-
    smoking--has been one of the Nation's major public health
    problems for most of the 20th century and continues at an
    unacceptable level in the 21st century. Indeed, it has become
    one of the world's major public health challenges.
         The tobacco problem is fundamentally a man-made problem.
    Cigarettes became one of the most successful consumer products
    in history in only a few decades and became an ever-present
    icon of American life--embedded in the culture and promoted by
    a powerful industry. Unfortunately, cigarettes are one of the
    most dangerous consumer products ever marketed. They are highly
    addictive and deadly, as even the tobacco companies now
    concede.
         If tobacco cigarettes were now being introduced into the
    marketplace for the first time, there is no doubt that they
    would be banned under any one of several consumer protection
    statutes. Of course, banning tobacco products is not feasible
    or wise. The challenge the country faces today is to develop a
    feasible strategy for rooting out a problem that is deeply
    entrenched in our economic and cultural life. There are still
    45 million cigarette smokers and another 9.7 million users of
    other tobacco products. Most of them regret taking up the habit
    and struggle to quit.
         The title of the committee's report probably got your
    attention. Let me explain what the committee means by ``ending
    the tobacco problem.'' In the committee's view, the Nation's
    long-term goal should be to reduce tobacco use so substantially
    that it is no longer a significant public health problem. The
    blueprint outlined in the report aims to set the Nation
    irreversibly on a course for achieving this objective.
         Optimists might say we are already well on our way to
    ending the problem. After all, the prevalence of smoking among
    adults has been cut in half--from 42 percent to 21 percent--
    since 1965. The prevalence of daily smoking among high school
    students is at its lowest level since annual monitoring began
    30 years ago. An increasing proportion of the indoor
    environment is smoke-free. The tobacco companies are defending
    themselves against an increasing number of lawsuits, and state
    juries outraged by the industry's deceptive conduct have
    imposed very large punitive damage awards. Why not just keep
    doing what we are doing and wait for these historical currents
    to bring the problem to an end?
         The committee concluded that maintaining our present
    course will not end the tobacco problem. There are already
    signs that the prevalence of smoking among adults is flattening
    and the rate of youth initiation has hovered around 20 percent
    for most of the past two decades even though it is down at the
    moment. The high rate of youth smoking is especially troubling
    because at least 80 percent of people who smoke begin to do so
    as adolescents when they cannot fully appreciate the grip of
    addiction and the future risk to their health.
         Moreover, quitting after decades of use is difficult.
    Despite the fact that 70 percent of smokers say they want to
    quit, the annual rate of cessation among people younger than 65
    remains low.
         Meanwhile, the tobacco industry is spending more than $15
    billion annually marketing its products to smokers and
    potential smokers in ever more creative ways while public and
    private resources devoted to preventing smoking and helping
    people quit are dwindling. It will probably come as a surprise
    to most Americans that the states use very little of the
    billions of dollars they are receiving under the Master
    Settlement Agreement to reduce tobacco use.
         Taking these realities into account, the committee
    believes that the annual toll of more than 400,000 smoking-
    related deaths will continue well into the 21st century.
         It is time to change course.
         For four decades, the tobacco industry successfully framed
    a public ``debate'' around the health consequences of smoking
    and the illegitimacy of governmental efforts to prevent or
    discourage people from smoking whenever and wherever they
    wanted. But that debate is over. The dangerous properties of
    tobacco and its impact on the public health are now beyond
    dispute and, as our report shows, aggressive measures to reduce
    smoking rest on a solid scientific and ethical foundation. The
    only debate now should be about how best to accommodate the
    legitimate interests of addicted smokers within a comprehensive
    national policy designed explicitly to reduce smoking and other
    forms of tobacco use.
         In its blueprint, the committee offers a two-pronged
    strategy for putting the Nation on an irreversible course for
    ending the tobacco problem. This strategy involves
    strengthening current tobacco control measures while
    transforming the regulatory environment for tobacco products.
         First, we have to invest in traditional tobacco control
    measures. The evidence is in: These interventions work. The
    report contains almost 100 pages documenting the effectiveness
    of the traditional tools of tobacco control, such as excise tax
    increases, indoor smoking restrictions, comprehensive state-
    based programs, media-based prevention campaigns, school-based
    programs, and cessation therapies and services. Specifically,
    the committee urges states to fund tobacco control programs at
    the level recommended by the CDC, to license all retail
    establishments that sell tobacco, and to ban the sale or
    shipment of tobacco products directly to consumers through mail
    order or the Internet.
         The committee also urges Congress to help fund state
    tobacco control activities and to fund a national youth-
    oriented media campaign. Further, the committee recommends that
    all insurance, managed care, and employee benefit plans,
    including Medicaid and Medicare, cover reimbursement for
    effective smoking cessation programs as a lifetime benefit.
         If all these measures were implemented with fidelity and
    the efforts were sustained, the committee projects that the
    prevalence of smoking could be cut in half, to about 10 percent
    by 2025. That would mean that about 11 million fewer people
    would be smoking in 2025 than would be the case if current
    trends continue.
         That would be a great accomplishment, but even if the
    investment were sustained for 20 years, it would not end the
    tobacco problem. More than 25 million Americans would still be
    smoking. And there remains the distinct possibility that the
    investment will not be sustained, momentum will be lost, and
    adult smoking rates will be 15 percent or higher 20 years from
    now.
         To put the Nation on a sure course for ending the tobacco
    problem, we also need to change the legal structure of tobacco
    control. Tobacco products are not ordinary consumer products.
    For no other lawful consumer product can it be said that the
    acknowledged aim of national policy is to suppress consumption
    altogether rather than to promote safe or responsible use. Yet,
    these dangerous products are essentially unregulated. Congress
    should enact a Federal regulatory statute that is suited to the
    unique history and characteristics of tobacco products.
         Congress should empower the Food and Drug Administration
    to regulate the manufacture, marketing, and distribution of
    tobacco products, and should permit the states to undertake
    additional interventions to complement Federal regulations in
    all domains except packaging and product characteristics. The
    committee concluded that the necessary authority should be
    conferred on FDA because it is the Nation's preeminent public
    health regulatory agency and because it is the only agency with
    the necessary combination of experience in product regulation
    and scientific expertise on tobacco-related disease and
    nicotine addiction. Among the key elements in the committee's
    proposed regulatory program are graphic package warnings
    modeled after those required in Canada; limiting advertising to
    a text-only, black-and-white format; banning any activities by
    tobacco companies that target youth; and aggressive regulation
    of retail outlets to help reduce initiation and promote
    cessation.
         The committee also reaffirmed recommendations by a
    previous IOM committee (Clearing the Smoke, 2001) that FDA be
    empowered to assure that any claims stating or implying that
    novel cigarette products reduce the risks of tobacco-related
    disease have a scientific basis, and that it be authorized to
    promulgate standards for tobacco products aiming to protect the
    public health. The committee specifically urges FDA to explore
    the feasibility of gradually reducing the nicotine content of
    cigarettes. The FDA already regulates pharmaceutical
    preparations containing nicotine, such as patches, ``gum'' and
    it seems odd, to say the least, that it has no authority to
    regulate the much more dangerous preparation containing
    nicotine that makes these other preparations medically
    necessary.
         Some people have worried that FDA regulation of tobacco
    would be construed by the public as government endorsement of
    the safety of the product. It seems highly unlikely that such a
    gross distortion of public understanding could occur when
    public and private agencies, including FDA itself, are taking
    aggressive steps to discourage people from using tobacco
    products and to help people quit. Of course, FDA should monitor
    public perceptions about the dangers of tobacco use as a key
    component of its overall surveillance programs, and should
    develop or require appropriate corrective communications to
    counter any misperceptions that may emerge concerning the
    health consequences of tobacco use or concerning the effects of
    using specific products.
         I have only touched on some of the many recommendations in
    the committee's report. However, the specific proposals are
    perhaps less important than the message and design of the
    blueprint as a whole. In the committee's view, it is time to
    transform the Nation's tobacco policy. Containing the problem
    is no longer good enough. The Nation should commit itself to
    the strong and sustained measures needed to end this critical
    public health problem.
         I would be pleased to answer your questions. Thank you.
                                  ----------

        Mr. Pallone. Thank you. And I should mention that your full
    statement is submitted for the record. We just try to keep to
    the 5 minutes. Dr. Jacobs, again thank you for being here.

       STATEMENT OF FRED JACOBS, M.D., COMMISSIONER, NEW JERSEY
                DEPARTMENT OF HEALTH AND SENIOR SERVICES

        Dr. Jacobs. Thank you very much, Mr. Chairman. Chairman
    Pallone, Congressman Ferguson, distinguished members of the
    Subcommittee on Health, I am very honored to be here today to
    testify in support of H.R. 1108, the Family Smoking Prevention
    and Tobacco Control Act. And I am delighted that all 10
    esteemed members of the New Jersey congressional delegation are
    cosponsors of this important legislation that would give the
    Food and Drug Administration the authority to regulate tobacco
    products.
        It has been more than 40 years since the U.S. Surgeon
    General first alerted the Nation that smoking is hazardous to
    our health. And, in my view, because smoking is the Nation's
    leading preventable cause of death, the FDA should have had the
    power to regulate tobacco products 40 years ago.
        There is no greater public health threat than smoking and
    secondhand smoke. No other product on the market today can
    cause death, lifelong disability, or cancer if used as
    directed. Last year, New Jersey implemented its landmark indoor
    smoke-free air act to reduce the harmful effects of secondhand
    smoke, and we also raised the legal age to purchase tobacco
    from 18 to 19 to decrease the likelihood of students in high
    school purchasing cigarettes. And we increased the State's
    cigarette excise tax for the fourth time to $1.77 per pack, the
    highest in the Nation at the time.
        And cigarette smoking continues to decrease among New
    Jersey middle school and high school students, according to the
    2006 New Jersey youth tobacco survey. And current smoking rates
    have dropped dramatically among middle school students and
    among high school students since 1999. During this same 7-year
    period, current use of any tobacco product has also
    significantly declined among high school students and middle
    school students as well.
        The New Jersey Department of Health and Senior Services has
    worked with community-based organizations, tobacco control
    advocates, and New Jersey teens to encourage young people to
    remain smoke-free or quit smoking if they have already started.
        And the effort has paid off as the declining rates of
    tobacco use demonstrate. So we, in the State of New Jersey,
    have enacted important tobacco control initiatives in ways that
    will prevent illness and save lives for generations.
        So I come before you today not only as the commissioner of
    the New Jersey Department of Health and Senior Services, but as
    a lifelong anti-tobacco advocate, a former chairman of the New
    Jersey Breaths advocacy group, and a physician who specialized
    in pulmonary disease for more than 45 years.
        I have seen firsthand in my practice in thousands of
    patients how tobacco ravages the body. There are more than
    4,000 toxic chemicals in cigarette smoke. 69 of them are known
    carcinogens. Exposure to these toxic contaminants can lead to
    respiratory infections, asthma, emphysema, lung cancer, heart
    disease, stroke, and death.
        In other words, smoking causes disease in nearly every
    organ of the body, as former U.S. Surgeon General Richard
    Carmona told us in 2004 when he released the new comprehensive
    report on smoking and health. More than 400,000 people die in
    the U.S. each year from tobacco-related illnesses. That has
    already been discussed. And that includes 11,300 in New Jersey.
    And up to 62,000 adult non-smokers die each year in the U.S.
    from the effects of secondhand smoke, according to the U.S.
    EPA, and this includes up to 1,800 people in New Jersey.
        It is our responsibility as public officials to protect the
    public health and safety. An important step we can take to
    provide this protection is to vest the FDA with the authority
    to regulate the levels of tar, nicotine, and other harmful
    components of tobacco products and to ensure effective
    oversight over the tobacco industry's efforts to develop,
    introduce, and promote products that they claim to be ``less
    harmful.''
        We must use every tool in our arsenal to promote smoking
    cessation, to reduce the risk of tobacco-related diseases, and
    to prevent our young people from becoming enticed by and
    addicted to tobacco products. After all, the future survival of
    the tobacco industry depends on addicting our children.
        Up until now, education, prevention, and advertising,
    funded in part by New Jersey's excise tax have been our
    strongest tools. And we all know that despite our best efforts,
    we have been outmatched by the advertising power, the lobbying
    clout, and the ingenuity of big tobacco.
        Our efforts in New Jersey are continuing. We still need to
    expand our outreach to smokers, encouraging them to quit and
    educating them about the highly effective quit services that
    New Jersey offers. We still need to promote tobacco use
    prevention among our children and teens, and we need to
    continue offering specialized smoking cessation programs for
    those teens who already smoke.
        And we still need to promote and enforce tobacco age of
    sale laws to better ensure that licensed vendors of tobacco
    products do not sell to minors. And we still need to extend
    secondhand smoke protection in the workplace to workers on the
    casino floors in New Jersey.
        This fall, I am traveling around the State as part of a
    major public awareness campaign to educate students, parents,
    school nurses, and pediatricians about the dangers of exposing
    children to the toxic effects of secondhand smoke in cars and
    in homes. And by the end of the year, I hope to have spoken
    before approximately 50 groups.
        I know I am getting to the end of my time, and I just want
    to emphasize in the last few seconds that we as public
    officials need more tools in our arsenal. The Nation needs the
    Family Smoking Prevention and Tobacco Control Act. The FDA
    needs premarket authority over all new tobacco products, and
    the FDA needs to set national standards controlling the
    manufacture of tobacco products and the identification of
    public disclosure of ingredients in such products.
        I urge you to protect the public health by approving the
    Family Smoking Prevention and Tobacco Control Act. Thank you
    very much for this opportunity to testify, and, of course, I
    will be happy to answer any questions. Thank you, Mr. Chairman.
        [The prepared statement of Dr. Jacobs follows:]

                       Statement of Fred M. Jacobs, M.D.

        Chairman Pallone, Congressman Ferguson, distinguished
    members of the Subcommittee on Health, good morning.
        I am honored to be here to testify in support of H.R.1108,
    the Family Smoking Prevention and Tobacco Control Act.
        And I am delighted that ten esteemed members of New
    Jersey's congressional delegation are co-sponsors of this
    important legislation that would give the Food and Drug
    Administration the authority to regulate tobacco products.
        It has been more than 40 years since the U.S. Surgeon
    General first altered the Nation that smoking is hazardous to
    our health.
        And in my view--because smoking is the Nation's leading
    preventable cause of death and disability--the FDA should have
    had the power to regulate tobacco products 40 years ago.
        There is no greater public health threat than smoking and
    secondhand smoke.What other product on the market today that is
    unregulated can cause death, life-long disability or cancer if
    used as directed?
        Last year, New Jersey implemented its landmark indoor
    Smoke-Free Air Act to reduce the harmful effects of secondhand
    smoke.
        We also raised the legal age to purchase tobacco from 18 to
    19 to decrease the likelihood of high school students
    purchasing cigarettes, and increased the state cigarette excise
    tax for the fourth time. At the time, that increase made the
    total tax of $1.77 per pack the highest in the Nation.
        I am happy to report that cigarette smoking continues to
    decrease among New Jersey middle-school and high-school
    students, according to the 2006 New Jersey Youth Tobacco
    Survey.
        Current smoking rates have dropped from 10.5 to 3.2 percent
    among middle school students and from 27.6 percent to 15.8
    percent among high school students since 1999.
        During the same 7-year period, current use of any tobacco
    products, including cigars, smokeless tobacco, cigarettes, and
    bidis--small, hand-rolled imported cigarettes--also
    significantly declined from 38.9 percent to 24.5 percent among
    high school students and from 18.9 to 8.4 percent among middle
    school students.
        The New Jersey Department of Health and Senior Services has
    worked with community-based organizations, tobacco-control
    advocates and New Jersey teens to encourage young people to
    remain smoke-free or to quit smoking if they have already
    started. The effort has paid off as the declining rates of
    tobacco use show.
        So we in the State of New Jersey have enacted important
    tobacco-control initiatives in ways that will prevent illness
    and save lives for generations.
        I come before you today not only as the Commissioner of the
    New Jersey Department of Health and Senior Services, but also
    as a lifelong anti-tobacco advocate, a former chairman of the
    New Jersey Breathes advocacy group and a physician who
    specialized in pulmonary diseases.
        And as a physician for nearly 40 years, I have seen first
    hand in thousands of patients how tobacco ravages the body.
        There are 4,000 toxic chemicals in cigarette smoke and 69
    of them are known carcinogens. Exposure to these toxic
    contaminants can lead to respiratory infections, asthma,
    emphysema, lung cancer, heart disease and death.
        In other words, smoking causes diseases in nearly every
    organ in the body as former U.S. Surgeon General Richard
    Carmona told us in 2004 when he released a new comprehensive
    report on smoking and health.
        More than 400,000 people die in the U.S. each year from
    tobacco-related illnesses--including 11,300 in New Jersey. And
    up to 62,000 adult nonsmokers die each year in the U.S. from
    secondhand smoke, according to the U.S. EPA. This includes
    between 1,000 and 1,800 New Jersey residents.
        It is our responsibility as public officials to protect the
    public health and safety. And an important step we can provide
    for the public's health is to vest the FDA with the authority
    to regulate the levels of tar, nicotine and other harmful
    components of tobacco products and to ensure effective
    oversight over the tobacco industry's efforts to develop,
    introduce and promote products that they claim to be ``less
    harmful.''
        We must use every tool in our arsenal to promote smoking
    cessation to reduce the risk of tobacco-related diseases, and
    to prevent our young people from becoming enticed by and
    addicted to tobacco products.
        Up until now, education, prevention and advertising--funded
    in part by New Jersey's excise tax--have been our strongest
    tools. And we all know that despite our best efforts, we have
    been outmatched by the advertising power, lobbying clout and
    ingenuity of Big Tobacco.
        Our efforts in New Jersey are continuing. We still need to
    expand our outreach to smokers encouraging them to quit and
    educating them about the highly effective quit services that
    New Jersey offers: NJ Quitline, QuitNet and the Quitcenters. We
    still need to promote tobacco use prevention among our children
    and teens. We need to continue offering specialized smoking
    cessation programs for those teens who already smoke. We still
    need to promote and enforce tobacco Age of Sale laws to better
    ensure that licensed vendors of tobacco products do not sell to
    minors. And we still need to extend secondhand smoke
    protections in the workplace to workers on casino floors in New
    Jersey.
        This fall, I am traveling around the state as part of a
    major public awareness campaign to educate, students, parents,
    school nurses and pediatricians about the dangers of exposing
    children to the toxic effects of secondhand smoke in cars and
    in homes. By the end of the year, I hope to have spoken before
    approximately 50 groups.
        But we public health officials need more tools in our
    arsenal. This Nation needs the Family Smoking Prevention and
    Tobacco Control Act. The FDA needs premarket authority over all
    new tobacco products. The FDA needs to set national standards
    controlling the manufacture of tobacco products and the
    identification, public disclosure and amount of ingredients in
    such products.
        I would urge you to protect the public health by approving
    the Family Smoking Prevention and Tobacco Control Act.
        Thank you for this opportunity to testify.
        I would be happy to answer any questions.

