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




 
      CAN TOBACCO CURE SMOKING? A REVIEW OF TOBACCO HARM REDUCTION

=======================================================================

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                COMMERCE, TRADE, AND CONSUMER PROTECTION

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED EIGHTH CONGRESS

                             FIRST SESSION

                               __________

                              JUNE 3, 2003

                               __________

                           Serial No. 108-31

                               __________

      Printed for the use of the Committee on Energy and Commerce


 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 house

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                    COMMITTEE ON ENERGY AND COMMERCE

               W.J. ``BILLY'' TAUZIN, Louisiana, Chairman

MICHAEL BILIRAKIS, Florida           JOHN D. DINGELL, Michigan
JOE BARTON, Texas                      Ranking Member
FRED UPTON, Michigan                 HENRY A. WAXMAN, California
CLIFF STEARNS, Florida               EDWARD J. MARKEY, Massachusetts
PAUL E. GILLMOR, Ohio                RALPH M. HALL, Texas
JAMES C. GREENWOOD, Pennsylvania     RICK BOUCHER, Virginia
CHRISTOPHER COX, California          EDOLPHUS TOWNS, New York
NATHAN DEAL, Georgia                 FRANK PALLONE, Jr., New Jersey
RICHARD BURR, North Carolina         SHERROD BROWN, Ohio
  Vice Chairman                      BART GORDON, Tennessee
ED WHITFIELD, Kentucky               PETER DEUTSCH, Florida
CHARLIE NORWOOD, Georgia             BOBBY L. RUSH, Illinois
BARBARA CUBIN, Wyoming               ANNA G. ESHOO, California
JOHN SHIMKUS, Illinois               BART STUPAK, Michigan
HEATHER WILSON, New Mexico           ELIOT L. ENGEL, New York
JOHN B. SHADEGG, Arizona             ALBERT R. WYNN, Maryland
CHARLES W. ``CHIP'' PICKERING,       GENE GREEN, Texas
Mississippi                          KAREN McCARTHY, Missouri
VITO FOSSELLA, New York              TED STRICKLAND, Ohio
ROY BLUNT, Missouri                  DIANA DeGETTE, Colorado
STEVE BUYER, Indiana                 LOIS CAPPS, California
GEORGE RADANOVICH, California        MICHAEL F. DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire       CHRISTOPHER JOHN, Louisiana
JOSEPH R. PITTS, Pennsylvania        TOM ALLEN, Maine
MARY BONO, California                JIM DAVIS, Florida
GREG WALDEN, Oregon                  JAN SCHAKOWSKY, Illinois
LEE TERRY, Nebraska                  HILDA L. SOLIS, California
ERNIE FLETCHER, Kentucky
MIKE FERGUSON, New Jersey
MIKE ROGERS, Michigan
DARRELL E. ISSA, California
C.L. ``BUTCH'' OTTER, Idaho

                   Dan R. Brouillette, Staff Director

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

        Subcommittee on Commerce, Trade, and Consumer Protection

                    CLIFF STEARNS, Florida, Chairman

FRED UPTON, Michigan                 JAN SCHAKOWSKY, Illinois
BARBARA CUBIN, Wyoming                 Ranking Member
JOHN SHIMKUS, Illinois               HILDA L. SOLIS, California
JOHN B. SHADEGG, Arizona             EDWARD J. MARKEY, Massachusetts
  Vice Chairman                      EDOLPHUS TOWNS, New York
GEORGE RADANOVICH, California        SHERROD BROWN, Ohio
CHARLES F. BASS, New Hampshire       JIM DAVIS, Florida
JOSEPH R. PITTS, Pennsylvania        PETER DEUTSCH, Florida
MARY BONO, California                BART STUPAK, Michigan
LEE TERRY, Nebraska                  GENE GREEN, Texas
ERNIE FLETCHER, Kentucky             KAREN McCARTHY, Missouri
MIKE FERGUSON, New Jersey            TED STRICKLAND, Ohio
DARRELL E. ISSA, California          DIANA DeGETTE, Colorado
C.L. ``BUTCH'' OTTER, Idaho          JOHN D. DINGELL, Michigan,
W.J. ``BILLY'' TAUZIN, Louisiana       (Ex Officio)
  (Ex Officio)

                                  (ii)




                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Burton, Steven L., Vice President, Smoking Controls Strategic 
      Development and Switch, Glaxo SmithKline Consumer Health 
      Care.......................................................    96
    Carmona, Vice Admiral Richard H., U.S. Surgeon General, 
      Public Health Service, Department of Health and Human 
      Services...................................................    40
    Muris, Hon. Timothy, Chairman, Federal Trade Commission......    34
    Myers, Matthew L., President and CEO, National Center for 
      Tobacco Free Kids..........................................   116
    Rodu, Brad, Professor, Department of Pathology, University of 
      Alabama at Birmingham......................................    86
    Sweanor, David T., Counsel, Non-Smokers Rights Association...   122
    Tomar, Scott L., Editor, Journal of Public Health Dentistry, 
      University of Florida College of Dentistry, Division of 
      Public Health Services and Research........................    81
    Verheij, Richard H., Executive Vice President, U.S. Smokeless 
      Tobacco Company............................................   103
    Wallace, Robert B., Vice Chairman, Committee to Assess the 
      Science Base for Tobacco Harm Reduction, Institute of 
      Medicine...................................................    78
Additional material submitted for the record:
    Alliance for Health Economic and Agriculture Development, 
      prepared statement of......................................   157
    Eisele, David W., prepared statement of......................   167
    Healton, Cheryl G., President and CEO, American Legacy 
      Foundation, letter dated June 10, 2003.....................   155
    Landrith, George, President, Frontiers of Freedom, letter 
      dated May 29, 2003.........................................   156
    Marzulla, Nancie G., prepared statement on behalf of 
      Defenders of Property Rights...............................   159
    Myers, Matthew L., President and CEO, National Center for 
      Tobacco Free Kids, letter dated June 20, 2003, enclosing 
      response for the record....................................   168
    Phillips, Carl V., Assistant Professor, University of Texas 
      School of Public Health, prepared statement of.............   163

                                 (iii)

  


      CAN TOBACCO CURE SMOKING? A REVIEW OF TOBACCO HARM REDUCTION

                              ----------                              


                         TUESDAY, JUNE 3, 2003

              House of Representatives,    
              Committee on Energy and Commerce,    
                       Subcommittee on Commerce, Trade,    
                                    and Consumer Protection
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10 a.m., in 
room 2123, Rayburn House Office Building, the Hon. Cliff 
Stearns (chairman) presiding.
    Members present: Representatives Stearns, Whitfield, Cubin, 
Shimkus, Shadegg, Bass, Terry, Fletcher, Ferguson, Issa, Otter, 
Tauzin (ex officio), Schakowsky, Solis, Markey, Brown, Davis, 
Stupak, Green, McCarthy, and Strickland.
    Also present: Representative Waxman.
    Staff present: Kelly Zerzan, majority counsel; Ramsen 
Betfarhad, majority counsel; Jon Tripp, deputy communications 
director; Jill Latham, legislative clerk; and Jonathan J. 
Cordone, minority counsel.
    Mr. Stearns. Good morning. The subcommittee will come to 
order.
    Without objection, the subcommittee will proceed pursuant 
to Committee Rule 4(e). So ordered.
    The Chair recognizes himself for an opening statement.
    I am pleased to welcome all of you to the Commerce, Trade, 
and Consumer Protection Subcommittee hearing on tobacco harm 
reduction.
    No one disputes the harm to human health from cigarette 
smoking. Smokers are at a 16-fold increased risk of lung 
cancer, 12-fold increased risk of chronic obstructive pulmonary 
disease, and a twofold increased risk of mild cardio-
infarction. Oncologists estimate that smoking related illnesses 
were responsible for 100 million deaths in the 20th century. 
Those ilnesses killed some 400,000 Americans every year.
    Over the last few decades this country has invested 
substantial public and private resources to encourage smokers 
to quit using tobacco. That investment has paid off. We have 
made great gains in reducing the use of cigarettes.
    While in 1965, 42 percent of Americans smoked cigarettes, 
today only 26 percent of men and 22 percent of women are 
smokers. While this is the good news, as noted in the Institute 
of Medicine report, ``Clearing the Smoke,'' the decline in the 
rates of smoking among adults has leveled off during the 
1990's.
    So where do we go from here? Today we are here to discuss 
tobacco harm reduction. Harm reduction strategies have been 
used for a number of years for a variety of different societal 
problems. For example, clean needle programs are used to 
prevent the spread of HIV. Methadone programs are employed to 
prevent the use of elicit drugs, and sex education is provided 
to stem the rising tide of teen pregnancy and disease.
    The title of our hearing, ``Can Tobacco Cure Smoking?'' at 
first blush seems counterintuitive. However, there is an 
increasing amount of research suggesting that some tobacco 
products are less harmful than others. For those smokers who 
can't seem to quit smoking, switching to a less hazardous 
product could save lives.
    Today we will hear from a diverse group of experts 
espousing a range of opinions on issues of tobacco harm 
reduction. We worked closely with the minority to insure a fair 
and balance panel of witnesses that can speak to the science of 
this issue.
    One of our witnesses today, Dr. Brad Rodu, will assert that 
smokeless tobacco products are 98 percent safer than 
cigarettes, and that by switching committed smokers to 
smokeless products, we can save lives, reducing the potential 
societal harms that may result from the promotion of tobacco 
harm reduction claims.
    Some believe that switching from one tobacco product to 
another does nothing to solve the tobacco problem. The Federal 
Trade Commission has general regulatory authority over 
misleading and deceptive advertising, as well as specific 
authority over the advertising and marketing of tobacco 
products.
    As tobacco companies attempt to market their products as 
reduced risk, as one company has already tried to do, the 
Federal Trade Commission will be in the position of evaluating 
these claims.
    So I look forward to hearing from Chairman Muris, how his 
Commission plans to deal with these, shall we say, vexing 
issues.
    We also hear from the Surgeon General, who is the principal 
advisor to the Secretary of Health and Human Services on public 
health and scientific issues. Tobacco has long been a subject 
of Surgeon General reports. As we move into a new era of 
tobacco debates, we welcome Vice Admiral Carmona to the 
Commerce, Trade, and Consumer Protection Subcommittee.
    Our goal should always be to reduce the use of tobacco. In 
that light, today's hearing provides an opportunity to examine 
the efficacy of the tobacco harm reduction approach which calls 
for minimizing and decreasing death among cigarette smokers 
without completely eliminating tobacco and nicotine use.
    In closing, I want to thank the witnesses for appearing 
before the committee. I look forward to their testimony, and I 
seek, in addition, unanimous consent to enter into the record 
the written testimony of Mike Szymanczyk, Chairman and Chief 
Executive Office, Philip Morris USA.
    Without objection, so ordered.
    [The prepared statement of Michael Szymanczyk follows:]
  Prepared Statement of Mike Szymanczyk, Chairman and Chief Executive 
                       Officer, Philip Morris USA
                            i. introduction
    On behalf of the more than 12,000 employees of Philip Morris USA, I 
am honored to submit these remarks regarding reduced exposure and 
reduced risk tobacco products, including their potential health impact 
and the challenges of sensibly regulating them. In particular, I'd like 
to emphasize our strong support for passage by the 108th Congress of 
meaningful and effective regulation of tobacco products by the Food and 
Drug Administration. We believe that legislation empowering the FDA to 
act should fully implement the thoughtful, comprehensive and rigorous 
regulatory principles articulated by the Institute of Medicine in its 
landmark report, Clearing the Smoke, which was commissioned by the FDA 
itself.
    We applaud the subcommittee for its leadership in holding this 
hearing. We agree with its interest in seeking a bipartisan way to 
fashion a coherent national tobacco policy. We look forward to working 
with you and your colleagues in the full House towards the passage of 
legislation that is designed to benefit adult consumers by reducing the 
harm caused by tobacco consumption, and to establish clear rules that 
will be applied to, and enforced uniformly throughout the tobacco 
industry.
    We hope to convey three critical points that we believe are 
relevant to the issues the subcommittee is considering:

 Philip Morris USA strongly supports legislation that would 
        provide the FDA with comprehensive, meaningful and effective 
        authority to regulate tobacco products. The FDA should have the 
        power to fully implement all of the 11 regulatory principles--
        including those relating to potentially reduced exposure/
        reduced risk products--recommended by the IOM Report.
 For many years now, we have been hard at work trying to 
        develop and consider ways to successfully market innovative 
        tobacco products that have the potential to reduce smokers' 
        exposure to harmful compounds in cigarette smoke. Our progress 
        has been encouraging thus far, and we have high hopes for these 
        products as we move forward.
 We would like very much to be able to bring these products to 
        market in the regulated environment contemplated by the IOM 
        Report, subject to FDA review of both the underlying science 
        and the communications about this science that we would make to 
        consumers. In the absence of FDA authority in this area, we are 
        forced into making a difficult choice between making claims 
        that haven't been validated by a government agency, on the one 
        hand, and not providing smokers with information that may be 
        important to them, on the other. Neither of these alternatives 
        would be ideal, in our view, either from our own perspective or 
        as a matter of public policy. Clearly, FDA regulation would be 
        the best approach.
    We hope that today will mark the beginning of a new and much better 
chapter in our nation's effort to feel confident that tobacco products, 
and the tobacco industry, are properly regulated, given both the 
dangers of the products and the acknowledgement that adults should 
continue to be able to make informed decisions about smoking for 
themselves.
    We are mindful that it has been nearly eight years since Dr. 
Kessler made his initial rulemaking proposal, and two years since the 
IOM published its report. Yet today, there is still no FDA authority to 
regulate tobacco products. My company wants very much to be a part of 
resolving the impasse and is convinced that the remaining policy 
differences can be resolved through mutually respectful discussions 
that seek such a resolution. We believe that a coherent, national 
tobacco policy can be crafted that will effectively deal with tobacco 
issues, without unintended consequences for the millions of consumers, 
employees, tobacco growers and retailers who will be dramatically 
affected by the results of Congressional action.
 ii. our support of tobacco products regulation by the fda, including 
          authorities based on iom's 11 regulatory principles
The Importance of FDA Regulation of Tobacco Products
    FDA regulation of tobacco products is an important Federal 
initiative that is certainly needed. For more than three years now, we 
have urged passage of an effective and comprehensive FDA regulatory 
policy, and we remain determined to be a constructive force in the 
effort that lies ahead to shape this policy.
    When we say that we strongly support ``effective'' regulation by 
the FDA, we mean it. We're not playing word games or referring to a 
weak or watered-down plan. ``Effective'', to Philip Morris USA, means a 
regulatory plan that is designed and funded in a way that can fully 
accomplish its stated objectives, including:

 Providing smokers with additional information about what's in 
        their cigarettes, and about the dangers of smoking--both now 
        and on an ongoing basis--as the science evolves and new 
        information becomes available;
 Aiding in the development of products that meaningfully reduce 
        the harm caused by smoking;
 And guiding the accurate communication of any implications of 
        switching to reduced risk or reduced exposure products that may 
        be developed, which includes being sure to communicate that 
        there is no ``safe'' cigarette, and the best thing to do from a 
        health standpoint is to quit smoking.
``Effective'' to us does not mean regulations that are loophole-ridden 
or intentionally weak, punitively cumbersome, or likely to generate 
unintended negative consequences--it means real reforms that get the 
stated and agreed upon job done.
    We believe that additional regulation makes sense for a number of 
reasons. Although these efforts are not often the focus of public 
attention, the fact is that we at Philip Morris USA devote enormous 
resources to developing products that have the potential of reducing 
the harm caused by smoking, running our factories, working with our 
suppliers, making our payroll and paying our taxes. We are asking for 
new regulation because today there are simply not sufficiently clear 
and consistent guidelines for the manufacture and performance of 
cigarettes. It is not clear, for example, how we and the rest of the 
tobacco industry should communicate to consumers about our products. 
What rules there are increasingly arise at the state level, which will 
inevitably lead to conflicting standards that could confuse consumers, 
disrupt interstate commerce and significantly complicate orderly and 
uniform manufacturing and distribution processes.
    Meaningful, effective and uniform FDA regulation would better align 
our business practices with society's expectations, and would further 
our goal of being a responsible, effective and respected manufacturer 
and marketer of tobacco products for adults who smoke. We believe 
Americans support meaningful and effective new regulation of tobacco 
product manufacturing processes, performance standards and how we 
communicate with consumers, especially about potentially reduced 
exposure and reduced risk products. The public also supports efforts to 
continue to build the momentum that has developed toward reducing the 
incidence of youth smoking. However, we don't believe that there is 
strong support in the country for the new rules to go too far, and 
significantly intrude on adults' continued ability to smoke if they 
want to.
    When Philip Morris USA first announced its support for FDA 
regulation of cigarettes, some were understandably surprised and 
skeptical, in part because our company--along with other major 
manufacturers, retailers and advertising groups--had opposed the 
agency's assertion of jurisdiction over tobacco products under the 
medical device statute in 1996. Our opposition to FDA's unilateral 
initiative was not disagreement with regulation per se, but rather 
disagreement with that specific kind of regulation. We continue to 
believe that regulation of tobacco products as medical products would 
be a mistake--despite the fact that nicotine is a drug, and we agree 
that cigarette smoking, and nicotine in cigarette smoke, are addictive 
``because tobacco regulation needs to focus on how we can reduce the 
harm to society of a dangerous, agriculturally-based product that is 
nonetheless legal for adults to use, and the medical device rules 
simply are not suited to that purpose.
    That is why we believe it is most appropriate that both major 
legislative proposals that have attracted attention in the past year--
H.R. 140, sponsored by Representatives Davis and McIntyre, and S. 2626 
from the last Congress, sponsored by Senators Kennedy, DeWine and 
others--regulate tobacco products under a new chapter of the Food, Drug 
& Cosmetic Act designed especially for such products. We're convinced 
that this is the right approach, and are extremely encouraged by the 
enormous similarities between the two bills. We believe that there is 
far more common ground in our views than there are differences. And, 
although on some issues there are some important divergences of opinion 
among the various stakeholders on a few issues, they are truly 
differences in degree only.
Our Support of Regulation by the FDA of Potentially Reduced-Exposure 
        and Reduced-Risk Products, Based on IOM's 11 Regulatory 
        Principles
    The IOM Report ``recommends strengthened federal regulation of all 
modified tobacco products with risk reduction or exposure reduction 
claims, explicit or implicit'', and proposes 11 regulatory principles 
to ``build on the foundation of existing food and drug law, with 
appropriate adaptations to take into account the unique toxicity of 
tobacco products.''
    Philip Morris USA has, for more than three years, been advocating 
many of the elements encompassed by the 11 regulatory principles 
contained in the IOM Report; many of these elements are already 
contained in bills such as H.R. 140 from this Congress and S. 2626 from 
the 107th Congress. As a step in moving forward to a thorough 
discussion of what we believe are the best components of an FDA 
regulatory process, we respectfully offer the following observations 
about IOM's 11 principles, the degree to which they are already 
reflected in bills like H.R. 140 and S. 2626, and ways in which we 
think that the legislation can be improved so as to better translate 
the IOM Report's principles into legislative language:
IOM Principle #1
    The Principle. Manufacturers of tobacco products, whether 
conventional or modified, should be required to obtain quantitative 
analytical data on the ingredients of each of their products and to 
disclose such information to the regulatory agency.
     Philip Morris USA's Position. We support the principle of 
providing quantitative information about the ingredients used in the 
manufacture of our cigarettes, with appropriate safeguards to protect 
trade secrets. We think that the FDA should be able to provide smokers 
with confidence that the ingredients added to cigarettes do not 
increase the inherent health risks of smoking, including increasing 
addiction. And, as discussed below regarding Principle #8, we have no 
objection to disclosing the results of our own ingredients testing to 
the FDA, so it can assess every ingredient we use.
     Translation into Legislative Language. This principle is 
specifically covered by section 904 of the new FDA title in both H.R. 
140 and S. 2626, which require all tobacco product manufacturers to 
provide to the agency, on an annual basis, ``A listing of all tobacco 
ingredients, substances and compounds that are, on such date, added by 
the manufacturer to the tobacco, paper, filter, or other component of 
each tobacco product by brand and by quantity in each brand and 
subbrand'', as well as ``All documents (including underlying scientific 
information) relating to research activities, and research findings, 
conducted, supported, or possessed by the manufacturer . . .''
IOM Principle #2
    The Principle. All tobacco products should be assessed for yields 
of nicotine and other tobacco toxicants according to a method that 
reflects actual circumstances of human consumption; when necessary to 
support claims, human exposure to various tobacco smoke constituents 
should be assessed using appropriate biomarkers. Accurate information 
regarding yield range and human exposure should be communicated to 
consumers in terms that are understandable and not misleading.
     Philip Morris USA's Position. We support this principle. 
We believe that the FDA should be authorized to require the disclosure 
of information about individual compounds in cigarette smoke, in 
addition to tar and nicotine, that it believes would be meaningful to 
consumers, as long as the information can be generated according to 
validated, standardized and commercially feasible test methods that 
reflect actual circumstances of human exposure, or reliably calculated 
on the basis of the test results obtained from such methods.
     Translation into Legislative Language. There are a number 
of provisions in H.R. 140 and S. 2626 that specifically embody this 
principle. Section 511(b) of H.R. 140 and section 917(b) of S. 2626, 
for example, both require the FDA--within 24 months--to create rules 
covering ``the testing, reporting, and disclosure of tobacco product 
smoke constituents and ingredients that the Secretary determines should 
be disclosed to the public in order to protect the public health. Such 
constituents shall include tar, nicotine, carbon monoxide, and such 
other smoke constituents or ingredients as the Secretary may determine 
to be appropriate.'' In addition, the bills' provisions empowering the 
FDA to assess health claims are discussed in more detail in several of 
the Principles below.
IOM Principle #3
    The Principle. Manufacturers of all potential reduced-exposure 
products should be required to conduct appropriate toxicological 
testing in preclinical laboratory and animal models as well as 
appropriate clinical testing in humans to support the health-related 
claims associated with each product and to disclose the results of such 
testing to the regulatory agency.
     Philip Morris USA's Position. We support this principle. 
In order to support marketing claims relating to reduced exposure or 
reduced risk, we believe that the best approach would be for a 
manufacturer to (i) design a cigarette that significantly reduces 
various harmful compounds in the inhaled smoke; (ii) provide scientific 
evidence that this change reduces biological activity in appropriate 
cellular and laboratory animal models; (iii) measure or model adult 
smoker exposure to the smoke from these cigarettes; (iv) share these 
results with the scientific and public health communities to seek to 
gain their agreement that the test results are scientifically valid and 
relevant to adult smokers, and also support a conclusion that the new 
cigarette design may, in fact, reduce the risks of smoking; and (v) 
work with regulatory agencies to appropriately communicate these 
results and their significance to adult smokers.
     Translation into Legislative Language. This principle is 
largely embodied in the two major FDA bills, where section 912(a)(2) of 
H.R. 140 and section 913(a)(2) of S. 2626 both authorize the FDA to 
designate a tobacco product as ``reduced risk'' based on a 
manufacturer's application that, among other things, ``demonstrates 
through testing on animals and short-term human testing that use of 
such product results in ingestion or inhalation of a substantially 
lower yield of toxic substances'' than other tobacco products, and ``if 
required by the Secretary, includes studies of the long-term health 
effects of the product.'' We believe that this language would more 
fully reflect the IOM Report's principle if, in addition to referring 
to ``reduced risk'' products, it specifically mentioned ``reduced 
exposure'' products. Clearly, as the IOM Report indicates and as its 
principles as a whole demonstrate, it is likely that the scientific 
data will support reduced-exposure claims before the FDA, or the 
scientific community in general, is prepared to conclude that a 
particular new cigarette will actually reduce the risk of contracting a 
tobacco-related disease.
IOM Principle #4
    The Principle. Manufacturers should be permitted to market tobacco-
related products with exposure-reduction or risk-reduction claims only 
after prior agency approval based on scientific evidence (a) that the 
product substantially reduces exposure to one or more tobacco toxicants 
and (b) if a risk reduction claim is made, that the product can 
reasonably be expected to reduce the risk of one or more specific 
diseases or other adverse health effects, as compared with whatever 
benchmark product the agency requires to be stated in the labeling. The 
``substantial reduction''' in exposure should be sufficiently large 
that measurable reduction in morbidity and/or mortality (in subsequent 
clinical or epidemiological studies) would be anticipated, as judged by 
independent scientific experts.
     Philip Morris USA's Position. As noted above, we support 
the principle that the FDA should regulate ``reduced risk'' claims. In 
addition, we support the principle that claims about reduced exposure 
to specific tobacco toxicants (i.e., harmful compounds in cigarette 
smoke) should be subject to FDA oversight. We agree with the IOM Report 
that government analysis of proposed exposure-reduction claims, and the 
data that should be required from manufacturers to support them, should 
be different than with respect to claims of actual risk reduction.
     Translation into Legislative Language. Section 912(a)(3) 
of H.R. 140 and section 913(a)(3) of S. 2626 both partially reflect 
this principle, as they provide the FDA with full authority to regulate 
risk-reduction (but not specifically exposure-reduction) claims, 
including requiring that the product carry ``a label prescribed by the 
Secretary concerning the product's contribution to reducing harm to 
health'' and comply ``with requirements prescribed by the Secretary 
relating to marketing and advertising of the product.'' H.R. 140 also 
reflects the IOM Report's judgment that accurate, non-misleading claims 
should be permitted rather than suppressed. We would respectfully 
suggest that the language in both bills could be improved by adding 
clauses that would both specifically incorporate IOM's exposure-
reduction concept, and adopt this Principle's specific language 
regarding the proper standard for what evidence would support either an 
exposure-reduction or risk-reduction claim.
    We also note that S. 2626 could be interpreted to permit FDA to 
refuse to permit any truthful, non-misleading claim regarding ``reduced 
risk'' or ``reduced exposure''--even if a valid scientific showing has 
been made--if the agency speculates that the claim could, for example, 
discourage quitting at some point in the future. This is a legitimate 
concern, but it is contrary to IOM Principle #4, and, we believe, 
should be addressed by clearly communicating the claim so that 
consumers are not misled, and accompanying the claim with a clear 
reminder that the best option from a health perspective is to quit. IOM 
also proposes dealing with this concern through post-market 
surveillance, which is discussed in Principle #6 below. Finally in this 
regard, both the Supreme Court and several Courts of Appeals have 
strongly indicated that the kind of suppression of truthful information 
advocated by some in the tobacco control community cannot withstand 
scrutiny under the First Amendment. A white paper discussing these 
cases in greater detail is attached to this Statement as Annex 1.
IOM Principle #5
    The Principle. The labeling, advertising, and promotion of all 
tobacco-related products with exposure-reduction or risk-reduction 
claims must be carefully regulated under a ``not false or misleading'' 
standard with the burden of proof on the manufacturer, not the 
government. The agency should have the authority and resources to 
conduct its own surveys of consumer perceptions relating to these 
claims.
     Philip Morris USA's Position. We support this principle 
for the reasons stated regarding Principle # 4 above.
     Translation into Legislative Language. In addition to the 
analysis above regarding Principle #4, we note that H.R. 140--through 
its linkage of FDA regulation to a tobacco quota buyout and a user fee 
that would fund both the buyout and the new regulatory regime--is the 
only major legislative proposal currently under consideration that 
would ensure that, as the IOM Report's Principle #5 urges, the FDA will 
in fact have ``the resources to conduct its own surveys of consumer 
perceptions relating to these claims.'' We would also respectfully 
suggest that both section 912(a)(3) of H.R. 140 and section 913(a)(3) 
of S. 2626 be amended so as to specifically incorporate IOM's ``not 
false or misleading'' standard for all claims regarding exposure or 
risk-reduction.
IOM Principle #6
    The Principle. The regulatory agency should be empowered to require 
manufacturers of all products marketed with claims of reduced risk of 
tobacco-related disease to conduct post-marketing surveillance and 
epidemiological studies as necessary to determine the short-term 
behavioral and long-term health consequences of using their products 
and to permit continuing review of the accuracy of their claims.
     Philip Morris USA's Position. We support this principle as 
articulated and further believe it should be expanded to clearly 
include application to products with reduced exposure claims. As noted 
above, the effects of these products on the overall harm caused by 
tobacco is a legitimate and valid public health concern, and one which 
needs to be monitored and studied. And, as we believe that the FDA 
should be able to determine which marketing claims are appropriate, it 
is sensible that it should make use of the sort of surveillance and 
studies noted in this principle.
     Translation into Legislative Language. Both major FDA 
bills contain provisions that fully embody this principle. Section 
912(e)(1) of H.R. 140 and section 912(a) of S. 2626 broadly empower the 
FDA to ``require a tobacco product manufacturer to conduct postmarket 
surveillance for reduced risk [of] a tobacco product of the 
manufacturer if the Secretary determines that postmarket surveillance 
of the tobacco product is necessary to protect the public health or is 
necessary to provide information regarding the health risks and other 
safety issues involving the tobacco product.'' For clarity, as 
indicated above regarding other provisions, we would suggest also 
adding an explicit reference to exposure-reduction claims, to ensure 
that the FDA is authorized to require post-market surveillance of them, 
too.
IOM Principle #7
    The Principle. In the absence of any claim of reduced exposure or 
reduced risk, manufacturers of tobacco products should be permitted to 
market new products or modify existing products without prior approval 
of the regulatory agency after informing the agency of the composition 
of the product and certifying that the product could not reasonably be 
expected to increase the risk of cancer, heart disease, pulmonary 
disease, adverse reproductive effects or other adverse health effects, 
compared to similar conventional tobacco products, as judged on the 
basis of the most current toxicological and epidemiological 
information.
     Philip Morris USA's Position. We support this principle. 
As IOM notes in its report, it is logical that the regulatory agency 
charged with evaluating the relative risks presented by different 
tobacco products--which we believe is most appropriately the FDA--
should not be overwhelmed with what would be the enormous task of pre-
approving every introduction of a new line extension using existing 
product designs, when such products do not make reduced risk or reduced 
exposure claims, and are certified by the manufacturer to present the 
same issues of public health as predicate tobacco products. Requiring 
pre-market approval of such products would not serve the public health 
interests identified by the IOM Report, and would pose substantial 
burdens on both the regulators and the manufacturers.
    Moreover, we support the IOM Report's concept of placing the burden 
on manufacturers to certify that any new product (including any 
existing brand which is introduced with changed characteristics) would 
not present increased risk, and then, on the basis of such 
certification, to introduce the product (without reduced risk or 
exposure claims) into the marketplace. As the IOM Report suggests, the 
FDA would then have the authority, if upon investigation it disagrees 
with the manufacturer's certification and concludes that there is in 
fact an increased risk, to seek the product's removal from the market. 
We do not advocate--and we do not believe Principle #7 would require--
that pre-market approval provisions ``grandfather'' today's tobacco 
products from further regulation. In whatever form they eventually 
take, performance standards (see Principle #9 below) would apply to all 
tobacco products (whether on the market today or introduced in the 
future).
     Translation into Legislative Language. All of the existing 
legislative proposals relating to pre-market approval are very complex, 
but we believe that the provisions of section 910 of H.R. 140 come the 
closest to fully embodying this principle. First, section 910 reflects 
the IOM Report's suggestion that products carrying exposure-reduction 
or risk-reduction claims be treated separately from new products that 
do not. Second, it requires manufacturers to submit extensive 
information about any such new product to the FDA at least 90 days 
prior to commercial introduction, and empowers the agency to ``suspend 
the distribution of the tobacco product that is the subject of that 
report if the Secretary determines that there is a reasonable 
likelihood that the tobacco product is not substantially equivalent to 
a tobacco product commercially marketed (other than for test marketing) 
in the United States . . .'' Finally, the concept of ``substantial 
equivalence'' is defined in section 910(a)(2) of H.R. 140--consistent 
with IOM's ``no increased risk'' concept--as being a product that 
either ``has the same characteristics as the predicate tobacco 
product'' or, in the alternative, ``has different characteristics and 
the information submitted contains information, including clinical data 
if deemed necessary by the Secretary, that demonstrates that it is not 
appropriate to regulate the product under this section because the 
product could not reasonably be expected to increase the health risks 
to consumers compared to a conventional tobacco product that is 
commercially marketed in the United States . . .''
IOM Principle #8
    The Principle. All added ingredients in tobacco products, including 
those already on the market, should be reported to the agency and 
subject to a comprehensive toxicological review.
     Philip Morris USA's Position. We support this principle 
for the reasons stated regarding Principle #1 above and Principle #9 
below.
     Translation into Legislative Language. From a legislative 
perspective in the major FDA bills, toxicological assessment of 
ingredients is part and parcel of the agency's performance standard 
authority, which is discussed below in the context of IOM Principle #9.
IOM Principle #9
    The Principle. The regulatory agency should be empowered to set 
performance standards (e.g., maximum levels of contaminants; 
definitions of terms such as ``low tar'') for all tobacco products, 
whether conventional or modified, or for classes of products.
     Philip Morris USA's Position. We support this principle, 
and have been actively advocating a Congressional grant of authority to 
the FDA to reduce harm by imposing mandatory performance standards on 
tobacco products, even including those that would require design 
changes that consumers might not like. Our main concern with this 
concept is that, if not translated carefully into legislative language, 
it could permit--or even require--the agency to do what nobody should 
want: to impose performance standards requiring changes that are so 
radical that tobacco products are effectively banned, or consumers are 
driven away from the legitimate market and towards illicit, completely 
unregulated products. We think that consumers, tobacco growers and many 
other stakeholders support our view that these standards should not 
make tobacco products unpalatable for adult smokers; no one would 
benefit from performance standards so radical that they further 
increase the demand for counterfeit or other illicit products.
    Specifically, we believe that the FDA should have the authority to 
ensure that ingredients used in the manufacture of tobacco products do 
not increase their inherent health risk or addictiveness; because the 
ingredients are under the manufacturers' control, this authority 
should, in our view, include the power to prohibit the use of any 
ingredient shown to increase health risks even if the ban would impact 
the product's taste. Apart from ingredients, we also support authority 
for the FDA to impose changes to the other design or inherent 
characteristics of a tobacco product--including the inherent properties 
of tobacco leaf itself--that it finds will protect public health, so 
long as the changes are technically feasible and would not negatively 
impact adult consumers' enjoyment of the product in a significant way. 
There is no public consensus supporting FDA actions that force radical 
changes on the design or inherent characteristics of today's tobacco 
products that adult smokers may not be prepared to accept. We believe 
that instead, FDA should use its enormous persuasive powers and 
regulatory tools to encourage consumers to quit, or--by utilizing the 
reduced risk/reduced exposure authorities contemplated by IOM's other 
principles--to switch to products whose design and composition the 
agency favors from a public health perspective.
    Ingredients. The major legislative proposals currently under 
consideration--including both H.R. 140 and S. 2626--contemplate the use 
of ``performance standard'' authority by the FDA to regulate 
ingredients used in the manufacture of tobacco products based on its 
belief of what would be appropriate to protect public health. We 
believe that this is a legitimate role for the agency to the extent it 
is used to ensure that ingredients do not increase the inherent risk of 
cigarette smoking, including by increasing its addictiveness. Tobacco 
products are inherently dangerous, but the government should have 
authority to make sure that nothing is used by manufacturers to make 
them even more so. Philip Morris USA stands ready to submit all of its 
ingredients to rigorous FDA review and testing, to share the results of 
testing it has previously conducted, and to work with the agency as it 
makes its own assessment of any added risks they may present.
    An approach that focuses on increased risk from ingredients has 
been explicitly adopted by the IOM Report, which asserts that ``. . . 
[FDA] should . . . have the authority to remove from the market 
ingredients . . . that do not meet [a] test of no increased risk . . 
.'' To be clear, we think that FDA authority to test and, if necessary, 
prohibit the use of specific ingredients it finds to increase the 
inherent risks of smoking should apply to ingredients currently in use 
as well as to new ones. There should be no ``grandfathering.''
    However, FDA authority over ingredients should not, in our view, 
extend beyond the concept of ``increased risk''. A broader scope--for 
example, based purely on what would be ``appropriate to protect public 
health''--could permit the agency, for example, to prohibit specific 
ingredients solely because they improve the taste of a tobacco product, 
on the theory that, by trying to make the products taste bad, 
consumption will drop and public health will be benefited. Under such 
an approach, the FDA could even order that bad-tasting ingredients be 
added to cigarettes, so as to decrease their palatability. These powers 
would be, we respectfully submit, simply incompatible with the 
principle that tobacco products are legitimate and that adults should 
continue to be permitted to consume them if they wish. To quote from 
the preamble to the FDA's own proposed tobacco rule from 1996:
        Black market and smuggling would develop to supply smokers with 
        these products . . . [which] would be even more dangerous than 
        those currently marketed, in that they could contain even 
        higher levels of tar, nicotine, and toxic additives.
    If regulation of cigarettes is to be based purely on eliminating 
their known inherent dangers, we readily agree that it would be best if 
nobody smoked at all. But Americans want to see a new regulatory regime 
that incorporates other values as well--tolerance, adults' continued 
ability to make their own decisions about issues that affect their 
health, law enforcement considerations, and the degree to which 
government should intrude generally into the realm of personal 
issues.1 If Congress is to reflect this consensus and 
balance these competing concerns, it will need to tailor FDA's 
authority so that it is focused on encouraging quitting and harm 
reduction for adults who continue to smoke, rather than trying to force 
Americans to adopt tobacco-free lifestyles.
---------------------------------------------------------------------------
    \1\ Indeed, the reason that the Supreme Court rejected FDA's 
initial ``medical device'' tobacco rule is that it determined that, 
under that approach, the agency would have been required to ban tobacco 
products, and that such a ban could not be squared with the overall 
national tobacco policy already put in place by Congress.
---------------------------------------------------------------------------
    Smoke Constituents and Other Performance Standards. For the same 
reasons, we believe that the FDA should have broad power to require the 
reduction or elimination of smoke constituents (the compounds produced 
by tobacco when burned), that will seek to reduce harm while ensuring 
that the agency will not order mandatory performance standards that are 
technically infeasible, or could only be met by design changes in 
tobacco products that adult smokers find unacceptable. For example, if 
there is no limitation whatsoever contained in the performance standard 
authority, the agency could force rapid, radical reductions in tar and 
nicotine yields, or require that manufacturers utilize filters that 
would eliminate the products' taste. Strategies such as these may well 
be legitimate in the effort to reduce harm, but we respectfully suggest 
that the strategies are best dealt with under the FDA's authority over 
reduced exposure and reduced risk tobacco products, discussed above.
     Translation into Legislative Language. H.R. 140 and S. 
2626 both fully embody--with one important difference between them--
IOM's suggestion that the FDA be provided with specific authority to 
impose performance standards, including those relating to added 
ingredients and smoke constituents. Section 907(a) of both bills 
empower the agency to
        adopt performance standards for a tobacco product if the 
        Secretary finds that a performance standard is appropriate for 
        the protection of the public health. This finding shall be 
        determined with respect to the risks and benefits to the 
        population as a whole, including users and non-users of the 
        tobacco product, and taking into account--(A) the increased or 
        decreased likelihood that existing users of tobacco products 
        will stop using such products; and (B) the increased or 
        decreased likelihood that those who do not use tobacco products 
        will start using such products. A performance standard 
        established under this section for a tobacco product shall 
        include provisions to provide performance that is appropriate 
        for the protection of the public health, including provisions, 
        where appropriate--(i) for the reduction [or elimination] 
        2 of nicotine yields of the product; (ii) for the 
        reduction or elimination of other harmful constituents or 
        harmful components of the product . . .
---------------------------------------------------------------------------
    \2\ This bracketed language appears only in S. 2626.
---------------------------------------------------------------------------
    The authority this language confers over ingredients extends beyond 
the concept of ``increased risk''. By permitting the FDA to change any 
ingredient if it concludes that such action is ``appropriate to protect 
public health'' (so long as the removal does not render the tobacco 
product ``unacceptable for adult consumption''), H.R. 140 would appear 
to permit FDA, for example, to prohibit or reduce specific ingredients 
solely because they improve the taste of a tobacco product, on the 
theory that, by trying to reduce the product's palatability, 
consumption will decline and public health will benefit. We're pleased 
that the notion of adult acceptability appears in H.R. 140, because it 
is compatible with the principle that tobacco products are legitimate 
and that adults should continue to be permitted to consume them if they 
wish. We respectfully suggest, however, that Congress consider revising 
this language, insofar as it relates to ingredients, to more fully 
reflect IOM's ``no increased risk'' concept.
    For the same reasons, we appreciate the fact that H.R. 140's 
performance standard authority applies the concept of adult 
acceptability to FDA's power to require the reduction or elimination of 
smoke constituents, or to order other mandatory design changes in 
tobacco products. Sensibly, the bill appears to contemplate that the 
FDA will use its authority regarding reduced risk and reduced exposure 
products--including those with low initial consumer acceptability--to 
encourage the proliferation of new product designs that have the 
potential of reducing the harm caused by smoking. Using this authority, 
the agency will have enormous ability to use its credibility with the 
American people to persuade adult smokers to switch to any alternative 
product designs of its choosing. New products that achieve a critical 
mass of adult consumer acceptance would then be ready to move to the 
next regulatory phase. If FDA concludes, after monitoring the 
marketplace in the manner suggested by IOM, that such a product 
innovation has been proven to reduce harm in the long term, the agency 
could--and, in our view, should--incorporate the results of the 
technology into a performance standard so that it becomes the new 
baseline for the entire category of tobacco products.
    The performance standard authority in S. 2626 does not contain any 
concept of adult acceptability, or any other limitation on the FDA's 
authority to radically re-design tobacco products ``to protect the 
public health.'' There is clearly a difference of opinion between those 
who believe that there needs to be specific policy direction from 
Congress to the FDA regarding consumer acceptability, and others who 
view health impact as the sole issue that the agency should be 
permitted to consider when it sets performance standards for tobacco 
products. We would note in this regard that every regulated consumer 
product is governed by a statutory standard reflecting Congress' policy 
judgment as to the values governing the rulemaking process. Just as 
medical devices need to be ``safe and effective'', a motor vehicle 
standard may only be imposed if it is ``reasonable, practicable, and 
appropriate for the particular type of motor vehicle . . .'', and 
standards under the Consumer Products Safety Act require a finding 
regarding ``. . . the probable effect of such rule upon the utility, 
cost, or availability of such products to meet such need.''
    Our view is that FDA's performance standard authority should 
recognize tobacco products as legitimate for adults to use if they 
wish; that the agency should operate within some reasonable boundaries 
making it clear that its mission is not to phase them out entirely. To 
us it seems entirely plausible that, under a pure ``public health'' 
standard, FDA could (or could be forced to) conclude that it is better 
for public health overall to ban tobacco products; that Prohibition 
would result in millions of people quitting, and that having millions 
more seeking black market products is an acceptable trade-off. Even if 
valid from a health perspective, this conclusion would not be good 
policy.
    The opposition by some to any notion of ``consumer acceptability'' 
for tobacco products has been justified by concerns that the term's 
vagueness will lead to ``endless litigation'', and that ``a reduction 
of tobacco consumption by 1% or less could be the basis for an industry 
claim that a new performance standard has left the product unacceptable 
to adults.'' 3 There are responses to these concerns: many 
countries around the world have clearly demonstrated that it is 
possible to gradually impose performance standards on cigarettes that 
governments deem beneficial within the realm of what adults will 
accept; for example, the European Union has, over the past several 
years and taking a step-by-step approach, established increasingly 
lower ceilings on tar, nicotine and, more recently, carbon monoxide 
yields as measured by machine tests. Moreover, it is unclear why 
``consumer acceptability'' should be any more susceptible to court 
challenge than equally-vague standards endorsed by the same advocates 
(and included in both S. 2626 and H.R. 140), such as ``the increased or 
decreased likelihood that existing users of tobacco products will stop 
using such products'', and, under the well-known Chevron doctrine, FDA 
would be afforded substantial deference by the courts in determining 
what the language means. In any case, there surely ought to be some 
language that can be worked out that would introduce some notion of 
reasonableness into the FDA's performance standard calculus, avoid 
unintended consequences, and serve the public health objective of 
tough, meaningful authority that will lead over time to real changes in 
tobacco products, and a significant reduction in the harm that they 
cause.
---------------------------------------------------------------------------
    \3\ Written statement of Matthew L. Myers, President, Campaign for 
Tobacco-Free Kids, to Senate HELP Committee (September 19, 2002).
---------------------------------------------------------------------------
IOM Principle #10
    The Principle. The regulatory agency should have enforcement powers 
commensurate with its mission, including power to issue subpoenas.
     Philip Morris USA's Position. We support this principle. 
We have spoken extensively about the need for meaningful and effective 
regulation of tobacco products; such regulation can be neither 
``meaningful'' nor ``effective'' without adequate enforcement powers 
for the FDA.
     Translation into Legislative Language. H.R. 140, like S. 
2626 before it, fully incorporates the existing enforcement authorities 
that the FDA is provided under the Food, Drug & Cosmetic Act, and 
applies those powers to enforcement of the new tobacco products chapter 
that the bill would create. We would respectfully suggest, in light of 
the recent influx of inexpensive foreign tobacco products--some of 
which are not in compliance with existing Federal and State laws 
applicable to all tobacco products, domestic or foreign--into our 
country, that these mechanisms be examined to ensure that the FDA will 
be both authorized and directed to ensure that all manufacturers and 
importers are required to fully comply with the full panoply of 
restrictions, requirements and standards that the agency decides to 
impose.
IOM Principle #11
    The Principle. Exposure reduction claims for drugs that are 
supported by appropriate scientific and clinical evidence should be 
allowed by the FDA.
     Philip Morris USA's Position. We support this principle. 
Our belief in the ability of adults to make their own decisions about 
smoking--and not smoking--encompasses cessation of tobacco use, 
including the use of pharmaceutical therapies for those smokers who 
want to quit, are having difficulty, and believe that the treatments 
might help.
     Translation into Legislative Language. IOM correctly notes 
that, under current U.S. law, the FDA already has authority in this 
area for drugs and medical devices; this issue need not be addressed 
legislatively as Congress considers a new chapter of the law relating 
to tobacco products. We believe strongly that cigarettes should be 
regulated as cigarettes, and not as medical products. This means that, 
as both H.R. 140 and S. 2626 provide, cigarettes should be regulated by 
FDA, but under a separate chapter of its governing statute. We're 
convinced that any legislation that attempts to shoehorn tobacco 
products into the existing medical categories is, as the Supreme Court 
has already found, simply taking the wrong approach.
  iii. our efforts to develop tobacco products that could eventually 
                   reduce the harm caused by smoking
    Having described the regulatory regime that we believe should be 
built to apply to all tobacco products--both conventional and novel--we 
now turn to the status of Philip Morris USA's efforts to develop 
products that we hope will be subject to these new regulations. One of 
our highest priorities today continues to be the development of 
cigarettes that have the potential to reduce the harm caused by 
smoking. The IOM Report exhaustively examines many of the issues 
involved in attempting to achieve this goal by reducing smokers' 
exposure to harmful compounds in cigarette smoke.
    Simply put, the public health community has identified a number of 
compounds--out of the thousands present in cigarette smoke--that are 
potentially harmful to smokers, without definitively settling on any 
specific one (or combination of them) as the recognized cause of lung 
cancer or other smoking-related disease. Accordingly, our basic 
strategy is to reduce smokers' exposure to as many of these compounds 
as we can, by means of products that will provide continued enjoyment 
to our consumers. If we're successful in finding ways of both reducing 
potentially harmful compounds and reducing smokers' actual exposure to 
them under real-world conditions, we believe that--although it will 
take some time--the FDA will be in position to help us evaluate whether 
our product development efforts are actually reducing the risk of 
tobacco-related diseases among current smokers. Then, determinations 
can ultimately be made about whether any reduced-risk tobacco product 
results in overall harm reduction across the population, because its 
risk-reduction potential is not offset by other factors, such as 
changes in smoking behavior, discouraging current smokers from quitting 
or encouraging nonsmokers to start.
    Our goal--which we believe provides both societal and shareholder 
value--is to design the best products that we can, and then, ideally 
under the regulatory oversight of the FDA, to convince as many adult 
smokers (who don't quit) as possible to use them. It seems clear to us 
that we will not be able to make progress in this area unless two 
critical conditions are met: first, that manufacturers such as 
ourselves are successful at developing and making available tobacco 
products that reduce smokers' exposure to harmful compounds compared to 
conventional cigarettes, and second, that current smokers are given a 
reason--through the communication of truthful, non-misleading 
information that avoids unintended consequences--to switch to these 
products, even though they may be less enjoyable than the cigarettes 
that most adults smoke today. For people who continue to smoke, we 
believe that this is the best way to assure that the overall harm 
caused by smoking will be meaningfully reduced.
    We have extensive research programs, both external and internal, 
that are focused on advancing our knowledge about tobacco smoke, 
including the compounds of smoke and smokers' actual exposure to them, 
to support our efforts to develop new product designs. We are 
continuing to devote substantial research and development efforts to 
develop and launch cigarettes that significantly reduce smokers' 
exposure to compounds that have been identified by public health 
authorities as harmful or potentially harmful. We are making progress 
in this area, and hope to introduce new products with appropriate 
consumer communications as quickly as possible.
    For example, one current result of our efforts is the introduction 
of an electrically heated cigarette smoking system (EHC), called 
Accord, in a limited test market without communications to consumers 
regarding reductions in potentially harmful compounds. The specially-
designed lighter heats the EHC to a lower temperature than that at 
which a lit cigarette burns; the lower the temperature of the tobacco, 
the lower the quantities of certain harmful compounds. In comparing the 
EHC to a standard lit-end industry reference cigarette, we first made 
evaluations of smoke chemistry, Ames activity (a measure of damage to 
DNA), cytotoxicity (a measure of cell damage and tissue irritation), 
and inhalation exposure in laboratory rats. Philip Morris USA 
scientists have shared many of these results with their colleagues in 
the scientific community; examples of their presentations are available 
on online at http://www.ehcss-science.com.
    More recently, we have conducted tests--including both clinical 
studies to assess the levels of potentially harmful compounds that 
smokers are actually exposed to, and machine tests that we believe more 
closely approximate actual smokers' behavior than the existing FTC 
method--comparing the results of smoking the EHC to those of smoking 
various commercially available conventional cigarettes. While we are 
still in the process of evaluating these tests, we hope that they will 
show that smokers of the EHC were exposed to substantially lower 
amounts of certain harmful compounds present in tobacco smoke than 
smokers of the conventional brand styles that were tested.
    In addition, we are working very hard on the development of a 
conventional lit-end cigarette which includes a state-of-the-art 
filter, that uses activated carbon that we hope will be shown to reduce 
certain harmful compounds in smoke. It works like a carbon water 
filter, which reduces some of the unwanted things in the water that 
people drink. This prototype cigarette design also includes flavor 
components to add flavor to replace tobacco flavors trapped by the 
carbon.
    Neither the EHC nor the cigarette with the new filter has been 
proven to reduce the risk of smoking-related disease, and smokers of 
these products would still be inhaling many compounds that are 
potentially harmful. But we believe that these product technologies 
show promise for the future, and that the FDA should be empowered as 
quickly as possible so that the agency can begin to work with us to 
evaluate their potential for reducing the risk of contracting smoking-
related disease, and the overall harm to the population caused by 
smoking.
    As we consider the details of the various legislative proposals 
that are active today, we respectfully urge Congress to keep in mind 
that innovation in developing new products are crucial to their 
ultimate success. In order to have any real impact, reduced exposure 
products must be acceptable to adult smokers. We see little overall 
benefit to consumers or society if harm reduction is not pursued in the 
context of cigarettes that adult consumers will continue to enjoy 
smoking. As the 1998 Canadian Experts' Committee on this subject 
concluded, ``[i]f smokers would not buy these products, product 
modification initiatives would fail.''
     iv. the wisdom of the iom principles, and the need for action.
    We now turn to a general overview of the policy issues relating to 
potentially reduced exposure and reduced risk tobacco products. This 
portion of our statement discusses our strong belief that FDA 
regulation--in line with the IOM Report's recommendations--is an 
essential component to an effective overall harm reduction strategy, 
the debate over whether this strategy is a good one, and the 
consequences of simply preserving the status quo.
The Need for FDA Regulation of Innovative Tobacco Products
    We strongly agree with the IOM Report that governments should help 
determine what is, and what is not, a ``reduced exposure'' or ``reduced 
risk'' tobacco product. Clearly, the best approach is for regulatory 
authorities to make such determinations, based on the best available 
scientific information. As the IOM Report indicates, a product should 
be designated and marketed as ``reduced exposure'' or ``reduced risk'' 
upon an adequate showing of potential exposure or risk reduction to 
current smokers. Whether a product offers potentially reduced exposure 
or risk to an individual smoker is a purely scientific (as opposed to a 
policy) question that FDA should determine based on the data; the 
policies of encouraging quitting, discouraging nonsmokers from starting 
and assessing overall harm reduction across populations is a separate 
question, and can and should be dealt with through post-market 
surveillance, educational programs and appropriate labeling.
    Moreover, we believe that the purpose of regulation in this area--
and the specific details of the FDA's legislative mandate--should be to 
encourage innovation, not to stifle competition and the development of 
potentially beneficial new technologies. We hope that everyone can 
agree that the FDA should not inadvertently be directed or permitted to 
actually inhibit the development of these products, and in the process 
to deny millions of today's smokers a genuine opportunity to 
potentially reduce their chance of contracting smoking-related 
diseases.
    Once, as a matter of science, the FDA concludes that a new product 
has the potential to offer reduced exposure or reduced risk, the best 
approach would be for the agency to play an important role in 
overseeing any claims--explicit or implied--made about it by its 
manufacturer regarding exposure or risk-reduction.
    Crafting appropriate claims regarding these tobacco products is an 
undertaking requiring great care and attention; we are mindful of the 
critical need for manufacturers to work with the FDA so that marketing 
messages clearly communicate that all smoking can be harmful, and that 
the best option from a health perspective is to quit. Once again, as 
with determinations regarding the scientific issues of potential 
exposure and risk-reduction, we believe that the best approach is for 
the FDA to decide what communications to consumers are appropriate on 
this subject.
    On the one hand, regulation should ensure that consumers are not 
mistakenly led to believe that a particular product may be an 
acceptable alternative to quitting from a health perspective. On the 
other hand, regulation should not be utilized as a tool to suppress 
legitimate, accurate and objective information about product 
developments that individuals may find to be beneficial or important. 
The key here is for all communications to consumers to be truthful and 
not misleading in the context of the fact that there is no safe 
cigarette.
The Debate Over Harm Reduction as a Strategy
    The IOM Report was commissioned by the FDA to (in the Report's 
words) ``address the science base for harm reduction from tobacco. The 
committee concluded early in its deliberations that the science base 
for harm reduction will evolve over time.''
    We're keenly aware that some members of the public health community 
are opposed to the very concept of developing and offering ``reduced 
exposure'' or ``reduced risk'' tobacco products, because they are 
concerned that their availability might discourage smokers from 
quitting or encourage them to start smoking. These advocates appear to 
believe that the only acceptable message for the government to 
communicate, irrespective of potential alternatives, is a directive to 
not consume tobacco products at all. Philip Morris USA respectfully 
disagrees with this way of thinking, and strongly believes that it 
would be wrong, if products that could ultimately reduce the harm 
caused by smoking are developed, to deny adult smokers access to 
information about their potential benefits. We're convinced that 
information about potentially reduced-exposure or reduced-risk 
products--that is truthful and not misleading--should be disclosed to 
consumers, so that they can consider the information and then decide 
for themselves which path to take.
    The IOM Report has some important things to say about the debate 
over whether ``reduced exposure'' and ``reduced risk'' tobacco products 
should be pursued:
        Some public health officials oppose the adoption of harm 
        reduction strategies because of concerns that promoting this 
        approach will not, over the long term, prove to be beneficial 
        to public health or to the individual tobacco users who might 
        otherwise have quit. Whatever the merits of this position, 
        marketplace forces already at work have put this issue on the 
        policy agenda, and new products are being developed and offered 
        as harm-reducing alternatives to conventional tobacco products 
        . . . Manufacturers should be permitted to market tobacco-
        related products with exposure reduction or risk reduction 
        claims only after [FDA] approval based on scientific evidence 
        (a) that the product substantially reduces exposure to one or 
        more tobacco toxicants and (b) if a risk reduction claim is 
        made, that the product can reasonably be expected to reduce the 
        risk of one or more specific diseases or other adverse health 
        effects, compared with whatever benchmark product [FDA] 
        requires to be stated in the labeling . . . [The] regulatory 
        process should not discourage or impede scientifically grounded 
        claims of reduced exposure, so long as steps are taken to 
        ensure that consumers are not misled . . .
The IOM Report recommends, among other things, that manufacturers be 
given ``the necessary incentive to develop and market products that 
reduce exposure to tobacco toxicants''; that consumers be ``fully and 
accurately informed'' about the health consequences of these products; 
that claims about their potential for reducing harm be regulated; and 
that research be conducted to ascertain the products' ``potential for 
harm reduction for individuals and populations.''
    In the absence of the regulatory oversight recommended by the IOM 
Report, Philip Morris USA is, as discussed in section III of this 
statement, making a genuine effort to develop potentially reduced 
exposure products in accordance with the Report's recommendations, 
recognizing that there is currently no regulatory agency to validate 
Philip Morris USA's research and development efforts, or any 
independent scientific experts available to fully assess these efforts 
without funding from either the government or ourselves.
The Status Quo is Unacceptable
    The questions regarding the IOM Report's recommendations and harm 
reduction as a strategy are important ones, worthy of thorough 
discussion, and we urge Congress to find the common ground and to pass 
legislation which will finally resolve them.
    Without Congressional action, Philip Morris USA will continue to 
face a genuine dilemma. We're aware that it would not be ideal to begin 
to communicate to consumers about our new products' potential benefits 
in the absence of FDA regulation; this is an important reason that we 
have been seeking it for such a long period of time. However, without 
new legislation and the regulatory oversight that would follow, we are 
faced with the choice of making good faith communications about our new 
products based solely on our rigorous internal and external scientific 
processes and our scientists' engagement with external stakeholders, or 
not communicating information that may prove to be important to over 40 
million consumers across the country. We note in this regard that time 
is not standing still--many of Philip Morris USA's competitors are 
already communicating directly with consumers about their new product 
designs; as the IOM itself said in its report, ``marketplace forces 
already at work have put this issue on the public policy agenda, and 
new products are being developed and offered as harm-reducing 
alternatives to conventional tobacco products.''
    Without new legislation that implements the IOM Report's 
principles, we would undoubtedly face criticism no matter which path we 
choose to take--but it is truly the millions of adult smokers in this 
country who have the most at stake here; we strongly believe that we 
would all be doing them a real disservice if we fail to come together 
to support the passage of legislation that will implement the IOM 
Report's recommendations, and place the FDA in the center of the 
critical decisions about tobacco products that, with or without 
regulation, are going to need to be made in the months and years ahead.
                             v. conclusion
    We believe that Congress has the opportunity to forge a new 
national tobacco policy that will create substantial new authority for 
the FDA to adopt regulations for tobacco products in accordance with 
the principles articulated in the IOM Report, while continuing to 
permit adults who wish to use them to do so legally. The issues you are 
considering today could make a substantial contribution to progress 
towards that goal. We hope this statement provides you with helpful 
input, and makes it clear that our company truly is supportive of a 
comprehensive and effective new regulatory regime that includes every 
area addressed by the IOM Report, and in practice will actually result 
in what we think everyone should be able to agree upon as a primary 
objective: reduced harm from tobacco consumption for both current and 
future generations.
    We also hope that you agree with our conclusion that the status quo 
simply is not serving the needs of American smokers, and that, as the 
IOM Report has noted, novel tobacco products are being--and will 
continue to be--marketed under whatever regulatory regime is in place. 
The issue before us is not whether such products will come into being; 
but rather what the degree of the governmental oversight of them will 
be. These issues are complex and controversial, but we pledge to work 
with anyone and everyone who wishes to join in this challenge, and 
commend this subcommittee for the progress this hearing represents as a 
critical next step.
                                Annex 1
  the debate over reduced-exposure and reduced-risk tobacco products: 
    full disclosure vs. government suppression of truthful and non-
                         misleading information
    Competing proposals to give FDA regulatory authority over tobacco 
products take different approaches to regulating potentially ``reduced-
exposure'' and ``reduced-risk'' tobacco products. These products have 
the potential to reduce the health risks associated with conventional 
tobacco products by, for example, lowering the smoker's exposure to 
toxic substances in the smoke. This paper takes the view that the 
approach most consistent with sound public policy and First Amendment 
protections is that which provides consumers with more information, 
rather than less or none at all. The public health safeguard in this 
approach is that FDA would decide both whether a product does indeed 
present reduced exposure or reduced risks, and what marketing claims 
may be made about the product. But once this determination is made, 
neither FDA nor any other government body could gag truthful and non-
misleading information about the product.
                           Executive Summary
    The debate over how to regulate these products has resulted in a 
debate over consumer communications. On one side are those who share 
the view that the government should simply evaluate claims based on 
their scientific merits and deal with any public health concerns by 
providing for full disclosure to consumers and through other public 
health measures. On the other side are those who fear that the very 
existence of these products, despite the fact that FDA would review, 
approve and regulate any accompanying claims, would have a net adverse 
public health impact by encouraging more people to start smoking in the 
first place and/or by discouraging from quitting people who adopt the 
misguided view that smoking is now ``safe.'' Therefore, this contingent 
supports giving the government authority to suppress reduced-exposure 
and reduced-risk claims about tobacco products.
    The government suppression tact flies in the face of the First 
Amendment and sound public policy. The Supreme Court has made clear 
that suppression of information is not a useful or suitably tailored 
restriction on commercial speech.
    The notion that benefits would result from suppressing truthful and 
non-misleading information tobacco products is premised on the 
speculation that adults might use this information in a manner that is 
disfavored by the government. A benefit deriving from this kind of 
paternalistic assumption, however, is not one that the Constitution 
recognizes as legitimate. Further, even if suppressed by the 
government, information concerning novel tobacco products is likely to 
reach consumers through any number of alternative sources. And FDA or 
another government agency will not have scientifically vetted this 
information.
    Moreover, suppressing information on reduced-exposure and reduced-
risk tobacco products would not necessarily advance the government's 
interest in protecting public health. In order to provide this 
speculative benefit to certain individuals, the government would have 
to impose clear harms on others--specifically, on those people who will 
use tobacco products regardless and who, because of the suppression of 
information, would be denied the ability to select products with 
demonstrated potential benefits. Thus, a significant part of the 
population may be denied crucial information in order to ``protect'' a 
speculative segment of the population.
    In addition, the government has available to it more narrowly 
tailored means of advancing its public health interests. For example, 
it could:

