[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
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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
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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\
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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/.
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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\
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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.
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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.