[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.

                                 
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