                      Attachment--Summary of Major Points

        There is no greater public health threat than smoking and
    secondhand smoke.
        We must use every tool in our arsenal to promote smoking
    cessation in order to reduce the risk of tobacco-related
    diseases, and to prevent our young people from becoming enticed
    by and addicted to tobacco products.
        It is our responsibility as public officials to protect the
    public health and safety. And an important step we can provide
    for the public's health is to vest the FDA with the authority
    to regulate the levels of tar, nicotine and other harmful
    components of tobacco products and to ensure effective
    oversight over the tobacco industry's efforts to develop,
    introduce and promote products that they claim to be ``less
    harmful.''
        New Jersey has taken a number of steps over the past two
    years to improve indoor air and decrease the likelihood that
    high school students will smoke. Last year, New Jersey
    implemented its landmark indoor Smoke-Free Air Act to reduce
    the harmful effects of secondhand smoke. New Jersey also raised
    the legal age to purchase tobacco from 18 to 19 to decrease the
    likelihood of high school students purchasing cigarettes, and
    increased the state cigarette excise tax for the fourth time.
                                  ----------

        Mr. Pallone. Thank you, Dr. Jacobs. We will now have 5
    minutes from the members, and I will start with myself. I am
    going to try to get in one question for each of you, if I can,
    in the 5 minutes here. Let me start with Professor Bonnie.
        The FDA, in their written testimony, say that H.R. 1108
    would be difficult to implement, undermines the public health
    roles of the FDA, and does not provide adequate resources for
    the agency to carry out the additional responsibilities. And I
    wanted to ask you, professor, did the IOM committee consider
    these arguments? If so, how did they reach the conclusion that
    the FDA is the most appropriate agency to regulate tobacco
    products? And how do you respond to criticisms of a bill that
    FDA regulation of tobacco would legitimize its use?
        Mr. Bonnie. Well, I apologize again for going over my time
    earlier, but that is also quite a large question that you just
    asked me.
        Mr. Pallone. I realize that.
        Mr. Bonnie. The committee did think about these matters,
    and I think, first of all, it should be recognized this is a
    challenge. Regulating this product is not like regulating other
    products, as I think the commissioner has indicated. And it is
    going to take some development of scientific knowledge and
    regulatory attention to develop a plan for doing so.
        On the other hand, I think if the FDA is adequately
    resourced to do the job, there is no other agency that is
    better suited to do it than the FDA. It would be a challenge
    for any agency, but I don't know what the alternative frankly
    is. There is no better alternative if we are going to grapple
    with the regulatory challenges. I don't think the alternative
    is to leave the product unregulated.
        The question is which agency is better suited. The
    committee discussed this at length and concluded that the FDA,
    the preeminent public health regulatory agency, has the
    scientific expertise to do this. As was indicated earlier, it
    regulates various nicotine products that are made medically
    necessary because of the nicotine in the tobacco products.
        In addition, it has tremendous range of regulatory
    experience that is most directly applicable to the product
    itself, even though it is a different kind of product, and it
    presents different challenges. So I think the committee did
    discuss this and concluded that there really is no agency that
    is better suited to do it.
        Mr. Pallone. I appreciate that. I think we face the same
    thing with every issue. Like we just finished with PDUFA and
    MDUFA, and I had a lot of criticism. I said, why are you giving
    additional power to the FDA because they don't do a good job?
    And I had the same answer which is who am I going to give it
    to?
        Mr. Bonnie. Right.
        Mr. Pallone. So I think you are right. What about the----
        Mr. Bonnie. The legitimation issue?
        Mr. Pallone. Yes.
        Mr. Bonnie. We did also talk about this and commented on it
    in the report. I think it is a compared-to-what question. I
    think it might be helpful if the committee were to think about
    what is the situation now. Here you have this product that
    everyone concedes is the most dangerous consumer product ever
    marketed, that is essentially unregulated, and where the only
    form of regulation, essentially from the national government,
    is an invisible warning on the side of the pack.
        Now, meanwhile we try very hard to get people not to smoke
    and to convince them not to smoke. But what do people think
    when a product of this kind is essentially regulated in more or
    less a laissez-faire manner without regulation? What inferences
    would they draw then?
        Now, let us compare it to the situation that would exist if
    the Congress confers the authority on the FDA that would be
    represented in this bill. The FDA would be directed to serve
    the public health interest by aggressively regulating the
    manufacture, distribution, and marketing of this product.
        To take a very specific example, explicitly the Act would
    enlarge and strengthen the public health warnings. It would
    also confer on the agency the authority to even strengthen them
    further and to provide graphic warnings, pictures of which
    actually appear in the committee's report.
        In addition, there would be strong and aggressive efforts
    undertaken not only by the State governments but other private
    agencies, as well as by the FDA and other agencies of the
    Federal Government to continue to aggressively try to convince
    people that they should not start and that they should quit.
        How in the face of all of that people would draw the
    inference that somehow it is being approved by the FDA in the
    face of all those efforts that the Government would be taking
    essentially escapes me. I do not think that this is really a
    serious problem. But even if it were to happen, the FDA should
    also monitor and survey through surveillance mechanisms
    consumer perceptions not only about smoking but about specific
    products. And if there were to be a problem in terms of
    misperceptions about the health consequences of tobacco use,
    then obviously the FDA should respond.
        Mr. Pallone. All right. Now, I have just a little bit of
    time here for Mr. Jacobs. But I wanted to ask you, you already
    heard some criticism about States who are not using all their
    money from the MSA, the agreement for tobacco cessation. Did
    you want to respond to that? And do you think this reflects any
    lack of urgency at the State level? And I guess you could also,
    if you could, Dr. Jacobs, explain the success that New Jersey
    has had with some of these anti-smoking initiatives.
        Dr. Jacobs. All right, thank you very much, Mr. Chairman.
    Well, as you know, we were spending $30 million a year.
    Smokeless States advised $45 million. We did $30 million when I
    was chair of New Jersey Breathes. This is back to the early
    part of the 21st century.
        And then as New Jersey's financial troubles became known to
    everybody--I guess they are not a secret--a decision was made a
    couple of governors ago to cut this down from $30 milion to $10
    million. It has been increased to $11 million. That is what is
    spent now on our comprehensive tobacco control program in the
    department, which includes things like Quitline, Quitnet, the
    Quitcenters, that do increase the rate of quitting by a factor
    of tenfold over trying alone, but still very low. It is still
    only about 30 or 40 percent success after 6 months because
    nicotine is so addicting that once you start, it is very hard
    to stop. And, of course, you have this additional benefit from
    that that it is hard.
        We, of course, in New Jersey and I am sure in other States
    as well, have priorities when it comes to limited funding. And
    our particular problems with the budget gap that we have been
    facing and will face again next year--we just had a cabinet
    meeting yesterday with the Governor on this issue--makes it
    incumbent upon us to look to the private side, to maximize the
    resources we have. Myself going around and speaking to all of
    these groups is one way to do it. We have been very successful
    in getting passage of the Smoke-Free Indoor Air Act. It took 10
    years of effort to do that. There are certain gaps yet, but we
    are working on those.
        I am very proud of what New Jersey has done, and I don't
    think we need to apologize that we haven't spent all of the
    money on the Tobacco Control Act, given the financial context
    of that money. And it doesn't excuse the Federal Government
    from stepping up to the plate and doing their job as well.
        Mr. Pallone. Thank you. Recognize Mr. Deal.
        Mr. Deal. Thank you. Mr. Bonnie, did your committee or your
    group undertake to give any estimate as to how much the cost
    would be in extra funding required or additional employees at
    FDA if they undertook the regulatory processes outlined in this
    legislation?
        Mr. Bonnie. No, the committee did not do cost assessment of
    what it would take.
        Mr. Deal. In general terms, would it be a substantial
    investment of resources and personnel, do you think?
        Mr. Bonnie. I don't know what substantial means. I think
    that the committee's sense was that again some agencies should
    have regulatory authority here. A lot of the attention has been
    focused on the review of new products and particularly those
    products that purport to reduce exposure to toxicants or to
    reduce risk ultimately of tobacco-related disease.
        And the challenge that it would take to gear up to conduct
    that kind of review and then, of course, review the products
    that would be submitted, it obviously would be dependent on how
    many applications were submitted for that kind of review.
        I think it should also be emphasized though that even
    though that particular aspect of the bill has gotten the most
    attention, and of course it is the most of the pages frankly of
    the bill, and it is built on the foundation that the Institute
    of Medicine laid in a 2001 report called ``Clearing the
    Smoke''--that very, very important pieces of this legislation
    aim to reduce prevalence all together rather than the harm
    reduction features of the bill.
        And the resources that would be needed in order to
    implement those portions of the bill, I think, are potentially
    considerably less than those that would have to be devoted to
    this more complex regulatory challenge. Although it, in turn,
    depends upon how many products would then be submitted.
        So I think there is a lot of guesswork here in terms of
    exactly what the requirements are going to be. We do know when
    the agency geared up in the mid 1990s to do this what the
    resources were to enforce--at least initially to develop and
    enforce the 1996 Tobacco Rule. So there is at least that kind
    of evidence.
        But so many of these proposals essentially would involve
    strengthening the warnings and doing the necessary science on
    that and then monitoring it. Some Federal agency should be
    doing that. And so I think the question would be again not
    about FDA but the cost of that kind of regulation, which it
    seems to me would be strongly supported, I think, by even
    members of the committee that have problems with this bill.
        So again I think the committee thought that the benefits of
    the regulation would justify whatever cost that could be
    incurred, but we did not do a cost assessment.
        Mr. Deal. I believe your testimony indicated there are
    about 45 million people who are smokers today in this society.
    Is that the correct figure?
        Mr. Bonnie. Yes.
        Mr. Deal. We just heard in Mr. Pallone's question and some
    of the comments in opening statements about the fact that
    States are not using a significant portion of their master
    settlement money for efforts to have cessation of smoking among
    that 45 million.
        What is the suggestion as to what we do with regard to
    those? That is a significant number of people that we shouldn't
    just ignore it appears to me. Did the institute, for example,
    take a look at that particular issue as to what should be done
    in that regard and how should that be done? Should it be
    through the master settlement funding or what other approach,
    if any, should be done if it appears that States like New
    Jersey and others are diverting more and more of those funds to
    purposes totally unrelated? Was there any study done on that?
        Mr. Bonnie. Yes, indeed again I am glad the congressman
    asked this question because the committee's blueprint does go
    on both tracks to try to strengthen the traditional tobacco
    control activities that have largely been at the State and
    local level. And we continue to need to be doing that;
    although, FDA regulation and activities could supplement what
    is being done.
        An important part of this bill is actually to remove one of
    the obstacles that now exist to more aggressive regulation at
    the State and local level by loosening the preemption and
    allowing the States to engage in regulations that supplement
    whatever Federal regulations are adopted.
        With regard to the funding of State programs, the committee
    did carefully look at what has been happening with the master
    settlement funds, also looked at tobacco excise taxes because
    States, of course, have been increasing tobacco excise taxes in
    recent years, some of which in some States have been
    specifically designated for supporting tobacco control
    programs.
        There may be constitutional limitations that may prevent
    set-asides of that kind in all the other States. But obviously
    it would be possible for the States to take a look at their
    revenue streamsin both cases and to devote additional monies to
    these tobacco control programs. And we have urged them to do
    that.
        Another problem that is related to this, of course, is the
    disparities in excise taxes that ends up, of course, with
    possible smuggling across State lines as some places begin to
    increase the excise taxes even more. So what we recommended
    that the States do is that the States that have the lower
    excise taxes increase their excise taxes to the level of the
    top quintile of the States in order to reduce this disparity.
    That would have the benefit of reducing consumption and also
    producing these additional revenues that could be used then to
    fund the tobacco control programs.
        So we offered that kind of strategy as a way to solve a
    multiple number of problems as well as, of course, the
    suggestion that the master settlement funds could be set aside
    specifically to do some of these activities. And Virginia, for
    example, is one of the States that actually does that.
        Mr. Deal. Thank you.
        Mr. Pallone. We will continue with some of the members, but
    just so everyone knows we have three votes at 15 minutes
    followed by two 5-minutes. So I will recognize Mr. Waxman, and
    then we will see how much time is left.
        Mr. Waxman. Thank you very much, Mr. Chairman. Mr. Bonnie,
    you answered Chairman Pallone's question about whether FDA was
    the appropriate place to have this regulatory authority over
    tobacco. Did the IOM committee look at other agencies of the
    Government, Federal Trade Commission, or Center for Disease
    Control? And why did you decide that those agencies were not
    appropriate?
        Mr. Bonnie. Well, we did talk about other possibilities. I
    might say, even as a historical matter, the IOM first looked at
    this question in 1994 when a committee on preventing nicotine
    addiction in children and youth was established, and issued a
    report called ``Growing Up Tobacco Free'' which then provided
    some of the scientific foundation for what the FDA did
    subsequently in its tobacco rule.
        In that committee, this issue was also addressed, and what
    the committee concluded at that time, again, was that it might
    be that there would be alternative ways to go about it and that
    there might be concerns about contaminating the FDA's overall
    mission, as Commissioner von Eschenbach has suggested. There
    might be concerns about undermining the agency's overall
    mission by giving them authority here.
        And the committee at that time thought that there might be
    a legitimate concern there, but the alternative that we thought
    was most plausible then was establish a separate agency. Now,
    of course, I don't think there is any interest in any member of
    Congress to establish a new agency.
        But at that point, we had looked at the regulatory agencies
    and thought none of the other ones would be suitable for the
    broad regulatory authority that would be needed. You needed a
    public health regulatory agency in order to be able to do it.
    Now, the Consumer Product Safety Commission, I think, thinks of
    itself, in some respects when it is involved in injury
    prevention and disease prevention activities as having a public
    health sort of regulatory posture.
        But, of course, it is a highly under-resourced agency that,
    I think, if we were worried about the FDA we would have all the
    more worries about the Consumer Products Safety Commission,
    which, of course, does not have the depth of regulatory
    experience in any of the areas that would be relevant that the
    FDA does.
        And, of course, the Federal Trade Commission again has a
    particular regulatory orientation, but it is not a public
    health regulatory agency with all the scientific expertise, of
    course, that the FDA would have.
        So we actually did think about the other possible
    regulatory agencies and though there was really no alternative
    to the FDA within the existing array of Federal regulatory
    agencies.
        Mr. Waxman. We talk about children being most affected.
    What approach do you think we could take that is directed at
    children as opposed to adult smokers or adults who might
    consider to be smokers?
        Mr. Bonnie. In terms of the initiatives that the Congress
    should take? Well, for example--well, I guess I will mention
    two, I think an overall part of the strategy is, in the
    committee's view, to have more aggressive regulation of the
    retail environment, not only to tighten and enforce youth
    access restrictions and, of course, all the States have at some
    level, and that there is a Federal role that is being played
    there now in terms of the Synar Amendment.
        Not only should those activities be strengthened but the
    overall retail environment and the marketing that goes on in
    the retail environment also needs to be more strongly addressed
    than is now the case. That is one of the areas where preemption
    under existing Federal law impedes more aggressive State
    action.
        So one of the things, the important things that the
    Congress could do is to get the Federal Government out of the
    way of efforts of the States to engage in more active
    regulation of the retail environment that largely would be
    aimed at preventing exposure of kids to pro-smoking messages in
    that environment.
        The other factor is to license the retailers in order to be
    able to set up appropriate regulatory mechanisms and, of
    course, the tobacco rule, if it were adopted, would set up a
    regulatory strategy that could support the State efforts in
    that area.
        The second thing, of course, is mass advertising. I
    emphasized how important the retail environment is, and we
    should not forget that while we are talking about regulation of
    advertising in magazines, for example. But the committee, of
    course, did look at, as the 1994 committee did, the committee
    did look at the messages to which youth are being exposed in
    various mass media, including the magazines and recommended a
    text-only, black and white approach to the regulation of
    advertising arguing and believing that that would be consistent
    with the constraints of the first amendment.
        So reviving the provisions of the FDA tobacco rule by
    granting authority to the FDA to do that and directing it, as
    the bill does, to reenact that regulation would be an important
    part of that strategy.
        Mr. Waxman. Thank you very much for your answers to my
    questions and for the terrific work that the IOM did giving us
    these recommendations.
        Mr. Pallone. We have 9 minutes left. Did the gentlewoman
    from Tennessee want to ask questions now or----
        Mrs. Blackburn. Thank you, Mr. Chairman. I probably could
    go ahead.
         Professor Bonnie, I did have a couple of questions for
    you. Litigation that is currently pending against cigarette
    companies, if we now had FDA certifying cigarettes as being
    less harmful, what will that do to some of these impending
    lawsuits? Did you all look at that? Have you given any thought
    to that?
        Mr. Bonnie. I am sorry, Congresswoman, my recall about what
    is precisely said about this in the report is not precise. We
    did, in recommending stronger FDA regulation, we did take into
    account that, of course, there would be some questions that
    would be raised about what the effect of that would be on
    various litigation and tort remedies.
        And I think in general the approach that was taken is the
    usual approach, I think, that is reflected in other product
    regulation statutes, which would be that if the State tort
    action, as would any direct regulatory action, were
    incompatible with the decision that had been explicitly made by
    the Federal regulatory agency, that that litigation would then
    be preempted by the Federal rule.
        But, I think, beyond that and particularly for actions that
    relate to fraud and deception, as an example, that those
    actions would survive. I think in general that was the approach
    that was taken. The general attitude that the committee had
    with regard to preemption is that the Federal rules with regard
    to packages and to product regulation, direct regulation of the
    product by the FDA basically should have preemptive effect on
    State action.
        Mrs. Blackburn. OK.
        Mr. Bonnie. But all other regulations should be----
        Mrs. Blackburn. Let me ask you this then. I think Philip
    Morris has more patents filed than anyone else on cigarettes
    that are less harmful or reduced risk. And one of the things it
    seems in Tennessee, whether it is intellectual property in
    dealing with our entertainers and our song writers, copyright,
    patent, intellectual property protection, is always a key
    component for us in these discussions.
        So what is going to happen if the FDA mandates a patented
    Philip Morris technology for a safer cigarette, an approved
    cigarette? Then do you have all your other manufacturers having
    to pay licensing fees to Philip Morris? Have we looked at that
    angle if you are going to get in there and micromanage that?
        Mr. Bonnie. I would love to be able to answer your
    question, but this is not something that the committee
    addressed in this report.
        Mrs. Blackburn. So you didn't think through to the end----
        Mr. Bonnie. The focus of this committee report overall was
    on preventing, reducing use and reducing prevalence of use. The
    harm reduction issue and what we should do about regulating new
    products was ancillary really to the function of this
    particular report. Those issues were addressed in----
        Mrs. Blackburn. Do you have a personal thought?
        Mr. Bonnie. Do I personally have a thought? No, I am not
    adequately informed enough to be able to answer your question.
        Mrs. Blackburn. OK, did you think activities from like DHS
    and CDC and all the other agencies that are working on smoking
    cessation and education, should they all be drawn in under the
    FDA?
        Mr. Bonnie. Again now I am speaking on--excuse me--trying
    to recall the committee deliberations so that I am speaking on
    behalf of the committee.
        Mrs. Blackburn. OK.
        Mr. Bonnie. And I think it is accurate to say that the
    committee's view was that the FDA authority here would not be
    in lieu of all the other efforts that would be being made by
    other Federal agencies.
        Mrs. Blackburn. It would be in addition to?
        Mr. Bonnie. Would be in addition to those efforts and
    particularly those that are designed to focus on the prevention
    of smoking and helping people quit. Obviously there are
    tremendous activities that are going on elsewhere in the
    Federal Government.
        Mrs. Blackburn. OK, thank you. Mr. Chairman, I have been
    reading Dr. Eschenbach's testimony while I have been sitting
    here this morning. I am disappointed that we don't have
    somebody from the FDA to participate in this, and I would hope
    that at some point we do have the opportunity to hear from him
    or somebody from the agency. I yield back.
        Mr. Pallone. I would just point out that we did invite
    them, and I don't really understand why they are not here. But
    we do have their written testimony at this point that we can
    reference. We will now stand in recess. The two of you can
    stay, I hope, right? We will be back in about maybe half an
    hour or so and continue with the questions. And so the
    subcommittee stands in recess until that time.
        [Recess.]
        Mr. Pallone. And the next person to be recognized is our
    vice chair, Mr. Green, for questions.
        Mr. Green. Thank you, Mr. Chairman. Dr. Bonnie, the IOM
    report discusses some of the significant successes that the
    tobacco control movement has had to date. Almost all of these
    successes though have been on the State level. The report lists
    increased tobacco excise taxes, and I know Texas has
    dramatically increased theirs. Youth access restrictions,
    prevention programs, media campaigns, cessation programs, grass
    roots community advocating, smoking restrictions such as those
    implemented last year in my home town.
        In fact, I congratulate my city council member, Cheryl
    Ovalado for her leadership on that effort. And I am proud of
    the work that Texas is doing on the State level, the research.
    In fact, it is even doing it at my alma mater, University of
    Houston.
        Yet despite all these steps, smoking rates remain high. And
    the IOM report recognizes we may have hit a limit on these
    programs' effectiveness and further recognize that almost all
    these steps address the demand side of the smoke equation. Dr.
    Bonnie, how can congressional efforts help address the
    cigarette tobacco supply problem in order to lower smoking
    rates? And does the available force, do they adequately meet
    these goals?
        Mr. Bonnie. Well, I guess speaking for myself, I think I
    would begin by enacting this bill. But just to put what you
    said in context, the committee was a little bit more optimistic
    than your statement indicated that we might, by strengthening
    the steps that Texas and other States have been taking, that we
    might continue to make a dent in smoking prevalence.
        But it would have to be sustained. It would have to be
    strengthened and sustained over a period of time, or
    backsliding is a continuing risk, and particularly because
    obviously the tobacco industry is--unless other steps are
    taken--going to continue its efforts to market the product and
    support smoking.
        So it is for two reasons then, I think, that we need to
    focus on the need for Federal action not to displace but to
    help supplement the State actions that you just referred to. So
    one is on the supply side. So here obviously we have a product
    that basically has not been regulated, and where substantial
    restrictions on the nature of the product or on access to it
    have not yet been taken.
        And in order to really do that with regard to the product,
    you have got to have Federal action. The State can't obviously
    deal with alterations in the product itself.
        But in addition, I don't want to underemphasize by
    emphasizing the need to move to supply side because everything
    that we have been doing so far has been on the demand side
    because of basically Federal exemption. So in order to move
    forward, we need to begin to regulate on the supply side, but
    also we need to strengthen the Federal role on the demand side
    as well.
        And this bill does that, and I think it is important to
    emphasize the other features of this bill that would strengthen
    activities on the demand side, such as the strengthening of the
    warnings, such as the regulation of marketing and advertising
    by restricting efforts to promote the use of the product.
        Mr. Green. OK, the IOM report does not advocate the banning
    of the tobacco products, and I know after the House passed the
    CHIP program with the tax increase in it, I heard from a lot of
    constituents who say well, if it is so bad, don't tax it, just
    ban it.
        Some statistics I want to make sure we get into the record
    that I know you are familiar with. Twenty-three percent of high
    schoolers currently smoke. Twenty-one percent of adults--that
    is about 45 million smokers--currently smoke. And 400,000
    Americans die every year from their own smoking, and tens of
    thousands more die from second hand smoke.
        Smoking kills more people than alcohol, AIDS, car
    accidents, illegal drugs, murders, and suicides combined. And
    can you explain to our committee the rationale why the IOM
    wouldn't just recommend just banning it in the conclusion, the
    prohibition of tobacco products is not appropriate?
        Mr. Bonnie. Well, you can imagine, we did discuss this at
    considerable length because of the charge that we had about
    developing a blueprint for the Nation to reduce tobacco use.
    And one of the very first issues that we were asked to address
    is actually to look at the question of how would we gauge the
    success over a period of time of any substantial efforts that
    were made to reduce use and what the goal is.
        And what we concluded is that at this point, we could just
    talk about ending the tobacco problem as a significant public
    health problem with a 20-year frame of reference. It might very
    well be that at some point further down the path, when you have
    significantly reduced prevalence, that you would face the
    question about why not take the next step.
        But clearly with 45 million smokers smoking and otherwise
    using other products that are addictive, it is clearly not
    feasible to adopt a prohibition approach. Obviously you would
    have to take into account the cost of trying to enforce a
    prohibition, the inevitable development of illicit markets and
    so on.
        So I think nobody on the committee thought that for the
    foreseeable future that prohibiting these products is a
    feasible option. So the question then is what do you do. In
    order to eventually move in the direction of substantially
    reducing the use of the product, and there are only really two
    choices that we have.
        One is basically to continue the regulatory environment
    that we now have, and the other is to engage in aggressive
    measures to try to discourage the use of the substance and to
    reduce prevalence in the way that this bill proposes to do.
        Mr. Green. Thank you, Mr. Chairman.
        Mr. Pallone. Mr. Buyer.
        Mr. Buyer. Tell my wife I had a V-8 for lunch, all right?
    In her attempts to keep me healthy, she is killing me.
        I went down a whole laundry list of a lot of products out
    there on the market today that we could regulate, and we seem
    to be sort of focusing on tobacco. There is a statement that
    was made that while tobacco is the plant, humans created this
    product. There is no health benefit. You could say the exact
    same thing as trans fats and refined sugar. Humans created
    those things, and we get a lot of bad effects from them. You
    know that. Coronary heart disease, the high insulin rates, the
    diabetes problems that we have to deal with with regard to our
    diet. And so I am just letting you know I am being very
    cautious and careful here with regard to the regulatory impact
    of this bill and what type of slippery slope are we going to
    take.
        I would endorse the harm reduction strategy, I guess, as my
    wife is doing to me. And we do that through individual choice.
    So let me ask this question of the panel. Of the tobacco
    products that are out there on the market today, are there some
    that are worse than others, or some that are better for one's
    health than others?
        Dr. Jacobs. Well, obviously there is a magnitude of
    difference in terms of the use and the abuse of cigarette
    smoking, and things that you inhale. Where you inhale the smoke
    itself is obviously more dangerous. But it is not like using
    other tobacco products is safe. So all of them have a risk.
        The difference between tobacco products and all of the
    other things that you mention is that tobacco products are
    addicting, and they are heavily marketed because of their
    addicting potential. So it is difficult to stop, and you have
    documented evidence of the danger, particularly when it is
    marketed to underage kids who can't really make a rational
    choice about it based on their own life experience.
        So whether you deal with trans fats or refined sugars or
    all the rest of the items you mentioned, there, I think, an
    educational program is at the basis of where that ought to be
    addressed. And that is what we are doing in New Jersey on
    childhood obesity and secondhand smoke in homes. We are not
    going to regulate secondhand smoke in homes. We are not going
    to tell parents you can't smoke in your home when there are
    kids present. How are we going to enforce that?
        But I believe strongly that if we educate people about what
    their conduct does in terms of harmful impact on their own
    children, that they will make a legitimate effort to alter that
    kind of conduct, such as smoking in homes and cars.
        So when it comes to the specific answer to the question,
    which tobacco products are safer than others, there are no safe
    tobacco products. Some are more dangerous than others, and if
    we want to do a risk reduction strategy and pick the low-
    hanging fruit, you would go directly to cigarette smoking
    because that is the one that has the greatest addiction
    potential and the greatest harm.
        Mr. Buyer. One of the challenges I have of picking FDA--and
    I know, Mr. Bonnie, you had to go through this decision-making
    process. When you look at the core mission of FDA and that
    they, by way of their culture, are focusing on the efficacy and
    safety of drugs and devices, that the culture is all about
    safety and health of a society. And now if we are going to take
    a tobacco product, and based on the testimony just now given by
    Dr. Jacobs, it is making choices among harm.
        All right, so this is a different mindset, and so if it is
