<DOC>
[108th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:88721.wais]
POTENTIAL REDUCED EXPOSURE/REDUCED RISK TOBACCO PRODUCTS: AN
EXAMINATION OF THE POSSIBLE PUBLIC HEALTH IMPACT AND REGULATORY
CHALLENGES
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
__________
JUNE 3, 2003
__________
Serial No. 108-38
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
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WASHINGTON : 2003
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky DANNY K. DAVIS, Illinois
JO ANN DAVIS, Virginia JOHN F. TIERNEY, Massachusetts
TODD RUSSELL PLATTS, Pennsylvania WM. LACY CLAY, Missouri
CHRIS CANNON, Utah DIANE E. WATSON, California
ADAM H. PUTNAM, Florida STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia CHRIS VAN HOLLEN, Maryland
JOHN J. DUNCAN, Jr., Tennessee LINDA T. SANCHEZ, California
JOHN SULLIVAN, Oklahoma C.A. ``DUTCH'' RUPPERSBERGER,
NATHAN DEAL, Georgia Maryland
CANDICE S. MILLER, Michigan ELEANOR HOLMES NORTON, District of
TIM MURPHY, Pennsylvania Columbia
MICHAEL R. TURNER, Ohio JIM COOPER, Tennessee
JOHN R. CARTER, Texas CHRIS BELL, Texas
WILLIAM J. JANKLOW, South Dakota ------
MARSHA BLACKBURN, Tennessee BERNARD SANDERS, Vermont
(Independent)
Peter Sirh, Staff Director
Melissa Wojciak, Deputy Staff Director
Rob Borden, Parliamentarian
Teresa Austin, Chief Clerk
Philip M. Schiliro, Minority Staff Director
C O N T E N T S
----------
Page
Hearing held on June 3, 2003..................................... 1
Statement of:
Leischow, Scott, Chief, tobacco control research branch,
National Cancer Institute, National Institutes of Health;
Lee Peeler, Deputy Director, Bureau of Consumer Protection,
Federal Trade Commission; Robert Wallace, chairman of the
Committee to Assess the Science Base for Tobacco Harm
Reduction, Institute of Medicine/National Academy of
Sciences; and Kathleen Stratton, Institute of Medicine..... 30
Szymanczyck, Michael E., chairman and CEO, Philip Morris USA,
Inc.; Dorothy K. Hatsukami, professor, University of
Minnesota; Jack Henningfield, professor, Department of
Psychiatry and Behavioral, Johns Hopkins University School
of Medicine; Lynn T. Kozlowski, professor and head of
Department of Behavioral Health, Pennsylvania State
University; David T. Sweanor, senior legal counsel, Non-
Smokers' Rights Association; David M. Burns, professor, San
Diego School of Medicine, University of California; Richard
H. Verheij, executive vice president, U.S. Smokeless
Tobacco Co................................................. 75
Letters, statements, etc., submitted for the record by:
Bell, Hon. Chris, a Representative in Congress from the State
of Texas, prepared statement of............................ 323
Burns, David M., professor, San Diego School of Medicine,
University of California, prepared statement of............ 200
Davis, Chairman Tom, a Representative in Congress from the
State of Virginia, prepared statement of................... 5
Hatsukami, Dorothy K., professor, University of Minnesota,
prepared statement of...................................... 128
Henningfield, Jack, professor, Department of Psychiatry and
Behavioral, Johns Hopkins University School of Medicine,
prepared statement of...................................... 137
Kozlowski, Lynn T., professor and head of Department of
Behavioral Health, Pennsylvania State University, prepared
statement of............................................... 145
Leischow, Scott, Chief, tobacco control research branch,
National Cancer Institute, National Institutes of Health,
prepared statement of...................................... 33
Peeler, Lee, Deputy Director, Bureau of Consumer Protection,
Federal Trade Commission, prepared statement of............ 41
Sweanor, David T., senior legal counsel, Non-Smokers' Rights
Association, prepared statement of......................... 193
Szymanczyck, Michael E., chairman and CEO, Philip Morris USA,
Inc., prepared statement of................................ 78
Towns, Hon. Edolphus, a Representative in Congress from the
State of New York, prepared statement of................... 321
Verheij, Richard H., executive vice president, U.S. Smokeless
Tobacco Co., prepared statement of......................... 211
Wallace, Robert, chairman of the Committee to Assess the
Science Base for Tobacco Harm Reduction, Institute of
Medicine/National Academy of Sciences, prepared statement
of......................................................... 58
Waxman, Hon. Henry A., a Representative in Congress from the
State of California:
Letter dated June 3, 2003.................................... 297
Minority staff report........................................ 10
POTENTIAL REDUCED EXPOSURE/REDUCED RISK TOBACCO PRODUCTS: AN
EXAMINATION OF THE POSSIBLE PUBLIC HEALTH IMPACT AND REGULATORY
CHALLENGES
----------
TUESDAY, JUNE 3, 2003
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 2:01, in room
2154, Rayburn House Office Building, Hon. Tom Davis (chairman
of the committee) presiding.
Present: Representatives Tom Davis of Virginia, Shays,
McHugh, Ose, Lewis, Platts, Putnam, Schrock, Duncan, Sullivan,
Carter, Janklow, Blackburn, Waxman, Towns, Maloney, Cummings,
Kucinich, Tierney, Clay, Watson, Van Hollen, Ruppersberger,
Norton, and Bell.
Staff present: Peter Sirh, staff director; Melissa Wojciak,
deputy staff director; Bill Womack, legislative director, Keith
Ausbrook, chief counsel; Jim Moore, counsel; David Marin,
director of communications; Scott Kopple, deputy director of
communications; Teresa Austin, chief clerk; Joshua E.
Gillespie, deputy clerk; Susie Schulte, legislative assistant,
Corinne Zaccagnini, chief information officer; Phil Barnett,
minority chief counsel; Kristin Amerling, minority deputy chief
counsel; Althea Gregory, minority counsel; Karen Lightfoot,
minority communications director/senior policy advisor; Josh
Sharfstein, minority professional staff member; Earley Green,
minority chief clerk; Jean Gosa, minority assistant clerk; and
Cecelia Morton, minority office manager.
Chairman Tom Davis. The committee will come to order.
Tobacco smoke is the cause of a great many illnesses, among
them, cancer, cardiovascular disease and stroke. Indeed, over
400,000 Americans die every year from tobacco-related illness,
the leading preventable cause of death. Imagine if this same
number of people died from a communicable disease such as SARS
or smallpox. The mere threat of such illnesses has been
sufficient to garner far greater public attention and response.
We are left with the question of how best to respond to
this situation. While smoking rates steadily declined from the
1960's to the end of the 1980's, we have reached something of a
plateau since the early 1990's. According to the most recent
figures, approximately one quarter of the adult population
smokes, 47 million people. Of this number, 70 percent express a
desire to quit. While 34 percent of this number will make an
attempt to do so annually, less than 3 percent will succeed.
These numbers beg the question of whether current approaches to
controlling tobacco-related morbidity and mortality are
sufficient.
In recent years, we have seen pharmaceutical products such
as the patch and nicotine gum emerge as cessation aids. We are
also seeing the emergence of the harm-reduction tobacco market.
That is, products that aim to decrease harm to health from
tobacco use without completely eliminating it. This latter form
of product is largely unregulated, and there are questions
whether these products, which give the impression of being a
safer alternative to conventional cigarettes, are in the public
interest.
In 1999, the Food and Drug Administration requested the
Institute of Medicine [IOM], to conduct a thorough study into
tobacco harm reduction products. In 2001, IOM published the
seminal work on the subject entitled, ``Clearing the Smoke,
Assessing the Science Base for Tobacco Harm Reduction.'' It is
this study and its recommendations that serves as the basis for
today's hearing.
Clearing the Smoke makes a number of recommendations and
sets out a number of principles for the ideal regulatory scheme
to oversee harm reduction products, referred to as potential
reduced risk products [PREPs], in tobacco in general. However,
as I read the study, the take-away messages are these.
First, it is feasible but not easy to produce tobacco
products that could expose a consumer to lower level of toxins
than conventional cigarettes. Second, it is possible that
reduced exposure to these toxins could reduce the risk of
tobacco-related disease and death. Third, great care must be
taken to ensure these products don't result in increased harm
to individuals and to the public's health in general.
Said another way, harm reduction presents both promise and
uncertainty. There is still much that we don't know about
tobacco-related illness, nor do we fully understand why people
smoke cigarettes in the first place. Finding the answer to
these questions is a critical component in harm reduction
efforts.
Tobacco harm reduction is not without its critics. As I
mentioned earlier, the core concern with these products is that
while they may be able to remove a degree of the risk from the
individual user, the notion of a safe product could prove
damaging to the population as a whole. Smokers who might
otherwise quit altogether could instead opt to use the safer
products. In addition, those who have already quit smoking
could be enticed to start anew.
Finally, children, a group already convinced of their own
invincibility, could be drawn to a life of tobacco dependency
by the lure of safe tobacco.
History bears out these concerns. Earlier attempts at harm
reduction, most notably the advent of the filtered cigarette
later followed by low yield cigarettes, were heralded by the
public health community. However, time has shown that these
were false hopes. All the vast majority of cigarettes today are
filtered. There has been no discernible decrease in morbidity
or mortality. Similarly, while low tar cigarettes may have
produced lower toxins as measured by an automated device, human
consumers changed their smoking behavior by inhaling more
deeply, for example, to leach out the same nicotine and tar
levels found in other cigarettes.
In the wake of these products, smoking rates increased and
public health suffered. To this day, most smokers use light or
low-tar products despite the information available that they
offer little if any improvement over other products. The
perception of safety is hard to break.
These concerns are well taken and must be given due
consideration as we move forward. However, given the fact that
a significant number of people will continue to use tobacco for
the foreseeable future, I am not of the opinion that these
concerns merit abandoning tobacco harm reduction in favor of an
abstinence-only approach. That said, development of this
marketplace must take place in the proper regulatory
environment. A scientific agency, in my opinion, Food and Drug
Administration, should oversee all tobacco products, but
especially products intended to be sold for harm reduction
purposes.
Currently, our regulatory structure has been turned on its
ear. Based on the IOM study as well as works from a great many
experts, including some of those in our panel today, it seems
obvious that pharmaceutical nicotine therapies present the
least amount of risk of any potential reduced exposure product,
but they are subjected to the most stringent regulatory
examination. Perhaps as a result they are quite expensive and
there are few options available to the consumer. Ironically,
potential reduced-exposure products made from tobacco, which
are regarded as the most risky form of these products, are
subjected to little if any regulation at present. I think we
should not only look for ways to increase regulation of tobacco
products, but also ways in which the FDA can facilitate a
vibrant medicinal nicotine market.
Finally, I believe it is important to achieve balance in
our efforts at tobacco harm reduction. As the IOM states,
manufacturers must be given the incentive to develop and market
products that reduce exposure to tobacco toxicants and that
have a reasonable prospect of reducing the risk of tobacco-
related disease. This incentive comes in the form of being able
to communicate the message that a given product does just that.
These claims must be based on good science, but if the science
is there, undue skepticism of regulators should not discourage
development.
The facts are these: Many experts believe harm reduction
could play an important role in decreasing tobacco-related
disease and death. If this is to work and the American people
are to benefit, two parties with little regard for each other
are going to have to learn to co-exist.
Future regulators and public health officials need the
ingenuity and resources the industry can bring to bear to
create palatable, acceptable, and less risky products that
current smokers use. The industry needs independent government
regulators to validate its science and confirm the value of the
products they wish to market to the public. Anything less will
surely return us to the days of snake oil. We must be prepared
to work past old notions regarding tobacco products. In this
vein, we will consider today the role smokeless tobacco plays
in this debate. Some believe there is scientific evidence that
smokeless does in fact represent a significant decrease in risk
compared to conventional cigarettes. If this is so, what do we
do with this information?
In closing, there are a great many questions to be answered
regarding potential reduced exposure products. We have
constructed two panels today that I believe will help us
understand many of the relevant issues, and I very much look
forward to today's hearing. I welcome all the witnesses to
today's hearing, and I look forward to hearing their testimony.
[The prepared statement of Chairman Tom Davis follows:]
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Chairman Tom Davis. I now recognize any other Members who
wish to make any opening statements. Any Members wish to make
statements? Mr. Ruppersberger.
Mr. Ruppersberger. Thank you, Mr. Chairman.
Today we are here to discuss the health implications and
public policy issues that surround the use and marketing of
reduced risk tobacco products. Reduce risk tobacco products are
cigarettes with lower carcinogens and less nicotine, products
that burn only when inhaled, producing less secondhand smoke,
and, finally, smokeless tobacco. Hopefully, in this hearing we
will get some insight as to whether these products are safer
than traditional cigarettes, and if the marketing of these
products is truthful and accurate. Ultimately, what we are
seeking are ways to help people to quit smoking. The questions
before the committee today are, No. 1, are reduced-risk tobacco
products a step in assisting smokers to quit, or are they just
a modified form of addiction with no real benefits? No. 2, if
we have evidence that a reduced-risk product can help a smoker
to quit even in stages, shouldn't we look at providing that
information? Congress needs to ensure that marketing of these
reduced risk products is accurate. Thank you, Mr. Chairman.
Chairman Tom Davis. Thank you. Any other Members wish to
make statements? The gentleman from South Dakota. Let me note,
Members have will have five legislative days to insert opening
statements into the record.
Mr. Janklow. Thank you, Mr. Chairman. I am going to be
extremely brief in my comments.
I am an individual who never smoked a cigarette in his life
until I went in the U.S. Marine Corps and was given free
cigarettes in my C rations and my K rations, and that is how I
started smoking. I currently have 105 pack years behind me
during the period of time when I did smoke. And only because of
serious medical problems that I had at one time was I able to
quit. The hardest thing I have ever done in my life was to quit
smoking. The addiction was the most difficult thing that I ever
dealt with. When I was another public life, I smoked every
single place where it was illegal. I smoked in meeting halls,
in my office, and other people's meeting halls, in the
hallways, every place I could to get a cigarette.
400,000 people a year die as a result of smoking in this
country. How much smaller would the group have to be before we
would put an all-out crime activity program together to deal
with individuals who brought about the death of hundreds of
thousands of Americans a year? There is no such thing as
reduced-risk smoking. You either smoke or you don't smoke. You
are either at risk or you are not at risk. And so, Mr.
Chairman, this is a terribly timely group that you have
convened as a panel, and it is the most appropriate subject
matter. Thank you for doing it.
Chairman Tom Davis. Thank you very much.
I recognize our ranking member, Mr. Waxman, for 5 minutes.
Mr. Waxman. Thank you very much, Mr. Chairman. I want to
acknowledge the statement just made by our colleague, Mr.
Janklow. I thought that was a very wise statement. I, too, have
been down that road. I was a smoker and gave it up, and I have
spent a great deal of my congressional career trying to bring
to people's attention the dangers of cigarette smoking. It is
really shocking, and people get numb to it, but it is really
shocking the number of deaths and amount of disease related to
cigarette smoking still in this country, even though many
people have given up cigarette smoking. Now we are holding a
hearing, and I appreciate the chairman calling this hearing, to
look at whether a reduced-risk tobacco product might be a
useful way for us to look to helping people in the future.
These kinds of products are already starting to appear on the
market. They have the potential to effect for good or ill the
health of millions of smokers. So it is important we look at
this carefully.
I am not opposed to any product that will reduce the risk
of heart disease, cancer, and other diseases caused by smoking.
If new technology can help, if it is not just another clever
marketing gimmick by the tobacco industry, I will bring an open
mind to this debate. But I have been down this road before, and
I know what the risks are. The claims that we are hearing today
about this new generation of safer cigarettes are strikingly
similar to claims I heard from the companies 30 years ago when
they started to market light and low tar cigarettes. And we
know how the experiment turned out.
