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88–721 PDF 2003

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

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

JOHN SULLIVAN, Oklahoma

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

TIM MURPHY, Pennsylvania

MICHAEL R. TURNER, Ohio

JOHN R. CARTER, Texas

WILLIAM J. JANKLOW, South Dakota

MARSHA BLACKBURN, Tennessee

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

CHRIS BELL, Texas

———

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

(III)

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

(1)

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

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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.

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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?

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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

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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 reducedrisk 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.

30

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

31

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

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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 reducedrisk 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

40

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

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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

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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.

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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

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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.

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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

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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 medicaVerDate 11-MAY-2000 10:36 Oct 16, 2003 Jkt 000000 PO 00000 Frm 00072 Fmt 6633 Sfmt 6633 D:\DOCS\88721.TXT HGOVREF1 PsN: HGOVREF1
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tion 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-tohead 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

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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.

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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

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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.

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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.

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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.]

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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.

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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

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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.

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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

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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-thecounter 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

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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

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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

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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-forone basis. I think that’s an easy determination to make with medicinal products. I think it’s an easy determination to make for lownitrosamine 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 researchVerDate 11-MAY-2000 10:36 Oct 16, 2003 Jkt 000000 PO 00000 Frm 00213 Fmt 6633 Sfmt 6633 D:\DOCS\88721.TXT HGOVREF1 PsN: HGOVREF1
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ers, 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 socalled 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

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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?

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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.

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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.

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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?

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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?

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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.

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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?

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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.

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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 CanaVerDate 11-MAY-2000 10:36 Oct 16, 2003 Jkt 000000 PO 00000 Frm 00320 Fmt 6633 Sfmt 6633 D:\DOCS\88721.TXT HGOVREF1 PsN: HGOVREF1
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dian 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 21⁄2 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

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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

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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,

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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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