    about prevention and its education, there are some steps that
    we can take. And so let me ask you is smokeless tobacco, would
    that be a useful step to advocate and permit sampling of such a
    product if we are trying to wean people off of cigarettes?
        Mr. Bonnie. You are asking me this question?
        Mr. Buyer. Yes.
        Mr. Bonnie. All right, well, I agree with everything that
    Dr. Jacobs said. So the problem is that all of these products
    are uniquely dangerous and are addictive. And so the slope is
    not as slippery, I think, as you were suggesting. And we also
    have to add that more than 80 percent of the users of any of
    these products began when they are kids, when they then not in
    a position really to appreciate the grip of addiction.
        So for all those reasons, we need to regulate these
    products in order to continue to reduce the amazingly large
    public health----
        Mr. Buyer. Let us get to the sampling question.
        Mr. Bonnie. OK.
        Mr. Buyer. Would you want to permit sampling as part of a
    harm reduction strategy to move them from cigarettes to
    smokeless than not at all?
        Mr. Bonnie. So what a regulatory agency needs to do, and
    the overall goal of regulation, is to prevent and discourage
    the use of all these products because that is what the public
    health demands. We also then have to deal with the issue of
    when people are using the products. What should be done as a
    matter of regulatory philosophy in order to help them make
    choices that will reduce the danger to them.
        And I think part of the new frontier, frankly, of tobacco
    control is the overall issue of harm reduction and whether or
    not people who cannot quit should have alternatives. But to say
    that alternative choices will be available is not to say that
    all of these products would not be regulated in order to
    protect the public health, and it certainly is not going to be,
    I don't think, would be the goal of any regulatory agency to
    encourage people to use a dangerous and addictive product.
        So I don't think that the regulatory agency, if you give
    FDA the authority, is going to be in the position of basically
    announcing to the public that our overall goal is to encourage
    people to use a smokeless tobacco, as an example.
        The goal is going to be to regulate all of these products
    in order to discourage people from using them to begin with and
    to the extent that it could be done, to reduce the dangers
    associated with the use of those products.
        But I can't imagine that it is going to become part of the
    agency's objective for exactly the reason that you said: to
    encourage people to think that there is a safe alternative in
    using these products.
        Mr. Pallone. Thank you. I recognize Mr. Gordon for a
    nanimous consent request.
        Mr. Gordon. Thank you, Mr. Chairman. I have a bill I wish
    to introduce. I am involved in a hearing in another committee,
    like a lot of folks. So let me just quickly say I ask unanimous
    consent to submit a statement by the U.S. Smokeless Tobacco
    Company, a constituent of mine, to be included as a part of the
    hearing record.
        Mr. Pallone. So ordered.
        Mr. Gordon. Thank you, Mr. Chairman.
        Mr. Pallone. And now I recognize the gentlewoman from
    Colorado, Ms. DeGette.
        Ms. DeGette. Thank you very much, Mr. Chairman. I want to
    thank both of you gentlemen for coming. You are both fabulous
    witnesses, and it is welcome testimony that we are hearing.
        I think I will start with you, Dr. Bonnie, and chime in,
    Dr. Jacobs. Some people in this hearing and in general argue
    that the Federal Government really doesn't need to regulate
    tobacco because States and local governments are doing it.
        And I think, Mr. Bonnie, you mentioned the Federal
    preemption issue a little while ago. I wanted to talk to you
    about my home State of Colorado because we are one of three
    States joining Maine and Delaware who have actually funded a
    tobacco prevention and cessation program at levels recommended
    by the CDC. And we have a comprehensive smoke-free bill that
    the legislature passed which prohibits smoking in workplaces,
    restaurants, bars, casinos.
        But Colorado is not allowed to prohibit billboards with
    tobacco advertisements from being posted next door to a school.
    Is that what you are talking about, why we need Federal
    regulatory authority?
        Mr. Bonnie. Yes.
        Ms. DeGette. And under this legislation, would the FDA be
    able to issue regulations that could control the types of
    advertising that I am talking about?
        Mr. Bonnie. I think under this legislation not only would
    FDA have the authority, subject of course to the constitutional
    constraints of the first amendment, which we could also
    discuss, but not only would FDA have the authority to regulate
    the advertising and marketing of the products, that as long as
    it was compatible with Federal regulation, the States would
    also have the authority to engage in----
        Ms. DeGette. And I think you concluded--and, Dr. Jacobs, I
    am sure you would concur--that the main problem we have right
    now in terms of U.S. smoking is that young people are
    continuing to smoke and tobacco companies are continuing to
    target young people, correct?
        Dr. Jacobs. Yes, that is right. That is not to say that you
    can't have an impact on the rate at which young people smoke.
    And New Jersey has done that. I left the numbers out of my oral
    testimony for the sake of time, but you have it in the written
    material.
        So that in our State, for instance, we have a group called
    Rebel. It is a national movement. It is called Reaching
    Everyone by Exposing Lies. It is a high school group. There are
    6,000 of these young kids in that group, about 300 schools. And
    they are the army that get out there. But once you start
    smoking, it would be helpful if we could ask, require tobacco
    companies to reduce nicotine content in cigarettes.
        I think that if there is dose response curve to addiction
    and you move down that dose response curve, logic would tell us
    it is easier to wean someone off of a substance to which they
    have a lower addiction potential than a higher addiction
    potential. And the recent data of Massachusetts----
        Ms. DeGette. Let me stop you, and I apologize. I don't have
    much time. That is a good thing to do, but the better thing to
    do would be to try to prevent them from becoming addicted to
    tobacco in the first place.
        Dr. Jacobs. Absolutely.
        Ms. DeGette. And part of that would be eliminating
    advertisements targeted directly to young people.
        Dr. Jacobs. But these, of course, are not mutually
    exclusive goals.
        Ms. DeGette. Right, exactly. We need to do it all. Now, I
    want to ask you about something I mentioned briefly in my
    opening statement. I told Mr. Waxman while we were on the floor
    voting I may be actually spurred to reintroduce this bill by
    this hearing. Several sessions of Congress, I introduced this
    legislation that I came up with. Right now, under Federal law,
    we tell States that they will lose Federal aid if they don't
    raise their drinking age to 21.
        So this bill I introduced said it is exactly the same bill,
    but for tobacco. That if States raise their age to which
    retailers could sell tobacco to 21, that would seem to me to
    really eliminate some of the problem of these young people
    getting addicted. What do you think about that kind of idea?
        Dr. Jacobs. We did that. Well, we didn't go to 21. We went
    from 18 to 19 in New Jersey to get the age of sale past high
    school.
        Ms. DeGette. Right.
        Dr. Jacobs. That was the idea. From 19 to 21, I think fine,
    but I think that was the idea. Enforcing the tobacco age of
    sale laws is an ongoing requirement. It is a bit of a
    challenge. It does take resources to do that.
        Ms. DeGette. Right, but we do it with alcohol, and it is a
    challenge. But we do it. And my concept in doing this bill to
    age 21 is it would make it consistent with alcohol. And then
    instead of targeting 14-year-olds, like they do now, because
    the age is 18, if it is 21, maybe they are only targeting 18-
    year-olds. And that at least helps you capture high school
    students, which, I think, are a really vulnerable target group.
    Mr. Bonnie, did you have any comment on that? I know it is
    probably not part of your book.
        Mr. Bonnie. Thank you. It is not. The committee did not
    take a position on the issue that you have just mentioned, but
    my own personal view would be I would be careful about this. On
    the one hand, as you have said, I think in terms of targeting,
    there is no doubt that the young adult audience of potential
    consumers is receiving a lot of industry attention, let us say
    18 to 24 years old. And there is some indication that
    initiation rates among that group are not falling and may even
    be increasing. So it is certainly a concern from a public
    health standpoint.
        On the other hand, I do think, as Dr. Jacobs said, that we
    have to worry about the practical issues of enforcement, of
    encouraging compliance and then promoting enforcement. And, of
    course, we focus on the retail outlets in terms of commercial
    distribution, but a lot of the distribution, of course, occurs
    outside the retail outlets in terms of social sources.
        So I think the issue is a bit of a complicated question. My
    own personal advice to you would be that this is one area where
    local options should be available. So if the Federal Government
    sets the floor, as the tobacco rule did, at 18, you should
    allow State and local governments to experiment with higher
    ages, just as Dr. Jacobs said. So that would be my personal
    view about this matter.
        Ms. DeGette. OK, thank you. Thanks so much for that advice.
        Mr. Pallone. The gentlewoman from California.
        Mrs. Capps. By default I concede. Thank you both for your
    excellent testimony, and there seems to be an agreement in the
    communities now that anti-smoking campaigns are finding it
    difficult to compete with the purchasing power of big tobacco
    advertising. I want to ask each of you a different question
    relating to this overall topic.
        Dr. Bonnie, could you please touch on what the committees
    found out about the effectiveness of tobacco companies'
    advertising? The companies argue that the goal of advertising
    is simply to attract current smokers to their brand, like brand
    competition. But I would argue that they are trying to go after
    new smokers as well. And I want to know your thoughts on this,
    and especially did you conduct any studies during your study of
    this overall topic specifically on the effect of advertising on
    children and teens?
        Mr. Bonnie. Well, the committee certainly looked very
    carefully into the issue that you are raising. The committee,
    of course, did not do studies of its own.
        Mrs. Capps. I know.
        Mr. Bonnie. It reviewed the available evidence, and I think
    there is, I think the committee had no doubt that the effect of
    advertising is not just simply about brand changes. That the
    advertising and marketing of the products has the effect of, if
    not the purpose of, increasing the overall demand for the
    product by recruiting new users, whatever the age that they may
    be, and also to have the effect of encouraging current smokers
    to continue to smoke. And that is, I think, an often overlooked
    feature of this just in terms of the various messages that are
    being conveyed by the products by the marketing.
        So I think that the committee's view, based on that
    evidence, was that a essential component of an overall strategy
    that is designed to reduce the prevalence of smoking has got to
    be to restrict the marketing and advertising of these products,
    that by its nature is designed to encourage consumption.
        Mrs. Capps. Right, thank you. I appreciate particularly in
    your testimony that you talked about the vulnerability of
    teenagers and young children because of their lack of
    decisionmaking in terms of long-term effects and that kind of
    thing. And that also this is by nature the new market. The
    younger and younger, the lifespan is going to be extremely
    lucrative for a tobacco company and also for the adjunct
    advertising mechanisms that they use.
        I really appreciate, Dr. Jacobs, your being here from the
    perspective of someone out there in the trenches, if you will,
    doing this work at the State level. We need the cooperation to
    reduce and get rid of this illness-causing habit. We need to
    employ every level of grass roots to the non-profit sector to,
    I think, I believe regulatory bodies.
        I wonder if you could discuss how this particular bill,
    H.R. 1108, might help your State to be more effective in the
    kind of anti-smoking messages that actually compete with
    deceptive advertising. You are trying to get out there a
    message that runs counter to what the tobacco companies are
    doing through their lucrative advertising medium.
        Do you think the passage of this bill could, for example,
    you are concerned about your young women, as I am. Do you think
    there would be a way to prevent publications from using ads
    like those for Camel No. 9 that I displayed?
        Dr. Jacobs. I would hope so. Of course, Professor Bonnie is
    the expert on the first amendment issues here, but leaving that
    aside for a second, if it could be done, so that truthful
    advertising that wasn't deliberately targeted to a youthful age
    group that must be targeted by these companies if they are to
    survive as corporations.
        Mrs. Capps. Exactly.
        Dr. Jacobs. I think we lose sight of that. Their corporate
    survival depends on their addicting our young people. That is
    simply the fact. So we need to do that. The other thing, of
    course, is to the extent that we have greater uniformity in the
    States, we will have less problem with importing cigarettes and
    other items that may be a different composition from Delaware
    and Pennsylvania and New York, which are freely transported now
    in and out of New Jersey.
        Mrs. Capps. Thank you very much. Any other comments from--
    --
        Mr. Bonnie. I would like to comment on this first amendment
    question if you still have the time.
        Mrs. Capps. I have 23 seconds. They are all yours.
        Mr. Bonnie. It is a very important part of the bill, and
    questions have been raised about the constitutionality. The
    committee again looked carefully at this, and the view that we
    have taken, which I believe to be an accurate description of
    the law, is that a text-only black and white restriction of the
    kind that was in the 1996 and would be revived here, is fully
    compatible with the first amendment because it protects the
    core first amendment interest that users, current users of
    tobacco products, and the companies that are communicating with
    them have, in receiving information about the product,
    information about price, information about contents, and we end
    up with products that purport to reduce exposure to dangerous
    substances or to reduce risk, to receive information about the
    relative risk of the products. It is about receiving
    information, and a text-only, black and white format for
    advertising full protects the right to receive information.
        What it gets rid of is the other messages that are being
    conveyed implicitly about what are thought to be, by the
    companies, benefits of using the product or perceived benefits
    of using the product through color and through images. And that
    would be restricted, and that is particularly dangerous, of
    course, with children.
        Mrs. Capps. Thank you. Just to hone in on that point, you
    don't see constitutionally if this bill passes and all the ifs
    that the FDA could then regulate against such kind of
    advertising as I demonstrated in the posters?
        Mr. Bonnie. That is the committee's view, and I think
    eventually, if and when, and certainly it will go to the
    Supreme Court if it is adopted. My view is that if this case is
    properly and well argued that--based on current case law at
    least--that it would survive constitutional review.
        Mrs. Capps. Thank you very much. I yield back.
        Mr. Pallone. Thank you. Dr. Burgess.
        Mr. Burgess. Thank you, Mr. Chairman. It is great to have a
    panel here with two lawyers and a doctor, even if one of them
    is the same person. That is a fascinating discussion about the
    first amendment. I never really thought about it in those
    terms, so the first amendment would apply to a PDF file that it
    is black and white and not to a larger font size, a bolding or
    italicized print. Maybe we ought to make that applicable to
    political advertising, and our lives would all be a lot easier
    over the next 2 years. What do you think? In political
    advertising, do you think we ever use that penumbra of
    psychological influences in political advertising to try to
    sway the voting public one way or the other?
        Let me ask a question. I apologize for being gone during
    most of the question and answer period. You heard my comments
    as the hearing got underway this morning. Dr. Jacobs, in your
    testimony, the statement ``we must use every tool in our
    arsenal to promote smoking cessation.'' And I think we probably
    both agree the biggest tool we have in our arsenal is don't
    ever start. It is the most effective way to lead to smoking
    cessation. But why do we even allow it? Why do we even have
    cigarettes? Why do we even allow them to be a legal entity in
    this country? If we are really serious about using every tool
    in the arsenal, wouldn't we just outlaw cigarettes?
        Dr. Jacobs. I guess if that was a feasible idea. Certainly
    from a public health standpoint it is a toxic, class A
    carcinogen. We would outlaw it the same way you outlaw the free
    sprinkling of asbestos fibers around the room. It is the same
    thing, but I think, as Professor Bonnie has pointed out in the
    IOM report, with 45 million addicted people in the United
    States right now, there would be substantial resources that
    would have to be brought to bear on that in order to
    accommodate that particular large population.
        I think from a public health standpoint, I would like to
    get rid of cigarettes. They don't do any good to anybody except
    the people who sell them, I guess.
        Mr. Burgess. Well, they do us a lot of good because of the
    tax revenue that we collect off of them.
        Dr. Jacobs. They do, and, you know, it is an interesting
    point you raise because in one of the budget hearings we have
    at the legislature in New Jersey, someone asked me that very
    question. They said, Dr. Jacobs, you are advocating people
    stopping smoking. What happens if they all stop and the
    hundreds of millions of revenue we have are gone? What are you
    saying about that?
        Well, listen, you are talking to the chief public health
    officer in the State. My goal is to stop people from smoking.
    If we do it, you will have to find the money some place else,
    but you are never going to get me to say we are going to
    encourage people to keep smoking because we need the money.
    That is simply not a balance we can have.
        That is not to say that the revenue isn't put to important
    uses. It is. But you don't use money to fund the functions of
    government by going ahead and killing people who are actually
    using that particular substance. So I think you cannot make
    that argument.
        Mr. Burgess. Well, on the issue of using every tool in the
    arsenal to promote smoking cessation, should we earmark a
    portion of the funds that we collect from the tobacco companies
    to really aggressive steps toward alleviating that burden of
    addiction from the 47 million people who are so addicted? We
    have new medications such as Chantix, the new medication that
    is out there that apparently has the ability to block at the
    receptor level, so a very powerful tool now that is within the
    hands of practitioners.
        Yet I will tell you, as a practitioner, as an OB/GYN
    practitioner, if I told someone they need to stop smoking, very
    rarely would I be able to get them into a program that their
    insurance company would participate with them and lead them to
    a state of smoking cessation.
        So to say to the smoking public we want you to stop and not
    provide them the tools to stop when we are collecting money
    from the company that we want to help them stop purchasing, it
    just seems to me that we should really be digging down and
    aggressively promoting smoking cessation activities rather than
    having the FDA regulate tobacco.
        Again, I raise the question that was partly in jest, but
    partly, if we are talking about a delivery system, crystal meth
    is--I mean it is an ideal delivery system if your goal is to
    get high from methamphetamine. They don't rely on any penumbra
    of advertising activities. They just simply make a much more
    addictive product, put it out there, and it sells itself.
        Well, why don't we do something to help break that cycle of
    addiction, and rather than focusing on the FDA regulating
    tobacco, why don't we put those monies toward smoking cessation
    activities? It would seem to be a much more judicious use of
    our time and effort.
        We just gave the FDA enormous new power. Probably not in
    the last 40 years has the FDA had the tools at their disposal
    that we just gave them last month, and now we are going to
    saddle them with something that is virtually impossible. And on
    top of that, it just thwarts their mission at every turn.
        Mr. Bonnie. Well, I think that--No. 1, I don't think either
    of these things are mutually exclusive. I think we should be
    doing both. And No. 2, I don't share your philosophy that the
    FDA is somehow outgunned in all of this or underresourced. If
    they are underresourced, then I think that there is a remedy
    for that in the Congress.
        If you have a Food and Drug Administration that has a goal
    and a mission, then they have to be adequately resourced and
    funded to do that goal. And if they are not adequately funded
    and resourced, then it is, I think, the responsibility of the
    Congress to see to it that they are. Not just in this, but in
    everything else they do.
        Mr. Burgess. Correct, but, Doctor, their mission is to see
    that the drug supply and the food supply in this country is
    safe, that drugs are safe and effective. You can't argue that
    nicotine is ever going to be safe. It is always effective in
    that it causes addiction, but it is never going to be safe.
        Mr. Bonnie. Well, I don't disagree with that. I don't think
    it is ever going to be safe in the present form certainly. And
    I don't know what the future will bring in terms of nicotine
    therapy, but neither do you. We just don't know.
        Mr. Burgess. I would be willing to live without it as a
    country. That is a trade-off I would readily accept.
        Mr. Bonnie. But I don't know that at this stage of the game
    that we can make the kind of choice, particularly the
    comparison with crystal meth. Crystal meth, of course, is not a
    legal product. I know you are saying this in jest, but this is
    not a legal product. Tobacco cigarettes are a legal product.
    They are sold by legal outlets after being manufactured legally
    in the United States, with certain age groups excepted.
        That being the case, there is a responsibility, if you are
    authorizing the sale in a legal structure, to at least have
    some relatively fair level playing field between those who are
    looking to improve the public's health by reducing consumption
    and those who have a corporate responsibility to increase
    consumption. And that is not a level playing field now.
        Mr. Pallone. We are 2 minutes over so I will--let me move
    on.
        Mr. Burgess. But Mr. Bonnie sat here faithfully----
        Mr. Bonnie. All right, quick points. Obviously the
    regulatory criteria would be different under this bill and not
    safe and effective. There is no reason that a single agency
    can't have different responsibilities where the regulatory
    criteria are different in order to deal with different types of
    social problems. And I do think that a public health agency's
    mission could accomplish both of those things.
        Mr. Burgess. But it could just as well be accomplished by
    the Federal Trade Commission and not even come under the
    preview----
        Mr. Bonnie. Well, I think a public health agency like the
    FDA has the public health expertise to do it that the FTC would
    not have. Second, on the dependency on the money, which I think
    you are right, that this is one of the problems of relying upon
    the tobacco excise taxes to fund other social programs.
        I think we would never end up reducing smoking
    substantially overnight and presenting this problem of getting
    off the addiction that public agencies have to tobacco
    revenues. It would obviously be over a longer period of time if
    we are aggressively implementing a policy to reduce the
    prevalence of smoking. And clearly State agencies can project
    what the revenues and can become less dependent on.
        Mr. Burgess. I don't disagree with him, but I think it
    would be a lot more aggressive----
        Mr. Pallone. Gentlemen, we are up to 3 minutes. I got to
    cut you off here, gentlemen. Let us move on to the next
    question. Mr. Engel of New York.
        Mr. Engel. Well, thank you, Mr. Chairman. I want to thank
    you for holding this hearing. It is very important, and I am
    proud to be a cosponsor of this bill. It just boggles my mind
    that so many people still don't understand the damage that they
    do to their health and their life by smoking. And I think it
    just makes sense to give the FDA the broad regulatory authority
    over manufacturing, distribution, and marketing of the use of
    tobacco products. I just think it is good, plain common sense,
    and we ought to pass this bill forthwith.
        Mr. Bonnie, this book that we have here, the IOM discusses
    some of the concerns raised by certain portions of the public
    health community, including some we will hear in our next panel
    of witnesses. The committee outlines of the concerns, and I am
    going to quote it. It is that quote that ``the proposed
    regulatory framework making reduced exposure or reduced harm
    claims in section 911 is too demanding and may impede the
    development of reduced exposure products by stifling innovation
    and retarding competition with safe products.''
        And that is a quote; however, ultimately the IOM concludes,
    and I am going to quote it again ``the fears about this
    legislation are overstated and that Federal tobacco product
    regulation is an essential element of the long-term strategy
    for achieving substantial reductions in tobacco use, in
    tobacco-related morbidity and mortality.'' That is a quote, so
    you came to that conclusion even after looking at the other
    side. So can you please explain how and why the IOM reached its
    conclusion?
        Mr. Bonnie. All right, so the IOM, as you quoted,
    considered the objections that have been raised to giving the
    agency Federal regulatory authority. And again I want to
    emphasize that there is a whole series of aspects of this bill
    that do not involve--that give the agency authority over the
    manufacture, marketing, and distribution of these products,
    that do not involve the issue of supposed risk reduction
    products and that are essential components of a strategy
    designed to reduce tobacco use.
        Again I mention the issue of strengthening warnings and
    regulating the retail environment. Those are very, very
    important parts of this bill.
        With regard to the issue of regulation of supposedly
    reduced risk products, the committee consulted not only the
    members who have economics background, but actually consulted
    other economists to think about what the potential incentive
    effects could be for adopting a regulatory program, such as
    that is envisioned in the bill in light of the criteria.
        And the argument has been that the criteria by requiring
    scientific evidence to support the claims that they want to
    make, that the criteria are so demanding that it would lock in
    benefits that some companies may now have, and it would
    discourage competition because of what would have to be done in
    order to substantiate those claims. The committee's view was
    that the claims need to be substantiated in order to avoid the
    kind of disaster that we had with regard to the light and low
    tar cigarettes in the past where people were mislead into
    believing that they were actually smoking a safer product.
        So substantiation of the claims is a non-negotiable item.
    They should be substantiated, or they should not be made, and
    then the issue is well how demanding is that going to be in
    terms of encouraging innovation. And the committee's conclusion
    was that actually this might liberate more competition,
    particularly by niche small companies that were actually trying
    to develop these products rather than deter it.
        Mr. Engel. Thank you. Let me ask you about another
    recommendation that the committee has recommended. All
    insurance, managed care, and employee benefits, including
    Medicare and Medicaid, cover reimbursement for effective
    smoking cessation programs as a lifetime benefit. Did the
    committee look at the cost associated with this recommendation?
        Mr. Bonnie. I think yes. With regard to the recommendations
    about prevention and cessation activities, I think that here is
    a situation where in every case when you look at the cost
    effectiveness of the intervention to reduce prevalence by
    reducing initiation and my promoting cessation. The public
    health benefits are so astounding for doing so that they do, in
    every case, substantially outweigh the costs of actually
    engaging in these activities.
        And cessation is actually, as Congressman Burgess said
    earlier, the benefits of cessation are very, very, well
    established if you can actually increase the demand for
    cessation and to provide the reimbursement that people need in
    order to be able to do it. It is the most undeveloped part of
    our tobacco control strategy. So we definitely looked at the
    costs of those interventions.
        Mr. Engel. Thank you. Makes sense to me. Dr. Jacobs, I am
    wondering if I can ask you one quick question. Is there
    anything in this bill that would impede the progress of States
    in their attempts to decrease the prevalence of tobacco use?
        Dr. Jacobs. I don't think so. I think the bill itself will,
    of course, give us more tools in terms of having the Federal
    Government weigh in on this issue in a more level comprehensive
    way, so that those States that don't have to begin at ground
    zero. You have already set a floor of regulation, which you
    can, if you need to, you can add to and build on. I think that
    would be the main value for us.
        Mr. Engel. OK, thank you very much. Thank you, Mr.
    Chairman.
        Mr. Buyer. Mr. Chairman, in a question I had for Mr. Bonnie
    in the discussion with regard to harm reduction strategy, we
    had the discussion about reduced risk products and components
    and the need to educate about alternatives. I had asked the
    question on sampling but never received a response with regard
    to whether sampling should be permitted or not. And I would ask
    that he address that. Is that permitted, Mr. Chairman?
        Mr. Pallone. Let me say the following. I didn't realize
    that Mr. Engel still had the time.
        Mr. Engel. No, I am finished, Mr. Chairman.
        Mr. Pallone. You are? Thank you. Now, you want to ask an
    additional question?
        Mr. Buyer. No, what I am asking, Mr. Chairman, is with
    regard to the ban on sampling that is in the bill, I had asked
    Mr. Bonnie about sampling, and he was not responsive to that.
    And I had asked that he be given time to be responsive.
        Mr. Pallone. If you would quickly, because we have to move
    on.
        Mr. Bonnie. All right. Well, I think actually it will be
    very quick because the provision of the bill that you are
    mentioning is what now? What is the provision of the bill?
        Mr. Buyer. That does not permit sampling as part of a harm
    reduction strategy. You testified that we should, with regard
    to regulatory scheme or schematic, permit alternatives out
    there with regard to products and components for people to
    transition from cigarettes to something else. If we are going
    to do that, shouldn't we permit sampling so they know what to
    go toward?
        Mr. Bonnie. Mr. Chairman, I would be happy to respond to
    this question in writing afterwards.
        Mr. Pallone. Sure, that would be great. And let me mention
    to----
        Mr. Buyer. We still don't get an answer.
        Mr. Pallone. Well, he is going to----
        Mr. Bonnie. Well, the committee actually did not address
    this question at all.
        Mr. Pallone. Yes, we would be happy to have you----
        Mr. Bonnie. And I would be happy to do it on my own in
    writing.
        Mr. Pallone. And let me also mention that you may get
    additional questions from other committee members within the
    next 10 days or so that we would ask you to respond to as well.
    Thank you both. I apologize to Dr. Jacobs. I didn't get an
    opportunity to talk to you at all today because I would have
    liked that opportunity. But I came in here. It has been real
    busy, so hopefully I will give you a call, and I can come to
    Trenton in the near future.
        Dr. Jacobs. Any time, Mr. Chairman.
        Mr. Pallone. Thank you. Thank you, both. And I would ask
    the next panel to come forward. OK, I think we are ready to
    begin. I want to thank you all for being here. Let me just
    introduce everybody. I will start on my left. I guess there is
    a slight change because Dr. Blum maybe has to leave early.
    First we have Dr. Alan Blum, who is a professor, and Wallace
    Endowed Chair in Family Medicine at the College Community
    Health Sciences for the University of Alabama, where he is also
    director of the Center for Study of Tobacco in Society. And
    then we have Dr. Risa Lavisso-Mourey, who is president and CEO
    of the Robert Wood Johnson Foundation in Princeton, New Jersey.
    And then we have Scott Ballin who is an attorney, steering
    committee member for the Alliance for Health, Economic, and
    Agricultural Development in Washington. Mr. James Winkler,
    general secretary of the General Board of Church and Society
    for the United Methodist Church. Mr. Henry Amour who is
    president and CEO of the National Association of Convenience
    Stores, and Dr. Jack Hemmingfield, who is vice-president for
    Research and Health Policy, Piney Associates in Bethesda,
    Maryland. And then last is Mr. William Corr, who is executive
    director of the Campaign for Tobacco-Free Kids. And again I
    would say we ask you to limit your comments to 5 minutes. Your
    written statements will be made part of the record in their
    entirety, and we may ask additional questions in writing for
    you afterwards within 10 days or so. So we will start with Dr.
    Blum.