While promising smokers that their new brands were better
for their health, the tobacco industry knew all along that
light and lower tar brands were just as dangerous as regular
cigarettes if not more so. In fact, companies designed the
cigarettes to fool the machines that measure the nicotine and
tar, because it would still then deliver a full dose of toxins
to smokers. The result was a deadly fraud. The National Cancer
Institute recently concluded that there is no convincing
evidence that light and low tar cigarettes provide any health
benefits.
It is no exaggeration to say that millions of people will
die because they believed that these products were safer than
conventional cigarettes. And this deception continues today.
Light and low tar cigarettes dominate the market, and tobacco
companies are aggressively defending their ability to use these
misleading terms on their labels.
Now, the topic of today's hearing is a new generation of
so-called reduced risk tobacco products. These products raise
the question whether history is repeating itself. Earlier
today, Representative Jan Schakowsky and I released a staff
report that examines the striking parallels between the low tar
experience and the new reduced-risk tobacco products on the
market. And I would like to ask unanimous consent that that
report be made part of the record.
Chairman Tom Davis. Without objection, so ordered.
[The information referred to follows:]
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Mr. Waxman. What this report underscores is the need for
comprehensive FDA regulation of any reduced-risk claim. If
health claims are allowed for new reduced-risk products in the
absence of effective regulation recording another public health
disaster, these products can be deadly. They can deter
cessation, cause former smokers to resume their addiction, and
even attract young people to tobacco products. Let me put this
as bluntly as I can. The tobacco industry cannot be trusted to
regulate itself. These simple but indisputable facts should
shape today's hearing. We cannot sit by while a wild west of
companies hawking their allegedly new and improved products
threatens the health of millions. Nor should we, as Members of
Congress, try to figure out for ourselves which claims should
be made by which companies and under what conditions.
Today's hearing will be most useful if we can work together
to understand how comprehensive FDA regulation of tobacco
products can be structured to best protect the public health. I
believe the Institute of Medicine has set out a workable
approach to potential reduced-risk products, and I am pleased
that the Institute is represented here today. I am also pleased
that the National Cancer Institute is testifying about the
state of science, and that we have been joined by distinguished
experts from across the country.
And I appreciate that Philip Morris CEO, Michael
Szymanczyck, took the initiative to speak with me yesterday
about some of these issues and is here today as well. I look
forward to the testimony of all the witnesses and to working
with my colleagues. This is not a partisan issue. There should
be no Democrat or Republican views. We want what is best to
protect the health of the American people and not go down that
road again that we did decades ago, where the American people
have been deceived into smoking a product that has caused so
much death and disease.
Chairman Tom Davis. Any other opening statements? If not,
we are going to move to our first panel of witnesses.
We have Scott Leischow, who is with the National Cancer
Institute; Dr. Robert Wallace, from the Institute of Medicine
who is not here. I understand he is still at the hearing over
at Energy and Commerce. Do we have someone else from--come
forward. Do you have the testimony to give? You can take
questions. Why don't you identify yourself for the record.
Dr. Stratton. My name is Kathleen Stratton.
Chairman Tom Davis. Dr. Stratton, thank you very much for
being with us.
And, Mr. Lee Peeler from the Federal Trade Commission.
It is the policy of the committee that all witnesses be
sworn before you testify. Please raise your right hands.
[Witnesses sworn.]
Chairman Tom Davis. In order to allow time for questions,
your total statements are in the record; if you could try to
keep it to 5 minutes. There will be a light on in front of you;
when it turns orange, 4 minutes are up, and red at 5. And that
will kind of be a guideline. Once it turns red, if you could
move to sum up. Again, your total statements are in the record.
Members and staff have read it and prepared questions based on
that. So, we will give you 5 minutes to highlight.
I will start, Dr. Leischow, if you would move to your
right.
STATEMENTS OF SCOTT LEISCHOW, CHIEF, TOBACCO CONTROL RESEARCH
BRANCH, NATIONAL CANCER INSTITUTE, NATIONAL INSTITUTES OF
HEALTH; LEE PEELER, DEPUTY DIRECTOR, BUREAU OF CONSUMER
PROTECTION, FEDERAL TRADE COMMISSION; ROBERT WALLACE, CHAIRMAN
OF THE COMMITTEE TO ASSESS THE SCIENCE BASE FOR TOBACCO HARM
REDUCTION, INSTITUTE OF MEDICINE/NATIONAL ACADEMY OF SCIENCES;
AND KATHLEEN STRATTON, INSTITUTE OF MEDICINE
Dr. Leischow. Thank you.
Good afternoon. I am Dr. Scott Leischow, chief of the
Tobacco Control Research Branch at the National Cancer
Institute of the National Institutes of Health. Thank you,
Representative Davis and distinguished members of the committee
for the opportunity to be with you today to discuss the issue
of tobacco harm reduction. Let me begin by emphasizing three
fundamental facts: No. 1, all tobacco products are hazardous.
No. 2, there is no safe level of tobacco use. And, No. 3, the
only proven way to reduce the enormous burden of disease and
death due to tobacco use is to prevent its use and to help
users quit.
In NCI's view, a product would be harm reducing if it
actually reduces disease and death for both individuals and the
population as a whole. This is an important distinction,
because even if a tobacco product is shown to reduce disease
risk in an individual, the availability of products that claim
to reduce harm may have harmful consequences on the population.
For example, smokers may see reduced harm products as a viable
alternative to quitting, and put off making a quit attempt.
Similarly, there is a risk that smokers who have quit will
return to using tobacco because they think that these products
may make it safe to do so.
The National Institutes of Health has funded many studies
on the health effects of tobacco over the last 50 years, and
currently funds a small number of investigator-initiated grants
on tobacco product health effects. We have also added questions
about tobacco product use and perceptions of tobacco products'
health risk to NCI's Health Information National Trends Survey,
which is in the record. Additionally, the Centers for Disease
Control and Prevention laboratory is analyzing the chemistry of
some newer tobacco products.
The tobacco industry also funds research on potential harm-
reducing tobacco products. However, we know very little about
their studies, and it is uncertain how many have been made
available for objective scientific scrutiny.
A broad-based research effort involving numerous scientific
disciplines is needed to answer critical questions about
potential tobacco harm-reduction products. The Institute of
Medicine report entitled Clearing the Smoke, and the
conclusions of a 2001 reducing tobacco harm conference that
were published by Dorothy Hatsukami and others recommend key
research questions to be addressed.
We also need to be mindful of the lessons we learned from
our experience with so-called low tar and low nicotine
cigarettes. When the causal relationship between cigarette
smoking and lung cancer was first established in the 1950's,
the tobacco industry began altering its products by first
adding filters, and then in the 1960's began marketing so-
called low tar and low nicotine cigarettes. However, because an
extensive objective testing program of those products was not
put into place, it took more than 30 years to conclude that
smokers who switched to light cigarettes did not reduce their
lung cancer risk. Research summarized in a recent NCI monograph
shows that many smokers switched to lower yield cigarettes out
of concern for their health in the belief that these cigarettes
are less risky or are a step toward quitting. In fact, the
monograph concluded that marketing and promotion of reduced
yield cigarettes may delay genuine attempts to quit. The light
cigarette experience taught us valuable lessons that we should
not repeat in the future.
There are 46 million smokers in the United States, which
represents just over 23 percent of the population. The
prevalence of smoking has decreased considerably since the
early 1960's, and during the 1990's, prevalence dropped
approximately 1 percent per year. Today we have much to offer
people who smoke and want to quit, including effective
behavioral treatments and medications. Smoking cessation
medications must undergo extensive testing for safety and
effectiveness and be scrutinized through objective review prior
to the release to the public. When used as directed, about 25
percent of those using such products are able to quit smoking.
There is no clinical evidence that long-term use of nicotine
replacement medications cause harm.
Unlike nicotine replacement products for smoking cessation,
tobacco products do not undergo rigorous objective scrutiny
either for their product constituents or tobacco industry
claims. Tobacco contains many disease-causing substances,
including tobacco specific nitrosamines, formaldehyde, arsenic,
and benzopyrene. And restrictions on marketing are few. Thus, a
new tobacco product might sit on a store shelf next to an FDA-
approved nicotine replacement product which is marketed for
smoking cessation. It is possible that the similarity of these
products will be confusing to the public and imply that a
tobacco product is safe and FDA approved when it is not.
The NCI developed a position in 1991 where we recommended
that the public avoid and discontinue the use of all tobacco
products, including smokeless tobacco. Additionally, the NCI
stated that nitrosamines found in tobacco products are not safe
at any level. Because the accumulated scientific evidence does
not support a change, we continue to endorse those statements.
Furthermore, we do not have enough evidence to conclude that
smokeless tobacco is a less hazardous alternative to
cigarettes. A framework needs to be developed and implemented
for the independent and objective scientific collection,
review, and interpretation of data on tobacco products
purported to reduce harm. This approach is vitally important so
that data are optimally synthesized and disseminated to
scientists, health providers, policymakers, and the public.
This will ensure that the public has accurate, unbiased
information on risk and harm prior to being faced with deciding
whether to use one of these tobacco products, an FDA approved
medication or no product at all.
The evaluation of new tobacco products purported to reduce
harm needs to be part of a broad tobacco control and prevention
initiative. We know that smokeless tobacco use causes disease,
and we do not know whether there may be any potential benefit
in promoting to current smokers the use of any of these
products purported to reduce harm. The only proven way to
reduce the death and disease caused by tobacco use is to
prevent youth from starting to smoke and to help smokers quit.
These are and must remain our highest priorities.
Thank you again for this opportunity to provide comments
regarding this very significant public health issue. And I am
happy to answer any questions you may have.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Dr. Leischow follows:]
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Chairman Tom Davis. Mr. Peeler.
Mr. Peeler. Thank you for the opportunity to appear here
today and discuss the FTC's role in the potential advertising
in reduced-risk tobacco products. My prepared statement
represents the views of the Commission, and my oral remarks and
responses to questions today represent my own views and do not
necessarily represent the views of the Commission.
The FTC's mission is to prevent unfair methods of
competition and unfair or deceptive acts or practices in the
marketplace. The Commission does this by ensuring that
advertising and marketing claims are truthful and not
misleading. Our jurisdiction over the advertising and marketing
claims includes jurisdiction over claims for cigarettes,
smokeless tobacco, and other tobacco products.
The FTC's law enforcement activities involving tobacco
advertising and promotion date back to the 1930's. Congress has
also given the Commission administrative responsibilities for
the health warnings required on the cigarette packaging and
advertising under the Cigarette Act, and both administrative
and enforcement responsibilities for the health warnings
required on smokeless tobacco packaging and advertising under
the Smokeless Tobacco Act.
The Commission does not prescreen advertising or marketing
claims for tobacco or any other product. Instead, the agency
addresses deception through post-market law enforcement action.
The marketing of potential reduced-risk tobacco products is
an important question. Despite the government and public health
communities' efforts, millions of Americans smoke today and are
addicted to nicotine. Many of these smokers will ultimately die
of smoking-related illnesses if they do not change their
behavior. In an ideal world, we would wish that all these
people would choose to quit smoking and would be able to do so
once they tried. The real world is quite different, however. If
truthful and substantiated marketing claims that a product will
significantly reduce health risk associated with smoking while
satisfying the addicted smoker's craving for nicotine could
provide a substantial benefit for those consumers who cannot or
will not quit. Conversely, if those claims were untruthful,
unsubstantiated, or misrepresented the extent of the benefit,
they would harm consumers. For those reasons, we review the
advertising for potential reduced-risk tobacco products on a
case-by-case basis to try to ensure that the information
consumers receive about reduced-risk products is accurate and
substantiated.
First, we ask what messages consumers take away from the
advertising in question. The next issue is whether those claims
are truthful, including whether they are supported by the
necessary substantiation. The Commission typically requires
that health claims be supported by competent and reliable
scientific evidence. In determining whether harm reduction
claims are substantiated, the Commission would turn to experts
both inside and outside the government science-based agencies
for assistance in evaluating scientific evidence.
In addition to discussing the role that we play regarding
tobacco advertising, the Committee has also requested that we
address the status of the U.S. Tobacco Petition, whether we
have examined statements by other tobacco products claiming to
be less risky, and what action the FTC intends to take on these
issues. As indicated in our written statement, the U.S. Tobacco
Petition was withdrawn in April 2002 prior to the Commission's
ruling on it. UST has recently submitted additional information
and requested the FTC consider holding a public forum to
discuss the issues in the petition.
The FTC does monitor ongoing tobacco advertising, and has
taken action to challenge claims it believes to be deceptive or
unsubstantiated, including our 1999 settlement with RJ Reynolds
resolving alleged unsubstantiated implied claims that their no
additive cigarettes were less hazardous than other comparable
cigarettes. I would caution, however, that the Commission
investigations are nonpublic, and the fact that the Commission
has not publicly challenged any particular claim does not mean
that the Commission has approved it. We intend to continue to
monitor tobacco advertising and conduct investigations where
appropriate, in addition, in consultation with scientific
agencies, we will consider UST's more recent request for a
public forum to discuss reduced-risk tobacco products.
Let me close by mentioning that in our view the discussion
of potential harm reduction tobacco products should also
encompass the question of whether so-called nicotine
replacement products, which are currently marketed only for
smoking cessation purposes, have a larger role to play in the
harm reduction arena. These products, which contain nicotine
and no tobacco should certainly be further evaluated for use by
consumers who are addicted to nicotine.
Thank you for the opportunity to discuss the Commission's
role in this important area.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Mr. Peeler follows:]
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Chairman Tom Davis. Dr. Stratton.
Dr. Stratton. Good afternoon, Mr. Chairman, members of the
committee. My name is Kathleen Stratton. I served as senior
staff director to the committee to assess the science base for
tobacco harm reduction of the Institute of Medicine. Dr.
Wallace, whose testimony I am presenting today, served as vice
chairman of that committee.
The work of the committee was conducted under a contract
initiated by the Food and Drug Administration. The committee
began its work in December 1999, and released its report,
``Clearing the Smoke, Assessing the Science Base for Tobacco
Harm Reduction,'' in February 2001. The committee was asked to
provide a framework for the assessment of tobacco and
pharmaceutical products that might be used for tobacco harm
reduction. However, the committee did not review specific
products.
I would like to emphasize several of the committee's
principle objections, conclusions, and recommendations.
First, for many diseases attributable to tobacco use,
reducing the risk of disease by reducing the exposure to
tobacco toxicants is feasible. Therefore, manufacturers should
have the necessary incentive to develop and market products
that reduce exposure to these toxicants and have a reasonable
prospect of reducing the risk of tobacco-related disease. This
incentive mentioned is the ability of manufacturers to make
exposure reduction or risk reduction claims if they are true.
However, I must note that the report is supportive of such
claims only if made in the context of a comprehensive national
tobacco control program that emphasizes abstinence-oriented
prevention and treatment, and if under the harm reduction
framework outlined by the committee, such as illustrated in the
next three points. These potential reduced exposure products
have not yet been evaluated comprehensively enough including
for a long enough time to provide a scientific basis for
concluding that they are indeed associated with the reduced
risk of disease compared to conventional tobacco use.
Regulation of all tobacco products is a necessary precondition
for assuring a scientific basis for judging the effects of
using the potential reduced exposure products, and for assuring
that the health of the public is protected.
Finally, and most importantly, the public health impact of
these products is all but unknown. They are potentially
beneficial, but the net impact on population health, on public
health could, in fact, be negative. Therefore, the health and
behavioral effects of using these products must be monitored on
a continuing basis. Basic clinical and epidemiological research
must be conducted to establish their potential for harm
reduction for individuals and for populations.
The committee outlined 11 principles for regulating these
products as you have mentioned, Mr. Chairman. The principles
address, for example, disclosure of product ingredients,
toxicity testing, premarket approval of claims, and issues
related to labeling, advertising, and promotion, and
postmarketing surveillance of the effects of these products on
the American public's health.
I would like to conclude this testimony by summarizing
three key public health messages about the potential for
improving health in the face of the availability of the
potential reduced exposure products.