 ensure that consumers are given all necessary information to 
        ensure that they are not misled regarding the health risks that 
        remain with reduced-exposure and reduced-risk tobacco products, 
        or that quitting or not starting is still the most risk-free 
        approach; and
 stress other public health programs to encourage smoking 
        cessation and prevention.
    In short, to quote the Supreme Court, ``the preferred remedy is 
more disclosure, rather than less,'' Bates v. State Bar of Arizona, 433 
U.S. 350, 375 (1977) (emphasis added), and ``[i]f the First Amendment 
means anything, it means that regulating speech must be a last--not 
first--resort.'' Thompson v. Western States Medical Center, 122 S.Ct. 
1497, 1507 (2002) (emphasis added). Indeed, ``if the [g]overnment [can] 
achieve its interests in a manner that does not restrict speech, or 
that restricts less speech, the [g]overnment must do so.'' Id. at 1506 
(emphasis added). Accordingly, legislation should task FDA with 
reviewing claims based on their scientific merits. FDA also should have 
ample authority to ensure that consumers are provided with full 
disclosure regarding such products. Other public health tools should 
supplement these efforts by continuing to encourage smoking cessation 
and prevention. This approach is consistent with the approach outlined 
by the Institute of Medicine: ``The regulatory process should not 
discourage or impede scientifically grounded claims of reduced 
exposure, as long as steps are taken to ensure that consumers are not 
misled . . .'' Institute of Medicine, ``Clearing the Smoke: Assessing 
the Science Base for Tobacco Harm Reduction'' (2001), at 7-13.
                             i. background
    In 2001, the Committee to Assess the Science Base for Tobacco Harm 
Reduction (the ``Committee'') of the Institute of Medicine (``IOM'') 
issued a report on reduced-exposure and reduce-risk tobacco products 
commissioned by the Food and Drug Administration (``FDA'').
    The Committee made clear that it recommends a regulatory approach 
based on sound science and full consumer disclosure. Prior to detailing 
its principles for the regulation of reduced-exposure and reduced-risk 
tobacco products (which the Committee referred to as ``potential 
reduced-exposure products,'' or ``PREPs''), the Committee stated:
        ``The committee did come to conclude that regulation of PREPs 
        is necessary and feasible . . . [R]egulation is needed to 
        ensure that the product labeling and advertising do not mislead 
        consumers and accurately describe the products' risks, 
        including the uncertainties that can only be resolved after 
        long-term use. Consumers should not use these new products on 
        the basis of explicit or implicit claims that these products 
        carry less risk than traditional tobacco products unless such 
        claims are true. Absent careful regulation of industry claims 
        about these products, informed choices by consumers will not be 
        possible, the potential benefit of harm reduction strategy is 
        likely to go unrealized, and the long and unsettling saga of 
        light cigarettes may well be repeated.''
IOM Report, at 7-2 (emphasis added).
    Notwithstanding IOM's recommendations, however, certain legislative 
proposals to grant FDA authority to regulate tobacco products appear to 
authorize FDA to suppress information about PREPs even if FDA has 
verified that these products actually have the potential to present 
potential benefits for consumers. For example, some proposals would 
permit manufacturers to make reduced-exposure or reduced-risk health 
claims only if FDA determines that the product actually reduces the 
risk of harm to individuals as a matter of science and is otherwise 
``appropriate'' for the ``public health.'' 4
---------------------------------------------------------------------------
    \4\ See e.g., H.R. 936, 108th Cong. Sec. 572(a)(1), (2) (stating 
that FDA must determine that ``based on the best available scientific 
evidence the product significantly reduces the overall health risk to 
the public when compared to other tobacco products,'' and that in 
approving reduced-risk claims, FDA must ``ensure [the claim's] accuracy 
and, in the case of advertising, . . . prevent such statement from 
increasing, or preventing the contraction of, the size of the overall 
market for tobacco products'' (emphasis added).
---------------------------------------------------------------------------
    This type of two-prong standard--with a ``scientific merits 
prong''' and an ``appropriateness'' prong--appears to respond to those 
segments of the public health community that have called for FDA 
discretion to suppress reduced-risk claims, notwithstanding their 
veracity, based on their potential effect on consumer behavior. See, 
e.g., National Cancer Society et al., Why the FDA Should Regulate 
Tobacco Products (June 27, 2002) (stating that FDA should have the 
authority ``to prohibit or restrict . . . claims that discourage people 
from quitting or encourage them to start using tobacco''); Campaign for 
Tobacco Free Kids, Critical Elements of FDA Authority Over Tobacco 
(Feb. 18, 2000) (``FDA should have the authority to prohibit . . . 
health claims that have an adverse effect on the overall risk to the 
American public . . .'').5
---------------------------------------------------------------------------
    \5\ For example, H.R. 936 provides that FDA must prevent reduced-
risk advertising claims from ``increasing, or preventing the 
contraction of, the size of the overall market for tobacco products.'' 
H.R. 936 Sec. 575(a)(2).
---------------------------------------------------------------------------
    Thus, under this two-prong standard, even if valid scientific 
evidence demonstrates to FDA's satisfaction that a product presents 
potential benefits, the agency could prohibit truthful and non-
misleading information about the product's reduced-exposure or reduced-
risk potential from being communicated to consumers in the marketplace.
     ii. the first amendment precludes this kind of suppression of 
                              information
    This approach to the regulation of PREPs would violate the First 
Amendment and sound public policy. First, the suppression of 
information would not materially and directly advance the government's 
legitimate interests in encouraging tobacco cessation and prevention. 
Instead, the suppression of information would harm a clearly 
identifiable group of individuals. Second, the government has far more 
tailored means at its disposal to address any impact of PREPs on the 
rates of smoking cessation and initiation. Such alternatives include 
the mandatory use of public health disclaimers to ensure that PREPs are 
not perceived as safe, and the pursuit of other public health programs 
to encourage tobacco cessation and prevention.
    The Supreme Court repeatedly has held that once a product is 
legally sold in the United States, the government may not deny adults 
truthful and non-misleading information about the product. Rather, the 
government must adopt more tailored restrictions to achieve its 
legitimate purposes. As the Supreme Court stated in its seminal 
commercial speech case:
        ``There is, of course, an alternative to [a] highly 
        paternalistic approach [to regulating commercial speech]. That 
        alternative is to assume that this information is not in itself 
        harmful, that people will perceive their own best interests if 
        only they are well enough informed, and that the best means to 
        that end is to open the channels of communication rather than 
        to close them . . . It is precisely this kind of choice, 
        between the dangers of suppressing information, and the dangers 
        of its misuse if it is freely available, that the First 
        Amendment makes for us.''
Virginia Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc., 
425 U.S. 748, 770 (1976).
    ``[B]ans against truthful, nonmisleading commercial speech . . . 
usually rest solely on the offensive assumption that the public will 
respond ``irrationally'' to the truth. The First Amendment directs us 
to be especially skeptical of regulations that seek to keep people in 
the dark for what the government perceives to be their own good.'' 
Thompson v. Western States Medical Center, 122 S.Ct. 1497, 1508 (2002), 
citing 44 Liquormart v. Rhode Island, 517 U.S. 484, 503 (1996) 
(plurality opinion).
    In Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001), the 
Supreme Court struck down certain restrictions on the advertising of 
tobacco products because those restrictions were not sufficiently 
tailored to fit the government's objective of protecting children. This 
holding reaffirmed that the Court will carefully scrutinize commercial 
speech restrictions, including in the case of tobacco products, to 
determine if less restrictive means are available to achieve the 
government's purpose. The Reilly Court also made clear that commercial 
speech restrictions continue to be subject to the following four-part 
inquiry developed by the Supreme Court in the Central Hudson case:
        ``For commercial speech to come within [the First Amendment], 
        it at least must concern a lawful activity and not be 
        misleading. Next, we ask whether the asserted government 
        interest is substantial. If both inquiries yield positive 
        answers, we must determine whether the regulation directly 
        advances the government interest asserted, and whether it is 
        not more extensive than is necessary to serve that interest.''
447 U.S. 557, 566 (1980). ``We have said that the last two steps of the 
Central Hudson analysis basically involve a consideration of the `fit' 
between the legislature's ends and the means chosen to accomplish those 
ends.'' Rubin v. Coors Brewing Co., 514 U.S. 476, 486 (1995).
    Simply put, the suppression of information about PREPs does not fit 
the government's interest in encouraging tobacco cessation and 
prevention.
A. The Suppression of Reduced-Risk Information Would Elevate Presumed 
        Paternalistic Benefits for Some Over Real Harms for Others
    The premise behind providing FDA with authority to suppress 
truthful and non-misleading information appears to be that the costs 
associated with the possible changes in the rates of cessation and 
initiation might outweigh the benefits resulting from communications 
about PREPs. To tilt the balance in this fashion, however, one would 
have to value the presumed benefits that may be provided to some 
individuals over the real costs that would be imposed on others. Such 
conjecture, however, cannot justify the suppression of truthful and 
non-misleading commercial speech under the First Amendment. ``Such 
speculation certainly does not suffice when the [government] takes aim 
at accurate commercial information for paternalistic ends.'' 44 
Liquormart, 517 U.S. at 507.
    Moreover, as detailed below, an abstract discussion about costs and 
benefits fails to illuminate the serious consequences of suppressing 
truthful information about PREPs.
1. The Paternalistic and Speculative Benefits Provided by the 
        Suppression of Information Are Insufficient to Pass 
        Constitutional Muster
    The suppression of information presumably would be intended to 
benefit that segment of the population that would quit or never 
initiate smoking if information about PREPs is not available, but who 
would choose to switch to or begin using them if they were made aware 
of these products. Viewed from a ``paternalistic'' perspective, this 
segment of the population would be benefited by the suppression of 
information. Attempting to justify the suppression of information on 
this basis, however, is at odds with the Constitution, because 
paternalism is not a legitimate governmental interest, and because the 
realization of this paternalistic benefit would be impermissibly 
speculative.
    The government ``does not have the broad discretion to suppress 
truthful, nonmisleading information for paternalistic purposes . . . '' 
44 Liquormart, 517 U.S. at 510. Indeed, the Supreme Court has 
``rejected the notion that the [g]overnment has an interest in 
preventing the dissemination of truthful commercial information in 
order to prevent members of the public from making bad decisions with 
the information.'' Western States, 122 S.Ct. at 1507. ``[T]he argument 
[for suppression] assumes that the public is not sophisticated enough 
to realize the limitations of advertising, and that the public is 
better kept in ignorance than trusted with correct but incomplete 
information. We suspect the argument rests on an underestimation of the 
public . . . [W]e view as dubious any justification that is based on 
the benefits of public ignorance.'' Bates v. State Bar of Arizona, 433 
U.S. 350, 374-375 (1977). ``To endeavor to support a restriction upon 
speech by alleging that the recipient needs to be shielded from that 
speech for his or her own protection . . . is practically an engraved 
invitation to have the restriction struck.'' Wash. Legal Found. v. 
Friedman, 13 F. Supp. 2d 51, 70 (D.D.C. 1998) (judgment vacated on 
other grounds). ``[T]he government may not restrict speech because it 
fears, however justifiably, that the speech will persuade those who 
hear it to do something of which the government disapproves.'' David A. 
Strauss, Persuasion, Autonomy, and Freedom of Expression, 91 Colum. L. 
Rev. 334, 334 (1991).
    Moreover, this justification for suppression of information would 
fail the third prong of the Central Hudson test because it would 
require the court ``to engage in the sort of ``speculation or 
conjecture'' that is an unacceptable means of demonstrating that a 
restriction on commercial speech directly advances the [government's] 
asserted interest.'' 44 Liquormart, 517 U.S. at 507. For example, in 
Rubin v. Coors Brewing Co., 514 U.S. 476 (1995), the Court concluded 
that the government's prohibition on displaying alcohol content on beer 
labels failed the third prong of Central Hudson because it would not 
sufficiently advance the government's interests in preventing 
``strength wars'' in the marketing of alcoholic beverages. The Court 
reasoned that the government's burden ``is not satisfied by mere 
speculation or conjecture; rather, a governmental body seeking to 
sustain a restriction on commercial speech must demonstrate the harms 
it recites are real and that its restriction will in fact alleviate 
them to a material degree.'' Id. at 487, quoting Edenfield v. Fane, 507 
U.S. 761, 770-771 (1993).6
---------------------------------------------------------------------------
    \6\ When viewed from a more ``utilitarian'' perspective, these 
individuals are not benefited at all by the suppression of information. 
From this perspective, adults are better off if they are left free to 
make their own decisions based on full information. As University of 
Chicago Law School Professor Cass Sunstein puts it, ``people should be 
allowed to select their preferred mixes of risk, employment, salary, 
medical care, and so forth.'' Cass R. Sunstein, Informing America: 
Risk, Disclosure, and the First Amendment, 20 Fla. St. U. L. Rev. 653, 
659 (1993); see also Martin H. Redish, Tobacco Advertising and the 
First Amendment, 81 Iowa L. Rev. 589, 592 (1996) (``The asserted 
justifications for such regulation of the truthful promotion of a 
lawful product derive exclusively from a premise of governmental 
paternalism that is fundamentally inconsistent with both the purposes 
served by free speech and the democratic system of which free speech is 
a central element.'')
---------------------------------------------------------------------------
    It is far from clear that suppressing information would ``in fact 
alleviate'' the perceived harms that might arise from the introduction 
of PREPs. Any information suppressed by the government likely would 
find its way to consumers through other channels, though almost 
certainly in a less accurate form that has not been subject to 
scientific verification. As the IOM Report notes, ``marketplace forces 
already at work have put this issue on the public policy agenda,'' and 
consumers will seek out PREPs ``with or without scientific guidance.'' 
IOM Report at 7-1, 7-2. Moreover, as discussed below, any advance in 
the public health that purportedly results from the suppression of 
information would be undermined by the adverse effects of such 
suppression on individuals who would have used PREPs had the suppressed 
information been available to them.
2. Real Harms Would Be Imposed by the Suppression of Information
    Though the benefits to be derived from the suppression of 
information about PREPS are speculative, it is clear that a separate 
group of individuals would be harmed by the suppression of such 
information. This group consists both of smokers who would have 
switched to PREPs instead of continuing to use conventional tobacco 
products, and nonsmokers who would have begun using PREPs instead of 
conventional tobacco products if they had been provided with 
information about PREPs. Regardless of one's philosophical bent, 
everyone should agree that this group, which ends up taking on more 
risks solely because of the suppression of information, is 
substantially harmed by that suppression.
    It is neither sound public policy nor constitutionally permissible 
for the government knowingly to harm a certain group of individuals by 
suppressing information for the presumed benefit of others. The Supreme 
Court held in the Western States decision that such a suppression of 
commercial speech cannot be reconciled with the First Amendment. 
Western States, 122 S.Ct. at 1508-09. In this decision, the Court 
invalidated provisions of the Food and Drug Modernization Act 
(``FDAMA'') that prohibited advertising of ``compounded drugs,'' 
7 which the government argued were necessary to ensure that 
drug compounding was not used to circumvent the new drug approval 
requirements of the Federal Food, Drug, and Cosmetic Act (``FDCA''). 
Id. at 1504-06.
---------------------------------------------------------------------------
    \7\ Drug compounding, a ``traditional component of the practice of 
pharmacy,'' is a process by which a pharmacist or doctor combines or 
alters drug ingredients to create a medication typically not 
commercially available and which is tailored to the needs of a 
particular individual, e.g., an individual that is allergic to an 
ingredient in a mass-produced product. Id. at 1500.
---------------------------------------------------------------------------
    The Supreme Court found that the prohibition on advertising of 
compounded drugs was impermissible, inter alia, because of ``the amount 
of beneficial speech'' that it prohibited without furthering the 
asserted governmental objective. Id. at 1508.8 Specifically, 
the Court pointed out that the prohibition would prevent pharmacists 
with ``no interest in mass-producing medications'' in circumvention of 
FDCA from telling doctors about alternative drugs available through 
compounding that would be useful in treating patients with special 
medical needs. Id. at 1508-09. The fact that such ``useful speech'' 
would be suppressed even though doing so would not ``directly further'' 
the government's asserted objective was ``enough to convince'' the 
Court that the challenged provisions were unconstitutional. Id. at 
1509.
---------------------------------------------------------------------------
    \8\ In response to the Western States decision, FDA issued a 
Federal Register notice seeking comments to ``ensure that its 
regulations, guidances, policies, and practices continue to comply with 
the governing First Amendment case law.'' 67 Fed. Reg. 34,942 (May 16, 
2002).
---------------------------------------------------------------------------
    Following Western States, the suppression of information about 
PREPs would be unconstitutional because it would result in real harm 
for certain groups of people without furthering a substantial 
governmental interest. The suppression of truthful, non-misleading 
claims clearly would redound to the detriment of certain individuals--
i.e., those who, had they been exposed to the claims, would have 
switched to PREPs from conventional tobacco products. Moreover, the 
only motivation for suppressing truthful and non-misleading reduced-
risk information would be the government's desire to prevent people 
from using the information to make choices that the government 
disfavors. Yet, as discussed above, the Constitution does not recognize 
such a motivation as a legitimate basis for restricting commercial 
speech. Under these circumstances, not only would the government 
impermissibly be saying that it knows what is best for certain of its 
citizens, but in doing so, it would affirmatively harm other citizens.
    The government's decision to suppress reduced-risk information also 
has severe consequences for the individual and, indeed, for our system 
of government as a whole:
        [T]he fundamental premise of the First Amendment--indeed, of 
        the very democratic system of which the First Amendment is such 
        an important part--is that citizens must be trusted to make 
        their own lawful choices on the basis of a free and open 
        competition of ideas, opinions, and information. If government 
        is permitted paternalistically to shield its citizens from such 
        open debate as a means of controlling their behavioral choices, 
        it will have simultaneously affronted individual dignity and 
        stunted the individual's personal and intellectual growth, a 
        developmental process that lies at the heart of the free speech 
        right. It will simultaneously have contributed to an 
        intellectual atrophy of the citizen that ultimately will 
        undermine her effective participation in the democratic system.
Redish, Tobacco Advertising and the First Amendment, supra, at 636.
B. More Targeted Approaches Are Available to Address Public Health 
        Concerns About PREPs
    Far more targeted approaches are available for the government to 
address concerns about the impact that PREPs might have on the rates of 
smoking cessation and initiation. FDA should ensure that information 
about the product's reduced-exposure or reduced-risk potential is 
presented to consumers in a truthful and non-misleading manner. Indeed, 
authority to prevent false and misleading product information is a 
standard FDA regulatory tool that currently applies to all product 
labeling and promotional materials regulated under FDCA, and that would 
be extended to tobacco products by proposals granting FDA authority to 
regulate such products. In addition, other public health tools to 
encourage tobacco cessation and prevention are available and currently 
in use.
1. FDA Should Consider Appropriate Use of Disclaimers to Address Public 
        Health Concerns
    The Supreme Court held in Western States that ``if the [g]overnment 
can achieve its interests in a manner that does not restrict speech, or 
that restricts less speech, the [g]overnment must do so.'' Western 
States, 122 S.Ct. at 1506-07 (emphasis added) (holding that the 
government failed to demonstrate that preserving the integrity of the 
FDCA drug approval process could not be achieved through means that 
imposed a lesser burden on speech than the FDAMA prohibition on 
advertising compounded drugs). Consequently, the advertising 
prohibition challenged in that case failed to satisfy the fourth prong 
of the Central Hudson test requiring that the restrictions not be more 
extensive than is necessary to serve the governmental interest. Id. See 
also Pearson v. Shalala, 164 F.3d 650, 655 (D.C. Cir. 1999) (there 
cannot be ``an absolute prohibition on . . . potentially misleading 
information . . . if the information also may be presented in a way 
that is not deceptive''); Wash. Legal Found. v. Friedman, 13 F. Supp. 
2d at 73 (FDA restrictions on particular forms of manufacturer 
promotion of off-label uses for FDA-approved drugs were considerably 
more extensive than necessary, and ``[t]he most obvious alternative is 
full, complete, and unambiguous disclosure by the manufacturer'').
    In Western States, the Supreme Court identified the use of so-
called ``disclaimers'' as an alternative way to ensure that consumers 
are not misled by advertisements. Western States, 122 S.Ct. at 1508 (a 
governmental interest in preventing misleading advertising could be 
achieved by ``the far less restrictive alternative'' of requiring 
compounded drugs to bear warnings stating that the drugs are not FDA-
approved and that their risks are unknown). The D.C. Circuit made the 
same conclusion in Pearson, stating that ``we are skeptical that the 
government could demonstrate with empirical evidence that disclaimers . 
. . would bewilder consumers and fail to correct for deceptiveness . . 
. ''. Pearson, 164 F.3d at 659-660; see also In re R.M.J., 455 U.S. 
191, 203 (1982) (``[T]he remedy in the first instance is not 
necessarily a prohibition but preferably a requirement of disclaimers 
or explanation.''). Furthermore, this principle is ``consistent with a 
well-established body of law that points to First Amendment limits on 
federal agencies' restrictions on commercial speech where less 
restrictive alternatives are available.'' Steven B. Steinborn & Kyra A. 
Todd, The End of Paternalism: A New Approach to Food Labeling, 54 Food 
& Drug L.J. 401, 402 (1999). ``Pearson stands as [a] reminder that 
regulatory agencies in general, and FDA in particular, must adopt a 
regulatory approach that recognizes the consumer's right to receive 
pertinent information.'' Id. at 413-414.
    Indeed, the Federal Trade Commission has long supported the 
position that disclaimers must be considered as an alternative when 
determining whether health claims about a product are misleading. See 
Nat'l Comm'n on Egg Nutrition v. FTC, 570 F.2d 157, 164 (7th Cir. 
1977); Margaret Gilhooley, Constitutionalizing Food and Drug Law, 74 
Tul. L. Rev. 815, 827 (2000); see also FTC Enforcement Policy Statement 
on Food Advertising, 59 Fed. Reg. 28,388, 28,393 (1994) (noting that 
the ``significant scientific agreement'' standard in the Nutrition 
Labeling and Education Act of 1990 (NLEA) is the appropriate standard 
to determine if health claims are misleading only in situations where 
the claims are unqualified).
    Providing consumers with additional information, such as through 
the use of disclaimers, is thus a more tailored means to address the 
potential impact of PREPs on smoking cessation and initiation. ``Any 
`interest' in restricting the flow of accurate information because of 
the perceived danger of that knowledge is anathema to the First 
Amendment; more speech and a better informed citizenry are among the 
central goals of the Free Speech Clause.'' Rubin, 514 U.S. at 497 
(Stevens, J., concurring) (emphasis added). FDA could require, for 
example, that every tobacco product designated as a PREP include 
labeling that reminds consumers that no tobacco product is safe and 
that the best option is to quit or not to start in the first 
place.9
---------------------------------------------------------------------------
    \9\ Of course, FDA could prohibit any reduced-risk or health claims 
for tobacco products that have not been approved by FDA. See, e.g., 
Whitaker v. Thompson, 239 F.Supp. 2d 43, 54 (D.D.C. Jan. 3, 2003) 
(holding that claims concerning the therapeutic effects of a dietary 
supplement on an existing disease condition that were not approved as 
permissible reduced-risk claims for the product were unlawful health 
claims).
---------------------------------------------------------------------------
2. Other Public Health Tools are Available to Address Concerns Related 
        to Smoking Cessation and Prevention
    An FDA-imposed restriction on the communication of information 
about PREPs is not the only policy tool available to address concerns 
related to tobacco use. As the Institute of Medicine noted, the 
regulatory system should not be viewed in isolation, but rather ``as an 
essential component of a package of public policy initiatives 
(including research, education and surveillance) that this committee 
believes is necessary to realize whatever benefit tobacco or 
pharmaceutical product innovation can offer in reducing the nation's 
burden of tobacco-related illness and death.'' IOM Report at 7-21, 22. 
``Harm reduction [should be] implemented as a component of a 
comprehensive national tobacco control program that emphasizes 
abstinence-oriented prevention and treatment.'' Id. at 7-21.
    In this regard, Congress appropriated more than $100 million to the 
Centers for Disease Control for its tobacco control efforts in FY--
2003. Further, many states have increased their spending on tobacco 
control efforts in the wake of the state attorneys general tobacco 
settlements (the ``MSA''). These state and federal tobacco control 
programs are in addition to the $1.5 billion that was earmarked in the 
MSA to fund tobacco control efforts through a national public health 
foundation, the American Legacy Foundation, which is overseen by the 
state attorneys general.
    Indeed, the government would have the burden of demonstrating that 
programs such as these could not adequately address the public health 
concerns raised by PREPs, which would obviate the need to suppress 
truthful, non-misleading information. ``If the First Amendment means 
anything, it means that regulating speech must be a last--not first--
resort.'' Western States, 122 S.Ct. at 1507.10
---------------------------------------------------------------------------
    \10\ The Supreme Court ruled in Western States that the government 
must consider non-speech related alternatives before resorting to 
restrictions on commercial speech. In the decision, the Court 
identified several non-speech alternatives to FDAMA's compounded drug 
advertising prohibition that might be effective in achieving the 
government's interest of ensuring the integrity of FDCA's drug approval 
process. Id. at 1506. These were (1) banning the use of commercial 
scale manufacturing or testing equipment for compounding drug products; 
(2) prohibiting pharmacists from compounding more drugs in anticipation 
of receiving prescriptions than in response to prescriptions already 
received; (3) prohibiting pharmacists from offering compounded drugs at 
wholesale to other state licensed persons or commercial entities for 
resale; (4) limiting the amount of compounded drugs that a pharmacist 
may sell out of State or sell or make in a given period of time; or (5) 
relying on the non-speech related provisions of FDAMA, which include 
requiring that compounding only be conducted in response to a 
prescription or a history of receiving a prescription, and limiting the 
percentage of a pharmacy's total sales that out-of-state sales of 
compounded drugs may represent. Id. at 1506. The government's failure 
to explain why these alternatives would not be adequate led the Court 
to conclude that FDAMA's advertising prohibition was more extensive 
than necessary. Id. at 1506-07.
---------------------------------------------------------------------------
                            iii. conclusion
    Based on these precedents and the IOM Report's recommendations, 
proposals to grant FDA authority over tobacco products should ensure 
that adult consumers are provided with truthful and non-misleading 
information about PREPs. ``[P]erhaps the first and most basic problem 
is that Americans lack the necessary information . . . [P]erhaps the 
first goal ought to be to ensure genuinely informed choices, rather 
than to dictate outcomes from Washington.'' Sunstein, supra, at 654.
    An outright ban on such information concerning PREPs would be 
inappropriate and unconstitutional. Instead, FDA should be empowered to 
assess and approve PREPs based on the scientific merits of the claims 
and then ensure that consumers are not misled about the risks 
associated with those products. Additional public health programs 
should continue to encourage smoking cessation and prevention.

    Mr. Stearns. At this point I would invite other members to 
do the same if they wish to enter documents into the record, 
and with that, I welcome my ranking member for an opening 
statement.
    Ms. Schakowsky. Thank you, Mr. Chairman. It is good to see 
you again.
    Well, you have got to hand it to the tobacco lobby. If 
there were such a thing as a chutzpa award, which roughly 
translates into brazen gall, the effort today, in my humble 
opinion, would be worthy of a prize.
    Under the guise of concern for public health, the tobacco 
industry has us here to discuss its efforts to gain advanced 
government approval or a marketing campaign that would promote 
tobacco products and their bottom line.
    ``Smokeless tobacco''--I put that in quotes--is a dressed 
up name for dip, chew or spit tobacco, U.S. Tobacco, UST, wants 
to market its spit tobacco as a safer alternative to smoking 
cigarettes. Smokeless tobacco is a threat to our Nation's 
public health and especially to the health of our children. Any 
type of claim that spit tobacco as a safer alternative to 
smoking requires a substantive body of evidence and an 
independent regulatory body capable of examining the claims.
    Such evidence and regulation does not exist. UST cannot 
back up their campaign slogans, and that is why they have asked 
the FTC, not the FDA, the FTC being a nonscientific regulatory 
agency, to review the claims they want to make.
    Tobacco causes cancer and other diseases, whether you smoke 
it, chew it, suck it, put it up your nose. It can and after 
sustained use probably will kill you.
    UST's argument that smokeless tobacco use is a healthier 
alternative to smoking is analogous to suggesting that one is 
better off jumping off the fifth floor of the building rather 
than the 20th because, of course, both are likely to cost you 
your life. They want to convince smokers who may be trying to 
quit or have quit, nonsmokers, children and others that their 
product is okay to use.
    If we allow them to make these false claims, then the 
Congress will share the blame for more lives lost to tobacco 
related diseases.
    The government has no business endorsing media campaigns 
for products like spit tobacco that lead to disease and 
premature death. First we should do no harm. If we send a 
message to the American public that it is okay to chew tobacco, 
we will be doing harm. If we, instead, want to truly discuss 
ways to reduce harm and promote health, we should spend time 
and money on legitimate ways to end the use of tobacco in any 
form, period.
    Today, along with Congressman Waxman, I will be releasing a 
report entitled ``The Lessons of `Light' and Low Tar 
Cigarettes.'' Without effective regulation, reduced risk 
tobacco products, so-called reduced risk tobacco products, 
threaten the public health.
    Mr. Chairman, I ask unanimous consent to insert this report 
into the record.
    Mr. Stearns. Without objection, so ordered.
    Ms. Schakowsky. Thank you.
    [The report appears at the end of the hearing.]
    Ms. Schakowsky. I think it is an important document to 
include in the official record because it underscores parallels 
documented by the Government Reforms Committee Democratic staff 
between the efforts of the tobacco industry to mislead the 
public into believing that so-called light and low tar 
cigarette products are a healthy alternative to regular 
cigarettes and the efforts currently underway by UST to 
convince the Congress the FTC, and the public of the virtues of 
its spit tobacco products.
    This report includes previously undisclosed internal 
industry documents and demonstrates that the products that are 
marketed as light and low tar are, in fact, not. We know that 
the tobacco industry duped the FTC's tests by designing 
cigarettes that only appeared healthier when tested by 
machines, but did not provide lower amounts of tar and nicotine 
to smokers.
    We know that the industry has for some time been well aware 
of the dangers these products pose. An internal company E-mail 
included in this report, a senior research scientists at 
British-American Tobacco stated, ``Our main problem appears to 
be the notion that the technology exists to make cigarettes 
which are appreciably less lethal. The technology does not 
exist. It will not exist.''
    The report also demonstrates that tobacco industry 
officials continue to deceive the public with information from 
industry, the National Cancer Institute, and the Department of 
Justice. The report provides clear examples of current 
``reduced risk'' product marketing, including the marketing of 
spit tobacco specifically designed to counter health fears, 
deceive consumers, deter quitting, and exploit the absence of 
effective regulation.
    The FTC allowed for the marketing of light and low tar 
products in the past, and the public was harmed. Now major 
lawsuits have ensued. In my home State of Illinois, a court 
recently ruled against Philip Morris and found that its 
creation of these brands was ``immoral, unethical, oppressive, 
and unscrupulous.''
    And UST is here today trying to present a case that their 
spit tobacco products are not as harmful as smoking and, 
therefore, the company should be allowed to make such 
statements on their packaging. UST's representatives want us to 
believe that they are offering a product that will improve 
overall health in the United States.
    Quite the opposite is true. We know from industry documents 
that UST has purposely targeted tobacco consumers in an effort 
to promote ``dual consumption,'' not cessation of smoking.
    We should not even be entertaining UST's claims absent a 
comprehensive review and serious regulation by the FDA. The FDA 
should have authority over all tobacco products, including spit 
tobacco, and authority to oversee the content, manufacture, 
sale, and marketing of the product. Absent this regulation, 
allowing marketing strategies that include comparative health 
claims will lure more kids into smokeless tobacco use and 
addiction, discourage current users from quitting, and may 
increase the overall amount of tobacco products being used in 
the United States.
    Mr. Chairman, I thank you for your indulgence in letting me 
go over. I think this is a very, very serious issue, and I 
appreciate the opportunity to discuss this important issue 
today with our witnesses.
    Mr. Stearns. I thank the gentlelady, and I will now 
recognize the Chairman of the full committee, who probably will 
not agree with you when you mention Tabasco sauce. The 
chairman, distinguished chairman of the committee, Mr. Tauzin.
    Chairman Tauzin. Thank you, Mr. Chairman.
    I would not recommend you smoke Tabasco sauce though. It is 
not necessarily a good idea.
    Let me thank you, Mr. Chairman, for convening this hearing, 
and I want to thank the Chairman of the Federal Trade 
Commission and the Surgeon General for coming to join us, and I 
hope it will be a very instructive session, particularly as we 
move to the second panel as well and get some insights as to 
this extraordinary issue.
    We have held hearings, as you know, in this committee on 
tobacco in the past, but this particular issue of tobacco harm 
reduction is not one I think that has been the subject of a 
great deal of congressional debate, frankly, a good 
understanding yet. It was back in 1964 that the Surgeon General 
released a report finding that cigarette smoking is a health 
hazard of sufficient importance to the United States to warrant 
appropriate remedial action.
    And we now know that smoking kills over 400,000 people 
annually in the United States alone, and that is more deaths 
each year than from AIDS, from alcohol, cocaine, heroin, 
homicide, suicide, motor vehicle crashes, and fires combined. 
You cannot ignore those kinds of statistics.
    And during the past 4 decades we have made unprecedented 
gains in preventing and controlling tobacco use. However, 
despite the massive education campaigns and years of 
litigation, and substantial price hikes designed to curb 
smoking, it has picked up. And when asked, most smokers say 
they want to quit. I think over 80 percent will say that in 
most surveys. Unfortunately very few of them are able to break 
the habit.
    There is no debate that the best option for any person 
using tobacco products is to stop, to stop using tobacco 
products, and particularly we need to continue to do all we can 
to discourage the use of these products by children.
    But we also know that nicotine is a remarkably addictive 
drug. Some have likened the addictive qualities of nicotine to 
the intense grip of cocaine or heroin. Unfortunately there are 
people who, try as they may, are unable or unwilling to kick 
the smoking addiction.
    Some in the medical community argue that we are giving 
these hardened smokers only one uninviting option: quit or die. 
Increasingly there are calls for options other than the quit or 
die approach, such as tobacco harm reduction. There are studies 
now that have found that some tobacco products, such as 
smokeless tobacco, are less hazardous than cigarettes, not 
unhazardous or safe, but less hazardous.
    These studies have resulted in a call for campaigns that 
would encourage smokers to switch from cigarettes to smokeless 
tobacco, which arguably could save many of the 400,000 people 
who will die every year, and that is an intriguing concept, and 
if science bears out these conclusions, we are faced with a 
myriad of questions that I hope we begin to think about and 
perhaps begin to answer today or at least set up a process 
whereby we might have the type of forums and discussions with 
officials and citizens of our country to find the answers to 
these questions.
    They include: should we communicate this reduced risk 
information to the consumer? Is a person who is faced with a 
quit or die option one of my children? Is that person to 
entitled to know that there is another option that can reduce 
the risk of death and perhaps even be a bridge to stopping 
smoking?
    If so, how should we communicate this information. 
Obviously the concern is if you communicate it improperly, you 
might encourage people to continue using tobacco, and that is 
not the goal obviously. So how do you do it properly?
    Will promotion of certain tobacco products as reduced risk 
dilute the anti-tobacco, anti-smoking message that we are 
sending children, in particular? And that is a deep concern.
    Finally, does a consumer have a right to know about safer 
tobacco products, about reduced risk products? We know in other 
countries, such as Sweden, they made that decision, that 
consumers were entitled to know, and there have been some 
remarkable results as a result of simply communicating that 
information to people who were faced with the quit or die 
option.
    So these are questions I hope we will answer today. The 
hearing is especially timely because the Federal Trade 
Commission is currently faced with a petition from the United 
States Tobacco Company that requests an advisory opinion on 
whether, based on current science, it may advertise its 
smokeless product as a safer alternative to smoking. I hope the 
Federal Trade Commission examines the issue carefully.
    I urge Chairman Muris to invest the commission's time and 
energy in a tobacco harm reduction workshop to more thoroughly 
evaluate these claims. I think it is time for that, just to 
have a very open and informative workshop so that we can 
understand whether we need to make some new policy decisions in 
this country.
    Few medical questions have stirred more public interest or 
created more scientific debate than the tobacco health 
controversy. The relationship between tobacco and health does 
not lead to easy answers.
    Nevertheless, there are 400,000 deaths in the United States 
attributed to smoking. It is increasingly apparent that we must 
continue to search for new and novel solutions.
    I want to thank you again, Mr. Chairman, for holding the 
hearing and look forward to hearing from our two distinguished 
witnesses today.
    Mr. Stearns. And I thank the Chairman.
    The gentleman from Massachusetts is recognized.
    Mr. Markey. Thank you, Mr. Chairman, very much and thank 
you for holding this hearing.
    To say that smokeless tobacco is a safer alternative to 
smoking cigarettes is very misleading. Smokeless tobacco 
products have known carcinogens and that are linked to oral 
cancer and they are addictive. This method of harm reduction 
may simply be trading one vice for another.
    A few years ago I introduced the Cigars Are No Safe 
Alternative Act that would impose restrictions on the sale of 
cigars because cigar use is not a safe alternative to smoking 
cigarettes either. People need to be informed of all of the 
risks of tobacco products.
    Just as with cigars and cigarettes, children especially 
must not be influenced by misleading advertising that glorifies 
the use or these tobacco products. Three thousand young people 
begin smoking in the United States every day. One thousand of 
these 3,000 will die from some lung related disease. Twenty 
percent of all Americans who die each year, die from some lung 
related smoking related disease. Obviously our goal should be 
to just stop it dead in its tracks.
    I believe that people should make informed decisions for 
themselves as to which is a better alternative and safer for 
them. However, people cannot make informed decisions about 
smokeless tobacco products because we do not even know all of 
the additives that these products contain and what harm they 
may cause.
    In fact, when the State of Massachusetts asked that these 
ingredients be disclosed, the tobacco industry sued them and 
won. So we do not even know all of the ingredients in these 
products.
    There are safe, FDA approved nicotine based products that 
are safe, and when Massachusetts used them in an advertising 
campaign it helped to reduce smoking from 20 percent to 14 
percent in the male population. But I do not believe that any 
governmental agency, the food and drug agency, the Department 
of Health and Human Services, or the Federal Trade Commission, 
should promote the use of tobacco products, especially when we 
know they are addictive, cancer causing, and gateways to 
further tobacco use.
    The U.S. Smokeless Tobacco Company continued to advertise 
in youth magazines despite signing a master settlement 
agreement in 1998 which prohibited indirect or direct 
advertising that targets youth. In Massachusetts, the Attorney 
General was sued by the tobacco industry after trying to 
implement regulations that would prevent advertising of 
smokeless tobacco products near schools or playgrounds.
    It is immoral to enhance a company's sales by targeting 
children to use an addictive substance that is detrimental to 
their health and is also illegal.
    I think that we have a very important subject that we are 
debating here today, but there is no greater cause of illness 
in the United States than tobacco. It is central to the 
responsibilities of this committee that we do nothing that 
enhances the likelihood that young people will embrace this as 
a life style habit.
    I thank you, Mr. Chairman.
    [The prepared statement of Hon. Edward J. Markey follows:]
Prepared Statement of Hon. Edward Markey, a Representative in Congress 
                    from the State of Massachusetts
    Mr. Chairman thank you for holding a hearing on such an important 
issue. To say that smokeless tobacco is a ``safer'' alternative to 
smoking cigarettes is misleading. Smokeless tobacco products have known 
carcinogens, are linked to oral cancer, and are addictive. This method 
of ``harm reduction'' may simply be trading one vice for another.
    A few years ago I introduced the CANSA Act (Cigar Are No Safe 
Alternative Act) that would impose restrictions on the sale of cigars, 
because cigar use is not a safe alternative to smoking cigarettes 
either. People need to be informed of all the health risks for all 
tobacco products. Just as with cigars and cigarettes, children 
especially must not be influenced by misleading advertising that 
glorifies the use of these tobacco products.
    I believe that people should make informed decisions for themselves 
as to which is a better alternative and safer for them. However, people 
can not make informed decisions about smokeless tobacco products 
because we do not even know all the additives that these products 
contain and what harm they may cause. In fact when the Commonwealth of 
Massachusetts asked that these ingredients be disclosed, the tobacco 
industries sued them and won, so we still do not know of all the 
ingredients in these products.
    There are safe FDA approved nicotine based products on the market 
which are made for the purpose of terminating a smoking habit. When 
Massachusetts promoted the use of these nicotine-based products to stop 
smoking the number of males who smoked daily was reduced from 20% to 
14%. The nicotine-based products are also more likely to be used by 
women, who make up a very small portion of the users of smokeless 
tobacco products. These nicotine-based products are a safe and 
effective way to end smoking. Let's work to enhance and promote this 
safe alternative instead of cancer-causing smokeless tobacco products.
    Smoking and tobacco use is a tremendous public health problem. 
Studies have shown that smokeless tobacco use is a gateway to smoking. 
We must end smoking, not shift the use of tobacco products.
    I do not believe that any governmental agency, the Food and Drug 
Agency, The Department of Health and Human Services, or the Federal 
Trade Commission should promote the use of a tobacco products, 
especially when we know they are addictive, cancer causing, and 
gateways to further tobacco use.
    The U.S. Smokeless Tobacco Company (USSTC) continued to advertise 
in youth magazine despite signing a Master's Settlement Agreement in 
1998 which prohibited indirect or direct advertising that targets 
youth. In Massachusetts the Attorney General was sued by the tobacco 
industries after trying to implement regulations that would prevent 
advertising of smokeless tobacco products near schools or playgrounds. 
It is immoral to enhance a companies' sales by targeting children to 
use an addictive product that is detrimental to their health and it is 
illegal.
    Promoting alternatives to smoking is a truly important endeavor and 
worthy cause but only when these products are safe, and will not 
enhance the use of tobacco products.
    I am glad that we are having this hearing today and happy to hear 
the testimony from our witnesses. I hope that we continue to work 
together to stop smoking by the most effective but safest means.
    Thank you.

    Mr. Stearns. I thank the gentleman.
    And the gentleman, Mr. Whitfield.
    Mr. Whitfield. Mr. Chairman, I guess we still have the 
policy of 8 minutes if you forego your----
    Mr. Stearns. We do if you want to forego your opening 
statement.
    Mr. Whitfield. I forego my opening statement.
    Mr. Stearns. Okay. The gentleman forgoes his opening 
statement.
    Ms. McCarthy.
    MS. McCarthy. Thank you, Mr. Chairman.
    I am going to be very brief and put my remarks in the 
record.
    I do want to thank you for this hearing, and I am glad to 
see the panel that we have before us.
    I am personally shocked by the tobacco industry and their 
gross misunderstanding of what an addiction is, and I certainly 
hope today that we can shed some light on that gross 
misunderstanding. I really believe their commitment should be 
to just fund program that dissuade our children from this 
addiction that their product causes and that they should be 
leading the effort to find and produce funds to help with 
programs that will actually get individuals to quit.
    You cannot address an addiction successfully by saying, 
``Just have a little bit.'' It will not work.
    And so I look forward to the panel's testimony, and 
hopefully that will help us help the industry understand that 
their gross misunderstanding of what an addiction is is not 
acceptable to this Congress.
    Thank you, Mr. Chairman.
    Mr. Stearns. I thank the gentlelady.
    The gentleman from New Hampshire, Mr. Bass.
    Mr. Bass. Thank you very much, Mr. Chairman, and I 
appreciate this interesting and quite controversial hearing.
    First of all, I do not smoke cigarettes and I do not chew 
tobacco. In fact, as a State senator, I introduced a bill to 
tax smokeless tobacco.
    However, from my perspective there are policymakers in 
government and in Congress who, if they had their choice, would 
chisel off the tobacco leaves on the podium in the Congress 
because somehow it would pollute and kill Members of Congress 
who happened to walk nearby. And the issue that we are going to 
have a hearing on today is not whether tobacco is safe for 
somebody to pick up and take up, but whether or not somebody 
who is smoking cigarettes, who may die of lung cancer, who 
other remedial means such as stopping smoking completely or 
using some of these other products which are advertised all 
over the place, whether those individuals ought to be able or 
ought to at least know that if you have a cigarette or a pack 
or two of cigarettes a day or you have a can of smokeless 
tobacco, which is going to be better for you?
    Now, they both may not be good for you, but I do not think 
you can escape the conclusion that if you have a choice between 
these two products that smokeless tobacco is probably going to 
be a better alternative that will prolong your life.
    And as I understand it, the Federal Trade Commission has a 
procedure underway to address this issue as to whether or not 
this industry can advertise in this manner, not bringing 
children in, not talking about lung cancer. Nobody ever 
suggested that chewing tobacco caused lung cancer or anything 
like that, but whether or not individuals who are addicted to 
cigarettes and have no other option might be able to see 
advertising that indicates that chewing tobacco might be a 
better alternative.
    I think it is a fair issue, and I am looking forward to 
hearing testimony from both our Surgeon General and the FTC, as 
well as the succeeding panels.
    And I will yield back, Mr. Chairman.
    Mr. Stearns. The gentleman yields back the balance of his 
time.
    The gentleman from Texas, Mr. Green.
    Mr. Green. Thank you, Mr. Chairman, and I would like to 
thank you and our ranking member for holding this hearing on 
tobacco harm reduction and the Federal Trade Commission's role 
in determining the appropriate advertising of smokeless 
tobacco.
    There is no question that smoking and tobacco use is 
hazardous to our health. That is hopefully one issue that all 
of us in the room can agree on. I represent an area where 
smokeless tobacco is used by a lot of our young men as a right 
of passage. Now, this may not be the case in New York or San 
Francisco, but when we discuss how to help Americans quit 
smoking and what warnings our tobacco products should display, 
the debate is bound to heat up.
    One thing is certain in my mind. Our efforts to discourage 
Americans from smoking cigarettes should not include advocating 
the use of smokeless tobacco products. Tobacco kills, whether 
it is inhaled or whether it is chewed, and that is a message 
that I think most folks would want our FTC and our government 
to send.
    Since the mid-1980's we have known that smokeless tobacco 
causes oral cancer, and to decrease one's risk of lung cancer 
by increasing his or her risk of oral cancer is not in the 
interest of public health.
    In resolving this marketing issue, the FTC is charged with 
ensuring that we do not send mixed messages to the consumer. 
Currently three rotating warning labels appear on smokeless 
tobacco packages, and they read:
    One, the warning ``this product may cause mouth cancer.''
    Another warning, ``this product may cause gum disease and 
tooth loss.''
    A warning, ``this product is not a safe alternative to 
cigarettes.''
    These warnings all send the same message. Smokeless tobacco 
is hazardous to your health. For the FTC to consider a label 
effectively promoting smokeless tobacco as a lower risk 
alternative to cigarette smoking, however, sends a very 
different message. It says that if you are going to use tobacco 
products but you also worry about your health, smokeless 
tobacco is the way to go.
    Not only is this message mixed. It also is based on 
questionable science. A policy shift of this magnitude should 
not be based on the study of the Swedish smokeless tobacco 
which contains fewer cancer causing agents, is regulated by the 
government and cannot be advertised. There simply are no 
parallels to be drawn.
    While the FTC has limited jurisdiction over tobacco, its 
mission is clear. It ensures that companies do not market their 
products in misleading or deceptive ways. To advertise 
smokeless tobacco as healthier for you than cigarettes is, in 
my mind, both misleading and deceptive because it holds the 
consumer's hand as it leaps to the rationalization that 
smokeless tobacco use is somehow okay. I do not believe that we 
should be in the business of promoting that mindset.
    Mr. Chairman, a former Speaker of the House, Jim Wright, a 
few years ago had reconstructive surgery at M.D. Anderson in 
Texas because of jaw cancer. I happened to see Speaker Wright 
after that and talked to him while he was in the hospital.
    I do not know the reason, like a lot of times things 
develop, but having been to M.D. Anderson and some of our great 
cancer facilities, I also know that cancer is not something we 
want to see, whether it is in a former Speaker of the House or 
in our children.
    And I yield back the balance of my time.
    Mr. Stearns. The gentleman yields back the balance of his 
time.
    The gentleman from Arizona, the Vice Chairman of the 
committee, Mr. Shadegg.
    Mr. Shadegg. Thank you, Mr. Chairman.
    And other than to express my appreciation for your holding 
this hearing to enlighten us all on this subject and to welcome 
Dr. Carmona, who is a resident of my State of Arizona and who 
came to his current position from the faculty of the University 
of Arizona, my alma mater, I will waive my opening statement 
and take my 8 minutes of questioning.
    Mr. Stearns. The gentleman waives his opening statement.
    The gentleman from Florida, Mr. Davis.
    Mr. Davis. Thank you, Mr. Chairman.
    I will reserve my time for questions.
    Mr. Stearns. The gentleman reserves the balance of his 
time.
    Mr. Terry, welcome. An opening statement?
    Mr. Terry. No opening statement.
    Mr. Stearns. No opening statement.
    Mr. Fletcher.
    Mr. Fletcher. I reserve.
    Mr. Stearns. Reserve the balance.
    The gentlelady, Mrs. Cubin.
    Mrs. Cubin. I will submit my statement for the record.
    Mr. Stearns. By unanimous consent, so ordered.
    [The prepared statement of Hon. Barbara Cubin follows:]
Prepared Statement of Hon. Barbara Cubin, a Representative in Congress 
                       from the State of Wyoming
    Thank you, Mr. Chairman, for holding this hearing today and 
sparking continued Congressional debate over what is right in educating 
consumers, reducing public health risks and proper regulation in 
communicating the truth about tobacco.
    I would also like to thank the distinguished panelists for joining 
us. Your diverse insight and expertise will certainly guide the 
continued examination of the tobacco harm reduction debate.
    The issue of tobacco related death and disease is one that deserves 
a fair, honest and scientifically-based debate. It is probable that 
each one of us here has a story to tell of a friend or loved one 
negatively affected by the dangers of smoking.
    Progress undoubtedly has been made in the research on the impacts 
of tobacco use. We have come a long way in educating consumers--both 
young and old--about the risks involved and ways to quit.
    There are also a growing number of options available to those 
addicted to nicotine with a desire to end their smoking habit by way of 
gradual or immediate means. These breakthroughs have opened new doors 
in overcoming addiction and new ground lies ahead that is worth 
continued exploration.
    Regardless of what product there is to sell or potential profit 
that exists, we must hold in the highest regard the human lives at 
stake here. Knowledge is power and should not be withheld in the 
constraints of perhaps an outdated paradigm in the battle to reduce 
smoking related fatalities and disease.
    According to the Centers for Disease Control, hundreds of 
Wyomingites die from diseases caused by smoking every year. If there is 
information available that would save the lives of hundreds of my 
constituents who smoke, then we have a responsibility to disseminate 
this life saving knowledge. To refrain from doing so would be 
deceitful.
    Today I hope the debate will be balanced, passionate and committed 
to the scientific data available to us. The people of my home state 
deserve to know all of the facts about tobacco use, further empowering 
their decisions as consumers and potentially saving their lives. I look 
forward to determining how best this should be done.
    I thank the Chairman again and yield back the remainder of my time.

    Mr. Stearns. Mr. Ferguson, an opening statement?
    Mr. Ferguson. I will make an opening statement, Mr. 
Chairman.
    Mr. Stearns. Okay.
    Mr. Ferguson. Thank you very much.
    I would like to begin by thanking you for holding this 
hearing on a subject that is really terribly important to the 
public health of our Nation. It is an undisputed fact that 
smoking is a killer, and according to the American Lung 
Association, smoking related diseases claim an estimated 
430,700 American lives each year, and it is directly 
responsible for 87 percent of lung cancer cases and causes most 
cases of emphysema and chronic bronchitis.
    I have had several family members, including grandparents, 
who have died of lung disease, emphysema, lung cancer, and 
other ailments related to their smoking. This list of ailments 
that smoking causes or hastens is well founded and it is 
alarming, and it has proven that smoking contributes to cancer 
of the lungs, the oral cavity, the esophagus, the larynx, and 
is a contributing cause of cancer in the pancreas, bladder, 
kidney, and cervix.
    Finally, smoking costs the United States approximately $97 
billion each year in health care costs and lost productivity. 
We need to do all that we can to help current smokers to quit 
and to insure that our children do not fall victim to this 
deadly habit.
    Increased education and various other public health 
initiatives have brought a gradual decline in smoking rates 
over the past 20 years. Studies have shown that 70 percent of 
smokers say that they are interested in quitting. Thirty-four 
percent of smokers actually attempt to quit.
    However, only less than 10 percent of those people and only 
2.5 percent of total smokers actually end up quitting. I think 
it is safe to say that if someone close to us has given up 
smoking or has tried, we all know how tough it actually is to 
break the habit. There are many products on the market that are 
specifically designed to help smokers break the habit. It is 
vital that the people of our country are fully informed of the 
risks involved not only by smoking, but of the various 
treatments and alternatives that help to wean someone off the 
habit.
    Many of the alternatives have undergone rigorous testing by 
the FDA, but we must be mindful of those alternatives that may 
actually lead to smoking or that actually may be harmful in 
their own right.
    Again, I want to thank you, Mr. Chairman, thank the members 
of this committee, and I want to thank our panelists who are 
here today.
    I yield back.
    Mr. Stearns. The gentleman yields back. I thank the 
gentleman.
    As is customary, we allow our colleagues who are not a 
member of the subcommittee, who are a member of the full 
committee for an opening statement, and that is Mr. Waxman from 
California. I welcome him.
    Mr. Waxman. Thank you very much, Mr. Chairman, for allowing 
me to participate in this hearing.
    Let me state at the outset I am not opposed in principle to 
harm reduction strategies that are targeted toward addicted 
smokers, but as we explore these possibilities, we need to 
remember that unsubstantiated health claims for tobacco 
products can have disastrous consequences, keeping smokers from 
quitting and encouraging teenagers to start.
    These are not abstract concerns. We have had a failed 
experiment with light and low tar cigarettes, and the advent of 
new reduced risk products poses similar risks. The report we 
are releasing today with Representative Schakowsky finds 
disturbing parallels between the public health disaster of 
light and low tar cigarettes and what companies like U.S. 
Smokeless Tobacco, UST, are trying to do now.
    Today the subcommittee is considering their request to 
market its dangerous and addictive product as safer than 
cigarettes. In November 1994, I chaired the last congressional 
hearing to focus on smokeless tobacco. We heard indisputable 
evidence that UST manipulated nicotine levels in its products 
to hook young users and then graduate them to stronger 
products. And we heard UST deny that smokeless tobacco is 
addictive.
    Nearly 9 years later UST still argues that smokeless 
tobacco is not a proven cause of disease and denies smokeless 
tobacco is addictive. UST claims its goal is to help smokers 
quit, but one of the company's strategic objectives is to 
promote dual consumption of cigarettes and smokeless tobacco, 
the very opposite of cessation.
    In a recent response, UST wrote to a ``Dear Colleague'' I 
sent out, they denied some of the points that I made. They said 
it was baseless to suggest the company added cherry flavoring 
to some of its products to appeal to children, but according to 
a 1980 memo, UST's Senior Vice President said that younger and 
lighter users prefer flavor and older users prefer tobacco 
taste.
    They wrote that they never employed a strategy to graduate 
young users to a more addictive product. This same document, 
however, shows that the company's objective was to provide new 
users with an easy graduation process.
    UST said it was misleading or inaccurate to suggest the 
company ever marketed to children, but a memo from a regional 
sales manager to the national sales manager indicates that UST 
had marketed smokeless tobacco to children as young as 13 or 14 
years of age.
    Mr. Chairman, because these documents speak to the clear 
need for an effective and comprehensive regulation prior to any 
health claims for smokeless tobacco, I would like to ask 
unanimous consent to include in the record a letter I have 
written to Chairman Tauzin that describes and attaches these 
documents.
    Mr. Stearns. By unanimous consent, so ordered.
    [The material appears at the end of the hearing.]
    Mr. Waxman. And I look forward to the testimony.
    Mr. Stearns. And I thank the gentleman.
    No one else seeks recognition.
    [Additional statements submitted for the record follow:]
Prepared Statement of Hon. Ed Towns, a Representative in Congress from 
                         the State of New York
    Mr. Chairman, and fellow Members, today's hearing raises an 
important issue do--``harm reduction'' products have a role in 
addressing the health issues associated with smoking.
    This issue of public health policy is of great importance. More 
than 50 million adult Americans smoke. The question we seek to address 
in this hearing is how may we, as policymakers, improve the health of 
those 50 million individuals. It should go without saying that public 
health policy of this nature cannot be made in a vacuum; we must take 
into account the ability, and indeed the rights, of individuals to make 
their own choices regarding their health.
    The Constitution recognizes that individuals should be allowed to 
hear and evaluate product information for themselves. In no other area 
of life is this right more important than in the area of personal 
behavior and health. These choices may affect not only the health and 
well being of the individual, but also the health and well being of 
family members. As such, those decisions should be well informed, based 
on accurate, uncensored, truthful and nonmisleading information.
    That is what is at the heart of this hearing today-the right of 
individuals to know the facts about products that impact their behavior 
and health. Today's witnesses have suggested in their written testimony 
that the facts are in dispute about the ability of tobacco ``harm 
reduction'' products to improve the health of those smokers who have 
not been able to quit smoking. Even if the research is unsettled on 
this issue, it does not mean that discussions should not begin on this 
matter. Mr. Chairman, I am hopeful that today's hearing will be the 
beginning of a dialogue on the question of ``harm reduction'' products 
and their relationship to health improvements for smokers.
                                 ______
                                 
Prepared Statement of Hon. Sherrod Brown, a Representative in Congress 
                         from the State of Ohio
    A man is driving home on a busy boulevard, going 50 miles an hour 
through a residential neighborhood, swerving from lane to lane and 
blowing through stop signs. He likes to speed and has no intention of 
slowing down, but when a warning light on his dashboard flashes on, he 
decides to buckle his seat belt. So, is his behavior ``less harmful'' 
than before he buckled up? Less harmful to himself? Less harmful to the 
other motorists and pedestrians on the road?
    Can you imagine a public service announcement saying ``Reckless 
driving is dangerous, but if you do choose to drive recklessly, 
remember to wear your seat belt?''
    Fundamentally, the same grim choice was implicit in the Federal 
Trade Commission's consideration of a petition by U.S. Smokeless 
Tobacco (UST) for an advisory opinion concerning the marketing of 
smokeless tobacco products as ``less harmful'' than cigarettes.
    The simple fact is that both cigarettes and smokeless tobacco 
products are dangerous and often deadly. To focus exclusively on 
whether one is more or less harmful than the other is to obscure the 
truth that both are potentially lethal.
    Because such a claim would obscure the truth, it would appear to be 
a textbook case of deceptive marketing. I was pleased to learn UST has 
withdrawn its petition.
    I hope, should UST or another manufacturer decide to revive it, FTC 
will reject it as fundamentally inconsistent with the legal prohibition 
on deceptive marketing.
    But the UST petition raised more than technical questions about 
commercial practices. It also reinvigorated debate over America's 
Quixotic and counterintuitive approach to the regulation of nicotine 
delivery systems.
    In the United States, the federal Food and Drug Administration 
(FDA) must approve products designed and marketed to help Americans 
kick the habit of nicotine addiction. FDA must--and should--verify that 
such products are safe and effective, because their use is recognized 
to have important public health consequences. But products designed and 
marketed to feed that same nicotine addiction are not regulated by FDA, 
ignoring the simple fact that their use has equal or greater 
consequences for public health.
    20,000 Ohioans die every year from tobacco-related illnesses, 
according to the Ohio Tobacco Use Prevention and Control Foundation. 
17% of Ohio's Medicaid dollars are spent on treatment for tobacco-
related disease, effectively imposing an annual tax of over $500 on 
every Ohio household. With these grave costs in mind, surely we should 
be working to end tobacco addiction, not perpetuate it.And approving 
misleading health-related marketing claims for smokeless tobacco would 
do just that: perpetuate America's addiction to tobacco.
    Our experience with the marketing of filtered and ``low-tar'' 
cigarettes amply illustrates the perils of marketing some tobacco 
products as ``safer'' alternatives to others.
    Clever marketing got consumers to try these products, but because 
they changed the way people smoked, they may well have been as harmful 
or more harmful than traditional cigarettes. Health claims for 
smokeless products may be even more dangerous, in that it is likely 
some consumers--including kids--will see smokeless products as 
supplements to, not substitutes for, smoking.
    Claims that smokeless tobacco products are less harmful than 
cigarettes raise very expansive questions with profound public health 
consequences. These questions are much too sweeping a decision to 
answer based only on the narrow scope of the FTC Act's unfair and 
deceptive marketing standard. In addition, a meaningful evaluation of 
any health claim requires technical and medical expertise well beyond 
the FTC, which is chiefly a consumer protection agency.Fortunately, we 
have a federal agency that has just that technical expertise: the FDA. 
The Institute of Medicine has maintained for years that all tobacco 
products should be regulated by the federal government, to facilitate 
responsible research and meaningful evaluation of health-related 
claims. If sound science and the protection of public health are our 
objectives, we should take the IOM's advice and give the job to an 
agency equipped to meet the challenge.
    Today's hearing raises important issues with broad implications for 
public health and responsible business practices. I welcome a lively 
discussion of these issues, and I look forward to the testimony of our 
witnesses.
    Thank you, Mr. Chairman.