    STATEMENT OF ALAN BLUM, M.D., PROFESSOR, WALLACE ENDOWED CHAIR
    AND DIRECTOR, THE CENTER FOR STUDY OF TOBACCO, SOCIETY, COLLEGE
          OF COMMUNITY HEALTH SCIENCES, UNIVERSITY OF ALABAMA

        Dr. Blum. Thank you, Mr. Chairman, members of the
    committee. The mission of the FDA is to ensure the safety of
    medications that treat disease, not substances that cause it. I
    feel strongly as a practicing family physician who has devoted
    the past 30 years to curbing the smoking pandemic, perhaps a
    longer continuous period than anyone else in this room, that an
    overstressed FDA is the wrong agency at the wrong time to
    regulate tobacco products.
        And I am proud this afternoon to report that yesterday the
    congress of delegates of the American Academy of Family
    Physicians, the largest subspecialty medical organization in
    the United States, considered the arguments against and for the
    bill and decided to withdrawal its endorsement of this bill,
    pending strengthening and amendments.
        By having to promulgate manufacturing and health standards
    for cigarettes under H.R. 1108, the FDA will be communicating
    the perception that cigarettes are now safer to smoke. Since
    smoking prevalence is directly proportional to the degree of
    perceived harm from smoking, FDA sanction of cigarettes may
    lead to an increase in smoking prevalence.
        The tobacco industry will most certainly take advantage of
    this bill to tell consumers through TV, newspapers, and the
    Internet that cigarettes are now regulated by the same agency
    that oversees our food and medicine.
        Indeed, Philip Morris, maker of the world's top selling
    cigarette, Marlboro, is already testing the waters. It is
    setting a new standard for chutzpah by enlisting the Nation's
    doctors and spreading the company's deceitful propaganda. For
    the first time in more than half a century, a cigarette maker
    is communicating directly to physicians by means of personal
    letters offering to supply unlimited copies of ``If You Decide
    to Quit Smoking'' a 52-page booklet that avoids mention of the
    word addiction, contains a total of three sentences that refer
    to diseases caused by smoking, and includes 17 color
    photographs, all of healthy, smiling people, and none of
    persons made ill from smoking or of their diseased hearts or
    lungs.
        Television ads for Philip Morris's Youth Smoking Prevention
    Campaign have been condemned as cynical and ineffective by the
    very health organizations that have joined with Philip Morris
    in backing this bill. Yet the company touts this program and
    its recruitment of college students at career fairs on
    university campuses across the country and half-page ads such
    as this in the campus newspaper that I am from, even though the
    only jobs it offers these students are on the Marlboro sales
    team, delivering fresh cigarettes to supermarkets, convenience
    stores, pharmacies, and bars.
        A student at one of these career fairs told me that Philip
    Morris is a great company. They don't just sell cigarettes.
    They help prevent smoking.
        Such tactics aimed at burnishing the company's nicotine-
    stained image among doctors, parents, college students, and
    university officials will flourish with the enactment of this
    bill. FDA regulation of tobacco products under H.R. 1108 would
    provide an unprecedented, unmerited legitimacy to cigarette
    makers, sending the message to consumers that cigarettes,
    however problematic, are now Government sanctioned.
        William Godshall, the most effective tobacco control
    advocate ever to work for the American Cancer Society, cites
    the more than 400 cigarette brand products on the U.S. market
    today, each with differing amounts of chemical additives and
    thousands of poisons in the smoke. He rightly questions the
    feasibility of correlating smoking-related deaths and diseases
    with the brands of cigarettes consumed, which the FDA would
    have to do if it is to make any valid assessment and
    recommendation about individual tobacco products.
        As Dr. Michael Siegel at Boston University's School of
    Public Health has pointed out, the public is simply not aware
    that there are over 4,000 poisons in cigarette smoke, including
    more than 40 cancer causers. If a consumer were informed that
    one such poison or two carcinogens had been reduced or removed
    from a cigarette brand, as Philip Morris intends to do, then he
    or she is going to infer that the problem is being taken care
    of or even solved. This ignores the dozens of other cancer
    causers in the cigarette and the other diseases cigarettes
    cause.
        In short, there is no evidence that tinkering with the
    levels of various components of cigarette smoke will result in
    a safer product, yet this is precisely the strategy that Philip
    Morris is counting on through H.R. 1108 to perpetuate the myth
    that research can discover a safe cigarette.
        Assisted by the University of Virginia and Duke University,
    which have taken over $40 million from Philip Morris, the
    company is on track in its plan to turn back the clock half a
    century to the Frank Statement to Cigarette Smokers issued by
    the tobacco industry in 1954, which pledged aid and assistance
    to the research effort into all phases of tobacco use and
    health.
        At this year's annual shareholders meeting of Philip
    Morris, company CEO Louis Camilleri praised this bill and
    promised that the company's new $350 million research center
    will solve societal problems raised by tobacco.
        FDA regulation, a new safe cigarette research center,
    lucrative research grants to a docile, academic community are
    the sheep's clothing that this wolf has donned to deceive the
    public and to ensure Marlboro's continued sale success.
        Does anyone with even a rudimentary knowledge of public
    health believe in the wisdom of yet another quest for a safe
    cigarette? The only safe cigarette is an invisible cigarette.
        Tobacco control advocate David Sweanor goes further,
    arguing that Philip Morris is trying to preserve the status quo
    by preventing effective competition from noncombustible tobacco
    products.
        Lastly, primary prevention, not taking up cigarettes in the
    first place, is universally agreed upon as the answer to end
    the tobacco pandemic. Reducing demand through paid mass media
    education is the cornerstone of primary prevention, yet nothing
    in this bill addresses or encourages major multimedia anti-
    smoking campaigns. Indeed, by creating the impression that the
    cigarette pandemic is being addressed by the Federal
    Government, this bill could be a disincentive for State and
    local governments to devote additional anti-smoking resources.
    We need to fight smoke with fire, not symbols, not ineffective
    bills crafted with the secretive input from America's biggest
    cigarette company.
        This bill is a godsend for Philip Morris. No one else will
    benefit.
        [The prepared statement of Dr. Blum follows:]

                          Statement of Alan Blum, M.D.

        The mission of the Food and Drug Administration (FDA) is to
    ensure product safety and to approve medications that treat
    disease, not substances that cause it. By all accounts, the FDA
    is struggling with the challenge of regulating an expanding
    universe of products and threats. It is the wrong agency at the
    wrong time to undertake oversight of tobacco products.
        By having to promulgate health standards for cigarettes,
    the FDA will be communicating the perception that they are now
    safer to smoke. Thus H.R. 1108 will increase doubt among
    consumers that cigarette smoking is truly injurious and lethal.
        The tobacco industry will most assuredly take advantage of
    this bill to remind consumers through the broadcast and print
    media and the internet that cigarettes are now regulated by the
    same agency that oversees the safety of our food and medicine.
        Industry leader Philip Morris, maker of the world's top-
    selling cigarette, Marlboro, is already testing the waters.
    It's setting a new standard for chutzpah, by enlisting the
    Nation's doctors in spreading the company's deceitful
    propaganda. For the first time in more than half a century, the
    cigarette giant is communicating directly to physicians by
    means of personal letters offering to supply their waiting
    rooms with unlimited quantities of If you decide to quit
    smoking---a 52-page booklet that avoids mention of the word
    ``addiction,'' contains a total of three sentences that refer
    to diseases caused by smoking, and includes 17 color
    photographs, all of healthy, smiling 20-somethings and none of
    persons made ill from smoking or of their diseased hearts and
    lungs.
        TV ads for Philip Morris' Youth Smoking Prevention campaign
    have been rightly condemned as cynical and ineffective by some
    of the very health organizations that have joined with Philip
    Morris in backing this bill. Yet the company touts this program
    in its recruitment of college students at career fairs on
    university campuses across the country (as well as on its Web
    site www.cantbeattheexperience.com), even though the only jobs
    it offers these students are in the Marlboro sales force,
    delivering fresh cigarettes to supermarkets, convenience
    stores, pharmacies, and bars.
        Such tactics aimed at burnishing the company's nicotine-
    stained image among doctors, parents, college students, and
    university officials will flourish with the enactment of this
    bill. FDA regulation of tobacco products under HR 1108 would
    provide an unprecedented and unmerited legitimacy to cigarette
    makers and would send the misleading message to consumers that
    cigarettes, however problematic, are now government-sanctioned.
        William Godshall, perhaps the most knowledgable and
    effective tobacco control advocate ever to work for the
    American Cancer Society, sees a parallel between the countless
    medications and food products overseen by the FDA and the more
    than 400 cigarette brand variations on the US market, each with
    differing amounts of scores of chemical additives and thousands
    of poisons in the smoke. He rightly questions the feasibility
    of correlating smoking-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.
        The public is not generally aware that there are over 4000
    poisons in cigarette smoke, including more than 40 cancer-
    causers. If a consumer is informed that one such poison or
    carcinogen has been reduced or removed from a cigarette brand,
    then he or she is going to infer that the problem is being
    taken care of or even solved. This ignores the dozens of other
    cancer-causers in that cigarette. In short, there is no
    evidence that tinkering with the levels of various constituents
    of tobacco smoke will result in a safer product.
        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. Moreover, it would be highly unethical to conduct such
    ongoing research on persons who smoke without providing
    constant cessation interventions. Having served as a member of
    the University of Alabama Institutional Review Board, which
    oversees research protocols to ensure the protection of human
    subjects, I cannot imagine that prospective comparison studies
    of different cigarettes would be approved by any legitimate
    scientific institution.
        Yet this is precisely the strategy Philip Morris is
    counting on to perpetuate the myth that research can discover a
    safe cigarette. Assisted by the University of Virginia and Duke
    University, which have thus far accepted over $40 million from
    the manufacturer of Marlboro in the past year, Philip Morris is
    on track in its plan to turn back the clock half a century to
    the ``Frank Statement to Smokers'' issued by the tobacco
    industry (in reaction to the myriad scientific studies
    implicating smoking in a host of diseases), which pledged ``aid
    and assistance to the research effort into all phases of
    tobacco use and health.''
        In his remarks to shareholders at this year's annual
    meeting of Philip Morris, Louis Camilleri, ceo of its parent
    company, boasted of his support of this bill and promised that
    the company's new $350 million research center in Richmond will
    seek to solve ``societal problems raised by tobacco.'' FDA
    regulation, the research center, and related grants to
    universities and medical schools make up Philip Morris' formula
    for Marlboro's continued sales success.
        Does anyone with even a rudimentary knowledge of public
    health seriously believe in the wisdom of yet another quest for
    a safe cigarette? Philip Morris has played this game before
    with its earlier cigarette research centers in the 1950s and
    1970s (One of the most complete and fully integrated facilities
    for tobacco research in existence anywhere in the world. Its
    every detail has been designed for translating the scientific
    theories and findings of basic research into practicalities.).
        It is deja vu all over again, and proponents of this bill
    are wittingly or unwittingly aiding and abetting the biggest
    member of Big Tobacco in institutionalizing junk science.
        Philip Morris' endorsement of both the FDA bill and the
    Institute of Medicine report supporting FDA regulation is
    eerily reminiscent of the Tobacco Industry Research Committee's
    Frank Statement of 1954: ``We accept an interest in people's
    health as a basic responsibility, paramount to every other
    consideration in our business...We always have and we always
    will cooperate closely with those whose task it is to safeguard
    the public health...In charge of the research activities of the
    Committee will be a scientist of unimpeachable integrity and
    national repute. In addition there will be an Advisory Board of
    scientists disinterested in the cigarette industry. A group of
    distinguished men from medicine, science, and education will be
    invited to serve on this Board. These scientists will advise
    the Committee on its research activities. This statement is
    being issued because we believe the people are entitled to know
    where we stand on this matter and what we intend to do about
    it.''
        And in 2007: ``Philip Morris USA believes regulation of
    tobacco products by the FDA could potentially create a new
    framework within which manufacturers can refocus their efforts
    to pursue reduced harm products.''
        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.
        Primary prevention---not taking up cigarettes in the first
    place---is universally agreed upon as the answer to end the
    devastating health toll caused by smoking. Reducing demand
    through paid mass media education is the cornerstone of primary
    prevention. Nothing in this legislation addresses or encourages
    major multi-media anti-smoking campaigns. Indeed, by creating
    the impression that the cigarette pandemic is being addressed
    by the Federal Government, the bill could be a disincentive for
    state and local governments to devote additional resources.
        We need to fight smoking with fire, not symbolic,
    tokenistic regulation. This bill is a godsend for Philip
    Morris. No one else will benefit.
                                  ----------

        Mr. Pallone. Let me just mention to everyone that we have a
    15-minute vote and then two 5-minute votes. So we probably have
    time for Dr. Lavizzo-Mourey, and then we are going to have to
    take a recess. So I recognize Dr. Lavizzo-Mourey.