First, the committee unanimously and strongly held that the
best strategy to protect human health from the dangers of
tobacco is to quit or not start tobacco use in the first place.
Second, with the appropriate and comprehensive research,
surveillance, education, and regulation, these products could
possibly reduce the risk of tobacco-related disease. However,
the net health impact is, once again, I should say, all but
unknown. Claims of reduced risk to the individual may well not
translate into reduced harm to the population. Although a
product might be risk reducing for the individual using it
compared to conventional tobacco products, the availability of
these products might increase harm to the population. This
could occur if tobacco users who might otherwise have quit do
not, if former tobacco users resume use, or if some people who
would not otherwise have initiated tobacco use do so because
the perception that the risk of these new products is minimal
and therefore acceptability.
Third, a comprehensive and verifiable surveillance system
is the crucial link between the availability of reduced
exposure products and reduced risk to the individual and
reduced harm to public health. It is imperative that we
understand what the American people are doing with regard to
these products and what is happening to their health.
Thank you for the opportunity to address you on this
important topic. A copy of my testimony and a copy of the
report, Clearing the Smoke, have been submitted for the record.
I am happy to answer any questions about the report.
[The prepared statement of Dr. Wallace follows:]
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Chairman Tom Davis. Thank you all very much.
Let me just start the questioning, Dr. Leischow, let me
start with you.
I know that the NIH has funded many studies on the health
effects of tobacco over the last 50 years, but we really don't
know much about what is in cigarette smoke. Well, let me ask
you this. How much do we know about what is in cigarette smoke
causing smoking-related illnesses?
Dr. Leischow. Well, actually, there has been a fair amount
of research that was conducted at NCI in the 1970's that looked
at tobacco products even with the intent to create a so-called
safer cigarette. That program didn't continue. The scientific
community has actually not conducted a lot of research in the
last few years. Much of it has been done by the tobacco
industry, and much of that research we don't know. I would have
to provide some testimony after this on some of the specifics
regarding tobacco products and what we know about the exact
constituents.
Chairman Tom Davis. I understand your position, that no
tobacco product that you can conceive of is safe today. But let
me just ask you this. In your opinion, is it feasible to
include tobacco products that, while not safe, provide a safer
source of nicotine to the consumer as part of efforts to reduce
tobacco-related morbidity and mortality?
Dr. Leischow. There is no evidence that----
Chairman Tom Davis. I didn't ask that.
Dr. Leischow. OK.
Chairman Tom Davis. We don't know at this point.
Dr. Leischow. Right.
Chairman Tom Davis. But if it were possible, would that be
something worth exploring? And if that were so, what agency
would we call on to regulate that and make the call to balls
and strikes?
Dr. Leischow. Well, it wouldn't be NCI. I mean, we are a
scientific agency. It would have to be a regulatory agency.
That is not something that we would make a decision on. I'm
afraid I just don't have a good answer for that one.
Chairman Tom Davis. And you don't know whether you could
make it safer or not at this point.
Dr. Leischow. We really don't know for sure. Certainly, the
IOM report indicated that it is scientifically conceivable, but
it is going to take a very extensive research and testing
program. And, as the IOH folks indicated, looking at
surveillance, the product itself, how people use the product,
which we know is a critically important point. You can create a
product that has various changes in the amount of nitrosamines
or other carcinogens, and but how people use that product will
oftentimes determine what impact it has on health. So there is
a lot of research that needs to be done.
Chairman Tom Davis. Dr. Stratton, do you have any thoughts
on that?
Dr. Stratton. Dr. Leischow is correct, that the report said
that it was within the scientific realm of feasibility, but
that they haven't been demonstrated and that there is too much
that is unknown. And more than the effects on the individual,
the committee was particularly concerned about the impact of
the products on public health, which is even harder to
understand.
Chairman Tom Davis. Right.
Dr. Stratton. With regard to regulation, which I believe
you asked Dr. Leischow, the committee didn't make a
recommendation of which specific agency, although it should
have the regulatory authority over these tobacco products,
although it did say that the Food and Drug Administration is
the most likely, and at this point, the most appropriate,
although there could be another agency if the right expertise
were brought to bear. But there was an implicit preference for
the Food and Drug Administration to be given that authority
over tobacco.
Chairman Tom Davis. There are products out there on the
market right now that purport to be safer from their own
advertising, lights, ultra lights, and the like. And we have no
scientific, independently verifiable data at this point that
indicates that is true; is that a fair statement?
Dr. Leischow. That is exactly right. And that applies to
both smoked tobacco products as well as smokeless tobacco
products. One of the challenges, as you indicated, that these
products are on the market--if I could even demonstrate. There
is a product that is marketed called Ariva. And this is
certainly no endorsement for products. But it is a tobacco
product that is actually on the shelf oftentimes right next to
an FDA approved smoking cessation medication. Both of these
products are, you know, it is a lozenge. So this is a tobacco
product, this is a pharmaceutical company FDA-approved product.
Very similar. And we don't know much about this one. We know a
lot about this one because it has gone through FDA review. But
this one is out there and consumers are using it presumably and
without again much information as to what the impact is of its
use.
Chairman Tom Davis. But to some extent, doesn't that make
the case that maybe this would be a good idea for the
government to look at those products and try to independently
verify whether in point in fact they do what they purport to
do?
Dr. Leischow. Well, clearly as a research question, yes.
And NCI has conducted that research, and we funded research in
that area. It is critical that we understand how these products
are used, what their constituents are and what their health
effects are, and then sort of answer some of the surveillance
questions: How do populations use them and what are the health
effects?
Chairman Tom Davis. I mean, one of the problems is that if
you have a safer product but it is not a safe product, you have
a hard time embracing that and trying to put any kind of
approval on that. And I understand that. You are the National
Cancer Institute, and you don't want to encourage somebody to
do something that is harmful to them even though it may be less
harmful than something else they would likely do otherwise. But
the reality is today a lot of people are using these products
under the impression that they are safer products, and there is
no evidence that they are. And the question, do we stand back
and say, well, gee, you know, we are going to wait for the
ultimate-ultimate solution, which may be politically not
viable? Or do we take in and take a step? And that is kind of
the quandary we face here.
Dr. Leischow. And it is an important question. And the
scientific community has begun to look at what are the
constellation of studies that need to be addressed. And in
fact, there was a meeting in February that included tobacco
industry scientists and representatives to even begin
discussing how the tobacco industry may contribute and play a
role in the testing of products in such a way that the public
health community would find that acceptable. So there is some
movement toward exploring how we might do this. We have to
develop a framework and a set of parameters that are acceptable
to all.
Chairman Tom Davis. And the tobacco industry has certainly
done a lot of research.
Dr. Leischow. Absolutely.
Chairman Tom Davis. The sharing and the verifiability and
all that stuff remains to be seen.
My time is up. I am going to yield now to Mr. Waxman for 5
minutes.
Mr. Waxman. Thank you very much, Mr. Chairman. I think your
questions are right on point. If there are products that are
out there and people are being told these products are going to
be safer in some way, if that is not accurate, I think the
public should have some confidence that the government is
regulating. And Dr. Leischow, you testified that these light
and low tar cigarettes do not reduce the risk of lung cancer
compared to regular tar cigarettes, and that many smokers
switch to lower yield cigarettes out of concern for their
health. Is that right?
Dr. Leischow. Exactly.
Mr. Waxman. These are not new products. These have been out
there for 30 years and light and low tar brands are still among
the most popular cigarettes in the United States. And I believe
and I think all evidence points to the fact that people think
they are doing themselves a favor by smoking these brands as
opposed to any other brand.
Dr. Leischow. Exactly. In fact, the questions you raised
are exactly why we have begun asking the public those questions
through a survey that is assessing how people perceive health
risks. And so we were asking about light cigarettes as well as
the use of these new purported harm reduction products.
Mr. Waxman. Now Dr. Wallace, we are pleased that you are
here with us along with Dr. Stratton. The chairman says he
needs to swear you in before I ask you any questions.
Chairman Tom Davis. I just have to----
[Witness sworn.]
Mr. Waxman. The Institute of Medicine has looked at the
issue of this harm reduction, tobacco harm reduction. Do you
believe there is adequate evidence to address whether some of
these newer products actually reduce risk to health?
Dr. Wallace. No, sir. That was the conclusion of the
committee, that there was not sufficient evidence in the
general case. A lot of the evidence rests with the long-term
health effects of the products. Other evidence has to do with
the standardization and what really is coming, what really gets
into the body when the product is used. And still other
evidence has to do with the public health side of this, which
is, what is the impact of a particular product used on other
people, on children, on changing practices by adults.
And so we felt that, while harm reduction was feasible,
that, in fact, the evidentiary case, the scientific evidence
has not been made yet.
Mr. Waxman. Dr. Leischow held up two packages of little
capsules. One has been approved by the FDA as a nicotine
delivery system to help people give up smoking. The other is a
tobacco product with nicotine that is supposed to be sold to
people with the idea, if they can't smoke, they should suck on
this mint, tobacco mint with nicotine in it.
Dr. Leischow, one was approved by the FDA and the other was
not.
Dr. Leischow. Exactly.
Mr. Waxman. Now, this other product presumably is to
encourage people not to give up smoking but to use this in
addition to smoking and during the times when they can't smoke.
Dr. Leischow. Right. In fact, the front of the box says:
When you can't smoke, specifically.
Mr. Waxman. Now, there was a hearing in another committee I
happened to be in attendance, and the people that make the
smokeless tobacco are urging that they be allowed to advertise
that they are safer than cigarettes. One, there is no evidence
they are safer than cigarettes. But it seems to me that people
who don't want to give up smoking but want something else will
probably use that product and smoke as well. Any evidence on
that?
Dr. Leischow. Actually, at this point, we don't. It is our
concern, and that is why we need to track the products, track
how people use them, and again track the health effects of
these products. So this is a very fast-moving field. And the
science quite frankly is having a hard time keeping up with
policy and with the use of the product.
Mr. Waxman. Excuse me for interrupting, but I see the
yellow light. Rather than go to the FDA that has the scientific
authority to evaluate some of these products from a medical
point of view, people are going to the FTC because they say
that the FTC should not stop them from making advertising
claims. Now, these products that are out there, low tar and
light cigarettes, were given a green light by the FTC 30 years
ago. That was a big mistake. We certainly don't want to repeat
that mistake with these new products.
Dr. Stratton, you said, the question is, who should
regulate? Who should regulate if we are trying to protect the
public from products that claim to be a safer alternative but
are not a safer alternative? Maybe Dr. Wallace wants to respond
to this. Should it be the FTC, the FDA? Who should regulate?
Dr. Wallace. Sir, the report didn't take a position on
which agency or agencies in the Federal Government should
actually do the regulation. My own personal view is that they
were leaning, our committee was leaning toward an FDA model,
scientifically based informed model.
Mr. Waxman. Thank you, Mr. Chairman.
Chairman Tom Davis. Thank you very much. Mr. Lewis, any
questions? Mr. Platts. Any questions over here on our side on
this panel? Mr. Schrock.
Mr. Schrock. Thank you, Mr. Chairman. Let me associate
myself with what Governor Janklow said. I'm a cancer survivor.
And I chose to smoke. I am going to make that clear. Nobody
forced me to do it, but when I was in Vietnam, they were free.
Anything free has to be good. Right? So I smoked myself nearly
to oblivion. But that doesn't mean I blame anybody but myself.
I did, and I choose not to now, forcing my wife and son to
choose not to, either.
But Mr. Peeler, I understand that Philip Morris USA has
recently petitioned the FTC to issue rules regarding the use of
the terms, as Mr. Waxman said, lights and low tars in light of
conclusions recently expressed by the NCI. What is the status
of that report? It may be in this volume of stuff, but I
haven't read it.
Mr. Peeler. I don't think it is. It has been received by
the FTC, and we will evaluate it. It is exactly the type of
issue that we would seek out the opinions of the scientific
agencies and the Federal Government in evaluating. And in fact,
as indicated in our written testimony, the area of tar and
nicotine testing is an area where the FTC has asked NCI's
assistance in the past, and we are working with those agencies
to try to develop an improved tar and nicotine test to replace
the one that exists now.
Mr. Schrock. Do you think that will be soon, the results?
Mr. Peeler. Well, when we have asked, what we have been
told is: You are an agency of lawyers and economists. You
shouldn't be developing the scientific test methods. And we
agree with that as long as that test method is at the FTC. And
we've recommended that it be transferred legislatively. But as
long as it stays at the FTC what we would do is seek the advice
of the government's scientific agencies on how to modify it. So
the question of whether that would be soon would be something
you would have to ask Dr. Leischow.
Dr. Leischow. Where it stands is this: After the Monograph
13 was released, we indicated that we were quite interested in
working with the FTC, and we remain so today. The request to
the FTC--the FTC request, I should say, initially went through
the previous Secretary for Health and Human Services. And we
are not clear whether NCI is still the agency that HHS would
request to do this. So, our interest is in working with FTC and
determining whether we are still the right agency, whether
another one like CDC or some other may be the optimal one to
move forward. So we are ready, willing, and able once we get a
directive from the new administration to do so.
Mr. Schrock. Keep us posted on that. Let me ask one more
question, Mr. Peeler. Given the criticism by the public health
community of both the FTC test and the use of the terms like
light, what additional actions does the FTC plan to take in
this area?
Mr. Peeler. Well, the first thing, I want to make clear
that the FTC has never approved of the use of the term low or
light. Those are under industry descriptors that are used under
industry guidelines. And as you may know, there is a
significant amount of litigation ongoing including litigation
as part of the U.S. Government's Justice Department suit that
involves those issues right now.
In terms of fixing our tar and nicotine testing system,
which produces the numbers but not the descriptors, as I said,
that is something that we have been actively engaged in looking
for answers on. And we do want to work with the Federal
Government scientific agencies to develop a fix to that system.
Mr. Schrock. OK. The government moves slow. It would be
nice if they could move faster on this kind of stuff, that's
for sure.
Thank you, Mr. Chairman.
Chairman Tom Davis. Thank you very much. Any questions on
this side? Mr. Ruppersberger.
Mr. Ruppersberger. Thank you.
Well, this issue will go on for a long time. And really the
issue is, how far does the government go to regulate a habit
that has harmed a lot of Americans. But we have the issue now
where people are smoking, where there is addiction; and how do
we deal with it. There has been a lot of settlements, a lot of
lawsuits involved. I think the States are putting a lot of
money into education and to helping people understand where we
need to go to deal with the issue involving children.
I want to talk, just address a couple issues concerning
consumption, and reduce the consumption and maybe the eventual
stopping of smoking. Do the cigarettes attempt to reduce the
amount of tar and nicotine help smokers both reduce consumption
and lead to the eventual stopping of their habit? Any data as
it relates to that issue?
Dr. Leischow. No.
Mr. Ruppersberger. Does the entire panel agree with that?
And no statistics or research one way or another?
Dr. Leischow. If I understand your question, I mean, the
evidence that was summarized in our Monograph 13 on light
cigarettes indicates that, in fact, that we have, in effect,
sustained smoking, you know, by having these products
available. People get a sense that they are using something
that is safer, and they are really not, ultimately.
Mr. Ruppersberger. Let me ask you, how effective are items
like the patch and nicotine gum in reducing or assisting people
to stop smoking?
Dr. Leischow. They can be quite effective. When used as
tested in the trials that got them approved by the FDA, 15 to
25 percent, sometimes even higher quit rates. The challenge is
in getting people who buy them on the market and then altering
the environment to use them according to the label. And that is
one of the challenges that again the scientific community and
the pharmaceutical companies have before them. But these
products can be effective when used appropriately. And we
certainly hope that more and new medications are developed in
the future that are even more effective.
Mr. Ruppersberger. Let me ask you this: Besides the patch,
education, nicotine gum, are there any other remedies available
to help people quit?
Dr. Leischow. Nicotine inhaler, nicotine nasal spray.
Mr. Ruppersberger. What kind of inhaler? Is that a
prescription inhaler?