    Mr. Stearns. Then we will welcome our two distinguished 
panelists, the Honorable Timothy Muris, Chairman of the Federal 
Trade Commission; Vice Admiral Richard H. Carmona, U.S. Surgeon 
General and Acting Assistant Secretary for Health, U.S. 
Department of Health and Human Services.
    Welcome, and, Chairman Muris, we will start with you.

   STATEMENTS OF HON. TIMOTHY MURIS, CHAIRMAN, FEDERAL TRADE 
 COMMISSION; AND VICE ADMIRAL RICHARD H. CARMONA, U.S. SURGEON 
GENERAL, PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                            SERVICES

    Mr. Muris. Thank you very much, Mr. Chairman.
    And I would just ask that the commission's full statement 
be placed in the record.
    Mr. Stearns. By unanimous consent, so ordered.
    Mr. Muris. I am Tim Muris, the Chairman of the Federal 
Trade Commission. I am certainly pleased to appear here today 
to discuss the FTC's role in the potential advertising of 
reduced risk tobacco products.
    The FTC's mission is to prevent unfair competition and 
unfair or deceptive acts or practices in the marketplace. The 
Commission does this by insuring that advertising and marketing 
claims are truthful and not misleading.
    Our jurisdiction over advertising and marketing claims 
includes jurisdiction over claims for cigarettes, smokeless 
tobacco, and other tobacco products. Indeed, the FTC's law 
enforcement activities involving tobacco advertising and 
promotion date back to the 1930's.
    Congress has given the Commission administrative 
responsibilities for the health warnings required on cigarette 
packaging and advertising under the Cigarette Act. We also have 
both administrative and enforcement responsibilities for the 
health warning required on smokeless tobacco packaging and 
advertising under the Smokeless Tobacco Act.
    The Commission does not pre-screen advertising or marketing 
claims for tobacco or any other product. Instead, the agency 
addresses deception through post market law enforcement. Health 
claims in advertising are particularly important to us, and I 
welcome your interest in the role we play in the marketing of 
potential reduced risk tobacco products.
    This is a very important question. Despite the efforts of 
the government and the public health community, 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 of 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 the health risk associated with 
smoking while satisfying the addicted smoker's craving for 
nicotine could provide a substantial health benefit to those 
consumers who cannot or will not quite.
    Conversely, if those claims were untruthful, 
unsubstantiated, or misrepresent the extent of the benefit, 
they would harm consumers.
    For these reasons, we would review advertising for 
potential reduced risk tobacco products on a case-by-case basis 
to try to insure that the information consumers receive about 
those products is accurate and substantiated. This review would 
be conducted using the same legal framework that we use for all 
consumer products under Section 5 of the FTC Act.
    First, we ask what messages consumers take away from the 
advertising in question.
    The next issue is whether the claims are truthful, 
including whether they are substantiated.
    The Commission typically requires that health claims be 
supported by reliable scientific evidence. In determining 
whether harm reduction claims are substantiated, the Commission 
would turn to experts, both inside and outside the government's 
science-based agencies, for assistance in evaluating scientific 
evidence.
    Let me close by mentioning that in my view, the discussion 
of potential harm reduction tobacco products should also 
encompass the question of whether so-called nicotine 
replacement products, which currently are marketed only for 
smoking cessation purposes, have a larger role to play in the 
harm reduction arena.
    These products, which contain only nicotine and no tobacco, 
should certainly be further evaluated for use by consumers 
addicted to nicotine.
    In conclusion, thank you for the opportunity to discuss the 
Commission's role in this important and evolving public health 
issue. I would be happy to answer any of your questions.
    [The prepared statement of Hon. Timothy Muris follows:]
 Prepared Statement of Hon. Timothy J. Muris, Chairman, Federal Trade 
                               Commission
    Mr. Chairman and members of the Committee, I am Timothy J. Muris, 
Chairman of the Federal Trade Commission (``Commission'' or ``FTC''. 
The Commission is pleased to have this opportunity to provide 
information concerning the potential advertising of reduced risk 
tobacco products.\1\ This statement discusses the Commission's mission, 
our activities in the tobacco area, and then addresses the process the 
Commission would use in examining the advertising of these products.
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    \1\ The written statement presents the views of the Federal Trade 
Commission. Oral testimony and responses to questions reflect my views 
and do not necessarily reflect the views of the Commission or any 
Commissioner.
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        ftc jurisdiction over tobacco advertising and marketing
    The FTC's mission is to prevent unfair competition and unfair or 
deceptive acts or practices in the marketplace. The Commission 
regulates national advertising, including the advertising and promotion 
of cigarettes, smokeless tobacco, and other tobacco products, pursuant 
to Section 5 of the Federal Trade Commission Act, 15 U.S.C. Sec. 45, 
which prohibits ``unfair or deceptive acts and practices in or 
affecting commerce.'' The Commission's activities promote informed 
consumer choice.
    The FTC's law enforcement activities involving tobacco advertising 
and promotion date back to the 1930s.\2\ In 1962, the FTC's request for 
technical guidance from the U.S. Public Health Service was among the 
factors that led the then-Surgeon General of the United States to 
establish an advisory panel to undertake a comprehensive analysis of 
the data on smoking and health. The work of the advisory panel, in 
turn, led to the historic 1964 Report of the Surgeon General finding 
that cigarette smoking presented significant health risks. In that same 
year, the Commission issued a regulation requiring tobacco companies to 
include health warnings in cigarette advertising and on packages.\3\ 
The FTC's regulation was superseded in 1965, before it went into 
effect, by the Federal Cigarette Labeling and Advertising Act 
(``Cigarette Act''),\4\ which required such warnings on cigarette 
packages.
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    \2\ See, e.g., Julep Tobacco Co., 27 F.T.C. 1637 (1938) 
(stipulation prohibiting claims that Julep cigarettes help counteract 
throat irritations due to heavy smoking and never make the throat dry 
or parched).
    \3\ See Trade Regulation Rule for the Prevention of Unfair or 
Deceptive Advertising and Labeling of Cigarettes in Relation to the 
Health Hazards of Smoking, 29 Fed. Reg. 8324, 8354 (1964).
    \4\ Pub. L. No. 8992, 79 Stat. 282 (1965), as amended by Pub. L. 
No. 98474, 98 Stat. 2204 (1984), and by Pub. L. No. 9992, Sec. 11, 99 
Stat. 393, 40204 (1985), current version at 15 U.S.C. Sec. 1331 (1994).
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    In 1972, the Commission once again addressed the issue of health 
warnings in cigarette advertising. Pursuant to its Section 5 authority, 
the FTC issued consent orders mandating for the first time that the 
major cigarette manufacturers place health warnings in cigarette 
advertisements.\5\
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    \5\ See Lorillard et al., 80 F.T.C. 455, 46065 (1972) (consent 
orders). Under the orders entered into with six tobacco manufacturers, 
the companies were required to disclose the Surgeon General's warning 
in identified forms of advertising. The consent orders were modified in 
1981, when the Commission sought civil penalties in federal district 
court against each of the cigarette companies for failure to comply 
with the 1972 orders. See United States v. Lorillard, No. 76Civ. 814 
(JMC) (S.D.N.Y. July 13, 1981).
    In 1982, the Bureau of Consumer Protection notified the House 
Committee on Energy and Commerce that the staff supported a new system 
of rotational health warnings. Letter from Timothy J. Muris, Director, 
Bureau of Consumer Protection, Federal Trade Commission, to The 
Honorable John D. Dingell, Chairman, Committee on Energy and Commerce, 
U.S. House of Representatives (Sept. 1, 1982). In May 1984, the 
Commission sent letters to Congress endorsing the concept of federal 
legislation to require a system of rotational health warnings that 
would appear in cigarette advertisements and on cigarette packages. 
Shortly thereafter, Congress amended the Cigarette Act to require 
rotational warnings for both advertising and package labeling.
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    Today, the Commission administers the Cigarette Act, and 
administers and enforces the Comprehensive Smokeless Tobacco Health 
Education Act (``Smokeless Tobacco Act'').\6\ The Cigarette Act 
instructs the Commission to take certain steps to implement the 
mandated Surgeon General's health warnings.\7\ The Smokeless Tobacco 
Act directs the FTC to promulgate regulations governing the health 
warnings on packaging and advertising for smokeless tobacco products. 
The Commission's regulations specify the placement and rotation of the 
warnings, and require companies to submit plans to the Commission 
setting forth their rotation schedules.\8\ Finally, the FTC enforces 
the ban in the Smokeless Tobacco Act on broadcasting smokeless tobacco 
advertisements on radio and television.
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    \6\ 15 U.S.C. Sec. Sec. 4401-4408.
    \7\ Although the Commission administers the Cigarette Act, the 
Department of Justice enforces it.
    \8\ 16 C.F.R. Sec. 307.
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    The Commission also publishes periodic reports on advertising and 
promotion activities in the cigarette and smokeless tobacco 
industries.\9\ Those reports provide information on sales and on 
expenditures for various categories of marketing expenditures. The 
Commission issued its first report on the cigarette industry in 1967 
and on the smokeless tobacco industry in 1987.
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    \9\ In addition, the Commission issued a report on cigar 
advertising and promotion in 1999.
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    In addition to its administrative and law enforcement 
responsibilities under the Cigarette Act and the Smokeless Tobacco Act, 
the Commission also has authority under Section 5 of the FTC Act to 
prevent unfair or deceptive acts and practices in connection with the 
marketing and sale of tobacco products. Pursuant to that authority, the 
Commission has taken a number of law enforcement actions against unfair 
or deceptive tobacco advertising and promotional practices. For 
example, in 1983, the Commission sued the Brown &Williamson Tobacco 
Corporation over ads that continued to describe Barclay as a 1 mg. of 
tar brand, even though the Commission had revoked Barclay's 1 mg. 
rating because the cigarette's unusual design prevented the cigarette 
test method from measuring Barclay's yields on a basis comparable to 
other cigarettes.\10\ Moreover, in 1997, the Commission issued a 
complaint against the R.J. Reynolds Tobacco Co. alleging that the 
company's Joe Camel advertising campaign caused or was likely to cause 
many young people to begin or continue to smoke, thereby exposing them 
to significant health risks.\11\ In 1999 and 2000, the Commission 
entered into consent agreements with several cigarette manufacturers, 
resolving charges that their advertisements implied that their ``no 
additive'' cigarettes were safer than otherwise comparable cigarettes 
because they did not contain additives.\12\ In 2000, the Commission 
also entered into a consent agreement with a company claiming reduced 
health risks for its herbal cigarettes.\13\
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    \10\ F.T.C. v. Brown & Williamson Tobacco Corp., 580 F. Supp. 981 
(D.D.C. 1983), aff'd in part, remanded in part, 778 F.2d 35 (D.C. Cir. 
1985).
    \11\ R.J. Reynolds Tobacco Co., 127 F.T.C. 49 (1999). The 
Commission's complaint was issued on May 28, 1997. On January 26, 1999, 
the Commission dismissed the complaint without prejudice because the 
relief sought had been achieved through, inter alia, the master 
settlement between the major tobacco companies and the attorneys 
general for 46 states.
    \12\ Santa Fe Natural Tobacco Co., Docket No. C-3952 (2000) 
(consent); Alternative Cigarettes, Inc., Docket No. C-3956 (2000) 
(consent); R.J. Reynolds Tobacco Co., Docket No. C-3892 (1999) 
(consent).
    \13\ Alternative Cigarettes, Inc., Docket No. C-3956 (June 14, 
2000) (consent). See also Alan V. Phan, 116 F.T.C. 162 (1993) (consent 
order settling allegations that advertisements misrepresented the 
health risks of smoking certain nontobacco cigarettes).
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    Testing for the tar and nicotine yields of cigarettes is also 
conducted by the tobacco industry under a methodology adopted by the 
Commission in 1967. For the past several years, the FTC has also 
actively sought the views of the Federal government's public health 
agencies about what changes should be made in that methodology.\14\ The 
agency has also recommended to Congress that authority for cigarette 
testing be given to one of the government's science-based public health 
agencies \15\ and we renew that recommendation here.
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    \14\ Letter from Donald S. Clark, Secretary, Federal Trade 
Commission to the Honorable Donna E. Shalala, Secretary, Department of 
Health and Human Services (Nov. 19, 1998).
    \15\ Federal Trade Commission Report to Congress For 1998 Pursuant 
to the Federal Cigarette Labeling and Advertising Act 6 (2000) (``the 
Commission strongly recommends that Congress give cigarette testing 
authority to one of the Federal government's science-based, public 
health agencies''); Federal Trade Commission Report to Congress For 
1997 Pursuant to the Federal Cigarette Labeling and Advertising Act 5-6 
(1999).
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                    ``reduced risk'' tobacco claims
    As with other products, the Commission's primary role for tobacco 
products is to ensure that products are marketed in a manner that is 
truthful, not misleading, and adequately substantiated. The Commission 
does not prescreen advertising claims for tobacco or any other product. 
Instead, the agency addresses deception in the marketing of tobacco 
largely through postmarket law enforcement actions targeted against 
specific false or misleading claims or unfair practices, just as it 
does for other products.
    Despite coordinated efforts of the government and the public health 
community, tobacco use in the United States continues to cause 
substantial health risks. Products that could significantly reduce 
those risks could provide a substantial health benefit. For example, 
products that satisfy a smoker's craving for nicotine with 
substantially fewer risks to health than cigarettes would have the 
potential to benefit consumers. At the same time, consumers may be 
injured if advertisers make harm reduction claims that turn out to be 
untrue or that exaggerate the benefits or safety of their products.
    There are currently a variety of products being developed or 
already in test markets that are intended to reduce the risks 
associated with smoking. These products include Eclipse (an R. J. 
Reynolds Tobacco Company product that heats, rather than burns, 
tobacco) and Accord (a Philip Morris USA system in which special 
cigarettes are smoked in an electronic lighter); cigarettes and other 
tobacco products with reduced levels of nitrosamines (one category of 
constituents in tobacco that have been classified as known 
carcinogens), such as that developed by Star Scientific, Inc.; and 
Omni, which Vector Tobacco, Inc. has marketed as ``the first reduced 
carcinogen cigarette.''
    There are also products termed ``nicotine replacement therapies'' 
(``NRT'') that the Food and Drug Administration currently allows to be 
marketed for smoking cessation purposes: nicotine gums, transdermal 
patches, lozenges, inhalers, and nasal sprays. These nicotine delivery 
devices have been studied and approved only for short-term use to help 
smokers quit smoking, rather than for long-term ``harm reduction'' use 
by people who are unable or unwilling to quit smoking.
    Finally, in February 2002, the United States Smokeless Tobacco 
Company (``USST'') petitioned the Commission for an advisory opinion 
regarding the acceptability of communicating in advertising a harm 
reduction claim for smokeless tobacco. USST withdrew the petition in 
August 2002, stating that it would provide the Commission with 
information from two upcoming scientific conferences that would be 
addressing issues relevant to the petition. On May 9, 2003, USST 
provided this additional information to the Commission, and asked that 
the Commission place this new information on the public record and hold 
a ``public forum'' to discuss these issues.
    In considering advertising or other marketing claims by potential 
reduced risk tobacco products, the Commission would consider whether 
harm reduction claims may be deceptive using the same legal framework 
that it uses for all consumer products under Section 5 of the FTC Act: 
whether the advertising conveys a message that is likely to mislead 
reasonable consumers to their detriment, including claims for which the 
advertiser did not have adequate substantiation. The Commission's 
experience suggests that harm reduction claims are likely to raise 
difficult questions of advertising interpretation, as well as complex 
scientific and public health issues.
    In examining a harm reduction claim, the first question that the 
Commission would address is what messages consumers take away from the 
advertising in question. Taking into account the full context of the 
advertising in which the claim appears, \16\ the Commission would seek 
to identify the range of messages--both express and implied--that 
consumers would take from the advertisement. These would include: (1) 
whether claims about a reduction in carcinogens and toxins in the 
product conveys risk reduction messages; and (2) whether consumers 
might take away from a harm reduction representation the message that a 
product containing known carcinogens was not just safer than 
cigarettes, but that it poses no risk or only a minimal risk.
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    \16\ The messages consumers take away from a particular statement 
in an advertisement depend on the overall context in which that 
statement appears. Accordingly, the Commission ordinarily evaluates 
each advertisement in its entirety. It is difficult to determine what 
messages consumers take away from a generic statement about a 
particular class of products without placing that statement in the 
context of an actual advertisement.
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    Once the Commission has determined what messages consumers take 
away from a particular ad, the next issue is whether those claims are 
truthful and substantiated. The FTC Act requires that objective claims 
about products and services be substantiated before the ad is 
disseminated. When the advertisement does not claim to have a specific 
level of substantiation supporting its claims, the Commission 
determines what constitutes a reasonable basis for those claims by 
analyzing the so-called ``Pfizer factors'': the type of claim; the 
benefits if the claim is true; the consequences if the claim is false; 
the ease and cost of developing substantiation for the claim; the type 
of product; and the level of substantiation experts in the field would 
agree is reasonable. Pfizer, Inc., 81 F.T.C. 23 (1972). In the context 
of safety claims, the FTC has typically required a substantiation 
standard of ``competent and reliable scientific evidence.''
    Analyzing the evidence whether any particular tobacco product is 
safer than traditional cigarettes, or whether a reduction in exposure 
to known carcinogens is associated with reduced health risks, requires 
expertise in biology, chemistry, toxicology, and epidemiology, among 
other fields. Moreover, the scientific issues raised by purported 
reduced risk products are often not only extremely complex, but may 
take years to develop.\17\ The Commission brings a unique market-based 
expertise to its scrutiny of consumer protection matters and our work 
often requires review and analysis of scientific literature. Because 
the Commission is an agency of lawyers and economists, however, and not 
a science-based agency, we rely on assistance from other experts in 
evaluating scientific evidence.\18\ Just as the Commission has 
requested the assistance of the Department of Health and Human Services 
in connection with the test method that produces cigarette tar and 
nicotine ratings, the Commission would require similar assistance in 
evaluating the substantiation for advertising claims made for reduced-
risk tobacco products.
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    \17\ The history of low tar cigarettes provides an example. One 
recent survey of current evidence concludes that although low tar 
cigarettes were initially marketed as safer alternatives than regular 
cigarettes, recent evidence suggests that they may convey no such 
benefit. See National Cancer Institute, Risks Associated with Smoking 
Cigarettes with Low Machine-Measured Yields of Tar and Nicotine, 
Smoking and Tobacco Control Monograph No. 13, at 9 (2001) (``When all 
of the epidemiological evidence is considered in the context of what is 
currently known about cigarette design and compensation, it does not 
support the conclusion that a reduction in disease risks has occurred 
in the population of smokers due to the design changes that have 
occurred in cigarettes over the last 50 years.'').
    \18\ Tobacco is not the only category of products for which the 
Commission turns to other federal entities that possess specialized 
scientific expertise. For example, the FTC works closely with the Food 
and Drug Administration in the dietary supplement field, and with the 
Environmental Protection Agency in the areas of energy conservation, 
gasoline marketing, and claims for pesticides.
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    Finally, although a determination that an individual risk reduction 
claim is truthful and substantiated would end the Commission's 
deception inquiry, broader public health issues may remain.\19\ For 
example, some commenters on the USST petition focused on the overall 
impact on public health from the marketing of these products; these 
comments argued that smokeless tobacco promoted as a reduced risk 
product might degrade overall public health, depending on how consumers 
react.\20\ Similarly, some commenters questioned whether such 
advertising and promotion might promote more widespread use of 
smokeless tobacco, rather than just as a replacement for smoking.\21\ 
Others, however, believe that notwithstanding this empirical question, 
the potential harm to public health is not clear enough to justify 
depriving individuals of information they might use to reduce risks to 
their own health.\22\ This debate on the public health effects of these 
alternative tobacco products is an important one the appropriate 
science-based agencies of the government need to address.
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    \19\ E.g., Institute of Medicine, Clearing the Smoke: Assessing the 
Science Base for Tobacco Harm Reduction 6 (2001) (potential reduced-
exposure products ``are potentially beneficial, but the net impact on 
population health could, in fact, be negative. The effect on public 
health will depend upon the biological harm caused by these products 
and the individual and community behaviors with respect to their 
use.'').
    \20\ E.g., Letter from Matthew L. Myers, President, Campaign for 
Tobacco-Free Kids to The Honorable Donald S. Clark, Secretary, Federal 
Trade Commission (Feb. 25, 2002) (comparative health claims made for 
smokeless tobacco must not only be truthful, but should promote the 
public health); Letter from Henry A. Waxman, U.S. House of 
Representatives and Senator Richard J. Durbin, United States Senate to 
The Honorable Donald S. Clark, Secretary, Federal Trade Commission 
(June 4, 2002) (noting that the potential health benefits that might 
result from smokers switching to smokeless tobacco were offset by the 
risks that some smokers who would have quit might, instead, switch to 
smokeless tobacco; that smokeless tobacco might become more attractive 
to nonsmokers; and that some of those nonsmokers--once addicted to 
nicotine--might switch to cigarettes). See also, e.g., WHO Scientific 
Advisory Committee on Tobacco Product Regulation, Recommendation on 
Smokeless Tobacco Products 3 (2003) (listing arguments against the use 
of smokeless tobacco for purposes of harm reduction).
    \21\ E.g., Letter from Matthew L. Myers, supra note 17 (despite 
USST's stated interest in making harm reduction claims to addicted 
adult smokers, FTC approval of petition would permit it ``to 
disseminate these claims in ads whose primary appeal could be to young 
non-tobacco users''); Letter from Dileep G. Bal, M.D., Chief, Cancer 
Control Branch, State of California Health and Human Services Agency--
Department of Health Services to The Honorable [Donald] S. Clark, 
Secretary, Federal Trade Commission (March 8, 2002) (``While USSTC 
[sic] claims that this health advisory is mean to claim harm reduction 
for the benefit of addicted adults, it would allow USSTC [sic] and 
other companies to market their products with this claim to young, non-
tobacco users as well).
    \22\ L. Kozlowski, Harm reduction, public health, and human rights: 
Smokers have a right to be informed of significant harm reduction 
options, Nicotine & Tobacco Research S55-S60 (2002) (noting that 
nicotine replacement therapies and snus [Swedish moist snuff] are much 
safer than cigarettes; that there is a basic human right to information 
that affects one's health; and that when the health risks from a 
product are relatively small, ``the level of increased use needed to 
maintain a public health equilibrium (no changes in population-level 
problems) becomes very high.'') (citation omitted). See also Tobacco 
Advisory Group of the Royal College of Physicians, Protecting smokers, 
saving lives: The case for a tobacco and nicotine regulatory authority 
2-5 (2002) (supporting comprehensive regulatory approach to tobacco in 
order to promote public health and noting that emergence of reduced 
risk products presents multiple challenges for regulators; smokeless 
tobacco is ``10-1,000 times less hazardous than smoking, depending on 
the product'' but its potential marketing as a harm reduction option 
raises various questions that must be addressed, including minimizing 
its use as a starter product for young smokers).
---------------------------------------------------------------------------
    Health claims in advertising, including tobacco advertising, are of 
particular importance to the Commission. The Commission welcomes the 
Committee's interest in the role that this agency will play in ensuring 
that the marketplace works efficiently to provide consumers with 
information that may enable them to reduce their risks of smoking-
related disease, while protecting them from claims that are not 
supported by sound scientific evidence. The agency is committed to 
reviewing 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 truthful and non-misleading.
                               conclusion
    The Commission thanks this Committee for focusing attention on this 
important and evolving public health issue, and for giving us an 
opportunity to present our views.

    Mr. Stearns. I thank the Chairman, and we welcome the U.S. 
Surgeon General.

          STATEMENT OF VICE ADMIRAL RICHARD H. CARMONA

    Mr. Carmona. Thank you, Mr. Chairman, distinguished members 
of the subcommittee. Thank you for the opportunity to 
participate in this important hearing.
    My name is Richard Carmona, and I am the Surgeon General of 
the United States.
    Let me start with a few statements that were once accepted 
throughout society that have now been relegated to the status 
of myth.
    Men do not suffer from depression.
    Domestic violence is a family or private matter.
    The HIV/AIDS epidemic is of no concern to most Americans.
    All of us here know that these three statements are very 
dangerous public health myths. My remarks today will focus on a 
fourth public health myth which could have severe consequences 
in our Nation, especially amongst our youth. Smokeless tobacco 
is a good alternative to smoking. It is a myth. It is not true.
    As the Nation's Surgeon General, my top responsibility is 
to insure that Americans are getting the best science based 
information to make decisions about their health. So I very 
much appreciate the opportunity to come before this 
subcommittee today and help refute this dangerous idea.
    First, let me emphasize this. No matter what you may hear 
today or read in the press reports later, I cannot conclude 
that the use of any tobacco product is a safer alternative to 
smoking. This message is especially important to communicate to 
young people who may perceive smokeless tobacco as a safe form 
for tobacco use.
    Smokeless tobacco is not a safe alternative to cigarettes. 
Smokeless tobacco does cause cancer. Our Nation's experience 
with low tar cigarettes yields valuable lessons for the debate 
over smokeless tobacco.
    Tobacco use is the leading preventable cause of death in 
the United States. Each year 440,000 people die of diseases 
caused by smoking or other forms of tobacco use. That is about 
20 percent of all deaths in the United States.
    The office I lead as Surgeon General has long played a key 
role in exposing the risks of tobacco use. In 1986, the Surgeon 
General's report, the Health Consequences of Using Smokeless 
Tobacco, reached four major conclusions about the oral use of 
smokeless tobacco.
    First, smokeless tobacco represents a significant health 
risk.
    Next, smokeless tobacco can cause cancer in a number of 
non-cancerous oral conditions.
    Third, smokeless tobacco can lead to nicotine addiction and 
dependence.
    And, fourth, smokeless tobacco is not a safe substitute for 
cigarette smoking.
    Recognizing these serious health consequences, Congress 
passed a Comprehensive Smokeless Tobacco Health Education Act 
in 1986. This law required the placement of Surgeon General's 
warnings on all smokeless tobacco products.
    Mr. Chairman and members of this subcommittee, I 
respectfully submit that smokeless tobacco remains a known 
threat to public health just as it was when Congress acted in 
1986. Time has only brought more disease, death, and destroyed 
lives.
    A national toxicology program of the National Institutes of 
Health continues to classify smokeless tobacco as a known human 
carcinogen, proven to cause cancer in people. As Surgeon 
General, I cannot recommend use of a product that causes 
disease and death as a lesser evil to smoking. My commitment 
and that of my office to safeguard the health of the American 
people demands that I provide information on safe alternatives 
to smoking where they exist.
    I cannot recommend the use of smokeless tobacco products 
because there is no scientific evidence that smokeless tobacco 
products are both safe and effective aids to quitting smoking.
    Smokers who have taken the courageous step of trying to 
quit should not trade one carcinogenic product for another, but 
instead could use Food and Drug Administration approved 
methods, such as nicotine gum, nicotine patches, or counseling.
    While it may be technically feasible to create a reduced 
harm tobacco product, the Institute of Medicine recently 
concluded that no such product exists today.
    When and if such a product ever is constructed, we would 
then have to take a look at the hard scientific data of that 
particular product. Our Nation's experience with low tar, low 
nicotine cigarettes is instructive to the issue at hand. Low 
tar, low nicotine cigarettes were introduced in the late 1960's 
and widely endorsed as a potentially safer substitute for the 
typical cigarette on the market at that time.
    Within a decade the low tar brands dominated the cigarette 
market. Many smokers switched to them for their perceived 
health benefits.
    Unfortunately, the true health effects of these products 
did not become apparent for another ten to 20 years. We now 
know that low tar cigarettes not only did not provide a public 
health benefit, but they also may have contributed to a natural 
increase in death and disease among smokers.
    This has taught us that we must move cautiously in 
recommending any supposedly safer alternative for people trying 
to quit smoking because now with more knowledge and the benefit 
of hindsight, the science does not support early 
recommendations on low tar cigarettes.
    Mr. Chairman, in the interest of time I will shortly ask 
that the remainder of my statement and the scientific 
information contained in it be considered as read and made part 
of the record.
    Mr. Stearns. Without objection, so ordered.
    Mr. Carmona. But before I do that, I would like to ask for 
this subcommittee and the Congress to help in getting the 
message out about the dangers and myths of smokeless tobacco.
    All of us in this rom are very concerned about our Nation's 
youth. Kids growing up today have a tough time of it. In 
addition to the normal struggles of puberty, many kids are 
facing a host of other challenges. Many, especially minority 
kids, must struggle to find their way in unsafe neighborhoods.
    So the temptation to engage in behavior that is not healthy 
and the opportunity to do so is very hard for our young people 
to resist. According to a 2000 survey by the Substance Abuse 
and Mental Health Services Administration, SAMHSA, and this is 
the national household survey on drug abuse, about 1 million 
kids from ages 12 to 17 smoke every day. Another 2 million kids 
smoke occasionally.
    And we know that smoking is often not a stand-alone risk 
behavior. It travels with others. The SAMHSA found that youth 
who were daily cigarette smokers or heavy drinkers were more 
likely to use illicit drugs than either daily smokers or heavy 
drinkers from other age groups. More than half of 12 to 17 year 
olds who were daily smokers had also used illicit drugs within 
the past month.
    Every day more than 2,000 kids in the U.S. will start to 
smoke, and more than 1,000 adults will die because of smoking. 
We have to get youth to stop starting, but the answer is not 
smokeless tobacco. We have evidence to suggest that instead of 
smokeless tobacco being a less dangerous alternative to 
smoking, just as smoking is a gateway to other drugs, smokeless 
tobacco is a gateway to smoking.
    So we must redouble our efforts to get our youth to avoid 
tobacco in all forms.
    We have some real work to do on the culture of smokeless 
tobacco, which is glamorized by some sports stars. Chicago Cub 
Sammy Sosa, who has made a public commitment to avoiding 
smokeless tobacco, is a great example for kids. Past baseball 
great Joe Garagiola is now Chairman of the National Spit 
Tobacco Education Program and regularly lectures young players 
against the dangers of smokeless tobacco.
    As Members of Congress, you can lead by example, too, not 
just in legislation, but in your own lives. I encourage you to 
avoid tobacco in all of its forms. Do not fall for the myth, a 
very dangerous public health myth that smokeless tobacco is 
preferable to smoking.
    Do not let America's youth fall to this myth either.
    Mr. Chairman, I ask that my written testimony be made part 
of the record and I thank you and I would be happy to answer 
any questions.
    [The prepared statement of Richard Carmona follows:]
Prepared Statement of Richard H. Carmona, Surgeon General, U.S. Public 
 Health Service, Acting Assistant Secretary for Health, Department of 
                       Health and Human Services
    Mr. Chairman, distinguished members of the Subcommittee, thank you 
for the opportunity to participate in this important hearing. My name 
is Richard Carmona and I am the Surgeon General of the United States of 
America.
    Let me start with a few statements that were once accepted 
throughout society that have now been relegated to the status of myth.

 Men do not suffer from depression.
 Domestic violence is a ``family'' or ``private'' matter.
 The HIV-AIDS epidemic is of no concern to most Americans.
    All of us here know that these three statements are very dangerous 
public health myths.
    My remarks today will focus on a fourth public health myth which 
could have severe consequences in our nation, especially among our 
youth: smokeless tobacco is a good alternative to smoking. It is a 
myth. It is not true.
    As the nation''s Surgeon General, my top responsibility is to 
ensure that Americans are getting the best science-based information to 
make decisions about their health. So I very much appreciate the 
opportunity to come before this Subcommittee today and help refute this 
dangerous idea.
    First, let me emphasize this:

 No matter what you may hear today or read in press reports 
        later, I cannot conclude that the use of any tobacco product is 
        a safer alternative to smoking. This message is especially 
        important to communicate to young people, who may perceive 
        smokeless tobacco as a safe form of tobacco use.
 There is no significant scientific evidence that suggests 
        smokeless tobacco is a safer alternative to cigarettes.
 Smokeless tobacco does cause cancer.
 Our nation's experience with low-tar cigarettes yields 
        valuable lessons for the debate over smokeless tobacco.
 Tobacco use is the leading preventable cause of death in the 
        United States.
    Each year, 440,000 people die of diseases caused by smoking or 
other form of tobacco useCthat is about 20 percent of all deaths in our 
nation.
    The office I lead as Surgeon General has long played a key role in 
exposing the risks of tobacco use. In 1986, the Surgeon General's 
Report The Health Consequences of Using Smokeless Tobacco reached four 
major conclusions about the oral use of smokeless tobacco:

1. Smokeless tobacco represents a significant health risk;
2. Smokeless tobacco can cause cancer and a number of non-cancerous 
        oral conditions;
3. Smokeless tobacco can lead to nicotine addiction and dependence; and
4. Smokeless tobacco is not a safer substitute for cigarette smoking.
    Recognizing these serious health consequences, Congress passed the 
Comprehensive Smokeless Tobacco Health Education Act in 1986. This law 
required the placement of Surgeon General's warnings on all smokeless 
tobacco products.
    Mr. Chairman and Members of the Subcommittee, I respectfully submit 
that smokeless tobacco remains a known threat to public health just as 
it was when Congress acted in 1986.
    Conversely, time has only brought more disease, death and destroyed 
lives.
    The National Toxicology Program of the National Institutes of 
Health continues to classify smokeless tobacco as a known human 
carcinogenCproven to cause cancer in people.
    As Surgeon General I cannot recommend use of a product that causes 
disease and death as a ``lesser evil'' to smoking. My commitment, and 
that of my office, to safeguard the health of the American people 
demands that I provide information on safe alternatives to smoking 
where they exist.
    I cannot recommend the use of smokeless tobacco products because 
there is no scientific evidence that smokeless tobacco products are 
both safe and effective aids to quitting smoking.
    Smokers who have taken the courageous step of trying to quit should 
not trade one carcinogenic product for another, but instead could use 
Food and Drug Administration -approved methods such as nicotine gum, 
nicotine patches, or counseling.
    While it may be technically feasible to someday create a reduced-
harm tobacco product, the Institute of Medicine recently concluded that 
no such product exists today. When and if such a product is ever 
constructed, we would then have to take a look at the hard scientific 
data of that particular product.
    Our nation's experience with low-tar, low-nicotine cigarettes is 
instructive to the issue at hand. Low-tar, low-nicotine cigarettes were 
introduced in the late 1960's and widely endorsed as a potentially 
safer substitute for the typical cigarette on the market at that time. 
Within a decade, the low-tar brands dominated the cigarette market. 
Many smokers switched to them for their perceived health benefits.
    Unfortunately, the true health effects of these products did not 
become apparent for another 10 to 20 years. We now know that low-tar 
cigarettes not only did not provide a public health benefit, but they 
also may have contributed to an actual increase in death and disease 
among smokers.
    First, many smokers switched to these products instead of quitting, 
which continued their exposure to the hundreds of carcinogens and other 
dangerous chemicals in cigarettes. Second, to satisfy their bodies'' 
craving for nicotine, many smokers unwittingly changed the way they 
smoked these low-tar cigarettes: they began inhaling more deeply, 
taking more frequent puffs, or smoking more cigarettes per day.
    In fact, we now believe that low-tar cigarettes may be responsible 
for an increase in a different form of lung cancer, adenocarcinoma, 
which was once relatively rare. This cancer is found farther down in 
the lungs of smokers, indicating deeper inhalations, and appears linked 
to a specific carcinogen particularly present in low-tar brands.
    We must learn the lessons of the low-tar cigarette experience. Not 
only did they fail to reduce an individual's risk of disease, but they 
also appear to have increased population risk by delaying quitting and 
potentially contributing to initiation among young people. This has 
taught us that we must move cautiously in recommending any supposedly 
safer alternative for people trying to quit smokingCbecause now, with 
more knowledge and the benefit of hindsight, the science does not 
support early recommendations on low-tar cigarettes.
    Mr. Chairman, in the interest of time I will shortly ask that the 
remainder of my statement and the scientific information contained in 
it be considered as read and made part of the record. But before I do 
that, I would like to ask for this Subcommittee and the Congress' help 
in getting the message out about the dangers of the myth of smokeless 
tobacco.
    All of us in this room are very concerned about our nation's youth. 
Kids growing up today have a tough time of it. In addition to the 
normal struggles of puberty, many kids are facing a host of other 
challenges. Many, especially minority kids, must struggle to find their 
way in unsafe neighborhoods.
    So the temptation to engage in behavior that is not healthy, and 
the opportunity to do so, is very hard for our young people to resist.
    According to a 2000 survey by the Substance and Mental Health 
Services Administration (SAMHSA) (The National Household Survey on Drug 
Abuse), about 1 million kids from age 12-17 smoke every day. Another 2 
million kids smoke occasionally.
    And we know that smoking is often not a ``stand-alone'' risk 
behavior; it travels with others. The SAMHSA survey found that youth 
who were daily cigarette smokers or heavy drinkers were more likely to 
use illicit drugs than either daily smokers or heavy drinkers from 
older age groups. More than half of 12-17 year olds who were daily 
smokers had also used illicit drugs within the past month.
    Every day, more than 2,000 kids in the U.S. will start to smoke, 
and more than 1,000 adults will die because of smoking. We have to get 
youth to stop starting. But the answer is not smokeless tobacco.
    We have evidence to suggest that instead of smokeless tobacco being 
a less dangerous alternative to smoking, just as smoking is a gateway 
to other drugs, smokeless tobacco is a gateway to smoking.
    So we must redouble our efforts to get our youth to avoid tobacco 
in all forms.
    We have some real work to do on the ``culture'' of smokeless 
tobacco, which is glamorized by some sports stars. Chicago Cub Sammy 
Sosa, who has made a public commitment to avoiding smokeless tobacco, 
is a great example for kids. Past baseball great Joe Garagiola is now 
Chairman of the National Spit Tobacco Education program, and regularly 
lectures young players against the dangers of smokeless tobacco.
    As Members of Congress, you can lead by example too, not just in 
legislation, but in your own lives. I encourage you to avoid tobacco in 
all its forms. Do not fall for the myth--a very dangerous public health 
myth--that smokeless tobacco is preferable to smoking. Do not let 
America's youth fall for it, either.
    From the perspective of individual risk, the cumulative effect on 
smokers of switching to smokeless tobacco is simply not known. But we 
clearly know that use of smokeless tobacco has serious health 
consequences. Overall, smokeless tobacco products have been classified 
as a known human carcinogen. And limited scientific data indicate that 
former smokers who switch to smokeless tobacco may not have as great a 
decrease in lung cancer risks as quitters who do not use smokeless 
tobacco.
    From the perspective of population risk, there are even more 
unanswered questions. Even if there was some decreased risk for smokers 
who switch to smokeless tobacco, that benefit may be more than offset 
by increased exposure of the overall population to this known 
carcinogen.
    The marketing of smokeless tobacco as a potentially safer 
substitute for cigarettes could lead to:

 More smokers switching to smokeless tobacco instead of 
        quitting tobacco use completely;
 A rise in the number of lifetime smokeless tobacco users if 
        more youth begin using smokeless tobacco;
 A rise in the number of cigarette smokers as a result of more 
        youth starting to use smokeless tobacco and then switching to 
        cigarette use; and
 Some former smokers returning to using tobacco if they believe 
        that smokeless tobacco is a less hazardous way to consume 
        tobacco.
    Concerns about youth initiation are especially troubling. The 
scientific evidence is clear that use of smokeless tobacco is a gateway 
to cigarette use. Young people may be especially attracted to smokeless 
tobacco if they perceive it to be safer than cigarettes. Studies show 
that more than one in five teenage males have used smokeless tobacco, 
with age 12 being the median age of first use. Surveys also show that 
more than two in five teenagers who use smokeless tobacco daily also 
smoke cigarettes at least weekly. Finally, independent research and 
tobacco company documents show that youth are encouraged to experiment 
with low-nicotine starter products and subsequently graduate to higher-
level nicotine brands or switch to cigarettes as their tolerance for 
nicotine increases.
    Finally, we simply do not have enough scientific evidence to 
conclude that any tobacco product, including smokeless tobacco, is a 
means of reducing the risks of cigarette smoking. At this time, any 
public health recommendation that positions smokeless tobacco as a 
safer substitute for cigarettes or as a quitting aid would be premature 
and dangerous. With the memory of our experience with low-tar 
cigarettes fresh in our minds, we must move extremely cautiously before 
making any statement or endorsement about the potential reduced risk of 
any tobacco product.
    Finally, my strong recommendation as Surgeon General is a call for 
sound evidence about tobacco products and their individual and 
population based health effects. We need more research. We need to know 
more about the risks to individuals of switching from smoking to 
smokeless; and we need to know more about the risks to the entire 
population of a promotion campaign that would position smokeless 
tobacco as a safer substitute for smoking.
    Until we have this science base, we must convey a consistent and 
uncompromised message: there is no safe form of tobacco use.
    Thank you. I would be happy to answer any questions.