      STATEMENT OF RISA LAVIZZO-MOUREY, M.D., PRESIDENT AND CEO,
             ROBERT WOOD JOHNSON FOUNDATION, PRINCETON, NJ

        Dr. Lavizzo-Mourey. Thank you, Mr. Chairman, Ranking Member
    Deal, and members of the subcommittee. Thank you for the
    opportunity to testify on the need for H.R. 1108, the Family
    Smoking and Prevention Control Act.
        I am Dr. Risa Lavizzo-Mourey, the president and CEO of the
    Robert Wood Johnson Foundation, which is the largest
    philanthropy in the country, devoted exclusively to improving
    the health and health care of all Americans. For more than a
    decade, the Robert Wood Johnson Foundation has worked
    successfully to reduce the prevalence of tobacco use using a
    two-pronged approach.
        First we have focused attention on policies and programs
    that are most effective, and second we have focused attention
    on action-oriented evidence-based policies aimed at preventing
    people from starting to smoke, helping current smokers to quit
    smoking, and protecting nonsmokers from the serious health
    harms of secondhand smoke.
        Our Nation has made significant progress in reducing
    tobacco use, especially at the State and local level. However,
    tobacco is still the leading cause of preventable death in this
    country. And we have heard the statistics this morning. I won't
    go into them, but they are in my written testimony.
        Most troubling is that our progress in reducing smoking has
    stalled among youth and adults in recent years. The good news,
    however, is that there is strong consensus among our Nation's
    public health experts on what actions are needed. Both the
    Institute of Medicine, as we have heard already, and the
    President's Cancer Panel have reached the same conclusions in
    their issued reports this year.
        An effective national strategy to reduce tobacco use must
    include a dual approach. First, stepped-up initiative at the
    local and State level, such as smoke-free air laws, tobacco
    price increases, public education and cessation practices
    preventing kids from smoking and protecting nonsmokers, and
    helping smokers quit.
        And second, the opportunity that is before you today:
    enactment of Federal legislation granting the FDA authority
    over tobacco products.
        Mr. Chairman, the FDA regulation is especially needed to
    address the continuing problem of tobacco marketing that
    appeals to children and misleads the public about the health
    risks and undermines the efforts of smokers to quit.
    Unfortunately, there is abundant evidence that the tobacco
    industry continues to engage in harmful practices, and I want
    to cite just a few examples that demonstrate how the industry
    continues to appeal to children and target vulnerable
    populations.
        We all remember the 1998 State Tobacco Settlement and the
    tobacco industry's promises to stop marketing to children. What
    has happened since then? Well, since 1998, the total marketing
    expenditures by the tobacco industry have doubled, reaching
    $13.4 billion in 2005, according to the FTC. This is nearly $37
    million a day to market addictive and deadly products.
        Cigarette advertising increased in youth-oriented
    magazines, as frequently as 2 years after the settlement. And
    even today, tobacco companies continue to run ads in magazines
    portraying smoking as cool and glamorous.
        The settlement, as you know, did not restrict in-store
    advertising and tobacco companies know that 75 percent of teens
    visit a convenience store at least once a week and therefore
    they have increased their advertising and promotions in these
    stores. Science tells us that this kind of marketing works. In
    fact, a study supported by the Robert Wood Johnson Foundation
    and published this May in the journal called Archives of
    Pediatrics and Adolescent Medicine has found that the more the
    cigarette industry markets to teens, the more they are exposed
    to cigarette advertising in retail stores, the more likely they
    are to smoke. The study also found that restricting these
    retail marketing practices would reduce youth smoking.
        In addition, the tobacco companies have regularly
    introduced new candy, fruit-flavored products. For example,
    recently R.J. Reynolds introduced a flavored version of Camel
    with very enticing names. These kinds of youth-oriented
    practices work. We know that they work and the tobacco
    companies have a long history of targeting other specific
    populations, most recently, marketing to women and girls as we
    have already heard with Camel No. 9, the same kind of notorious
    efforts that we have long eschewed. Camel No. 9 continues the
    tobacco industry's long history of targeting women and girls
    beginning back in 1968 with ``You've come a long way, baby.'' I
    can tell you as a physician, even though they say smoking is
    glamorous, there is nothing at all glamorous about the
    increased death rates from lung cancer that have occurred as a
    result of this legacy of marketing to girls and women.
        The tobacco companies have similarly targeted African-
    Americans and Hispanics, especially children in these
    communities, and one of the most egregious and recent examples
    is Kool Mix, a marketing campaign that used a hip hop theme.
        Mr. Chairman, let me just conclude by saying the FDA is
    uniquely qualified to achieve the goals because of its
    regulatory experience, the scientific knowledge and public
    health mandate this agency has. Thank you.
        [The prepared statement of Dr. Livizzo-Mourey follows:]

                     Testimony of Risa Lavizzo-Mourey, M.D.

        Chairman Pallone, Ranking Member Deal, and Members of the
    Subcommittee, thank you for this opportunity to testify about
    the need for H.R. 1108, the Family Smoking Prevention and
    Tobacco Control Act. I am Dr. Risa Lavizzo-Mourey, President
    and CEO of the Robert Wood Johnson Foundation, the Nation's
    largest philanthropy devoted exclusively to improving the
    health and health care of all Americans.
        For more than a decade, the Robert Wood Johnson Foundation
    has worked successfully to help reduce the prevalence of
    tobacco use through a two-pronged approach. First, we have
    funded research to learn which policies and programs are most
    effective. Second, we have focused attention and fostered
    action on evidence-based policies aimed at preventing people
    from starting to smoke, helping current smokers quit and
    protecting non-smokers from the serious health harms of
    secondhand smoke.
        Tobacco use is still the leading cause of preventable death
    in our country--causing more than 400,000 preventable deaths in
    the United States each year, sickening millions more, reducing
    the productivity of our workforce and undermining our Nation's
    economic competitiveness due to $100 billion a year in tobacco-
    related health care bills.
        Today we are asking you, the Congress, and the Federal
    Government to provide the leadership needed to address this
    significant threat to the health of our Nation. One of the most
    important things you can do now would be to give the FDA
    authority over tobacco products.
        Our country has made significant--although by no means
    sufficient--progress, especially at the state and local level.
    A growing number of states and localities have increased taxes
    on tobacco products, enacted smoke-free air laws that cover all
    workplaces and public places, and funded tobacco prevention and
    cessation programs. Collectively, we have also made great
    strides in getting effective tobacco cessation treatments into
    clinical practice and through state and national quitlines, and
    many health and health care policy changes have boosted access
    to and use of evidence based treatments.
        The best measure of progress is that fewer Americans, both
    youth and adults, are smoking. Youth smoking rates have
    declined by 37 percent since peaking in 1997, and adult smoking
    rates have steadily declined as well.
        But we have not yet turned the corner on this pervasive
    health threat which continues to take an enormous toll in
    health, lives and money in our country. Nearly one in four high
    school students still smokes and nearly 21 percent of all
    Americans remain addicted to this deadly product. Most
    troubling of all is the fact that our progress in reducing
    smoking has stalled among both youth and adults in recent
    years.
        Our challenge today, Mr. Chairman, is to resist complacency
    and for all levels of government to redouble efforts to reduce
    tobacco use. The good news it that we know what to do, and
    there is a strong consensus among our Nation's public health
    experts about the science-based actions that must be taken. As
    both the Institute of Medicine and the President's Cancer Panel
    recommended in landmark reports issued this year, this strategy
    must include both stepped-up initiatives at the state and local
    level and enactment of Federal legislation granting the FDA
    authority over tobacco products.
        As the IOM concluded, ``Incremental reforms'' will not end
    the Nation's tobacco problem. A more fundamental shift must
    occur. It is time for Congress and other policymakers to change
    the legal structure of tobacco policy, thereby laying the
    foundation for a strategic initiative to end the Nation's
    tobacco problem--that is, reducing tobacco use to a level that
    is insignificant from a public health standpoint.''
        These expert conclusions regarding FDA authority are
    critical.
        Mr. Chairman, there are many reasons why we need FDA
    regulation of tobacco products in addition to and in support of
    the ongoing efforts to reduce tobacco use at the state and
    local government. I will name two:

         FDA authority over tobacco has a high probability
    of stopping tobacco marketing that targets our children and
    undermines the effective prevention measures in states and
    communities.
         FDA authority over tobacco has a high probability
    of stopping tobacco industry practices that undermine efforts
    to help smokers quit. These include the manipulation of tobacco
    products to make them more addictive and the deceptive
    marketing of light and low-tar cigarettes and other so-called
    ``reduced risk'' products.

        Mr. Chairman, we all know that the tobacco companies
    continue to engage in these harmful practices today.
        While the 1998 tobacco settlement, known as the Master
    Settlement Agreement or MSA, curtailed some tobacco marketing
    to children, the MSA addressed less than 20 percent of all
    tobacco marketing expenditures. Federal Judge Gladys Kessler
    found last year that tobacco companies continue to market in
    ways that appeal to young people and continue to recruit
    children as new tobacco users. In Judge Kessler's words:
    ``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.''
        The tobacco companies have circumvented MSA restrictions by
    dramatically increasing overall marketing expenditures and
    constantly finding new ways to market their products, many of
    which appeal to kids. Between 1998, the year of the MSA, and
    2005, the last year for which data is available, the major
    tobacco companies nearly doubled their total marketing
    expenditures from $6.9 billion to $13.4 billion, according to
    the Federal Trade Commission. That is nearly $37 million each
    and every day--much of it appealing to kids.
        There are many examples of how the tobacco companies
    continue to market in ways that appeal to children:

         The MSA did not place specific restrictions on
    advertising in print media, such as magazines. As a result,
    cigarette advertising increased in youth-oriented magazines in
    the two years after the MSA, and tobacco companies continue to
    place magazine ads that portray smoking as cool and glamorous.
         The MSA did not restrict in-store advertising.
    Knowing that 75 percent of teens visit a convenience store once
    at least once a week, the cigarette companies have increased
    their advertising and promotions in and around these stores. In
    fact, retail marketing now makes up about 90 percent of all
    cigarette marketing expenditures, according to the Federal
    Trade Commission. Science tells us this kind of marketing
    influences youth behavior. A study supported by the Robert Wood
    Johnson Foundation and published this May in the journal
    Archives of Pediatrics and Adolescent Medicine found that the
    more cigarette marketing teens are exposed to in retail stores,
    the more likely they are to smoke. The study also found that
    restricting these retail-marketing practices would reduce youth
    smoking.
         While the MSA banned large billboards, it
    permitted outdoor signs up to 14 square feet in size, even if
    placed right next to schools or playgrounds.
         Since the MSA, the tobacco companies have
    regularly introduced new candy and fruit-flavored tobacco
    products that clearly are intended as starter products for new
    tobacco users, most of whom are children. The R.J. Reynolds
    company, for example, introduced new flavored Camel cigarettes
    with names like Twista Lime, Warm Winter Toffee and Mocha Mint.
    A 2005 Harvard School of Public Health study concluded,
    ``Flavored cigarettes can promote youth initiation and help
    young occasional smokers to become daily smokers by masking the
    natural harshness and taste of tobacco smoke and increasing the
    acceptability of a toxic product.'' Survey data reveal that
    youth are almost twice as likely as adults to be aware of these
    flavored products and their advertising, and youth smokers are
    much more likely than older ones to have tried them.

        Unfortunately, this youth-oriented marketing works.
    According to the 2005 National Survey on Drug Use and Health,
    more than 81 percent of youth smokers prefer the three most
    heavily advertised cigarette brands--Marlboro, Camel and
    Newport. Numerous studies have found an association between
    tobacco marketing and youth smoking initiation and progress to
    regular use. As the National Cancer Institute found in a 2002
    report, ``the conclusion that there is a causal relationship
    between tobacco marketing and smoking initiation seems
    unassailable.''
        In addition to targeting youth, the tobacco companies also
    have a long history of targeting specific populations that have
    had historically lower smoking rates, and that tobacco
    companies regarded as potential new ``customers,'' including
    girls and women and African American and Hispanic youth.
        The most recent example of tobacco marketing to women and
    girls is R.J. Reynolds' Camel No. 9 cigarette introduced
    earlier this year by the same company that brought us the
    notorious Joe Camel. The Oregonian newspaper has aptly called
    Camel No. 9 ``Barbie Camel.''. Camel No. 9 comes in a shiny
    black box with a tiny pink camel and pink and teal borders. Ads
    in the most popular fashion magazines associate Camel No. 9
    with everything a teenage girl aspires to be: glamorous,
    sophisticated and beautiful. And then there are the promotional
    giveaways: berry lip balm, cell phone jewelry, cute little
    purses and wristbands, all in hot pink.
        Camel No. 9 continues the tobacco industry's long history
    of targeting women and girls, dating back to the ``You've Come
    A Long Way Baby'' campaign Philip Morris launched in 1968.
    These campaigns have cynically equated smoking with
    independence, sophistication and beauty and preyed on the
    unique social pressures that women and girls face. The
    marketing of cigarettes as ``slims'' or ``thins'' and later as
    ``low-tar'' and ``light'' also played into young women's
    concerns about weight and health.
        As a physician, I can tell you that there's nothing
    glamorous or beautiful about cancer and heart disease, which
    have been the main consequences for women. While death rates
    for most cancers have declined among women, rates have
    skyrocketed for lung cancer. Since 1987, lung cancer has been
    the leading cancer killer among women, surpassing breast
    cancer. Heart disease is the overall leading cause of death
    among women, and smoking accounts for one of every five deaths
    from heart disease. Altogether, more than 178,000 women die of
    tobacco-related diseases each year. This is the lethal legacy
    of the tobacco industry's targeting of women and girls.
        The tobacco companies have similarly targeted African-
    Americans and Hispanics, especially children in those
    communities. One of the most egregious recent examples is Brown
    & Williamson's marketing campaign for Kool cigarettes, called
    Kool Mixx. This hip-hop themed campaign featured images of
    musicians, disc jockeys and dancers on cigarette packs and in
    advertising. It even included radio giveaways with cigarette
    purchases.
        Again, the evidence is powerful that this targeted
    marketing works, especially on children. Take Lorillard's
    Newport cigarettes, which have been marketed to African
    Americans longer and more heavily than any other brand. While
    about 42 percent of African-American adults who smoke prefer
    Newport, 80 percent of African-American youth smokers prefer
    this brand.
        This marketing has a devastating impact on the health of
    African Americans. While African Americans smoke at roughly the
    same rates as whites, they die at a higher rater from smoking-
    caused diseases. African American men bear an especially high
    burden of death and disease, with lung cancer rates almost 40
    percent higher and average death rates about 30 percent higher
    than for white men.
        The tobacco industry has similarly targeted Hispanic
    communities. As they have done with women and African
    Americans, the industry has sought to associate smoking with
    the culture, music and aspirations of the Hispanics and
    Latinos. One recent ad campaign for Kool cigarettes featured
    multicultural images, concerts with Latino musicians and
    aspirational slogans such as ``It's about pursuing your
    ambitions and staying connected to your roots.'' It is truly
    offensive that the tobacco industry would exploit ethnic
    communities to sell a deadly and addictive product.
        Mr. Chairman and members of the Subcommittee, these
    examples make it abundantly clear why the FDA needs the
    authority and resources to effectively regulate tobacco
    products and their marketing. With the authority that you can
    give, the FDA can finally stop tobacco marketing and sales to
    children; eliminate special flavored cigarettes that appeal to
    and target youth smokers; prevent tobacco companies from
    deceiving the public about the health risks of their products
    and undermining efforts to help smokers quit; and take other
    necessary steps to protect public health and save lives. These
    steps will significantly enhance state and local efforts to
    reduce tobacco use and help address the tobacco industry's
    targeting of specific populations, resulting in an excess
    burden of disease borne by many of the most vulnerable among
    us. The FDA is uniquely qualified to help achieve these goals
    because of its regulatory experience, scientific knowledge and
    public health mandate. With the powerful public health
    combination of FDA authority over tobacco products and enhanced
    efforts at the state and local level, we can achieve the goal
    that the Institute of Medicine has set for us--to eliminate
    tobacco use as one of the most pressing public health problems
    in the United States.
        Thank you for your attention to this issue and the
    opportunity to testify.
                                  ----------

        Mr. Pallone. Thank you, and I apologize. We are going to
    have to take about half an hour break for the 3 votes and then
    we will be back. Thank you all. The committee stands in recess.
        [Recess.]
        Mr. Waxman [presiding]. The subcommittee will come back to
    order. Chairman Pallone is managing a resolution on the House
    floor and asked me to chair the continuation of the hearing
    from this morning.
        Mr. Ballin, I think you are next. Is that right?
        Mr. Ballin. Yes, sir.
        Mr. Waxman. There is a button on the base of the mic and we
    will have the clock going. Of course, all of your full
    statements will be in the record and we would like to ask you
    if you could to keep to the 5-minute time.

    STATEMENT OF SCOTT BALLIN, ATTORNEY, STEERING COMMITTEE MEMBER,
      ALLIANCE FOR HEALTH, ECONOMIC, AND AGRICULTURE DEVELOPMENT,
                             WASHINGTON, DC

        Mr. Ballin. Mr. Chairman, it is an honor to be here today.
    In some ways I think I have come full circle on this issue. I
    testified before this subcommittee in support of FDA oversight
    way back in the early part of the 1990s and had the privilege
    to work with Congressmen Mike Synar and Bob Whittaker at that
    time, both who served on this subcommittee and who were the
    first to introduce legislation to give the FDA regulatory
    authority over tobacco products, and I would be remiss if I did
    not recognize you who I worked with over the years and your
    staffs. You have been a leader not only on this issue but on
    many other tobacco-related issues, and I commend you for that
    continued leadership today as well.
        I think I am here supposedly as a minority witness but I
    would rather be thought of as a witness for both the majority
    and the minority because I am here to encourage both parties to
    work together in crafting FDA legislation that will serve the
    public health and establish a regulatory structure that will
    serve those needs 10 to 15 years down the road. This
    legislation is long overdue and Congress needs to act and act
    soon. FDA is the right agency to regulate tobacco products. I
    know that some of my colleagues probably think that our
    suggestions today with some amendments will detract from the
    focus of this legislation but I think there are some things
    that need to be considered as this subcommittee looks at the
    amendments that will have to be addressed by this committee
    during a markup.
        The testimony we have submitted for the record today
    hopefully will be of some assistance to members of the
    committee from both parties as well as from those from both the
    tobacco and non-tobacco States. We have patiently waited 15
    years for enacting of this critically important legislation and
    spending a few more weeks to make potential improvements would
    in our opinion be time well spent.
        Our organization, AHEAD, was formed as an outgrowth of a
    project funded by the Robert Wood Johnson Foundation that
    brought public health advocates and growers together in the
    mid-1990s to talk about contentious tobacco issues. I
    personally learned a great deal from that experience about the
    critical importance of dialog and engagement, and if there is
    anything I want to emphasize today in my testimony, it is that
    challenging views, opinions and behaviors as well as listening
    and looking for opportunities for changes can have a
    significant and positive effect on outcomes.
        I am not going to go into details as to why this
    legislation is needed. We heard a lot of that this morning, and
    for me personally and for our organization, AHEAD, oversight by
    FDA is a given. AHEAD strongly agrees with much of what has
    been said and articulated by the other witnesses here today in
    support of FDA. I think that where we may have some differences
    of opinion is how best to move forward to accomplish our shared
    goals and objectives. My experience over the last several years
    has led me to conclude that in addition to giving the agency
    authority, we also need to have great engagement between the
    stakeholders to discuss the complex issues, debate and dialog
    those issues which many of those issues were raised this
    morning. Some of these discussions can and will obviously take
    place at FDA as part of the regulatory process but even that
    may take some time, and I strongly support and encourage
    discussions outside of the legislative process to address some
    of these issues as has been done this morning during some of
    the discussions and dialogs with this committee.
        Good decisionmaking can't be done in a vacuum and we can't
    merely rely on using the tobacco industry's past bad behaviors
    as an excuse for not challenging or engaging them in the
    dialog. Stakeholders need to look beyond their own agenda if
    for nothing other than to understand what other factors, both
    positive and negative, need to be considered. We need more
    interaction between the scientific research community, experts
    in advertising and marketing, agronomists, tobacco and
    pharmaceutical companies, scientists, producers as well as the
    consumer who often gets left out of these discussions. Today's
    environment isn't just about big tobacco's past and potential
    future abuses. It is also about changing the competitive
    environment between the tobacco companies, old and new,
    pharmaceutical industries and the biotech companies. It is also
    about technological advances in making it feasible to reduce
    and remove toxins and pesticides from tobacco leaf.
        Our suggestions for this legislation are contained in our
    testimony but I would like to just sort of review them very
    quickly. First, we would like to say and suggest that all
    tobacco and nicotine products be brought under the same
    umbrella at FDA through maybe a center on tobacco and nicotine
    and that there should be classification panels similar to the
    medical device panels used to review combustible products, non-
    combustible products and therapeutic products. We also suggest
    regulating products based upon risks and relative risks and
    intended uses so that users of tobacco and nicotine products
    are fully informed about the products they use. We also support
    expanding and upgrading the scientific advisory committee to
    include experts in agronomy and plant technology, labeling and
    marketing and consumer affairs. We also would suggest that
    there be greater interagency cooperation, and that was alluded
    to earlier this morning.
        Conspicuously absent from today's hearings are the tobacco
    and the pharmaceutical companies. It would be of great interest
    to hear from them publicly and for the record as to where they
    stand on a number of the issues pertaining to the FDA
    regulation. The so-called tobacco industry is no longer the
    monolithic giant it once was, and as long as tobacco remains
    legal, the industry must be more transparent and accountable in
    what they do.
        Also missing from today's hearing are the voices of the
    tobacco producers who produce the tobacco that goes into
    tobacco products and also is used in nicotine products, and I
    hope that there will be a time that they can also come to this
    committee. We also encourage this committee to contact the
    Agriculture Committee and ask them to hold some hearings on the
    importance of agricultural production of tobacco, looking at
    the health and safety issues related to that aspect because
    that will impact FDA regulation.
        Mr. Chairman, I would like to thank you in particular for
    your leadership on this and we look forward to working with you
    in the future.
        [The prepared statement of Mr. Ballin follows:]

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        Mr. Waxman. Thank you very much, Mr. Ballin. I appreciate
    your testimony.
        Mr. Winkler, I am looking forward to hearing from you.