Dr. Leischow. It is actually right now prescription in the
United States. In some other countries, it is actually over the
counter. Nasal spray, which is a prescription product. And then
the product called Zyban that is a brand name which is a
nonnicotine medication is also approved and has been shown to
be effective for smoking cessation.
Mr. Ruppersberger. What would you like to see, as a group
or individually, what do you think needs to be done by the
Secretary of Health and Human Services to deal with the issue
of first the smoking addiction, and then second, to get into
the issue that we are talking about here today?
Mr. Peeler. Well, for FTC's standpoint, I would reference
you to our prepared statement where we did say that we thought
exploring a greater range of possible claims for nicotine
replacement products would be something that we thought was
valuable.
Mr. Ruppersberger. Do you think we need more cooperation
from the Federal Government with the States, since the States
seem--the States have settled with the tobacco industry or have
programs themselves? Do you think the programs that you have
seen nationally are effective, or do you think one is different
than the other? How would you look at the pictures as relates
to cooperation between State and Federal and individual States?
Dr. Leischow. It is variable. But, quite frankly, there is
quite a bit of cooperation that is happening now. CDC is the
lead agency in that respect. They are doing an absolutely bang-
up job linking the States and bringing various Federal partners
into the mix. For example, there is a group of States that have
quit lines, toll free quit lines. And so there has been an
effort between the States and Federal agencies to link those
quit lines to see how we can most effectively use those to help
the millions of smokers in the United States to quit.
Mr. Ruppersberger. I see my time is almost up. I want to
ask this last question: Who is more likely to quit their
addictions, smokers or smokeless tobacco users?
Dr. Leischow. To my knowledge, there has not been a head-
to-head comparison that way. Both involve----
Mr. Ruppersberger. Should there be?
Dr. Leischow. That's a great idea. That's a good research
study. And some of the other folks this afternoon may have
answers to that, Dr. Henningfield or others. But the challenge
is that addiction to nicotine is fundamental to both of them.
Nicotine is exceedingly addicting, and quitting either of those
products is hard.
Mr. Ruppersberger. In your opinion, do you think one is
different than the other?
Dr. Leischow. I have no evidence that one is easier or
harder. They are both difficult to quit in most cases.
Mr. Ruppersberger. Thank you.
Chairman Tom Davis. Any other questions on this side? Mrs.
Blackburn.
Mrs. Blackburn. Thank you, Mr. Chairman.
Dr. Stratton, I think I would like to begin with you and
then I have a question for Dr. Wallace. And I want to talk with
you a little bit about timeframes and also what we can do at
looking at some of these incentives. You mentioned, Dr.
Stratton, in the testimony that you gave for us, that the
committee had some objectives, some conclusions, and some
recommendations. And in this, at point No. 1 for you, you said
that for many diseases that are attributable to tobacco use,
reducing the risk of disease by reducing exposure to tobacco
toxicants is feasible. Therefore, manufacturers should have the
necessary incentive to develop.
Now, in talking about this, looking at incentives, do you
feel like it is the government role to incentivize, that it
should be the private sector's role to provide the incentive?
Or what exactly do you mean with that statement?
Dr. Stratton. First, I would like to say that although it
is the first listed in my testimony, it is certainly not the
primary or most important. It does, however, set the stage for
the following three points: In my testimony, I hope I mentioned
that the incentive that the committee clearly intended was the
ability to make exposure reduction claims or risk reduction
claims if they are true, and if it is done in the context of
comprehensive tobacco control and comprehensive tobacco
regulation. So the incentive is the ability to make claims, if
they are true.
Mrs. Blackburn. Thank you.
And then Dr. Wallace, going to the IOM report, it is stated
frequently that it will be difficult and time consuming to
determine the degree of exposure reduction achieved. Now, do
you have any timeframe at all before a product could truly make
a claim of reducing risk; and how long are you talking there?
Weeks, months, years? And how can some of the delays be
avoided?
Dr. Wallace. First of all, there has to be I think enough
of a scientific base so that the product would be either out
there already or some tentative claim about exposure might be
made. In terms of the health outcomes, these, of course, can be
many, many years. Unfortunately for pregnant women, you can
sometimes get answers fairly quickly about the health of the
fetus, for example. Certain--for heart attacks, you might get
an answer in a few years because, in fact, there is a
reasonable relationship between smoking cessation for harm
reduction and the risk of heart attack. For the cancers, for
the chronic lung disease, for some of the other very important
outcomes of tobacco smoking, it could take decades. There may
be no way to compress that.
Mrs. Blackburn. Thank you very much.
Chairman Tom Davis. Anyone else on this side like to be
recognized? Yes, ma'am, go ahead. The lady from California.
Ms. Watson. Thank you, Mr. Chairman.
To the panel. In California, in the 1980's we started doing
intense policymaking. Our ranking member was a leader in that
effort. We finally got down to where we disallowed smoking on
airplanes. I just heard recently where a gentleman died of an
asthmatic attack after asking to be removed from the smoking
section.
I want to know if the Institute--anyone who would like to
respond--has looked into if there are any advanced methods of
clearing the air in an airplane. Since most of us are global,
and I believe this is a Greek airline, I am not sure of the
facts. I was just really discouraged to hear that, A, they were
allowing smoking; and, B, someone who asked to be moved was not
accommodated and he ended up dying. I've always been concerned
about that secondhand smoke and smoking aboard planes. So have
we done any more research on clearing the air in that can or
that plane of cigarette smoke? Anyone that wants to respond.
Dr. Leischow. I'm unaware of that, and we can certainly
explore it and get information to you after this meeting.
Ms. Watson. I believe at this time that most airlines
internationally prohibit smoking, but I found that possibly
there are a few and there might be some coming from the Far
East, but I would like any information on that, if you know of
any of the airlines. I think we need a drive internationally
with the WHO about prohibiting smoking on airlines because
those airlines do come to our shores and our airspace, and I'm
very concerned. So if someone can provide me that information
at later time, I'd appreciate it. Thank you.
Chairman Tom Davis. Anyone else who wishes to be recognized
before we hear the next panel?
The gentleman from Missouri.
Mr. Clay. Thank you, Mr. Chairman. Real quickly, just for
anyone on the panel, would someone who continues to smoke
cigarettes and has not been successful trying medicinal
nicotine products be better off switching to smokeless tobacco?
And any one of you can try to answer that one.
Dr. Leischow. We don't have evidence on that. We don't have
adequate evidence on that. There have been some claims made
that may be safer, but we still have a long way to go to
understand what the impact might be of a person doing that. So
we just don't have the data.
Mr. Clay. OK. The Royal College of Physicians in London has
concluded that the consumption of noncombustible tobacco is of
the order of 10 to 1,000 times less hazardous than smoking,
depending on the product. Does this conclusion provide
substantiation for a statement? Advertising that smokeless
tobacco is significantly less risky than cigarette smoking?
Mr. Peeler. When you look at substantiation in advertising,
you have to look at what the expressed claims are and the
implied claims. When you look at what claims consumers take out
of advertising, you look at both what the expressed claims are
and what the implied claims are. So if that claim was made in
advertising, we would want to know--we would want to answer two
questions.
The first thing is we'd want to know was that
recommendation itself based on confident, reliable scientific
evidence; and the second thing we would want to know is did
that advertisement convey a broader claim that has proven that
smokeless tobacco would reduce the risk? And in answering those
questions, we would turn to government scientific agencies to
assist us in the evaluation of the science.
Mr. Clay. OK. Thank you. Thank you, Mr. Chairman. That's
all the questions.
Chairman Tom Davis. Thank you very much.
Any other questions from Members?
The gentleman from Connecticut.
Mr. Shays. The gentleman asked the question about the Royal
College of Physicians. I would just like to ask the IOM, do you
envision any circumstance that would allow a product to be
made, reduced exposure claims initially to make those later be
followed by actually reduced claims once the claims have been
verified? In other words, intuitively you say these are reduced
claims, but you don't have the documentation to establish it.
Can you envision that happening?
Dr. Wallace. In fact, again we said that the answer is yes.
We said that this was feasible. We just don't feel that the
evidence is in place yet for any of the products and that in
the context of a national tobacco control program and followup
of populations to know what's happening to the community at
large, to Americans in general in their tobacco use habits that
it's entirely feasible that these claims can at some point be
made.
Mr. Shays. Does the panel basically accept that people will
smoke no matter how serious they believe the physical results
can be a negative? I mean, is there just a basic acceptance on
the fact that people are going to smoke? And that's my
question. I mean, do any of you envision a world in which a
country simply will not have smokers? I'd like each of you to
answer.
Dr. Wallace. Just to start, we didn't address the issue of
prohibition, if that's where you're going, but we certainly
look at differences in populations, differences among
countries, effects of treatments as they become available; and
it's not outside the realm of possibility that in fact we can
suppress the use of tobacco products to a substantial degree.
Mr. Shays. The basis for my asking this question is that
when you deal with an issue of a product being less harmful,
we're saying it is harmful but it's less harmful, the logic of
having a less harmful product is people are going to smoke and
therefore better that they smoke a less harmful or that they
chew a less harmful product to satisfy their desire to have
tobacco, and all I'm doing is just trying to understand the
mindset. It's not about prohibition.
Is there generally an acceptance on the part of you in the
positions you're in that we're going to have a country in the
world where you're going to have smokers, whether they smoke
tobacco or they chew it, and that better that it be--that there
is a logic to the process that we then try to encourage them
and encourage the companies to develop a less harmful product?
I can tell you what my answer is. My answer is, yes, they
are going to smoke and, yes, better that they have less
harmful. I want to know what you think. That's what I'm asking.
I will start with you, Dr. Stratton.
Dr. Stratton. Dr. Wallace and I actually represent the same
organization, so hopefully we'll give the same answer.
Dr. Wallace. You can pass if you'd like.
Dr. Stratton. I will pass to Dr. Wallace on this.
Mr. Shays. This might be the only fun we have today.
Dr. Wallace. No. I wouldn't do that to her.
Mr. Shays. I will defer to the chairman's guidance, and you
should clearly.
Dr. Wallace. Thank you. Just very quickly, I believe that
the very notion of harm reduction implies that at least in the
foreseeable future that there will be tobacco use and we did
accept that; and the committee, with all the caveats and
programs that we recommended, accepted the notion of harm
reduction as being feasible, but it has to be scientifically
proven and regulated, etc., and--but we did accept that.
Mr. Shays. Mr. Peeler.
Mr. Peeler. As we said in our written testimony, there are
about 50 million Americans that smoke regularly, and I think
there was testimony this morning that quitting rates--while
people quit, quitting rates are pretty low. So we think that a
large number of Americans will continue to smoke and that if
there were risk reduction products that can make truthful
substantiated risk reduction claims, that could be beneficial
to those smokers, but that leaves open to the question that I
think has been discussed here this morning which is, you know,
are there products that we are confident enough will produce a
risk reduction?
Mr. Shays. I will be finished just with your answer,
Doctor.
Dr. Leischow. I don't see tobacco going away anytime soon,
but certainly within the realm of possibility that alternatives
could be created, there are pharmaceutical products that could
deliver some of the same constituents that people use nicotine
products for, tobacco products for, but without all the harmful
substances. So certainly it's within the realm of possibility.
Scientifically how it will play out is, of course, unclear.
Mr. Shays. Thank you, Mr. Chairman.
Thank you, gentlemen.
Chairman Tom Davis. Thank you, Mr. Chairman.
The gentleman from Maryland, Mr. Van Hollen.
Mr. Van Hollen. Thank you, Mr. Chairman.
I just have a few questions for Mr. Peeler, trying to get a
sense of the difference in responsibilities and oversight with
respect to FDA versus the FTC. Because if we're going to get
truthful answers to these scientific questions, it seems to me
we're better off if we get them before the fact than after the
fact, and you said the FTC can only really jump in here after a
claim has been made for the most part. So, just to be clear,
FDA can assess the scientific claims before approving a
product; is that right?
Mr. Peeler. For most products that FDA regulates--I mean,
it varies with the product, but for most products, particularly
if it was a risk reduction claim, FDA would preapprove that
claim before it was made.
Mr. Van Hollen. Right. And the FTC does not have that
authority?
Mr. Peeler. No. The FTC does not have the authority to
preapprove claims.
Mr. Van Hollen. And with respect to marketing claims made
before the marketing of the product and the ability to put
restrictions on the claims that are made, FDA has that
authority now; is that right?
Mr. Peeler. Not for tobacco products. I mean, that's why
you're here.
Mr. Van Hollen. No. I understand that. But with respect to
other products, where scientific claims are made about the
medical efficacy of those products.
Mr. Peeler. With respect to drug products, that's true of
other types of products, not for all the products FDA
regulates. The FTC's authority, again, is to take action if the
advertising is either deceptive or if it's unfair, and it's
really the deception analysis that applies primarily to
advertising.
Mr. Van Hollen. When you look at that, do you look at just
the very narrow question about whether someone has made an
outright false statement or do you also look at the broader
question about whether people might be misled about a
particular product?
Mr. Peeler. We clearly look at the broad question of
whether people will be expressly or implicitly misled. But as
we indicated in our testimony, there are a number of public
health questions that have been raised that go beyond, that
look at deception which have been discussed here this morning
that we would not necessarily look at after determining that
there was adequate substantiation.
Mr. Van Hollen. Right. I guess maybe--correct me if I'm
wrong. My understanding was with respect to light and low tar
cigarettes that FTC has not disputed those claims, is that
right, that have been made with respect to advertising of those
products?
Mr. Peeler. I would not say that's correct. We have reports
going back as early as 1981 questioning low and light claims
and raising concerns about them. We continue to operate our tar
and nicotine testing system, and we're seeking advice on how to
change the numbers. We have never officially endorsed low or
light cigarette claims.
Mr. Van Hollen. Not endorsed, but I mean the advertising
that's been going on for years and years now, you've never
stopped it, have you?
Mr. Peeler. We have not taken any law enforcement actions
against it. I believe that those claims are subject to the
Justice Department's ongoing litigation.
Mr. Van Hollen. Let me ask you, do you believe that people
have been misled into thinking that those products are safer
than the other cigarette products?
Mr. Peeler. Well, I think, given the fact that's in
litigation between the United States and the companies right
now, I just leave it with that.
Mr. Van Hollen. I just think it points to the weakness
sometimes in protecting public health through the FTC, which is
that you're only able to get into the game after a product is
being advertised. In this case, it's been advertised for years,
and I think common sense will tell you most people think that
the claims of low tar and light cigarettes means it's in fact
healthier when in fact it has not been proven.
Mr. Peeler. Right, and we have put out consumer education
saying that is not right, that the only way to reduce your--the
only safe cigarette is not smoking.
Mr. Van Hollen. It's not right, but they continue to be
able to advertise that; right? Right?
Mr. Peeler. There are still claims on packages, yes.
Mr. Van Hollen. Thank you.
Chairman Tom Davis. Any more questions of this panel before
we move on to the next panel?
If not, let me dismiss this panel with our thanks. Thank
you very much. You've added greatly to our wealth of
information.
We'll take about a 3-minute recess as we switch. We'll be
back in about 3 minutes.
[Recess.]
Chairman Tom Davis. We now move to our second panel.
We have Michael Szymanczyck, CEO of Phillip Morris USA;
Dorothy Hatsukami from the University of Minnesota; Dr. Jack
Henningfield from Johns Hopkins University School of Medicine;
Dr. Lynn Kozlowski from Penn State University. David Sweanor is
still at the other hearing. He's from the Non-Smokers' Rights
Association.
Excuse me. He just came. Perfect timing.
Do you need a minute or anything or are you OK?
Mr. Sweanor. I'm fine.
Chairman Tom Davis. David Burns from the San Diego School
of Medicine, and Mr. Richard Verheij from U.S. Smokeless
Tobacco. He's here as well now. Great.
As the policy of our committee, we swear in all the
witnesses before you testify.
[Witnesses sworn.]
Chairman Tom Davis. In order to allow time for questions,
if you would limit your testimony to 5 minutes or thereabouts.