    Mr. Stearns. Again, without objection, so ordered.
    I will start the questions, and Admiral, I think I will 
start with you.
    The European Union has a policy on smokeless tobacco, and 
it has been written by the leading tobacco control public 
health advocates in the European Union, and they stated that on 
the average that ``Scandinavian and American smokeless tobaccos 
are at least 90 percent safer than cigarettes.''
    Now, I respect your position. It is a lot different than 
all of ours, but do you agree with the European Union policy 
that what they said, 90 percent safer than cigarettes? I mean 
just yes or no.
    Mr. Carmona. No, sir, I do not.
    Mr. Stearns. Okay. We know that the Institute of Medicine 
report states that smokeless tobacco, ``the overall risk is 
lower than for cigarette smoking and some products, such as 
Swedish snus may have no increased risk.''
    Now, this is the Institute of Medicine report. So I ask 
you: do you agree with the Institute of Medicine?
    Mr. Carmona. That particular statement, no.
    Mr. Stearns. Okay. You know, the heart of our hearing today 
is smokeless as an alterative for people who cannot stop 
smoking, and I will give you an example. Let us say your son 
just turned 16 and he had to drive a car, and you had a small 
sports car in your garage and you also had a brand new Volvo. 
And I think all of us in this room would agree that the Volvo 
is safer than a very small sports car.
    And you knew your son was just starting out and you had to 
look at the two products. Would you not say the Volvo is a lot 
safer for your 16 year old son to drive than a very small 
sports car?
    Mr. Carmona. I think it is actually an unfair analogy, sir. 
In most cases, probably so.
    Mr. Stearns. Yes. But, I mean, they both are dangerous, but 
you know, what we are trying to do is just see if there are 
degrees here, and then work off of the Institute of Medicine 
report, as well as some of the European Union policy positions.
    Chairman Muris, how does the FTC evaluate an advertising 
claim? For example, if there is dueling science like there 
might be here, and a great respect for the Surgeon General, how 
do you actually reach a conclusion when there is this 
advertising claim and you have dueling science involved?
    Mr. Muris. Well, the first thing that we do is look to see 
the message the advertising claim communicates to a reasonable 
person in the intended audience, and that is a very, very 
important step because, depending on how the various 
disclosures would be made, it would not surprise me if an 
audience understood them differently. I have not seen copy 
testing of such particular advertising claims. I do not know 
that they exist, but they would be viewed by the intended 
audience quite differently.
    Once we understand what we call the take-away is, then we 
would look in terms of substantiation at what we thought was 
competent and reliable scientific evidence, and again, it 
partly depends on what the claim is.
    If the claim is one that is unqualified, it would not 
surprise me if people interpreted it as something close to a 
scientific consensus or at least the majority scientific view. 
So that would be relevant.
    We also look at what we call the Pfizer factors. Pfizer was 
an FTC opinion about the substantiation doctrine about 30 years 
ago. One of the crucial factors in that case trying to balance 
the impact of making mistakes, and you can make two sorts of 
mistakes here. You can make the mistake of allowing false 
advertising or preventing truthful advertising, and we try to 
look at the consequences of those mistakes.
    Mr. Stearns. The FTC has brought a number of cases against 
companies making health claims related to cancer treatments, 
weight loss, and cures for HIV/AIDS, arthritis, hepatitis, 
Alzheimer's disease, diabetes, and many other diseases. How has 
the FTC proceeded on those cases and how do these cases differ 
from advertising claims made by tobacco companies?
    Mr. Muris. Well, most of the cases that we brought involve 
fraud where there is no scientific controversy. In weight loss 
advertising, for example, we have--and the Surgeon General has 
helped us in this area--we have a very aggressive campaign 
against deceptive and fraudulent weight loss advertising. We 
held a workshop at which we both participated last November, 
where one of the things we were trying to do is to get 
advertisers or--I am sorry--the media to police some of the 
more obviously false claims.
    So it is an area in which we spend a lot of resources, but 
it is an area in which we do not have to make difficult 
scientific choices.
    Mr. Stearns. Just to conclude, Admiral, let us say we all 
know that smoking is the leading cause of preventable death in 
the United States, but I have seen some people here in the 
House, Members of Congress, who cannot seem to stop smoking. 
What do we do?
    I mean, a person cannot stop smoking. How do we approach 
those people?
    Mr. Carmona. Well, I think there is a wide range of 
possibilities that include substitution therapy, as I mentioned 
in my opening remarks, behavioral therapy and behavioral 
modification, and of course, we need to continue to do research 
in that area.
    But I think what we do not do is substitute one carcinogen 
for another.
    Mr. Stearns. Okay. Thank you.
    The ranking member.
    Ms. Schakowsky. Thank you, Mr. Chairman.
    You referred to the Institute of Medicine, and I have that 
report in front of me, and I would just like to read Conclusion 
Five for Dr. Carmona.
    It says, ``Regulation of all tobacco products, including 
conventional ones as recommended in IOM 1994, as well all other 
PREPs.,'' and PREPS. stand for potential reduced exposure 
products; so we are talking about spit tobacco, ``is a 
necessary precondition''--we are talking about regulation--``is 
a necessary precondition for assuring a scientific basis for 
judging the effects of using PREPs and for assuring that the 
health of the public is protected.''
    So they are making their conclusions by stating that all 
tobacco should be regulated. And so I am wondering then if in 
terms of the IOM report if you find any contradictions in what 
they say and if you would find anything in what they say as, in 
fact, recommending the use as a harm reduction alternative.
    Mr. Carmona. No, ma'am. The IOM report I think is a very 
good report, and I think one of its conclusions that is most 
important is that they found that there really were no products 
that were available today that had been scientifically tested, 
such as smokeless tobacco products that would be safe to 
recommend or use.
    So I think their study was a very good one overall.
    Ms. Schakowsky. Thank you.
    Mr. Muris, if the FTC were to regulate the advertising of 
spit tobacco and such an advertising campaign had an incidental 
appeal to minors, would the FTC be able to regulate the 
advertisements on that basis alone?
    Mr. Muris. Well, first of all, the FTC has two bases to 
proceed. One is on the basis of deception, and we would 
obviously need to know a lot more. So this answer is 
necessarily very, very qualified.
    I think in terms of appeal to youth, the Commission would 
be much more likely to proceed as it did in the Camel case, 
based on its unfairness jurisdiction. At least in that case the 
allegations were that the appeal to youth was far more than 
incidental.
    I think, again, I would have to know a lot more, but that 
fact, the fact if the appeal was just incidental, would make it 
very hard to use the unfairness jurisdiction.
    Ms. Schakowsky. Right, and if such an advertising campaign 
were to result in more people using smokeless tobacco in 
addition to cigarettes rather than instead of using cigarettes, 
would the FTC be able to regulate the advertisements on that 
basis alone?
    Mr. Muris. It would be very hard for us to make public 
health judgments outside of the context of whether the 
advertising was deceptive or not. That is primarily what we do.
    On the other hand, clearly when you are balancing my answer 
to the Chairman's question, when you are balancing the two 
kinds of risk, the consequence here of allowing advertising 
that is, in fact, fraudulent, that is part of those 
consequences. So we would consider it in that sense.
    Ms. Schakowsky. If such an advertising campaign were to 
result in a dramatic reduction in the number of people who quit 
tobacco completely, would the FTC be able to regulate the 
advertisements on that basis alone?
    Mr. Muris. Again, I think my answer is identical. We would 
not look at this in the first instance under our statutes in 
terms of a simple public health calculation. However, that 
would be a very important fact in terms of weighing the 
consequences of the substantiation, as I just indicated to the 
last question.
    Ms. Schakowsky. And would that be true then of such an 
advertising campaign were to result in a dramatic increase in 
the number of new tobacco users; would the FTC be able to 
regulate advertisements on that basis alone?
    Mr. Muris. I think my answer would be the same, and I would 
direct you in more detail to our testimony, particularly page 9 
where we discuss some of those issues.
    Ms. Schakowsky. So despite the fact that the advertisements 
were not directly aimed at children, despite the fact that they 
said that you should use it as a substitute, if negative 
consequences occurred, you are saying that, in fact, you could?
    I do not read your mandate that way.
    Mr. Muris. Well, first of all and most importantly, and 
asking any question does not provide a full context of what the 
advertising campaign would look like, and that full context 
would be essential and possibly dispositive in what we could 
do.
    It is true, as our testimony states, that--let me just 
quote it to you. ``Although a determination that an individual 
risk reduction claim as truthful and substantiated would end 
the Commission's deception inquiry, broader public health 
issues may remain,'' and that is the sense in which I was 
talking about how we do not under our statutes make simply a 
public health determination, if that determination could ever 
be simple.
    It is true, however, in looking at substantiation that the 
Pfizer factors require a balance of what statisticians call 
Type 1 and Type 2 errors, which, as I explained, we try to look 
at the consequences of us making a mistake, and the factors 
that you are talking about are consequences of a mistake. We 
would certainly consider those, and the presence of those 
factors would require us to want a higher level of 
substantiation before we allowed the claims.
    Ms. Schakowsky. Thank you.
    Mr. Stearns. The gentlelady's time has expired.
    The Chairman of the full committee, Mr. Tauzin.
    Chairman Tauzin. Thank you, Mr. Chairman.
    Let me see if I can do something that I have tried with my 
staff to understand. I have got the best experts in the country 
here in front of me now.
    Dr. Carmona, first of all, let me thank you for your strong 
and, I think, extraordinary advocacy to help Americans 
understand the dangers of smoking tobacco. I do not think 
anybody quarrels with you on those issues today.
    What we are focusing on, obviously, is a question of 
whether or not there are other options other than the quit or 
die option that Americans unfortunately are faced with when it 
comes to tobacco.
    In regard to that, I have tried to have an understanding 
with my staff on the nature of nicotine. I am not a smoker. So 
I have never had this addiction problem for nicotine. My body 
does not crave it. I do not desire it. I do not smoke, and I do 
not want to smoke. And so I am trying to understand it as a 
non-smoker.
    And I am trying to place nicotine in the category of 
substances that are addictive that I do understand. I 
understand cocaine and heroin and what it does to lives in my 
district and in this country. I understand that when people 
start on these kinds of addictive substances it can ruin their 
lives, and they crave it to the point where it can even kill 
them.
    I am a caffeine addict. I drink coffee all day long. I 
confess. I know what that addiction feels like. I know I have 
to have my cup of coffee in the morning, and I have got to have 
it all day long to keep me going.
    But I also know that caffeine is not likely to kill me in 
the sense that cocaine and heroin might kill me. It might not 
be good for me. It might make me overactive. It might make me 
hypertensive. I do not know what, but it is not likely to do 
the damage that cocaine and heroin do.
    Where do you place nicotine in that scale? Is it closer to 
caffeine or is it closer to cocaine and heroin?
    Mr. Carmona. It is hard to put it in a scale in that 
comparison, but although they are both addictive, they have 
different mechanisms of action, and the caffeine works by 
modifying certain enzymes, xanthene oxidase, I think, 
specifically, and it works through phosphodiesterase mechanism 
they call it, and what it does is it works on your 
cardiovascular system. It will speed up your heart, and it will 
have cardiovascular effects that you become dependent on.
    And so----
    Chairman Tauzin. How about nicotine?
    Mr. Carmona. Nicotine works by a different mechanism, but 
nicotine has direct adverse cardiovascular effects that are 
tied to accelerating cardiovascular disease. It has bad effects 
on your heart, bad effects on the blood vessels and can 
accelerate atherosclerotic disease, and so on.
    So that we are not just talking about cancer here. We are 
talking about other effects on the body that can be found.
    Chairman Tauzin. It has other negative effects.
    Mr. Carmona. Yes, sir.
    Chairman Tauzin. Does it have any positive effects? I was 
told by staff that there is at least some scientific evidence 
that it has some positive effects on some categories of human 
conditions. Is that true or false?
    Mr. Carmona. Well, only if you are talking about, you know, 
biochemistry of the body, but----
    Chairman Tauzin. How about Tourette's syndrome?
    Mr. Carmona. Oh, you are talking about as a treatment.
    Chairman Tauzin. Yes.
    Mr. Carmona. As a treatment now.
    Chairman Tauzin. That is what I am saying. Isn't it used 
positively in some cases, like treatments of----
    Mr. Carmona. I have never used it, and if it is, then it is 
probably not very common, but I would imagine in the literature 
people have tried to use it.
    Chairman Tauzin. Here is where I am going and I want your 
feedback on it. If Americans who have become accustomed to, 
addicted to the habit of getting nicotine into their body were 
able to get it into their body in some other fashion other than 
the use of tobacco, would that be a positive social development 
in America in terms of the Nation's health or would it be a 
negative one?
    Mr. Carmona. Well, again, you know, I am less inclined to 
comment on social developments than I am on science.
    Chairman Tauzin. Well, on science then. Would it be good 
for Americans' health, for people who need nicotine or believe 
they have to have it or are addicted to it to get it in some 
other fashion other than to having to burn tobacco to get it?
    Mr. Carmona. Well, we have mechanisms presently available 
through nicotine products that----
    Chairman Tauzin. I know we do. I am asking you is that 
good.
    Mr. Carmona. It is an option that is available. I mean, the 
best of all options obviously is not to smoke at all and not to 
become addicted.
    Chairman Tauzin. Nobody disagrees with that.
    Mr. Carmona. Okay.
    Chairman Tauzin. But if the option is quit or die, and what 
I am saying is if you have to get nicotine in your system 
because you are addicted to it and you cannot quit--I mean, the 
quit rate is like 2 to 3 percent a year in this country, and we 
know people are having a pretty difficult time quitting. 
Recognizing that, knowing that we are going to lose an awful 
lot of people to the effects of not quitting, if these folks 
can get their nicotine in some other way other than burning 
tobacco and sucking all of the nitrosamines and all of the 
other substances into their lungs, would that be a positive 
thing for the health of the country?
    Mr. Carmona. Well, yes, and it already is where you have 
patch. We have gum. We have mechanisms that have been tested 
and found to be safe and effective means.
    Chairman Tauzin. Right. Let me turn to the FTC Chairman.
    If, in fact, people come up with products, tobacco products 
or non-tobacco products that can, in fact, deliver nicotine to 
folks who have been addicted to it and cannot seem to quit 
using it, is your department the right agency to regulate the 
truth of those ads?
    Mr. Muris. Our mission is certainly to evaluate the 
truthfulness of and including substantiation of advertising. 
That can require us, and in this case it would, to work with 
scientists both in and out of the government because the issues 
here in the substantiation arena are issues on which their 
experts----
    Chairman Tauzin. Yes, you get thrown into the health arena 
here.
    Mr. Muris. And we are not, right.
    Chairman Tauzin. Yes, and you are not health officials. But 
nevertheless, your agency's function is to examine the 
truthfulness or lack of truthfulness of advertising of American 
products. Is that part of your agency's mission?
    Mr. Muris. Yes, but what I am saying is the substantiation 
issues here turn on scientific issues to which we----
    Chairman Tauzin. Therefore, you would have to turn to 
people like----
    Mr. Muris. [continuing] seek help.
    Chairman Tauzin. [continuing] Health Department officials 
to help you.
    Mr. Muris. Absolutely.
    Chairman Tauzin. And if science was available to help you 
understand whether or not an advertisement was, in fact, 
truthful or not truthful, that gave people in America better 
information about options that might be available to them when 
it comes to getting nicotine, would it not be in the interest 
of this country for you and our health officials to conduct 
some public forums and to see whether or not all of this is a 
good avenue to approach or not?
    Mr. Muris. Well, in the abstract, Mr. Chairman, I certainly 
think that is a good idea. Again, because the issues are 
ultimately scientific, they would need to take the lead, the 
scientific agencies.
    Chairman Tauzin. Well, except they tell us it should be 
your lead because you end up being the one to say yes or no on 
the truthfulness of the ads. If they can help you understand 
that and help you conduct forums that all of us in America, 
scientists, consumers, advocates, pro and con, all kinds of 
people can come and debate it and discuss it. Why wouldn't you 
want to help create that type of forum for us?
    Mr. Muris. Well, that is a different issue than taking the 
lead. I would certainly think that we would--I know, speaking 
for myself. Obviously my colleagues would have to vote--be 
willing to participate in such fora not just to talk about 
particular products, although that would be important, but to 
talk about what endpoints, what kind of scientific evidence is 
relevant.
    I mean, I agree with the premise here that we have 
somewhere near 50 million people who smoke, and it is a very 
addictive product. I obviously defer to the scientists on that, 
but it obviously is a very addictive product. Many people have 
difficulty quitting, and I think there are potential--and the 
key word is ``potential''--public health benefits from 
addressing that issue, and it is one of----
    Chairman Tauzin. Well, we at least ought to hear about it 
and talk about it.
    Mr. Chairman, my time is up. I just want to make the point. 
If you do not take the lead and the Health Department says you 
should take the lead and they do not want to take the lead, we 
never get these forums going. Somebody has got to take the lead 
to organize it, and I do not know whether you or Tommy 
Thompson. We need to put you in a room together, and you all 
can flip a coin to see who calls the meeting.
    But my guess is it would help us immeasurably in this 
country if one or both of you would take the lead.
    Thank you, Mr. Chairman.
    Mr. Muris. I understand. Thank you.
    Mr. Stearns. I thank the Chairman.
    The gentlelady, Ms. McCarthy is recognized for her 
questions.
    Ms. McCarthy. Thank you, Mr. Chairman. I pass.
    Mr. Stearns. The gentlelady passes.
    Mr. Whitfield.
    Mr. Whitfield. Thank you, Mr. Chairman.
    Mr. Muris, it is my understanding that UST, U.S. Tobacco, 
had asked your agency, I guess back in February 2002, for an 
advisory opinion to make certain statements in its advertising 
about their smokeless tobacco products. Is that advisory 
opinion still pending or what is the status of that?
    Mr. Muris. Well, it is not what they asked us to do. They 
did not give us advertising on which they asked an opinion. 
They gave us a general statement without the context of 
advertising, and as explained in our--I cannot obviously talk 
about non-public proceedings in a public forum--but as 
explained in our testimony, generically presenting something to 
us in that manner caused us problems.
    They withdrew the petition. They have recently sent us 
additional information and asked that we hold a public forum, 
but the petition has been withdrawn.
    Mr. Whitfield. Now, what would be the purpose of the public 
forum?
    Mr. Muris. I think, although they can speak for themselves, 
my understanding is the public forum would involve some of the 
issues, many of the issues I was just discussing with Chairman 
Tauzin.
    Mr. Whitfield. One of the statements made evidently in 
their letter to your agency was that the Surgeon General in 
1986 concluded that smokeless tobacco is not a safe substitute 
for smoking cigarettes. While not asserting that smokeless 
tobacco is safe, many researchers in the public health 
community have expressed the opinion that the use of smokeless 
tobacco involves significantly less risk of adverse health 
effects than smoking cigarettes.
    Now, does your agency have the capability to render a 
decision on whether or not advertising based on that type of a 
statement would be accurate or truthful?
    Mr. Muris. The question with such advertising would be 
whether it was substantiated. We do not have expertise to 
evaluate the substantiation, the scientific evidence. We would 
turn to scientific experts within and without the government.
    I cite a few very briefly. We cite in our footnotes to our 
testimony just very brief introductions to some of the 
scientific evidence, but that is where we would have to turn.
    Mr. Whitfield. And you would be able to do that?
    Mr. Muris. Sure. We would be able to ask for cooperation 
and assistance. Obviously it would be in the discretion of the 
people we asked as to how much they participated and what they 
told us.
    Mr. Whitfield. And going to the scientists to come up with 
a scientific analysis of the claims under the current system 
that you would do that, you would feel comfortable with the 
conclusion said? I mean the process.
    Mr. Muris. Well, let me, again, put the process in context. 
When you have advertising, we look to see if the advertising in 
the first instance is deceptive. Advertising of this nature 
would almost certainly be advertising that contained an 
explicit or implicit claim that there was substantiation for 
the risk reduction.
    We, again, are not experts on the science necessary to 
evaluate that claim. So that is why we would turn to the 
scientific community. I have confidence in the process in 
general. How it would work in this particular case, you know, 
we would have to see.
    Mr. Whitfield. Yes. Admiral Carmona, would you support the 
abolition of all tobacco products?
    Mr. Carmona. I would at this point, yes, sir.
    Mr. Whitfield. So you would support a law in Congress that 
all tobacco products would be illegal?
    Mr. Carmona. No, sir, I did not say that. You asked me 
would I support banning or abolishing tobacco products. Yes.
    Legislation is not my field. If Congress chose to go that 
way, that would be up to them, but I see no need for any 
tobacco products in society.
    Mr. Whitfield. But if Congress were to pass legislation 
making tobacco an illegal product, you would be comfortable 
with that?
    Mr. Carmona. I would have no problem with that.
    Mr. Whitfield. Okay. Now, the purpose of this hearing 
today, if oral tobacco is to play a role in harm reduction, 
would you agree it is not necessarily to show that it does not 
cause cancer, but it simply needs to be substantially less 
hazardous than smoking?
    Mr. Carmona. If I understand your question correctly, sir, 
I would say that we already know it is a carcinogen, one. And 
if we were looking to test any other theories, certainly the 
fact that it is a carcinogen would be important, and in my 
mind, you do not need to do any further testing. If you already 
know it is a carcinogen, it would not be an acceptable 
substitute.
    Mr. Whitfield. So whether or not it is less harmful would 
not make any difference to you then?
    Mr. Carmona. I if there are those who are doing research in 
this area and they have thought of unique ways that this can be 
helpful, I am always willing to listen to research.
    Mr. Whitfield. Okay.
    Mr. Carmona. But right now substituting one carcinogen for 
another, I do not see a benefit.
    Mr. Whitfield. Okay, and I understand that, but you are 
saying if there is scientific evidence there that shows that it 
is less harmful, that that is something that you would be 
willing to look at.
    Mr. Carmona. I would always be willing to look at any 
scientific evidence, sir.
    Mr. Whitfield. Okay. Now, the Royal College of Physicians 
in December 2002, which is England's oldest medical 
institution, and among its functions is to advise the 
government, the public, and the medical community on health 
care issues, stated that as a way of using nicotine, the 
consumption of noncombustible tobacco is of the order of 10 to 
1,000 times less hazardous than smoking.
    Would you agree with that or not?
    Mr. Carmona. I would not, sir.
    Mr. Whitfield. Are you aware of any scientific data that 
would disagree with that statement?
    Mr. Carmona. Sir, not so much disagree, but I do not think 
they have enough scientific data to justify making that 
statement.
    Mr. Whitfield. You do not think they have enough data to 
justify it?
    Mr. Carmona. That statement, yes.
    Mr. Whitfield. And you have read this report that they have 
rendered?
    Mr. Carmona. Yes, I have, sir.
    Mr. Whitfield. Now, on this issue of smokeless tobacco as a 
gateway to increased smoking, do you have any evidence to show 
that it is a gateway to increased use of tobacco products?
    Mr. Carmona. Yes, sir. There are studies to demonstrate 
that it does act as a gateway and can eventually increase 
smoking in all individuals.
    Mr. Whitfield. Now, what about there was reference earlier 
to this European Union study about smokeless tobacco, and in 
that study, they make all sorts of statements. They said Sweden 
has the lowest level of tobacco related mortality in the 
developed world by some distance, approximately half the 
tobacco related mortality of the rest of the European Union. 
Sweden has the lowest male smoking prevalence in Europe. Half 
of the tobacco in Sweden is now consumed as a smokeless tobacco 
product, and this share has steadily grown since 1970.
    They go on and on and on, and they make all sorts of 
arguments that one of the reasons that there is less mortality 
in Sweden is because of these so-called smokeless products, and 
I am sure you have read those reports as well.
    But do you have any scientific evidence that would refute 
that report?
    Mr. Carmona. Well, on those reports, sir, I think there are 
many potential confounding factors that have not been fully 
looked at. People smoke or chew for a variety of reasons, and 
to assume that a decreased morbidity and mortality in a 
population is solely due to the fact that somebody is chewing 
tobacco, I am sure they all drink milk also or have a cup of 
coffee, and you could equally attribute changes to other 
variables that maybe have not been looked at.
    So it is a much more complex problem.
    Mr. Whitfield. I see my time has expired.
    Mr. Stearns. The gentleman's time has expired.
    The gentleman from Texas, Mr. Green.
    Mr. Green. Thank you, Mr. Chairman.
    Admiral Carmona, during the previous Congress members of 
this committee have introduced legislation which would give the 
FDA a broad authority to regulate tobacco products, including 
strong restrictions on advertising and marketing tobacco 
products, protection for young people against exposure to 
environmental tobacco smoke and tough company specific 
surcharges to encourage companies to reduce youth smoking. Do 
you think it is important for our Congress this time to enact 
legislation to give the FDA that authority to regulate these 
tobacco products?
    Mr. Carmona. Well, sir, I appreciate the question, but not 
being in the regulation business, I think it is important that 
Congress looks at this and makes determination if it is 
something that they want to move ahead with that would be in 
the best interest of the protection of the American public.
    Whether or not the FDA does it, I think strong oversight 
and scrutiny is important by whatever mechanism you all choose 
to do.
    Mr. Green. Okay. Thank you.
    I understand the position you are in, and I appreciate the 
best answer you could give.
    Mr. Muris, one of the rotating warnings on packages of 
smokeless tobacco reads ``Warning, this product is not a safe 
alternative to cigarettes.'' Let us say that you are a 
cigarette smoker who saw an ad promoting smokeless tobacco as a 
product with reduced risk, if that was allowed, and you go to 
your local convenience store and decide to try it out.
    Yet ripping open the top of it, you read the warning that 
this product is not a safe alternative to cigarettes. Would you 
feel as if you received a mixed message as to the health 
benefits of that package of smokeless tobacco?
    Mr. Muris. Well, it obviously depends--and this is just to 
preface this. This is a very important part of what we would 
do, is to look at the take-away as to what a reasonable person 
in the intended audience understood. It obviously depends on 
what the advertising said.
    It is quite possible that even though couched in the 
language of ``safer,'' that people would receive, you know, 
depending on how it was written and what all was in the ad and 
the totality of the circumstances, it is possible that people 
would receive a message of safe in which case they would be 
conflicting.
    Mr. Green. Okay. Thank you.
    The Federal Trade Commission Act provides that an act or 
practice is illegal if it ``causes or is likely to cause 
substantial injury to consumers which is not outweighed by 
countervailing benefits to consumers or to competition.''
    Even if we were to assume that scientific evidence were 
true that smokeless tobacco use can reduce the number of deaths 
associated with smoking, in your opinion does this outweigh the 
substantial injury caused to consumer?
    Mr. Muris. Well, you are now turning to a second part of 
our statute, which is unfairness, and I talked about this 
briefly a little while ago.
    In the context that we would be looking at, and this is 
part of balancing in a different way than I was mentioning 
before, but similarly of balancing the benefits and the costs, 
and that is what that part of the statute requires.
    I think it is a factual question on which, you know, we 
would have to seek evidence.
    Mr. Green. Thank you, Mr. Chairman.
    And I yield back my time.
    Mr. Stearns. The gentleman yields back the balance of his 
time.
    The gentleman from New Hampshire, Mr. Bass.
    Mr. Bass. Thank you, Mr. Chairman.
    As I mentioned in my opening statement, we have heard 
comments about young men using smokeless tobacco as a right of 
passage. We have heard a possible connection between health 
problems with the former Speaker of the House and chewing 
tobacco, although I do not know whether that is true or not.
    The Surgeon General has recommended that perhaps Members of 
Congress need behavioral modifications. I would definitely 
agree with that.
    But the real issue here today is a narrow one, and my first 
question is for Chairman Muris.
    Understanding, sir, that the FTC has a difficult mission 
protecting consumers from deceptive and misleading advertising, 
it involves judgment calls, and reasonable person standards. 
Given that you already do this currently for weight loss 
products and other such items based on a comparative advantage, 
which is the subject of this hearing, could the FTC establish 
guidelines that would offer needed protection and more accurate 
information, in your opinion?
    Mr. Muris. Well, in general I think you have to take 
advertising in its context and as you find it. There is the 
issue I was just mentioning, the issue of how consumers 
understand claims, and then there is the issue on which we 
spent most of the time in the questions you have asked me about 
the substantiation.
    Because one of the claims that would be in these ads would 
be an explicit or an implicit claim that there is scientific 
substantiation for a risk reduction claim.
    I think we would have to emphasize both things. I do not 
think we are ready to do guidelines particularly involving the 
second issue because we would need to have a much greater 
discussion with the scientific community about what risk 
reduction claims mean, about the appropriate endpoints for 
measuring them, about evidence from around the world, about a 
whole host of issues.
    Mr. Bass. But it is perfectly legitimate or reasonable for 
the FTC to conduct studies involving comparative advantages of 
one product over another. It does not have to be an absolute.
    Mr. Muris. There is nothing in principle that prevents 
comparative claims. The Commission with my predecessor, one of 
the best things he did more than 30 years ago when he was at 
the FTC, he got the networks to eliminate their restrictions on 
comparative advertising.
    Comparative claims are important kinds of claims.
    Mr. Bass. Okay. Admiral Carmona, I appreciate your 
testimony, and my colleague from Kentucky, Mr. Whitfield, 
brought up the issue of the English or the British report that 
in essence drew a conclusion regarding the relative benefit or 
whatever of smokeless tobacco versus cigarettes.
    I would be interested in if you would be willing to provide 
the subcommittee with a further explanation as to exactly what 
scientific evidence you find in that report invalid.
    I will say now I have never heard of it, and I have not 
read it, but you have basically disputed the claims that are 
made in this report and said they are invalid and they are not 
based upon adequate science and if you were an officer, you 
would be willing to analyze those claims and explain exactly 
what mistakes they made that led to that particular conclusion.
    I would be interested to read about it.
    Mr. Carmona. We would be happy to provide you with the 
information, sir, and generally it is not that it is invalid. 
We felt that there was not enough information to support their 
thesis, that more research needed to be done before you could 
come to that conclusion.
    Mr. Bass. Okay. I do not think anybody here is suggesting, 
sir, that you recommend one product over the other, but 
suppose, but I do not like to use hypotheticals, but would you 
agree that advertising that explains the mortality rates of one 
product over another, that infers a conclusion that smokeless 
tobacco was less harmful than cigarette smoking, would that 
fairly describe an aspect of the harm reduction that we are all 
seeking?
    Mr. Carmona. Well, we are all seeking harm reduction. I do 
not think that fairly describes quite a complex problem because 
where you might be able to argue that a product has one 
component that may reduce risk, when you look at the product 
broadly and all of its risk factors, there may be more harm or 
less harm than others.
    So I do not think, sir, it is as simple as just describing 
that because there are many variables that we are looking at in 
these comparisons.
    Mr. Bass. Mr. Chairman, my time has expired, and the point 
that I am trying to drive at in this line of questioning is 
that there is no perfect product for any problem, and there is 
probably no substance in this country or no issue or product 
that is more controversial, with the possible exception guns, 
than tobacco.
    However, within the context of this debate if a public good 
is being achieved, albeit not a perfect one, is it not a good 
idea for policymakers and agency heads to examine this 
realistically and objectively because ultimately we are all 
seeking the same goal, which is reduction in deaths due to this 
particular substance.
    And I will yield back.
    Mr. Stearns. And I thank the gentleman, and we have had a 
hearing dealing with guns, too.
    Mr. Bass. I know.
    Mr. Stearns. The gentleman from Massachusetts.
    Mr. Markey. Thank you, Mr. Chairman, very much.
    I do have a bias in this field. My father died from lung 
cancer, and he died 3 years ago. And although he smoked two 
packs of Camels a day from the age of 12 until 67, it never 
caught him until he was 89, and then it just showed up even 
though he was otherwise perfectly healthy, and then he died 
from lung cancer 3 years ago, although the doctor had said, 
until it showed up, that he was going to live to 100.
    So that is a big loss in our family to have a guy in 
perfectly healthy condition mentally and physically to die 
because of it.
    But what I remember most is that when I was 13, he told me 
because I was the oldest, that he started smoking at 12 and 
that he knew I would be starting in the next couple of years 
because every boy smoked, all right, but that he should not 
expect him to pay for the Camels; that I was going to have to 
earn the money. Just do not take the money out of his pockets 
or anything.
    But he knew that we would all smoke. That was his message 
to me when I was a 13 year old boy.
    So because of the Surgeon General's decision in the mid-
sixties and the continuation of public education, we have been 
partially at least able to stem that tide of the inevitable 
deaths that occur from young boys and girls starting to smoke 
because they feel like they have to.
    So one of my concerns here from a public health perspective 
is the secret additives that are included not only in 
cigarettes, but also in the smokeless tobacco kind of products 
that are sold, and I know that HHS is one of the only entities 
to have the secret list of ingredients.
    Do you think that it would be helpful for there to be a 
release of the secret additives to the public so that even if 
smokeless tobacco is advertised as being safer than smoking 
tobacco that the public would then still be able to see what 
the additives were and to be able to judge that it is still 
much too big of a risk to undertake at all and help mothers and 
fathers to convince their kids not to start?
    Doctor?
    Mr. Carmona. Sir, I am not aware of the legal complexities 
involving the release of such information, but I know that our 
scientists have looked at it, and in aggregate they have 
published information as to many carcinogenic agents, as well 
as other factors that are contained within smoke products that 
can cause not only cancer, but other disease.
    But as far as the release of that, I think that it is out 
of the scope of my practice, sir, and I am not sure of the 
legalities of that, but certainly----
    Mr. Markey. If it was within our power, would you make the 
list of the secret additives public?
    Mr. Carmona. I think that I would ask my colleagues who 
were actually at the bench doing the research to ascertain if 
there was any benefit, additional benefit to that that would be 
released within the research, and then I would make my decision 
on that.
    Mr. Markey. Any additional benefit?
    Mr. Carmona. Knowing the specifics, yes.
    Mr. Markey. If the public knew what the additives were and 
it was determined that they would be more likely not to start 
using it if they knew, would you then be supportive of 
releasing the additive information?
    Mr. Carmona. Again, sir, that is one of the factors I would 
consider, but also looking at the entire context of how this 
information is being used by our scientists and if there was 
some health status that could be achieved by releasing this 
information, then certainly that would move me in that 
direction.
    Mr. Markey. So there are carcinogens in these additives. 
You also mentioned other diseases caused by these additives. 
What are they?
    Mr. Carmona. Well, chronic obstructive pulmonary disease, 
acceleration of cardiovascular disease, you know, stroke, heart 
attacks, things like that. So not all necessarily cancer 
related, but very significant diseases also.
    Mr. Markey. So let me ask you, Chairman Muris. If the 
public does not have access to information about secret 
ingredients and additives in smokeless tobacco, aren't claims 
regarding the potential health benefits of smokeless tobacco 
likely to be deceptive or misleading because the information 
about the additives that are in the smokeless tobacco are not 
available for the public to make that determination themselves?
    Mr. Muris. Well, let me preface with two general 
statements.
    One, I have never looked explicitly at what this 
information is, but from the standpoint of what we do, there 
would obviously be a heavy presumption in favor of more 
information and not less, and someone would have to make a very 
good argument, and you know, not having looked at it, I do not 
know what that argument might be, to withhold information.
    Mr. Markey. Thank you.
    Mr. Stearns. The gentleman's time has expired.
    Mr. Shimkus. No, Mr. Shadegg. Mr. Shadegg.
    Mr. Shadegg. Thank you, Mr. Chairman, and thank you for 
holding this hearing.
    I will tell you I am mystified by it all, and I kind of 
wonder where it is taking us.
    Let me start with the issue of your jurisdiction at the 
FTC. As I understand it, you have jurisdiction arising out of 
the concept of deception and the concept of unfairness; is that 
correct?
    Mr. Muris. Yes.
    Mr. Shadegg. On the concept of deception, as I understand 
your testimony, before you could allow a label to say this 
product is safer than, that is, smokeless tobacco is a safer 
alternative to cigarette smoking, you would have to have 
evidence which substantiated that point; is that correct?
    Mr. Muris. Among other things, yes, sir.
    Mr. Shadegg. Okay. Dr. Carmona, it is your belief that 
while there have been studies done on that point, they simply 
are not sufficient, that is, not enough studies or not enough 
subjects, not enough contrasting information to reach that 
conclusion; is that right?
    Mr. Carmona. In the particular instance of smokeless 
tobacco?
    Mr. Shadegg. Yes, to reach the conclusion that smokeless is 
safer than.
    Mr. Carmona. Yes, that is correct, sir.
    Mr. Shadegg. Okay. So you believe the FTC could not, in 
fact, substantiate that first threshold criteria of whether or 
not it is safer than; is that right?
    Mr. Carmona. That is right, sir.
    Mr. Shadegg. The whole topic puzzles me. For example, this 
is a can of smokeless tobacco. This particular can has the 
warning that says, ``This product may cause gum disease and 
tooth loss.''
    One of the issues I hear in the testimony here today is a 
relative one, which is if we say or if we allow the claim to be 
made that smokeless tobacco is safer than cigarettes, which you 
believe cannot be substantiated, but others believe could be 
substantiated, are we then deceiving people into using 
smokeless tobacco as a safe alternative?
    Now, we know that one of the labels that is already on 
smokeless tobacco says this product is not a safe alternative 
to cigarettes. That raises the issue of, okay, what is the 
truth. If you give less than all of the truth, are you somehow 
deceiving people?
    And, Dr. Carmona, that is your concern, is it not?
    Mr. Carmona. Yes, sir. My concern is that, you know, that 
definition of the word ``safer'' as it relates to these 
products, that, in fact, if you take one piece out of context 
and make an assumption that, well, because there is less of a 
certain chemical, therefore, it is safer where the science is 
not there to support it, and we ignore the fact that, as you 
just pointed out, sir, gum disease, tooth problems and so on 
are also problematic, it is very difficult to say that, and 
that is why I view that substitution argument as oversimplified 
for a very complex problem and one that I could not support 
because it is still detrimental to the American public.
    Mr. Shadegg. Let me ask you both. As I read the information 
I am provided, right now although the warning on cigarettes is 
a Surgeon General's warning and the warning on smokeless 
tobacco is not a Surgeon General's warning, it just says a 
warning; both are as a result of congressional actions and 
neither are as a result of FTC action standing alone or Surgeon 
General action standing alone; is that correct?
    Mr. Carmona. I believe so, sir.
    Mr. Muris. Yes. The FTC got the ball rolling, but then 
Congress stepped in 40 years ago or almost 40 years ago.
    Mr. Shadegg. And so it is going to be our job to try to 
spell out at least currently what should be specified on the 
label, if anything.
    Dr. Carmona, if the Congress does not step in and specify 
what should be spelled out, do you have the jurisdiction to 
issue your own warning?
    Mr. Carmona. Well, I think that one of the things I have 
probably that is most important is the so-called bully pulpit. 
I can certainly speak out regularly on the hazards of all 
tobacco products, and I would certainly intend to do that along 
with my colleagues where the scientific basis allows me to do 
so.
    Mr. Shadegg. and I suppose it would be your position that 
if someone were to propose that they wanted to advertise 
smokeless tobacco as safer than cigarettes, you would want to 
add ``but not, in fact, safe'' because of these other dangers; 
is that right?
    Mr. Carmona. I would be opposed to such advertising.
    Mr. Shadegg. And you would like to see the Congress, if the 
Congress were to step into this field and specify what had to 
be put on claims about smokeless tobacco, to make sure if 
anyone had wanted to make a claim that smokeless tobacco was 
safer than cigarettes, but they would go beyond that and say, 
``But, however, still not safe because it causes all of these 
issues, the potential for mouth cancer, potential for gum 
decay, tooth disease, other things''; is that right?
    Mr. Carmona. Well, sir, my intent would never be to attempt 
behavioral modification on the Congress.
    Mr. Shadegg. But we look to you for expertise and we 
should.
    Mr. Carmona. But what I would strongly support is that 
Congress take into account all of the scientific evidence 
before us, some of which you have completely outlined right 
now, in making their decision to protect the American public.
    Mr. Shadegg. One of the things that concerns me is that of 
the three labels Congress has specified for smokeless tobacco, 
and I understand they rotate. So my understanding is that one 
third of all cans would have to contain one of these; one third 
the second; and one third the third. One of them, quite 
frankly, I think you could make the claim that it is deceptive 
precisely because it does not go far enough.
    One of the three labels is, ``This product may cause gum 
disease and tooth loss.'' I would suggest that if I were a 
young kid picking up this can and read this particular can, 
which says it may cause gum disease and tooth loss, I would be 
a lot less concerned about its use than if read, ``This product 
may cause mouth cancer,'' which raises the next question of, 
well, why does it say mouth cancer. Why doesn't it say this 
product may cause cancer? Because if you want to scare somebody 
and you warn them this product may cause cancer, I suggest that 
is going to have a greater impact on them than perhaps any of 
the other three alternatives that are there.
    So one of my concerns is what we will have when we start 
down the slippery slope, when it is the U.S. Congress that 
decides what the precise wording of any warning ought to be.
    Mr. Carmona. Well, we are certainly concerned, my 
colleagues and I, sir, that any references to ``safer'' that 
are not clearly spelled out, are not scientifically justified 
may, in fact, just do that, cause young people to start earlier 
and feel that it is a safe thing to do; that there is 
relatively little risk; and as you have pointed out, the whole 
story is not being told.
    Mr. Shadegg. Let me go back to the FTC on the issue of, 
okay, one issue would be the issue of deception, and that is 
would it be deceptive to claim that smokeless tobacco is safer 
than cigarettes.
    Your second element of jurisdiction is that of unfairness. 
Under the second rubric, unfairness, would you consider it 
necessary to go on and provide the disclosure however not safe?
    Mr. Muris. Well, the Commission has rarely, and I mean 
rarely, used unfairness to evaluate advertising. It almost 
always uses deception. There is a tremendous First Amendment 
problem from saying an advertisement is truthful, yet we can 
stop it. So we would much more likely use on the unfair--I mean 
our deceptive authority.
    It is clear that in any of these ads we would be concerned 
with the take-away. By that I mean an understanding by the 
intended audience that no matter what the word said, that a lot 
of people thought that it meant safe, and that would be a big 
concern.
    Mr. Shadegg. You would be concerned that an implication 
that safer might cause somebody to conclude it was safe.
    Mr. Muris. Sure, depending on, you know, how the disclosure 
was made and what else was in the end.
    Mr. Shadegg. Before my time expires, I simply want to 
conclude by pointing out that according to the information that 
I have in 1981, the FTC issued a report to Congress that 
concluded that health warning labels had little effect on 
public knowledge and attitudes about smoking. So it says public 
labels do not do anything.
    Congress responded by enacting a law requiring health 
warning labels. I think it is quite interesting what we do 
here.
    Thank you very much.
    Mr. Stearns. The gentleman's time has expired.
    Mr. Davis is recognized.
    Mr. Davis. Thank you, Mr. Chairman.
    Chairman Muris, in reviewing your written statement on page 
8, you suggest that in the context of safety claims, the FTC 
has typically required a substantiation standard of competent 
and reliable scientific evidence. In my opinion, this issue 
ultimately boils down to respect. How much respect are we going 
to have for our consumers, for our citizens in terms of how 
high the standard we set as far as judging the accuracy and 
truthfulness of any disclosure you would approve or this 
Congress would approve so people can make safe decisions, not 
necessarily the right decision.
    Can you elaborate a little bit as to exactly how high the 
standard is you would employ if you were to find yourself in a 
proceeding judging the marketing of smokeless tobacco?
    Mr. Muris. Well, yes, sir. The first question obviously 
turns on what the ads would say in their full context and, 
therefore, what the take-away from consumers would be. The more 
qualified the take-away that the consumers received, the lesser 
the substantiation.
    On the other hand, as I mentioned, the so-called Pfizer 
factors before, because I personally believe, again, just 
speaking for myself--obviously my colleagues could have 
different views--because the consequences of making a mistake 
here are so serious in terms of, you know, the potential 
adverse effects on public health, people who might otherwise 
have quit, what the effects might be on children; that would 
indicate that the bar should be very high.
    Mr. Davis. The debate here today seems to center upon the 
word ``safer.'' It seems to me as a lay person that by its very 
nature in whatever context the word ``safer'' is used, and it 
invariably is a vague term; it is not a qualitative 
connotation.
    Under what circumstances could safer ever constitute a 
sufficiently acceptable standard under this very high standard 
you have just described?
    Mr. Muris. Well, again, there are two questions that I 
think you really have to keep distinct. One is how consumers 
understand the words, and I believe it is possible to 
communicate safer as opposed to safe, but then the second 
question is about the scientific evidence.
    And the scientific evidence, I believe, would have to be 
very high, but we do not even know. I mean, again, we are not 
scientists. The scientific community, I think it would be very 
useful for them to do more work on issues involving what sort 
of evidence is it that they would want, what sort of evidence 
that they would look at.
    Because I do agree with the general premise that some 
members have made that we do have upwards of 50 million people 
who smoke. Many of them find it very difficult to quit. The 
simplest place to start, if I could just end, I believe, and I 
would like to explore with the FDA, the potential for broader-
based claims for the gums and the patches that the Surgeon 
General mentioned.
    Right now those can only be used for very narrow purposes. 
They can only be marketed as part of quitting. They cannot be 
marketed as sort of a long run replacement. It seems to me, 
again, it would be up to the FDA ultimately because they 
regulate this, but it would seem to me that there are very 
large potential benefits from being able to tell people about 
the longer run possibility.
    Mr. Davis. And I commend you on that. I do not think we 
should be afraid of the risk reduction. The Surgeon General has 
said that. I think we need to be painfully objective about 
this.
    But it just seems to me as a lay person that the question 
is not whether a safer type of marketing could ever be 
acceptable under this very high standard, but that it really 
would be a disclosure as to how much safer or how less safer, 
don't you think?
    Mr. Muris. Oh, well, absolutely you would need to 
understand the question of quantity in that sense, not just the 
question of a qualitative difference, and I agree with that.
    It even may be true, a complication of the nicotine 
products, the gums and patches, and why I used the word 
``potential'' is there is some evidence, and, again, I am not a 
scientist. The scientists would have to explore it. There is 
some evidence of potential dangers from nicotine itself beyond 
addiction.
    Mr. Davis. In the Footnote 17 on page 8, you seem to 
acknowledge the possibility that evidence that is presented to 
you that you rely upon for approval later proves to be faulty. 
That is a problem.
    Do you have the authority to go back and revisit any 
approval of the disclosure that has been made on a product if 
subsequent scientific evidence reveals it is not sufficiently 
accurate?
    Mr. Muris. Absolutely, and the basis of the substantiation 
doctrine by its very nature recognizes that when the science 
changes, then the ability to make the claims changes.
    Mr. Davis. I would like to give the Surgeon General an 
opportunity to comment on any of these points if he would care 
to.
    Mr. Carmona. Well, sir, simply I agree with where you are 
going with this. I think there is qualitative and quantitative 
aspect to the word ``safe'' or ``safer,'' and certainly 
quantitatively we have to be able to define that, but also in 
its entirety as I alluded to earlier in my remarks.
    Taking one variable out of context and simply stating that 
there is an improvement or it is simply safer does not address 
the spectrum of risk, of which there are many variables.
    So I think it is to the public's benefit that we are very 
clear on how that word is used.
    Mr. Davis. Thank you, Mr. Chairman.
    Mr. Stearns. The gentleman's time has expired.
    Mr. Issa.
    Mr. Issa. Thank you, Mr. Chairman.
    I might preface this by saying I am a recovering smoker of 
13-plus years. So I am very aware and every day think about the 
error of my smoking in my youth and my not so youth judging 
from when I finally quit, but I do have some questions because 
I do not think we are dealing with tobacco here. We are dealing 
with the question of a blank substance relative to other blank 
substances, claims, interpretation for whether or not they are 
allowed versus other claims.
    And hopefully we can forget the word ``tobacco'' in the 
discussion today for purposes of thinking about whether or not 
safer, which does seem to be the key word, is appropriate or 
inappropriate to be considered.
    And what I would like to, first of all, do is ask the 
Surgeon General one question, which is what is the health 
benefit of butter.
    Mr. Carmona. Let's see. There are nutrients within butter.
    Mr. Issa. Butter is basically fat; is that right?
    Mr. Carmona. No, no.
    Mr. Issa. What are the benefits of fat then perhaps is a 
better question.
    Mr. Carmona. Fat is necessary. It is essential to our 
growing everything from making steroids in your body to new 
cells require fats.
    Mr. Issa. And isn't the excess consumption of fat the No. 1 
health problem in America, in combination with not enough 
exercise.
    Mr. Carmona. It certainly contributes to obesity, sir. Yes, 
sir.
    Mr. Issa. Okay, and yet the low fat butters and the 
alternate butters appear to be able to claim that they are 
better and safer. I have read enough packaging to get this idea 
that this plasticized butter that tastes marginal at best, not 
margarine, but marginal, gets to make that claim.
    And, Chairman Muris, I guess the question is: how do they 
get to make the claim that they are better if essentially the 
difference is less fat, which the Surgeon General has said is 
okay? It is essential.
    Mr. Muris. Well, health claims are regulated by a statute 
that Congress passed in 1991, the NLEA, and there are a variety 
of hoops through which you have to jump. So even though we are 
involved in that area and, in fact, Dr. McClellan, the head of 
the FDA, and I made an announcement last year where he is 
hoping, given the way science is changing, he is hoping that 
advertising and labeling can keep up with the changes in 
science.
    But there is a special, you know, regulatory regime for 
those.
    Mr. Issa. Okay. So the fact that butter is essentially not 
bad and fat is not bad, then if you have less of it claiming 
that it is better would be probably inappropriate on the face 
of it all, forgetting about the taste of butter, forgetting 
about what we all put on. Then, in fact, we have a different 
standard for tobacco than we have for fat.
    Doctor, I guess my next question is you support banning 
tobacco. Does that allow you to be an honest broker in the 
question of less bad and more bad?
    I would personally say that I would have a hard time if I 
supported outright banning something. We would be happy to see 
Congress passing a law that would do that.
    And then I was asked: well, are we going to allow the good 
instead of the perfect if the good might, in fact, perpetuate 
consumption of this for a while?
    I would probably inherently say, ``Well, geez, I do not 
want to have anything that might lower a little bit the health 
risk, but perpetuate the consumption.''
    Is that something that you are having to deal with in your 
testimony today?
    Mr. Carmona. Well, no, sir, and let me elaborate. First, I 
want to respectfully disagree with your analogy with butter 
because it is much more complex than is presented, and I think 
it is an unfair analogy.
    Second, I am not having any problem with it because the 
driving factor in what I have testified to is that the 
substance we are talking about is a proven carcinogen. It 
causes cancer. So that----
    Mr. Issa. Reclaiming my time from the witness, I guess the 
problem we have is we are talking about less and more and 
trying to understand whether or not less or more is an honest 
statement, and that is why I am trying to get to the bottom of 
this.
    It appears to me as though other than tobacco we have this 
theory that you are innocent until proven guilty. In tobacco 
you are guilty until proven innocent, and so for the Chairman, 
I guess, my question to you would be, because my time is 
evaporating here, we have made a big point in this country, and 
accurately so, that we are concerned about second hand smoke, 
sufficiently that, in fact, it has been found to be something 
that one has to get rid of, and that is why we ban smoking in 
public areas in State after State.
    If, in fact, second hand smoke is clearly bad, then aren't 
you better if you have no second hand smoke because you have no 
first hand smoke? The risk to people around a smokeless tobacco 
consumer is by definition zero versus whatever you have with 
cigars, pipes and cigarettes.
    Would that not meet the first threshold of a claim?
    Mr. Muris. Well, sure, but now you are addressing a 
different question. If smokeless tobacco made a claim based on 
no second-hand smoke, you know, we would evaluate that on it 
its merits. That is obviously different than the earlier claim 
we were talking about.
    Mr. Issa. So just one last follow-up. So what I am hearing 
is that even though there is no smoke and anybody could figure 
out that it must be safer, you are saying that if they made 
that claim, then you would think about evaluating it. Do we 
need science to determine----
    Mr. Muris. Well, no. I am saying----
    Mr. Issa. [continuing] that smoke has no second hand smoke 
claim?
    Mr. Muris. The evaluation could be very quick, but 
obviously if someone asks us, let us go back to the premise. 
The premise was we were asked about these claims. I cannot give 
an answer without an evaluation, even if the evaluation occurs 
in a twinkling of an eye.
    Mr. Stearns. The gentleman's time has expired, and the 
gentlelady from California, Ms. Solis.
    Ms. Solis. Thank you, Mr. Chairman.
    Thank you, Dr. Carmona for being here. It is good to see 
you. I know on occasion we talked about some of these chronic 
illnesses that face our communities, especially minority 
communities and the Latino community.
    And I wanted to ask you, and I do not know if this has come 
up, what the cost is in terms of prevention for tobacco use now 
that you know of in terms of government trying to combat the 
use, trying to get youth to stay out of, you know, going into 
that bad habit of smoking.
    Mr. Carmona. I do not have a dollar amount for you. I 
certainly can get that, but whatever it is, I know that when we 
look at prevention across the board, we spend far, far too 
little on all prevention activities in this country.
    Ms. Solis. Would you say that the number of youth, 
particularly minority youth in terms of smoking, has gone up in 
the last 10 years or it has gone down?
    Mr. Carmona. I think it has slightly increased where other 
areas or other subsets have decreased. This is still a 
population that is at greater risk.
    Ms. Solis. I saw some information regarding, I guess, a 
percentage decrease for young Latinas in terms of smoking. I 
kind of understand why that is happening, because more women at 
least are going in for prenatal care and are being advised of 
low birth weight that their child would experience if they 
continue to smoke.
    Is that something that your office is also advocating?
    Mr. Carmona. Well, the epidemiology and demographics of 
smoking are tracked very carefully by CDC on a routine basis, 
and they have all of those numbers broken down, again, by 
ethnicity, by geographic location, by age, and so on.
    So it really depends which group you are speaking of. In 
some areas it has plateaued out, but in some there are still 
subgroups, Latinos specifically, who are at slightly increased 
risk, and every once in a while we see a little increase.
    Ms. Solis. One of the explanations that we were given is 
that, in fact, if you were advocating for use of smokeless 
tobacco, that that probably or could lead to use of tobacco, 
cigarettes. What is your opinion on that?
    Mr. Carmona. Yes, we do look at smokeless products as being 
a gateway to smoking. It can be still a sense of security that, 
again, as I have said earlier, this is a lesser threat. It is a 
safer means to get your nicotine and chew, and we are 
definitely concerned about that for the reasons I have already 
mentioned.
    Ms. Solis. One of the other questions I have is women, I 
think, overall, my understanding is that the rate has actually 
gone up; is that correct, in terms of cigarettes?
    Mr. Carmona. It depends on the age group, and I would have 
to look at that data, but the aggregate, if it has, it is very 
slightly in aggregate. But, again, breaking down the 
populations, minority populations' age and demographics you 
will have peaks and leveling off periods that are different 
than the aggregate data when you just lump all women together, 
for instance nationally.
    Ms. Solis. The information I have is that women account now 
for about 39 percent of all smoke related deaths in the U.S.
    Mr. Carmona. That is correct.
    Ms. Solis. I guess one of the questions I would have is if 
we are trying to get women to stop smoking and using an 
alternative measure here, in this case smokeless tobacco, I 
cannot think of too many women who would want to chew tobacco, 
you know, and I would love to hear more about that. Because I 
think that is a real issue that we are really skirting the 
issue here, and how do you deal with that?
    Mr. Carmona. Well, I think that is, you know, a social and 
cultural part of our society where young men embrace that and 
most women reject it.
    Ms. Solis. Well, wouldn't that have an impact on modifying 
maybe their behavior?
    Mr. Carmona. Oh, yes, ma'am. Absolutely, yes.
    Ms. Solis. So I am still very skeptical about the direction 
of where we are going with all of this because I know that in 
our community, and especially in California, the State of 
California is pretty progressive in terms of prevention, 
tobacco smoking and all of that, and restricting where you can 
use cigarettes.
    In fact, we have an initiative that was passed, Prop. 10, 
that you are probably aware of that is a dedicated source of 
funding strictly for prevention.
    So my question goes to while we are spending a lot of money 
to try to treat the illness, cancer, respiratory, emphysema, at 
the same time we are raising revenue to try to tell youth to 
give them the message and young people not to smoke.
    Mr. Carmona. Yes.
    Ms. Solis. And then we are saying, on the other hand, well, 
it is okay to chew tobacco when, in fact, studies, I guess, are 
not clear on how severe that might be.
    My question is, you know: where are we going with this in 
terms of giving accurate information that smokeless tobacco may 
be harmful, could be maybe in different degrees obviously. 
Maybe you do not get cancer in 10 years. Maybe you suffer from 
tooth decay a lot faster, which we see in our community, by the 
way.
    And I would ask, you know, what your opinion is on that.
    Mr. Carmona. Congresswoman, my opinion is that, as I have 
stated, irrespective of the debate here today, I see no 
scientific evidence to support the use of smokeless products 
for any reason, and they are hazardous to your health, from 
causing cancer to causing oral disease, including gingivitis, 
tooth decay, as well as a host of other diseases.
    So without further evidence to refute that, I could not 
support its use in any fashion.
    Mr. Stearns. The gentlelady's time has expired.
    Ms. Solis. Thank you. Thank you very much.
    Mr. Stearns. Mr. Fletcher.
    Mr. Fletcher. Thank you, Mr. Chairman, and thank you for 
conducting this hearing.
    Let me say first having spent most of my adult life up 
until the political side of things encouraging people to stop 
smoking and using tobacco products, I think it is interesting 
that we come to today where we are talking about relative risk 
of different products.
    There is no question as we look at the IOM report, 180,000 
deaths from the cardiovascular disease, 150,000 from cancer, 
about 85,000 from respiratory disease related to tobacco use, 
and so there is no question that if we had a perfect world, 
that no one would smoke or use products that are harmful to 
their health.
    But, in fact, that is not the case. We do have a free 
society, and I think in a free society it is very important to 
remember that a couple of things are important.
    One, I think it is extremely important to be intellectually 
honest with the population so that they can make choices. Some 
people choose to smoke even though they know the risk is there. 
I think 75 percent of the people that are smoking would like to 
quit. That means there is 25 percent that do not even want to 
quit.
    So outside of prohibition, which even though some may 
support that, I think we probably have it nigh to impossible to 
control and regulate. We went through prohibition in the early 
part of the last century with some abysmal results.
    But given that, let me look, and I want to present a couple 
of things. I have looked over these reports, and I know the 
Surgeon General has commented on that. One was the Royal 
College of Physicians of London, and these are, you know, 
pretty reputable folks. In fact, they have been around a lot 
longer that probably most of our even Harvard and some of our 
early medical institutions. I mean these are folks that spend 
their life doing research.
    And they come up and say a way of using nicotine, the 
consumption of noncombustible tobacco is on the order of 10 to 
1,000 times less hazardous than smoking, depending on the 
product. Some manufacturers want to market smokeless tobacco's 
harm reduction option for nicotine users, and they may find 
support for that in the public health community.
    But the bottom line is it is a pretty big spectrum. So the 
science is pretty unclear. It is 10 to 1,000 times. Even 10 is 
pretty significant if that is the low balling side.
    Now, I do not support and have certainly found it 
intolerable that companies in the past have made marketing 
attempts toward younger individuals and maybe not always been 
truthful in what they said they would market and things. And so 
I think it is clear that we have some sort of guidelines for 
advertising, for marketing a product.
    But I also look at given the fact that Royal College is 10 
to 1,000 times less, there is also the European. These are some 
pretty reputable people, too, that have spent a lifetime just 
in research. They said oral tobacco may play a role in harmful 
reduction. It is not necessary to show that it does not cause 
cancer. It just needs to be substantially less hazardous than 
smoking, even allowing for the cautious assumption about health 
impact.
    So that is what you were talking about, the European, I 
guess. The smokeless tobacco and other oral tobaccos are a very 
substantially less dangerous way to use tobacco than 
cigarettes, and it goes on to talk about a number of different 
other things, but it does at least acknowledge, and this is a 
study of some physician researchers that smokeless tobacco has 
reduced health.
    Now, the Scandinavian study--and I know the Surgeon General 
mentioned that some of the factors were not controlled--there 
was one of those studies where they were controlled fairly 
well. Let me read those to you.
    This was a Lagergin study. It was a case controlled study, 
patients with adenocarcinoma of the esophagus, gastric, cardio, 
and esophageal squamous cell carcinoma. It said many potential 
confounders were considered, including age, sex, education, 
cigarette smoking, alcohol consumption, dietary intakes. It did 
not mention coffee specifically. Dietary intakes of fruit and 
vegetables and energy intake, BMI, reflux symptoms, physical 
activities.
    It talked about the substantial reduction. I agree that the 
science is not totally--I mean there are a lot of studies that 
can be done, and the science is not totally complete in this 
area. But one of the questions I have got for both of you is if 
we could have certainly an initiative for regulating tobacco 
products, whether it be FDA or whether it be FTC on the 
marketing of it, and it was marketed in such a way that it was 
very clear to not use the word ``safe'' or ``safer,'' but say 
you had a relative scale from 1 to 10, and say you could say, 
well, given the current knowledge that we have, you know, 
filterless cigarettes, maybe a 10; smokeless, somewhere less 
there.
    And, by the way, I come from a district that produces 
burley, which is for cigarettes, not for smokeless tobacco.
    Given the fact that we live in a free society and it is 
important to get information out, and given the fact that I 
know some people feel that this gateway issue may promote more 
people, but wouldn't it be incumbent upon us to provide that 
information to them, that there is a relative risk?
    And I say that because I have got a brother that I tried to 
get to stop smoking. He was smoking. We got him to stop. He 
started dipping snuff. Finally when we could not get him to 
stop altogether, we just kind of quit, and, yes, he went back 
to smoking. But I never told him about reduced risk.
    And I just wonder that given the fact that even second hand 
smoke causes some injuries of what we might do if we give the 
public intellectually honest information about the relative 
risk, and I would just like both of you to comment on that.
    Mr. Carmona. Well, if I might, I will just comment on the 
science first, and then I will pass off to my colleague on the 
advertising.
    I certainly respect your opinions as a colleague, as a 
fellow physician, sir, but the Swedish study, I know that they 
looked at an endpoint of oral cancer risk and not 
cardiovascular disease or other causes of mortality in a more 
broad sense. So it is only one endpoint.
    So I think variables also in outcome, as well as the inputs 
for the research I think are equally important.
    Mr. Fletcher. May I interrupt you just to ask you a 
question?
    Mr. Carmona. Yes, sir.
    Mr. Fletcher. Do you believe that smoking has the same 
cardiovascular risk as smokeless tobacco, say, the Swedish 
smokeless?
    Mr. Carmona. I would have to review the data more 
specifically, but I know there is risk. If it is the same or 
lesser, then we get into that issue again of is it safer.
    Mr. Fletcher. Yes, relative risk. That is what studies are 
about. There is no absolute there.
    Mr. Carmona. Yes, and so the other issue is when we are 
talking about the amount of nicotine, for instance, and you do 
not also talk about carcinogenicity, then you just negate the 
fact that we know that these are cancer causing compounds, and 
so if you just address the issue of, well, is this a safe way 
of using this to withdraw somebody from their nicotine 
addiction.
    Well, again, my premise is that if I know that this is a 
carcinogen, then I really could not in good faith recommend it 
for any other use when I know no matter what else you are using 
it for----
    Mr. Fletcher. I agree. We do not recommend it for use, 
period, but I am talking about a relative scale, just getting 
information out to the public. It is kind of like on HPV and 
cervical cancer. You know that. We talk about the use of 
condoms does not totally prevent HPV and cervical cancer, but 
it reduces the risk, and there are a lot of folks on different 
sides of the aisle that have a different approach to that.
    Mr. Carmona. Yes, I understand, and I can understand where 
you are coming from and some of the research is looking at this 
a little bit different as a matter of policy. But, again, it 
comes back to the cancer causing effects or carcinogenicity of 
this for me, that when you say on a relative risk and you say, 
``Okay. Well, smoking let us say is a ten and maybe this 
product is a five, but it still causes cancer.''
    So if you say the relative risk is lower, all right, I 
cannot argue with you if we show that statistically, but it is 
still a cancer causing agent, which is why I am concerned.
    Mr. Fletcher. I agree.
    Mr. Chairman.
    Mr. Stearns. The gentleman's time has expired.
    The gentlelady, Ms. Cubin.
    Ms. Cubin. Thank you, Mr. Chairman, and thank you for 
calling this hearing today.
    I was one of those members that did request because I 
believe that knowledge is power, and I want to point out that 
we are not here today talking about the ills of smoking. We all 
know that. We all believe it, and we accept it.
    We are also not talking about marketing tobacco products to 
children. If I had three wishes and I found the bottle on the 
shore and the genie popped out, I would probably wish for 
enough money to take care of myself and my family and meet our 
needs until we die. I would probably ask for good health for 
myself and my family. And the third thing would be that I would 
wish for all children to make decisions that were beneficial to 
their bodies as far as health is concerned.
    So, you know, I am a mother, and I actually have a son that 
chews smokeless tobacco, and I hate it. When I was a little 
girl, my grandfather chewed smokeless tobacco. I am from 
Wyoming, and probably we have as many people that use smokeless 
tobacco as anyone.
    But what I am thinking about are the 10 million adults that 
are going to die in the next 10 years or the next two decades I 
should say, that are going to die from actions related to 
smoking, conditions related to smoking.
    I have a degree in chemistry, and whenever we would be 
arguing an issue in science, the first thing we would always do 
is challenge the studies that were cited by--I was also in 
debate--the studies that were challenged by the other side.
    And so, Dr. Carmona, you do not accept as valid because it 
is not comprehensive enough the study by Britain's Royal 
Academy of Medicine; is that correct? Was that the reason you 
gave during your questioning and statement?
    Mr. Carmona. Yes. Not that it was invalid, but that to make 
a decision you need much more information, and my colleagues 
also who study this----
    Ms. Cubin. Yes. Okay. Well, then does it follow that the 
same level of comprehensiveness must be followed to support the 
statement you made that smokeless tobacco is a gateway to 
smoking? Is there a study that you can cite that has more 
comprehensive basis than the Royal Academy's?
    And if so, would you please furnish that?
    I would like a comparison actually of the studies 
themselves and why the study that you are quoting as far as the 
gateway to smoking is concerned is superior to the basis of 
this study by the Royal Academy. Would you provide that to us?
    Mr. Carmona. Yes, ma'am.
    Ms. Cubin. Thank you.
    Mr. Carmona. I did not mean to imply that it was superior, 
but I would be happy to provide the information to you.
    Ms. Cubin. Sure. You did not say it was superior, but you 
base your opinion on something, and I am just curious to know 
how you substantiate that in your own mind, and I would 
appreciate it if you would provide that to us.
    Another point that I wanted to bring up is that science is 
changing. Mr. Muris brought that up earlier in response to a 
question that science is changing. In the 1986 Comprehensive 
Smokeless Tobacco Health Education Act, Congress ordered that 
three messages be alternated on snus cans. You notice I call it 
snus because that is what my grandpa always called it. That is 
politically correct to me.
    Anyway, one of those statements is this product is not a 
safe alternative to cigarettes. Well, since your agency did not 
come up with that language that it is not a safe alternative to 
cigarettes, Mr. Muris, I wonder if you have a responsibility.
    I mean, obviously the Congress did that, but trying to 
decide who has a responsibility to get this information 
forward, I mean, it is your agency's responsibility that the 
correct information be out there. This language was done in 
1986. Isn't there information that would cause you to at least 
look at that and make a recommendation to the Congress if they 
are the ones to do the language, which I do not think, frankly, 
that Congress should be doing that? I think it should be done 
in your agency.
    Mr. Muris. Well, the history of this issue is many, many 
years ago, in the mid-1960's, my agency tried to do something, 
and Congress immediately stepped in, and my agency has had the 
wisdom since the to----
    Ms. Cubin. To stay out?
    Mr. Muris. Well, we have issued reports and we have done 
other things, but we have not tried to by rulemaking do 
something that Congress has made it pretty clear that it wants 
to do.
    Look. In the bigger----
    Ms. Cubin. But that is really not my point. My point really 
is if this statement is factually wrong, I mean, if we cannot 
make the statement that non-tobacco products--well, let me see. 
Where did I write this down? I wish I could keep track.
    Go ahead and answer what you were going to say.
    Mr. Muris. Well, in the very large context, and I do not 
want to lose sight of that here in the specifics, this hearing 
is very important because potentially--and that is obviously 
the key word--there are very large public health benefits to be 
made from addressing the problem of people who cannot or will 
not quit smoking.
    And that is why I said a place to start where I think we 
can do more, and again, it is potential, and the FDA already 
regulates this, and that is why I said I would obviously need 
to talk to them, is with the non-tobacco risk reduction 
products, the gums and the patches.
    They right now can only be marketed for a very limited 
purpose. So consumers cannot be told about their potential for 
that group of smokers who are unwilling to go off of nicotine 
entirely.
    Ms. Cubin. So what I have drawn from this hearing today so 
far is that if more people were using snus instead of smoking 
cigarettes, that our national health care bill would be lower; 
that there would not be people suffering from second hand smoke 
from other smokers; that improvement would be seen in our 
national health picture.
    And I just think it seems to me, General, or I mean 
Admiral--excuse me.
    Mr. Carmona. No problem.
    Ms. Cubin. But it is something that we should consider. I 
do not think anyone is saying that the use of snus is a healthy 
thing to do, but I certainly do not think that we can say that 
it is not a healthier thing to do than smoke cigarettes.
    So my time is up, and if you would like to respond to that, 
that would be great.
    Mr. Carmona. I think my remarks, ma'am, have been directed 
to the science that we have at hand today, that there is no 
evidence at this point to use that as a substitute. What we do 
know about the product is that it can cause cancer and other 
diseases.
    I also stated earlier though if there is research to the 
contrary, if there is research that can define some role, my 
colleagues and I are always happy to look at that to see if 
there is a possibility, but as of this date we have seen none.
    Mr. Stearns. The gentlelady's time has expired. The 
gentleman from Idaho, Mr. Otter.
    Mr. Otter. Thank you, Mr. Chairman.
    And I along with the rest of the panel want to thank you 
very much for calling this most important hearing.
    I have always been adverse to putting the fist of 
government into the glove of courtesy. I know many times when I 
was in my State legislature we passed no smoking in public 
places even though it was not a government building or was not 
a government called meeting, and I always voted against those 
kind of bills because I felt that I had a personal 
responsibility, if I did not want to be in part of that 
environment, that I should go to the restaurant owner and say, 
``I am not going to eat here any longer as long as you do not 
have a no smoking section or as long as I cannot avoid second 
hand smoke.''
    But I want to make an admission like my colleague from 
California, Mr. Issa, that I, too, am a recovering smoker. I 
quit for my son's first birthday 34 years ago, and it is 
probably one of the smarter things that I have ever done, but I 
did it because I recognized that it is personal responsibility.
    And it is unfortunate that so many of the things that we do 
in Congress, and I have only been here a little over 2 years 
and a few months, but so many of the things that we do here in 
Congress is we try to substitute the national consciousness and 
the national Treasury for personal choice, and of course, I 
have to look right back on the immediate past of the tobacco 
lawsuits that we had.
    And even when I did smoke 35 years ago, I never bought a 
pack of cigarettes that probably did not have that warning on 
it. And I say ``probably'' because I doubt if I read it more 
than once or twice, only as a novelty, I guess, when it first 
appeared.
    But I made that choice. I made that choice to smoke, and I 
watched as the generation just before us, as many of the folks 
in my generation watched as that generation just before us that 
had smoked 10 years more than we had started suffering the 
consequences of that behavioral choice.
    Well, I think we have sent a far more dangerous message to 
our youth about smoking or not smoking or choosing to use 
tobacco in any form or not to use it when we have substituted 
the national Treasury and the national consciousness through 
Congress action, through the Judiciary Department's action of 
bringing a lawsuit against the tobacco companies.
    They were warned: do not smoke. Then we go back and sue 
them anyway and say we are going to hold you responsible. That 
is past history. I disagree with that.
    I suspect when I was in the military, and you could have 
called me General, Barbara, I was in the armored calvary, and 
it was not unusual for us during training or during OJT or AIT 
to stop the column and break and say, ``Smoke them if you have 
got them.''
    And sometimes they were supplied in our food packets. 
Anyway, I suspect that got a lot of people smoking.
    But anyway, what I would like to ask, I guess, both of you, 
it has not been unusual for the government, as Congresswoman 
Cubin made the point earlier, that knowledge is power, and one 
of the responsibilities this republic, this government does 
have to its citizens is to make them as knowledgeable as 
possible and then stay out of their way and allow them to use 
that knowledge for choices.
    And it seems to me that if there is evidence and whether or 
not you disagree with these early on reports, it has not been 
unusual, Mr. Muris, for the FTC to allow cigarette makers to 
say, ``This new filter that we have got on here allows for less 
tars and less nicotine. This new cigarette is a little less of 
this and a little less of that,'' and thereby enhancing the 
possibility that it is probably not as dangerous as the one 
without a filter or is the one referred to earlier, and I don't 
want to pick on any particular company, but the Camel 
cigarette.
    And I know when I first stated smoking if you could smoke a 
camel, you were tough. You know, you probably got off a little 
easier with something with a filter on it, but my point is: why 
isn't it your responsibility to make people more knowledgeable 
and, therefore, more free to make the right decision by adding 
up and subtracting the causes and the amount of danger there is 
in different products?
    We do it all the time, less salt, less sugar, less fat. We 
hear it all the time. Why isn't that our responsibility 
irrespective of your feeling and the Admiral's feeling about 
all of them being bad?
    And with that I will yield back.
    Mr. Stearns. The gentleman's time has expired.
    Would you like to answer the question, Mr. Chairman?
    Mr. Muris. Sure, if you want.
    Mr. Stearns. Sure, go ahead.
    Mr. Muris. I do believe in the importance of knowledge, and 
as I mentioned just a few minutes ago, in the potential of 
public health benefits from risk reduction products. There are 
obviously important attributes here. This is a product that 
used as intended causes you great damage, and I think everybody 
recognizes that.
    And our experience with the tar reduction has not been a 
particularly happy one because of the phenomenon called 
compensation by which people smoke the cigarettes harder and, 
therefore, get more damage than if they smoked them on some 
relative level. So that just shows us that we need caution.
    Mr. Carmona. I would just briefly comment that I agree with 
your premise, sir, as far as the right of people to choose, and 
in a perfect world, we would hope that armed with the 
appropriate information that people would make the right 
decisions, but often their individual decisions have impact on 
a population at large, and sometimes I think where markets fail 
or common sense fails regulation sometimes is essential.
    We do it with speed laws because we know people drive too 
fast, and we have been able to demonstrate that by slowing them 
down there are less accidents.
    We know that seatbelts save lives, and in many states 
people felt it was their right not to wear one. Yet the impact 
to the population and the cost of health care on the whole was 
significant. So we had regulation for that and helmets and a 
number of other things.
    And I think, again, in a perfect world I would agree with 
you that it would be nice that people would make prudent 
decisions based on the information before them, which is part 
of my job to bring that scientific information forward. 
However, they do not always make the right decisions. And their 
poor decisions can adversely impact the population as a whole.
    Mr. Stearns. The gentleman's time has expired.
    The gentleman from Ohio, Mr. Brown, is recognized for 5 
minutes.
    Mr. Brown. Thank you, Mr. Chairman.
    I first would like to recognize Dr. Carmona, whom I shared 
a podium with at the American Public Health Association meeting 
in Philadelphia and was very impressed with his words then and 
all that he shared with us.
    Mr. Chairman, I would like to yield my time to Mr. Waxman, 
who has alerted Americans to the dangers of all forms of 
tobacco more than anyone in this body. So Mr. Waxman, if I 
could.
    Mr. Waxman. Thank you very much, Mr. Brown.
    Thirty years ago the FTC was fooled by the tobacco 
companies into allowing them to advertise low tar and light 
cigarettes, and as a result millions of Americans switched to 
those products because they thought it would protect their 
health.
    As a result of that, millions of American died because they 
were not safer products. In fact, they were not even what they 
claimed to be.
    Now I think what we have before the FTC is another attempt 
by an industry to commit a fraud on the American people, and 
that is to try to present smokeless tobacco as a safer 
alternative. Now, the first question is: is it a safer 
alternative?
    And, Dr. Carmona, you have been so clear on every question 
that has been raised on that point, the safer alternative. Is 
that a fair statement?
    Mr. Carmona. Yes, sir.
    Mr. Waxman. Now, let us say for argument purposes it was 
safer, slightly, harmful but safer. Well, it is only safer if 
people will use it instead of smoking, not if they use it in 
addition to smoking.
    Is there any evidence that anybody can show that people 
will give up cigarette smoking because they have got a safer 
alternative? I submit there is no evidence at all, none.
    Now, another theory. If you advertise this product as a 
safer alternative to cigarettes, kids might start using this 
product. In fact, I think this is what this is all about. Kids 
are not using this smokeless tobacco as much because they have 
caught onto the fact that it does them a great deal of harm. 
When it says cancer of the jaw, kids start picturing what 
cancer of the jaw means, and more and more of them are giving 
up smokeless tobacco.
    But if they are told it is a safe alternative, they might 
say, ``Well, I will try this safer alternative.''
    But we do have evidence, don't we, Dr. Carmona, that people 
who use smokeless tobacco are starting to get the nicotine 
habit and then they can move on to cigarettes? Isn't that an 
accurate statement?
    Mr. Carmona. Yes, sir, there is scientific evidence to 
support that.
    Mr. Waxman. So the question that Mr. Muris said is is there 
a potential public health benefit. Well, it is hard for me to 
see that there is a potential public health benefit.
    So the FTC allows this advertising. We will have to see 20 
years down the road what harm we have done because the FTC 
operates to allow advertising, unlike the FDA, which would 
screen any kind of claim in advance.
    I really am struck by the fact that it has been a long time 
since the Congress has held any hearings about tobacco. Today 
two committees are holding hearings on tobacco. We are not 
looking at the Institute of Medicine recommendations, which 
said that they had a strategy. This was an HHS advisory 
committee, that they thought could lead to a cessation of 
smoking and lead to 3 million lives being saved. Five million 
people could quit within 1 year.
    Instead, what the two committees of Congress are looking at 
is what the industries want. Today we are looking at what U.S. 
Tobacco would like. This afternoon we are going to look at what 
U.S. Tobacco and Philip Morris would like.
    That is what the Congress has come to. We respond to the 
industry pressure to bring this issue up. Mr. Muris, this is a 
hearing for you. This is a hearing to impress you that a lot of 
Members of Congress would like you to be receptive to U.S. 
Tobacco's attempt to rejuvenate their market.
    Well, I would hope that we rely on science, and the science 
is not there. The science is not there. The politics may be 
because tobacco is rich and powerful, but the science is not 
there, and I would hope that you look at the science very, very 
carefully.
    And I am awfully nervous when a bunch of lawyers are making 
the decision on science when it ought to be up to something 
like the FDA or the Surgeon General or the Institute of 
Medicine to make the decision. I know you will consult with 
them.
    I do not know if you are aware, either of you, that Philip 
Morris once surveyed 85 former users of smokeless tobacco and 
found that 53 were now smoking, and I would like to introduce 
for the record Philip Morris' report on how people who were 
using smokeless tobacco didn't wean themselves off from 
cigarette smoking, that they are either back to smoking or 
moved on to smoking, and I would hope we can get that in the 
record.
    Mr. Stearns. Fine. By unanimous consent, so order.
    [The report appears at the end of the hearing.]
    Mr. Waxman. Mr. Chairman, I appreciate the opportunity you 
have afforded me to participate in this hearing, and I just 
hope that people do not get fooled a second time the way the 
FTC was fooled 30 years ago and then we look back 20 years from 
now and think about all of the people that got cancer of the 
jaw and moved on to cigarettes and used cigarettes and 
smokeless tobacco, and rather than the potential public health 
benefit, we ended up with a potential public health disaster.
    Mr. Stearns. The gentleman from Ohio's time has expired.
    Mr. Shimkus is recognized.
    Mr. Shimkus. Thank you, Mr. Chairman, and I am going to be 
brief. We have already been here a long time, and I think we 
are going in cyclical debates on this issue.
    I will just say that we have a debate over words, and 
basically it is an agreement that there is a risk to smokeless 
tobacco, but the real question is: is there a lower risk than 
smoking and whether that is second hand smoke or whether that 
is all of these other things?
    Have we considered--and I would think I would go to Dr. 
Carmona first--have we as a country considered commissioning 
our own study that would address many of the questions that 
were broached today to insure that we have factual, scientific 
evidence?
    And if we have not so far, would we consider doing so? And 
if not, why?
    Mr. Carmona. Well, sir, there are many studies that have 
been done in the literature. I mean literally hundreds of 
studies on a broad range of issues regarding smoking cessation 
and so on and including smokeless products, and there are 
ongoing studies now both at CDC that are ongoing as we speak 
and programs that are funded throughout the United States at 
universities and other areas that NIH funds that are addressing 
many of these questions.
    Now, if there are specific questions that are not being 
answered or that you felt that needed to be addressed, 
certainly we would be willing to entertain that, and I would 
pass it on to my colleagues who are doing the research.
    But there is a broad range of research that has taken place 
and continues to take place on these subjects.
    Mr. Shimkus. So I guess the question for me is based upon 
the current research that you have available to review, and 
obviously you do not have the information from the ongoing 
research, nothing that has been said with respect to the IOM 
report--that still does not provide enough information to make 
a determination whether there is any significant benefit for 
someone going from tobacco used in cigarettes versus smokeless?
    Mr. Carmona. Well, I think the IOM report was fairly clear 
and said that there was no evidence and there are no products 
on the market today to advocate for that type of substitution. 
So the IOM report is fairly clear, I think, in its conclusion.
    Mr. Shimkus. That is all I have, Mr. Chairman.
    Mr. Stearns. I thank the gentleman.
    I want to thank both of you for your patience, and we 
appreciate your testimony.
    Mr. Whitfield. Mr. Chairman, may I just ask unanimous 
consent? I would like to submit one other question to Admiral 
Carmona relating to the Center for Disease Control.
    Mr. Stearns. Unanimous consent request is granted.
    Mr. Whitfield. Thank you.
    One minute? Oh, submit it for the record, oh, by unanimous 
consent.
    I would say in just conclusion that Mr. Waxman talked about 
a study that suggests that smokeless tobacco is a gateway to 
cigarettes, but I think also he should have been fair and 
pointed out that there is also a study that refutes that 
gateway theory stating that the gateway study that was made was 
flawed.
    And Mr. Waxman, of course, will be in the second hearing 
this afternoon on the same subject.
    So we welcome now the second panel. The second panel 
consists of Dr. Robert Wallace, M.D., Institute of Medicine, 
Vice Chair, Committee to Assess the Science Base for Tobacco 
Harm Reduction.
    Dr. Scott L. Tomar, editor, Journal of Public Health 
Dentistry, University of Florida College of Dentistry, Division 
of Public Health Services and Research.
    Dr. Brad Rodu, professor, Department of Pathology, 
University of Alabama at Birmingham.
    Mr. Steven Burton, Vice President of Smoking Controls 
Strategic Development and Switch, Glaxo SmithKline Consumer 
Health care.
    Mr. Richard H. Verheij, Executive Vice President, U.S. 
Smokeless Tobacco Company.
    Mr. Matthew L. Myers, President and CEO, National Center 
for Tobacco Free Kids.
    And Mr. David T. Sweanor, Counsel, Non-smokers Rights 
Association.
    I urge the members to stay for the second panel because if 
we are talking about the science, then we have people who can 
actually speak to that science, and so it would be very helpful 
for members if they can to come back to continue our 
discussion.
    We have an order in my witness list that I will use if you 
do not mind, and so I am going to ask Dr. Wallace to start off 
with his opening statement. Five minutes, and if you want to 
take less and make your opening statement part of the record, 
obviously that would be appreciated. We have a large panel 
here.
    So we will start off with you, Dr. Wallace, and welcome and 
thank you.