    STATEMENT OF JAMES WINKLER, GENERAL SECRETARY, GENERAL BOARD OF
              CHURCH AND SOCIETY, UNITED METHODIST CHURCH

        Mr. Winkler. Thank you, Mr. Chairman. I am Jim Winkler,
    general secretary of the United Methodist General Board of
    Church and Society of the United Methodist Church. As you may
    know, our denomination is the third largest in the United
    States with more than 8 million members in nearly 35,000 local
    congregations.
        I am also chair of Faith United Against Tobacco, a broad-
    based coalition of faith leaders. Since it was founded in 2002,
    Faith United Against Tobacco has grown to include over 20
    national faith denominations and organizations. In addition to
    our agency, the coalition includes the Ethics and Religious
    Liberty Commission of the Southern Baptist Convention, the
    National Council of Churches, the Presbyterian Church USA, the
    Commission on Social Action of Reformed 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.
        I appreciate this opportunity to testify in favor of H.R.
    1108, Family Smoking Prevention and Tobacco Control Act,
    lifesaving legislation to authorize the Food and Drug
    Administration to regulate tobacco products. We have made
    enactment of the tobacco legislation introduced by yourself and
    Mr. Davis one of our top legislative priorities for this
    Congress. The legislation is long overdue, and on behalf of the
    many members of our faith groups united in our coalition, I
    strongly urge Congress to take action now and enact this
    critically important legislation with all due speed.
        In addition to our national effort to convince Congress to
    enact FDA regulation of tobacco, 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 Methodist, Southern Baptist 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.
        Our focus on the Federal level has always been on enacting
    legislation to give FDA authority over tobacco products.
    Recently, 24 national faith leaders from our coalition sent a
    letter to every Member of the Senate and the House urging
    support for the FDA legislation. The signers of this letter
    represent very diverse groups including Christian, Jewish,
    Muslim and Sikh denominations whose members include 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 hold widely diverse positions on other important
    social and political issues but we are and we will remain
    united in our desire to reduce smoking, especially among
    children and in our commitment to the enactment of this
    legislation authorizing the FDA to regulate tobacco products.
        Our faith traditions teach us it is morally wrong to know
    the good that should be done and not do it. It is also morally
    wrong to leave the most impressionable and vulnerable among us,
    our children, unprotected from tobacco enticements that
    confront them and so we in the faith community believe that
    those who are called to positions of leadership and power have
    a moral imperative to exercise their power to safeguard the
    men, women and children of our country from falling into the
    pitfalls of tobacco abuse.
        All members of Faith United Against Tobacco believe that
    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 an obligation both
    morally and as guardians of our citizens 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.
        Mr. Chairman, I want to thank you especially for your
    leadership in this effort. We are happy to work alongside you.
    Thank you.
        [The prepared statement of Mr. Winkler follows:]

                           Statement of James Winkler

        Good morning, Chairman Pallone, Representative Deal and
    Members of the Subcommittee. I am James Winkler, General
    Secretary of the General Board of Church and Society of The
    United Methodist Church. As you may know, The United Methodist
    Church is the third largest religious denomination in the
    United States, with more than 8 million members worshipping in
    nearly 35,000 local congregations in the United States.
        I am also the Chair of Faith United Against Tobacco, a
    broad-based coalition of faith leaders. 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 General Board of Church and Society of The United Methodist
    Church, our coalition includes the Ethics & Religious Liberty
    Commission of the Southern Baptist Convention, 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.
        I appreciate this opportunity to testify in favor of H.R.
    1108, 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
    Representatives Henry Waxman and Tom Davis one of our top
    legislative priorities for the 110th Congress. This legislation
    is long, long overdue, and, on behalf of United Methodists and
    the many members of the other faith groups united in our
    coalition, I strongly urge you to take action now and to enact
    this critically important legislation with all due speed.
        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.
        Our focus at the Federal level has always been on enacting
    legislation to give the FDA authority over tobacco products.
    Recently, twenty-four 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. The signers of this letter represent very diverse
    groups, including Christian, Jewish, Muslim, and Sikh faith
    denominations, whose members include 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
    widely diverse positions on other important social and
    political issues. But we are, and we will remain, united in our
    desire to reduce smoking, especially among children, and in our
    commitment to the enactment of this legislation authorizing the
    FDA to regulate tobacco products.
        Many Americans now know the terrible statistics about the
    toll of tobacco on our families--over 1200 Americans die each
    day, every day from tobacco use. Another 1200 will die
    tomorrow; and the day after that; and every single day of the
    year. In all, 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, there are tragic faces
    attached to these frightening statistics. Every day clergy in
    our faith groups assist families in burying mothers and
    fathers, sisters and brothers who die absolutely preventable
    and premature deaths caused by tobacco addiction. And, more
    often than not, these addictions began at a young age. We,
    then, are left with the difficult task of trying to comfort
    their grieving survivors. Every one of these people who dies of
    tobacco use leaves behind families and friends who miss them
    very much and suffer their untimely and tragic loss.
        I speak this morning from personal experience. My father,
    uncle, and brother are United Methodist clergy. All of them
    have dealt with church members over the years who have become
    addicted to tobacco and each of them have dealt directly with
    the negative effects of cancer on their congregations and the
    families who have suffered from this product.
        Literally, millions of Americans have died 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 a future that is cut short
    due to lack of knowledge about the ingredients and addictive
    nature of tobacco. 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 faith groups in our
    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 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, dog
    food and nicotine cessation products, but has no authority over
    tobacco, a product that causes more preventable deaths than any
    other.
        The United Methodist Church is unwavering in its
    declaration to ensure protection for all of God's children
    especially from harmful and addictive products. Our Faith
    Coalition is simply asking that tobacco products be subject to
    the same common sense consumer protections that apply to other
    products. Why should manufacturers of nicotine 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 excessive 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 and spiritual reasons.
    Our faith traditions inform us that our bodies are gifts from
    God and, therefore, should be treasured and treated with
    dignity. This means, among other things, that tobacco companies
    should not be allowed to entice our children to pollute their
    bodies. While each adult 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, to end the marketing of these
    products to children and to significantly reduce the illness
    and death that these practices can produce.
        Our faith traditions teach us that it is morally wrong to
    know the good that should be done and not do it. It is also
    morally wrong to leave the most impressionable and vulnerable
    among us, our children, unprotected from the tobacco
    enticements that confront them. And so, we in the faith
    community believe that those who are called to positions of
    leadership and power have a moral imperative to exercise their
    power 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 and without the full knowledge of the dangers of tobacco
    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 the bill before you, but it was killed
    in a conference committee. And on August 1, the Senate
    Committee on Health, Education, Labor and Pensions passed this
    bill. 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.
        All members of Faith United Against Tobacco believe that
    the United States 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 an obligation, both morally and as guardians of our
    citizens 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 H.R. 1108, bipartisan legislation to provide
    the Food and Drug Administration authority to regulate tobacco
    products.
        Chairman Pallone, Representative Deal, and other Members of
    the Committee, I thank you for permitting me to testify this
    morning. I will be happy to entertain any questions.
                                  ----------

        Mr. Waxman. Thank you very much, Mr. Winkler. I appreciate
    your testimony.
        Mr. Armour.

        STATEMENT OF HENRY ARMOUR, PRESIDENT AND CEO, NATIONAL
                   ASSOCIATION OF CONVENIENCE STORES

        Mr. Armour. Thank you, Mr. Chairman, for giving me the
    opportunity to testify before you today. My name is Henry
    Armour. I am the president and CEO of the National Association
    of Convenience Stores. Founded in 1961, NACS is a not-for-
    profit trade association representing more than 2,200 retail
    member companies in the United States and abroad. NACS is the
    preeminent representative of interests of the convenience store
    operators. The convenience store industry in the United States,
    with over 145,000 stores, posted $569 billion in total sales in
    2006. More than 70 percent of NACS members are small family
    businesses owning and operating 10 or fewer stores.
        I appreciate this opportunity to share the convenience
    store industry's views regarding H.R. 1108. Tobacco sales are a
    highly important component of our members' businesses.
    Convenience stores sell more than 60 percent of the cigarettes
    sold in the United States in more than 20 million transactions
    per day.
        I want to make clear that NACS takes no position with
    respect to the manufacturing provisions in H.R. 1108. That is
    not our issue. Our industry simply wants to sell legal products
    responsibly under regulatory regimes that are fair and
    effective. With respect to retail sales, the overall approach
    taken in this bill has not changed much from previous
    legislative proposals that Congress has considered over the
    past decade. The facts on the ground, however, have changed
    dramatically.
        During the past 10 years, the rates of retail noncompliance
    nationwide fell from 40.1 percent in 1997 to 10.9 percent in
    2006. You can see a chart over here to my left showing that
    decline. Virtually every State has shown consistent
    improvement, and in 2006 for the very first time every single
    State in the Nation reduced its rate of sales to minors below
    the threshold set by Congress. Our goal is to completely
    eliminate illegal tobacco sales and clearly the regulatory
    scheme in place has been and continues to be very effective in
    making progress towards achieving this goal. In our view, some
    of the specific provisions and omissions in the bill are less
    effective than they might be.
        H.R. 1108 puts at risk a retailer's license to sell tobacco
    even if that retailer has an excellent compliance program. I
    disagree with this approach. While there may be fines imposed
    for any violation, losing the ability to sell tobacco often
    means that a convenience store goes out of business and is
    sold. Forcing a store transfer is too harsh a sanction if a
    business owner has done everything in his or her power to
    prevent a violation and may likely result in less diligent
    owners operating the store.
        Another problem with this legislation is that it makes the
    FDA responsible for duplicating the regulation of retailers
    when States are already doing this well. We all know and have
    heard this morning that the FDA has its hands full trying to
    keep our food supply and pharmaceutical products safe and
    adding responsibility to regulate over 300,00 retail
    establishments that are not currently under its jurisdiction
    will undoubtedly put even greater strains on the agency.
        This legislation also does not adequately cover sales made
    through the Internet or on Native American lands. A cigarette
    purchased over the Internet or an Indian reservation is no less
    harmful to the youths of America and should be regulated in the
    same manner as all other cigarette sales.
        There are other concerns with this legislation but there is
    one particular issue that I would like to call to your
    attention. In 1997 the FDA prohibited the sale of over-the-
    counter smoking cessation products like Nicorette gum in
    convenience stores. I must say that the reasoning behind this
    decision baffles me. If we are serious about wanting people to
    stop smoking, we should want them to be able to get products
    that help them quit in convenient settings and in those places
    where they would purchase cigarettes. This legislation ought to
    fix this mistaken policy.
        If the committee is going to legislate with respect to
    retail sales, then it should with the current effective system,
    not against it. Setting standards for State regulation, closing
    loopholes for Internet and Native American sellers, providing
    incentives for retailers to have good compliance programs and
    allowing convenience stores to sell smoking cessation products
    are critical elements to sound regulation of tobacco sales.
        We would welcome the opportunity to work with you to
    address these concerns. I thank you for your time and the
    opportunity to share NACS's view with you. Thank you very much.
        [The prepared statement of Mr. Armour follows:]

                           Testimony of Henry Armour

         My name is Henry Armour and I am President and CEO of the
    National Association of Convenience Stores (NACS). Founded in
    1961, NACS is a non-profit trade association representing more
    than 2,200 retail and 1,800 supplier company members in the
    United States and abroad. NACS is the pre-eminent
    representative of the interests of convenience store operators.
    The convenience store industry in the United States, with over
    145,000 stores across the country, posted $569.4 billion in
    total sales in 2006. More than 70 percent of NACS members are
    small family businesses owning and operating 10 stores or less.
         I appreciate this opportunity to share the convenience
    store industry's views regarding H.R. 1108, the Family Smoking
    Prevention and Tobacco Control Act. Tobacco sales are a highly
    important component of NACS member's businesses. Convenience
    stores sell more than 60 percent of the cigarettes sold in the
    United States in more than 20 million transactions per day.
    Such sales, on average, constituted nearly thirty four percent
    of the in-store sales at NACS members' retail locations in
    2006. Tobacco is a legal product that is important to the
    economic viability of the convenience store industry. I have
    firsthand experience with the everyday realities of operating a
    business and selling tobacco products. Before coming to NACS, I
    owned and operated a chain of more than 50 retail outlets in
    the states of Washington, Oregon, and California.
         I want to make clear that NACS takes no position with
    respect to the manufacturing provisions in H.R. 1108--that is
    not our issue. Our industry simply wants to sell legal products
    responsibly under regulatory regimes that are fair. And we do
    have quite a bit of experience with the retail sale of tobacco
    products. In our view, H.R. 1108 should take a different
    approach to the regulation of retail tobacco sales. My
    testimony will explain why we believe a system of state
    regulation with Federal goals--like the current system--is the
    right one and why the approach taken in H.R. 1108 should be
    changed to reflect the lessons we have learned.

         The Current System for Regulating Tobacco Retailing is Working

         Underage Sales Are Falling. H.R. 1108's overall approach
    to retail sales has not changed much from previous legislative
    proposals that Congress has considered and failed to enact for
    the past decade. While the overall approach has been largely
    stagnant, however, the facts on the ground have changed
    dramatically.
         The Department of Health and Human Services recently
    released the latest numbers regarding state efforts to enforce
    laws against tobacco sales to minors. Since the mid-1990s,
    states have faced the possibility of losing some of their
    substance abuse and mental health services grant funds if they
    have not reduced the rate of violations of these laws to below
    20 percent. This Federal standard, known as the Synar
    Amendment, has produced consistently improving results.
         During the past 10 years, the violation rates nationwide
    have fallen every single year. In fact, the percentage of
    retail violations found nationally fell from 40.1 percent in
    1997 to 10.9 percent in 2006. Virtually every state has shown
    consistent improvement. And in 2006, for the first time, every
    single state in the Nation reduced its rate of sales to minors
    below the threshold set by the Congress. I have included a copy
    of this latest report as exhibit A to my testimony. There does
    not appear to be any other way to read this report than to
    conclude that our current system of regulating retail sales of
    tobacco is making progress. In light of these clear findings,
    Congress should not impose costly regulations that are
    unnecessary and counterproductive. Instead, Congress should
    continue its successful policy of working with states to ensure
    that they diligently regulate tobacco sales.
         Retailers Are Taking Action to Reduce Underage Sales. Part
    of the reason for the success of the Synar Amendment is the
    effort put forward by retailers. Convenience store operators
    and other retailers have dedicated considerable resources and
    money trying to prevent tobacco sales to minors by investing in
    employee training, signage, company-operated stings, incentives
    for employees, and enforcement of company policies. Some
    retailers have even installed electronic age verification (EAV)
    devices to help eliminate these sales.
         In order to assist in the elimination of tobacco sales to
    minors, retailers, wholesalers and manufacturers have formed
    the Coalition for Responsible Tobacco Retailing. This Coalition
    developed the ``We Card'' training program, which provides
    education and training to help retailers prevent underage
    tobacco sales. The program includes development and
    dissemination of retailer best practices to tobacco retailers
    across the country. The ``We Card'' training materials include
    signage, training videos, training guides, posters, interactive
    on-line training, and daily reminder calendars. To date, over
    one million ``We Card'' kits have been distributed to retailers
    nationwide. ``We Card'' offers hundreds of classroom training
    sessions that train almost 10,000 retailers annually. Indeed,
    since its inception, ``We Card'' has held over 2,070 classroom
    training sessions in all 50 states in the U.S. and U.S.
    territories. In the past decade, over 100,000 owners, managers
    and frontline employees have been trained by ``We Card.''
         In addition to NACS, ``We Card'' has been endorsed by the
    National Grocers Association, the National Retail Federation
    and the National Association of Police Organizations. Forty-
    four state coalitions have been assembled to support state
    level training and education and 236 regional, state and local
    trade associations support the ``We Card'' initiative. Several
    governors, mayors, state attorneys general, and tobacco control
    boards throughout the United States have also endorsed this
    program.
         Many retailers have strengthened their efforts to reduce
    the sales of tobacco products to minors by incorporating ``We
    Card'' into a multi-pronged approach to combat this problem. In
    addition to the training and signage included in the ``We
    Card'' program, many companies have set stringent company
    policies. Retailers across the United States understand that
    solely training employees and setting a ``No ID-No Sale''
    policy is not enough to eliminate these sales. Without
    enforcement of their policy, the inclusion of incentives and/or
    use of additional tools retailers would not be able to be
    successful. For example, many companies conduct mystery shopper
    programs. Through these programs, companies hire teenagers to
    conduct company operated stings in order to obtain an accurate
    account of their compliance rate, and continually remind their
    employees of the company's tobacco retailing policy. These
    mystery shopper programs are becoming more prevalent throughout
    the industry. Additionally, many retailers have instituted
    incentive programs for their employees. Many employers are
    providing incentives, either through bonuses or other benefits,
    for those employees who pass a company operated sting. Some
    retailers also have adopted zero tolerance policies. For those
    companies, if an employee is caught even once selling to a
    minor that person is terminated on the spot. Retailers are also
    looking at other, non-traditional, avenues to assist in this
    effort. Many companies are purchasing EAV devices to help
    eliminate calculation errors. An EAV will electronically read
    birth date information stored on state driver's licenses to
    determine whether a consumer can purchase an age-restricted
    product, thus removing an element of human error.
         Independent studies have shown that retail education and
    training as well as asking for proper identification can help
    prevent underage tobacco sales. A University of Idaho study
    conducted for the Idaho Department of Health compared retailers
    using the ``We Card'' program to retailers using other
    materials or no materials at all. The study found:

         The violation rate among retailers using ``We
    Card'' materials was 7.22 percent, while the rate for other
    retailers was 16.96 percent.
         Retailers displaying ``We Card'' materials were
    12.9 times more likely to ask for identification than not to
    ask for identification, while other retailers were 4.9 times
    more likely to ask for identification than not to ask for
    identification.

               Shortcomings of the Retail Provisions of H.R. 1108

        Not only does NACS differ with the overall approach to
    tobacco retailing taken by H.R. 1108, some of the specific
    provisions and omissions in the bill are less effective than
    they should be and/or are unfair.
         Retailers Should be Encouraged to Sell Responsibly. The
    first thing to note is that in most areas of regulation we do
    not hold people liable for things over which they do not have
    control. Penalizing activity that we have no ability to control
    loses does not deter illegal conduct--it is simply punitive.
    That is important to note when legislating on this subject.
    When I ran a chain of convenience stores, I had compliance
    plans in place to try to ensure that we followed the laws with
    respect to selling age-restricted products like tobacco. For
    example, we conducted comprehensive training for all employees
    to ensure that they were trained on their responsibilities for
    checking ID cards and we had a zero tolerance policy if they
    failed to follow the rules, including immediate termination if
    tobacco was sold to a minor. We also conducted sting operations
    on our own stores to try to detect problems and correct them.
    But I could not guarantee that an employee would never make a
    mistake or intentionally violate my company policies.
    Unfortunately, H.R. 1108 puts at risk a retailer's license to
    sell tobacco even if that retailer has an excellent compliance
    program but has one or two bad employees who unintentionally
    (or intentionally) sell to minors. I believe that is the wrong
    approach. While there may be fines imposed for any violation,
    losing the ability to sell tobacco often means that a
    convenience store goes out of business. That is just an
    economic reality given the very thin margins in the industry
    and the number of adults who frequent convenience stores in
    order to buy tobacco. Closing the store is too harsh a sanction
    if a business owner has done everything in his or her power to
    prevent a violation. And such a harsh sanction against
    companies with quality compliance programs may have the
    unintended consequence of stores being sold to individuals with
    no such training programs. In addition, having a provision
    requiring an adequate compliance program as a condition to
    avoid the loss of a license to sell tobacco can be a powerful
    incentive for retailers to do the right thing. In our view it
    would help us make real progress on this issue if retailers had
    this incentive for implementing strong compliance programs.
         The States, not FDA, Should Have Primary Enforcement
    Responsibility. Another problem with this legislation is that
    it makes the Food and Drug Administration responsible for
    duplicating the regulation of retailers when states are already
    doing a good job in this area. We now have a decade of
    experience with the Synar amendment in place and retailer
    noncompliance rates have gone down every single year. As I said
    earlier, the national weighted average noncompliance rate in
    1997 was 40.1 percent and last year that number fell to 10.9
    percent. While our goal is to completely eliminate tobacco
    sales to minors, the current system is a real success story and
    is certainly making progress toward achieving our goal.
         Rather than creating a new Federal bureaucracy for retail
    sales, Congress should be looking at ways to improve upon the
    successes we have gained through the Synar Amendment's
    incentive to states. We are willing to work with the Committee
    in setting standards that state regulations must meet, making
    Synar's requirements tougher, or otherwise, but it is difficult
    to see why adding an already overtaxed FDA on top of the
    current system of state regulation will improve the system. We
    all know that the FDA has its hands full just trying to keep
    our food supply safe and adding the responsibility to regulate
    300,000 retail establishments that are not currently under its
    jurisdiction will undoubtedly put even greater strains on the
    agency.
         Innovative legislative activity relating to the retailing
    of tobacco is occurring in the States. Pennsylvania, Texas,
    Idaho, Colorado, Michigan, Florida, Ohio and others have laws
    that offer an affirmative defense for retailers who take
    necessary compliance measures to avoid underage sales. These
    laws incentivize retailers to take appropriate measures to
    ensure their businesses comply with the law and the approach
    has been quite successful. H.R. 1108 would remove some of these
    incentives and make retailers subject to a loss of their
    license to sell tobacco even if they do everything right. That
    change threatens to undo some of the progress made by these
    states.
         Pennsylvania, Missouri and Iowa have enacted laws that
    place the shared responsibility upon retailers, minors and
    clerks. In Missouri, the law allows for the assessment of a
    fine upon clerks as well as retailers. The person making the
    underage sale is then subject to a fine of $25 for the first
    offense, $100 for the second offense and $250 for subsequent
    offenses. In Pennsylvania, minors purchasing or attempting to
    purchase tobacco products are required to participate in
    tobacco education programs, lose their driving privileges, or
    be fined. In fact, many states have passed laws creating
    penalties for minors who purchase or possess tobacco and have
    been successful in curtailing underage smoking.
         Vermont law provides that people under age 18 who possess
    tobacco will be fined $25 and, if the fine is not paid within
    60 days, will lose their driver's license for up to 90 days or
    their initial eligibility for a driver's license will be
    delayed by up to 1 year. If a person under age 18 misrepresents
    his or her age to buy tobacco, then that individual will be
    subject to a $50 fine or 10 hours of community service or both.
    Vermont's approach is working. Vermont's 2005 Youth Risk
    Behavior Survey showed that smoking rates among eighth graders
    in the State have steadily fallen from 26 percent in 1997 to 22
    percent in 1999 to 13 percent in 2001 to 8 percent in 2005. For
    all Vermont students surveyed (including students in grades 8
    through 12), smoking rates fell from 36 percent in 1997 to 31
    percent in 1999 to 22 percent in 2001 to 16 percent in 2005. In
    all, Vermont experienced a drop of more than 50 percent in
    youth smoking over a 4-year period. In fact, the Campaign for
    Tobacco-Free Kids called Vermont's results ``among the most
    impressive in the Nation.'' The Centers for Disease Control and
    Prevention (CDC) has noted that the number of states and
    localities imposing such penalties is increasing.
         H.R. 1108 fails to include any penalties for minors who
    attempt to purchase tobacco. That means they have absolutely no
    deterrent and the same 17-year old can attempt to buy
    cigarettes at a store over and over again and get tobacco from
    older friends, family members, the Internet or elsewhere
    without threat of sanction. This is a major flaw in the
    legislation. We have penalties when minors possess age-
    restricted products like alcohol because we understand that
    taking action on both the supply and the demand side of the
    equation is more comprehensive and produces better results.
         Some States have used incentives based on new technology
    to try to get better results. New York and Connecticut, for
    example, have passed state legislation giving retailers an
    affirmative defense if they purchase and use EAV (electronic
    age verification) devices solely for the purpose of age
    verification on sales of age-restricted products.
         All of these state activities have affected where minors
    get tobacco products. According to the most recent Youth Risk
    Behavior Surveillance study conducted by the CDC, the
    percentage of students who said they purchased their cigarettes
    from a store or gas station fell from 38.7 percent in 1995 to
    15.2 percent in 2005. Minors now report that friends and family
    members are more frequent sources of tobacco products than
    convenience stores. This demonstrates that we need to adjust
    our thinking to address all of the ways that minors get
    tobacco. It also shows that States, localities, and private
    efforts are having an effect and should be given the
    opportunity to make further improvements.