When it turns orange, 4 minutes is up. When it's red, your 5
minutes are up and move to summary.
Mr. Szymanczyck, I will start with you, and we'll move
straight down the row. Thank you for being a witness. You're
testifying here today voluntarily, and we're happy to have you.
Thank you.
STATEMENTS OF MICHAEL E. SZYMANCZYCK, CHAIRMAN AND CEO, PHILIP
MORRIS USA, INC.; DOROTHY K. HATSUKAMI, PROFESSOR, UNIVERSITY
OF MINNESOTA; JACK HENNINGFIELD, PROFESSOR, DEPARTMENT OF
PSYCHIATRY AND BEHAVIORAL, JOHNS HOPKINS UNIVERSITY SCHOOL OF
MEDICINE; LYNN T. KOZLOWSKI, PROFESSOR AND HEAD OF DEPARTMENT
OF BEHAVIORAL HEALTH, PENNSYLVANIA STATE UNIVERSITY; DAVID T.
SWEANOR, SENIOR LEGAL COUNSEL, NON-SMOKERS' RIGHTS ASSOCIATION;
DAVID M. BURNS, PROFESSOR, SAN DIEGO SCHOOL OF MEDICINE,
UNIVERSITY OF CALIFORNIA; RICHARD H. VERHEIJ, EXECUTIVE VICE
PRESIDENT, U.S. SMOKELESS TOBACCO CO.
Mr. Szymanczyck. Thank you, Mr. Chairman and members of the
committee. On behalf of the more than 12,000 employees of
Philip Morris USA, I am very honored today to respond to the
thoughtful questions that the chairman posed regarding the
development of potentially reduced risk and reduced exposure of
tobacco products. I think these issues are important and
timely, especially in the context of the unique dangers of
tobacco.
There is no safe cigarette. Smoking causes lung cancer,
heart disease, emphysema, and many other diseases; and the best
way to reduce the risks of these diseases is to quit. Smoking
is addictive, and the public health community unanimously
encourages people to quit smoking. Nevertheless, many adults
continue to smoke, and these millions of adult smokers should
not be discarded by our national tobacco policy. In addition to
preventing you from smoking and encouraging cessation, the
government should seek products that will be of potential
benefit to these people.
These issues have been significant factors in leading us to
strongly support passage of meaningful and effective regulation
of tobacco products by the Food and Drug Administration, like
that contained in the chairman's bill H.R. 140 and like a great
majority of the bill introduced in the last session by Senators
Kennedy and DeWine, S. 2626.
We believe that these objectives can best be achieved by
FDA regulation. Guided by the Institute of Medicine's landmark
report on reduced risk and reduced exposure to cigarettes, that
report commissioned by the FDA suggested 11 regulatory
principles as a road map to the development and the scientific
and social evaluation of these products.
At Phillip Morris USA one of our highest priorities has
been and continues to be the development of cigarettes that
have the potential to reduce harm caused by smoking, and the
lessons we have learned reaffirm the Institute's
recommendations. Simply put, the public health community has
identified a number of compounds that are harmful to smokers
without definitively settling on any specific one or
combination as the recognized cause of lung cancer or other
diseases. Accordingly, our strategy at Philip Morris USA is to
try to reduce smokers' exposure to as many of these compounds
as we can with products that are acceptable to consumers and
don't cause unintended consequences in the marketplace. If we
are successful in finding ways to reduce harmful compounds and
smokers' actual exposure to them under real world conditions,
we believe that, although it will take some time, the FDA will
be in a position to help us evaluate whether our product
development efforts are actually reducing the risk of tobacco-
related diseases among current smokers.
At Philip Morris USA we have extensive internal and
external research programs, and we believe that we are making
progress with two distinct types of products. One product,
called Accord, is an electronically heated cigarette, heating
tobacco to a lower temperature which yields lower quantities of
certain potentially harmful compounds. A second product is a
traditional cigarette with a state-of-the-art activated carbon
filter which likewise reduces some of the compounds in smoke.
We strongly agree that the Federal Government should help
determine what is and what is not a reduced exposure or a
reduced risk tobacco product. The best approach is for the FDA
to make such determinations based on the best available
scientific information and to encourage innovation and
competition in the development of new technologies. Then the
FDA should play an important role in overseeing any claims,
explicit or implied, made by manufacturers regarding potential
benefits.
As I remarked earlier, there is a real urgency to this
legislation. As the IOM noted, novel tobacco products are being
introduced and marketed today without significant regulatory
oversight, and we are convinced that the status quo doesn't
serve smokers or society.
As an example, we may soon face a serious dilemma. If we
become convinced that a product is potentially better for the
consumer, presenting real reduced exposure, that may one day
reduce the risk of a disease, the fact is that until FDA
oversight is in place we will not have an accepted and official
external process to review our work. We intend to responsibly
bridge this transition period and to continue to take our
research to a number of government agencies and scientific
organizations for review and comment, but in the context of
this situation, the sooner we have FDA regulation the better
for everyone.
These issues are complex and controversial, but we pledge
to be a constructive force in shaping this policy and to work
with anyone and everyone who wishes to join into this
challenge, and we thank the committee for holding this hearing
and for attention to this matter.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Mr. Szymanczyck follows:]
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Chairman Tom Davis. Dr. Hatsukami.
Dr. Hatsukami. Mr. Chairman, I want to thank you for the
opportunity to present before this committee.
My name is Dorothy Hatsukami, and I'm a professor at the
University of Minnesota Medical School. I have conducted
research in the area of tobacco dependence for over 20 years.
During the past 4 years I've been funded by the National
Institutes of Health to study approaches and measures for
reducing tobacco toxin exposure. I also served on the Institute
of Medicine committee that examined the issue of tobacco harm
reduction. I've been asked to answer questions on the
feasibility and acceptability of reduced exposure, reduced risk
products as an alternative to smokers and the research
challenges that are related to tobacco harm reduction.
At the present time, the feasibility or acceptability of
reduced exposure, reduced risk products as an alternative for
smokers unable to quit is simply unknown. It is important to
keep in mind that assessment of these products and any claims
of reduced exposure of risk involve examining the impact on the
individual as well as the population at large. For example,
individuals may show a reduction in tobacco toxin exposure.
However, if more people start tobacco use or fewer people quit
because they perceive these alternative products as safer, the
total net harm may be increased.
The following four steps should be taken to assure public
health and to avoid public health disaster. To date, quitting
tobacco is the only known way to reduce tobacco-related
mortality and morbidity. Thus, strong messages for tobacco
prevention and cessation should continue to be the primary
focus with the public. Furthermore, priorities should be given
to continued efforts to develop, promote, and provide
treatments for cessation. Currently, medicinal nicotine
products yield a significantly better safety profile than any
tobacco products. In our study, subjects assigned to the
nicotine patch condition experience significantly less
carcinogen levels than those assigned to reduced exposure
smokeless tobacco or cigarette products. Therefore, the
priorities should be to provide and promote the safest product
for our tobacco users and to increase the success rates for
abstinence by improving on our existing treatment methods.
Second, a strong research agenda should be developed that
addresses, one, understanding tobacco addiction and developing
the best treatments possible to achieve abstinence; two,
developing and testing biomarkers that measure tobacco toxin
exposure and that are related to the development of disease
states; three, determining the extent of reduction in tobacco
toxin exposure that will result in reduced risk for disease;
four, determining the absorption of tobacco toxins from these
tobacco products in humans and understanding the reasons for
individual differences in the degree of exposure and disease
susceptibility; five, determining how messages regarding these
potential reduced risk products can be conveyed to the public
so that the prevention or cessation efforts are not
compromised; and, six, examining the prevalence and pattern of
use of these reduced exposure products either alone or in
combination with conventional tobacco products. To date,
current knowledge in these areas is very limited.
Third, organizations independent of the tobacco industry
should test and determine the impact of these products. These
organizations should test for toxins within the product itself
and in the case of cigarettes, as it is burned. In addition,
the uptake of tobacco toxins in these reduced risk products and
the consequences of this exposure should be assessed. An
independent organization could also be responsible for
conducting postmarketing surveillance in order to assess for
prevalence and pattern of use of tobacco products with
purported reduced exposure.
Finally, regulatory authority over tobacco products is
essential. An organization such as the FDA that can critically
evaluate the evidence base for exposure reduction claims as
well as regulate marketing efforts is crucial to protect the
public health. Without oversight, the public could not be
assured of the validity of the industry claims of reduced risk
or informed about tobacco toxin constituents to which they are
exposed; and therefore informed decisions could not be made.
Tobacco companies need to be required to submit their novel
products and claims to the FDA prior to the appearance of these
products and claims regarding these products in the
marketplace.
The FDA should also be given the authority to establish
manufacturing standards for all tobacco products so that
development of less toxic cigarettes or other tobacco products
can become standard rather than the exception. To me, it is
unconscionable that we currently have the technology to
potentially reduce toxin in tobacco products and yet do not
have a mechanism in place to require that all tobacco products
meet these lower levels. Requiring the reduction of tobacco
toxins in all tobacco products would be important should they
be demonstrated to lead to potential reduction in risk for
disease.
In summary, the answer to the questions regarding whether
reduced exposure, reduced risk products are alternatives for
smokers who are unable to quit depends on the effects of these
products on the individual and the population at large, which
is information that we do not yet have. Therefore,
understanding the impact of these products on public health
will require research. In addition, we need to develop the
infrastructure and the resources to conduct the necessary
research and to evaluate these products at all levels. But to
fully protect public health, we need FDA regulatory authority
over tobacco products.
Thank you again for this opportunity to present to you.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Dr. Hatsukami follows:]
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Chairman Tom Davis. Dr. Henningfield.
Dr. Henningfield. Thank you very much.
I am speaking here on my own behalf and not as a
representative of the organizations of which I am a member or
serve.
I am professor of the Johns Hopkins Medical School,
director of the Robert Wood Johnson Foundation Innovators
Awards Program, and vice president of Pinney Associates. In
addition, I consult on treatment products such as nicotine gum
and patch, and I share a patent on a potential new product.
This gives me real-world experience on the challenges of
product development and the challenge of threading the eye of
the regulatory needle.
Let me start with a few fundamental facts.
Chairman Tom Davis. I want to make sure your mic is on. Is
it on?
Dr. Henningfield. It is.
Chairman Tom Davis. Put it a little closer to you.
Dr. Henningfield. Is this better? I'm sorry. Should I start
over or keep going?
Chairman Tom Davis. Go ahead. Keep going.
Dr. Henningfield. Thank you.
A few fundamental facts. Tobacco addiction is the most
pernicious and persistent form of all forms of drug addiction.
It leads the majority of users to daily, deadly use with 50
percent of regular smokers dying prematurely. Tobacco cessation
is the only scientifically proved route to reducing disease
risks, and the benefits are powerful and fast for one of the
biggest killers of tobacco users, heart disease. Cessation also
benefits children. It reduces the risk of asthma and other
diseases and keeps them from smoking.
Comprehensive tobacco control efforts are based on solid
public health principles. They reduce tobacco use, and they
save lives.
We've seen striking increases in cessation and declines in
tobacco use by kids in recent years. Tobacco programs work,
especially in individual States that have implemented the
programs most dramatically.
Could we reduce the risk of disease with products that are
less poisonous? This was the premise of the Federal Trade
Commission's approach to encourage reduced tar and nicotine
cigarettes beginning in the 1960's. It was also the implied
premise of smokeless tobacco products marketed to high school
college athletes beginning in the 1970's. What happened? Light
cigarettes delayed quitting, and supposedly safer smokeless
tobacco was a magnet for athletes who were considered to be at
very low risk for any form of tobacco use. Both experiments on
the American people were disasters and went awry for decades
before individual independent researchers and not the companies
revealed the public health damage.
This experience is a reminder that the road to harm
reduction is paved with good intentions but littered with land
mines. It should be navigated with science and regulatory
oversight. This was the core path articulated in the 2001 IOM
report.
FDA regulated cessation products are tested for safety and
efficacy. Their labeling and marketing is regulated to promote
proper use and discourage harmful use. They improve public
health by helping people achieve freedom from tobacco. None are
known to cause problems such as initiating nicotine dependence,
fostering tobacco use or delaying cessation.
On the other hand, in the vacuum of FDA regulation of
nonmedicinal nicotine products, the 19th century days of snake
oil have reemerged with a vengeance. Some of these products are
before you, in front of me. New products have been released
every 3 to 4 months, with no sign of letting up.
These products include nicotine delivery devices that are
heated by carbon fuel and electronic ignition systems, a Tic
Tac-like tobacco lozenge, and smokeless products marketed to
help smokers remain smokers with slogans such as ``Any Time Any
Where'' or for ``When You Can't Smoke.'' There are cigarettes
implying safety with health claims of ``reduced carcinogens,''
``the next best thing to quitting,'' ``80 percent less second-
hand smoke.'' One has a misleading claim of ``nicotine free.''
By Internet, there are lollipops--complete with ``lollipop
luggage;'' nicotine water; and, most recently, nicotine wafers.
Some of these products have Web sites amounting to virtual
versions of horse-drawn patent medicine carts. Absent
meaningful nicotine regulation, absent the science foundation,
Americans are guinea pigs for these products.
Is it possible that some of these products are real
advances toward improved public health? Perhaps, but there is
no way for consumers, public health officials, or Congress to
know. Why? Because these products have not been rigorously
studied by independent scientists, and we lack an FDA system of
regulation built around the key principle of premarket
evaluation. FDA regulation can expedite a drug to help people
quit, it can expedite development, or it can crush it.
The agency's flexible, encouraging approach to AIDS
medicines development helped lead the world away from the view
of AIDS as a death sentence to the understanding of AIDS as a
treatable and manageable disease. Unfortunately, with tobacco
treatment products, FDA has not kept pace with the public
demand or potential new treatment developments.
Tobacco users want and need increasingly flexible products.
Much more is possible. Medications could be used to reduce
smoke exposure, but FDA inflexibility has left such
applications on shelves.
With support from NIH, small developers have made great
progress on a vaccine-like long-acting medicine to help people
stay quit if they quit, but this may require an entirely new
model of FDA evaluating efficacy.
In short, FDA has existing authorities that could unleash
improvements in treatment, appeal, diversity and availability.
It just needs to apply them.
In conclusion, I urge that you consider the wisdom of
former Surgeon General C. Everett Koop who testified in support
of over-the-counter marketing of nicotine gum and patch. In
summary, he said, it's easy to get the disease, hard to get
treatment. As a Nation we must reverse this.
FDA issued its rule to regulate tobacco in the same year it
approved over-the-counter nicotine gum and patch. Time has
proved that FDA was on target from the perspective of science
and health. We need to get back on track. We need FDA to be
appropriate and flexible. We need it to be engaged. We need it
to be supported by equally engaged CDC and NIH efforts to
provide the science and surveillance to assure that we are on
the path to better health in America.
Thank you very much.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Dr. Henningfield follows:]
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Chairman Tom Davis. Dr. Kozlowski.
Dr. Kozlowski. Thank you for this opportunity to testify.
It's an honor to be here.
I'm professor and head of the Department of Biobehavioral
Health at Penn State. My opinions are my own and not
necessarily those of Penn State.
Strong, pharmaceutical-type governmental regulation of all
tobacco products is urgently needed. Such regulation will
provide grounds for commercial claims, help reduce product
risks, and help prevent continued abuses of consumers.
Some prominent governmental public health information on
smokeless tobacco already makes health claims, is fundamentally
misleading, and is not supported by science. Let me repeat
that. Some prominent governmental public health information on
smokeless tobacco already makes health claims, is fundamentally
misleading, and is not supported by science.
If I were drafting a Web page for youth on smokeless
tobacco and cigarettes, I might begin: ``you are dumb to use
smokeless tobacco and you are way dumber to smoke.''
Contrast the National Center for Drug Information, a
government Web site, Tips for Teens: The Truth About Tobacco.
Question: Isn't smokeless tobacco safer to use than cigarettes?