  STATEMENTS OF ROBERT B. WALLACE, VICE CHAIRMAN, COMMITTEE TO 
 ASSESS THE SCIENCE BASE FOR TOBACCO HARM REDUCTION, INSTITUTE 
 OF MEDICINE; SCOTT L. TOMAR, EDITOR, JOURNAL OF PUBLIC HEALTH 
DENTISTRY, UNIVERSITY OF FLORIDA COLLEGE OF DENTISTRY, DIVISION 
 OF PUBLIC HEALTH SERVICES AND RESEARCH; BRAD RODU, PROFESSOR, 
 DEPARTMENT OF PATHOLOGY, UNIVERSITY OF ALABAMA AT BIRMINGHAM; 
 STEVEN L. BURTON, VICE PRESIDENT, SMOKING CONTROLS STRATEGIC 
DEVELOPMENT AND SWITCH, GLAXO SmithKLINE CONSUMER HEALTH CARE; 
 RICHARD H. VERHEIJ, EXECUTIVE VICE PRESIDENT, U.S. SMOKELESS 
TOBACCO COMPANY; MATTHEW L. MYERS, PRESIDENT AND CEO, NATIONAL 
 CENTER FOR TOBACCO FREE KIDS; AND DAVID T. SWEANOR, COUNSEL, 
                 NON-SMOKERS RIGHTS ASSOCIATION

    Mr. Wallace. Thank you, Congressman.
    I was the Vice Chair of the committee that put the Clearing 
the Smoke report together, and just for the record, I am a 
professor of epidemiology and internal medicine at the 
University of Iowa.
    I am going to paraphrase my remarks, and I would like them 
to be entered into the record, along with the report itself.
    Mr. Stearns. Your opening statement will be part of the 
record. By unanimous consent, so ordered.
    Mr. Wallace. Thank you.
    Let me first say in part because I responded to the earlier 
testimony this morning that we dealt with a range of harm 
reduction products and tobacco and not particularly related to 
smokeless tobacco. In fact, we did consider smokeless, but we 
also considered other tobacco devices and delivery systems, and 
we also considered nicotine replacement therapy as well.
    We basically had four conclusions in our report, and one is 
that we think that for many diseases attributable to tobacco 
use reducing the risk by reducing exposure to tobacco toxicants 
is, in fact, feasible.
    However, while we think that manufacturers of these 
products should have an incentive to make claims, this 
incentive could only be done in the context of a comprehensive 
national tobacco control program that has emphasized abstinence 
oriented prevention and treatment and only if the harm 
reduction assessment has been thoroughly scientifically vetted.
    We also concluded that these potential reduced exposure 
products have not yet been evaluated, as others have said, and 
certainly not comprehensively enough to provide a scientific 
basis for concluding that they are associated with reduced risk 
compared to convention tobacco use.
    We concluded that regulation of all tobacco products is 
necessary in order to assure a scientific basis for judging the 
effects of particular products versus others.
    We concluded also that from a public health perspective, 
and it has been said several times this morning that it is very 
important to understand the public health impact of introducing 
new products and making claims about products, and therefore, 
the health and behavioral effects of all of these products must 
be monitored on a continuing basis.
    We suggested a regulatory framework. It is long and 
detailed, and I would just highlight just four of the many 
principles. They included disclosure of product ingredients, 
toxicity testing, pre-market approval of claims, and issues 
relating to labeling, advertising, and promotion, and also post 
marketing surveillance so that, in fact, we can find out what 
happens to Americans when these products are released both in 
terms of their behaviors and with respect to these products and 
in terms of their health.
    Finally then I just have three public health messages that 
I have culled from the report. One is that the committee 
strongly felt that the best strategy, of course, is to never 
use tobacco at all, and if you are using it, to quit and I 
think that needs emphasis.
    Second, with appropriate and comprehensive research, 
surveillance, education, and regulation, we do feel that these 
products could possibly, emphasize ``possibly,'' reduce the 
some of the risk of tobacco related disease, but the net health 
impact, again, is unknown, and although the products may be 
risk reducing for an individual, they may, in fact, increase 
the risk to populations.
    And then finally, our third public health message is that 
we pled for a comprehensive and verifiable surveillance system 
being the crucial link to understand the relationship between 
the availability of these products and reduced risk both to 
individuals and reduced harm to the public health in general.
    So I very much appreciate your willingness to hear me out, 
and I would be happy to answer questions.
    [The prepared statement of Robert Wallace follows:]
 Prepared Statement of Robert B. Wallace, Vice-Chairman, Committee to 
   Assess the Science Base for Tobacco Harm Reduction, Institute of 
                 Medicine/National Academy of Sciences
    Good morning, Mr. Chairman and members of the Committee. My name is 
Robert Wallace. I am Professor of Epidemiology and Internal Medicine at 
the College of Public Health, University of Iowa. I served as Vice-
Chairman of the Committee to Assess the Science Base for Tobacco Harm 
Reduction of the Institute of Medicine. The Institute of Medicine 
operates under the 1863 charter by Congress to the National Academy of 
Sciences to advise the government on matters of science, technology, 
and health.
    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. For the 
purposes of this report and in keeping with general definitions, 
tobacco harm reduction refers to decreasing the burden of death and 
disease, without completely eliminating nicotine and tobacco use. 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'd like to emphasize several of the committee's principal 
objectives, conclusions and recommendations.
    1. For many diseases attributable to tobacco use, reducing the risk 
of disease by reducing exposure to tobacco toxicants is feasible. 
Therefore, manufacturers should have the necessary incentive to develop 
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 is the ability of manufacturers to make exposure-
reduction or risk-reduction claims. 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 assessment and regulatory framework outlined by the 
committee, such as illustrated in my next three points.
    2. These potential reduced-exposure products have not yet been 
evaluated comprehensively enough to provide a scientific basis for 
concluding that they are associated with a reduced risk of disease 
compared to conventional tobacco use. Consumers therefore should be 
fully and accurately informed of all the known, likely, and potential 
consequences of using these products. The promotion, advertising, and 
labeling of these products should be firmly regulated to prevent false 
or misleading claims, explicit or implicit.
    3. 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.
    4. 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, or 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 populations.
    The committee outlined several general principles for regulating 
these products. These 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.
    I'd like to conclude my testimony by summarizing three key public 
health messages about the potential for improving health in the face of 
the availability of the potential reduced exposure products:
    1. The committee unanimously and strongly held that the best 
strategy to protect human health from the dangers of tobacco is to 
quit--or not to start tobacco use in the first place.
    2. With 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 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,
 former tobacco users resume use, or
 some people who would have not otherwise initiated tobacco use 
        do so because of perceptions that the risk with these ``new'' 
        products is minimal and therefore acceptable.
    3. 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.
    I 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.

    Mr. Stearns. I thank Dr. Wallace.
    Dr. Tomar.

                   STATEMENT OF SCOTT L. TOMAR

    Mr. Tomar. Good morning. My name is Scott Tomar, and for 
the record, I am an associate professor with the University of 
Florida College of Dentistry.
    I thank you for the opportunity to testify on the issue of 
marketing smokeless tobacco as a potential harm reduction 
strategy for cigarette smoking. I think this is an important 
public health area, but it represents a tobacco industry 
marketing strategy that is both highly flawed and potentially 
dangerous, and I will outline these.
    First, smokeless tobacco causes cancer and is addictive. It 
is a mistake to promote it as safer, as a safer alternative to 
smoking while safe sources of nicotine are available, such as 
gum and path.
    In the mid-1980's, the U.S. Surgeon General and the 
International Agency for Research on Cancer concluded that 
snuff use causes oral cancer, gum disease, and nicotine 
addiction. Based on available evidence, UST's products are 
still carcinogenic.
    More recent research suggests that snuff use may increase 
the risk of cardiovascular disease, including heart attack. 
Smokers should be encouraged to use proven, safe sources of 
nicotine to quite smoking and not snuff.
    Second, U.S. Smokeless Tobacco Company has a long history 
of marketing oral snuff to young males with no history of 
tobacco use, including promotion of low nicotine starter 
products. Allowing them to make safety claims may increase 
nicotine addiction among youth.
    Heavy promotion of oral snuff led to huge increases in use 
by young males from the early 1970's until the mid-1990's. 
Between 1970 and 1991, the prevalence of snuff use among men 18 
to 24 years old increased more than 8-fold. This increase was 
no accident, but was the result of a sophisticated marketing 
campaign that developed, advertised, and promoted use of oral 
snuff starter products with low levels of free nicotine as part 
of a graduation strategy that encouraged new users to move up 
to brands higher in nicotine as tolerance developed.
    The high nicotine brands are highly addictive and high in 
cancer causing nitrosamines.
    Public health groups work aggressively to educate young 
people on the dangers of oral snuff. In 2001, 14.8 percent of 
male high school students reported current use of smokeless 
tobacco, which is down from 20.4 percent in 1993.
    That decline was accompanied by an increase in the 
proportion of high school students who perceive that regular 
use of smokeless tobacco carries great risk of harm. Allowing 
UST to make claims that these products are relatively safe 
could reverse this trend and result in an increase in use by 
youth.
    Third, UST has failed to protect consumers by failing to 
inform, by not lowering known cancer causing agents in its 
product or informing consumers about their toxic and addictive 
properties.
    Oral snuff contains dangerously high levels of cancer 
causing agents called tobacco specific nitrosamines, to TSNAs. 
USDA does not acknowledge or inform their consumers that 
conventional oral snuff causes cancer or is addictive.
    In addition, UST refuses to report brand specific product 
content, nicotine dosing, or the levels of TSNAs. A recent 
study conducted by the American Health Foundation found that 
snuff brands manufactured by UST had TSNA levels that were 15 
to 23 times higher than those found in a popular Swedish brand, 
and that TSNA levels in UST's products, such as Copenhagen, 
increased as much as 137 percent after the products were stored 
at room temperature for 6 months.
    In contrast, no significant changes were observed in the 
TSNA levels of brands made by Swedish Match. That study 
demonstrates that it is technologically feasible to produce 
oral snuff products that are significantly lower in TSNAs than 
those that are currently ont he market. UST has the 
manufacturing technology to reduce the level of nitrosamines in 
all of its brands, yet has not done so.
    UST has refused to voluntarily reveal the amount of free 
nicotine in its products. When I was an epidemiologist with the 
Office on Smoking and Health, we asked the company to provide 
this information to the American people. They flatly refused 
and denied that they were able to manipulate the nicotine 
dosing properties of its snuff products.
    UST's contentions are strongly contradicted by peer 
reviewed science and by sworn depositions of its own chemists.
    When Massachusetts passed a law requiring brand specific 
disclosure of additives that affect toxicity and addiction, UST 
and the other tobacco companies sued the state.
    Fourth, promotion of oral snuff as a safer alternative to 
smoking may have unintended public health consequences. I 
recently published two studies on this topic. The first looked 
at smoking initiation among U.S. males age 12 to 17 and found 
that young males who were not smokers at baseline but used 
smoker's tobacco were three times more likely than young males 
who never used smokeless tobacco to be smokers 4 years later.
    In contrast, only 2.4 percent of current smokers and 1.5 
percent of ``never smokers'' became smokeless tobacco users by 
the 4-year follow-up.
    The second study looked at adult male tobacco users and 
found that U.S. men were 2.5 times more likely to be former 
snuff users who now smoked than to be former smokers who 
currently use snuff. One in 5 males who were daily snuff users 
also smoked, as were 40 percent of occasional snuff users.
    These studies suggest that smokeless tobacco may be a 
gateway for adolescent smoking. Males in the United States are 
far more likely to switch from snuff to cigarette smoking than 
vice versa, and many men who use snuff are still smoking.
    In UST's current advertising for Revel, the brand is 
marketed as a complement to smoking, not as a complete 
substitute or as way to quit smoking. The product is marketed 
for use in settings when smoking is barred and, therefore, 
undermines the impact of clean indoor air laws on smokers' 
decision to quit.
    UST uses similar marketing messages for its Skoal products. 
These products can actually delay or prevent smoking cessation.
    Fifth, there is no evidence that the oral snuff use is 
effective in helping smokers to quit either in the United 
States or in Sweden. Not a single randomized controlled trial 
has been reported that shows----
    Mr. Stearns. Dr. Tomar, your time has expired. You are over 
by a minute. You are welcome if you can to finish up.
    Mr. Tomar. I will save the rest for questions.
    Just concluding that smokeless tobacco causes cancer; that 
its promotion might actually increase cigarette use, and many 
states in the United States have actually been able to reduce 
both smoking and smokeless tobacco use without promoting one 
substitute for the other.
    [The prepared statement of Scott L. Tomar follows:]
Prepared Statement of Scott L. Tomar, Editor, Journal of Public Health 
                               Dentistry
1. Smokeless tobacco causes cancer and is addictive. To promote it as a 
        ``safer'' alternative to smoking while safe sources of nicotine 
        (patch and gum) are available is a mistake.
    Oral snuff is a finely cut, processed tobacco that the user 
typically places between the lip and gum. Nicotine is released from the 
tobacco and absorbed by the membranes of the mouth. In 1986, the US 
Surgeon General concluded that use of this product causes oral cancer, 
gum disease, and nicotine addiction. More recent research suggests that 
snuff use increased the risk of cardiovascular disease, including heart 
attack. Swedish research shows that male snuff users have twice the 
rate of cardiovascular death as non-users. Smokers should be encouraged 
to use proven, safe sources of nicotine to quit smoking not be 
encouraged to use snuff. There is no evidence that smokers who switch 
to oral snuff use have a lower risk of disease or death; they are still 
exposed to high levels of carcinogens.
2. USSTC has a long history of marketing oral snuff to young males with 
        no history of tobacco use including promotion of low nicotine 
        ``starter'' products. Allowing them to make ``safety'' claims 
        may increase nicotine addiction among youth.
    Use of oral snuff has risen dramatically among young men. From 1970 
to 1991, the prevalence of snuff use among men aged 18 and older rose 
from 1.5% to 3.3%; among men 18-24 years old, it increased more than 
eightfold from 0.7% to 6.2%, making this age group the heaviest users 
of the product among those surveyed.
    In the 1980s, USSTC operated a college marketing program on over 
200 campuses. The company continues to routinely sponsor fraternity and 
college events today. In 1998, U.S. Smokeless Tobacco Company (USSTC) 
signed the Smokeless Tobacco Master Settlement Agreement (STMSA) 
settling lawsuits against USSTC and agreed not to directly or 
indirectly target youth in their advertising and promotion. USSTC 
continued to heavily advertise in youth magazines after signing the 
STMSA and USSTC annual advertising expenditure rose from $5.4 million 
pre-STMSA to $6.1 post. It was only after the Attorney General 
threatened legal action did the company drop ads in youth magazines. 
When Massachusetts banned smokeless tobacco advertising in 1999 near 
schools and playgrounds, USSTC and other tobacco companies successfully 
sued the state.
    A 1989 National Collegiate Athletic Association (NCAA) survey of 
college athletes found a 40% increase (from 20% to 28%) in smokeless 
tobacco use from 1985 to 1989. Among NCAA baseball players, an alarming 
57% were users. There is new evidence that suggests that these 
increases are no accident, but the result of a sophisticated marketing 
campaign that developed, advertised, and promoted use of oral snuff 
starter products with lower levels of free (un-ionized) nicotine as 
part of a graduation strategy that intended new users to move up to 
brands higher in nicotine as tolerance developed. The high nicotine 
brands are highly addictive and high in cancer-causing nitrosamines.
    Public health groups aggressively worked to educate young people on 
the dangers of oral snuff. In 2001, 14.8% of male high school students 
reported current use of smokeless tobacco, down from 20.4% in 1993. 
According to the University of Michigan, that decline was due to an 
increase in their knowledge about the dangers of smokeless tobacco. 
Allowing USSTC to make claims that these products are ``safer'' than 
cigarettes could reverse this and result in an increase by youth.
3. USSTC has failed to protect consumers by failing to inform by not 
        lowering known cancer-causing agents in its products or 
        informing consumers about their toxic and addictive properties.
    Oral snuff contains dangerously high levels of cancer casing agents 
called tobacco specific nitrosamines (TSNAs). Unlike the major 
cigarette companies, who now admit that their products cause cancer and 
are addictive, USSTC doesn't acknowledge or inform their consumers that 
conventional oral snuff causes cancer or is addictive. In addition, 
USSTC refuses to report product content, nicotine dosing, or the levels 
of TSNAs by brand. In 2000, the Massachusetts Department of Public 
Health contracted with the American Health Foundation to determine how 
new and existing technologies affect the levels of tobacco specific 
nitrosamines in six brands of oral snuff. The Department obtained 
brands of snuff sold in the state as well as one brand, Ettan, sold in 
Sweden. The America Health Foundation research found that the Swedish 
Match brand and its U.S. subsidiary brand had total TSNA levels between 
2.8 ug/g (Ettan) and 7.5 ug/g (TimberWolf). These levels were far lower 
than that found for the standard brands available in the state. UST, 
Swisher and Conwood brands ranged from16.6 ug/g to 127.9 ug/g. The same 
study examined the effect of product aging over two, four and six 
months. Product aging involves placing the tobacco product on a shelf 
at room temperature and retesting the TSNA levels at the specified time 
periods. The study found that certain U.S. brands had large increases 
in TSNA levels. Copenhagen increased 137% over the six-month time 
period and Skoal increased 20%. Silver Creek increased 9% over a four 
month time period. No significant changes were observed in the levels 
of Swedish Match or its subsidiary brands.
    The study shows that the levels in the brands manufactured under 
new technologies were significantly lower than levels of TSNAs in those 
brands that were produced under the standard manufacturing processes. 
Also, brands that employed the new processes show no increase in TSNAs 
when aged. The study demonstrates that it is technologically feasible 
to produce oral snuff products for adults that are significantly lower 
in TSNAs than many of those currently on the market.
    USSTC has the manufacturing technology to reduce the level of 
nitrosamines to the same level as those found in Swedish products in 
all of their brands, yet they have not done so. According to the 2000 
Surgeon General's Report, ``if a new technology exists that can 
significantly reduce levels of known carcinogens in a tobacco product, 
then that technology should be used.'' Before manufacturers make claims 
that oral snuff is a ``safer'' alternative to cigarette smoking, TSNA 
levels should be lowered to the maximum extent possible for all 
products. Biomarkers should also be developed to determine if a 
reduction in TSNAs actually reduces cancer risk and the research and 
any claim of reduced harm approved by an independent health regulatory 
agency.
    USSTC has refused to disclose the levels of TSNAs in their brands, 
warn consumers about possible TSNA formation and aging or voluntarily 
reveal the amount of free nicotine (additive potential) in their 
product to consumers. I met with USSTC attorneys and representatives 
several years ago, when I was an epidemiologist with the Office on 
Smoking and Health, and asked the company to provide to this 
information to the American people; they not only refused to provide 
it, they denied that they are able to manipulate the nicotine dosing 
properties of their snuff products. It has been firmly documented in 
the scientific literature that USSTC can, and does, control the 
nicotine dosing properties of its products, and has used that ability 
to promote addiction among young people. When Massachusetts passed a 
law requiring the disclosure by brand of additives that effect toxicity 
and addiction, USSTC and the other tobacco companies successfully sued 
Massachusetts.
4. Promotion of oral snuff as a ``safer'' alternative to smoking may 
        have unintended public health consequences.
    I recently published two studies on this topic. The first looked at 
a smoking initiation among U.S. males aged 12-17 and found that young 
males who were not smokers at baseline but smokeless tobacco users were 
three times as likely to be smokers four years later (23.9% vs. 7.6%) 
as young males who never used smokeless tobacco. In contrast only a 
2.4% of current smokers and 1.5% of never smokers became smokeless 
tobacco users by follow-up.
    The second study looked at adult male tobacco users and found that 
U.S. men were 2.5 times more likely to be former snuff users who now 
smoked than to be former smokers who currently used snuff. One in five 
males who were daily snuff users also smoked. This combined use of 
tobacco products may undermine the impact that smoke-free policies have 
on quitting smoking. This research suggests that smokeless tobacco may 
be a gateway for adolescent smoking and males in the United States are 
far more likely to switch from snuff to cigarette smoking than vice 
versa.
    In USSTC's current advertising for its low TSNA snuff brand, Revel, 
the brand is marketed as a complement to smoking, not as a complete 
substitute or as a way to quit smoking. There is no information 
included in the ads or packaging on the dangers of smoking including 
lung cancer, no advice on how to quit smoking or information about 
smoking cessation programs. Rather the product is marketed for use in 
settings when smoking is barred and in doing so result in undermining 
the impact of clean indoor air laws on smokers' decision to quit. USSTC 
use similar marketing messages for its SKOAL snuff products. These 
products can actually delay or prevent smoking cessation.
5. There is no evidence that oral snuff use is effective in helping 
        smokers to quit, either in the United States or Sweden.
    Not a single randomized controlled trial has been reported that 
shows that oral snuff is effective in helping smokers to quit. Such 
evidence is required before the manufacturers of any other drug can 
make health claims about their products. In contrast, USSTC has 
presented no credible evidence that their products are effective 
smoking cessation devices, yet their proposed marketing strategy 
clearly implies that smokers can switch to their snuff products. 
USSTC's proposed marketing strategy amounts to a widespread, 
unregulated experiment on human populations. Such an experiment may 
have very serious negative side-effects, including promotion of tobacco 
initiation by young people and reduced rates of smoking cessation among 
adult smokers.
    Even in Sweden, where claims have been made that oral snuff use is 
responsible for its declining smoking rates, there is no evidence that 
snuff played a major role. In fact, careful examination of the data 
from Sweden reveals the following: (1) per capita consumption of 
cigarettes remained constant in Sweden during the 1970s while snuff use 
was rapidly increasing, suggesting that the growth in snuff use was not 
the result of substitution of cigarettes for snuff; (2) nearly all of 
the growth in oral snuff use in Sweden since the 1970s has been among 
males who started using these products when they were 16-24 years old, 
the group that also had the lowest smoking cessation rates in Sweden, 
and not among adult smokers trying to quit; (3) the prevalence of daily 
smoking has been declining among men and women in Sweden since 1980, 
although less than 2% of Swedish women use snuff and the prevalence of 
daily snuff use among men has remained relatively constant; (4) several 
large studies that followed cohorts of Swedish adults over time found 
that smokers who also used snuff were no more likely than smokers who 
did not use snuff to quit smoking; (5) a very small proportion of 
Swedish smokers who quit did so by switching to snuff; and (6) tobacco 
control measures implemented in Sweden, including bans on all tobacco 
advertising in periodicals and electronic media, prohibition of free 
products and industry sampling practices, dissemination of health 
information about smoking, increased taxation on cigarettes, and 
widespread clean indoor air policies are probably responsible for most 
of the decline in smoking in Sweden.
6. Major health bodies have carefully looked at this issue and 
        recommended that smokeless tobacco not be promoted as reduced 
        harm products until more research is done and the research and 
        claims are approved by a health, regulatory agency.
    The Institute of Medicine (IOM) and the World Health Organization 
have both reviewed this issue and have concluded that smokeless tobacco 
should not be promoted as a ``safer'' alternative to smoking. IOM 
concluded that more research is needed and according to IOM, research 
and claims on ``reduced'' harm products, including smokeless tobacco, 
should be reviewed and approved by an independent health regulatory 
agency before they are marketed.
    Sweden has lowered smoking rates but this is due to the Swedish 
comprehensive tobacco control program and not the availability of 
snuff. Massachusetts and California have reduced male smoking far below 
that of Sweden (14% MA, CA daily smoking vs. 18% Sweden). This has been 
done without promoting snuff as a safe substitute to smoking. In fact, 
we have been able to reduce the use of cigarettes and snuff among young 
people and adults in the United States in the past decade. Safe forms 
of nicotine are available including nicotine gum and patches that have 
been approved as effective smoking cessation medications by the Food 
and Drug Administration. These should be promoted as ways to quit 
smoking, not smokeless tobacco.
7. Research on the advertising for other ``reduced risk'' tobacco 
        products shows that advertising may be deceptive and 
        misleading.
    The Massachusetts Tobacco Control Program (MTCP) has conducted two 
studies on advertising claims for other ``safer'' tobacco products. The 
first was R.J.R's Eclipse cigarette, which made a claim that there was 
no cigarette like Eclipse based on a comparison of smoke carcinogens 
between Eclipse and a ``typical'' ultralight cigarette, Merit Ultra 
Light. RJR claimed that the level of carcinogens was 80% lower than 
Merit. MTCP commissioned research comparing Eclipse to two other ultra 
light cigarettes, Now and Carlton, and found that Eclipse actually had 
higher levels of certain carcinogens. Eclipse had 734% more 
acetaldehyde than Now and 475% more acreolein. Also, as RJR redesigned 
this product from its 1988 predecessor, Premier, to present, levels of 
NNK increased by 1200% from 2.4 ng/g to 32 ng/g and NNN increased 160%. 
Based on this research, MTCP has concluded that the claim by RJR that 
``There is No Cigarette Like Eclipse'' is deceptive since MTCP found 
two existing brands, Now and Carlton, that had similar levels of smoke 
carcinogens.
    A second study MTCP commissioned was a Mall Intercept Survey of 600 
smokers who reviewed ads for Omni and ADVANCE cigarette brands compared 
to ads for regular and light cigarettes. The Institute of Medicine has 
called these products PREPS, potential reduced exposure products. Study 
results are based on a convenience sample of 600 smokers 18-65 years 
old. Respondents were asked to examine selected advertisements for 
Regular cigarettes, Light cigarettes, and the new tobacco products 
(ADVANCE, Eclipse, and Omni) and answer questions regarding their 
perceptions of the products advertised and the messages conveyed by the 
specific advertisements.
    In side-by-side comparisons, smokers indicated that they thought 
PREP products posed fewer tobacco-related health risks, lower levels of 
carcinogens, and lower tar levels. Specifically:

 Smokers perceived PREP tobacco products as having lower health 
        risks than Light or Regular cigarettes.
 Smokers perceived PREP tobacco products as having a lower 
        level of things that might cause cancer than Light or Regular 
        cigarettes.
 Smokers perceived PREP tobacco products as having a lower 
        level of tar than Regular cigarettes, and a similar level to 
        Lights.
 Perceptions of PREP tobacco product's health risks relative to 
        Light cigarettes were generally consistent across subgroups of 
        the study population.
 Men, people with lower educational attainment, and white non-
        Hispanic individuals were more likely than others to perceive 
        that PREP tobacco products pose lower health risks than do 
        Regular cigarettes.
    Prior to participating in this study, only a few smokers had seen 
advertisements for or had smoked PREP tobacco products. For the vast 
majority, the primary source of information for assessing PREP tobacco 
products' properties, including their health and safety, were the 
advertisements viewed during the study. Their opinions regarding the 
advertisements included the following:

 Most smokers interpreted the PREP tobacco product 
        advertisements as conveying positive messages about health and 
        safety.
 Many smokers interpreted the PREP advertisements as saying 
        that these products would be helpful in quitting smoking.
 Most smokers believed that claims made in cigarette 
        advertisements must be approved by a government agency.
    In conclusion, smokeless tobacco causes oral cancer, and if 
promoted as a ``safer'' alternative to smoking may actually increase 
cigarette use. Florida, Massachusetts, and California have reduced 
smoking rates without promoting smokeless tobacco and safe forms of 
nicotine such as gum and patch already exist. These should be promoted 
as ways to quit smoking as part of comprehensive tobacco control 
campaigns.

    Mr. Stearns. Okay, and I thank you very much, especially 
coming from the University of Florida, which I represent. So I 
certainly welcome you and appreciate your participating.
    Dr. Rodu.

                     STATEMENT OF BRAD RODU

    Mr. Rodu. Mr. Chairman and members of the committee, I am 
honored to appear here today.
    Despite limited success, the 40 year old American anti-
smoking campaign is an astounding failure in one crucial 
respect. It has helped too few adult smokers to quit.
    National statistics reveal the magnitude of this failure: 
404,000 deaths a year. The campaign fails inveterate smokers in 
two ways. First, they are counseled merely to change their 
behavior. For example, a government smoking cessation manual 
tells doctors to recommend ineffective coping tips, such as 
``keep your hands busy, doodle, knit, type a letter.''
    ``Keep a daydream ready to go.''
    Second, smokers are told that they must achieve nicotine 
abstinence in order to quit. They are advised to use nicotine 
medications temporarily. These medicines are expensive and 
unsatisfying.
    As a result, they rarely work. A recent review reported a 7 
percent success rate for over-the-counter nicotine medications. 
The authors called this result ``modest'' and even 
``efficacious.''
    We call programs with 7 percent success rates abject 
failures.
    Over the past decade we have developed an alternative quit 
smoking strategy for inveterate smokers based on permanent 
nicotine maintenance. Nicotine is addictive, but can be 
consumed as safely as caffeine. It is tobacco smoke that kills. 
Eliminate the smoke, and you eliminate virtually all the risk.
    We recommend that smokers permanently switch to other 
products containing nicotine, including smokeless tobacco. Ours 
is a harm reduction strategy because we are focused on reducing 
disease and deaths instead of tobacco and nicotine abstinence.
    We recommend smokeless tobacco because it has three 
attributes for long-term maintenance. First, smokeless delivers 
nicotine nearly as rapidly and as efficiently as smoking. Yes, 
it is just as addictive as smoking, which is why it is an 
effective substitute.
    Second, smokeless is 98 percent safer than smoking. Our 
research documents that the average smoker loses 8 years of 
life. The average smokeless user loses only 15 days. The only 
consequential risk from long-term smokeless tobacco use is 
mouth cancer. Even this risk is very low, proven by more than 
20 epidemiologic studies over the past 50 years. In fact, the 
risk of death from long-term smokeless use is about the same as 
that from automobile use.
    Third, smokeless actually works for smokers. In 1998, we 
published the first clinical trial testing smokeless as a 
cigarette substitute. Most of our subjects had failed 
repeatedly to quit using gum and patches. Twenty-five percent 
of them quit with smokeless.
    We have 7 years of follow-up now, and the substitution is 
sustainable.
    Population studies from Sweden prove that smokeless is an 
effective substitute. For 50 years Swedish men have had the 
lowest smoking rate and the highest smokeless usage rates in 
Europe. The result, rates of lung cancer, the sentinel disease 
of smoking, among Swedish men are the lowest of 20 European 
countries.
    Not so for Swedish women whose lung cancer rate ranks fifth 
highest in Europe. I understand tobacco use patterns in Sweden. 
I lived there for 6 months last year, conducting research on 
this subject. I published two studies with Swedish colleagues 
that clearly demonstrate that smokeless was primarily 
responsible for a decline in smoking among men from 19 percent 
in 1986 to 11 percent in 1999.
    Throughout this entire period, men smoked less frequently 
than women, a pattern different from that of every other 
society in the world where men invariably have higher smoking 
rates.
    Our strategy has evoked criticisms that are inaccurate, 
irrelevant, or both. The usual complaints involve protecting 
children. We emphasize that our strategy is tailored to adult 
smokers. This is not a children's issue. Eliminating children's 
access to tobacco is important, but the 10 million Americans 
who will die from smoking over the next two decades are now 
adults. Withholding life saving information from these adults 
in the name of protecting children is shortsighted, even 
immoral.
    For 10 years we have been portrayed as lone advocates of 
our harm reduction strategy, but now good company has joined 
us. Last year Britain's Royal College of Physicians reported 
that products like smokeless are safer than cigarettes. Their 
report stated, ``As a way of using nicotine, the consumption of 
noncombustible tobacco is on the order of 10 to 1,000 times 
less hazardous than smoking, depending on the product.'' The 
report suggested that some smokeless manufacturers may want to 
market their products ``as a harm reduction options for 
nicotine users, and they may find support for that in the 
public health community.''
    A growing number of public health experts now agree with 
our harm reduction strategy because the antiquated quit or die 
approach is increasingly recognized as insufficient. For 48 
million American adults cigarette smoke is the problem. To 
answer the question posed by this hearing, smokeless tobacco 
can be part of the solution.
    [The prepared statement of Brad Rodu follows:]
 Prepared Statement of Brad Rodu, Professor, Department of Pathology, 
  School of Medicine, University of Alabama at Birmingham and Philip 
Cole, Professor Emeritus, Department of Epidemiology, School of Public 
              Health, University of Alabama at Birmingham
    The Centers for Disease Control and Prevention report that 440,000 
Americans die from smoking-related illnesses every year. However, even 
this enormous number does not adequately describe the extraordinary 
burden that cigarette smoking imposes on American society. Our research 
provides additional perspective: If smoking-related lung cancer did not 
occur, cancer mortality rates in the United States would have declined 
continuously since 1950 (Figure 1).\1\ Thus, for the past 50 years the 
American cancer ``epidemic'' has primarily consisted of one disease, 
cancer of the lung, and has been due to one dominant lifestyle factor, 
cigarette smoking. It is compelling evidence that the anti-smoking 
campaign in the United States, now nearly 40 years old and of ever-
increasing intensity, has failed to help adult smokers to quit.
    Conventional approaches to cessation have failed because they offer 
smokers only behavioral therapy. An excellent example is a 1993 NCI 
smoking cessation manual, How to Help Your Patients Stop Smoking, which 
advises physicians to recommend coping tips such as ``Keep your hands 
busy--doodle, knit, type a letter;'' ``Cut a drinking straw into 
cigarette-sized pieces and inhale air;'' ``Keep a daydream ready to 
go.'' \2\ Such advice has little effect on adult smokers because they 
need nicotine. Conventional programs also fail because they offer adult 
smokers only temporary nicotine replacement. But these products are 
expensive and provide low doses of nicotine at doses too low to prevent 
craving and withdrawal. A recent review of over-the-counter nicotine 
medications revealed that their success rate is 7%.\3\ The authors 
characterized this result as ``efficacious'' and ``modest.'' We 
characterize programs with 7% ``success'' rates as abject failures.
    All these programs are failures because they require smokers to 
quit nicotine completely. This is incorrect, as well as ineffective. 
Over the past decade we published epidemiologic and clinical studies 
that provide the scientific foundation for a new smoking cessation 
strategy. It involves permanent nicotine maintenance using products 
other than 
cigarettes.\4\,\5\,\6\,\7\,\
8\) Our strategy is based on the fact that nicotine, while addictive, 
is about as safe as caffeine, another widely consumed addictive drug. 
It is tobacco smoke, with its thousands of toxic agents, that leads to 
cancer, heart disease and emphysema. Eliminate the smoke, and you 
eliminate virtually all of the risk.
    We recommend many types of nicotine delivery systems, including 
smokeless tobacco (SLT) products. These products are well suited to 
replace cigarettes because they have four key characteristics: 1) They 
provide nicotine levels similar to those from smoking; 2) They are 
vastly safer than smoking; 3) They are socially acceptable and are 
cost-comparable to cigarettes; and 4) there is evidence that they help 
smokers quit. No other products have this combination of features to 
help smokers quit now.
    Nicotine Delivery: SLT rapidly delivers a dose of nicotine 
comparable to that from smoking (Figure 2). Thus, smokeless tobacco 
satisfies smokers, a necessary criterium for any agent intended as a 
permanent substitute. In comparison, nicotine medications provide only 
about one-third to one-half the peak nicotine levels of tobacco 
products, which is unsatisfying for many smokers.
    Safety: SLT use has been the subject of intensive research for over 
50 years. The only consequential adverse health effect from long-term 
SLT use is oral cancer. However, more than twenty epidemiologic studies 
over the past 50 years have established that this risk is very low.\9\ 
Our research documents that SLT use imposes only about 2% of the 
mortality risk of smoking.\4\,\7\ We found that the average 
reduction in life expectancy from SLT use is only 15 days.\5\ In 
contrast, the average smoker loses almost 8 years. For further context, 
the risk of death from long-term use of smokeless tobacco (12 deaths in 
every 100,000 users per year) is about the same as that from automobile 
use (15 deaths in every 100,000 users per year).\10\
    Social Acceptability: Opponents of our strategy often argue that 
smokers will never use disgusting ``spit'' tobacco. That term is 
insensitive and inappropriate when used by health professionals. First, 
it is demeaning and degrading both to current SLT users and to smokers 
who may wish to try this strategy. Second, and more importantly, the 
term is incorrect, because new SLT products can be used invisibly and 
are more discreet than chewing gum.
    Evidence that SLT products work: In 1998 we published the first 
trial assessing SLT substitution as a quit-smoking method.\11\ After 
one year 25% of inveterate smokers, most of whom had failed repeatedly 
to quit even with prescription nicotine gum or patches, had 
successfully substituted SLT for cigarettes. We have followed this 
group for seven years, and our results suggest that SLT substitution is 
sustainable (manuscript submitted).
    Data from Sweden support the role of SLT in harm reduction at the 
population level. For 50 years men in Sweden consistently have had the 
lowest smoking rate and the highest SLT usage rate in Europe. The 
result: Rates of lung cancer--the sentinel disease of smoking--among 
Swedish men have been the lowest in Europe for 50 years. World Health 
organization statistics reveal that Swedish men have the lowest rates 
of lung cancer among 20 European countries (Figure 3). Not so for 
Swedish women, whose lung cancer rate ranks fifth highest in Europe 
(Figure 4). One of us (BR) is very familiar with tobacco use patterns 
in Sweden. He lived there for six months last year conducting research 
on this subject, resulting in two published studies with Swedish 
colleagues that demonstrate that SLT was primarily responsible for a 
decline in smoking among men from 19% in 1986 to 11% in 1999 
\12\,\13\ (Figure 5). This figure reveals the lower rate of 
smoking among men than among women for the entire period of study. We 
emphasize that this is the reverse of the pattern seen in virtually 
every other society in the world, where men invariably have higher 
smoking rates than those of women.
    Our strategy has evoked criticisms that are inaccurate, irrelevant 
or both. The usual complaint is that providing risk information about 
SLT to adults will prompt children to use these products. We 
painstakingly point out that our strategy is tailored to adult smokers. 
This is not a children's issue. Eliminating children's access to 
tobacco is important, but the 10 million Americans who will die from 
smoking over the next two decades are now adults. Withholding life-
saving information from these adults, in the name of children, is 
shortsighted, even immoral.
    An extension of the children's theme is that SLT could serve as a 
gateway to smoking. This notion never had a sound basis, and current 
research shows it to be wrong. Furthermore, and most unfortunately, for 
twenty years the dominant public health message has been that SLT use 
and smoking are equally risky. In fact, this erroneous message is 
reinforced by the mandated warning on packages of SLT (``This product 
is not a safe alternative to cigarettes''). Regrettably, surveys show 
that 80% of smokers believe that smokeless tobacco is as dangerous as 
smoking, and continue to smoke. This message may also cause some SLT 
users to switch to cigarettes, an unfortunate and lethal behavior.
    Finally, for ten years we have been portrayed as lone advocates of 
a flawed public health strategy. But now good company has joined us. 
Last year Britain's Royal College of Physicians, one of the world's 
most prestigious medical societies, issued a report on tobacco 
regulation in the United Kingdom called ``Protecting Smokers, Saving 
Lives''.\14\ This report marked the first time a major health 
organization acknowledged that products like smokeless tobacco are 
safer than cigarettes. The report stated ``As a way of using nicotine, 
the consumption of non-combustible [smokeless] tobacco is on the order 
of 10-1,000 times less hazardous than smoking, depending on the 
product.'' The report continued with an even bolder statement, 
acknowledging that some smokeless tobacco manufacturers may want to 
market their products ``as a `harm reduction' option for nicotine 
users, and they may find support for that in the public health 
community.''
    A growing number of public health experts now agree with our harm 
reduction strategy, because the antiquated quit-or-die strategy is 
increasingly recognized as a failure. Cigarette smoke is the problem 
for 48 million adult smokers. To answer the question posed by this 
hearing, smokeless tobacco can be part of the solution.

                               References

    \1\ Rodu B, Cole P. The fifty-year decline of cancer in America. 
Journal of Clinical Oncology, Volume 19: pp 239-241, 2001. UAB-TRF
    \2\ Glynn TJ, Manley MW. How to help your patients stop smoking: a 
National Cancer Institute manual for physicians. NIH Publication No. 
93-3064. Bethesda, MD; 1993.
    \3\ Hughes JR, Shiffman S, Callas P, Zhang J. A meta-analysis of 
the efficacy of over-the-counter nicotine replacement. Tobacco Control, 
Volume 12, pp 21-27, 2003.
    \4\ Rodu B. An alternative approach to smoking control. The 
American Journal of the Medical Sciences, Volume 308, pp 32-34, 1994.
    \5\ Rodu B, Cole P. Tobacco-related mortality. Nature, Volume 370, 
p 184, 1994.
    \6\ Rodu B, Cole P. The rewards of smoking cessation. Epidemiology, 
Volume 7, pp 111-112, 1996.
    \7\ Rodu B, Cole P. Nicotine maintenance for inveterate smokers. 
Technology, Volume 6, pp 17-21, 1999.
    \8\ Rodu B. For Smokers Only: How Smokeless Tobacco Can Save Your 
Life. Sumner Books, Los Angeles, ISBN 0-9666239-0-8.
    \9\ Rodu B, Cole P. Smokeless tobacco use and cancer of the upper 
respiratory tract. Oral Surgery, Volume 93, pp 511-515, 2002. UAB-TRF.
    \10\ National Highway Traffic Safety Administration. Traffic Safety 
Facts 2001. Available at: http://www-nrd.nhtsa.dot.gov/pdf/nrd-30/NCSA/
TSFAnn/TSF2001.pdf
    \11\ Tilashalski K, Rodu B, Cole P. A pilot study of smokeless 
tobacco in smoking cessation. The American Journal of Medicine, Volume 
104, pp 456-458, 1998.
    \12\ Rodu B, Stegmayr B, Nasic S, Asplund K. Impact of smokeless 
tobacco use on smoking in northern Sweden. Journal of Internal 
Medicine, Volume 252, pp 398-404, 2002. UAB-TRF
    \13\ Rodu B, Stegmayr B, Nasic S, Cole P, Asplund K. Evolving 
patterns of tobacco use in northern Sweden. Journal of Internal 
Medicine, Volume 253, pp 660-665, 2003. UAB-TRF
    \14\ Royal College of Physicians. Protecting Smokers, Saving Lives. 
Available at: http://www.rcplondon.ac.uk/pubs/books/protsmokers/
index.asp
    \15\ Sullum J. For Your Own Good: The Anti-Smoking Crusade and the 
Tyranny of Public Health, pp 67-70, The Free Press, New York, 1998.
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    Mr. Stearns. Thank you Dr. Rodu.
    At this time, Mr. Burton, would you give your statement, 
please?