         The Retail Provisions of H.R. 1108 Can and Should be Improved

         If the committee moves forward with H.R. 1108, it must
    address some of the most difficult--and growing--problems in
    tobacco retailing.
         Internet and Native American Sales. The improving
    compliance rates I noted earlier do not cover sales made
    through the Internet or on Native American lands. We do not
    know how often these retailers check IDs to make sure their
    customers are old enough to purchase tobacco. What we do know
    is that what you typically see when you attempt to purchase
    tobacco on the Internet is woefully inadequate. In many cases,
    when a customer clicks on a pack of cigarettes on a website to
    try to purchase tobacco, a box appears. The wording can vary
    slightly but often says that by clicking ``OK'' the purchaser
    verifies that he or she is 18 years old. As if this ``honor
    system'' approach were not inadequate enough, many of these
    sites only have one box--the one that says ``OK.'' A minor
    could not respond that he was underage even if he wanted to do
    so. H.R. 1108, however, revives 10-year old FDA regulations
    that exempt Internet and mail order purchases from the
    requirement for checking IDs. This makes no sense. Internet
    cigarette sales are now about 14 percent of the national
    market. That is big business. IDs can be checked at the point
    of delivery--and often are when alcohol is shipped--so there is
    no reason to exempt these sales from regulation.
         Any legislation also should address tobacco sales on
    Native American reservations. Without explicit provisions
    making clear that the law should be enforced on reservations,
    the history on these issues shows that such sales will be
    ignored. Yet, Native American tobacco retailers have increased
    their share of the retail tobacco market over the past several
    years and there is no reason why they should not abide by the
    same rules, and deal with similarly effective enforcement
    mechanisms, as their off-reservation competitors. This can be
    done without violating tribal sovereignty and is essential if
    Congress's goal is to have a fair and comprehensive bill. A
    cigarette purchased over the Internet or on an Indian
    reservation is no less harmful to the youths of America and
    should be regulated in the same manner as all other cigarette
    sales.
         Sales of Smoking Cessation Products. A number of other
    problems exist in this legislation, including placing
    responsibility in the wrong place for labels and setting
    unrealistic penalties, but there is one issue in particular
    that I would like to call to your attention. Several years ago,
    FDA entered into a consent decree preventing convenience stores
    from selling over-the-counter a popular smoking cessation
    product, Nicorette gum. This was done when the product first
    became available over-the-counter so there was no evidence of
    any kind that there were issues with sales of these products in
    convenience stores. Indeed, products like Nicorette are sold
    over the counter today at drug stores from a shelf right above
    cartons of cigarettes. Why drug stores can offer these products
    and the local convenience store cannot baffles me. If Congress
    is serious about wanting people to stop smoking, it should
    enable people to get products that help them quit in convenient
    settings and in those places where they would purchase
    cigarettes. Prohibiting such sales is counter-productive.

                                  Conclusions

         As noted, the current system of state regulation to try to
    meet Federal goals is making measurable progress. This approach
    should be preserved. If the Committee is going to legislate
    with respect to retail sales, then it should work with the
    current system--not against it. Four elements are critical.
         First, the legislation should preserve the role of states
    as the regulators of retail tobacco sales but could set
    additional Federal goals that states must meet. Such
    legislation could range from compliance targets like those set
    in the Synar Amendment to detailed model legislation that
    states must adopt and enforce. NACS has advocated for this type
    of approach in the past and experience has shown that it is the
    right way to address retail sales. The bottom line is that
    states have the experience and resources to regulate retail
    sales--the FDA does not. States have a record of a decade of
    solid progress in reducing tobacco sales to minors--the FDA
    does not. States have the enforcement and judicial personnel to
    enforce the law and provide due process to retailers--FDA does
    not. In fact, just a cursory glance at the newspapers
    demonstrates that the FDA is an agency that is already
    stretched incredibly thin. It is being asked to address more
    issues--including new questions about the safety of imported
    food and drugs--without enough resources. Adding the
    responsibility of policing more than 300,000 retailers of
    tobacco products across the Nation is a prescription for
    disaster for the FDA and will not improve efforts to curb youth
    smoking. Instead, it may make things significantly worse. State
    regulation to meet Federal standards is an approach that works
    in this area. Let's do what works.
         Second, any new legislation should explicitly address
    tobacco sales over the internet and on Indian reservations and
    require all tobacco retailers to obey the same rules.
         Third, Congress should adopt appropriate incentives for
    companies to implement effective compliance programs by
    protecting them from losing their license to sell tobacco
    products.
         Finally, Congress should lift the ban on the sale of
    smoking cessation products in convenience stores.
         I thank you for your time and for the opportunity to share
    NACS' views with you. I welcome any questions you may have.
                                  ----------

        Mr. Waxman. Thank you very much, Mr. Armour.
        Dr. Henningfield.

    STATEMENT OF JACK E. HENNINGFIELD, VICE PRESIDENT, RESEARCH AND
             HEALTH POLICY, PINEY ASSOCIATES, BETHESDA, MD

        Mr. Henningfield. Mr. Chairman and members of the
    committee, thank you for the opportunity to testify and 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. H.R. 1108 is
    vital to get FDA off the bench and onto the field to help
    address a category of product that kills more than 400,000
    Americans every year.
        Many people do not understand how FDA could help prevent
    tobacco use, addiction and related diseases. Let me help you to
    understand. Many people think of tobacco products as relatively
    simple concoctions of tobacco and flavorings that people smoke
    for simple pleasure, with full awareness of the dangers, and
    that smoking is a completely free choice. But 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 regulatory oversight to
    draw the line on practices that unnecessarily increase harmful
    and addictive effects. Over time, FDA authority could lead to
    less addictive and less harmful products and regulation of
    marketing to reduce deception.
        Existing and future tobacco products need to be regulated.
    Existing products are used by more than 50 million Americans,
    killing more than 1,000 every day. Setting standards for
    chemicals that can heighten addictiveness such as ammonia and
    acetaldehyde and flavorings such as menthol, chocolate, cherry,
    honey and others could be steps towards less addictive and less
    attractive tobacco products. Developing performance standards
    for toxicants such as heavy metals, arsenic, tobacco-specific
    nitrosamines, carbon monoxide, formaldehyde could reduce toxin
    exposure to 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 they left my throat raw compared to lights. Let me
    tell you a few things she didn't know. She assumed there were
    Government standards. She thought they were regulated. She
    thought there were standards for light cigarettes. She thought
    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 a 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 have really good eyes. If you tear the paper
    from a cigarette filter and hold it to a light, you can see
    bands of tiny holes about three-eighths to one-half inch from
    the end. This is right where they can be easily covered by
    fingertips or lips and unbeknownst to most smokers, blocking
    some of the holes can easily double or triple delivered tar and
    nicotine. I did a demonstration on this a few years ago for my
    son's third grade class, and his classmates reacted with
    clarity and passion. Their comments included ``that is
    cheating. They can't do that.'' That is cheating and there is a
    means of stopping it and preventing such deception for food
    products, for dog food, and for drugs but not for tobacco, not
    until tobacco is regulated by FDA.
        New generations of products appear to be following the same
    commercially effective model of light cigarettes. Lights are
    just the tip of the iceberg, and new products and new marketing
    campaigns are used to assuage fears about tobacco so as to hook
    more people and to keep those who are using to keep using.
    These products will need their own standards and they will need
    standards that are studied and developed before the products
    are allowed to be marketed so that marketing does not
    inappropriately promote use. FDA is the right agency and the
    only agency with appropriate experience to develop and enforce
    product performance standards. FDA was designed to assess
    safety in ingredients and resultant toxicant exposures for a
    broad range of products. Furthermore, tobacco products are drug
    delivery systems at heart. Even the tobacco industry admits
    this in their own documents. Moreover, tobacco products are
    designed to heighten and deceive and heighten addiction risk.
        Finally, let me emphasize that FDA authority will not make
    tobacco products safe, is not the answer to American's tobacco
    problem in its own right. It should not be seen as a substitute
    for comprehensive tobacco control efforts. In fact, FDA
    regulation should be viewed as a partner in tobacco. The bill
    will bring the most sophisticated health regulatory body in the
    world to the table finally in partnership with tobacco control
    experts seeking to reduce tobacco use and prevent it in
    children. FDA will then be positioned to serve these efforts
    because it will restrict the ability of the industry to modify
    their products, use descriptors and marketing that undermine
    prevention and cessation. I therefore urge expeditious passage
    and implementation of the Family Smoking Prevention and Control
    Act. Thank you very much.
        [The prepared statement of Mr. Henningfield follows:]

                       Statement of Jack E. Henningfield

        Thank you for the opportunity to testify on H.R. 1108, 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 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 US 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 one thousand 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 1700-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 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.
        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 H.R. 1108. 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 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 AmericansToday,
    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 that are intended to hide them. When the
    cigarettes are smoked according to the FTC method, the holes
    leak anywhere from about 20-90% 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.
        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
    manufactures 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 with 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 H.R. 1108.. I therefore urge
    its most expeditious passage and implementation.
                                  ----------

        Mr. Waxman. Thank you very much, Dr. Henningfield.
        Mr. Corr, I think the last time I chaired a hearing on
    tobacco, you were on this side, not that side. We are pleased
    to welcome you.

    STATEMENT OF WILLIAM V. CORR, EXECUTIVE DIRECTOR, CAMPAIGN FOR
                           TOBACCO-FREE KIDS.

        Mr. Corr. Thank you, Mr. Chairman, very much for those
    remarks, and Mr. Sullivan, thank you both for your patience. We
    know this has been a long day and we appreciate you giving us
    the opportunity to testify.
        This legislation, Mr. Chairman, as you know, and its
    predecessor bills have been under consideration and evaluation
    in multiple Congresses. In this Congress, this legislation has
    200 cosponsors. The public overwhelmingly supports this bill.
    Five hundred and nineteen public health medical and faith
    organizations support it. As you heard this morning, the
    Institute of Medicine has recommended it, and the President's
    cancer panel in August recommended that FDA be given the
    authority to regulate tobacco products.
        You have heard from other witnesses about the tobacco
    company's behavior. I would like to take just a moment to show
    you what it looks like. Tobacco companies design and market
    products to influence and addict our children. The company's
    business model in fact, depends upon the addiction of children
    to replace the lifetime customers who die each year. Please
    look at these couple of ads and consider who they are designed
    to attract. This first one, it is hard to see possibly but it
    is ``back to school special.'' If you look in the lower right-
    hand corner, you will see a hand with chalk writing on the
    board. The key question is this designed for adults who want to
    switch brands or is this designed for our children? Here are
    some ads that as you will see are on a Good Humor ice cream
    freezer, and here is an ad that appeared in Sports Illustrated
    in 2006.
        Consider also flavored products. Who are these ads for? It
    may be hard to see but the ad is Camel, pleasure to burn. And
    this is Liquid Zoo coming in any number of flavors--coconut,
    chocolate, strawberry, mint. Again, who are these products
    designed for, switching adults or for children? And as just was
    pointed out, the companies are still marketing light and low-
    tar products with their implied health benefits, even though
    the companies know well that there are no health benefits.
        Beyond these marketing abuses, tobacco companies manipulate
    nicotine and other ingredients to assure addiction. They add
    and delete additives without oversight, even though some of
    them are addicting or deadly. These slides, if I may, involve
    the companies' claims of reduced-risk products to show you how
    they have designed deceptive marketing that misleads adult
    users in order to keep them as customers. This first ad
    compares the carcinogen levels and the claim is made that with
    Eclipse there is an 80 percent reduction in carcinogens. There
    is no evidence to back this up. There is no regulatory agency
    with objective scientific credentials to evaluate these claims.
    In the next ad for Omni, you will see reduced carcinogens,
    premium taste, and the company claims they are introducing the
    first cigarette to significantly reduce the major causes of
    lung cancer in smokers. These kinds of claims are going totally
    unregulated. And last, beyond these marketing abuses, companies
    are manipulating the ingredients.
        This is a list of possible, probable and known cancer-
    causing chemicals in cigarette smoke. There are over 60 known
    carcinogens in cigarette smoke. Some of these can be easily
    removed in the manufacturing process but have not been because
    it is entirely at the discretion of the companies.
        Regulating tobacco company marketing and advertising and
    regulating the content of tobacco products are two of the key
    authorities that are contained in this legislation that are
    urgently needed. Mr. Chairman, FDA is the only agency that can
    carry out the responsibilities of this legislation. It is the
    only Federal agency that combines scientific expertise,
    regulatory expertise and a public health mandate. No other
    Federal agency combines these three essential capabilities.
        In light of this kind of industry behavior and recognizing
    that only FDA has the ability to implement this legislation, I
    would like to comment very quickly on something Commissioner
    von Eschenbach said in his written testimony. He said, ``We are
    concerned that the public will believe that products approved
    by the agency are safe and that this will actually encourage
    individuals to smoke more rather than less.'' As was pointed
    out earlier, the current status quo allows the public to be
    mislead repeatedly by the companies with misleading ads like
    ``light and low tar.'' But more importantly, what I want to
    bring to the committee's attention is that there are provisions
    in H.R. 1108 that address this very issue. The bill authorizes
    FDA to stop any statement by the companies that would mislead
    the public like being ``FDA approved.'' The bill mandates new
    warnings covering the top 30 percent of the front and back of
    the pack. This is a mockup of what Camel No. 9 would look like
    with such a written warning, and FDA has the authority under
    the bill to expand this to 50 percent of the top, front and
    back of the product and to use graphic pictures. So imagine a
    consumer picking up a pack of cigarettes with half of the pack
    a diseased lung, and the question is, is this a Government
    stamp of approval?
        Just to point out to you as well, the Senate HELP Committee
    added additional provisions because they also addressed this
    issue as it came up in their markup. They have added a
    congressional finding and they added an explicit prohibition on
    company statements implying that FDA has regulated their
    products.
        Mr. Chairman, I realize that my time is expired. I wanted
    to make some other remarks about the testimony of the retailers
    but we will add those for the record.
        [The prepared statement of Mr. Corr follows:]

                          Testimony of William V. Corr

         Chairman Pallone, Ranking Member Deal, and members of the
    Health Subcommittee, thank you for this opportunity to testify
    in support of H.R. 1108, 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 Bill Corr, and I
    am the Executive Director of the Campaign for Tobacco-Free
    Kids, the Nation's largest non-profit, advocacy organization
    solely devoted to reducing the harm caused by tobacco use and
    exposure to secondhand smoke.
         H.R. 1108 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. Far from being the excessive regulation
    that some have claimed, this carefully crafted, thoughtfully
    balanced legislation would correct the glaring absence of
    regulation of tobacco products 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, H.R. 1108 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 H.R. 1108 has been before the Congress for close to a
    decade. A bill virtually identical to H.R. 1108 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 two-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. The Court commented that ``tobacco use,
    particularly among children and adolescents, poses perhaps the
    single most significant threat to public health in the United
    States.''
         In May of this year the Institute of Medicine issued a
    report, ``Ending the Tobacco Problem--a Blueprint for the
    Nation,'' in which it strongly recommends that Congress enact
    the pending legislation granting FDA broad regulatory authority
    over the manufacture, distribution, marketing and use of
    tobacco products. In addition, the President's Cancer Panel
    issued a new report in August with a call to action on how to
    significantly reduce tobacco use and its devastating toll in
    the United States and around the world. The report of this
    prestigious panel of national experts appointed by the
    President, including Dr. LaSalle Leffall of the Howard
    University College of Medicine, Lance Armstrong and Dr.
    Margaret Kripke of The University of Texas M.D. Anderson Cancer
    Center, concluded: ``The Panel recommends foremost that the
    influence of the tobacco industry--particularly on America's
    children--be weakened through strict Federal regulation of
    tobacco products sales and marketing.''
         Thus, it is no surprise that H.R. 1108 has broad
    bipartisan support including liberals and conservatives and
    Representatives from every geographic region of the country. It
    has been endorsed by every major national public health
    organization, many organizations representing health care
    providers (see attached letter), 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 from 70
    percent of voters in a national poll. State surveys from around
    the country have consistently found similar 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 whether tobacco companies should be required to take
    measures to make cigarettes less harmful; whether tobacco
    companies should be prevented from making claims that some
    products are less harmful than others unless FDA determines
    those claims are true; or whether 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

         H.R. 1108 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 1200 people every
    day. The critical word is ``prematurely.'' Fifty percent of the
    people who die from tobacco die in middle age.
         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. The fact is
    that almost 80 percent of the adults who smoke began their
    deadly habit before age 18.
         While some hoped that the 1998 Master Settlement Agreement
    (MSA) would end tobacco marketing to children, in August 2006,
    Federal District Court Judge Gladys Kessler found tobacco
    companies liable for engaging in a 50-year conspiracy to
    defraud the American public--which included continuing to
    market in ways that appeal to young people and continuing 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 2005, the latest year for which data are available, the
    major cigarette companies almost doubled their marketing and
    promotional expenditures from $6.73 billion to a staggering
    $13.1 billion--more than $35 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 twenty-one, as well as those under
    eighteen. 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 that
    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 its 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 influences 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 towards 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 doubled its marketing expenditures with
    knowledge of the impact of its marketing on children; continued
    marketing ``light'' and ``low tar'' cigarettes despite clear
    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 two-year investigation, impact tobacco use by children. It
    also 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
    drugs and medical devices 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.
         A perfect example is the marketing of smokeless tobacco
    products to children. Smokeless tobacco companies in the United
    States have a long history of creating new products that appeal
    to kids and marketing them aggressively to children, including
    adding candy flavors. Even after the Smokeless Tobacco Master
    Settlement Agreement, smokeless tobacco companies continued to
    advertise heavily in magazines with high youth readership and
    to market to youth through a number of channels, including
    sports events like auto racing and rodeos that are widely
    attended by children. Since 1970, smokeless tobacco has gone
    from a product used primarily by older men to one used
    predominantly by young boys. In 2005, the most recent year for
    which FTC data is available, the total marketing expenditures
    of the top five smokeless tobacco companies in the U.S. were
    more than $250 million.
         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 H.R. 1108 are consistent with the Supreme Court's
    analysis in Lorillard 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\
    ---------------------------------------------------------------------------
        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/.
    ---------------------------------------------------------------------------
         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.
         No Federal agency currently has the authority to require
    tobacco companies to disclose, in a meaningful way, what is in
    each product; 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. H.R. 1108 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. H.R. 1108 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 non-users'' 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\
    ---------------------------------------------------------------------------
        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 H.R. 1108 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 non-smokers to start. The goal is protecting the
    pubic and saving lives, and the standard set forth in H.R. 1108
    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
    towards 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 non-tobacco users to
    start or discourage 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.
         This bill does hold store owners responsible for illegal
    tobacco sales to children, a policy supported by 87 percent of
    voters, but 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.
         During consideration of this legislation by the Senate
    HELP Committee, additional provisions were added by the
    Committee to accommodate the concerns of retailers. Those
    provisions include: clarifying that retailers receive formal
    notice of violations; establishing a graduated system of fines
    for violations that eliminates uncertainty for retailers;
    mandating the provision of a hearing by phone or at a nearby
    facility; and a number of other procedural protections. The
    public health community has not opposed any of these
    accommodations.
        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 bill responds to these concerns by
    providing new resources for FDA to create a new office and hire
    new, 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.
         Recognizing that the tobacco responsibilities should be
    implemented by new staff, the Senate HELP Committee, during its
    consideration of the legislation, created a new center for
    tobacco products to carry out the purposes of this legislation.
    This provision was designed to clarify the intent of the bill's
    authors that FDA authority over tobacco products will not
    interfere with other FDA activities.