No. There is no safe form of tobacco.
As generally available in the United States, smokeless
tobacco is doubtless safer than cigarettes to individual users.
For example, smokeless tobacco is not a significant cause of
lung cancer or other respiratory disease, which together
account for about 60 percent of death from cigarettes.
Individuals have rights to honest health information.
Disinformation should not be used to discourage tobacco use.
Making a smokeless tobacco user of any age think that smokeless
is just as dangerous as cigarettes could actually foster a
switch to cigarettes.
But doesn't smokeless tobacco cause cigarette smoking?
The terms ``Gateway'' and ``Starter product'' are
ambiguous. They confuse the correlational effects and causative
effects. Concern about product switching should arise mainly if
smokeless tobacco as a significant cause of subsequent smoking,
but there is little evidence of causation. Rather, it is more
likely due to other factors--for example, risk taking--making
some individuals more likely to experiment with both tobacco
products and make other individuals less likely to experiment
with any tobacco products.
The large majority of male smokeless tobacco users in the
United States appear to either have used smokeless tobacco
only--and to have never smoked--or started smoking before using
smokeless. Therefore, neither group began to smoke as a result
of smokeless tobacco use. Research on smokeless tobacco should
also explore the extent to which smokeless could prevent
smoking in high-risk youth.
I have been asked to talk about the risk/use equilibrium
briefly. Some have expressed concern that more individuals
using a reduced-risk product could lead to an overall public
health loss. The risk/use equilibrium offers a sense of scale
to this truism. Basically the equilibrium plots, for increasing
levels of risk reduction, how much increase in use is needed
for no change in public health cost to result from a new
reduced-risk product. With only a small reduction in risks, as
perhaps from a novel cigarette product, even a small increase
in the percentage of users of this product could eliminate any
public health benefit. For products that reduce risks
dramatically, such as medicinal nicotine products, the likely
risk reduction is so large that the chances for a net public
health loss are vanishingly small, if not impossible. For low-
nitrosamine moist snuff, the risk reduction is probably so
large that an increased number of users would also be unlikely
to reach the level of producing a net public health loss.
It will be challenging and may take years to do the needed
research to confirm the likely small risks from novel smoke
products. However, current toxicological and epidemiological
research on smokeless tobacco in the United States and even
more so from medicinal nicotine show that significant risk
reduction is available in these products.
In closing, the current regulatory vacuum should not keep
us from saying: To use smokeless is dumb and to smoke is
dumber--much dumber. That there is a promise of harm reduction
from smokeless tobacco and medicinal nicotine should add to the
urgency of objective governmental regulation. Without such
strong regulation, this promise could easily be wasted.
Thank you.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Dr. Kozlowski follows:]
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Chairman Tom Davis. Mr. Sweanor.
Mr. Sweanor. Thank you very much. I'm also going to be
speaking on my own behalf, rather than organizations that I
work with.
My name is David Sweanor. I'm a lawyer based in Canada.
I've spent just over 20 years now working full time on a whole
range of tobacco-control policies in Canada and around the
world, many of which I believe have been very successful and
certainly had significant impacts in overall consumption; and
issues of toxicity reduction is something that I'm very
interested in.
I think, to put it all in perspective, what we're looking
at by way of policy in tobacco control and public health goals,
is we're trying to reduce death and disease as much as we
possibly can; and there's really three ways we can do that: We
can prevent the onset of tobacco use, we can encourage and
facilitate cessation, and we can reduce toxicity for those
people who don't quit.
This is an incredibly important task, given the size of the
health problem; and you all have heard that from many people. I
need not repeat it, but I think it's worth noting a few things
about the lack of information smokers have.
Many smokers believe light cigarettes are significantly
less hazardous. I think that is one of the most pernicious
frauds that either of our countries currently face. They also
believe that nicotine causes cancer and, as a result, they're
less likely to use approved, effective nicotine medications to
help them quit. If they do use them, they won't use as much as
they should or for as long as they should. They also believe
that smokeless tobacco causes cancer every bit as much as
smoking, hence are less likely to use it.
Well, is there a way out of this mess? I think there is
because at least theoretically, if we look at this, nicotine is
the primary reason why people smoke, but combustion is the
primary reason they're dying. Were we to introduce cleaner
delivery systems at least in theory that makes a whole lot of
sense, and if we're able to do this through some sort of
regulated framework from a body that FDA would make available I
think reduced toxicity could really complement what else we're
doing on prevention of onset and cessation.
I don't think this is just theoretical. When we look at
alternative products, we know, for instance, that medicinal
nicotine products have been used by some people for long
periods of time with no indication of adverse effects. We also
know that many other countries have approved these medicinal
products, things like patches and gum, etc., for uses that are
not approved for here; that it can be used longer term; it can
be used for smoking reduction; it can be used for temporary
abstinence, relapse prevention.
In the case of smokeless tobacco, there is an absolutely
fascinating example from Sweden where a market has been
transformed from one that was dominated by combustion-based
delivery to one now dominated by smokeless products, and the
smokeless products simply don't have the same sort of health
impact. The disease rates in Sweden follow the trends of
smoking rates, not the trends of overall tobacco use.
So were we to move on this I think we do need to look at
some sort of comprehensive oversight. It has to be something
like FDA and for various reasons, in terms of protecting public
health, giving consumer protection and actually allowing the
market to function.
We need to have answers to some questions such as just how
much less risky is a product compared to cigarettes on a one-
for-one basis. I think that's an easy determination to make
with medicinal products. I think it's an easy determination to
make for low-nitrosamine smokeless products. But what about the
whole range of other products that people are bringing out? How
do we make that determination? How do we look at what impact
these products will have if they only replace some cigarettes?
Where do we put these products on a range of the continuum of
risk so that we can give people information about where they
can be in terms of relative risk? How do we make sure these
products aren't going to interfere with cessation or encourage
uptake of smoking? And how do we communicate messages?
I think this is an absolutely critical issue now because
even if tobacco companies were to give totally accurate
information that could truly save people's lives, nobody will
believe them. There has to be some way of giving information to
the public that the public will actually understand and trust.
These are very tough issues. I think we know where we need to
be. There's a serious question of what do we do in the meantime
and how do we get there.
I think certainly as a preliminary step we should be
looking at the FDA and the FTC, using the regulatory authority
they already have over medicinal products to liberalize that
market, make these products more widely available for a wider
range of indicated uses. That's a first step.
I think it should be fairly quick to move on issues like
low-nitrosamine smokeless tobacco products, but I think we also
need discussion, getting more dialog because, ultimately, we're
in a situation now where there's no longer a question of
whether there will be alternatives to cigarettes or whether
consumers will get information, it's how do we evaluate these
products and how would we make sure they get accurate
communications?
Thank you.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Mr. Sweanor follows:]
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Chairman Tom Davis. Dr. Burns.
Dr. Burns. Thank you, Mr. Chairman and members of the
committee. I'm delighted to be here in front of you.
I am David Burns. I'm a professor of medicine and professor
of family and preventative medicine at UCSD School of Medicine.
I was the editor of the monograph on low tar cigarettes for the
National Cancer Institute. I chair a committee for the State of
Massachusetts to advise them on the measurement of harm
reduction, and I sit on the Scientific Advisory Committee on
Tobacco for the World Health Organization which looks at
regulatory issues. I have also testified in litigation against
the tobacco industry. My opinions are my own and not any of
those organizations.
I've been asked to address the issues of what lessons we've
learned from our experience with low tar and nicotine
cigarettes, and I think that there are several. The first of
them is that no single test can be an adequate measure of the
risk potential for these products. That is true not only
because it is a complex issue. It is also true because the user
interacts with the product, and design changes will lead people
to use a product differently, and therefore a single test or a
single protocol cannot reflect that diversity of actual use.
The second lesson we've learned is that external tests of
the product are really not adequate. We need to have tests
derived from the use of the product in people who actually use
it. The complexity of transferring from chemical measurements
to actual human exposure is formidable, and it is not possible
from simple chemical measurements to understand the level of
exposure that individuals will actually receive. We need to
assess the exposure that occurs in the people who actually use
the product, and we need to base that assessment on what their
other choices might have been. A product that substantially
lowers the toxicity of exposure will not be a harm reduction
product if the people who use it would otherwise have quit
smoking, and so the interpretation of data from these products
needs to be done in the context of people who actually use it
and what their other choices might have been. The claims that
are made quite obviously need to be based on science, and we
need to be sure that the claims made do not exceed the existing
science that is available.
Last, as everyone has told you today, harm reduction can
only be assessed in the context of adequate regulatory control
by an agency that has sufficient scientific expertise to
interpret the data presented to it. Absent that regulatory
control, we cannot ensure that accurate information will be
provided to the consumer.
I thank you for your attention.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Dr. Burns follows:]
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Chairman Tom Davis. Mr. Verheij.
Mr. Verheij. Mr. Chairman and members of the committee,
good afternoon.
I am Richard Verheij, executive vice president, external
affairs for U.S. Smokeless Tobacco Co. I would like to thank
this committee for convening this hearing to examine the issue
of tobacco harm reduction and the regulatory challenges.
We see this hearing as a significant step in the country's
ongoing efforts to address the issues raised by the continued
use of tobacco products by millions of Americans. Indeed, 50
million Americans smoke. The Institute of Medicine has
predicted that a significant proportion of those individuals
will continue to do so despite a multitude of approaches with
the ultimate objective of total tobacco cessation. This
prediction has prompted the public health community to consider
new complementary strategies, including tobacco harm reduction.
As we proceed today, it's helpful to keep a couple of
things in mind. First, this debate is not about whether
smokeless tobacco is considered safe. Rather, it is about the
increasing consensus in the public health community that
smokeless tobacco is significantly less harmful than
cigarettes.
Second, this debate is not about whether smoking cessation
is the best public health strategy. Rather, it is about whether
there are complementary strategies which public health
advocates believe will save millions of lives.
We're here today because of the millions of adult smokers
who do not quit and do not use medicinal nicotine products.
Many in the public health community believe that a harm
reduction strategy based on communicating to adult smokers
truthful information about other options can have a significant
impact on both those individual adult smokers and public health
generally. Simply stated, many researchers have expressed the
opinion that use of smokeless tobacco is significantly less
harmful than cigarette smoking. Based on that judgment, these
same researchers advocate that adult smokers who do not quit
and do not use medicinal nicotine products switch completely to
smokeless tobacco.
There is increasing consensus on this crucial issue among
members of the public health community, some of whom are
testifying before this committee today. However, despite this
increasing consensus, it is documented that the vast majority
of adult smokers are unaware of this information. One
researcher has stated that, ``until smokers are given enough
information to allow them to choose products because of lower
health risks, then the status quo will remain.''
Our company, along with those public health advocates,
believes that it is crucial that this information be made
available to adult smokers. Such communication will help adult
smokers make more informed decisions.
We look forward to discussing the real question, how best
to communicate this important information. We know there are a
variety of opinions on this topic. We welcome a serious and
open dialog that brings to the table all the relevant parties
to express their viewpoints and concerns. That is why we urge
the Federal Trade Commission to initiate a forum that will
bring together researchers, public health advocates,
regulators, tobacco control experts, and tobacco product
manufacturers to examine the most appropriate means for
communicating this information to adult smokers.
Let me state clearly for the record that U.S. Smokeless
Tobacco Co. is committed to restricting tobacco use to adults
only. This commitment is not just rhetoric. It is backed by
concrete action. In 1997, we were the only smokeless tobacco
company to support the proposed tobacco resolution. When that
proposal failed, we became the only smokeless tobacco company
to enter into the Smokeless Tobacco Master Settlement Agreement
with attorneys general of 45 States in various territories.
We are providing more than $100 million to the American
Legacy Foundation for programs to reduce youth usage of
tobacco. Our company is committed to proceeding in a
responsible and deliberate manner that reflects the current
state of the science and addresses the concerns of the public
health community.
This debate presents a broad societal question: How should
we collectively communicate information to adult smokers that
many in the public health community believe will prolong and
save lives? This is truly an unprecedented opportunity. Public
health advocates, researchers, tobacco control advocates, and
tobacco product manufacturers all agree on the fundamental
principle that a harm reduction strategy could represent an
important component of a comprehensive public health policy on
tobacco. There may be disagreement on how best to implement
this strategy. Nevertheless, given the stakes, this issue
deserves serious consideration. We believe this hearing
represents a significant step in this process.
May I ask that U.S. Smokeless Tobacco Co.'s written
statement submitted to the committee on May 30 be incorporated
in its entirety to the hearing after testimony today.
Chairman Tom Davis. Without objection, so ordered. Thank
you very much.
[The prepared statement of Mr. Verheij follows:]
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Chairman Tom Davis. I want to thank all of you.
This is actually a historic occasion, Mr. Szymanczyck,
hearing your testimony here today, contrasting with--as you go
over the past years what we've heard from other executives.
Let me ask a question to you and to Mr. Verheij. How can
the public be sure that the products you want to market as
reduced risk really are reduced risk, won't be harmful to
public health, won't be marketed to children, aren't just an
attempt to increase market share?
Mr. Szymanczyck. Well, Congressman--Mr. Chairman, I----
Chairman Tom Davis. I like ``Mr. Chairman'' better.
Mr. Szymanczyck. I believe that the public shouldn't have
to trust the tobacco company in that regard. I believe that
there needs to be a process for them to trust and that there
needs to be someone in charge of that process that they can
trust and that's why I'm supporting FDA regulation and
supporting a process outlined by the Institute of Medicine to
deal with a particular issue within FDA regulation and that's
the development of reduced exposure so-called reduced harm
products.
I think that they have to have some sort of an external
process, and when you look at a piece of legislation like H.R.
140 what you see is that it spells out regulatory authority for
the FDA, in particular, over these reduced harm products as
well as all other tobacco products, and it also gives the FDA
authority to make decisions about communication so as to make
sure that, for example, kids aren't induced to smoke or other
unintended consequences like people who were former smokers
starting to smoke or situations where people who might be
quitting might make a decision to continue to smoke. So I don't
think that it's the tobacco company they should trust. I think
it's the process, and I think that process needs to be driven
by the FDA.
Chairman Tom Davis. There is considerable risk for your
company in doing that. They may decide your ultra lights don't
meet their criteria or something under those circumstances,
right?
Mr. Szymanczyck. Absolutely. I think that is correct, But I
think that is what we have to do.
Chairman Tom Davis. Let me ask you, Mr. Verheij. I
understand you like the FTC as opposed to the FDA on this. Is
that correct?
Mr. Verheij. Let me start with the underlying premise.
Unlike claims associated with new reduced-risk products, there
are a number of leading medical and research institutions
around the world and many researchers who already believe the
data that is there to conclude that smokeless tobacco is
significantly less harmful than cigarettes. The question is,
should that information be communicated to adult smokers who do
not quit and do not use medicinal nicotine products? After all,
that market is 50 million adult smokers. The fact is that no
person under the age of 18 need ever take up smokeless tobacco
because the 50 million adult smokers is a huge opportunity to
market to.
There are steps that we can take to make sure that these
communications are not directed at nonconsumers, at persons
under the age of 18, or at persons who have already quit. So we
believe that while the process--and we believe this is a
process. The process has started over a number of years. A step
in the process was the Institute of Medicine report. A step in
this process, frankly, was our filing with the Federal Trade
Commission, because that is the agency which is charged with
regulating tobacco advertising, tobacco communications.
We went to the Federal Trade Commission because we thought
it was the responsible thing to do in terms of starting to make
these types of communications to adult smokers. We are all here
because there is significant controversy about doing that. So,
at the time, the Federal Trade Commission was the agency
charged with doing so. We know that they are quite able to go
to FDA and to any other arm of the government, as Chairman
Muris testified in the other hearing this morning, or to go to
outside experts to evaluate the science and the line of claims.
We thought that would be a significant advance of the process,
as are this hearing this afternoon and the hearing this morning
also significant steps in this process.
Chairman Tom Davis. Thank you.