                  STATEMENT OF STEVEN L. BURTON

    Mr. Burton. Thank you, Mr. Chairman.
    My name is Steve Burton, and I am responsible for the over-
the-counter stop smoking aids that are marketed by Glaxo 
SmithKline Consumer Health Care. I have been involved in this 
field since 1996, and currently our products include the 
Niccoderm nicotine patch, Nicorette gum, and more recently the 
Commit lozenge.
    GSK's chief concern is that unproven health claims for 
tobacco products threaten efforts to help smokers quit. The 
distinction between so-called reduced risk products and FDA 
approved medicines could not be clearer to us.
    The reduced risk products are designed to perpetuate 
tobacco use and our products are designed to end tobacco use, 
and the emergency of novel tobacco products must not obscure 
the fact that there is only one proven way today to reduce the 
harm of tobacco use, and that is to quit completely.
    I have heard the term today about the committed smoker, and 
I have to tell you that in my experience with consumers and the 
research that we have done, we do not have very many committed 
smokers. Over 70 percent of smokers want to quit at any one 
point in time, and nearly all smokers have tried to quit. And 
over the past decade we have made substantial progress in 
reducing the prevalence of smoking.
    Prevention efforts have stopped millions of our young 
people from starting to use tobacco, and courageous and 
motivated smokers who make multiple quit attempts on their way 
to becoming tobacco free are also heros in the fight against 
tobacco use.
    Our plea today is to reject the policy that would 
discourage smokers from quitting. We do not accept the 
proposition that smokers do not want to quit and that more 
cannot be done to increase the acceptance and effectiveness of 
the quitting options.
    As we have already heard today, and I am not going to 
repeat comments from other members of the panel, there has been 
no reduction in the death and disease burden from tobacco from 
the use of light cigarettes, and the same may be true of the 
so-called reduced risk products that are before this panel 
today.
    As we learned with lights, the way in which consumers 
actually use a tobacco product in the real world largely 
determines its risk, as much or more than the product's 
inherent toxicity.
    For example, it is very plausible that smokeless products 
would be used in addition to existing cigarette consumption 
rates that would delay quitting, leading not to a decline, but 
an increase in risk.
    In fact, dual use of cigarettes of cigarettes and smokeless 
tobacco products has apparently been one of the marketing 
objectives of the smokeless tobacco industry.
    Our own market research of Eclipse, one of the so-called 
reduced risk products, brings this point home. In a consumer 
survey, GSK found that most a quarter, 24 percent of smokers 
considered Eclipse to be completely safe, with 3/4 expecting 
that Eclipse would reduce health risks by at least 50 percent.
    After hearing about Eclipse, there was a net decrease of 19 
percent in smokers who were contemplating quitting within 6 
months and 15 percent of young adults who had recently quit 
smoking were interested in buying Eclipse.
    Thus, with the emergence of so-called reduced risk tobacco 
products ex-smokers may start smoking again, and likewise those 
who never smoked, particularly adolescents, may take up smoking 
for the first time. And millions of smokes who otherwise might 
have quit completely could delay or miss opportunities to 
become tobacco free.
    In light of these threats we need a regulatory body that 
evaluates the public health impact of so-called reduced risk 
products before they enter the market. That agency must have 
the in-house scientific expertise to determine the appropriate 
design and evaluation of the studies to be done before 
approval. That regulatory body is the Food and Drug 
Administration.
    It should decide whether there is an adequate scientific 
basis to support the so-called reduced risk claims that tobacco 
manufacturers seek sot make.
    As to the treatment of tobacco dependence, we have 
certainly not exhausted our opportunities collectively to 
innovate in this area. Addiction experts agree that the appeal 
and effectiveness of currently marketed treatments could be 
enhanced dramatically. FDA should encourage sponsors to develop 
new indications and uses for current products and work flexibly 
with sponsors to accelerate development of new and innovative 
treatments.
    Promising drugs should, for example, be fast tracked under 
FDA's existing authority, and there are new treatments on the 
way.
    On the tobacco side, GSK welcomes tobacco based products 
proven to meaningfully reduce the risks of smoking. Of course, 
health claims, either express or implied, must be approved by 
FDA before being exposed to the most vulnerable within our 
society: those who have recently quit, or are highly motivated 
to quit or are tempted to begin smoking.
    At GSK we stand ready to assist the subcommittee today in 
any way that we can. We thank you for the opportunity to appear 
before you today, and I would certainly be happy to answer any 
questions that you may have for me later.
    Thank you.
    [The prepared statement of Steven L. Burton follows:]
    Prepared Statement of Steven L. Burton, Vice President, Smoking 
  Control, Strategic Development and Switch, GlaxoSmithKline Consumer 
                               Healthcare
                              introduction
    Thank you, Chairman Stearns. My name is Steve Burton and I am the 
Vice President of Smoking Control, Strategic Development and Switch for 
GlaxoSmithKline Consumer Healthcare (GSK). I have had responsibility 
for marketing over-the-counter nicotine replacement therapy products 
(Nicorette gum, NicoDerm CQ patch, and most recently the Commit 
lozenge) since they were switched from prescription status in 1996. On 
behalf of GSK, let me thank you and members of the Subcommittee for the 
opportunity to participate in this important hearing and to share GSK's 
views on the matter before Congress and the public health community at 
large. GSK applauds the subcommittee for holding this hearing titled 
``Can Tobacco Cure Smoking--A Review of Tobacco Harm Reduction.'' My 
testimony will concentrate on what can be done to help smokers who are 
concerned about their health and interested in reducing the risk of 
smoking. In particular, I want to offer what we have learned through 
our research with consumers to help illustrate what they expect novel 
tobacco products to provide and how they might be used in a real world 
setting. I will also comment on the adverse public health consequences 
that could arise when smokers have the new choice to use novel tobacco 
products instead of FDA approved medicines and other scientifically 
proven methods of quitting. We believe that an understanding of 
consumer beliefs and behavior can play a critical role in the design 
and effective implementation of public health programs and that will be 
our principal contribution today.
 smoking as the leading cause of preventable death and tobacco control 
                        policy progress to date
    You are familiar with the staggering statistics associated with the 
use of tobacco. 440,000 Americans die prematurely each year because of 
tobacco use (CDC 2002a). More than 6 million of our children alive 
today will die prematurely later in life because of their use of 
tobacco (CDC 2002b). The use of this deadly and addictive product 
constitutes the leading preventable cause of death and disease in the 
United States each year. While we need to accelerate our progress in 
reducing the harm of smoking, we should be proud of the fact that 
millions of smokers have been able to quit completely, youth initiation 
has been on the decline, and overall prevalence of smoking is slowly 
trending downward. These significant public health gains are the result 
of a combination of environmental factors and changes in public health 
policy led by our elected officials, our regulatory community and the 
public health field. Examples of these efforts include higher tobacco 
taxes, restrictions on smoking in the workplace and public places, 
greater availability of proven treatments, and successful state-based 
and national youth prevention programs. These and other factors have 
encouraged more smokers to make serious quit attempts and to be more 
successful in achieving a smoke free status. GSK has played a small but 
important part in the overall effort to help adult smokers become 
tobacco free, and our primary mission remains to reduce the mortality 
and morbidity associated with smoking by offering smokers proven 
methods of quitting completely--the ultimate way to reduce risk.
       new challenges to recent progress in helping smokers quit
    It is well established that overcoming an addiction to tobacco is 
one of the most daunting and enduring medical challenges an individual 
can face. In fact, it usually takes multiple attempts for most smokers 
to become abstinent, and each effort takes a high degree of motivation 
and personal courage to overcome the psychological and physiological 
effects of withdrawal from the highly addictive and often socially 
rewarding use of a cigarette.
    To overcome this powerful addiction, smokers need encouragement and 
support to promote quit attempts and to convert these attempts into 
positive health outcomes. This includes making effective use of 
available treatments. Smokers receive this encouragement in a number of 
ways--from their friends, their health care professional, and also from 
their government and other public institutions. The decision to quit is 
easily influenced by smokers' beliefs in their own ability to quit and 
by their understanding of the alternatives they have to mitigate the 
risks of smoking. Our research with smokers suggests that the 
unregulated availability of so-called reduced risk products could lead 
millions of smokers to delay or reconsider quitting. A perception that 
novel tobacco products have the endorsement of our public institutions 
would discourage smokers' commitment to quitting and introduce the 
confounding and potentially very deceptive notion that smokers can now 
reduce their risk or even ``quit'' by continuing to smoke with these 
novel tobacco products, a so-called ``harm reduction'' approach. While 
the health benefits of a harm reduction approach have yet to be proven 
and remain largely theoretical, the risks of unregulated access to 
novel tobacco products are clear and present dangers that could undo 
years of progress by Congress, the FDA and the public health community 
of which we are a part.
    As you no doubt have heard, the great fear held by many public 
health experts is that these new tobacco products may be nothing more 
than a scientifically sophisticated version of the ``light'' cigarette. 
The introduction of ``light'' and ``ultra light'' cigarettes is an 
object lesson in how policy decisions can unwittingly mislead the 
public and undermine cessation. Public health officials now believe, 
many decades too late to be of any help to the health-concerned smoker 
who switched to lights over the last thirty years, that lights appear 
to have been deliberately designed so as not to reduce tar and nicotine 
deliveries when smoked by human beings.
    As the National Cancer Institute recently stated, in the definitive 
study from the federal government on the deception linked with 
``lights,'' ``Marketing this illusion of risk reduction would have been 
of concern even if the target for these brands had been confined to 
continuing smokers. Instead, these brands were targeted at those 
smokers who were thinking of quitting in an effort to intercept the 
smokers and keep them smoking cigarettes.'' (USDHHS, 2001, page 5)
    Due in large part to the deliberate design of ``lights,'' there was 
no reduction in the death and disease burden from tobacco as a result 
of the marketing of ``light'' cigarettes. NCI concluded that ``The 
absence of meaningful differences in smoke exposure when different 
brands of cigarettes are smoked and the resultant absence of meaningful 
differences in risk make the marketing of these cigarettes as lower-
delivery and lower-risk products deceptive for the smoker. The reality 
that many smokers chose these products as an alternative to cessation--
a change that would produce real reductions in disease risks--makes 
this deception an urgent public health issue.'' (USDHHS, 2001, page 1)
    Thirty years ago, well-intentioned public health officials 
encouraged health-concerned smokers who could not quit smoking to 
switch to ``lights.'' At all costs, we must avoid repeating the 
mistakes with today's products that were made thirty years ago with 
``lights.''
    consumer understanding of risk of and interest in novel tobacco 
                                products
    At the outset, one critical fact must be recognized. Complete 
abstinence is the only method that reduces the future health risk of 
smoking to almost zero, and allows for an ex-smoker to achieve a long-
term prognosis essentially equivalent to a never smoker after 10-15 
years of abstinence (USDHHS, 1990). The emergence of novel tobacco 
products does not change this fact. Novel tobacco products have not 
been studied with the same rigor of smoking cessation medicines and 
methods. Nor have the studies that have been conducted on these 
products been submitted to FDA for evaluation. There is only one proven 
way to reduce the harm from tobacco, and that is to quit.
    On the other hand, consumers are all too willing to grasp at the 
belief that novel tobacco products are indeed safe and effective 
alternatives to smoking their current cigarettes. As an example, we 
fielded a large consumer survey that exposed the Eclipse concept (a 
novel cigarette design that is claimed to primarily heat rather than 
burn tobacco) to 1000 smokers and 499 ex-smokers. In the survey, after 
hearing a brief account of claims for Eclipse, almost all current 
smokers (91.4%) thought Eclipse was safer than Regular cigarettes. 
Moreover, almost a quarter (23.9%) considered Eclipse to be completely 
safe. On average, participants expected that Eclipse would reduce 
smoking risk by 62.1% compared to Regular cigarettes, with three 
quarters (75.9%) expecting that Eclipse would reduce health risks by at 
least 50%. Eclipse was also regarded as significantly safer than 
current Light or Ultra Light cigarettes. Compared to the 23.9% who 
regarded Eclipse as completely safe, only 9.4% and 11.3% regarded 
Lights and Ultra Lights, respectively, as completely safe. The fact 
that consumers perceive novel tobacco products to carry less health 
risk than smoking even light or ultra light cigarettes should be 
troubling to those who are concerned with the death and disease caused 
by tobacco products.
    We know that approximately 70% of smokers are interested in 
quitting (CDC, 2002c). GSK's mission is to reduce death and disease by 
inspiring more smokers to become tobacco, and ultimately, nicotine 
free. The scientific data behind our treatments, such as Nicorette gum, 
NicoDerm CQ patch, the Commit lozenge, and the prescription smoking 
cessation drug Zyban, has been evaluated and approved by the Food and 
Drug Administration. These products have been approved as being both 
safe and effective for use in trying to quit. With the help of our 
products and those of other treatment providers, millions of smokers in 
this country have successfully stopped smoking and eliminated all of 
the risk of continued tobacco use.
unintended consequences of novel tobacco products--consumer perspective
    From a public health perspective, we should be concerned about the 
new crop of tobacco products bearing unproven claims to reduce exposure 
and risk. The greatest danger is that these products may pose a 
significant threat to cessation efforts--regardless of whether a smoker 
would have used one of our products in a quit attempt or chosen another 
quit method. Smokers who see the claims for products like Eclipse may 
now think that a safer cigarette genuinely exists. This may make them 
less interested or inclined to try to quit smoking entirely.
    There is the added concern that ex-smokers may start smoking again, 
thinking that they can now safely consume tobacco products. Likewise, 
those who never smoked, particularly adolescents, may take up smoking 
for the first time, using one of these new products under the 
assumption that a safe cigarette exists.
    The consumer survey data commissioned by GSK on smoker and ex-
smoker attitudes towards Eclipse, one of the new generations of tobacco 
products sold by R. J. Reynolds, confirms these concerns (Shiffman, 
Pillitteri, Burton, et al, unpublished manuscript). Reynolds makes 
explicit health claims about reductions in disease risks for Eclipse, 
including ``less risk of cancer,'' and ``a lower risk of chronic 
bronchitis, possibly even emphysema'' (www.eclipse.rjrt.com, December 
2002).
    The survey found that 57.4% of smokers said they were ``somewhat 
likely'' or ``very likely'' to purchase Eclipse within the next six 
months. Most importantly, after hearing about Eclipse, there was a net 
decrease of 19% in smokers who were contemplating quitting within 6 
months. Furthermore, 15% of the young adults who had recently quit 
smoking were interested in buying Eclipse.
    In a second study focusing on a novel smokeless tobacco product 
among smokers interested in quitting, similarly high levels of purchase 
interest were reported. Around 41% of the sample were very or somewhat 
likely to want to use the novel smokeless product. Purchase intent 
(46%) was higher in consumers with an interest in using nicotine 
replacement therapy to quit, a surrogate for smokers more likely to 
actually commit to a serious quit attempt. When asked how they would 
use these smokeless products, 15% of the sample reported they would use 
the smokeless tobacco product as a substitute for cigarettes at times 
when they could not smoke, 29% as a way to reduce their smoking rate, 
and another 36% as a way to cut back on their smoking in preparation 
for quitting.
    These results suggest that Eclipse, and its new brethren of 
tobacco-based products that have not been proven to reduce the risk of 
smoking in any meaningful way, are a threat to cessation and risk 
converting ex-smokers back to their deadly addiction.
    Do these products genuinely reduce exposure and risk? We do not 
know because exposure and risk are determined by the overall pattern 
and years of use by smokers in real world conditions, not just by 
physical makeup of the product. Nor do we know how these products 
perform in the laboratory. But here are a few observations that should 
be of profound concern to the public health community of which you are 
a part. Eclipse advertising declares that exposure to carbon monoxide 
may be higher than traditional cigarettes. Eclipse has been shown to 
contain filaments of glass particles not found in traditional 
cigarettes that would be inhaled deeply into the lungs (IOM 2001). The 
new Quest cigarette offers a program claiming to reduce levels of 
nicotine consumption while keeping the level of cancer-causing tar 
unchanged--and the tar levels are higher than the majority of low tar 
brands consumed today. Many experts would argue that, as was the case 
with ``light'' cigarettes, smokers of Quest would consume a greater 
number of the reduced nicotine cigarettes in order to avoid withdrawal 
and maintain the reinforcing effects of their nicotine addiction. These 
smokers could end up consuming more tar with the reduced nicotine 
cigarette than their traditional brand of cigarette.
  scientific perspective--the risk/benefit equation for novel tobacco 
                                products
    I expect the scientific community and tobacco control experts to 
provide their view on the potential risks and benefits of expanded use 
of novel tobacco products. They believe the tobacco industry's 
motivation is to perpetuate the use of tobacco-based products by 
introducing a new generation of tobacco products. By offering promises 
of reduced exposure to toxins in tobacco smoke, and even making claims 
to reduce the risk of cancer and other diseases, these products raise 
profound and troubling public health policy questions for our partners 
in the tobacco control community.
    We should consider carefully the recent findings published in the 
American Journal of Epidemiology, that reductions in cigarette use, as 
measured by daily smoking rates, had no impact on health risks from 
smoking among a large population of heavy smokers (Godtfredsen et al, 
2002). Smokers who attempt to reduce the harm of smoking by cutting 
down on the number of cigarettes they smoke compensate in the same way 
that smokers of so-called light cigarettes compensated by smoking each 
cigarette more deeply. Smokers who attempt to reduce their smoking 
rates without the support of pharmacotherapy experienced the same 
degree of harm as smokers who did not reduce their smoking rates.
    The novel tobacco products take various forms. Some burn tobacco or 
employ novel technologies to burn or heat tobacco. Others are tobacco-
based but do not burn. The combusting products include Omni and 
Advance, and promise to reduce or eliminate exposure to a subset of 
toxins in tobacco smoke. The novel products include Eclipse and Accord, 
and claim to reduce toxin levels or secondhand smoke. The non-
combusting (i.e. smokeless) products include Ariva, Revel, and Exalt, 
promise tobacco satisfaction in situations (e.g. at work or on a plane) 
where smoking is not possible or permitted.
    Whether they combust or not, all of these products are aimed 
squarely at the health-concerned smoker. They have entered the 
marketplace in the absence of any independent scientific evaluation of 
their claims, and without any governmental scrutiny of the products or 
their claims.
    Equally troubling are the claims for the smokeless products, like 
the Ariva tobacco lozenge. In isolation, one could argue that a 
tobacco-based product that does not burn tobacco leaf has a lower risk 
profile than one that does. But this could be a short-sighted view to 
take given the historical behavior of the smokeless tobacco industry 
operating outside of a credible regulated environment. Reviews of past 
marketing practices report that this industry deliberately targeted 
young males, particularly athletes, in the 1970s and revived lagging 
sales by promoting use of smokeless among teenage boys who had not 
previously used tobacco. Further, these same reports note that this 
industry specifically designed and promoted products with varying 
levels of nicotine delivery, perceived strength and a range of flavors 
(including ``candy-like'' flavors) so as to facilitate early use by 
adolescents and their progression to more addicting, higher nicotine 
products (FDA Proposed and Final Rule, 1995 and 1996; Bonnie and Lynch, 
1994).
    Furthermore, the health benefits of products like Ariva presumably 
result in part from the assumption that Ariva would be used to 
completely replace all cigarette use and thus overall exposure to 
toxins would decrease. It is equally plausible that smokeless tobacco 
products would be used in addition to a smoker's typical level of 
cigarette consumption, and this is precisely the type of real world 
consumer behavior that must be assessed prior to market entry, not 
years after this unfortunate consequence has been documented 
retrospectively.
    Smokers who might have otherwise been inclined to try to quit, may 
latch on to a smokeless product bearing an ``Anytime. Anywhere.'' or a 
``WHEN YOU CAN'T SMOKE'' claim, and use it to perpetuate their smoking 
through the dual use of combusting and non-combusting tobacco. In fact, 
the United States Smokeless Tobacco Company expressed the view in their 
2000 annual report that the dual use of cigarettes and smokeless 
tobacco ``represents great potential for future expansion of the 
business'' (UST, Inc, Annual Report, 2000, page 9).
    In the absence of public health-based regulation of these products, 
and well controlled studies of actual patterns of consumer use 
completed prior to market entry, we have no way of knowing whether this 
new generation of products will reduce exposure and risk in any 
meaningful way when used by smokers under normal or typical conditions 
of use. Nor do we understand the impact on quitting behavior amongst 
those smokers who otherwise would have achieved complete abstinence 
when they are exposed to the unsubstantiated claims of these novel 
tobacco products. Even more of a concern, we will not know what effect 
this marketing will have on the possibility of young people initiating 
tobacco use. The unfettered access to the marketplace for these 
products has created a massive, uncontrolled clinical trial, with 
commercialization and hefty promotion and advertising preceding a 
scientifically credible demonstration that there is adequate proof to 
support the marketing claims and expected public health outcomes of 
these products.
   regulatory approaches for novel tobacco products: recommendations
    The most appropriate way to assess the potential risks and benefits 
of these products is through a regulatory system that assures the 
public of comprehensive regulation of all tobacco products; a system 
where a public health-based regulatory agency evaluates products and 
claims before they enter the marketplace. As this Subcommittee goes 
forward with its consideration of the role of tobacco-based products in 
a harm reduction framework, we need to ensure that an appropriate 
degree of scientific and regulatory accountability is brought to bear 
on any tobacco products that purport to reduce exposure or risk. One 
way to achieve this accountability is by insisting that no product or 
claim should appear in the marketplace until it has been evaluated by 
an independent, public health-based regulatory authority. Such an 
agency, and we believe it should be FDA, should decide whether there is 
an adequate scientific basis to support whatever claims the 
manufacturer seeks to make.
    Whereas the tobacco-based products are carefully designed to 
perpetuate tobacco use, or at least could have that real world effect, 
in contrast GSK and other providers of treatment interventions offer 
quitting programs rigorously studied and evaluated for their safety and 
efficacy by FDA prior to appearing in the marketplace. We are proud of 
the collaboration we entered into with Congress, the FDA and the public 
health community in the mid-1990s to expand access and utilization of 
nicotine replacement therapies by marketing them as over-the-counter 
medications starting in 1996. , , , . We have been encouraged by the 
evidence that offering treatments directly to consumers can 
significantly increase utilization of these products to support quit 
attempts.
    Yet, we have not exhausted our opportunities to innovate in the 
area of tobacco dependence treatment through the use of pharmaceuticals 
and other public health interventions that expand utilization while 
also improving outcomes, as recent success in the area of quit lines 
have shown. We believe it should be the policy of our government to 
encourage sponsors to develop new indications and uses for current 
products, and to work with sponsors to accelerate development of a 
range of novel treatment products. GSK has a number of new products 
that offer the promise of more consumer acceptable formulations and 
regimens and a range of experimental drugs are in development within 
industry and academia. For instance, over-the-counter nicotine 
replacement therapy products are limited to up to 12 weeks of use as 
compared to six months or more under their former prescription status. 
Addiction experts have argued that the appeal and effectiveness of 
currently marketed treatments could be enhanced dramatically should we 
consider new uses and indications such as combination therapy, use of 
intensive behavioral interventions alongside pharmacotherapy, reduction 
of cigarettes alongside a gradual increase in medicinal nicotine 
administration, and use of NRT for relapse prevention and long term 
maintenance of cessation. Promising drugs and interventions like these 
should be fast tracked when judged by the FDA to qualify for such 
status.
    Finally, GSK welcomes scientifically validated and regulated claims 
for tobacco-based products. It is not our position that novel tobacco 
products cannot be marketed today under existing tobacco regulations or 
that it is unconceivable that such products might make a public health 
contribution. Our position is that any health claim, expressed or 
implied, should be scientifically demonstrated and reviewed by FDA 
before such claims are exposed to the most vulnerable within our 
society--those who have recently quit, are highly motivated to quit, or 
are tempted to begin smoking. For a marketplace flooded with unproven 
and unregulated health claims for novel tobacco products will not only 
undo years of progress in the tobacco control effort but also damage 
our capacity to bring even more effective and consumer accepted 
treatments to the millions of consumers who want and deserve meaningful 
improvements in their health status.
    Today half of ever smokers have become former smokers. Our 
challenge and yours is to ensure that successful quitters are not lured 
back to smoking and the vast majority of smokers who can and will 
eventually quit completely are not discouraged from reducing the harm 
of smoking to zero. As to the remainder of smokers who may not be able 
to quit, and we would argue that we have many opportunities yet before 
us to reduce this number further, we need to find interim and credible 
solutions to reducing harm to their health. The current cadre of novel 
tobacco products, if allowed to remain in the market absent scientific 
evidence of a positive health impact within the population, should 
nonetheless be prohibited from making implied or expressed claims of 
health improvement until such time as adequate proof and public health 
regulatory approval has been obtained.
    At GSK, we stand ready to assist the Subcommittee in any way that 
we can on these critically important and challenging questions of how 
to reduce the extraordinary death and disease toll caused by the use of 
tobacco products.
    Thank you for the opportunity to appear before you today. I would 
be happy to answer any questions that the subcommittee might have.

                               References

    Centers for Disease Control and Prevention. (1997). Impact of 
promotion of the Great American Smokeout and availability of over-the-
counter nicotine medications, 1996. Morbidity and Mortality Weekly 
Report, 46, 868-871.
    Centers of Disease Control and Prevention. (2000). Use of FDA-
approved pharmacologic treatments for tobacco dependence. Morbidity and 
Mortality Weekly Report, 49, 665-668.
    Centers for Disease Control and Prevention. (2002a). Annual 
smoking-attributable mortality, years of potential life lost, and 
economic costs--United States 1995-1999. Morbidity and Mortality Weekly 
Report, 51, 300-3.
    Centers for Disease Control and Prevention. (2002b). Tobacco 
control state highlights 2002: Impact and opportunity. Atlanta, GA: 
Department of Health and Human Services, Centers for Disease Control 
and Prevention, National Center for Chronic Disease Prevention and 
Health Promotion, Office on Smoking and Health.
    Centers for Disease Control and Prevention. (2002c). Cigarette 
smoking among adults--United States, 2000. Morbidity and Mortality 
Weekly Reports, 49, 642-5.
    Food and Drug Administration. (1995). 21 CFR Part 801, et al. 
Regulations restricting the sale and distribution of cigarettes and 
smokeless tobacco products to protect children and adolescents; 
proposed rule analysis regarding FDA's jurisdiction over nicotine-
containing cigarettes and smokeless tobacco products; notice. Federal 
Register, 60 (155), 41314-41792.
    Food and Drug Administration. (1996). 21 CFR Part 801, et al. 
Regulations restricting the sale and distribution of cigarettes and 
smokeless tobacco to protect children and adolescents; final rule. 
Federal Register, 61 (168), 44396-45318.
    Godtfredsen NS, Holst C, Prescott E, Vestbo J, Osler M. (2002). 
Smoking reduction, smoking cessation, and mortality: a 16-year follow-
up of 19,732 men and women from The Copenhagen Centre for Prospective 
Population Studies. American Journal of Epidemiology, 156 (11), 994-
1001.
    Institute of Medicine. (2001). Clearing the smoke: Assessing the 
science base for tobacco harm reduction. Stratton K, Shetty P, Wallace 
R, Bondurant S (eds). Institute of Medicine.
    Keeler TE, Hu TW, Keith A, Manning R, Marciniak MD, Ong M, & Sung 
HY. (2002). The benefits of switching smoking cessation drugs to over-
the-counter status. Health Economics, 11, 389-402.
    Lynch BS, & Bonnie RJ. (Eds.). (1994). Growing up tobacco free: 
preventing nicotine addiction in children and youths. Washington, DC: 
National Academy Press.
    Shiffman S, Gitchell J, Pinney J M, Burton SL, Kemper KE, & Lara 
EA. (1997). Public health benefit of over-the-counter nicotine 
medications. Tobacco Control, 6, 306-310.
    U.S. Department of Health and Human Services. (2001). Risks 
associated with smoking cigarettes with low machine-measured yields of 
tar and nicotine. Monograph Number 13. U.S. Department of Health and 
Human Services. Public Health Service. National Institutes of Health. 
National Cancer Institute.
    UST Annual Report, 2000.
    U.S. Department of Health and Human Services. (1990) The health 
benefits of smoking cessation: A report of the Surgeon General. U.S. 
Department of Health and Human Services. Public Health Service. Centers 
for Disease Control. Center for Chronic Disease Prevention and Health 
Promotion. Office on Smoking and Health. DHHS Publication No. CDC) 90-
8416.

    Mr. Stearns. Thank you, Mr. Burton.
    And at this time, Mr. Verheij, if you would give your 
opening statement.

                  STATEMENT OF RICHARD VERHEIJ

    Mr. Verheij. Good afternoon, Mr. Chairman and members of 
the committee. I am Richard Verheij, Executive Vice President, 
External Affairs, for U.S. Smokeless Tobacco Company.
    I would like to thank this committee for convening this 
hearing to examine the issue of tobacco harm reduction. 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 is helpful to keep a couple of 
things in mind. First, this debate is not about whether 
smokeless tobacco is considered to be safe. Rather, it is about 
the increasing consensus in the public health community that 
smokeless tobacco is significantly less harmful.
    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 are 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 
increase in 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 choices.
    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 relevant parties to 
express their viewpoints and concerns.
    That is why we urge the Federal Trade Commission to 
initiate a forum that would bring together all of these parties 
to examine the most appropriate means for communicating this 
important information to adult smokers.
    Let me state clearly for the record that U.S. Smokeless 
Tobacco Company 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 and 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 activists, 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 that process Thank you for holding this 
very timely hearing. May I ask that U.S. Smokeless Tobacco 
Company's written statement, which was submitted to the 
committee on May 30th, be incorporated in its entirety into the 
hearing record after my statement today?
    Mr. Stearns. By unanimous consent, so ordered.
    [The prepared statement of Richard Verheij follows:]
  Prepared Statement of Richard H. Verheij, Executive Vice-President, 
                     U.S. Smokeless Tobacco Company
    U.S. Smokeless Tobacco Company (``USSTC'') welcomes the opportunity 
to participate in this hearing regarding tobacco harm reduction. This 
issue is of immense importance to the 50 million adult tobacco 
consumers in the United States, to the public health community, to 
medical practitioners and to tobacco manufacturers.
    For decades, the public health community in the United States has 
asserted that cigarette smoking is the most deadly epidemic of modern 
times. For almost as long, the message of the public health community 
to cigarette smokers has been monolithic: stop all use of tobacco. Over 
the past several years, however, an increasing number of public health 
advocates have voiced doubts about what some have called the ``quit or 
die'' approach to smoking cessation.
    Rather than rely entirely on programs intended to achieve total 
cessation of tobacco use, this segment of the public health community 
is urging that a more pragmatic goal be adopted--that of tobacco ``harm 
reduction.'' One method of achieving tobacco harm reduction, according 
to a growing number of researchers, is to encourage those cigarette 
smokers who do not quit and do not use medicinal nicotine products to 
switch completely to smokeless tobacco products. This strategy, 
however, is complicated by the fact that the vast majority of adult 
cigarette smokers in the United States--despite the generally accepted 
scientific view to the contrary--believe that cigarette smoking and 
smokeless tobacco use involve the same risk of adverse health effects.
    The issue of tobacco harm reduction and the potential role of 
smokeless tobacco products in that effort is at a crossroads. The 
debate is no longer about whether smokeless tobacco is considered by 
the scientific community to be a significantly reduced risk alternative 
compared to cigarette smoking. The question now is whether that 
information should be communicated to adult cigarette smokers or 
whether it should be suppressed.
    Set forth below is a brief description of USSTC and its smokeless 
tobacco products, followed by a review of some of the more significant 
issues relating to smokeless tobacco in the context of tobacco harm 
reduction.
                                i. usstc
    USSTC is the leading U.S. producer and marketer of moist smokeless 
tobacco or moist snuff. Copenhagen and Skoal--two of USSTC's brands--
are America's best-selling moist snuff products. Two other brands--
Rooster and Red Seal--were introduced within the last five years, and 
hold established positions in the marketplace. A new pouch product--
Revel--has been test marketed. USSTC maintains manufacturing and 
processing facilities in Franklin Park, Illinois; Hopkinsville, 
Kentucky; and Nashville, Tennessee.
    In 1997, USSTC was the only smokeless tobacco company to support 
the proposed tobacco resolution. When the proposal failed to pass the 
Congress, USSTC became the only smokeless tobacco company to enter into 
the Smokeless Tobacco Master Settlement Agreement (``STMSA'') with 
Attorneys General of various states and U.S. territories. Pursuant to 
the STMSA, USSTC is providing up to $100 million (plus an inflation 
adjustment), over a 10-year period, to the American Legacy Foundation 
for programs to reduce youth usage of tobacco and combat youth 
substance abuse, and for enforcement purposes.1 Moreover, 
USSTC agreed to limitations on its advertising and marketing efforts, 
even though this put USSTC at a competitive disadvantage with other 
smokeless tobacco manufacturers.2
---------------------------------------------------------------------------
    \1\ Youth usage of smokeless tobacco, as reported in surveys 
conducted by various federal government agencies and by the University 
of Michigan, has declined substantially in recent years. For example, 
in 2001 the authors of the report on the University of Michigan's 
Monitoring the Future national survey noted that ``[t]he use of 
smokeless tobacco by teens has been decreasing gradually from recent 
peak levels in the mid-'90s, and the overall declines have been 
substantial.'' Johnston LD, O'Malley PM, Bachman JG. (2001) Monitoring 
the Future national results on adolescent drug use: Overview of key 
findings 2000. (NIH Publication No. 01-4923). Bethesda, MD: National 
Institute of Drug Abuse, at p. 34. More recently, these same authors 
reaffirmed their earlier findings, noting that the overall declines in 
teen use of smokeless tobacco have been ``substantial'' and that ``teen 
use of smokeless tobacco is down by about one-half from the peak levels 
reached in the mid-1990s.'' Johnston LD, O'Malley PM, Bachman JG. 
(2003). Monitoring the Future national results on adolescent drug use: 
Overview of key findings, 2002. (NIH Publication No. 03-5374). 
Bethesda, MD: National Institute on Drug Abuse, at p. 34.
    \2\ These restrictions include, among other things, eliminating 
outdoor advertising of smokeless tobacco products, such as billboards 
and signs in arenas, stadiums, shopping malls, video-game arcades, and 
on public transit. In addition, USSTC voluntarily limited itself to one 
brand-name sponsorship in any 12-month period, and agreed to 
discontinue distribution to the public of non-tobacco merchandise, such 
as caps and T-shirts, bearing the brand name, logo, or trademark of any 
smokeless tobacco product.
---------------------------------------------------------------------------
    As these facts and the remainder of this statement will make clear, 
USSTC is truly a ``distinctly different'' tobacco company. Annexed as 
Attachment A to this statement are copies of excerpts from UST Inc.'s 
(USSTC's parent company) annual reports for 2000, 2001 and 2002 that 
discuss the ways in which USSTC is a ``distinctly different'' tobacco 
company.
     ii. smokeless tobacco in the context of tobacco harm reduction
A. Introduction
    Since the Surgeon General's Report in 1964,3 there has 
been substantial public health discussion about the potential health 
effects of tobacco use. Various public health organizations have 
identified the risks of cigarette smoking as including cancer (e.g., 
lung, oral cavity, esophagus, larynx, pancreas, bladder, kidney), 
chronic obstructive pulmonary disease, myocardial infarction, and 
stroke.4 The Centers for Disease Control and Prevention 
(``CDC'') estimates that cigarette smoking caused approximately 442,000 
premature deaths in the United States in 1999.5 The Surgeon 
General has indicated that the ideal way to avoid such health risks is 
to abstain from cigarette smoking.6 Nonetheless, 47 to 50 
million adults in the U.S. continue to smoke cigarettes. This number 
represents approximately 25 percent of all U.S. adults.7
---------------------------------------------------------------------------
    \3\ U.S. Department of Health, Education and Welfare. Smoking and 
Health. Report of the Advisory Committee to the Surgeon General of the 
Public Health Service. 1964.
    \4\ Stratton K, Sherry P, Wallace R, Bondurant S (eds.). Clearing 
the smoke. Assessing the science base for tobacco harm reduction. 
Institute of Medicine. National Academy Press, Washington, D.C., 2001, 
at pp. 367-68.
    \5\ Centers for Disease Control and Prevention. Annual Smoking-
Attributable Mortality, Years of Potential Life Lost, and Economic 
Costs--United States, 1995-1999. MMWR 2002; 51: 300-303.
    \6\ U.S. Department of Health & Human Services, Preventing Tobacco 
Use Among Young People: A Report of the Surgeon General (1994); see 
also Smoking As A Health Hazard, American College of Cardiology 
Position Statement, available at http://www.acc.org/clinical/position/
72565.pdf.
    \7\ The National Center For Chronic Disease Prevention and Health 
Promotion estimates that 47 million adults in the United States smoke 
cigarettes. Targeting Tobacco Use: The Nation's Leading Cause of Death, 
Tobacco Information and Prevention Source (2001). The U.S. Department 
of Health and Human Services estimates that more than 57 million 
Americans currently smoke cigarettes. Preventing Death and Disease From 
Tobacco Use, Fact Sheet (Jan. 8, 2001). Other reports suggest that the 
number of smokers in the United States is between 46.5 and 50 million. 
Cigarette Smoking Among Adults-United States, 1999, MMWR Highlights 
(Oct. 12, 2001) Vol. 50, No. 40; Treating Tobacco Use and Dependence, 
U.S. Public Health Service, Fact Sheet (June 2000).
---------------------------------------------------------------------------
    The Surgeon General reached a judgment in 1986 that use of 
smokeless tobacco products ``can cause cancer.'' 8 
Federally-mandated rotating warnings on smokeless tobacco product 
packaging and advertising state:
---------------------------------------------------------------------------
    \8\ U.S. Department of Health & Human Services, The Health 
Consequences of Using Smokeless Tobacco: A Report of the Advisory 
Committee to the Surgeon General (1986).

---------------------------------------------------------------------------
        WARNING: THIS PRODUCT MAY CAUSE MOUTH CANCER

        WARNING: THIS PRODUCT MAY CAUSE GUM DISEASE AND TOOTH LOSS

        WARNING: THIS PRODUCT IS NOT A SAFE ALTERNATIVE TO 
        CIGARETTES.9
---------------------------------------------------------------------------
    \9\ Comprehensive Smokeless Tobacco Health Education Act of 1986, 
15 U.S.C. Sec. Sec. 4401-4408.

    Numerous methods have been suggested by public health advocates for 
achieving tobacco harm reduction, including urging cigarette smokers to 
smoke fewer cigarettes, developing ``less hazardous'' cigarettes and 
creating alternative sources of nicotine, such as nicotine inhalers. A 
growing number of tobacco harm reduction proponents, however, are 
arguing for an additional method for achieving their goal. Based on the 
generally accepted view in the scientific community that smokeless 
tobacco use involves significantly less risk of adverse health effects 
than cigarette smoking, they would encourage those cigarette smokers 
who do not quit and do not use medicinal nicotine products to switch 
completely to smokeless tobacco products.
B. The IOM Report
    A logical starting point for discussion of smokeless tobacco in the 
context of tobacco harm reduction is the 600 page report issued in 2001 
by the Institute of Medicine (``IOM'') entitled: Clearing the Smoke. 
Assessing the Science Base for Tobacco Harm Reduction (``IOM Report''). 
The IOM was established in 1970 by the National Academy of Sciences to 
examine policy matters pertaining to public health, and acts under the 
Academy's congressional charter to be an advisor to the federal 
government and to assess issues relating to medical care, research and 
education. The IOM tobacco harm reduction project was undertaken at the 
request of, and was supported by, the U.S. Food and Drug 
Administration. The IOM Report explains the need for a tobacco harm 
reduction strategy as follows:
        Despite overwhelming evidence and widespread recognition that 
        tobacco use poses a serious risk to health, some tobacco users 
        cannot or will not quit. For those addicted tobacco users who 
        do not quit, reducing the health risks of tobacco products 
        themselves may be a sensible response. This is why many public 
        health leaders believe that what has come to be called ``harm 
        reduction'' must be included as a subsidiary component of a 
        comprehensive public health policy toward tobacco.10
---------------------------------------------------------------------------
    \10\ Stratton K, et al. (2001) at p. 201.
---------------------------------------------------------------------------
    Tobacco ``harm reduction'' is defined in the IOM Report as follows:
        For the purposes of this report, a product is harm-reducing if 
        it lowers total tobacco-related mortality and morbidity even 
        though use of that product may involve continued exposure to 
        tobacco related toxicants. Many different policy strategies may 
        contribute to harm reduction. However, this report focuses on 
        tobacco products that may be less harmful or on pharmaceutical 
        preparations that may be used alone or concomitantly with 
        decreased use of conventional tobacco. (Original emphasis). 
        11
---------------------------------------------------------------------------
    \11\ Id. at p. 2.
---------------------------------------------------------------------------
    It is clear from this definition of ``harm reduction'' that, in the 
view of the IOM, it is not necessary to demonstrate that a product is 
``safe'' or ``harmless'' in order for that product to play a role in 
tobacco harm reduction.
    The IOM Report had the following to say with respect to smokeless 
tobacco products:
        Smokeless tobacco products are associated with oral cavity 
        cancers, and a dose-response relationship exists. However, the 
        overall risk is lower than for cigarette smoking, and some 
        products such as Swedish snus may have no increased risk. It 
        may be considered that such products could be used as a PREP 
        [Potential Reduced-Exposure Product] for persons addicted to 
        nicotine, but these products must undergo testing as PREPs 
        using the guidelines and research agenda contained 
        herein.12
---------------------------------------------------------------------------
    \12\ Id. at. p. 434.
---------------------------------------------------------------------------
    There has been criticism of the IOM Report's recommendation that 
all products proposed for use in the context of a tobacco harm 
reduction strategy require substantial and elaborate scientific testing 
to demonstrate their harm reduction benefits. For example, Clive Bates, 
former Director of the United Kingdom's Action on Smoking and Health, 
has made the following comments:
        The report places very substantial evidential requirement on 
        those seeking to bring PREPs to the market with a health 
        related claim. The easiest approach for the public health and 
        regulatory community is to demand near complete certainty 
        before approving the marketing of any PREPs. At first sight 
        this appears prudent, but it is actually a transfer of risk 
        from the regulator to the smoker. With insurmountable 
        evidential hurdles in place, the regulator may sleep easy in a 
        cocoon of professional skepticism.13
---------------------------------------------------------------------------
    \13\ Bates C. Clearing the smoke or muddying the water? (Editorial) 
Tobacco Control 2001; 10: 87-88.
---------------------------------------------------------------------------
    The IOM Report's focus on the need for further research and 
demonstration of harm reduction benefits may be understandable in the 
context of new or novel tobacco products or so-called ``safer'' 
cigarettes. When it comes to smokeless tobacco, however, there is 
considerable agreement in the scientific community that the use of 
smokeless tobacco involves significantly less risk of adverse health 
effects than cigarette smoking.
    As Professor Lynn Kozlowski, Head of the Pennsylvania State 
University Department of Biobehavioral Health, has stated in a 
commentary published last year in the journal Nicotine and Tobacco 
Research:
        The failure of governments to establish any effective 
        regulation of tobacco products can be seen as arguably the 
        greatest failure of public health policy for the past 100 
        years. I have recently been in a meeting with several 
        distinguished scientists and opinion leaders interested in 
        smoking-related public policy and regulation. The majority of 
        these individuals expressed an unwillingness to express any 
        public opinion about would-be harm reduction products for 
        tobacco, until such time as proper regulatory/evaluation 
        systems were in place to unequivocally judge the degree of harm 
        reduction afforded by the products as used by society. (This 
        might be viewed as in keeping with the position of the 
        Institute of Medicine report.) Clearly the best of all possible 
        research has not yet been done on snus or medicinal nicotine, 
        but, equally clearly, it is wrong to assume that we lack 
        practical scientific bases for estimating that there will be 
        harm reduction to individual smokers from these products. 
        Though it is important to attain proper regulation over tobacco 
        and harm reduction products, this goal is logically and 
        ethically independent of the need to provide smokers today with 
        what information we do have about the risks of various 
        products. (Emphasis supplied).14
---------------------------------------------------------------------------
    \14\ Kozlowski LT. Harm reduction, public health, and human rights: 
Smokers have a right to be informed of significant harm reduction 
options. Nicotine and Tobacco Res 2002; 4 Suppl 2: 55-60 at p. 58.
---------------------------------------------------------------------------
C. There is General Agreement in the Scientific Community Regarding the 
        Comparative Health Risks of Cigarette Smoking and Smokeless 
        Tobacco Use
    USSTC's February 5, 2002 Request to the Federal Trade Commission 
(``FTC'') for an advisory opinion 1515, which is discussed 
below, contains excerpts from 50 scientific publications, many of which 
were peer-reviewed, that assert or support the proposition that the use 
of smokeless tobacco involves significantly less risk of adverse health 
effects than cigarette smoking. Additional scientific information and 
publications that became available subsequent to February 5, 2002 is 
reviewed in USSTC's May 9, 2003 submission to the FTC, which is also 
discussed below. Two of the publications referenced in that 
supplemental submission reflect the generally held view in the public 
health community regarding the comparative health risks of cigarette 
smoking and smokeless tobacco use. Those publications can be expected 
to have a significant impact on the tobacco harm reduction debate, and 
therefore merit some discussion.
---------------------------------------------------------------------------
    \15\ Throughout this statement reference will be made to USSTC's 
February 5, 2002 and May 9, 2003 submissions to the Federal Trade 
Commission and attachments thereto. Those documents and their 
attachments can be found at: http://www.ftc.gov/os/
otherpubliccomments.htm and http://www.ussmokeless.com. Hereafter, 
documents that are part of these submissions will be indicated as 
follows: ``See Website.''
---------------------------------------------------------------------------
i. Royal College of Physicians Report
    In December 2002, the Royal College of Physicians (``RCP'') issued 
a landmark report entitled Protecting Smokers, Saving 
Lives,16 which assessed various issues relating to future 
tobacco regulation in the United Kingdom. The RCP is England's oldest 
medical institution; among its main functions is to advise the 
government, the public and the medical profession on health care 
issues.
---------------------------------------------------------------------------
    \16\ Tobacco Advisory Group of the Royal College of Physicians. 
Protecting smokers, saving lives. Royal College of Physicians of 
London, 2002. See Website.
---------------------------------------------------------------------------
    The 2002 RCP Report recognized that tobacco harm reduction must be 
an essential element of any tobacco regulation program:
        A tobacco and nicotine regulatory authority should have a clear 
        objective:
        . . . to reduce the overall burden of tobacco-related disease 
        by contributing to a reduction in smoking prevalence and by 
        regulating to reduce the harm caused to continuing nicotine 
        users.'' (Original emphasis) 17
---------------------------------------------------------------------------
    \17\ Id. at p. 24.
---------------------------------------------------------------------------
    The 2002 RCP Report also recognized that smokeless tobacco would be 
a key component of any tobacco harm reduction strategy:
        Smokeless Tobacco:
        As a way of using nicotine, the consumption of non-combustible 
        tobacco is of the order of 10-1,000 times less hazardous than 
        smoking, depending on the product. Some manufacturers want to 
        market smokeless tobacco as a `harm reduction' option for 
        nicotine users, and they may find support for that in the 
        public health community.18
---------------------------------------------------------------------------
    \18\ Id. at p. 5
---------------------------------------------------------------------------
    The issuance of the RCP's 2002 Report is not the first time that 
the RCP has led the way on tobacco and health issues. In March 1962, 
the RCP issued a report on smoking and health which concluded that 
cigarette smoking caused lung cancer. Shortly after the issuance of 
that report, the U.S. Surgeon General, Dr. Luther L. Terry, established 
the Surgeon General's Advisory Committee on Smoking and Health to 
produce a similar report for the United States. That report was 
released in January 1964 and is generally referred to as the 1964 
Surgeon General's Report. Its conclusions were similar to those of the 
1962 RCP Report.
ii. White Paper on European Union Smokeless Tobacco Policy
    In February 2003, a group of tobacco and health researchers and 
public health advocates from the United Kingdom, Sweden and Austria 
published a white paper entitled European Union policy on smokeless 
tobacco. A statement in favour of evidence-based regulation for public 
health.19 The authors recommend that the current European 
Union ban of smokeless tobacco be replaced with a regulatory program 
based on the recognition that smokeless tobacco is substantially less 
harmful than cigarette smoking and could play a significant role in 
tobacco harm reduction. The group summarized the ``public health case'' 
favoring smokeless tobacco as follows:
---------------------------------------------------------------------------
    \19\ Bates C, Fagerstrom K, Jarvis M, Kunze M, McNeill A, Ramstrom 
L. European Union policy on smokeless tobacco. A statement in favour of 
evidence-based regulation for public health. February 2003. See 
Website.
---------------------------------------------------------------------------
        We believe that the partial ban applied to some forms of 
        smokeless tobacco in the European Union should be replaced by 
        regulation of the toxicity of all smokeless tobacco. We hold 
        this view for public health reasons: smokeless tobacco is 
        substantially less harmful than smoking and evidence from 
        Sweden suggests it is used as a substitute for smoking and for 
        smoking cessation. To the extent there is a ``gateway'' it 
        appears not to lead to smoking, but away from it and is an 
        important reason why Sweden has the lowest rates of tobacco-
        related disease in Europe. We think it is wrong to deny other 
        Europeans this option for risk-reduction and that the current 
        ban violates rights of smokers to control their own risks. For 
        smokers that are addicted to nicotine and cannot or will not 
        stop, it is important that they can take advantage of much less 
        hazardous forms of nicotine and tobacco--the alternative being 
        to `quit or die' . . . and many die. (Original emphasis) 
        20
---------------------------------------------------------------------------
    \20\ Id. at p. 2.
---------------------------------------------------------------------------
    Among other points made in the white paper are the following:
        [F]or oral tobacco to play a role in harm reduction it is not 
        necessary to show that it does not cause cancer--it just needs 
        to be substantially less hazardous than smoking. Even allowing 
        for cautious assumptions about the health impact, snus--and 
        other oral tobaccos--are a very substantially less dangerous 
        way to use tobacco than cigarettes. Smokeless tobaccos are not 
        associated with major lung diseases, including COPD and lung 
        cancer, which account for more than half of smoking-related 
        deaths in Europe. If there is a CVD risk, which is not yet 
        clear, it appears to be a substantially lower CVD risk than for 
        smoking. Smokeless tobacco also produces no environmental 
        tobacco smoke (ETS) and therefore eliminates an important 
        source of disease in non-smokers and children. These are very 
        substantial benefits in reduced risk to anyone that switches 
        from smoking to smokeless tobacco and we believe the public 
        health community has a moral obligation to explore this 
        strategy. It is likewise ethically wrong to actively deny users 
        the option to reduce their risk in this way.21
---------------------------------------------------------------------------
    \21\ Id. at p. 3.
---------------------------------------------------------------------------
                                *  *  *
        The risk to the user arising from use of a smokeless tobacco 
        product varies by product and is to some extent uncertain--
        notably in the area of heart disease (though at worst the heart 
        disease impact appears to be substantially less than smoking). 
        However, we are confident that the evidence base suggests that 
        it is reasonable to formulate the overall relative risk as 
        follows: on average Scandinavian or American smokeless tobaccos 
        are at least 90% less hazardous than cigarette smoking. In a 
        spectrum of risk, snus is much closer to NRT [nicotine 
        replacement therapy] than it is to cigarette smoking. (Original 
        emphasis) 22
---------------------------------------------------------------------------
    \22\ Id. at pp. 3-4.
---------------------------------------------------------------------------
D. Individual Risk Versus Population Risk
    One concern raised by some in the public health community with 
respect to ``reduced risk'' tobacco products is that, while a product 
might reduce the health risk to an individual, the aggregate public 
health impact on the population might be negative. Thus, for example, 
it is argued that if a ``safer'' cigarette reduced the health risks 
associated with cigarette smoking by 10 percent, but resulted in a 20 
percent increase in cigarette use (either through new smokers or by 
causing some smokers who otherwise would have quit to continue 
smoking), the aggregate public health impact would be negative. 
Professor Kenneth E. Warner of the University of Michigan gives the 
following example:
        [C]onsider the implications of Star Enterprise's advertising 
        that its new cigarette, Advance, yields fewer nitrosamines than 
        conventional cigarettes. Informed that most cigarette smoke 
        contains nitrosamines and that nitrosamines are carcinogenic, 
        would smokers preparing to quit flock to the new cigarette 
        instead, believing that it would greatly reduce their risk of 
        smoking-induced lung cancer? The net health consequences are 
        unclear: for those smokers who would have continued smoking 
        anyway, switching to Advance might well reduce risk. For 
        smokers who would have quit, or former smokers induced to start 
        smoking again by the availability of this purportedly ``safer'' 
        product, the active marketing of a low-nitrosamine cigarette 
        clearly would increase risk. The net impact would depend on the 
        unpredictable balance between such effects.23
---------------------------------------------------------------------------
    \23\ Warner KE. Reducing harm to smokers: Methods, their 
effectiveness and the role of policy. In: Regulating Tobacco. Rabin RL, 
Sugarman SD (eds.) Oxford University Press, Oxford. 2001. Chapter 5, at 
pp. 133-134.
---------------------------------------------------------------------------
    Professor Kozlowski has developed a ``risk/use equilibrium'' chart 
24 to assess the issue of individual risk reduction versus 
aggregate population impact. The chart compares the ``decrease in 
danger (%)'' displayed on the horizontal axis to the ``multiplier to 
achieve equal risk'' on the vertical axis.
---------------------------------------------------------------------------
    \24\ Kozlowski L, Strasser AA, Giovino GA, Erickson PA, Terza JV. 
Applying the risk/use equilibrium: use medicinal nicotine now for harm 
reduction. (Editorial). Tobacco Control 2001; 10: 201-203.
---------------------------------------------------------------------------
    According to Professor Kozlowski's analysis, a tobacco product that 
reduces risk by only 10 percent raises a difficult public health issue 
because an 11 percent increase in use of the product would offset the 
risk reduction in the population as a whole, and an increase in excess 
of 11 percent would result in a negative public health impact on the 
population as a whole. On the other hand, a tobacco product that 
results in a reduced risk in excess of 90 percent presents a relatively 
easy public health issue since the increase in usage necessary to 
offset the reduction in risk is so substantial--more that 1,000 
percent--that it is highly unlikely to occur.
    Given the predominant view in the public health community that the 
risk of adverse health effects associated with smokeless tobacco 
products is slight compared to that of cigarette smoking, researchers 
believe it is highly unlikely the public health benefit of cigarette 
smokers switching to smokeless tobacco would ever be offset by 
increased usage of smokeless tobacco.
    Professor Kozlowski expressed his agreement with this conclusion in 
a recent publication entitled Harm Reduction, public health, and human 
rights: Smokers have a right to be informed of significant harm 
reduction options, in which he applied his ``risk/use equilibrium'' 
analysis to smokeless tobacco:
        When risks from a product are relatively small, the level of 
        increased use needed to maintain a public health equilibrium 
        (no changes in population-level problems) becomes very high 
        (Kozlowski, Strasser, Giovino, et al., 2001) . . . For a 
        product like snus, if the risk is even 1% that of cigarettes, 
        use would have to increase 100 times to equal the problems from 
        cigarettes. If the risk from snus were as much as 5% that of 
        cigarettes, use would still have to increase an unlikely 20 
        times for the public health problems to equal those from 
        cigarettes.25
---------------------------------------------------------------------------
    \25\ Kozlowski LT (2002) at p. 58.
---------------------------------------------------------------------------
E. The Swedish Experience
    Proponents of encouraging ``inveterate'' cigarette smokers to 
switch to smokeless tobacco products point to the history of cigarette 
smoking and smokeless tobacco use in Sweden as support for their view. 
Swedish males have the highest rate of smokeless tobacco use and the 
lowest rate of cigarette smoking of any Western country, and the daily 
use of smokeless tobacco by Swedish males now exceeds that of 
cigarettes (18.2 percent daily smokeless tobacco users versus 17.1 
percent daily cigarette smokers).26 The following chart 
illustrates the changing pattern of tobacco use in Sweden during most 
of the past century, including the fact that smokeless tobacco use has 
overtaken cigarette smoking in recent years for the first time since 
World War II.27
---------------------------------------------------------------------------
    \26\ Henningfield JE, Fagerstrom KO. Swedish Match Company, Swedish 
snus and public health: a harm reduction experiment in progress? 
Tobacco Control 2001; 10: 253-257, at p. 254.
    \27\ Adapted from Swedish Match's Third Quarter Results, October 
23, 2001, as posted on Company's web site. The figures cited reflect 
reported taxable shipments of snuff and cigarettes, measured in tons.
---------------------------------------------------------------------------
    Tobacco and health researchers have linked Sweden's low rate of 
``tobacco-related mortality'' to its high prevalence of smokeless 
tobacco use and low prevalence of cigarette smoking:
        Sweden, with a long tradition of smokeless tobacco use (16% of 
        adult males use smokeless tobacco daily) and the highest 
        penetration of NRT [nicotine replacement therapy] use, is the 
        only European country that has reached (19%) the World Health 
        Organization's target of 20% smokers in the adult population by 
        the year 2000; about 35% of all nicotine consumed comes from 
        nonsmoked deliver[y] forms. The tobacco-related mortality in 
        Sweden is by far lower than in any other European or North 
        American country, although nicotine consumption may not be 
        lower than in other countries.28
---------------------------------------------------------------------------
    \28\ Balfour DJK, Fagerstrom KO. Pharmacology of nicotine and its 
therapeutic use in smoking cessation and neurodegenerative disorders. 
Pharmacol Ther 1996; 72: 51-81, at p. 71.
---------------------------------------------------------------------------
    In 2001, a New Scientist article summarized the Swedish experience 
in the context of tobacco harm reduction:
        [S]mokers [in Sweden] aren't faced with the quit-or-die 
        dilemma. Instead of using a nicotine replacement therapy with 
        the aim of quitting both smoking and ultimately nicotine, they 
        can continue using tobacco as a recreational drug, safe in the 
        knowledge that it probably won't kill them. It's all down to a 
        product called `snus,' a form of moist ground tobacco that you 
        pop between your lip and gum.29
---------------------------------------------------------------------------
    \29\ Wilson C. My friend nicotine. New Scientist 2001; 10: 28-31, 
at p. 29.
---------------------------------------------------------------------------
                                *  *  *
        The `Swedish experiment,' as it has come to be known, has 
        inspired some health campaigners to press for a more 
        enlightened approach to the smoking epidemic. It's a concept 
        they call `harm reduction.' `If you look at Sweden, we have a 
        living example of the concept in action,' says Clive Bates, 
        director of ASH.30
---------------------------------------------------------------------------
    \30\ Id. at p. 30.
---------------------------------------------------------------------------
    Also of interest is Swedish survey data regarding the use of 
smokeless tobacco as a smoking cessation aid presented at two 
scientific conferences in late 2002. At the 3rd International 
Conference on Smokeless Tobacco: Advancing Science and Protecting 
Public Health, held in Stockholm, Sweden in September 2002, Dr. Lars M. 
Ramstrom, Director of Stockholm's Institute for Tobacco Studies, 
reported on a recent nationwide survey of a representative sample 6,700 
adults in Sweden sponsored by the Swedish National Institute of Public 
Health. Dr. Ramstrom reports the following in the press summary of his 
presentation:
        ``Among males snus is the most commonly used and most effective 
        smoking cessation aid.'' In support of this conclusion, Dr. 
        Ramstrom cites survey data indicating that ``76% of male Ever 
        Daily Smokers have made at least one attempt to quit smoking. 
        Around 40% of the ``triers'' report that at their latest 
        attempt they have used some kind of smoking cessation aid. 36% 
        of these males have used nicotine gum, 20% nicotine patch and 
        55% have used snus as a smoking cessation aid. No other kind of 
        cessation aid has been used by as much as 10%.31 The 
        proportion of those who have succeeded to quit smoking 
        completely is 50% for gum users, 34% for patch users, 65% for 
        snus users.'' 32
---------------------------------------------------------------------------
    \31\ Dr. Ramstrom noted that the total exceeds 100% because some 
smokers used more than one aid.
    \32\ Ramstrom L. Press summary entitled: Snus as a substitution for 
smoking--the Swedish Experience. See Website.
---------------------------------------------------------------------------
    At the 4th European Conference of the Society for Research on 
Nicotine and Tobacco: Improving Knowledge and Treatments of Nicotine 
Addiction, held in Santander, Spain in October 2002, Clive Bates made a 
presentation entitled ``Harm Reduction and Smokeless Tobacco.'' One of 
the points made was that ``snus is an important factor in the low 
smoking prevalence in Sweden. It is used for cessation and as an 
alternative to smoking.'' He cited data from a 2001 survey commissioned 
by the Swedish Cancer Society reporting that, among 1,000 ex-smokers, 
33% used snus as a smoking cessation aid, compared to 17% who used 
nicotine replacement therapies.33
---------------------------------------------------------------------------
    \33\ Bates C. Presentation: Harm reduction and smokeless tobacco. 
See Website.
---------------------------------------------------------------------------
    The European Union white paper also points to smokeless tobacco as 
the explanation for Sweden's low rate of tobacco-related mortality:
        Evidence from Sweden suggests snus plays a positive public 
        health role as a substitute for smoking and as an aid to 
        smoking cessation. It is impossible to be definitive about 
        this, because it is impossible to run a controlled trial on a 
        whole nation.
        However, consider the following:
         Sweden has the lowest levels of tobacco-related 
        mortality in the developed world by some distance--
        approximately half the tobacco related mortality of the rest of 
        the EU.
         Sweden has the lowest male smoking prevalence in 
        Europe (16% daily) and low female (c. 22%) prevalence.
         However, it has comparable male tobacco prevalence and 
        total consumption to neighbours Norway and Denmark--suggesting 
        the big difference is in the type of tobacco used, rather than 
        overall propensity to use tobacco or consume nicotine.
         About half of tobacco in Sweden is now consumed as 
        snus--this share has steadily grown since 1970s.
         33% of ex-smokers report use of snus--almost twice the 
        number that report use of a pharmaceutical treatment (17%). 
        Among males who have used a single aid to stop daily smoking, 
        and succeeded to do so, some 70% had used snus and some 30% had 
        used some kind of NRT.
    Some have raised a question as to whether the Swedish experience is 
applicable to the United States, asserting that Swedish moist snuff 
products contain lower levels of so-called tobacco-specific 
nitrosamines (some of which have been reported to be laboratory 
carcinogens) than U.S. moist snuff products. For example, Professor 
Newell Johnson in an article published in 2001 entitled ``Tobacco Use 
and Oral Cancer: A Global Perspective'' conceded that ``on present 
evidence, snuff habits as they exist in Scandinavia and probably in the 
United States carry lower risk of serious health hazards'' 
34 than cigarette smoking, but also made the following 
comment:
---------------------------------------------------------------------------
    \34\ Johnson N. Tobacco use and oral cancer: A global perspective. 
J Dent Educ 2001; 65: 328-339, at p. 328.
---------------------------------------------------------------------------
        In Scandinavia it is clear that local snuff is not a major risk 
        factor: two recent case-control studies of oral cancer cases in 
        Sweden have failed to show an association. This is because 
        Swedish snus is not fermented and contains much lower 
        nitrosamine levels than fermented tobaccos. The view that 
        smokeless tobacco use may be associated with a lower risk of 
        oral cancer in the United States has led to a movement to 
        advocate the practice as a less dangerous alternative to 
        smoking and an aid to nicotine withdrawal in those addicted to 
        smoking.35
---------------------------------------------------------------------------
    \35\ Id., at pp. 332-333.
---------------------------------------------------------------------------
    In fact, there is currently no significant difference in tobacco-
specific nitrosamine (TSNA) levels in U.S. moist snuff products 
compared to Swedish moist snuff. Data reported in scientific literature 
by researchers from the American Health Foundation, together with data 
published by Swedish researchers, 36 show that the average 
levels of TSNAs in the major U.S. the moist snuff products decreased 
77% between 1980 and 1994 (the last time that data for both of these 
products was reported in the scientific literature), and that currently 
there is no significant difference between the levels of TSNAs in those 
products compared to Swedish moist snuff products. A chart depicting 
this data follows:
---------------------------------------------------------------------------
    \36\ Andersson G, Bjornberg G, Curvall M. Oral mucosal changes and 
nicotine disposition in users of Swedish smokeless tobacco products: A 
comparative study. J Oral Pathol Med 1994; 23: 161-167 (1993 Swedish 
data); Djordjevic MV, Brunnemann KD, Hoffmann D. The need for 
regulation of carcinogenic N-Nitrosamines in oral snuff. Food Chem 
Toxicol 1993; 31: 497-501 (1992 U.S. data and all earlier data); 
Hoffmann D, Djordjevic MV, Fan J, Zang E, Glynn T, Connolly GN. Five 
leading U.S. commercial brands of moist snuff in 1994: assessment of 
carcinogenic N-Nitrosamines. J Natl Cancer Inst 1995; 87: 1862-1869 
(1994 U.S. data).
---------------------------------------------------------------------------
        This view is supported by a report issued in 1997 by the 
        Swedish National Board of Health and Welfare, which concluded:
    Recent data suggest that the differences [in TSNA levels reported 
in American and Swedish moist snuff] have grown smaller, and that it is 
now questionable to make a sharp distinction between use of American 
and Swedish moist snuff when assessing risks--at least where TSNA 
content is concerned.37
---------------------------------------------------------------------------
    \37\ Ahlbom A, Olsson UA, Pershagen G. Health hazards of moist 
snuff. SoS Report 1997; 11:3-29, at p. 7.
---------------------------------------------------------------------------
F. The Gateway Issue
    One argument relied upon by those who oppose the use of smokeless 
tobacco as a component of a tobacco harm reduction strategy is that 
smokeless tobacco may be a causal ``gateway'' to cigarette smoking, 
that is, smokeless tobacco use may cause consumers to later take up 
cigarette smoking.
    The authors of the EU white paper reject the notion of a causal 
``gateway'' from smokeless tobacco to cigarette smoking based upon 
their assessment of empirical data from Sweden and their analysis of 
the studies relied upon by those who argue that there is a ``causal'' 
gateway effect. Indeed, the authors of the EU white paper conclude that 
the Swedish data suggest that smokeless tobacco prevents rather than 
promotes cigarette smoking:
        Gateway effects. There is concern that smokeless tobacco will 
        function as a lead-in to smoking for people that would not 
        otherwise smoke. Such `gateway effects' are always contentious, 
        and they are hard to demonstrate for the simple reason that we 
        do not know what smokeless users would have done in the absence 
        of smokeless tobacco--they may have simply moved straight to 
        smoking. Gateways can act in the opposite direction too--they 
        can be `exits' rather than `entrances'. Smokers may move to 
        smokeless tobacco or use smokeless tobacco to quit, where they 
        would otherwise have continued to smoke. Starters on smokeless 
        tobacco may continue as smokeless users but otherwise have 
        started with cigarettes, so that smokeless tobacco is a 
        diversion from smoking. In both the US and Sweden, most 
        smokeless tobacco use cannot be a gateway to smoking, either 
        because smokeless users never started smoking or because they 
        started smoking first. For the minority who started using 
        smokeless before cigarettes they may or may not have had their 
        smoking caused by smokeless use.
        Exit or entrance gateway? Understanding the order in which 
        tobacco users take up different products is an important and 
        necessary factor in establishing a gateway effect and whether 
        the gateway is an exit from or entrance to smoking, but it is 
        not in itself sufficient to establish a gateway from smokeless 
        to cigarettes. The basic problem is that it is difficult to 
        know whether those that start with smokeless tobacco would 
        otherwise have started on cigarettes in the absence of 
        smokeless tobacco. The data from Sweden suggest that the 
        gateway is more likely to be an `exit' from smoking than an 
        `entrance'. Among Swedish males with a primary use of snus no 
        more than 20% ever started smoking, while 45% of other males 
        did become smokers. In addition to this compelling evidence 
        from the pattern of transitions, Sweden has the lowest rate of 
        male smoking in Europe, combined with high levels of snus use. 
        There is no other credible explanation for such low male 
        smoking prevalence than the displacement and cessation of 
        smoking through smokeless tobacco use. In total therefore, the 
        Swedish data suggest that uptake of snus use prevents rather 
        than promotes smoking and therefore contributes a net public 
        health benefit. There have been studies in the United States 
        that claim to show a gateway effect from smokeless tobacco use 
        to smoking for a minority of smokeless users. However, these 
        studies or related commentary have generally drawn causal 
        inferences based on observation of transitions between often 
        poorly defined categories of tobacco use, and sometimes from 
        groups that are unrepresentative of the general population, 
        such as the military. Psychosocial predictors of smoking 
        initiation (school performance, parental smoking, risk taking 
        etc.) can be used to assess which smokeless tobacco users might 
        otherwise have been smokers. When these confounding factors are 
        taken into account, the data do not show that initial smokeless 
        tobacco use adds to the propensity to become a smoker.
    Additional data from Sweden contradicting the theory of a causal 
``gateway'' from smokeless tobacco to cigarette smoking was recently 
published by Rodu et al. in a paper entitled Evolving patterns of 
tobacco use in northern Sweden.38 The researchers report on 
their analysis of data from a prospective follow-up study of 
approximately 3,400 men and women in northern Sweden, and describe the 
evolving patterns of tobacco use in this population over the period 
1986 to 1999. While the researchers conclude that ``the use of snus 
played a major role in the decline of smoking rates amongst men in 
northern Sweden,'' 39 some of their data is of particular 
relevance to the ``gateway'' issue. They report that among men who used 
moist snuff but had never smoked at the beginning of the study, not a 
single person switched to cigarette smoking during the follow-up period 
of 5 to 13 years, and only 1 percent of these men used both moist snuff 
and cigarettes during the follow-up period.
---------------------------------------------------------------------------
    \38\ Rodu B, Stegmayr B, Nasic S, Cole P, Asplund K. Evolving 
patterns of tobacco use in northern Sweden. J Intern Med 2003; 253: 
660-665.
    \39\ Id. at p. 660.
---------------------------------------------------------------------------
G. Cigarette Smokers' Misperception that Smokeless Tobacco and 
        Cigarettes Involve Equal Health Risks and Their Right to 
        Accurate Information
    At the November 2001 meeting of the National Conference on Tobacco 
or Health in New Orleans, Louisiana, Dr. K. Michael Cummings of New 
York's Roswell Park Cancer Institute, and his colleagues, presented 
results of a survey of a nationally representative sample of over 1,000 
adult cigarette smokers regarding their beliefs about tobacco products. 
Of particular interest was the fact that 82% of adult cigarette smokers 
responded that they believed smokeless tobacco was just as likely to 
cause cancer as smoking cigarettes.40
---------------------------------------------------------------------------
    \40\ Presentation by Dr. K. Michael Cummings at the National 
Conference on Tobacco or Health in November 2001.
---------------------------------------------------------------------------
    Given these survey results, it was not surprising that in a 2002 
publication, Dr. Cummings made the following comments regarding the 
comparative health risks of smokeless tobacco and cigarettes, and the 
need to provide adult cigarette smokers sufficient information to 
permit them to make informed choices regarding the tobacco products 
they choose to use:
        Competition to produce more consumer-acceptable medicinal 
        nicotine products would be helped by educating consumers about 
        what factors in tobacco products really contribute to disease 
        risk. Ironically, many smokers do not perceive much difference 
        in health risk between smokeless tobacco products, nicotine 
        medications and cigarettes. Yet if all nicotine products were 
        put on a risk continuum the actual difference between smokeless 
        and nicotine medications would be seen as fairly minor compared 
        to the difference in disease risk between smoked and smokeless 
        products (Stratton et al. 2001). Until smokers are given enough 
        information to allow them to choose products because of lower 
        health risks, then the status quo will remain. Capitalism, and 
        not governmental regulation, has the greatest potential to 
        alter the world-wide epidemic of tobacco-related disease. 
        (Emphasis supplied) 41
---------------------------------------------------------------------------
    \41\ Cummings KM. Can capitalism advance the goals of tobacco 
control? Addiction 2002; 97: 957-958 at p. 957.
---------------------------------------------------------------------------
    Professor Kozlowski has also commented recently concerning the 
urgent need to provide cigarette smokers with information regarding 
risk reduction options and their right to receive such information:
        Cigarettes kill about half of those who smoke them . . . It is 
        urgent to inform smokers about options they have to reduce 
        risk. This needs to be done in ways that inform smokers as 
        fully as possible that never starting and complete quitting as 
        soon as possible are the best choices to promote health, while 
        also indicating that snus or medicinal nicotine (the latter 
        more than the former) would be preferable to continued smoking. 
        Also, complete substitution of these products should be 
        encouraged over mixing them with continued smoking. The harm 
        reduction message will be complex. There will be many ways to 
        give it. Some will misinterpret even the most artfully framed 
        message. Notwithstanding, public health policy in this instance 
        lacks compelling justification to override the human rights of 
        the individual. Individuals have the right to such health 
        relevant information.42
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    \42\ Kozlowski LT. (2002) at p. 59.
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H. USSTC's Request for FTC Guidance
    On February 5, 2002, USSTC filed a request with the FTC seeking 
issuance of an advisory opinion regarding the acceptability of 
communicating in advertising that smokeless tobacco products are 
considered to be a significantly reduced risk alternative as compared 
to cigarette smoking (See Website). USSTC noted in its request that 
issuance of an advisory opinion by the FTC would address an issue of 
significant public interest to adult tobacco consumers, USSTC, and 
other smokeless tobacco manufacturers. USSTC explained the rationale 
behind its request as follows:
        USSTC requests that the Commission issue an advisory opinion 
        supporting the use of statements in advertising that provide 
        the public with truthful and substantiated information about 
        the harm reduction that a growing number of public health 
        advocates believe can result from switching from cigarettes to 
        smokeless tobacco products. The benefits of making such 
        information available to consumers would be twofold: it would 
        provide ready access to scientific opinion that otherwise would 
        be difficult or costly to obtain, and it would help adult 
        consumers make better educated choices about the tobacco 
        products they use. As the federal agency with authority over 
        tobacco advertising, the FTC should act affirmatively to 
        provide guidance in this area.
        USSTC believes that the types of information it proposes to 
        communicate in advertising are truthful, non-misleading and 
        substantiated. At the same time, USSTC recognizes that cross-
        category (i.e., smokeless tobacco advertisements directed at 
        adult smokers) comparative advertising of reduced risk tobacco 
        products raises issues which currently are the subject of 
        ongoing public health debate. Providing USSTC with an advisory 
        opinion would inform USSTC and other smokeless tobacco 
        manufacturers of the criteria the FTC will apply when 
        considering such statements. At a minimum, FTC consideration of 
        these issues would advance the public debate on the issue of 
        tobacco harm reduction, and increase the amount of information 
        available to the public regarding reduced risk alternatives to 
        cigarette smoking. Indeed, as part of its consideration of this 
        request, the FTC may wish to hold a public workshop or similar 
        forum to facilitate a full exchange of views on the issues 
        involved.
    USSTC's request made clear that any statement USSTC made would be 
truthful and non-deceptive, and gave an example of the type of 
statement contemplated:
        USSTC proposes to disseminate advertisements with the following 
        or similar statements:
                The Surgeon General in 1986 concluded that smokeless 
                tobacco ``is not a safe substitute for smoking 
                cigarettes.'' While not asserting that smokeless 
                tobacco is ``safe,'' many researchers in the public 
                health community have expressed the opinion that the 
                use of smokeless tobacco involves significantly less 
                risk of adverse health effects than smoking cigarettes. 
                For those smokers who do not quit, a growing number of 
                researchers advocate switching to smokeless tobacco 
                products.
    Following the submission of its request to the FTC, USSTC 
representatives met with FTC staff representatives on May 21, 2002 in 
order to present an overview of various issues relating to its request, 
as well as to answer any questions that might be raised by the FTC 
staff. Following the presentation and discussion, USSTC provided to the 
FTC staff additional information and documentation responsive to their 
requests. A similar meeting was held with representatives of Department 
of Health and Human Services public health agencies on May 30, 2002. 
Copies of the presentation materials relating to these meetings are 
annexed as Attachments B and C.
    In the spring and summer of 2002, smokeless tobacco and tobacco 
harm reduction was the topic of discussion and debate at various 
scientific conferences and public policy forums in the United States 
and abroad. On May 16, the subject was discussed at a scientific 
conference in London entitled Harm Reduction, Smoking and Smokeless 
Tobacco; on May 29, the issue was the subject of a forum entitled 
Marketing Highly Regulated Products at Northwestern University in 
Chicago; on June 20 through 22, the issue was discussed at the Third 
European Conference on Tobacco or Health in Warsaw, Poland; on June 26, 
the issue was debated at a seminar sponsored by the American Council on 
Science and Health in New York City; and on July 16, the issue was the 
subject of debate at the CATO Institute in Washington, DC.
    In the summer of 2002, USSTC became aware of the scheduling of two 
very important scientific conferences that would include a public 
debate directly relevant to USSTC's request. On September 22 through 
25, 2002, the Centers for Disease Control, the National Cancer 
Institute, and the Stockholm Center of Public Health, Center For 
Tobacco Prevention, would sponsor the 3rd International Conference on 
Smokeless Tobacco: Advancing Science & Protecting Public Health, in 
Stockholm, Sweden. The conference would bring together leading experts 
on smokeless tobacco, and feature a session on tobacco harm reduction. 
Similarly, the 4th European Conference of the Society for Research on 
Nicotine and Tobacco was to be held on October 3 through 5, 2002, in 
Santander, Spain. This conference would also include discussion and 
presentations of research findings on current scientific issues 
relating to smokeless tobacco, including harm reduction. In view of the 
pendency of these scientific conferences, on August 12, 2002, USSTC 
temporarily withdrew its request for an advisory opinion so that it 
would have the opportunity to provide for the FTC's consideration 
significant new information expected to be presented at these 
conferences.
    On May 9, 2003, USSTC submitted to the FTC information regarding 
smokeless tobacco as a reduced risk alternative to cigarette smoking 
that had been presented or published subsequent to the August 2002 
temporary withdrawal of its request for FTC guidance. As expected, the 
Stockholm and Santander conferences produced important new information 
relevant to USSTC's request. More significantly, however, two 
publications had appeared in late 2002 or early 2003 that will have a 
major impact on the public debate regarding smokeless tobacco in the 
context of tobacco harm reduction. Those publications, discussed above, 
are a report from London's Royal College of Physicians and a white 
paper prepared by a group of European tobacco and health researchers 
and public health advocates. In addition, several other scientific 
publications or documents had appeared that were relevant to USSTC's 
request for FTC guidance.
    Significant new information from the above-referenced scientific 
conferences and publications was reviewed in USSTC's May 9, 2003 
filing, submitted together with copies of the referenced materials (See 
Website).USSTC suggested in its submission to the FTC that the 
Commission may wish to consider holding a workshop or other forum to 
address the appropriateness of conveying tobacco harm reduction 
information as part of smokeless tobacco advertising. USSTC continues 
to believe that such a workshop would afford all of the participants in 
this public health debate an opportunity to present their views in a 
constructive and productive manner. It might also help form a consensus 
as to how we move forward on this important public health issue and 
could provide guidelines to ensure that any comparative risk 
communication is directed at adult smokers to avoid any unintended 
consequences.
                            iii. conclusion
    Some tobacco control activists have taken the position that USSTC 
should be prevented from communicating to adult cigarette smokers the 
prevailing view in the scientific community regarding the comparative 
health risks of tobacco products. Interestingly, they also believe that 
neither the federal government nor the public health community has any 
responsibility to undertake that task.
    On the other hand, some in the public health community believe that 
communication of that vital information could have a significant 
positive impact on the lives of adult cigarette smokers. Indeed, some 
in the public health community believe that USSTC must confront the 
question of whether it has a responsibility to step forward and 
communicate this critical information to adult cigarette smokers in 
light of the vacuum created by the federal government and the tobacco 
control activists.