              FDA Is the Right Agency to Regulate Tobacco Products

        Some have argued that the FDA is not the right agency to
    regulate tobacco products, but that is essentially an argument
    for no regulation of tobacco products at all. It is an argument
    for the continuation of the unacceptable status quo in which
    tobacco products kill more than 400,000 people in the United
    States each year. This is because FDA is the only agency with
    the scientific expertise and regulatory experience to
    effectively regulate tobacco products to reduce the death and
    disease they cause.
         There is no question that tobacco products are uniquely
    lethal and different from any other product on the market. In
    fact, if tobacco products were introduced for the first time
    today, they wouldn't be allowed on the market at all. But the
    reality is there are nearly 50 million addicted tobacco users
    in the United States and public health experts recognize it is
    not feasible to ban tobacco products. The question then is
    this: What government agency is best qualified to regulate this
    dangerous product to reduce the death and disease it causes?
    The FDA is the only agency that can do the job well.
         Some have argued that other Federal agencies, such as the
    Federal Trade Commission (FTC), the Centers for Disease Control
    and Prevention (CDC), the National Institutes of Health (NIH),
    the Environmental Protection Agency (EPA), or even the
    Agriculture or Treasury Departments (USDA/DOT) would be more
    appropriate to handle the job of tobacco product regulation.
    But the FDA is a public health regulatory agency, and the
    others are not. The FTC's primary orientation is law
    enforcement and broad consumer protection; the NIH's is
    research; the CDC is primarily focused on preventing disease
    outbreaks, injury and disability. EPA works to develop and
    enforce regulations that implement environmental laws enacted
    by Congress; the Alcohol and Tobacco Tax and Trade Bureau at
    the Treasury Department describes its mission as ``to collect
    taxes owed;'' and USDA is primarily involved with the business
    of farming, not in overseeing non-food manufactured products
    such as cigarettes.
         These other agencies do not have the requisite expertise
    to regulate the design and content of tobacco products or to
    know about the accuracy of health claims about these products.
    The FTC, for example is, by its own admission, an ``agency of
    lawyers and economists'' and is not a science-based agency. The
    FDA is the only agency with the scientific expertise,
    regulatory experience and skills, and public health mission to
    effectively regulate tobacco products and the health claims
    about them.
        Impact on Tobacco Companies: Some tobacco companies have
    argued that this bill will give an advantage to one tobacco
    manufacturer over others, that some tobacco companies cannot
    comply with stringent FDA regulations and that industry leaders
    will benefit by the bill's restriction of tobacco marketing.
    None of these arguments have 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.
         That said, it should be noted that H.R. 1108 contains
    several provisions that consider small manufacturers''
    resources and take into account that they may need more time
    and technical assistance to comply, including making clear that
    FDA should take into account the financial resources of the
    different manufacturers in setting effective dates for good
    manufacturing standards, and that FDA should minimize,
    consistent with the public health, economic loss to domestic
    and international trade.
         In addition, the Senate HELP Committee went even further
    during its consideration of the legislation, creating a special
    office within FDA tasked with providing assistance to small
    tobacco product manufacturers. The Senate Committee also added
    a representative of small manufacturers to the Tobacco Products
    Advisory Committee as a non-voting member.
         The bill's marketing restrictions are also fair and
    balanced. Today, close to 90 percent of all new long term
    smokers began as 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 and promotion. 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 forty 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.
         Mr. Chairman, in summary, the Campaign strongly supports
    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.

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        Mr. Waxman. Thank you very much. We will be pleased to add
    any further comments you have for the record.
        Before we start questioning, let me indicate that two of
    our witnesses had to leave to do another engagement so members
    of the committee will be afforded the opportunity to submit
    questions in writing to any of our witnesses after the hearing
    and of course for those of you here, we would welcome you to
    respond to those questions.
        Let me start off with Dr. Henningfield. Dr. Blum and others
    have raised concerns about the authority given to FDA under the
    bill to regulate the design and contents of cigarettes. Some
    have suggested that tinkering with the ingredients in a
    cigarette in the hopes of making it less dangerous is a fool's
    errand and that it amounts to conducting R&D for the tobacco
    industry while misleading consumers into thinking that
    cigarettes are safe. Do you agree with that assessment?
        Mr. Henningfield. No, I don't. Currently, we know that even
    an old-fashioned simple cigarette is deadly and addictive just
    like an old-fashioned muzzle-loading rifle is deadly. Modern
    cigarettes are more like armor-piercing bullets with laser
    guidance and rapid fire. That is the difference and that is
    part of the reason, for example, why police departments often
    oppose armor-piercing bullets: they kill more people more
    rapidly. Modern cigarettes are designed with a lot of different
    kinds of innovations, chemical and physical, to increase their
    ability to pierce the armor. Last night I looked at a Camel
    snus Web site where it explained that the pleasure occurs about
    5 minutes after you put the snus in your mouth. Snus is a type
    of oral smokeless tobacco product. Now, the flavor, which I
    thought they used to say is where the pleasure was, occurs as
    soon as you put it in the mouth. They have obviously designed
    it to deliver the nicotine to the brain in about 5 minutes.
    That is by design, and in my experience, that was designed to
    be very effective at hooking people.
        Mr. Waxman. Well, what would you think about the idea of
    lowering or even eliminating the nicotine in cigarettes
    completely? Would it reduce or--I know the bill wouldn't allow
    nicotine to be completely eliminated, but with respect to
    reducing the nicotine to extremely low levels, is there any
    scientific evidence that there is a level of nicotine below
    which it is no longer addictive?
        Mr. Henningfield. We know that there is a threshold and
    people that have looked at this agree. Whether or not lowering
    nicotine over time is something that could or should be done is
    another question. I believe that FDA needs to have the
    authority to do that but I myself who have argued how that
    could work have argued in my writings with others that before
    you would implement such a policy, we need a lot of things in
    its place including treatment, including more research as to
    how to do it. So I think the agency should have the authority.
    The tobacco industry itself has argued that that would be
    tantamount to prohibition. They understand the power of
    nicotine to addict. So I don't think it is something FDA should
    launch as a first effort. I concur with the FDA's own
    conclusion in the 1990s on this matter.
        Mr. Waxman. Mr. Corr, let me follow up that question with
    you. I am interested in how well you think the bill would
    address a complex scientific issue like regulating nicotine
    levels. I know that some have raised concerns that if FDA
    lowered the amount of nicotine in cigarettes, consumers would
    simply smoke more or inhale more deeply, possibly endangering
    their health more than if the levels had remained the same. Is
    this really a danger, and under this bill, would FDA be
    required to order a change in nicotine levels if there was
    evidence that it would cause people to smoke more or inhale
    more deeply to get the nicotine they need out of the cigarette?
        Mr. Corr. Mr. Chairman, this legislation gives FDA the
    authority it needs to make science-based public health
    decisions. The standard for many of its decisions will be
    appropriate for the protection of public health. In the
    instance you are talking about, FDA would have to make a
    decision based on the science as to what level of--what the
    consequences might be, as Dr. Henningfield just said, of
    reducing nicotine. There are no mandates with regard to
    nicotine levels in this bill. There is simply authority for the
    agency to act consistent with public health.
        Mr. Waxman. And you would disagree with Dr. von Eschenbach
    when he says that there is little science available to FDA on
    which to base decisions on tobacco product standards. He
    doesn't think for that reason that FDA ought to have
    jurisdiction. You made it very clear in your presentation that
    you thought FDA was the place to have this regulatory agency. I
    guess he is fearful that they don't have the science at that
    agency. How would you respond?
        Mr. Corr. This legislation would anticipate that FDA would
    act based upon sound science. They would have the regulatory
    authority and the mandate to protect public health. Dr.
    Henningfield can speak to the state of current science but the
    agency's responsibility would be to compile the science and to
    make sound public health decisions. Once again, the bill does
    not mandate any particular action with regard to product
    standards. It simply gives the agency the authority to protect
    public health.
        Mr. Waxman. Thank you very much.
        I want to yield to my colleague.
        Mr. Sullivan. Thank you, Mr. Chairman, and I want to thank
    the witnesses for being here today and we all I think can agree
    that we don't want kids smoking and we want to do all we can to
    make sure they don't. I think everyone wants that. We don't
    want kids buying cigarettes. We hope they don't even start. We
    don't want any kid to start down that path but this is a big
    issue about the regulatory efforts of the agency to regulate
    this product, and I have a question for Mr. Ballin. Mr. Ballin,
    you have written extensively about the difference between
    combustible tobacco products, non-combustible tobacco products
    and alternative nicotine products. Does the legislation before
    us today adequately reflect those differences, and if not, how
    could it be improved to do so?
        Mr. Ballin. Well, in the testimony I have submitted, we
    have suggested that it might be more appropriate for all
    nicotine and tobacco products to be brought under one umbrella
    and that we address the overlapping regulatory issues for
    combustible products, non-combustible products and also the
    therapeutic products so that we can label things according to
    risk and relative risk, restrict advertising and marketing of
    those products based on risks and relative risks so that the
    consumer for the first time when they go into the CVS and look
    at that wall of all those various products will understand what
    those products do and do not do. We are far from that because
    there have been certain scientific research studies that when
    people are asked what is more dangerous, they get it all wrong.
    A lot of people think smokeless products are a lot more
    dangerous than cigarettes. They also think that some of the
    nicotine replacement therapies are more dangerous than
    cigarettes. We have got a lot of sorting out to do with respect
    to making sure that consumers are fully educated, understand
    the risks and relative risks of the products available to them.
        Mr. Sullivan. And also in your view, does this bill provide
    adequate incentives for the industry to develop reduced-risk
    products like smokeless tobacco?
        Mr. Ballin. Well, I think one of the things that we have
    suggested but it is not our suggestion, it was the Institute of
    Medicine as well as others, that there have to be incentives
    for industry, and I am not just talking about the tobacco
    industry. I am also talking about giving incentives to
    pharmaceutical companies and other biotech companies who are
    working in these areas to develop these products. I didn't see
    much in the bill that does that. I think there needs to be
    greater encouragement with regulatory oversight. You have to
    have the oversight in order to be able to do it effectively.
    You just can't say go do this because we are going to end up
    along the same lines that Dr. Henningfield has mentioned, going
    down the low-tar, low-nicotine road. You have got to have
    regulation but we also have to give incentives for companies to
    change their behaviors.
        Mr. Sullivan. Thank you.
        And Mr. Armour, in your opinion, does H.R. 1108 give
    massive new authority to the FDA to regulate the retailing of
    tobacco products? I know that socially responsible retailers go
    to great lengths to assure their employees do not make illegal
    sales. States already regulate retail outlets so they can be
    given standards to follow without adding huge costs. Is this
    not the case if FDA regulates retail sales correctly?
        Mr. Armour. Congressman, the short answer is yes. As you
    saw from the chart, the States have done an excellent job in
    reducing non-compliance since 1997 and I think in the testimony
    this morning, it was pointed out that there were State by State
    interesting ways to reduce youth access to tobacco and our
    concern is by creating an entirely new bureaucracy at FDA
    duplicating State efforts that we are going to replace or put a
    whole other system there that interferes with what has been an
    effective system. I think it is important, as I said in my
    testimony, we don't oppose it at all. We take no position on
    FDA regulation of the manufacturing process of cigarettes. We
    do have problems with H.R. 1108 with respect to retailing
    because we think at State level it has been done effectively.
    We think that the Federal Government can set standards as it
    did in the Synar amendment to further reduce youth access to
    tobacco.
        Mr. Sullivan. Thank you very much. I appreciate that. I
    think that was a good answer. I appreciate it. Thank you.
        I yield back.
        Mr. Waxman. Thank you very much.
        Mrs. Capps.
        Mrs. Capps. Thank you, Mr. Chairman, and Mr. Corr, thank
    you, each of you. This has been a long day for you and some of
    us have had to come and go, but I believe the topic is of such
    importance that I am glad you stayed and thank you very much
    for the testimony each of you have given.
        Mr. Corr, I am interested in learning a little bit more
    from you how this legislation would impact the labeling for a
    product like Camel No. 9 which clearly targets young women and
    girls. You referred to it in your testimony, and I don't know
    if you remember way back to the opening statements but we will
    get the charts up again, and I am co-chair now of the
    Congressional Caucus for Women's Issues and several of us, and
    not just us, have made it a point to become involved in this
    issue that does directly relate to, we feel, enticing new
    consumers of tobacco. It is my understanding that the
    legislation before us would require the removal of terms such
    as ``light'' and ``low'' and ``mild'' which have misled smokers
    into believing that these products might be less risky or less
    harmful than other regular cigarettes. Is that correct?
        Mr. Corr. That is correct, Congresswoman Capps.
        Mrs. Capps. And there seems to be a lot of bright pink in
    the advertising on the packaging for Camel No. 9. I would think
    that the use of pink coloring and terms such as ``luscious''
    would be directed toward attracting young girls to this
    product. I wonder if you have, because your organization does
    target young children and teenagers and hoping that they don't
    smoke and working toward that goal, would this legislation do
    anything about the colors? Could it be useful to structure the
    advertising such as is used now in the magazines that young
    women are attracted to for Camel No. 9 as one example of the
    kind of packaging and promotional materials? Would it do
    anything about the use of terms such as ``luscious''?
        Mr. Corr. Congresswoman, the legislation as you pointed out
    does ban terms like ``light,'' ``low'' and ``mild.'' It also
    gives FDA the authority to consider other aspects of
    advertising and marketing and its impact on young people. For
    example, based on evidence that terms like ``luscious,''
    colors, imagery were being used in a way that influenced and
    attracted young people, the agency would have the authority to
    prohibit that.
        Mrs. Capps. And in your work with young children, have you
    determined that they are vulnerable to, they are easily
    persuaded by such colors and use of such language?
        Mr. Corr. There is a well-established record to that
    effect. It is why the FDA in its 1996 rule requires that all
    advertising and promotion in publications, at point of sale,
    and on outdoor billboards would be black-and-white text only;
    removes the imagery and colors that are so attractive to young
    people. It still allows, as Mr. Bonnie pointed out this
    morning, the companies to continue to communicate other
    information to adults consistent with the first amendment.
        Mrs. Capps. Well, I took it upon myself to, as I was
    waiting in line at the grocery store to pick up a magazine like
    this one and thumbing through it like we are inclined to and I
    have seen a lot of young kids doing the same kind of mimicking
    their parents or the older adults that they are with but when
    you turn to a page like this, and you see it blown up there,
    but this is what it looks like in this month's issue of Glamour
    magazine, and I don't mean to pick on them particularly but
    they are one of several women's magazines that run these very
    ads and have been doing so now for several months right around
    back-to-school time. This ad over here is the one that is very
    deceptive because it is called Dress to the Nines. You notice
    this fashionable shoe is replicated in the word ``stiletto''
    over here and if you look down here to see where you can get
    some of this free stuff, you are directed to camelsmokes.com.
    There are two pages worth of tobacco advertising right here and
    if you thumb through, this page looks like several other pages
    of fashion layouts in a magazine that is known for this. Young
    kids are thinking about what to buy. When they go back to
    school, they want to look like the big girls and this is what
    they pick up.
        Mr. Corr. In the absence of FDA regulation, you and others
    have raised this to the attention, the consciousness of the
    American people and to these magazines. Possibly they will stop
    it. It is just a matter of time before you see another kind of
    advertising like this that they will come up with. It is why it
    is imperative that the FDA have the authority on an ongoing
    basis to evaluate and regulate advertising and promotion to
    protect public health.
        Mrs. Capps. Thank you. I understand that when Camel No. 9
    was launched, promotional events were planned in several States
    to generate interest in the new cigarette. At these events,
    women were given pink-colored goody bags with promotional
    items, many with the Camel logo on them, including makeup, hand
    lotion and even cell phone jewelry, which is typically used not
    by career women but by teenagers, teenage girls. It is my
    understanding that under this legislation, FDA would be allowed
    to restrict these types of giveaways. Is this true?
        Mr. Corr. Yes, it is, Congresswoman. Any kind of brand name
    on these products, recognizable patterns of color, those types
    of things would be prohibited.
        Mrs. Capps. There is a history with this with Joe Camel,
    right?
        Mr. Corr. There is a long history with this.
        Mrs. Capps. Thank you very much all of you.
        I yield back.
        Mr. Waxman. Thank you, Mrs. Capps.
        Mr. Deal.
        Mr. Deal. Thank you, Mr. Waxman.
        I apologize to the panel members for not having been here
    for hearing all of your testimony. We had an important bill on
    the floor of the House that we have been debating and that is
    where I was. And I will not bore you with further questions
    because I don't know what you have already answered and I would
    certainly not want to be duplicative of questions you have
    already entertained.
        Mr. Chairman, I would ask unanimous consent that the
    written testimony from the chairman of Phillip Morris USA be
    included in the record.
        Mr. Waxman. Without objection.
        Mr. Deal. Let me just say though to all of you that
    obviously there are some different points of view that have
    been expressed both by others as they looked at the
    legislation. I do think it is helpful for us to hear those
    concerns, if possible to have the legislation address those
    concerns, and I thank Mr. Waxman for his willingness to listen
    to concerns and make concessions even prior to this hearing
    here today as this legislation was being crafted. I do thank
    all of you for taking your time and we regret that we prolonged
    your day with votes but that is just the nature of the beast
    here, and with that, I would yield back my time.
        Mr. Waxman. Thank you, Mr. Deal.
        I too want to join in thanking each of you for your
    presentation and willingness to wait this long day for this
    hearing and I want to continue to work with all of you on this
    legislation. We want to get the very best product because I
    think we all share the same goals.
        That concludes the hearing and we stand adjourned.
        [Whereupon, at 3:30 p.m., the subcommittee was adjourned.]
        [Material submitted for the record follows:]

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                          Statement of Mike Szymanczyk

            Chairman and Chief Executive Officer, Philip Morris USA

        On behalf of the nearly 11,000 employees of Philip Morris
    USA (PM--USA) I am very pleased to submit these remarks, and to
    express our strong support for H.R. 1108, legislation that
    would give the Food and Drug Administration (FDA) authority to
    regulate tobacco products. Almost five years after we announced
    our full support for FDA regulation, PM--USA remains committed
    to passage of comprehensive regulation of tobacco products.
    H.R. 1108 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.
        H.R. 1108 is the result of many difficult choices and
    compromises by all those who have been involved in this process
    over the last several years. 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 Congressman Waxman and Congressman Davis for the
    leadership they have shown on this issue. Likewise, we
    appreciate the leadership shown by Senator Kennedy and Senator
    Cornyn in introducing companion legislation in the United
    States Senate. We look forward to working with you and your
    colleagues in the Senate to enact this legislation 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. H.R. 1108 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.
        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, non-misleading
    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 invested in extensive research programs that focus
    on advancing our knowledge about tobacco and tobacco smoke to
    support our efforts to develop and launch new product designs.
    We believe these product technologies and related approaches
    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 and other potential
    harm reduction products must be acceptable to adult tobacco
    users. We see little benefit to consumers or society if harm
    reduction is not pursued in the context of tobacco products
    that adult consumers will enjoy using. As the 1998 Canadian
    Experts' Committee, which addressed potential harm reduction
    products for smokers, 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, H.R. 1108 grants the agency an essential role
    in performing its own assessment and oversight of 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
    H.R. 1108 correctly gives FDA jurisdiction over communications
    to consumers. Future FDA regulations should ensure that
    consumers are not mistakenly led to believe that the use of a
    particular tobacco product reduces the health risks as much as
    quitting. At the same time, we do not believe future
    regulations should be utilized as a tool to suppress
    information that is truthful and not misleading.
        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 using tobacco products. 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. PM--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 facts of reduced
    exposure or reduced risk products and the potential benefits of
    such products. Section 911 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 in its 2001
    report 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...'' We believe that approach is both good policy and
    required by the first amendment.

                  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.
        H.R. 1108 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.

                Section 901--FDA Authority Over Tobacco Products

        H.R. 1108 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.'' While
    the bill extends the scope of FDA's authority to all
    manufacturers of tobacco products selling tobacco products in
    the United States, it also makes clear that FDA does not have
    the authority to regulate tobacco growers. FDA will not be on
    the farm.

                    Section 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.

                 Section 904--Submission of Health Information

        The bill requires, within six months of passage, submission
    to the Secretary of documents and information concerning
    ingredients, compounds, paper, filter and other components of
    tobacco products as well as content, delivery and form of
    nicotine. PM 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.

                        Section 905--Annual Registration

        H.R. 1108 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.

     Section 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 three-year delay for
    compliance to ensure that manufacturers have ample opportunity
    to comply.

                         Section 907--Product Standards

        H.R. 1108 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 towards
    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.

                  Section 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 2001
    report, the lnstitute of Medicine 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
    H.R. 1108 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 2001 Institute of Medicine Report.

                             Section 920--User Fees

         H.R. 1108 requires the Secretary to require tobacco
    product manufacturers and importers to pay for providing,
    equipping and maintaining adequate service for regulating
    tobacco products. PM--USA believes the collection of such user
    fees is reasonable, assuming appropriate oversight and strict
    collection and enforcement by the agency.

              Section 102--Repromulgation of FDA's 1996 Final Rule

        Within 30 days of enactment of H.R. 1108 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 one 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 or different
    restrictions on the sale, distribution, advertising and
    promotion of tobacco products if the Secretary determines that
    the regulation would protect the public health and, as the bill
    specifies, the marketing and advertising restrictions are
    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 is important. 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.
         PM--USA will also work with FDA and other interested
    stakeholders to make sure that any advertising or marketing
    restrictions comport with the first amendment.

             Section 201--Cigarette Label and Advertising Warnings

        This section of H.R. 1108 specifies nine new warning labels
    required to appear on cigarette packages and advertisements.
    The warnings must comprise at least the top thirty-percent of
    the front and rear panels of the package, and at least twenty-
    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. PM--USA fully supports these provisions
    regarding the new warning labels and their size and placement.
    PM--USA also supports the grant of authority to FDA to modify
    or enlarge these warnings in the future through a rulemaking
    process where the potential benefits, risks and unintended
    consequences of such proposed changes will be thoroughly
    examined.
        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. We
    do not believe that H.R. 1108 is designed to, or would in fact,
    give any one tobacco company a commercial advantage over
    others, notwithstanding the assertions of some manufacturers.
    Tobacco companies know very well that the first amendment of
    the Constitution guarantees that the FDA could not ban tobacco
    product advertising. An appropriate and constitutionally sound
    regulation of tobacco products and advertisements would
    effectively ensure 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 constitutionally proper advertising or marketing
    restrictions 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 H.R. 1108, which represents a truly historic
    opportunity to establish a comprehensive and coherent national
    tobacco policy.