Let me just ask quickly, Dr. Burns, you've had extensive
experience in this through the years. The Swedish experience is
often sited as an example of reduced tobacco in action. Could
you offer your thoughts? Is smokeless tobacco less harmful than
cigarettes? And, if so, is it responsible to convey this
information to current smokers?
Mr. Burns. The answer to your question is both yes and no.
There is no question that smokeless tobacco is less harmful
than cigarette smoking for individuals who have used it
exclusively for their lifetime. That information is only
relevant to individuals who have never used either product, and
the clear public health recommendation for those individuals is
not to start using either.
We lack three critical pieces of information. The first is
the harm to people who have switched after substantial use of
cigarettes to smokeless tobacco. We don't have data on that. We
also don't have data that individuals who would not otherwise
quit can be persuaded to switch to smokeless tobacco as adults.
And, third, we don't know the impact of a harm reduction
message keyed to adults on the absolute rate of initiation of
smokeless tobacco use among adolescents.
Those questions are very critical ones to allow--that would
need information in order to allow us to assess whether or not
that type of claim should be made and whether, if the claim is
made, it will create a benefit or cost to society.
Chairman Tom Davis. Thank you very much. My time is up.
Mr. Waxman.
Mr. Waxman. Thank you very much, Mr. Chairman.
If we are going to have risk reduction kinds of products,
it seems to me that the place to evaluate it is among
scientists; and the FDA has been entrusted with looking to see
whether a product, if it is marketed for a medical or health
result, is efficacious, it actually accomplishes that result.
Now it seems to me that your position is that the FDA
should have that power. Is that right, Mr. Szymanczyck?
Mr. Szymanczyck. That is correct.
Mr. Waxman. Now, Mr. Verheij, don't you think the FDA ought
to have that power?
Mr. Verheij. Well, I think--we've looked at the current FDA
proposals, and the concern we have with any of the current FDA
proposals is they would actually--the mechanisms would preclude
the types of cross-category claims that we would like to make
against the products that Mr. Szymanczyck's company makes. We
have laid out in a----
Mr. Waxman. I don't understand why that is the case. If you
want to make a claim that using smokeless tobacco is less
harmful than cigarette smoking and that people ought to use
smokeless tobacco instead of cigarettes, it seems to me that
there is some scientific findings that have to be made before
we reach the conclusion that is a good recommendation to the
American people. The place to do that is among scientists, and
FDA has always been the place where scientists have made those
kinds of evaluations.
Mr. Verheij. Well, I think I am talking more about
structural impediments in many of the current FDA proposals,
such as--and we met with your staff about 10 days ago, I think,
including your bill, Congressman, which would preclude those
types of claims which, from our standpoint, doesn't make sense.
Mr. Waxman. OK. Let me ask you this. I understand that you
are hesitant to say FDA ought to do it. My view is, if you go
to the Federal Trade Commission, they can only act after the
fact. So in effect what we are doing is trusting U.S. Tobacco
to regulate itself, and I want to ask whether that is a wise
decision. It is my understanding that U.S. Tobacco has never
accepted that smokeless tobacco causes mouth cancer or that
smokeless tobacco is addictive. Is that still your position?
Mr. Verheij. Well, first of all, as defined by the Surgeon
General, smokeless tobacco is considered to be addictive.
Mr. Waxman. Did you accept that? Is that your position? Not
just the Surgeon General's position.
Mr. Verheij. Well, as defined by the Surgeon General, it is
considered addictive. And I think there is really----
Mr. Waxman. Do you agree with the Surgeon General?
Mr. Verheij. Well, as defined by the Surgeon General,
exactly, it is considered addictive. No doubt.
Mr. Waxman. I see. And it does cause mouth cancer?
Mr. Verheij. Well, based on the scientific data, scientific
literature, taken as a whole, we have not taken a position that
the product is safe.
Mr. Waxman. I haven't heard such a way of avoiding an
answer since I had the CEOs in 1994 before me. They have all
come around to admitting the connections between cigarette
smoking and disease. It seems to me you are hedging on that
issue.
Last month, I wrote to all Members to express my concern
about UST's request to market smokeless tobacco with health
claims, and UST sent me a response about 10 days ago. Since
receiving that response, I have obtained copies of internal
documents that flatly contradict U.S. Tobacco's statements.
I want to ask unanimous consent to include in the record a
letter I have written to Chairman Davis that describes and
attaches these documents.
Chairman Tom Davis. Without objection, it will be made part
of the record.
[The information referred to follows:]
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Mr. Waxman. In UST's response to me 2 weeks ago, the
company claimed it never employed a graduation strategy to hook
young people on starter products and then move them to more
addictive products. Is this still your position?
Mr. Verheij. Well, I think we were asked that same question
10 years ago and we had thought we had adequately responded to
that in terms of the graduation process or the discussion by
some people. The company never drove the marketing strategies
of our company, because----
Mr. Waxman. One document I have, and I have introduced
today, was a memo from the senior vice president of marketing
to the president of the company; and it shows the company's
objective is, ``provide new users with an easy graduation
process.'' Now, UST also wrote me that it was baseless to
suggest that cherry flavoring was added to smokeless tobacco in
order to attract young people. Is that still your position?
Mr. Verheij. Absolutely. I think if you go into the local
pharmaceutical today, there are a lot of cherry-flavored
products like Maalox, all intended for adults. In fact, they
have a proviso on the back of the label that says, keep out of
the hands of children. Cherry is a very appealing flavor
amongst adults, and it has been a flavor that has been used in
conjunction with tobacco products for over 150 years.
Mr. Waxman. Well, the document that is now in the record
demonstrates that there was a clear understanding by the senior
vice president of marketing and president, they understood
that, ``younger and lighter users prefer a flavor, not
unnatural,'' while older and heavier users prefer real tobacco
taste. Do you still think it is baseless to think that cherry
flavors were added to appeal to young consumers?
Mr. Verheij. As I said, there are a number of products
clearly intended for adults on drugstore shelves today.
Mr. Waxman. What about your product? What about your
product? Was that intended to attract kids to use your product?
Mr. Verheij. Not at all. We found that cherry flavor was a
flavor that appealed to adult tobacco consumers.
Mr. Waxman. Well, my point, Mr. Chairman--I know the time
is up. But my point I think is made: U.S. Tobacco simply can't
be trusted to regulate itself. I think the result could easily
be a public health disaster. And I know they are trying to play
games with the Federal Trade Commission to get them to back
away from striking down these irresponsible claims the U.S.
Tobacco wants be making. I think it is irresponsible, and I
have other questions in the second round as to whether this is
really a risk reduction or harm reduction strategy or another
public health disaster in the making.
Chairman Tom Davis. The gentleman's time has expired.
Mr. Shays.
Mr. Shays. Thank you, Mr. Chairman. I will defer to my
other colleagues but before the first round is over I will have
some questions.
Chairman Tom Davis. Mr. Schrock.
Any questions over here? Any other questions?
The gentlelady from California.
Ms. Watson. Thank you so much, Mr. Chairman.
It is too late to deny that tobacco is an addictive drug
that has destroyed the health and caused the early deaths of
millions of people. There is too much at this time damning
scientific evidence about the dangers of nicotine for anyone to
claim that nicotine can somehow be made healthier or less
harmful. Now, I have said--and I want to commend all of the
panelists, the first panel and now the second panelists. But I
just heard a discourse that I would call ridiculous. The
gentleman on the end as he was questioned avoided answering
questions.
To me, cigarette smoking is like rat poison. Any amount of
rat poison is still rat poison. And nicotine, I don't care who
studies, who researches or who uses it or what flavors you put
in, it is still rat poison; and I think any scientific-minded
and thinking person would agree to that.
But I want to ask--is it Mr. Verheij?
Mr. Verheij. Yes.
Ms. Watson. OK. I want to be sure I pronounce your name
correctly.
I am sitting here with cancer facts: Snuff or smokeless
tobacco is a finely ground or shredded tobacco. And chewing
tobacco--and I am going to ask you if this is true and would
you agree with it. Chewing tobacco and snuff contain 28 cancer-
causing agents. Would you agree?
Mr. Verheij. Well, looking at the--as I----
Ms. Watson. Wait a minute. Give me a yes or a no.
Mr. Verheij. Well, these are----
Ms. Watson. My time is short. Give me a yes or no.
Mr. Verheij. I think, if I recall the list correctly----
Ms. Watson. Excuse me. Can you answer yes or no? You might
say, no, you can't answer.
Mr. Verheij. I would need to give a complete answer to
respond to your question.
Ms. Watson. Thank you.
Smokeless tobacco users have an increased risk developing
cancer of the oral cavity. Is that a true statement, yes or no?
Mr. Verheij. Based on the studies that were available in
1986, that is what the Surgeon General concluded.
Ms. Watson. OK. Is there any redeemable features of using
snuff or spit tobacco?
Mr. Verheij. Well, as I think I indicated in the opening
remarks, the----
Ms. Watson. Can you answer me directly when I raise a
question with you? Because my time is short. Do not force me to
run out of time.
Mr. Verheij. In the context of tobacco harm-reduction
strategy, many people believe that smokeless tobacco is an
option that should be taken seriously, yes.
Ms. Watson. You believe smoking tobacco can be taken
seriously--smokeless tobacco can be taken seriously?
Mr. Verheij. I think we heard a number of people on this
panel indicate that it should be taken seriously, yes.
Ms. Watson. When chewing tobacco and snuff contain 28
carcinogens, you think that it should be taken seriously?
Mr. Verheij. I think a number of leading research and
medical institutions agree with that statement, it should be
taken seriously as an option.
Ms. Watson. What do you agree with?
Mr. Verheij. I think they make a very compelling case; and,
indeed, a number of people on this panel have made a very
compelling case for smokeless tobacco as an option for those
adult smokers who do not quit.
Ms. Watson. Mr. Chairman, I have heard these bizarre
arguments and that reduced exposure or reduced-risk tobacco
products are better for your health than regular tobacco
products. If I understand the reasoning correctly, this is kind
of like saying a smaller or lethal dose is better for those who
are trying to stop using tobacco products. I was hoping that in
this hearing we would hear the kind of information necessary to
support the creation of a regulatory framework which would save
our children from the dangers of nicotine. I have heard at
least two of the presenters talk about market share. I have
heard them talk about the marketplace. I am saddened that the
people who are representing the tobacco industry are looking at
market share and marketplace more than look at saving our
children from the dangers of nicotine in any size, form,
dosage, or whatever.
So, Mr. Chairman, I want to thank you for providing us this
hearing so I could hear for myself.
I want to commend the ranking member, because I watched
continuously the hearings that you held many years ago when you
had the representatives of the tobacco industry raise their
hands and you asked them the question: Is nicotine addictive?
And they said no. So I hope we can gain more information. And
thank you for indulging me.
Chairman Tom Davis. Thank you. Let me just note, I think we
have heard today that we didn't hear those comments today. I
think at least in the part of when testifying today that the
industry takes a more responsive view today.
Any questions over here? Mr. Shays.
Mr. Shays. Thank you.
Basically, I come to this hearing with some heartfelt
feelings. One is that you had to be an idiot not to know that
smoking was harmful to your health. For as long as I have
lived, practically, but certainly by the time I was in
elementary school but clearly by the time I was in high school,
and I graduated high school in 1964, I knew that smoking was
very harmful to your health. So I have wrestled with some of
the court cases that have taken place in which people take no
ownership for what they do.
It is very clear that Philip Morris has said that it is
harmful. When they said it wasn't harmful, I frankly thought,
well, that is a foolish statement, because it was harmful many,
many years ago.
I am here because I know people are going to continue to
smoke in spite of the fact they know it is harmful. And I am
intrigued by the process of saying is it a wise public policy
for us to see if we can have less harmful products? Should we
incentivize Philip Morris to come in with a product that is
less harmful?
And I agree with you, Mr. Szymanczyck, there is no way that
someone is going to believe the tobacco company. We need to
have someone from the outside basically pass judgment.
I intuitively believe that if you chew tobacco it is less
harmful. My answer to the question that was asked to you would
have been that, there is no question, Mr. Verheij. I would have
said, you know, it does cause cancer and we know it. But I
guess we are not there yet in saying it. But in terms of--
because both are harmful. And I think you know that, and I
think you have basically said it without saying it.
So I would like to ask the health care folks. I would say
intuitively that smokeless tobacco is less harmful, but it is
still harmful. I would like to just go down the line with you,
Dr. Hatsukami and Dr. Kozlowski, and I guess, Mr. Sweanor, you
are the only one who is not a health care expert, is that
correct, on this issue? Am I right or wrong?
Mr. Sweanor. I would probably still hold myself out as an
expert.
Mr. Shays. Well, then let's go from our two bookends and
answer the question: Is smokeless tobacco less harmful?
Dr. Hatsukami. I think that on the surface it appears to be
less harmful when you take a look at the effects of smokeless
tobacco products on health compared to cigarettes. But you have
to look a little bit deeper than that. There are a lot more
concerns associated with it. You have to take a look at the
effects on the individual as well as the population level.
On the individual level, people do not do what you want
them to do or what you expect them to do. And my concern about
the claim that smokeless tobacco is less harmful, is that
people will use both cigarettes and smokeless tobacco products.
Mr. Shays. So let me put it in my words, and if I can go
on--and disagree with me if I am wrong. What I sense you saying
is, if we are successful and we do see a number of smokers and
tobacco users, either if it is smoking or chewing tobaccos,
that is the best way to improve the health situation. If in
fact we come up with better products but don't increase the
number of people who use tobacco, then we will have made a
positive forward movement. But if in the process of coming in
with better products we create a lot more tobacco users, then
it is a negative.
Dr. Hatsukami. That is right. If we create more tobacco
users, it is a negative. And if we have dual use of tobacco
products, that may be potentially a negative.
Mr. Shays. OK. Then let's just keep on now. Thank you.
That's helpful.
Yes, sir.
Dr. Henningfield. Smokeless tobacco is deadly for the young
people who never would have taken up tobacco but for the
advertising. It is deadly for the adults who keep smoking
because now they don't have to quit. It is theoretically
possible that it could offer reduced risk for some individuals,
but we don't know the conditions under which that would occur.
So it depends. How it is used is as important as how it is
made.
Mr. Shays. Fair enough.
Doctor.
Dr. Kozlowski. I think smokeless tobacco is less dangerous
for the individual user. I think if someone came to an informed
toxicologist, epidemiologist and said, I am going to use
smokeless tobacco, I am going to use cigarettes, is one of them
more dangerous than the other? I can't imagine an informed
person saying that they are equally dangerous. They would say
that the smokeless tobacco is less dangerous to the individual
user.
Mr. Shays. Thank you.
Mr. Sweanor. Yes. On a one-for-one basis, smokeless tobacco
is certainly much less hazardous than smoking cigarettes,
though still more hazardous than something like medicinal
nicotine or using nothing at all.
Mr. Shays. Fair enough. Thank you. And I am sorry I made
some false assumptions here.
Go ahead.
Dr. Burns. My opinion is that smokeless tobacco is clearly
less hazardous for individuals who have only used smokeless in
comparison to individuals who have only used tobacco
cigarettes. That is, however, not the choice that is being
offered in a harm reduction strategy to adult confirmed
smokers, and we simply do not have the evidence on that. It is
a promise, but it is a promise for which we lack the evidence.
Mr. Shays. So we need information.
Chairman Tom Davis. Thank you all.
Any other questions? Mr. Sullivan.
Mr. Sullivan. Thank you, Mr. Chairman. These are some
questions you already asked, but I came in late, and I would
like to ask them again.
And, first, it's Mr. Verheij. What is your understanding of
the prevailing view in the public health community regarding
the comparative health risk of traditional smokeless tobacco
products such as Skoal and Copenhagen compared to cigarette
smoking? Has the U.S. Smokeless Tobacco Co. communicated this
comparative risk information to adult cigarette smokers?