    Mr. Verheij. Thank you.
    Mr. Stearns. Mr. Myers.

                   STATEMENT OF MATTHEW MYERS

    Mr. Myers. My name is Matthew Myers. I am the President of 
the Campaign for Tobacco Free Kids, and I am here today 
representing my organization.
    Today this committee has bene given a false choice. It is 
not about whether more should be done to reduce the harms of 
tobacco but how. This committee and its members do not face the 
Hobsean choice, do nothing or choose to use smokeless tobacco. 
The choice is not quit or die.
    Every one of the major public health organizations in this 
nation have an agenda for how we can reduce the death toll of 
tobacco. This committee, if it is serious about reducing the 
death toll of tobacco, has a prominent role to play.
    Let me start out by saying there are constructive things 
that we can and should do together. Despite the rhetoric, this 
nation has never funded a sustained, national, preventive 
public education campaign aimed at tobacco, either at children 
or to help people quit. If we want to reduce the number of 
people who smoke, States like Massachusetts, California, and 
Mississippi have shown we can do a great deal that we are not 
doing.
    Two, the Department of Health and Human Services 
Interagency Council on Smoking and Health have come up with a 
comprehensive report on smoking cessation. If we want to help 
those smokers quit, the answer is not to throw up our hands, as 
Mr. Rodu suggested. We have learned in states that have adopted 
aggressive programs with quit lines and access to smoking 
cessation programs that we can dramatically reduce the number 
of people who smoke.
    We all say that there are people out there who cannot quit, 
and there are, but there are many people out there who can quit 
who we have not helped.
    Three, there are proven smoking cessation products out 
there that have been shown to be safe and effective. We are 
doing far too little to encourage their broader use for harm 
reduction, to encourage their development in a manner that will 
make a major difference.
    And, fourth, our organization and every one of the major 
organizations in this nation have come before this committee 
before and have urged this committee to grant the Food and Drug 
Administration comprehensive regulatory authority over all 
tobacco products. If we want to do harm reduction based on 
science, not rhetoric; if we want to make the truism that 
knowledge if power, then we will insure that there is a 
government agency that has regulatory authority over the 
product so that we will know and consumers will know what is in 
that product; so that we will know and consumers will know 
truthfully not just what the manufacturers want us to know but 
the truth, the full truth about the relative harmful effects of 
those products.
    We will be in a position where we will be able to control 
the advertising. So we will not have to have a rhetorical 
debate in the abstract about whether marketing of relative 
health claims will make a difference in terms of the number of 
people who start or stop. We will have the authority of the 
agency to accomplish the goal we set out in this case.
    So that if this committee is truly serious about reducing 
the harms caused by tobacco, let me suggest there are three 
things we can do right off the bat. Let me also ask that we 
have this debate today about the use of smokeless tobacco in 
the real world, and the real world is this.
    As Dr. Carmona has said, smokeless tobacco as used in the 
United States has been conclusively shown to be a cancer 
causing agent. Smokeless tobacco as used in the United States 
is different than smokeless tobacco as a produce used in 
Sweden. It has far higher levels of nitrosamines, and in my 
testimony I have provided you specific studies that have been 
done that demonstrate that smokeless tobacco in the United 
States has infinitely higher levels of nitrosamine. The two 
most popular products, both made by UST fall into that 
category.
    Second, smokeless tobacco product or snus, as Congressman 
Cubin referred to it, in Sweden is controlled for other things. 
It is controlled for cadmium, lead, arsenic, nickel, chromium, 
benzopyrene. It is controlled for none of those things in the 
United States.
    If Sweden has a different experience, it is because they 
have a different regulatory regime. They have a different 
product.
    Three, Sweden is different for another reason that we need 
to think about seriously. Sweden bans tobacco advertising. 
Smokeless tobacco companies in Sweden did not make health 
claims on advertisements. That is not what happened. The 
scientific community communicated accurate, helpful information 
to consumers in the absence of consumers being bombarded by 
uncontrolled advertising, and that is what I really want to 
talk about here.
    In the United States today, in the absence of FDA 
regulation over this industry and this product, what are we 
really talking about when we are talking about this. Well, let 
me show you the reality of where we will see advertisements for 
smokeless tobacco products with claims that they are safer.
    Off to my left are two ads. The first ad on the far right 
is ``Cock-a-Doodle Freakin' Do.'' When we met with U.S. 
Smokeless Tobacco and said is this the kind of advertisement 
that under current law you would be permitted to make this 
claim in, the answer was yes.
    When we asked would the FTC have the authority to prohibit 
you from making such a claim in that ad if you got what you 
wanted, the answer to that was no. They did say, however, that 
that ad embarrassed them because of its obvious appeal to kids, 
and on February 28, 2002, wrote to us to say that ad would 
never appear again.
    Well, it did not. The ad on the left did. The reality is in 
the absence of meaningful regulation over tobacco marketing, it 
is not a guess. It is a virtual guarantee that we will do the 
same thing that we did in the 1980's, use this kind of 
advertising to expand the number of children who use tobacco 
products.
    And let me suggest when it is a child who uses smokeless 
tobacco, we are not talking about reduction of risk. We are 
talking about a cause of cancer.
    Now, a second thing that is very important and a very real 
concern----
    Mr. Stearns. I just need you to sum up.
    Mr. Myers. And I will.
    The risk of using smokeless tobacco to discourage quitting 
of those who cannot is also very real. Two thousand, the 
President of UST in describing his marketing strategy 
explicitly said the goal is dual use.
    For people who might otherwise quit because of clean indoor 
air restrictions, we want them to be able to use this product. 
For people who switch to dual use, they increase the risk of 
disease.
    And let me just finish with one critical last point. It is 
nice to have this debate in the abstract. We have to have it in 
the reality. There may be a place to discuss the role of 
smokeless tobacco, but it should take place only after this 
committee has worked with the rest of the Congress to grant the 
Food and Drug Administration the kind of regulatory authority 
to accomplish the goals you have all talked about.
    We heard a great deal today about 400,000 people dying. 
There is much we can do to solve that problem.
    [The prepared statement of Matthew Myers follows:]
 Prepared Statement of Matthew Myers, President, Campaign for Tobacco-
                               Free Kids
    Good morning Mr. Chairman, and members of the Committee. My name is 
Matthew Myers. I am the President of the National Center for Tobacco-
Free Kids, a national organization created to protect children from 
tobacco by raising awareness that tobacco use is a pediatric disease, 
by changing public policies and by actively countering the special 
interest influence of the tobacco industry.
    Mr. Chairman, I want to thank you for inviting me to testify on the 
question of whether tobacco, and specifically smokeless tobacco, can 
cure smoking. The question seems simple and straightforward enough, and 
so deserves a simple and straightforward response. The answer today is 
the same as it was almost twenty years ago when the House Energy and 
Commerce Committee last held hearings on the health effects of 
smokeless tobacco products. In the absence of the kind of meaningful 
regulation of both the content and marketing of smokeless tobacco 
products that could be provided by the Food and Drug Administration 
(FDA), the answer is no.
            smokeless tobacco is a cause of serious disease
    Let us start with a basic premise: smokeless tobacco products as 
sold in the United States have been found to increase the risk of oral 
cancer and other serious diseases. The Surgeon General, the National 
Cancer Institute, the American Cancer Society, the American Dental 
Association, the Scientific Advisory Committee to the World Health 
Organization and numerous other scientific bodies have all determined 
that there is conclusive evidence that smokeless tobacco products as 
sold in the United States increase the risk of serious disease. This 
conclusion is no surprise. Scientists have identified twenty-eight 
cancer-causing chemicals in these products.
    Today we are seeing history repeat itself. Just as we had the last 
time this committee met to discuss smokeless tobacco, we have a 
smokeless tobacco industry that refuses to acknowledge the health 
effects of its products seeking government approval to use health-
related claims in advertising whether or not that advertising's primary 
appeal is to children. In 1985 the then President of the Smokeless 
Tobacco Counsel testified before this Committee ``it has not been 
scientifically established smokeless tobacco is a cause of any human 
disease.'' In April 1999, a spokesperson for the United States 
Smokeless Tobacco Company, a subsidiary of U.S. Tobacco (UST) was 
quoted in the Providence Journal as claiming that it has not been 
``scientifically established'' that smokeless tobacco is ``a cause of 
oral cancer.'' This statement resulted in the Rhode Island Attorney 
General suing UST for violating the multi-state settlement agreement's 
prohibition on making false statements about the health effects of its 
tobacco products. UST was required to pay $15,000 to the Attorney 
General's office to fund efforts to prevent youth tobacco use and to 
formally acknowledge that the Surgeon General and other public health 
authorities have concluded that smokeless tobacco is addictive and can 
cause oral cancer.
    Just last year, UST claimed in a letter to the Federal Trade 
Commission (FTC) that ``smokeless tobacco has not been shown to be a 
cause of any human disease.'' UST would have this committee think that 
it is new evidence that has motivated it to seek approval to market its 
products as a safer alternative to cigarettes. The unfortunate reality 
is that this is a company that has never acknowledged that its products 
cause harm. How can you have a meaningful discussion about the 
potential to use a cancer-causing product to reduce the harm from 
smoking with an industry that won't acknowledge that its products cause 
harm and hasn't agreed to meaningful government regulation?
         smokeless tobacco advertising has increased youth use
    There is a second basic point about which there can be no dispute. 
Twenty-five years ago few young people in this country used smokeless 
tobacco products. However, in large part in response to a massive 
marketing campaign that in part portrayed smokeless tobacco use as 
safer than cigarette smoking, the number of people who used these 
products and the demographics of who used these products changed in the 
early 1980's. Smokeless tobacco usage among young males rose 
dramatically. As a nation we experienced a sixty percent upswing in 
smokeless tobacco use among young men resulting from a decade of 
smokeless advertising. The lesson is clear: in the absence of 
meaningful government regulation, our children are vulnerable to 
smokeless tobacco marketing that portrays smokeless tobacco use in a 
manner that kids find acceptable. Largely because the major smokeless 
tobacco manufacturers have fought FDA regulation of both their products 
and their marketing, our kids are as vulnerable today as they were 25 
years ago.
    Was it an accident that smokeless tobacco use rose in the 1980's 
even as the leading smokeless tobacco companies argued that they didn't 
market to kids? The answer from their own documents is no. According to 
internal company documents, UST developed a graduation strategy some 
time ago for hooking kids as new smokeless tobacco users. As one 
document states:
        ``New users of smokeless tobacco attracted to the product for a 
        variety of reasons are most likely to begin with products that 
        are milder tasting, more flavored, and/or easier to control in 
        the mouth. After a period of time, there is a natural 
        progression of product switching to brands that are more full-
        bodied, less flavored, have more concentrated `tobacco taste' 
        than the entry brand.''
    UST has also used the addition of flavorings to increase the appeal 
of its products to children. In 1993, cherry flavoring was added to 
UST's Skoal Long Cut, an entry or starter product. A former UST sales 
representative revealed that, ``Cherry Skoal is for somebody who likes 
the taste of candy, if you know what I'm saying.''
    Many had hoped that when the United States Smokeless Tobacco 
Company signed its settlement agreement with the states in 1998 its 
marketing practices would change dramatically. It did not happen 
because UST has apparently interpreted the broad prohibition against 
targeting youth as not requiring it to change the kind of advertising 
and youth oriented imagery that it has previously used that has made 
its products so appealing to children. A May 2002 study by the 
Massachusetts Department of Public Health found that UST's overall 
magazine advertising increased 135% from 1997 to 2001. The study also 
found that UST's advertising in magazines with high youth readership 
increased 161% during the same time period. For the period 1997-2001, 
UST's expenditures in youth magazines increased from $3.6 million to 
$9.4 million. Thus, smokeless tobacco advertising that appeals to 
children has continued unabated. One only has to look at the images 
projected by this advertising to understand its appeal to children. 
While UST may increase or decrease its advertising in certain magazines 
for its own purposes when it chooses, the evidence is that the MSA has 
not provided the legal club that was anticipated. In addition, although 
the multi-state settlement agreement has limited UST's ability to 
continue to do brand name sponsorships of some events and teams, UST 
continues to be a promotional sponsor of both professional motor sports 
and rodeo and bull riding.
    There is a legitimate concern that in the absence of meaningful 
government regulation of smokeless tobacco products, and how they are 
marketed the disastrous experience of the early 1980's could be 
duplicated again today. If that occurred, more lives would be 
needlessly lost as the result of an effort that started out seeking to 
reduce the harm caused by tobacco products.
                  not all smokeless products are alike
    There is a third fundamental point--not all smokeless tobacco 
products are alike. UST has continued to market products far higher in 
one cancer-causing class of agents--nitrosamines--than its counterparts 
in Sweden, despite the technical ability to produce low nitrosamine 
products. Data concerning Swedish snus is often cited by UST in support 
of its desire to market its products--all of its products, including 
its products with very high nirtrosamine levels--as a way to reduce the 
risks of tobacco use because of some data that indicates that it has 
not been associated with an increase in cancer in Sweden.
    Swedish smokeless products are much lower in cancer-causing 
nitrosamines than U.S. products. In 1995 the average Tobacco Specific 
Nitrosamines (TSNA) in Swedish Snus was approximately 5 mg/kg. By 2000 
that number had been reduced to 2 mg/kg. An independent study conducted 
for the State of Massachusetts by the American Health Foundation in 
2001 found, in contrast, that while the Swedish snus it tested 
contained 2.8 ug/g TSNA's, UST's two largest selling products--Skoal 
and Copenhagen contained 64 ug/g and 41.1ug/g TSNA levels, 
respectively.
    Even more disturbing, a new study just conducted by the American 
Health Foundation for the Massachusetts Department of Health that 
examined nitrosamine levels in snuff over the last three decades found 
that nitrosamine levels actually rose in one of the two most popular 
American brands in 2003 after declining in 2002. The American Health 
Foundation found that the TSNA levels in these brands this year were 
22.0 and 27.9 ug/g respectively--levels far higher than those found in 
Sweden at any time in the last thirteen years. These findings are 
critical to the Committee's consideration because TSNA's are widely 
accepted as the most serious carcinogens in oral snuff made in the 
United States.
    The American Health Foundation discovered another distinction 
between American smokeless tobacco products and Swedish snus. The 
nitrosamine levels of U.S. smokeless products increase once they leave 
the manufacturing plant and continue to increase the longer they sit on 
the shelf, in one case by an amazing 137 percent over six months. 
Swedish snus does not. It is clear that American manufacturers like UST 
know how to produce low nitrosamine smokeless tobacco products, but 
have chosen not to do so in their most popular products.
    Nitrosamines are not the only harmful component in smokeless 
tobacco products and this is another distinction between American 
smokeless tobacco products and those in Sweden. Swedish snus is also 
controlled for heavy metals found in smokeless tobacco products, like 
cadmium, lead, nickel and chromium, as well as substances such as 
arsenic, BaP's, and pesticides. None of those controls apply to 
American products. It is for these reasons that organizations like the 
Scientific Advisory Council to the World Health Organization in 
November 2002 distinguished between the evidence that it found 
conclusively linked U.S. smokeless tobacco products and oral cancer and 
the evidence that it found that the health effects of Swedish Snus were 
more uncertain.
    There is a third distinction between what is described as the 
Swedish experience and the likely result in the U.S. The marketing and 
advertising of smokeless products in the United States and Sweden is 
completely different. Sweden forbids the marketing and advertising of 
all tobacco products, and no claims in advertising about relative 
safety of these products are permitted. In the United States there are 
few restrictions on the advertising and marketing of smokeless tobacco 
products, and UST wants to make explicit claims about the relative 
safety of its products.
    The difference in the laws governing marketing in the two countries 
is critical. When our organization met with representatives of UST and 
asked if they believed that there was anything to prevent UST from 
using ads featuring roosters with what we perceived to be youth 
oriented slogans placed in youth oriented magazines to promote their 
products as less hazardous than cigarettes, they were quick to say no. 
They went further. UST said that if they were given permission to claim 
that their products were less hazardous than cigarettes, it was their 
belief that the FTC did not have the legal authority to tell them what 
kinds of ads or magazines those claims could appear in.
      claims of reduced risk could dissuade smokers from quitting
    There is a fourth fundamental point. Another potential risk to 
permitting smokeless tobacco to be marketed as a harm reduction 
mechanism in the absence of meaningful government regulation is that 
claims of risk reduction could lead smokers who would otherwise quit 
not to do so. The risk is real. In August 2001, UST announced plans to 
market a new smokeless tobacco product called Revel. UST is marketing 
the new product as a way to consume tobacco in places or situations 
when smoking is not allowed or is not socially acceptable. Many smokers 
quit after the enactment of restrictions on smoking in the workplace. 
There is legitimate concern that in the absence of any regulation of 
where and how smokeless tobacco products are marketed, some current 
cigarette smokers who would otherwise quit will switch instead to Revel 
or other smokeless products. This concern is compounded by studies that 
show that claims of reduced risk can lead consumers to falsely 
underestimate the relative benefits of quitting versus switching.
 there is much the federal government can and should do to reduce the 
                        harm of tobacco products
    My fifth point: There is a great deal that can and should be done 
to reduce the harm caused by tobacco. It is a misplaced priority to 
focus so much attention on smokeless tobacco in the current environment 
when there is so much that everyone agrees on that will make a real 
difference. Let me highlight some of the actions this Congress and the 
executive branch could take that will reduce the harms currently being 
caused by tobacco use in our society.
    1) The federal government is doing far too little to fund programs 
or adopt policies that have been proven effective in reducing tobacco 
use. Comprehensive tobacco prevention programs have been proven to work 
in every state that has tried them. Yet, the federal government has not 
funded a meaningful national sustained public education campaign.
    2) The federal government is doing far too little to fund cessation 
programs or to promote and make available the cessation tools that have 
been proven to help smokers quit. A recent Report conducted at the 
request of the Department of Health and Human Services laid out a 
comprehensive plan to encourage and assist smokers to quit. It should 
be adopted and implemented.
    3) The FDA already has authority over FDA approved medicinal 
nicotine products. These products have been proven to be safe, at least 
for short-term use, but little has been done to encourage their 
improvement or to explore their long-term use and potential for harm 
reduction. Before we turn to a cancer-causing agent as a tool to reduce 
the harms caused by tobacco, shouldn't we first make sure we have done 
everything we can to maximize the potential role of safe products that 
our government has already reviewed and approved? FDA can initiate a 
review of the use of nicotine replacement products without the need for 
further legislation, and it should do so.
comprehensive regulation of tobacco products by the fda iis a necessity
    My sixth and, perhaps, my most important point: The single most 
important action this Congress can take to reduce the harm that current 
tobacco products are causing is to provide the FDA with meaningful 
authority over all tobacco products. In case we needed further proof, a 
study conducted by scientists at the Centers for Disease Control and 
Prevention published in the journal Nicotine & Tobacco Research just 
last Friday demonstrated once again that without a federal agency that 
has oversight over tobacco products consumers are being deprived of 
critical information about the risks of individual products and are 
being sold products that contain more toxins than are necessary. The 
study found that even while tar levels in Marlboros have gone down over 
the last several decades, nitrosamine levels in Marlboros have 
increased and are higher, in fact, than most locally produced popular 
brands in other countries throughout the world.
    The high nitrosamine levels may provide at least a partial 
explanation for why cancer rates have not declined as expected when tar 
levels declined. Don't be confused; the importance of this study is not 
that we can save lives if we just reduce nitrosamine levels in 
Marlboros. The real importance of this study is that there are dozens 
of known carcinogens and toxic substances in current tobacco products 
that we are not controlling and about which the public is not being 
informed. This study proves that the reduction of any one toxin may 
have little impact if you don't control the level of other toxic 
substances, and that you cannot count on manufacturers on their own to 
provide this information truthfully and completely to consumers. The 
lesson is clear--what you don't know will kill you. In the absence of 
government regulation tobacco manufacturers--smokeless and cigarette--
will not produce the least hazardous product possible and consumers 
will not have the type of complete information needed to make a truly 
informed choice.
    The latest study reminds us that in the absence of a governmental 
agency with the authority to require manufacturers to test and disclose 
the toxic substances in their products, claims that any tobacco 
products reduce the risk of tobacco-related disease should not be 
trusted or permitted. Our experience with both light and low tar 
products demonstrates why this is so important. For decades tobacco 
manufacturers have advertised light and low tar products in a manner 
that they knew led consumers to believe that these products were safer 
than traditional cigarettes. The evidence is now conclusive that these 
light and low tar products have not in fact reduced the overall risk of 
disease. This public health tragedy could have been avoided if tobacco 
manufacturers had been required to disclose to the FDA the levels of 
different toxins in their products and their knowledge about the actual 
levels of tar and other harmful substances that consumers were 
receiving.
    Mr Chairman, this hearing dramatically underscores the pressing 
need for Congress to give the Food and Drug Administration the 
authority to regulate tobacco products effectively. A discussion about 
harm reduction has to begin with a discussion about providing the FDA 
with the kind of authority that is necessary to protect consumers, 
verify claims, and require that all reasonable steps are taken to 
reduce the harm caused to smokers. Is there a role for smokeless 
tobacco in a comprehensive effort to reduce the death toll from tobacco 
overseen by the FDA? No one has the information to make that decision 
today. The FDA should be open to all strategies that are scientifically 
based and that will save lives. The decision about what role smokeless 
tobacco plays in that overall scheme is a decision that can only be 
made by the FDA after it has all of the relevant information before it.
    Why the FDA? The FTC lacks both the authority and the expertise to 
do the job by itself. I worked at the Federal Trade Commission and was 
responsible for that agency's tobacco-related activities. The job of 
the FTC is to stop false, deceptive or misleading advertising. It is 
not a science-based agency. It lacks the authority to restrict 
smokeless tobacco marketing that appeals to children or to prevent 
claims of reduced risk to be used to make these products more 
attractive to children. It further lacks the authority to evaluate 
different smokeless tobacco products for relative safety, to require 
smokeless tobacco manufacturers to disclose to it changes in the 
product that could impact its relative harm or to require smokeless 
tobacco manufacturers to lower the level of toxic substances in their 
products. The FTC is most effective when it is able to work with the 
FDA with regard to products over which both have jurisdiction. If FDA 
is given this authority over tobacco products, the two agencies working 
together could make a very positive difference.
    Mr. Chairman, if UST and the other smokeless tobacco companies are 
serious about reducing the harm caused by tobacco and about assuring 
that the marketing of its products as less hazardous contributes to 
public health, they would support giving FDA the strong authority it 
needs to regulate tobacco products as outlined by the major public 
health groups. I have no doubt that FDA would have had this authority 
already but for the opposition of the major cigarette and smokeless 
tobacco manufacturers. They should not now be rewarded for their 
opposition to meaningful government regulation by being permitted to 
make health-related claims that we lack the ability to verify only 
because of the lack of such regulation.

    Mr. Stearns. And I thank the gentleman.
    Mr. Sweanor.

                   STATEMENT OF DAVID SWEANOR

    Mr. Sweanor. Thank you very much, Mr. Chairman.
    I am David Sweanor. I am a lawyer based in Canada. I spent 
the last 20 years working full time on a broad range of tobacco 
control activities both in Canada, where I am very pleased with 
a lot of what we have accomplished, including the last 12 
months. We appear to have knocked per capita consumption down 
by over 12 percent, which is a world precedent setting rate of 
decline.
    I have also been very involved in activities globally, 
although the views I express today are going to be those of 
mine and not for any of the organizations I have worked for.
    The public policy goal, public health goal of tobacco 
control is important to keep in mind. What we are trying to do 
is to reduce death and disease, and there is three broad ways 
we can do that. We can reduce tobacco onset. We can facilitate 
cessation, and we can reduce toxicity for those who use the 
product.
    This is important because the status quo is truly horrible. 
We have got a product that dominates the market that kills half 
of its long term users. Among these long term users we have 
people who believe that nicotine itself is what causes cancer. 
Many people do not want to use medicinal nicotine products 
because of the fear of cancer. They are less likely to use 
them. They will not use them as long as they should or as much 
as they should.
    They believe smokeless tobacco causes cancer at least at as 
great a rate as smoking. And perhaps most importantly, they 
believe light cigarettes are significantly less hazardous.
    Well, what do we do with a mess like this? And I think that 
a key part of understanding potential solutions is to recognize 
that though nicotine is a primary reason people would be 
smoking, combustion is a primary reason that they are dying.
    So that in theory at least reduced risk products make a 
tremendous amount of sense, and I think properly regulated by a 
body like FDA, these products have the potential to complement 
the other aspects of what we are doing in tobacco control of 
supporting what we are doing to prevent onset and to encourage 
cessation.
    But this is not merely theoretical. We do have examples of 
elsewhere in the world where medicinal products are given a 
broader range of indicated uses. We have examples of people who 
have used medicinal products for years with no apparent ill 
effects.
    We do have the example from Sweden where there has been a 
massive transformation in their market from one dominated by 
cigarettes to one dominated by smokeless tobacco, with a 
concomitant decline in the rates of disease that follows 
smoking. It does not follow tobacco use.
    In theory at least, there is a spectrum of risk here, and 
there would be the ability to offer products with information 
so that consumers get to decide where in that spectrum they 
want to be. I think to work though, you do need to have some 
form of comprehensive regulation. Without it, you cannot 
guarantee public health. You cannot give consumers protection, 
and I would argue you cannot effectively allow the operation of 
a marketplace because there is a whole lot of questions that 
come out, such as how do we know that a product really does 
reduce risk on a one for one basis compared to a standard 
cigarette.
    I would say that is fairly easy. There is no problem 
dealing with that dealing with medicinal nicotine. I don't 
think there is any problem with that dealing with low 
nitrosamine smokeless tobacco. The Surgeon General clearly 
does.
    How would we know that a product might only reduce some or 
what would be the impact if it only reduces some of the 
cigarettes somebody might otherwise smoke? Where does the 
product fit on that spectrum of risk? How does it impact on 
things like cessation and youth uptake, and how do you 
communicate a message to the public?
    Because one of the problems we have now is that even 
totally truthful communications from a tobacco company will 
probably not be believed. There has to be some way that people 
can get honest communications that are believable so that they 
are in a position to do something that their own health.
    I think these are very difficult issues, but I think that 
there is also a need for prompt action. You have got roughly 
1,300 Americans dying every day as a direct result of cigarette 
smoking. What do we do?
    Well, we do need that broad regulatory framework for all 
tobacco products, and in the meantime, we need to look at 
things like what should we do with medicinal nicotine. I mean, 
one of the clear consensuses that I have been hearing here 
today is that everybody seems to think we should have broader 
access to these products.
    Well, surely there can be some way that your committee can 
alert the FDA and the FTC that you want them to do that. You 
want them to examine the role of these products in harm 
reduction. While they are at it, what can they do to set 
something in place that allows the manufacturers of smokeless 
products to come forward and say, ``Here is what we have got on 
offer as well.''
    There ought to be more discussion about this. There needs 
to be a way that people can dialog and discuss what is 
happening because I do not think it is any longer a question of 
will there be alternative products or should we give 
information to consumers. It is a question of how are we going 
to evaluate those products and how are we going to get truthful 
information to consumers in a way that is actually going to 
allow them to make more informed decisions about their own 
health.
    Thank you.
    [The prepared statement of David Sweanor follows:]
   Prepared Statement of David Sweanor, Counsel, Non-Smokers' Rights 
                              Association
    Thank you very much for the opportunity to appear before this 
committee to talk about a truly critical issue for global public 
health.
    My name is David Sweanor, and I am counsel to the Non-Smokers' 
Rights Association [NSRA] in Canada, an organization I have worked for 
for over 20 years. NSRA has been a primary driver for a very full range 
of public health policies aimed at reducing the toll from tobacco. 
These include health-oriented tobacco tax policies, restrictions on 
tobacco sales, comprehensive restrictions of tobacco advertising and 
promotion, detailed package-based heath information--including picture-
based warnings covering 50% of packages and package inserts giving 
additional health information, comprehensive disclosure of additives 
and sales data, and regulatory authority over tobacco manufacturing 
standards. These policies have played a key role in very significant 
drops in Canadian tobacco consumption, which have outpaced US declines. 
Last year alone, and largely due to very significant cigarette tax 
increases, per capita consumption in Canada fell by 8%. I believe that 
this is two to three times the rate of decline in the US.
    In addition to my work in Canada I have, for many years, been very 
involved in tobacco control issues in this country, and globally. It is 
because of my interest in global public health, combined with the 
policy interactions between Canada and the United States, that I 
welcome the opportunity to speak to you today.
               the public health goals for tobacco policy
    It is possible to articulate a concise view of the public health 
goals of tobacco control activities. The ultimate goal is to reduce 
death and disease as much as is practically possible within the 
constraints of law and with respect for human rights. To achieve this 
goal there are essentially three broad areas of intervention. We can 
expand current efforts to prevent smoking onset and that encourage and 
facilitate cessation but we must also reduce the toxicity for those who 
continue to use tobacco.
    While many nations have done much to try to prevent onset of 
smoking, far fewer have made significant strides in promoting and 
facilitating cessation, and almost none have moved significantly on 
issues of toxicity reduction. This is a major concern to me since 
preventing the uptake of smoking, even when successful, will not have a 
significant impact on disease rates for another 20-30 years due to the 
lag between the onset of smoking and the development of the resulting 
diseases. To put this into an American perspective, the World Health 
Organization estimates that roughly 10 million Americans will die as a 
direct result of cigarette smoking in the next 20 to 25 years. All of 
these people are currently smokers, most say they'd rather not be 
smoking, and only cessation and toxicity reduction can impact on this 
unfolding tragedy.
    In short, the status quo is horrible. Cigarettes dominate the 
market, and will kill roughly 50% of their long-term users. Few 
consumers turn to FDA approved Nicotine Replacement Therapies such as 
the patch, oral inhaler, and lozenge. FDA-approved products have slowly 
increased in sales but consumers currently have far too few choices to 
replace their cigarettes and inadequate information to facilitate 
changes in their delivery system. The development of long-term 
replacement products appears to have been stymied by the FDA, and there 
has been no meaningful consideration of using these products for long-
term harm reduction. It makes no sense that so little consideration has 
been given to how to better use products that the FDA has reviewed and 
approved as safe--at least for short term use--to address the broader 
problems of how best to help more people quit and how to help about 
smokers who have tried to quit and can't. It also makes no sense that 
there has not been more discussion about whether or under what 
conditions smokeless tobacco products might be used to reduce the 
disease risk for smokers who cannot quit. The fact that prestigious 
bodies such as the Royal College of Physicians have pointed out that 
smokeless tobacco can be between 90% and 99.9% less hazardous than 
cigarettes cries out for serious examination of how these products can 
be used as part of an overall effort to reduce tobacco's health toll.
                  there may be a way out of this mess.
    Nicotine is the primary reason for tobacco use. It provides various 
pharmacological effects sought by many smokers. But it is also, 
especially when delivered through cigarette smoking, highly addictive. 
Yet nicotine itself is apparently responsible for only a very small 
part of the health damage caused by tobacco use. The reason smokers are 
dying in such great numbers is that they are obtaining their nicotine 
through the repeated inhalation of smoke. Nicotine provides the demand 
for tobacco, but it is combustion that is the principal reason for the 
morbidity and mortality.
    Simply put, cigarettes are an exceedingly ``dirty'' delivery system 
for the drug nicotine. If Americans got their nicotine by brewing 
tobacco leaves and their caffeine by smoking tea leaves we would be 
looking at a very different national disease profile, with tea likely 
responsible for hundreds of thousands of deaths per year and tobacco 
very likely a sidelight on the broader health picture.
    Replacing ``dirtier'' delivery systems with cleaner ones is an 
obvious measure to take in efforts to reduce toxicity for those who are 
going to continue using nicotine. Different nicotine delivery devices 
will have differing levels of risk. Theoretically we could place all 
these products on a spectrum and look at ways to give information and 
other incentives that would encourage consumers to move toward the 
lowest risk products that can still meet their needs. And one could 
also imagine a system of incentives that would encourage manufacturers 
to work to create products with lower and lower toxicity levels.
    But, like most seemingly straightforward public policy solutions it 
gets rather complicated in the real world. If it were truly easy to 
prevent a half million deaths a year in this country I am sure these 
hearings would not even be necessary since the corrective measures 
would have been taken many years ago.
                        the complicating issues
    We need to avoid making or reinforcing the mistakes of the past. 
Millions of smokers smoke ``light'' and ``mild'' cigarettes in the 
false believe that they are actually safer. It took years for 
independent scientists and governments to discover that these products 
are actually part of a massive consumer deception on relative risk. An 
effective harm reduction strategy must begin with an end to all forms 
of deception on relative risk and comprehensive science based 
regulation of all tobacco products and the marketing for those 
products. There needs to be a governmental agency that knows the whole 
truth about the relative health risks of different products and that is 
in a position to insure that consumers are provided the whole truth in 
a non-misleading way that promotes the overall public health. Without 
comprehensive regulation both the government and consumers cannot be 
sure they have complete information or the tools to best protect the 
public health.
    Regulation is only a first step, and is not an end in itself. It 
needs to be based on clear goals. Here, briefly, are some of the issues 
I think we need to consider when looking at potential reduced-risk 
products:

1. What is the degree of certainty that we want to have that a product 
        truly does reduce risk compared to standard cigarettes? On a 
        one-for-one basis this is not a difficulty when looking at 
        medicinal nicotine products such as the patch and nicotine gum 
        that are already fully regulated. It should also not be a 
        difficulty with low nitrosamine smokeless tobacco, given the 
        massive differences in potential disease risk compared to 
        cigarettes, if there was a mechanism that could stipulate the 
        actual level of nitrosamines and other harmful substances in 
        these products. If all cigarette use were simply replaced by 
        medicinal nicotine and low nitrosamine smokeless tobacco 
        products the death rates would be massively lower. But there 
        are many products, especially combustion-based products, where 
        the degree of risk reduction is by no means understood. There 
        needs to be some system in place that can credibly evaluate the 
        relative risks of all tobacco products.
2. What about the risk from a product that only replaces some 
        cigarettes? It is quite possible that a product could be far 
        less hazardous than cigarettes, but replace so few of the 
        cigarettes that someone smokes that it would have no 
        appreciable impact on risk. Yet if smokers believe such a 
        product to have significant health benefits they are, once 
        again, being deceived. How can we develop guidance on issues of 
        ``smoking reduction''?
3. How can we effectively place various current and future products on 
        a ``continuum of risk'' so that we can communicate to users the 
        information they need to make fully informed decisions? Many 
        smokers believe that ``light'' cigarettes are significantly 
        less hazardous than regular cigarettes, which is perhaps the 
        greatest consumer deception of our time. Consumers also believe 
        that the ``tar'' and nicotine listed on ads is what they 
        actually get from smoking various cigarettes. As shown in 
        Appendix 1, many also believe that nicotine causes cancer and 
        that using smokeless tobacco is as deadly as smoking. In 
        addition most harbor misunderstandings about the workings and 
        potential risks from medicinal nicotine that only serve to keep 
        them from availing themselves of these proven safe and 
        effective means of quitting smoking. This level of confusion 
        about such a critical public health issue is truly alarming, 
        and could possibly even worsen as new and unregulated products 
        hit the market.
4. How can we prevent efforts at toxicity reduction from undermining 
        our efforts on cessation and prevention of uptake? The main 
        planks of good public policy should be complementary rather 
        than adversarial. If the promise of toxicity reduction reduces 
        quitting or encourages more people to enter [or re-enter] the 
        market the unintended consequences could negate any potential 
        health gains from the intervention. This is the reason that 
        meaningful regulation of both claims and how potential harm 
        reduction products are marketed is critical.
5. Who should communicate messages to the public? One of the realities 
        of the present environment, and one borne out by the history of 
        foods and drugs prior to the existence of the FDA, is that 
        without strong government oversight those with a vested 
        interest in selling products should not be trusted to 
        communicate full and truthful information. With foods and 
        pharmaceuticals there are now stronger grounds to believe 
        claims due to the intervention of a credible, objective and 
        expert third party. Such third party validation is as important 
        to tobacco companies as it is to public health. Even a tobacco 
        company that tried to tell the truth about a massively reduced-
        risk product would probably not be believed in today's 
        environment. It is critical that FDA be given effective 
        authority over all tobacco products in order to ensure that 
        consumers are not misled about the relative risks of different 
        products, including reduced risk tobacco/nicotine products.
6. How can we be assured that the messages conveyed to the public are 
        being appropriately interpreted? What if smokers believed that 
        smokeless tobacco was something they could switch to after they 
        developed a smoking related disease like lung cancer? What if 
        they believed that all smokeless tobacco [including, say, that 
        sold in Sudan or Central Asia] had the same risks? There 
        appears to be a strong need for an institutionalized form of 
        post-marketing surveillance, both to assess attitudes and 
        behaviors.
7. How do we stay on top of what could be a rapidly changing 
        environment? Approximately 45 million Americans spend roughly 
        $80 billion a year buying a dirty drug delivery system that is 
        killing over 400,000 of them--and tens of thousands of non-
        smokers--annually. If this market were subject to effective FDA 
        regulation that actually promotes competition based on good 
        science and marketing that is not misleading, private 
        enterprise and informed consumers would cause a marketplace 
        revolution. Just as did the legal reforms on foods and drugs in 
        1906 and 1938.
    These are tough issues. But the need to address them is truly 
monumental. Your fellow citizens are dying from tobacco use, but they 
are also dying for want of truthful information on relative risks and 
from a lack of viable alternatives to cigarettes. There is a need for 
prompt action. The FDA and FTC already have authority over medicinal 
nicotine. I would hope that they would begin an immediate examination 
of how they might use their existing authority to expand the 
availability of these products and to explore their potential for harm 
reduction. Smokeless tobacco products could also be a key part of a 
harm reduction strategy if a federal agency were given the authority to 
regulate the content of these products and how they are advertised. I 
would hope that this, too, could be done quickly.
    There are no easy answers. There is, instead, a need to balance 
potential risks and benefits. There is a need to assess the science 
behind new products and the best way to communicate relevant 
information to consumers, and how best to regulate a market in order to 
give maximum protection for consumers. There is also a great need to 
stimulate discussion on how to proceed. It is no longer a question of 
whether there will be alternatives to cigarettes or whether truthful 
information on relative risks should be communicated to consumers. It 
is, instead, an issue of how to evaluate products and of how to 
communicate information in a way that complements public health goals 
and provides consumers with much needed information about the relative 
risks of alternative products.
    Thank you for your time,

