[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]




 
     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


                                 ______

88-721              U.S. GOVERNMENT PRINTING OFFICE
                            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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