Mr. Verheij. We have not. Our initial step in the process
was to go to the Federal Trade Commission to get some guidance
on to how we might communicate this information. You know, I
think part of the debate and part of the process here is to
resolve whether--with what--in conjunction with what types of
products can these types of communications be made and who
should make these types of communications.
I think, to respond to Congressman Waxman's concerns about
the company making a communication, frankly, you could take the
company out of the equation; and then the question is, what
obligation does the Federal Government and the public health
community have to communicate to adult smokers who are not
quitting that--fairly much a consensus here--under a certain
set of circumstances that smokeless tobacco is significantly
less harmful? So it is not only limited to a communication from
the company through some broad advertising campaign. We are
talking about information going to adult smokers through some
mechanism.
Mr. Sullivan. Also, what is your understanding of the
perception of adult cigarette smokers regarding the comparative
health risks of smokeless tobacco compared to cigarette
smoking?
Mr. Verheij. Well, I think it is documented by some in the
public health community that more than 80 percent of adult
smokers believe that smokeless tobacco is as dangerous as
cigarette smoking; and that is consistent with what we are
finding in focus groups as we--you know, as we move forward and
try and address some of these concerns about unintended
consequences and misinterpretations of the message, we would
sit with these focus groups; and to a person they all believe
that at this time, based on the information they have been
given to date, smokeless tobacco is as dangerous as cigarette
smoking, which obviously you heard is not the view of some of
the people on the panel.
Mr. Sullivan. Thank you.
I have another question for Dr. Henningfield. Two
questions. What obligation does a tobacco product manufacturer
have today if it has a product that it believes would provide a
reduced risk to smoking cigarettes?
Dr. Henningfield. I think that today there is no reason
that a tobacco manufacturer cannot and should not be making all
of their products with as low of levels of poisons as possible.
We know that tobacco products are made with higher levels of
poisons than is necessary. I don't see any reason that they
can't be reducing those poison levels immediately. The question
is, what claims should be made? Because claims could undermine
the theoretical benefit.
Mr. Sullivan. Also, does the manufacturer have an
obligation to inform adult smokers that there is a less harmful
way for that smoker to satisfy his or her need for nicotine
than smoking regular cigarettes?
Dr. Henningfield. I think the obligation is to make the
products with as few poisons as possible and to market them in
ways that recruit as few new people as possible. But the
statement to somebody that might--a statement such as you
mentioned may recruit new smokers, may recruit new tobacco
users, may keep people who are using tobacco using. And so
those kinds of statements have potential to do great harm, and
that is why I believe they should be regulated.
Mr. Sullivan. Thank you.
Chairman Tom Davis. Thank you very much.
I have got a couple questions. Dr. Kozlowski, in your
testimony--well, much has been said about the research
challenges that--attending harm reduction products. From
reading your paper, which agrees on tobacco industry funding of
university research, it seems that the entrenched positions of
some involved parties might be one of the hardest challenges to
overcome. Do you agree?
Dr. Kozlowski. Yes. I think there are strongly held
entrenched positions here.
Chairman Tom Davis. Do you think the scientific community
is willing to objectively examine the science behind reduced
risk claims?
Dr. Kozlowski. I think they are. But I think it would be
very helpful to have strong FDA-type oversight. I mean, I think
you need a regulatory context.
Chairman Tom Davis. Kind of an umpire to help?
Dr. Kozlowski. Right.
Chairman Tom Davis. OK. Mr. Szymanczyck, let me ask, on
page 221 of the IOM study, the question's asked whether tobacco
manufacturers would be willing to demonstrate their good faith
by agreeing to voluntarily submit claims to reduced exposure or
reduced harm to FDA, FTC, CDC, or some other appropriate agency
for their review and comments and to conform to agency
suggestions. What are your thoughts on that?
Mr. Szymanczyck. Well, I don't think it should be a
voluntary process. I think it should be mandatory.
Chairman Tom Davis. OK. I think you have been pretty clear
on that at this point.
Mr. Szymanczyck. And I think it should be FDA.
Chairman Tom Davis. Also, Dr. Kozlowski, in your testimony
you cite a government Web site that claims smoking and
smokeless use are equally dangerous; and you I think assert
that is untrue. Have you informed the government entity
responsible for the maintenance of this site of this?
Dr. Kozlowski. Not directly. The CDC made a similar
mistake. I did inform them, and that Web site was changed. And
I published a paper in Public Health Reports this month on
that.
Chairman Tom Davis. We would be happy to have that, if you
want to submit it.
Dr. Kozlowski. I have submitted it.
Chairman Tom Davis. Thank you.
Mr. Sweanor, let me ask you. If we look at Sweden as a
model--and we've talked about the Swedish model here today--are
there perhaps demographic issues peculiar to that country that
would not apply here in the United States?
Mr. Sweanor. I am sure there are. I'm not sure what that
would do in terms of the applicability of the model. I mean,
clearly they're different countries, different populations,
different cultures.
Chairman Tom Davis. OK. Canada employs many of the tobacco
control methods the United States currently does not. These
include large picture-based warnings, inserts, giving health
information, comprehensive disclosure of additives. Some say we
should concentrate our efforts on these measures rather than
the idea of tobacco harm reduction. Have you got any comments
on that, any experience whether that is working?
Mr. Sweanor. Sure. I think it is certainly working, the
combination of what we are doing, particularly having had very
significant price increases. We have seen per capita
consumption fall by just over 12 percent in the last 12 months,
which is unprecedented. These are made in the United States.
These are just Canadian cigarettes that are sold in Canada with
the warnings, the package inserts. We have in some of our
provinces made medicinal nicotine products available free of
charge for people who want to quit smoking. We have an
advertising ban, sponsorship bans, the whole range of public
health measures.
Chairman Tom Davis. I will let you finish, but, also, what
does this do to the underground market? Because we see in the
United States sometimes, when the rates go up, you get an
underground market that has more problems.
Mr. Sweanor. Sure. We had a significant problem in the
early 1990's. Because of U.S. taxes being as low as they were,
the Canadian manufacturers started shipping very large
quantities, billions of Canadian-style cigarettes, in upstate
New York, which not very surprisingly came right back into the
country illegally. That forced our taxes down, brought our
prices down, and delayed a whole lot of the measures that we
were doing. So our declines per capita consumption ended,
leveled off; and it is only now that they are starting to go
down again.
I think the question is, what is the combination of
measures that the totality of which gives the greatest gains in
terms of public health. And that is why I say we do need to do
things that reduce the onset of smoking, that encourage and
facilitate cessation, and that reduce toxicity. The fact is we
may have reduced per capita consumption by about 20 percent in
the last 2\1/2\ years. That means 80 percent of them are still
there. What are we going to do for them?
Chairman Tom Davis. And I think it's a question of how far
down can you go. And what--there will always be the usage, at
least in the present. And then how we handle that is one of the
purposes of the hearing.
Mr. Sweanor. I think we have to look at how do we
individualize. As successful as we have been in the 20 years
that I have been very involved in this, I don't think we have
been very successful in certain subgroups of the population. I
don't think we have reduced smoking among schizophrenics, for
instance. I think we do have to look at what sort of
interventions can we make to get the greatest overall benefit
to public health, and there is no single measure that replaces
everything else. It's a combination.
Chairman Tom Davis. Thank you very much.
Mr. Waxman.
Mr. Waxman. That was an interesting point that you made. I
gather Canada has many aggressive policies to discourage people
from smoking and to get them to give up smoking or not to even
start than the United States has. Is that right?
Mr. Sweanor. Yes. I might point out, it isn't hard to do
more than the United States has on some of these things. Other
countries around the world also have much larger warnings. Ours
are picture-based. I would be pleased to pass them around with
the package inserts.
The idea--I mean, it ties back to Congressman Shays's
question. Well, everybody knows this is bad for them. They have
known that for a long time. We try to push the whole idea of
informed consent. It means more than knowing something is bad
for you. I mean, I know that flying back to Ottawa tonight
could be harmful to my health. I need to know, is that because
someone is going to gun me down on my way to Dulles, or is it
because it is just a normal risk of taking an airplane? For
smokers, they need to know what are the things that can happen
to them.
Mr. Waxman. So they need to be more informed, and there
needs to be more of an aggressive policy to try to get that
information to them and to try to raise the prices and do other
things that would discourage people from smoking. Let me just
ask you that, yes or no, because----
Mr. Sweanor. Yes. But you want to combine the motivation
and facilitation. It is one thing to have a whole lot of people
who are now very interested in quitting and trying to; it is
another thing to make available for them the products and
services that make it more likely they will be successful in
doing that.
Mr. Waxman. That is a very good point.
And, Dr. Hatsukami, following up on that point, do you
think we have reached the point in this country where we could
say we are at a plateau and we should just figure those who
smoke are going to continue to smoke and let's see if we can
reduce the harm to them with something else? Or can we do more
to reduce the number of smokers in this country?
Dr. Hatsukami. I think that we can do more to reduce the
number of smokers in this country.
There was a wonderful document that was presented to the
Interagency Committee on Health and Smoking that Dr. Fiore was
chairing that laid out a comprehensive approach to trying to
get people to quit smoking, including developing new
treatments, making treatments available to individuals; and I
think that if we follow that proposal we can in fact reduce the
amount of smoking in this country among those who remain
smokers.
Mr. Waxman. Then the key point is, if some people are going
to continue to smoke, are there products that might do them
less harm? And that I think is the essential issue of this
hearing.
Mr. Szymanczyck, Philip Morris is sending a message it
supports FDA regulation of tobacco products, and you will work
to accomplish this goal this year. As a long-time supporter of
FDA regulation, I am pleased to hear that message. However, I
point out that all FDA regulation is not created equal. Strong
regulation could prevent millions of children from smoking,
help millions more smokers quit, and reduce the risks of those
who remain. Weak regulation could provide government approval
for poorly justified claims and wind up repeating the light and
low tar experience which was a public health disaster.
So what I want to explore with you is, in this bill, H.R.
140, which you support, there are some provisions there that I
wonder if it leads to more harm than good in the goal of FDA
handling this matter. For example, you give FDA authority, but
then they can't ban any class of cigarettes or tobacco
products. What is a class? Would a cherry-flavored product that
is made to appeal to kids be a class that FDA should not be
able to regulate?
Mr. Szymanczyck. Well, Congressman, I believe that refers
to a class being like cigarettes or class being like smokeless.
I don't believe it refers to a particular flavor or an
ingredient. The FDA would have an authority under H.R. 140 to
make those kinds of decisions.
Mr. Waxman. Do you think they should?
Mr. Szymanczyck. Absolutely. I think that H.R. 140 does
give them the authority to make determinations regarding
ingredients.
Mr. Waxman. Another part of the bill says FDA can't
regulate to make products unacceptable to consumers. Now, some
people raise the issue, well, that can be an issue, that can be
a phrase that can be litigated every time an industry doesn't
like what FDA is doing. Dr. Henningfield, do you have any
thoughts on this bill and how some of these provisions in the
way the bill is written might keep FDA from doing the things
that I think maybe everybody here should say they should do?
Dr. Henningfield. Yes. Very briefly, there are things in
cigarettes that are designed to make them more attractive, like
adding chocolate, menthol, and other things. I think these
kinds of substances need to be evaluated. If FDA, for example,
determined that chocolate, which turns carcinogenic when
burned, should be banned, that should be an FDA decision even
if that banning made the cigarette taste a little less good.
Mr. Waxman. What do you think about that, Mr. Szymanczyck?
Mr. Szymanczyck. Congressman, I think that, once again, the
bill is designed, as I understand it, to give the FDA the
authority to make the decision about ingredients. The consumer
acceptability part of it is simply designed to make sure that
there aren't unintended consequences. So in terms of what Dr.
Henningfield has said, I think I would agree with them. I think
the protocols have to be put in place to make sure that any of
those decisions made don't result in unintended consequences.
I really don't see that as any different relative to
reduced risk or reduced exposure products. There could be
unintended consequences there, too, like people not quitting
who might have quit, like kids starting to smoke. I think the
message here relative to these particular items that have been
put into H.R. 140 like the one you are mentioning are all
designed to have the FDA understand as a part of its authority
it needs to focus on unintended consequences as well as the
public health goal that it has.
Mr. Waxman. I think you make a very good point. One of the
unintended consequences of the drafting of a bill is that, if
we don't draft it clearly, it could mean that the kinds of
things that you and I both believe FDA should have the power to
do could be litigated when they do it because someone could
make an argument that, in effect, these restrictions on FDA's
authority would be violated.
So my point to you in the limited time I have is, if we
agree--which is pretty historic for Philip Morris and I to
agree--that FDA ought to have jurisdiction, if we do agree on
that, I think we have to be very careful and clear in drafting
the legislation to make sure that FDA has the full authority to
do what is important for the public health. Not to make
products unacceptable to the consumers in a broad sense but to
make sure that the products that are going to be marketed that
consumers still may want to use--and they have a right to use
them--be as safe as possible. So I raise that issue, and I want
to put it out there.
Mr. Chairman. I see my time is up.
Chairman Tom Davis. I will grant you more time, if I can
just interject one comment.
Mr. Waxman. Sure.
Chairman Tom Davis. I mean, one of the purposes of the
section you referred to in the legislation is so the FDA
couldn't come out and just basically abolish it. We think that
should be--being cigarettes--that ought to be a legislative
action, that should not be a regulatory action, and that is
basically the safeguard that was put in there. However
inartfully it may be worded, I believe that Representative
McIntyre who authored the bill, but I co-sponsored it, putting
down our marker that there ought to be FDA regulation, it ought
to be strong, it ought to be forceful. The consumers ought to
be able to rely on it.
But there would have to be some limits on it in terms of
abolishing a product with as many users that it has in
accomplishing through regulation what they couldn't do through
judicial fiat and couldn't do legislatively. So there is a lot
of--I want to assure my friend that there is a lot of room to
work on this, and I appreciate him clarifying his concerns.
Mr. Waxman. I don't believe in prohibition. As much as I
wish people wouldn't smoke, I don't believe in refusing the
rights of adults to smoke. I would, however, limit the
marketing and especially to kids the attempts to get them to
smoke. And when it comes to these products that may be safer
alternatives for those who are going to smoke no matter what, I
want a clear, scientific evaluation of whether we are getting
something worthwhile and making a public health improvement or
whether we are buying into something that can turn out to be a
serious mistake. I must say that I want to make that very, very
clear.
That is why I come back to where you are, Mr. Szymanczyck,
that FDA is the agency that should have that authority, because
it is basically science that ought to dictate this, not the
marketing ambitions of the smokeless tobacco people or regular
cigarette companies or anyone else that stands to make some
extra money out of it. It ought to be based on good science in
the public interest.
So, with that, Mr. Chairman, I have other questions, but I
think what we have done at this hearing has been worthwhile,
and so I am going to yield back the balance of my time.
Chairman Tom Davis. All right. Anyone else want to add
anything? The gentleman from Connecticut, Mr. Shays.
Mr. Shays. You know, the only thing I would add is to thank
you for taking on a heavy-hitting issue and that we could have
a conversation about it in a fairly instructive way which I
think is a sign of maturity on the part of the industry as well
as the committee. I thank you for that and yield back, Mr.
Chairman.
Chairman Tom Davis. Thank you very much.
Let me thank this panel, all of you; and let me
particularly thank the tobacco executives that are here coming
up. This is a historic first. It is the first step in a long
journey, but it is a step forward, as opposed to where I think
we have been going before. Obviously, a lot of diversity of
opinion here as there is on the panel. But as we try to get to
this and look at legislation this I think will go down as a
historic hearing.
We appreciate everyone's indulgence and preparation in
answer to questions. If anyone wants to submit something that
maybe they weren't asked or want to put it in the record, you
have 5 days, and we will be happy to make that part of the
record as well.
Thank you all very much. These proceedings are adjourned.
[Note.--Additional statements and information may be found
in committee files.]
[Whereupon, at 4:44 p.m., the committee was adjourned.]
[The prepared statements of Hon. Edolphus Towns and Hon.
Chris Bell and additional information submitted for the hearing
record follows:]
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