    Mr. Stearns. I thank the gentleman.
    We are in the process of having three votes. We have about 
a little over 7 minutes left on the first vote, and we have two 
5 minute votes. And I will come back by voting early on the 
third vote.
    So I think we have got about a 15 to 18 minute break. So I 
appreciate that if you will be patient with us, the committee 
is going to be recessed for 15 to 20 minutes.
    [Brief recess.]
    Mr. Stearns. Will the subcommittee reconvene?
    I think at this point we have finished the opening 
statements. So I will start with some questions. Let me get 
right to this question.
    Dr. Rodu, oral cancer is a risk of using smokeless tobacco 
products. What is the risk of using such products, and how does 
that oral cancer risk compare to the use of cigarettes? That is 
the bottom line.
    Mr. Rodu. Oral cancer is a risk of smokeless tobacco use. 
That risk has been well defined by 20 epidemiologic studies. 
The risk can be quantified and was quantified by a 1981 study 
in the New England Journal of Medicine.
    Of 100,000 long term, that is, above 40 years or so, use of 
smokeless tobacco, of 100,000 users, 26 of them will develop 
oral cancer every year. Of that number, about 12 or 13, 
unfortunately, it is tragic, but they will die.
    Now, we also know the risks of smoking, and the risks of 
mouth cancer from smoking are somewhere in the range of double 
that risk. So the point I always make is that the smoker who 
switches to smokeless tobacco also reduces his or her risk for 
that disease as well.
    Mr. Stearns. You heard the Surgeon General when I tried to 
talk to him about the degree of risk between cigarette smoking 
and the smokeless tobacco, and the Surgeon General noted in his 
testimony that there is no significant scientific evidence that 
suggests smokeless tobacco is a safer alternative to 
cigarettes.
    And I even tried to push the idea of the Volvo versus the 
Miata, the very small sports car.
    Do you agree with his statement?
    Mr. Rodu. Quite frankly, I am dumbfounded by his statement. 
The scientific evidence that is out there both from the 20 
epidemiologic studies, from four cardiovascular disease studies 
in Sweden, from our work over 10 years published in numerous 
journals, including high quality journals like Nature, American 
Journal of Medicine; I just do not know how a Surgeon General 
can come to that conclusion, and in fact, I would be willing to 
submit a portfolio of research to him for his review and 
response because I am quite surprised.
    Mr. Stearns. Dr. Wallace, what additional issues need to be 
researched before you would be comfortable allowing companies 
to claim reduced risk product, whether it be a cigarette, 
smokeless product, or a medicinal nicotine?
    Mr. Wallace. Sure. There are many. We laid out in the 
report a long term research agenda, but some of the things that 
need to be done more quickly are to begin to understand how it 
affects the behavior. If you were to make a claim like that, 
how does it affect children's behavior? How does it affect 
physician behavior in making recommendations, but most 
importantly adult behavior?
    How does it change their habits? How do they use tobacco 
products? And what happens to them in the long term?
    All of these tobacco products may have outcomes that 
include things other than cancer, and we have to pay attention 
to those. So there is a whole menu of things to do. So there is 
a lot of research left to be done.
    A very important bit of the research agenda finally then 
would be to try to identify indicators in the body that future 
risks of cancer, heart disease, small fetuses, whatever the 
outcomes happen to be, in fact, might be different and reliably 
predict in advance. Otherwise you have to wait a very long time 
to see the effects of some of these products.
    Mr. Stearns. Dr. Tomar, you have heard Mr. Waxman talk, and 
in your opening statement we talked about this report that you 
have. In a study conducted by Dr. Lynn Kozlowski recently 
published in Nicotine and Tobacco Research, he indicated your 
gateway theory to be statistically unreliable because he argues 
you fail to take into account well known psychosocial 
predictors of smoking initiation, such as below average school 
performance, depressive symptoms or fighting.
    Now, this is your chance to give your side. So how do you 
respond to what he said about your report?
    Mr. Tomar. Well, there are two approaches. One, in the 
original paper that Dr. Kozlowski supposedly refuted, the 
argument I made in that paper is that if there are common 
psychosocial risk factors that account for moving from one 
tobacco product to another, wouldn't we expect it to move in 
both directions?
    And in fact, what we found was that 40 percent of young 
males who were using smokeless tobacco at the beginning of that 
study 4 years later had either added cigarettes to their use of 
smokeless tobacco or had switched to smokeless. We found almost 
no movement from cigarettes to smokeless tobacco.
    So that was the first one, and then actually you need to 
read the reply that has been accepted for publication in that 
same journal to Dr. Kozlowski's analysis. As I read his 
analysis using the same variables that he claimed were so 
critical and that I had omitted, and in fact, when I did the 
analysis limited to the group that actually uses the products, 
non-Hispanic white males and those who were under 16 at the 
beginning of the study, in fact, smokeless tobacco was not only 
a statistically significant predictor of subsequent smoking. It 
was a stronger effect than the risk behavior predictors that he 
felt were such a critical omission.
    Mr. Stearns. I will let someone else. Dr. Rodu, you may 
want to comment based upon the study from Sweden.
    Mr. Rodu. Yes. We have a study of tobacco use among adults 
in Sweden, and we saw, in essence, no effect of gateway from 
smokeless tobacco use to smoking, and that is among adults. 
Largely, the predominant public health message in Sweden, of 
course, is that snus is safer than smoke. I do not think there 
is anyone that doubts that in the Swedish environment.
    In the United States, the dominant public health message is 
that smokeless tobacco is just as dangerous as smoking, and 
that is seen in Mr. Sweanor's testimony. And so we have an open 
gate. It is an open gate for transition back and forth between 
smoking and smokeless tobacco use based on convenience, not 
based on health.
    So that you know, the other thing about gateway is that it 
is a convenient issue when you look at smoking is a gateway to 
smokeless or vice versa and drinking and sex and all kinds of 
behaviors, when, in reality, these behaviors are all grouped; 
they are all associated; and they are all present in a small 
proportion of our teenagers, and it is unfortunate, but it is 
association instead of causation.
    Mr. Myers. Mr. Chairman, could I just make two quick points 
with regard to that because I think they are vitally important?
    One is Sweden does not permit the kind of advertising I 
showed before so that the interaction between different 
products is really quite different because you do not have the 
same market forces. As a matter of fact, in Sweden, the same 
company for a long time owned both the major cigarette company 
and the same smokeless company.
    The second, and the reason we have a real life example in 
the United States is, you know, in the mid-1970's virtually no 
kids used smokeless tobacco products. The kind of marketing 
that I showed you that UST was engaging in through 2002 kicked 
in around the late 1970's, early 1980's, and what we saw was a 
little explosion of smokeless tobacco use.
    And part of the ad themes in those cases was a safer 
message, implicit safer message. So that when we talk about a 
concern about kids in this country, we are not talking some 
sort of ephemeral thing. We are talking about a real life 
example of what happened here.
    Now, we do not have any different kind of regulation today. 
We had all hoped in 1997 that the master settlement agreement 
would bring about a change in tobacco marketing by companies 
like UST, and instead what we saw was a dramatic up-tick in 
marketing, particular in youth oriented magazines until several 
Attorneys General threatened them.
    When they got out of those magazines, they used carefully 
the word ``we are suspending advertising in magazines like 
Rolling Stone,'' not ``we are getting out permanently.''
    So the concern that we all have is that in the absence of 
government regulation that controls the kind of marketing, that 
puts in place the kinds of regulations that they have in 
Sweden, that the effort to promote health reduction will, in 
fact, result in an explosion in youth smoking.
    Is it possible to deal with that? Perhaps if the FDA had 
full and comprehensive regulatory authority, we could, but that 
is what we ought to really be talking about here.
    Mr. Stearns. Okay. My time has expired.
    The ranking member.
    Ms. Schakowsky. Thank you.
    Dr. Rodu, is it not true that in 1999 the University of 
Alabama at Birmingham received $1.25 million unrestricted 
research grant from the United States Tobacco Company of 
Greenwich, Connecticut?
    Mr. Rodu. That is correct.
    Ms. Schakowsky. And is it also not true that the award 
supports the UIB Tobacco Research Fund, and you are the 
principal investigator?
    Mr. Rodu. That is correct.
    Ms. Schakowsky. I wanted to ask Mr.--I want to say it 
right--Verheij?
    Mr. Verheij. That is right.
    Ms. Schakowsky. Verheij a question. UST has indicated that 
it is a company that can be trusted not to use health claims 
for smokeless tobacco to attract children or to deter people 
from quitting. I want to talk a little bit about the ads, but I 
would like to ask whether you have told the whole truth today 
to Congress about levels of carcinogens called tobacco specific 
nitrosamines in your product.
    In your written testimony, you stated today, ``There is 
currently no difference in tobacco specific nitrosamine levels 
in U.S. moist snuff compared to Swedish moist snuff.'' However, 
your testimony only includes data on U.S. brands up to 1994, 
and if you will look at this chart, which is based on data 
provided by the Massachusetts Department of Public Health based 
on research by the Institute for Cancer Prevention, it shows 
that the levels of tobacco specific nitrosamines in your two 
leading products doubled between 1994 and today.
    The average level in the last 4 years has been 26.7 
micrograms compared to an average level of less than 10 in 
Swedish products for the last 20 years.
    Why did you not share any more recent data than 1994 with 
the committee today?
    Mr. Verheij. Well, we would be happy to share recent data. 
The fact is that products that we have introduced into the 
market over the past year, they have some of the lowest 
nitrosamine levels of any product in the world, including as a 
comparison to Swedish product.
    The data you have there is from the State of Massachusetts. 
We met with the State of Massachusetts with respect to their 
methodology. In fact, I had a phone call with Dr. Connolly 
probably 3 weeks ago where he was giving me current data on 
some of our leading brands.
    Our objective----
    Ms. Schakowsky. Are you talking about your moist product?
    Mr. Verheij. Yes, indeed, and including two new pouch 
products that we have introduced.
    The fact is I think as we have indicated in our submission, 
we have reduced nitrosamine levels more than 80 percent in our 
products over the last 20 years to the point that a Swedish 
government report in 1997 concludes that the differences were 
so small at this point that the differences in relative risk 
were negligible.
    Our objective is to reduce nitrosamine levels to the lowest 
levels possible. In the context----
    Ms. Schakowsky. Let me just say that my understanding is 
that the 2000 data, which you were given on August 16th, 2001, 
says that it is now 52.7 micrograms for that year.
    Mr. Verheij. And I would have to go back and look 
particularly at the timing of that. They were taking data 6 
months out from when the product was introduced on the shelf. 
Those products are not on the shelves after 6 months at all.
    And in fact, looking at data that we have, and again, I 
would be happy to provide the committee, in terms of our 
leading brands, we are talking about levels of 12 to 14 parts 
per million. We continue to work to reduce those to the lowest 
level possible.
    Ms. Schakowsky. Did you put any shelf life or expiration 
data on your productions?
    Mr. Verheij. Actually we do. On the Copenhagen product, 
there is a made date, and within 30 days of that made date that 
product is either purchased or taken off the shelf by our sales 
people.
    We have guaranteed to be fresh dates on our other products, 
which indicate the optimum period within which we think 
consumers should purchase the product. So we do have made dates 
on it.
    Ms. Schakowsky. So I understand that you refuse to accept a 
maximum shelf life for your product, that is, any kind of 
requirement to have a shelf life.
    Mr. Verheij. Not at all. We had a good discussion with Dr. 
Connolly at the time; showed him the fact that our products 
turn 52 times a year, the most made dates, the most shopped 
product other than milk in terms of date, and in fact, these 
products were coming off the shelves, and any significant 
increase in nitrosamine levels were toward the end of the 6-
month period when these products are not available to 
consumers.
    Ms. Schakowsky. Okay. Let me ask you this. In a letter the 
company wrote February 5, 2002, it says, ``It is UST's position 
that smokeless tobacco has not been shown to be a cause of any 
human disease.'' That was in a letter from Brian Cave, LLP, to 
the Federal Trade Commission. That is your submission to the 
FTC.
    Mr. Verheij. And I think we have also made clear in our 
public filings that based on the scientific literature taken as 
a whole, the company has not taken the position that the 
product is safe, and the question on the table in the context 
of the debate we have all been talking about here is the fact 
that smokeless tobacco is considered to be considerably less 
harmful than cigarette smoking, and whether that information--
--
    Ms. Schakowsky. No, no. That is not what I am asking. ``Has 
not been shown to be a cause of any human disease.'' Mr. 
Verheij. I do not think that statement is inconsistent with the 
position that we have taken, which is that we have not taken a 
position that the product is safe.
    Ms. Schakowsky. Dr. Tomar, would you respond to that?
    Mr. Tomar. Well, it seems to be contradicted by Dr. 
Rodgers' earlier statement, where he acknowledged that these 
products cause cancer. It has certainly been established by the 
International Agency for Research on Cancer and the U.S. 
Surgeon General.
    Mr. Verheij. If I may follow up on that, the fact is that 
based on studies that were available in 1986, the Surgeon 
General reached the judgment that smokeless tobacco can cause 
oral cancer.
    Ms. Schakowsky. You know, actually I have gone over my time 
already and want to make one other point.
    I just think that this is an astonishing statement given 
the unanimous actually, including Dr. Rodu's statement about 
disease.
    Now, why anyone would think that this magazine with Britney 
Spears on the cover might be read by young boys I have no idea, 
but I just want to say this is December 2001, and in it is an 
ad showing a fire fighter putting out a fire, clearly one of 
the heroes of 9/11, ``a bit braver, a pinch better,'' and it is 
for Skoal.
    I just want to say that given that and the ad for Rooster, 
it is not credible to say that these products are not pitched 
to children.
    Thank you.
    Mr. Verheij. Mr. Chairman.
    Mr. Stearns. The gentlelady's time has expired.
    Yes?
    Mr. Verheij. Mr. Chairman, if I may for 1 second.
    Mr. Stearns. Sure, yes.
    Mr. Verheij. I think there has been a lot of focus on old 
ad campaigns some of which, you know, once certain concerns 
were brought to our attention like the rooster ads that Mr. 
Myers showed, we discontinued those once we took a second look.
    The fact is what we are talking about in this debate is 
communications to adults about information that there is an 
increasing consensus in the scientific community that smokeless 
tobacco is considerably less harmful than cigarette smoking.
    And we are urging a workshop where all of these parties can 
participate so that we can come up with guidelines that will 
address everybody's concerns before those communications are 
made. And, frankly, you could take our company out of it 
entirely.
    That means the remaining issue is to what degree does the 
government and the public health community have an obligation 
to communicate this important information to adult smokers who 
are not quitting.
    Mr. Stearns. The gentlelady's time has expired.
    The Chairman of the full committee, Mr. Tauzin.
    Chairman Tauzin. Thank you, Mr. Chairman.
    Mr. Myers, you made the point several times that we tend to 
be debating this in the abstract and we ought to look at real 
world information and real life conditions, and I think that is 
a good point.
    One of the things you have pointed out to us, however, was 
that the story in the Washington Post over the weekend that 
said smoking is projected to kill a billion people worldwide 
this century and that one out of two long term users of 
cigarettes will die, that is not abstract. That is real. And 
that is pretty awful.
    And I think what we are beginning to have here is a debate 
on whether or not we can do something about those real life 
statistics.
    I want to tell you a real life example and the reason why I 
have got such an interest in here in this debate and why I want 
to see this indeed, not just workshops but forums and 
discussions and more hearings, and I want to see the scientific 
evidence debated and the policy issues debated.
    One of the people I love dearest in my life is the former 
chief of my local staff who served me four times as chief of 
staff. He has two sons. One is a Navy Seal and the other is a 
college student right now, he and his son both addicted to 
smoking.
    They were able to use the product called Revel, which is 
one of the newest, I think, products you were talking about, 
the pouch spitless variety of smokeless tobacco. It has made 
the difference for them. Both of these people used it where 
they have never been able to quit smoking before, and they quit 
smoking, and now they have quit using this product, and they 
are completely off of tobacco.
    That is a real life example. I have got a couple of kids I 
would love to see quit smoking. They try, and they cannot quit, 
and if there are products like this Revel, if there are 
products that are being developed that not only are 
considerably less harmful than the cigarettes my children are 
smoking----
    Mr. Myers. Mr. Chairman.
    Chairman Tauzin. Let me just finish.
    If there are products like that and there are products like 
that that can be a bridge for people like my dear friend and 
his son who went from smoking cigarettes to using these 
products, to using no tobacco products; if there are products 
like that, doesn't it make sense for us to find some way to 
allow someone, if not the company, someone to communicate the 
existence of those products to the adults of this world, the 
billion people worldwide who are going to die in this century 
if we do not give them another option?
    Mr. Myers. Mr. Chairman, let me response.
    Chairman Tauzin. Please.
    Mr. Myers. Because the organizations with which I work 
spend day and night trying to figure out how we can reduce the 
death toll from tobacco.
    Chairman Tauzin. I know you do.
    Mr. Myers. We do it at all levels. We try to help prevent 
kids from starting, which is the best way.
    Chairman Tauzin. Yes.
    Mr. Myers. We try to make more funds available to help 
people to quit. And you know, sadly in most states we are not 
doing that. So that your friends, your colleagues, your loved 
ones should have more resources available to you, and I would 
hope we would work together.
    Third, based on your statement this morning, I know you 
share our concern, that you do not want to see the unintended 
consequences of this action, and for us to avoid the unintended 
consequences that will occur by the kinds of ads that I have 
shown, the only way we can do that and make sure that your 
loved ones are provided the best tools available to quit, 
whatever they may be, is to make sure that we have a 
comprehensive regulatory system.
    Chairman Tauzin. Yes, but I have limited time, Mr. Myers.
    Mr. Myers. Well, let me----
    Chairman Tauzin. No, no. You opened it up. I have limited 
time.
    Mr. Myers. To ahead.
    Chairman Tauzin. That is a good debate, and we are having 
it. We have been having that one for years, whether the Food 
and Drug Administration ought to regulate tobacco, and that 
debate is going to go on, I suspect, for a long time, but in 
the meantime my children are smoking cigarettes.
    Mr. Myers. Well----
    Chairman Tauzin. In the meantime there are 400,000 citizens 
who are going to die because they cannot quit smoking even 
though they want to.
    I have got some examples of what is going on in Europe. 
These are what is required in the EU on cigarettes. These are 
the warnings they put out in the EU. ``Smokers die younger.'' 
``Smoking kills.'' ``Smoking seriously harms you and others 
around you.'' ``Smoking clogs your arteries and cause heart 
attacks and strokes.'' ``Smoking kills.'' ``Smoking can damage 
the sperm and decrease its fertility.''
    I mean, the EU puts out warnings like we do not even think 
about putting out on cigarettes, and the EU is now saying, 
leading tobacco experts in the EU are saying information to us 
telling us they think they made a mistake when they partially 
banned smokeless tobacco products because they are looking at 
Sweden and they are seeing how Sweden is really seriously 
reducing the deaths from lung cancer to males who have been 
able to use something other than a cigarette to get their 
nicotine habit satisfied.
    Answer, please.
    Mr. Myers. Two quick points, and they are very important 
ones.
    One, we would welcome to work with you to improve the 
health warning on tobacco products.
    Chairman Tauzin. Good.
    Mr. Myers. So that it is serious.
    Two, the recommendations----
    Chairman Tauzin. Yes, but wait a minute.
    Mr. Myers. Wait, wait. Let me respond.
    Chairman Tauzin. No, no.
    Mr. Myers. Go ahead.
    Chauirman Tauzin. I have got the time, and I am not going 
to let you do that to me.
    I am not telling you we do not have these warnings. I am 
telling you the EU is telling us these warnings are not 
working.
    Mr. Myers. No, that is not what they are saying.
    Chairman Tauzin. No, I am reading their report, and they 
are telling us that they are seriously considering repealing 
their ban----
    Mr. Myers. No, no.
    Chairman Tauzin. [continuing] because they are looking at 
the only country in the EU that met the World Health 
Organization's target of reducing smoking prevalence to 20 
percent. The only country was Sweden.
    Mr. Myers. May I just have the opportunity----
    Chairman Tauzin. Where, in fact, they promoted the use of 
something other than smoking cigarettes.
    Mr. Myers. I think it is very important to understand 
exactly. The report you are referring to is written by five 
people for the EU, not the EU. What it recommends, just as the 
Royal College of Physicians recommends, is that no health 
claims be permitted in the absence of a comprehensive 
regulatory system like we are proposing for FDA. That is what 
the EU recommendation is.
    Now, the EU has banned smokeless tobacco, and they said, 
``We should go back and relook at that.'' But what they have 
said about health claims is that health claims should only be 
permitted within the context of a comprehensive regulatory 
system so that we do not have the unintended consequences, so 
that we do not market them to kids, and----
    Chairman Tauzin. My time is up.
    Mr. Myers. [continuing] so that we know what is in them.
    Chairman Tauzin. My time is up.
    I accept the fact that we ought to be very, very careful 
how we regulate these health claims.
    Mr. Myers. But we are not doing that now.
    Chairman Tauzin. But wait, wait. Let me make the point.
    But we are never going to get there if the Surgeon General 
has never ever read some of these reports that look at that 
there are alternatives that are less harmful than smoking 
tobacco.
    We are never going to get there if the head of the FTC, who 
has jurisdiction to verify the validity of claims, is not 
willing to lead a forum, a discussion; if the Health Department 
in this country is refusing to lead it because they think the 
FTC ought to lead it.
    And if you are going to keep insisting that the Food and 
Drug Administration ought to do it, we are going to have this 
debate forever while alternative options that should be 
discussed, that should be available to my children and to my 
dearest friend who finally found one of these, used it, and got 
off of cigarettes, are never even discussed publicly because we 
are too scared to talk about the truth about where the science 
is really going.
    If the science is really going there, if people in this 
country can know that there are alternatives for them to use to 
get off of smoking cigarettes to get the nicotine highs, and 
they are not finding out about it because we are too afraid, 
too unwilling to lead and have some open discussions and 
debates about them to figure out how to regulate it properly to 
make it work well, then shame on us.
    And I agree with you. We ought to have that great debate. 
Help us have that debate.
    Mr. Myers. Mr. Chairman, my most important point----
    Chairman Tauzin. Yes, sir.
    Mr. Myers. [continuing] is that in the absence of 
comprehensive regulation your desire to do good will produce a 
public health tragedy.
    Chairman Tauzin. That is a fair concern.
    Mr. Myers. It will turn into a marketing tool for the 
tobacco industry.
    Chairman Tauzin. That is a fair concern, and that ought to 
be part of the debate.
    Thank you, Mr. Chairman.
    Mr. Stearns. The Chairman's time has expired.
    The gentleman from Texas.
    Mr. Green. Thank you, Mr. Chairman.
    And I appreciate the line of questioning from our Chairman. 
I think our children or smokers know the alternatives because, 
like our Chairman, I have had a father-in-law who died of lung 
cancer and a brother-in-law who died of lung cancer, and they 
tried everything. And in fact, they even chewed, too, and they 
still died of lung cancer, but that was because of smoking.
    But I think our children know alternatives just like they 
know alternatives already that we do not want to tell them 
about the use of condoms, but that is a debate that this 
committee has had other times.
    Let me ask Mr. Sweanor, and having read your testimony 
where you talk about placing dirtier delivery systems with 
cleaner systems, and I know we talk about different ways, but 
obviously you have never sat next to someone who chewed and had 
to spit in a cup next to you, but let me ask you some 
questions.
    Does Canada recognize smokeless tobacco as a safer 
alternative?
    Mr. Sweanor. As far as I know, that is a debate that simply 
has not happened in Canada. Smokeless tobacco is actually 
rarely used in Canada.
    Mr. Green. Okay. You mean not even in the western 
provinces?
    Mr. Sweanor. Alberta actually does have use of smokeless 
tobacco, and that is now a debate emerging with the Drugs 
Education Agency in Alberta.
    Mr. Green. Because we have rodeos in Texas and the Midwest 
like in Canada and Alberta and other parts. But what tobacco 
control measures are in place in Sweden that are not in place 
in the United States? For example, the tax rates; the smoke 
free indoor air law includes restaurants effective the first of 
next year in advertising. Is there a difference on how Sweden 
treats all tobacco products?
    Mr. Sweanor. Yes, in different ways. There will actually be 
less protection from second hand smoke in Sweden than what I 
find many places in the United States now, but Sweden does have 
a ban on tobacco advertising. It has a fairly comprehensive----
    Mr. Green. Is that both a print ban and an electronic ban?
    Mr. Sweanor. Yes, yes. It is like Canada or the rest of the 
European Union. It has much larger warnings on packages, 
further disclosure to consumers, restrictions on how the 
product is displayed at retail.
    Mr. Green. Okay. Let me go on. Are Swedish customers or 
consumers told by companies or the government that smokeless 
tobacco is a safer alternative to cigarettes?
    Mr. Sweanor. I found that to be a very interesting thing 
because they are----
    Mr. Green. Is it a program by the companies or the 
government that allows them to say that it is a safer 
alternative? Does Sweden do that?
    Mr. Sweanor. No. My experience is that the government has 
not told them that. The companies have not explicitly told them 
that, but that information is got to them through the 
scientific community and through simply word of mouth.
    Mr. Green. Okay.
    Mr. Sweanor. I think similar to----
    Mr. Green. Okay. Let me because I only have a couple of 
minutes left.
    Are you aware that Sweden has an active program to reduce 
snuff tobacco use and that the Swedish Health Ministry aims 
primarily to get people to quit tobacco entirely?
    Mr. Sweanor. Yes, that is certainly their goal, is to 
reduce tobacco use entirely.
    Mr. Green. Okay, and so all of this study that has been 
talked about the science that we are quoting a Swedish study, 
even the Swedish health ministry has an active program to 
reduce snuff tobacco use.
    Mr. Sweanor. It is aimed at overall reduction of death and 
disease by reducing tobacco use in all forms as much as 
possible Mr. Green. Mr. Chairman, let me introduce into the 
record and I ask consent to introduce into the record 
information from the Swedish Health Ministry about their 
handling of smokeless tobacco, and it is addressed to Mr. 
Sharfenstein, and it says your question number 1, whether 
advertising claims on reduced risk are permitted for smokeless 
tobacco in Sweden and the regulation of tobacco products in 
Sweden are contained in Tobacco Act, and I will put the whole 
letter in the record.
    It concludes it is not permitted to use advertising claims 
on reduced risk as the legislation does not permit for 
advertising for tobacco products as was defined as commercial 
advertisement, according to the Swedish constitution, and no, 
that the Ministry of Health and Social Affairs does not have a 
campaign to switch to smokeless tobacco in the meaning of the 
product or snuff.
    I would like to ask unanimous consent to have that placed 
in the record.
    Mr. Stearns. Without objection, so ordered.
    [The information referred to follows:]

              Ministry of Health and Social Affairs
                                                     Sweden
                                                        2 June 2003
    Dear Mr Sharfstein, I've been appointed by Mr Magnusson to answer 
your questions on the Swedish tobacco legislation and policy.Your 
question no (1). Whether advertising claims on reduced risk are 
permitted for smokeless tobacco in Sweden
    The regulations of tobacco products in Sweden are contained in the 
Tobacco Act. This Act does not distinguish between different tobacco 
products, no matter which area of legislation concerned. Therefore the 
prohibition of the advertising for tobacco products remains the same no 
matter the product would be a cigarette or any other tobacco products, 
such as oral tobacco.
    To conclude on this matter, it is not permitted to use advertising 
claims on reduced risk, as the legislation does not permit for 
advertising for tobacco products in what is defined as commercial 
advertisement according to the Swedish Constitution. When marketing 
tobacco products a businessman shall observe particular moderation. In 
particular, advertising or other marketing may not be invasive, 
actively seeking new areas of trade nor encourage the use of tobacco.
    Your question no (2) and (3)
    No, the Ministry for Health and Social Affaires does not have a 
campaign to switch to smokeless tobacco, in the meaning of the product 
of snuff.
    On the issue of cessation there is a national telephone line The 
Stop Smoking Line, which is given national resources, in order to offer 
a national competent advice on cessation. The main focus for this 
branch of the County of Stockholm is smoke cessation, even though there 
are a significant number of users of oral tobacco as well who make use 
of their service.
    In a recent Government Bill the government concluded that one of 10 
public health goals would be to raise the ambition on tobacco 
prevention. The main focus are:

--a tobacco free start in life for all children by 2014
--a decrease by half of the groups of adults who are smoking most by 
        2014
--a decrease by half of children, under 18 according to Swedish 
        legislation, who use tobacco cigarettes or oral tobacco, i.e. 
        snuff at the year of 2014,
--no person should be subjected against his will to smoking by those 
        around him or her.
    In the same Bill the Government underlined the need for further 
research into the health aspects of oral tobacco, and it was also 
considered that this was already a task for the National Institute for 
Public Health.
    The Government has also directed 30 million Swedish Crowns (cirka 3 
800 000 US dollar) to the area of tobacco prevention, each year during 
a period of 3 year from 2002 to 2004. The Government has also 
underlined smoking cessation as being one of the areas of prevention 
where the health care has a specific responsibility. The resources 
directed to tobacco prevention in the health care sector are managed by 
the County Council, and as tobacco prevention is an integrated part of 
the health care system it is difficult to a specified on how much is 
spent on tobacco prevention.
    During the past three years there has been an influx of new and 
cheaper cigarettes in Sweden. These so called low price cigarettes, 
which hold a price that has been around 10 Swedish crowns (circa 1.27 
US dollar) lower than the most popular tobacco brand in the most sold 
category of cigarettes, is taxed according to an EC-directive. The 
consumer price on the most popular brand in the most sold category is 
38.50 Swedish crowns, (circa 4.9 US dollar). As the EC-legislation has 
been changed the Swedish government has taken the opportunity to raise 
the taxation on this group of cigarettes to 90 percent of the tax on 
the most popular brand in the category of the most sold cigarettes. The 
Swedish government has chosen the level of 90 percent as it has been 
shown in the past that sudden increases in the taxation might affect 
the level of smuggled goods into Sweden. The reason for the increase 
was among other things the knowledge that a low price on cigarettes 
might trigger the consumption. Therefore a survey has also been started 
on a monthly basis in order to improve knowledge on the consumption of 
tobacco.
    Since 1997 Sweden has an age limit on the sale of tobacco products 
of 18 years of age, no matter being cigarettes or oral tobacco. There 
is no sanction according to this legislation on the person under the 
age limit, as the sanction was to be placed on the seller.
    Even though it is prohibited by the law to sell tobacco products to 
persons under the age of 18, it has been shown that there are still a 
considerable number of persons under the age of 18 that are able to buy 
tobacco there has been an introduction of a notification system of 
sellers of tobacco. This has been introduced in order to improve the 
compliance of the Tobacco Act. The National Institute for Public Health 
was according asked to give a report in the beginning of 2004 on the 
consumption of tobacco by persons under the age of 18 years.
    In the Swedish Tobacco Act there is a catalogue of premises that 
are to be smoke free. In practice the only public premise that is not 
smoke free is the restaurants and cafes. From January 1, 2003 every 
restaurant or cafe have to provide for that a part of the premise is 
smoke free. The Swedish parliament has also stated that the goal is 
smoke free restaurants from January 1, 2004. There is a report from the 
Swedish National Institute on what it takes to fulfill the parliaments 
goal on smoke free restaurants. This report is no distributed for 
consultation with national authorities, organizations and other 
interested parties. Finally, what can be said on the catalogue of smoke 
free premises in the Swedish Tobacco Act, it does not regulate outdoor 
environments, except for school playground.
    The Swedish Council on Technology Assessment in Health Care has 
confirmed that the use of nicotine replacement products is a major part 
of a successful cessation policy. As these are approved as 
pharmaceutical products these are sold the sales places of the Swedish 
Pharmaceutical Monopoly.
            Yours Sincerely,
                                           Ulrika Lindblom,
                                                       desk officer

    Mr. Green. And with the brief time I have left, Mr. 
Verheij, UST uses a Swedish study as a foundation for its 
argument that should be able to advertise that smokeless 
tobacco is less harmful. However, Mr. Myers points out that 
snus products in Sweden are very different than the products 
marketed here. For example, he states that the levels of cancer 
causing nitrosamines in Swedish products are much lower than 
the United States.
    Could you comment on that in what brief time I have left?
    Mr. Verheij. I would be happy to.
    The fact is that we have successfully reduced nitrosamine 
levels in our products to extraordinarily low levels, and some 
of the products we have introduced recently have levels much 
lower than any other smokeless tobacco product in the world.
    Another reason why we believe the Swedish model is 
applicable is I think as Mr. Sweanor pointed out, the fact is 
that culturally and through the public health community, the 
type of communication we are talking about today is actually 
reaching adult smokers.
    Mr. Green. Okay.
    Mr. Verheij. That is not happening here in the United 
States.
    Mr. Green. Let me talk about it because I think there is a 
new study, I understood, from the State of Massachusetts which 
indicates that nitrosamine levels are increased in U.S. 
products.
    Is that you all's products?
    And I would like Mr. Myers if he had a brief comment on 
that.
    Mr. Myers. Sure. Yes, the sad reality is that in several 
independent studies done by the American Health Foundation for 
the State of Massachusetts, they found something quite 
inconsistent with what Mr. Verheij said. What they found was 
that for the two most popular products from UST, one study done 
in 2001 found that the comparable Swedish product had 2.8 parts 
per million of nitrosamines, whereas Copenhagen had 41.1 and 
Skoal had 64.0. Those products are not comparable by any remote 
imagination.
    And also attached to my testimony is an updated report, 
again, done for the State of Massachusetts, not done 
exclusively in Massachusetts. Samples were picked up around the 
country by one of the most respected labs.
    And what it found there, too is that in 2003 nitrosamine 
levels in the two most popular brands by UST remain about 10 
times higher than those that we are comparing in Sweden. It is 
a very disturbing thing because the numbers for these two are 
22.0 and 27.9 compared to under 2 for the comparable products 
in Sweden.
    So we are talking not apples and oranges even, but apples 
and grapefruits is the difference here. Unfortunately when the 
State of Massachusetts asked U.S. Tobacco if they would agree 
to a 10 parts per million, much higher than in Sweden, the 
answer was no.
    I think what it is time for us to do is to compare apples 
to apples, and if we are really interested in low nitrosamine, 
what we need to do is have a regulatory agency that can set 
standards for it so that we can protect consumers and 
accomplish the goals of this committee.
    Mr. Green. Thank you, Mr. Chairman.
    Mr. Verheij. Mr. Chairman, if I just may----
    Mr. Stearns. Sure.
    Mr. Verheij. [continuing] because I think Mr. Myers is 
comparing apples and refrigerators. The fact is----
    Mr. Green. I would think more like apples to gasoline 
maybe.
    Mr. Verheij. Well, at least if it is apples at least they 
are healthful.
    No, I think that the fact is the appropriate comparison 
between the data that Mr. Myers cited from Sweden is comparison 
to the types of products that Chairman Tauzin was pointing out, 
which is the Revel product, which has the lowest levels of 
nitrosamines of any smokeless tobacco product in the world, and 
that is the appropriate comparison.
    Because pouch products are 50 percent of the market in 
Sweden, unlike here, which is about 3 percent. So the notion is 
not to compare Copenhagen with a pouch product in Sweden. They 
should be comparing a pouch product in Sweden with a pouch 
product in the United States, and, in fact, the levels are 
comparable or lower.
    Mr. Myers. What is stunning is that UST has demonstrated in 
Revel that it can produce a low nitrosamine product, but what 
it sells to most Americans, Copenhagen and Skoal, it has 
nitrosamine levels multiples of that.
    If they can produce it for Revel, why don't they produce 
for every one of their products? Why should some people be in 
more jeopardy than others?
    Mr. Stearns. One last word here before we move on.
    Mr. Verheij. I appreciate that, Mr. Chairman.
    The fact is that we are working to reduce the levels of 
every product we had. In Revel we are working with a product 
that was newly introduced last year with new technology. We can 
now take that technology and start applying it to products like 
Copenhagen that have been on the market for 180 years, and that 
does not happen overnight without dramatically changing 
Copenhagen.
    The overall goal is to reduce the levels to the lowest 
levels possible in the world in such products as Revel.
    Mr. Stearns. The gentleman's time has expired.
    The gentleman from Kentucky, Mr. Whitfield.
    Mr. Whitfield. Thank you, Mr. Chairman.
    Mr. Myers, you have made some comments and Mr. Verheij made 
some products about their product, Revel, and comparing that 
with snus, and a number of people have indicated in their 
testimony today that if the U.S. had a similar regulatory 
system, as they have in Sweden, that that would make a 
difference.
    So is it your position that if the U.S. had a similar 
regulatory system that you would have no objection to products 
like snus or Revel?
    Mr. Myers. If the U.S. had a comprehensive regulatory 
system, then scientists with full knowledge about the product 
would be able to make appropriate comparative science claims. 
We are not in a position to do that.
    You know, we just learned how little we really know. There 
was a recent study done on Marlboro that we thought had reduced 
tar levels for many years that discovered, in fact, Marlboros 
have among the highest nitrosamine levels of products anywhere 
in the world.
    What we need is an agency that can control each of the 
potential toxic substances and then make a scientific decision. 
We will abide by the science, whatever that is.
    Mr. Whitfield. Now, do you think that in Sweden and the 
European Union they have valid science on this issue?
    Mr. Myers. There are widespread disputes about both what 
the cause of the Swedish experience is and what the impact of 
the Swedish experience is, but you know, one of the very 
documents that you cited this morning, the one written by the 
five scientists to the European Union, had an explicit sentence 
in it that says, ``We do not know if the experience in Sweden 
would apply anywhere outside of that experience because of the 
full maze of regulatory mechanisms they have in place and the 
difference in the product.''
    What I would be willing to say to you is let us give an 
agency like the FDA the kind of authority over it so that it 
can make sure that if these products can, in fact, reduce the 
harm to disease, then there is an agency to control so that 
they accomplish the goal.
    Step one is giving an agency the authority to do the job.
    Mr. Whitfield. How many of you on the panel agree that 
there is sufficient scientific evidence already in Sweden or 
elsewhere that smokeless tobacco is safer to use than 
cigarettes?
    Mr. Myers. I would be happy to start that if you want.
    Mr. Whitfield. Well, I think I know how you----
    Mr. Myers. Well, let me just say because I think it is 
important. For the----
    Mr. Whitfield. Let me get----
    Mr. Myers. [continuing] overwhelming majority of Americans.
    Mr. Whitfield. Let me get Dr. Rodu in on this. Dr. Rodu, 
you raised your hand.
    Mr. Rodu. Well, yes, I raised my hand to agree with your 
statement that smokeless tobacco use is on the order of 98 
percent safer than smoking. I think that the epidemiologic 
research published by others over the last 50 years 
substantiates that. Our own epidemiologic models substantiate 
that.
    Mr. Stearns. Will the gentleman yield just for a second?
    Dr. Wallace, I understand you are on the first panel of 
another committee. So we want to thank you for coming, and you 
are welcome to leave now so that our colleagues can share your 
wisdom.
    Mr. Wallace. Thank you, Congressman. I appreciate it.
    Mr. Stearns. Sure.
    Mr. Whitfield. Mr. Sweanor, did you want to make a comment?
    Mr. Sweanor. Certainly my view is on a one-for-one basis, 
there is no doubt that smokeless tobacco products such as is 
sold in Sweden or the United States is going to be much, much 
less risky than getting your nicotine by smoking a cigarette.
    Mr. Whitfield. Now, Mr. Myers, do you accept Mr. Verheij's 
statement that Revel has nitrosamines equal to the level of 
snus or do you have any basis of knowing that?
    Mr. Myers. it is exactly why we need a regulatory agency, 
so that we can have a regulatory agency that tests it and we do 
not have to depend on what U.S. Tobacco tells us.
    Mr. Whitfield. Okay. I notice that in the European Union 
evidently they recently changed their warnings and they said 
this tobacco product can damage your health and is addictive as 
it applies to smokeless tobacco, but they removed the warning 
about cancer.
    Is anyone aware of that?
    Mr. Myers. That is in Sweden, not in the European Union, 
sir.
    Mr. Whitfield. That was in Sweden?
    Mr. Myers. Yes.
    Mr. Whitfield. Okay.
    Mr. Myers. Sweden does not permit the sale of smokeless 
tobacco. I mean the European Union does not permit the sale of 
smokeless tobacco.
    Mr. Whitfield. Mr. Sweanor?
    Mr. Sweanor. Yes, it is an EU role that applies to Sweden, 
which still has the ability to sell smokeless tobacco. My 
understanding is it was removed because the evidence simply was 
not there to substantiate it. The evidence coming out of Sweden 
could find no conclusive proof that the product was causing 
cancer at all.
    Mr. Whitfield. Recently CDC came out with a study about 
nitrosamines and the content in certain American products, and 
the bottom line to that is I know since that report has come 
out or since the beginning of it, the way you dry this tobacco 
has changed. The technology has been changed.
    But would you make the argument that tobacco grown in 
foreign countries is safer than the tobacco grown in the U.S.?
    Mr. Myers. I am glad you raised that issue. The study done 
by the CDC was of Marlboros manufactured both abroad and here. 
So it is an American brand, but it includes foreign made 
cigarettes under Philip Morris International as well.
    What it found was that Marlboro had higher levels of 
nitrosamines in the vast majorities of countries in which it 
was sold not matter where it was manufactured. The problem was 
not American tobacco. It was not American manufacturers. The 
problem was how Philip Morris chose to manufacture that 
product, which was particularly disturbing because a study by 
British American Tobacco showed that when Philip Morris 
actually enters countries with Marlboro, they initially produce 
low nitrosamine products equal to the level in the country and 
then gradually they raise them up so that there is a conscious 
decision going on, or at least a noncaring decision going on, 
that has nothing to do with American tobacco.
    American tobacco is the best in the world.
    Mr. Whitfield. Mr.Rodu?
    Mr. Rodu. Could I make one quick comment about nitrosamines 
to place it in perspective?
    The epidemiologic studies performed between the 1950's and 
1980's that show a relative risk of smokeless tobacco mouth 
cancer association at about 2 to 4 were conducted in people who 
were using products where the nitrosamine levels were in the 
100's.
    Now we are talking about nitrosamine levels in the single 
digits and teens, and we are arguing differences that are very, 
very small compared to products used 40 years ago.
    Mr. Whitfield. I would like to ask Mr. Myers just one other 
question if I could.
    You have been pretty emphatic about this, which I 
understand. I did not see this, but recently they said on C-
SPAN that you replied to someone who called in, and that you 
made the comment cigarettes are the most dangerous form of 
tobacco used. Literally one out of two long term users of 
cigarettes will die from tobacco use. Smokeless tobacco, cigars 
are harmful but not to the same magnitude.
    Did you say that?
    Mr. Myers. It sounds like an accurate quote of what I would 
have said. The important issue here is whether or not the 
government is going to put a stamp of approval to make a health 
claim in an unregulated environment that could have tragic 
marketing consequences.
    The position I take that these claims should not be 
permitted in the absence of meaningful regulation reflects the 
absolute consensus of every single major American public health 
organization, from the American Medical Association to the 
American Cancer Society, the American Lung Association, to the 
American Public Health Association, the American Dental 
Society.
    There is no emerging consensus on the other side. This is 
the view of the public health community.
    Mr. Stearns. The gentleman's time has expired.
    I would say to the gentleman from Kentucky I heard Mr. 
Myers say that U.S. tobacco is the best in the world. So I 
think you can take that back to your constituents.
    Mr. Whitfield. Maybe you could go down and visit with my 
farmers.
    Mr. Myers. I actually do all of the time.
    Mr. Stearns. Mr. Stupak.
    Mr. Stupak. Thank you, Mr. Chairman, and I apologize for 
being late, but I did catch some of this in between meetings. 
So just a couple of questions, if I can.
    Is there any profile or high risk individuals who should 
not use tobacco?
    Mr. Myers. Humans.
    Mr. Stupak. Well, I mean besides humans. But I mean is 
there certain characteristics that you look for? In some drugs 
there are considered high risk patients for this use. Is there 
anything like that? No profile like that has been done?
    Mr. Myers. Not to the best of my knowledge. It is true that 
one out of two long term users of tobacco products will 
eventually die from the disease. That means that one out of two 
do not, but it is worse than playing Russian roulette. The real 
concern is that virtually every one of them start as a child, 
and what we need to do is break that step.
    Mr. Stupak. Dr. Rodu, in answer to my friend's question 
over there, you are talking about when the study was done 
between the fifties and the sixties that certain parts were in 
the 100's and you said now it is down to single digits and it 
really did not make any difference from a health risk area? Can 
you explain that a little bit more?
    Mr. Rodu. Yes, okay. Let me clarify that.
    When most of the epidemiologic studies were performed it 
was between the 1950's and the 1980's. They measured smokeless 
tobacco associated risks in users during that period, and 
during that period nitrosamine levels were in the range of the 
hundreds. They were quite a bit higher than they are today.
    So we have a relative risk from that period in the range of 
two to four, and that is what we have based all of our 
epidemiologic models on.
    Now we are talking about products that are substantially 
lower, and in fact, the American Health Foundation has said 
that they are at least 70 percent lower than they were in the 
1970's. So we are talking about a shift downward in risk from 
the 1950's through the 1980's. So we go from two to four down. 
We are going toward one, and one being the risk of a nonuser of 
tobacco.
    Mr. Stupak. Is it fair to say then, as maybe UST would 
argue then, that it is safer now than it was in the fifties to 
eighties?
    Mr. Rodu. Well, Mr. Verheij can respond for UST. I believe 
that products are safer now than they were in the 1980's.
    Mr. Stupak. Because of this nitrosamine?
    Mr. Rodu. Yes, because of nitrosamine level reduction.
    Now, when you have a relative risk to start with of around 
two to four, it is very difficult to show without enormous 
populations and huge studies any more reduction in risk. So 
that reduction is going to be very difficult to quantify, but 
in fact, the safer products can be the better off we all are.
    Mr. Stupak. Okay. Mr. Verheij, UST petitioned the FTC to 
advertise this as safer, correct? And then that was withdrawn, 
that petition?
    Mr. Verheij. We actually petitioned the FTC for an advisory 
opinion. We thought that instead of going out and communicating 
this information to adult smokers who were not quitting that we 
would get some guidance from the Federal Government. It was 
unlike anything any other tobacco company had done.
    Mr. Stupak. But did you withdraw the petition?
    Mr. Verheij. We have temporarily withdrawn the petition. We 
have supplemented the record probably 3 weeks ago.
    Mr. Stupak. Okay, and there has been some talk about doing 
a workshop on this issue now, right, with the FTC?
    Mr. Verheij. That is certainly what we are urging, a 
workshop. We believe this is a process. The Institute of 
Medicine report was a process. Our filing with the FTC was a 
process. This hearing today is part of the process, and we 
think a workshop would be a very important part of the process.
    Mr. Stupak. If you did a workshop, would FDA be invited to 
that workshop?
    Mr. Verheij. Absolutely. We would encourage that.
    Mr. Stupak. The Centers for Disease Control?
    Mr. Verheij. Absolutely.
    Mr. Stupak. Should FDA regulate smokeless tobacco then?
    Mr. Verheij. Well, there have been a lot of proposals about 
fda regulating cigarettes and smokeless tobacco. Historically 
we are opposed to that because the fact was it was going to 
regulate----
    Mr. Stupak. Right.
    Mr. Verheij. [continuing] it as a medical device.
    Mr. Stupak. But if you are talking about it being safer, 
smokeless tobacco would be safer, and if FDA regulates 
nicorette and all of this other stuff to help you reduce your 
smoking, if this is a product that is safer and encourages less 
smoking, shouldn't they also regulate smokeless tobacco then?
    Mr. Verheij. Well, as we have laid out in our public 
filings, we believe that if there was a regulatory regime that 
recognized this concept of tobacco harm reduction and the 
distinct differences between smokeless tobacco and cigarettes, 
that is something the company would seriously consider 
supporting.
    Mr. Stupak. But if it is tobacco harm reduction, shouldn't 
we also know that not only from an advertising point of view 
but also health point of view, and that is where the FDA, CDC 
and others, NIH, would come in?
    Mr. Verheij. I think that is implicit in the process. I 
think what you see here along the panel, however, is a 
difference of viewpoint, is when, in fact, we are going to 
begin communicating to adults this information about the fact 
that smokeless tobacco is considerably less harmful. Mr. Myers 
would say 5 years in the future when we get FDA regulation.
    Mr. Stupak. Sure.
    Mr. Verheij. Dr. Rodu says we should have started this 10 
years ago. So you see a range of views, and that would be a 
part of the discussion at the forum.
    Mr. Stupak. But aren't you really saying that we should 
advertise first and then let the FDA look at it second? Isn't 
that what you are saying?
    Mr. Verheij. Well, I think the broader societal question is 
as we move through this process, what are we going to 
communicate?
    And I believe Chairman Tauzin raised the concern about what 
are we doing today. Yes, everyone is moving toward some 
increased regulation, but I think a number of people on the 
panel here are saying what should be done today. What type of 
communication?
    And, again, take the company out of it, but what type of 
communication should come from the public health community to 
adult smokers who are not quitting today?
    Mr. Stupak. But should the public health concern be 
addressed before you advertise? I mean, there is advertising 
for smokeless tobacco in Sports Illustrated, the USA Today's 
sports page. It seems like the advertising is getting ahead of 
the health concerns.
    Mr. Verheij. And I think, Congressman, that the underlying 
assumption that there would be some broad based advertising in 
Sports Illustrated or some publication that has some concern, 
again, take the company out of it. Say there is no 
communication from the company.
    Mr. Stupak. Okay.
    Mr. Verheij. The remaining question is: what type of 
communication will come either from the government or from the 
public health community about truthful, accurate information 
about the significant differences between smokeless tobacco and 
cigarettes.
    Mr. Stearns. The gentleman's time has expired.
    The gentlelady is recognized.
    Mrs. Cubin. Thank you, Mr. Chairman.
    It troubles me that I have heard today in this hearing 
that, to paraphrase, we will not even consider a possible 
action that could benefit smokers unless we have Federal 
regulation of that. In fact, we will not even consider looking 
at whether or not a product is beneficial unless we have 
Federal regulation.
    I disagree with that very much. I do not think that the 
first thing that we ever should do is look to Federal 
regulation to solve our problems, although there certainly is a 
point in our society when that is appropriate.
    As far as Federal regulation of these tobacco products, 
tobacco, whether you smoke it or whether you use snus, is a 
legal product. Now, if this should ever happen that it does 
become regulated under the FDA, then what is the next thing? 
Are we going to be regulating cream gravy or white sauce, as it 
might be called here in the northeast?
    It just bothers me that some people think the only way to 
solve a situation is that the government has to take control. 
Historically they do not do that good a job.
    So I do not think that you can rule out listening to 
scientists who have done studies. You cannot rule out listening 
to information and facts that are presented to you simply 
because the Federal Government does not have regulation over 
that area.
    I would like to start by asking a question, just kind of a 
general question about truth in advertising. Commercial 
advertising is protected by the First Amendment, provided that 
it is truthful----
    Mr. Stearns. Will the gentlelady just move her mic a little 
closer to her.
    Mrs. Cubin. Oh, yes. Thank you.
    --providing that it is truthful and not mislead. The 
government may regulate commercial speech if it has a 
compelling interest in doing so and its regulation is 
reasonably tailored to directly advance that interest.
    In relation to the promotion of tobacco reduction products, 
what compelling State interest is directly advanced by 
suppressing truthful, reasonably tailored messages to the 
public?
    Do you understand the question?
    Mr. Myers. I will start with you because it is based on a 
misconception, and that is----
    Mrs. Cubin. No, you will not start. You have talked more 
here today than everyone, and we know how you feel.
    Mr. Myers. But the government does not----
    Mrs. Cubin. No, sir. I would like to address someone else.
    Mr. Stearns. The gentlelady controls the time.
    Mrs. Cubin. Thank you.
    I do not care. The question I want to ask is that the 
government can regulate commercial speech if it has a 
compelling interest in doing that and the regulation is 
reasonably tailored to directly advance that interest that the 
Federal Government has.
    So in relation to the promotion of tobacco harm reduction 
products, is there then a compelling State interest directly 
advanced by suppressing this truthful, non-misleading 
advertising?
    Mr. Verheij. Congresswoman, if I may start with that, and 
then maybe others will chime in.
    The fact is we believe there is no compelling interest by 
the state, particularly when you look at the offsetting 
potential benefit to public health that people like Mr. Sweanor 
and Dr. Rodu and many others have articulated, to the fact that 
this information through some mechanism--and again, I think 
everyone focuses on our company as proposing we would be the 
only avenue.
    Frankly, we would like to get out of the middle of that 
fight because of concerns and go back to if we are taken out of 
the equation, what obligation does the government or the public 
health community have to communicate this information----
    Mrs. Cubin. Exactly.
    Mr. Verheij. [continuing] to adult smokers.
    Mrs. Cubin. Exactly, and there are scientists and 
researchers that are available that are nonbiased. Like you 
said, take tobacco out of the equation. They could produce good 
information that we could base decisions on without Federal 
oversight and without Federal regulation.
    If the information is accurate and fairly presented, 
doesn't the public have a right to receive that information and 
evaluate for themselves the usefulness of that information?
    Yes, Dr. Rodu.
    Mr. Rodu. Ms. Cubin, we have tried for 10 years to publish 
strongly scientifically based research in order to help, and I 
believe your husband is a practicing physician.
    Mrs. Cubin. That is correct.
    Mr. Rodu. In order to help people like him help their 
patients because we believe knowledge is power, and it can help 
him help patients to make decisions that allow them to lead 
longer and healthier lives.
    Mrs. Cubin. Thank you.
    I do appreciate that, and that is exactly the course that 
my husband has tried to follow because that is one thing he 
tells every single patient that comes in there that smokes, 
carte blanche. You must stop smoking.
    And they tell him, ``I cannot stop smoking.''
    And at that point, he needs help in dealing with them when 
they have tried gum and when they have tried patches. You know, 
anything else would be a benefit to him and especially to his 
patients.
    Mr. Rodu. Ma'am, we would like to say he is in the 
trenches.
    Mrs. Cubin. Thank you.
    Mr. Rodu. And the closer you are to real patients and real 
problems the more likely you are to consider an option like 
smokeless tobacco.
    Mrs. Cubin. And that is the truth. I agree with you.
    Mr. Burton. Congresswoman, could I weigh in?
    Mrs. Cubin. I do not see who is weighing in.
    Mr. Burton. I am sorry.
    Mrs. Cubin. Yes, you bet, Mr. Burton.
    Mr. Burton. I guess I will come back to a comment that I 
think I heard the Surgeon General make this morning, which was 
in the presence of truthful and accurate information, 
nonetheless consumers might be incapable of making the right 
decision in their own interest, as well as the interest of the 
public health.
    Mrs. Cubin. Excuse me. Would you repeat that?
    Mr. Burton. Certainly. I guess the point I am making or 
want to make is harking back to something that the Surgeon 
General said, and I think I have this from my own experience in 
being before the agency, the FDA, on drug applications. One of 
the burdens we as a drug supplier have to meet is a 
demonstration that information can be correctly interpreted. 
Can it be understood by the average consumer and can the net 
behavior actually be within the bounds of what we expect and 
what we know to be a safe and efficacious use of that product?
    So I think in part my answer and I think part of the answer 
of the Surgeon General was that even information--and I am not 
accepting that the information as you framed it is necessarily 
truthful and accurate--but were it to be found to be so, I 
think the question is can consumers take that information, 
interpret it, and act accordingly.
    And I think from our research and from what we have heard 
from other public health experts, it is not only an individual 
decision, but it is also a public health population impact that 
we need to be concerned about. If that information is targeted 
to a different group of people, like young adults who might 
otherwise not start smoking, upon hearing what may be truthful 
and accurate information to a so-called committed smoker, if 
that young adult decides to begin using those tobacco products 
on the assumption that that is a safe alternative, I think that 
is a public harm that I think counters the public interest of 
providing that accurate information.
    Mrs. Cubin. Thank you.
    I appreciate that, but that is a very weak response when 
you consider the 10 million people that are going to die over 
the next 2 decades because we are worried about children 
starting to use a tobacco product, when in fact we do not even 
know--and I have heard no source that quotes that smokeless 
tobacco is a gateway drug.
    Just real quickly.
    Mr. Stearns. The gentlelady's time has expired.
    Mrs. Cubin. Just real quickly. I have been waiting all day.
    Mr. Stearns. Okay. Do you want to take unanimous consent?
    Mrs. Cubin. Well, what are you going to do, Markey?
    No, I would like to ask one other question. I would like to 
ask for unanimous consent for one question.
    Mr. Stearns. The gentlelady has asked for unanimous consent 
for one question. Is there any objections?
    Mr. Myers, I understand you have been waiting patiently and 
you have to be on this other panel. So I think you are welcome 
to leave. You have given yeoman's service here since 10 
o'clock. So if you have to be on another panel.
    Mr. Myers. I am not on another panel, but I do have an 
emergency that I have to go to.
    Mr. Stearns. Okay. Well, that is fine. That is fine. We 
appreciate your staying this long and your patience and so 
forth.
    Mr. Myers. Thank you.
    Mr. Stearns. The gentlelady is recognized.
    Mrs. Cubin. I do not want to be redundant and most of the 
questions that I wanted to ask have been asked and answered, 
but I would like to as Mr. Verheij a question.
    Back to the Swedish study that males are reported to have 
the highest rate of smokeless tobacco use and the lowest rate 
of cigarette smoking in any Western country, and the daily use 
of smokeless tobacco by Swedish males now, as has been stated, 
is that of the use of cigarettes. Tobacco related mortality in 
Sweden is reported to be lower than any other European or 
American country.
    From the point of view of comparative health risk, 
comparing cigarette smoking to smokeless tobacco or snus, as we 
call it, would you describe your company's Revel product and 
what your marketing plans for that are?
    Mr. Verheij. I would be happy to. The fact is that a number 
of researchers believe that the Swedish model is, indeed, 
applicable here in the United States. The difference is that, 
as I think one of the panel members noted, there is a cultural 
acceptance there as to the fact that smokeless tobacco is 
considered to be significantly less harmful than smoking.
    And, yes, it is not a communication from a tobacco company 
to consumers in a newspaper, but when I was there in September 
for a conference on smokeless tobacco, there was a full page ad 
in the primary newspaper signed by four leading Swedish 
researchers, talking about this conversion from smoking to 
smokeless tobacco, and the fact is how fortunate they thought 
Sweden was to have smokeless tobacco as an alternative for 
those smokers who do not quit.
    So I think that is a good example where the communication 
does not have to come from a tobacco company.
    When we began marketing Revel or at least test marketing 
Revel, it was advertised as a product for the times: you cannot 
smoke. The fact is we would prefer to market Revel to adult 
smokers who are not quitting on the basis of completely 
switching from smoking to smokeless tobacco because what we 
have found out in the research is that to convince a smoker to 
switch to smokeless tobacco, they need a very compelling 
reason, and they need a very compelling reason because an 
overwhelming percentage of them have been taught over decades 
now that smokeless tobacco is as dangerous as cigarette 
smoking, and so they think they are trading oral cancer for 
lung cancer.
    They are shocked when they are provided truthful, accurate 
information about research in this country and other countries 
concluding that smokeless tobacco is significantly less harmful 
than cigarette smoking.
    Once they hear about that research and actually accept it, 
then they have that compelling reason, and Revel is designed to 
attract adult cigarette smokers, adult cigarette smokers only, 
and I think any communication we plan in conjunction to that 
will be directed to only that audience.
    Mrs. Cubin. Thank you.
    Mr. Stearns. The gentlelady's time has expired.
    Mrs. Cubin. Thank you.
    Mr. Stearns. The gentleman from Massachusetts.
    Mr. Markey. Thank you, Mr. Chairman, very much.
    I do not think anyone is going to debate that it is less 
dangerous. I think we are going to accept the fact that it is 
less dangerous, but that is a little bit like saying, well, you 
know, we have been playing Russian roulette with three bullets 
in a six-chamber gun and now we are going to reduce it down to 
only one bullet in the six-chamber gun. So it is obviously a 
safer game playing Russian roulette with only one bullet rather 
than three bullets in a six-bullet chamber.
    But eventually if you play the game long enough, then 
enough people are going to get harmed that most people would 
say that is too dangerous a game to be played. And I think that 
is, you know, why you have the level of concern that members 
are indicating, Mr. Verheij, today.
    Let me ask this. The Massachusetts Attorney General and 
others wanted to examine and reveal to the public the additives 
that are being put into smokeless tobacco products. Why can't 
the public know what those ingredients are so they can make up 
their own mind as to whether or not they or their family 
members would use that product?
    Mr. Verheij. As you know, Congressman, under the 1986 act 
we as a company and an industry are required to report all of 
our ingredients to HHS, which I think the Surgeon General 
confirmed this morning indicated that they had an ability to 
look at that list, and every year we dutifully file that list, 
and to the extent that HHS has a concern, it is explicitly 
authorized to report to Congress about the concerns they have.
    In connection with that, however, there are measures taken 
to protect the proprietary interests that the companies have in 
unique ingredients used in the product.
    As for another state, for example, Texas has adopted a 
similar statute and, in fact, the industry reports its 
ingredients to Texas.
    I think where the difference was in Massachusetts, that in 
our view and the industry's view, that the statute at the time 
that was put into place was really not a disclosure statute, 
but it was really a forfeiture statute where we would have 
forfeited the proprietary value of the ingredients we used, and 
the court of appeals agreed with that argument.
    Mr. Markey. I understand that, but the problem is from a 
consumer perspective, as the Surgeon General said today, there 
are carcinogens in your product and those carcinogens also 
contribute to other types of diseases, cardiac disease in 
addition to respiratory.
    Mr. Verheij. Well, I think now, if I understand your 
question correctly, we have shifted from ingredients, which are 
those items that are added to the product by the company, all 
of which are approved for use in food or food grade, unlike 
other tobacco products, and I think by your question, I 
understand you want to switch to constituent levels of 
nitrosamines.
    And as indicated earlier, the Massachusetts Department of 
Health has conducted at least one survey. We have met with the 
department in terms of trying to evaluate that data. Dr. 
Connolly of your State called me about 3 weeks ago. He was 
particularly concerned about levels in competitor's product, 
gave me some idea of the levels of the constituent levels in 
our product in the current survey. He is very concerned about 
the fact of being able to continue that testing, although his 
budget has been cut dramatically.
    And we actually engaged in a discussion about industry 
funding of that survey for him on an annual basis so that the 
State of Massachusetts can actually do that.
    Mr. Markey. Well, would U.S. Smokeless Tobacco Company 
support a regulation which mandates that all smokeless tobacco 
products contain nitrosamine levels below 10 micrograms per 
gram if this were implemented in Massachusetts?
    Mr. Verheij. Well, I think we had an agreement with Dr. 
Connolly that everyone was moving in the direction of trying to 
reduce it to the lowest levels possible. I guess I would have 
some questions about the level of 10 parts per 1,000,000 
because when Dr. Connolly proposed that, when he was advised by 
a newspaper reporter about the levels of nitrosamines in the 
Revel product, which is around 2 to 3 parts per million, his 
response was, ``Well, there is no magic about 10.''
    So I think it would be worthwhile for everyone, the 
industry in your State and Dr. Connolly to get together and 
work out some standards that he perhaps as an encouragement to 
the industry, goals and targets which we would be happy to sit 
down and work with him to do that.
    Mr. Markey. I think in general that the American public has 
become acclimated to knowing what is inside of the products 
which they purchase. My father late in life became a health 
food nut. I would have sworn that a guy that used to just put a 
whole can of sardines and slice off 12 heads at once and then 
pop them all in his mouth when I was a boy would become a 
health food fanatic at 70 and 75, 80 and 85, but he did.
    And so here is a product thought that----
    Ms. Cubin. Would the gentleman yield?
    Mr. Markey. I will be glad to.
    Ms. Cubin. Are you supposed to cut the heads off of 
sardines before you eat them?
    Mr. Markey. Well, my father thought it was fun if they all 
squirted toward my brother's head.
    Ms. Cubin. Oh.
    Mr. Markey. And it was just kind of----
    Ms. Cubin. Being from Wyoming.
    Mr. Markey. My father was a milkman for the Hood Milk 
Company.
    Ms. Cubin. Well, thank you.
    Mr. Markey. And his form of humor was lost on my mother, 
although my brothers and I thought it was very funny.
    Ms. Cubin. I can relate to that.
    Mr. Markey. But anyway, I am just saying his eating habits 
were not the best, but he later just became a fanatic in 
studying every single ingredient in every single thing that he 
put into his system, and but for smoking the doctor said he 
would have gone on indefinitely over the age of 100.
    And here is a product though that we know is inherently, 
you know, dangerous because of the carcinogens that are in it, 
and the more information which is out there, I think the more 
likely that there would be an abstinence that was total. That 
is not to be an unimaginably high goal a generation ago, but 
the whole culture has changed.
    If my father could change, anyone could change, and all I 
am saying to you is that that information is what you are 
denying the public under the guise of proprietary information, 
competitive advantage, but in fact, in my opinion it is to deny 
the public the knowledge of the danger which their bodies are 
being exposed to by having these kinds of products put near 
their bodies.
    I thank you, Mr. Chairman.
    Mr. Verheij. Mr. Chairman, if I may just respond to that 
last point, the fact is that I heard the Surgeon General this 
morning very strongly indicating that, in fact, as these 
ingredients are reported to the Federal Government, they have 
mechanisms, including his bully pulpit, if there was a concern 
to educate the public about ingredients in tobacco products.
    We share your concern about educating the public, but in 
the context of educating the public about the fact that there 
are dramatic differences between the relative risks between 
smokeless tobacco and cigarettes, and they are not getting that 
information either.
    Mr. Stearns. The gentleman's time has expired.
    Mr. Tomar. Mr. Chairman.
    Mr. Stearns. We will allow you to answer. Do you want to 
reply also?
    Mr. Tomar. Yes. I just wanted to speak to the issue of the 
additives to smokeless tobacco products. I used to be an 
epidemiologist with the Office on Smoking and Health, and so I 
was able to see that list of more than 500 chemicals that are 
added to smokeless tobacco products. When we were there, we 
asked them to provide brand specific information on that, and 
they refused.
    They also do not provide any information on concentration 
or quantity on any of those 500 chemicals, and a number of the 
chemicals that are added to those products are specifically to 
affect the nicotine dosing properties of those products. That 
feeds into their whole graduation strategy of being able to 
manipulate the nicotine dosing properties. We ask them to 
provide information on pH. The degree of alkalinity of the 
product affects the rate of nicotine absorption. They refuse to 
provide brand specific information.
    If the company really wants to disclose truthful 
information to the public, they can start with what they 
already have.
    Mr. Stearns. The gentleman's time has expired.
    The gentleman from New Hampshire.
    Mr. Bass. Thank you very much, Mr. Chairman.
    I just want to emphasize that we are here today to talk 
about relativity, not absolutes, and I do not think any member 
of this subcommittee believes that smoking cigarettes or the 
use of tobacco products is good for your health or should be 
condoned, especially amongst minors, and a lot of the debate 
today has revolved around accusations that somehow minors are 
going to get into the business of chewing tobacco or smoking 
cigarettes, which has always been a problem, and in my home 
state, it is a misdemeanor to possess tobacco products of any 
sort under the age of 18. There are criminal penalties for 
that, and the local law enforcement community enforces that, 
and nobody here today is advocating that.
    And so the issue is for those individuals that cannot 
terminate the use of cigarettes, what other options exist, and 
we have talked about a lot of different opportunities, and the 
other issue of whether or not the smokeless tobacco industry 
can advertise or discuss in an advertisement any kind of 
relative benefit of their product versus any other.
    I have two questions, one for Mr. Verheij and another one 
for Dr. Tomar.
    Mr. Verheij, if U.S. Tobacco were to advertise smokeless 
tobacco products as being less harmful than cigarettes, how 
would you advertise that fact under government guidelines, 
without influencing minors to use the product?
    Mr. Verheij. Well, we have given that some thought, and 
there are a number of ways that we communicate directly to 
adults. We have adult only facilities where people are carded 
or only 18 and over are admitted. In fact, we get information 
about the tobacco habits of those particular individuals. We 
find out if they are smokers, and we could make a communication 
right there.
    There are also direct mail lists of adult smokers. I mean, 
I think people envision some broad based advertising program, 
and frankly, it would not be very effective because it would be 
so diffuse when you are really trying to address adult smokers 
who are not quitting.
    The optimal from our standpoint would be take us out of the 
equation. If as Dr. Rodu indicated all of those physicians in 
the trenches, if it was physicians were advised by the 
government that, in fact, here you have a patient who is a 
smoker who they have tried the gum, they have tried the patch, 
and they are not quitting, that they could advise that patient 
of smokeless tobacco as a significantly less harmful option, 
then the company would not have to make any type of 
communication if that is the type of communication the 
government and the public health community were giving to these 
adult smokers who do not quit.
    Mr. Bass. Dr. Tomar, I understand that you were listed as 
an expert witness in an action brought by the Washington State 
Attorney General to recover the health care costs of tobacco 
use, and that you prepared a report estimating that the health 
care costs related to smokeless tobacco used were less than 1 
percent of those. Is that true?
    Mr. Tomar. I would have to go back and look at the figures, 
and it has been a number of years. I do not remember the exact 
figure.
    Mr. Bass. Okay. Well, you would be kind enough to check up 
on that and advise the committee I would be very grateful to 
you.
    Mr. Chairman, I yield back.
    Mr. Stearns. Do you mind yielding the balance to the 
gentleman?
    Mr. Bass. I would like to yield to the gentlelady from 
Wyoming.
    Ms. Cubin. Thank you very much.
    The question I wanted to ask, and maybe, Mr. Burton, you 
will know or, Mr. Verheij, maybe you will know: are physicians 
right now prevented from telling their patients that they 
believe smokeless tobacco is a healthier alternative, is 
healthier than smoking, although not a healthy alternative?
    And, Dr. Rodu, you may know that answer. Anyone, just speak 
up.
    Mr. Verheij. Well, let me start. Just based on our 
conversations with physicians, which we do on a frequent basis 
in terms of trying to identify the issues related to smokeless 
tobacco, and I believe there have been some submissions for the 
record from treating physicians and head and neck surgeons, 
what is taught in public health school is that smokeless 
tobacco is as dangerous as cigarette smoking, and they are 
stunned to find out that many researchers believe that 
smokeless tobacco is significantly less harmful.
    Ms. Cubin. But do you know, Dr. Rodu, is there a 
prohibition against physicians telling their patients that?
    Mr. Rodu. No, none whatsoever. It is called informed 
consent.
    Ms. Cubin. Correct.
    Mr. Rodu. As long as we provide both the risks and the 
benefits of any treatment that we recommend, we are fulfilling 
our obligations as health professionals in letting people make 
choices.
    Ms. Cubin. And, Mr. Burton, is that the sort of thing that 
doctors also have to do when they are recommending a 
prescription that perhaps your company might manufacture when 
they are prescribing the medication?
    Mr. Burton. Certainly physicians would advise their 
patients of the risk and benefits of a particular course of 
action. Certainly I think a significant difference being the 
fact that when you are talking about pharmaceuticals or 
medicines, they have been reviewed by the agency, the FDA. They 
have been proven to be safe and effective, and the physician 
within that context can go beyond based on his understanding or 
her understanding of the science to maybe amplify what is in 
the approved labeling for that particular drug.
    Ms. Cubin. Thank you.
    Thank you, Mr. Bass.
    Mr. Stearns. And the gentleman's time has expired, and our 
hearing has expired, and we are completing.
    By unanimous consent, all members will have 5 working days 
to enter any extraneous material they wish to put in.
    I think it has been an excellent debate, and I want to 
thank the witnesses sincerely for this long afternoon. We need 
to focus on the science of this debate. The science should lead 
the way, and if the science tells us that lives can be saved, 
we need to investigate these options.
    I hope the Federal Trade Commission will seriously consider 
putting together a workshop on tobacco harm reduction. If we 
can save even a handful of people out of the 400,000 people who 
die every year, it will be worthwhile to do.
    I also want to thank staff for getting all of this 
balanced, I think a very balanced hearing, and I think the 
thesis of our hearing has been accomplished, namely, that 
smokeless tobacco needs to be explored as an alternative for 
persons who cannot stop smoking, and we need more research on 
that.
    And with that, the subcommittee is adjourned.
    [Whereupon, at 3:18 p.m., the subcommittee meeting was 
adjourned.]
    [Additional material submitted for the record follows:]

                                 American Legacy Foundation
                                                      June 10, 2003
The Honorable Cliff Stearns
Chairman
Subcommittee on Commerce, Trade and Consumer Protection
Energy & Commerce Committee
Washington, DC 20515

The Honorable Janice D. Schakowsky
Ranking Member
Subcommittee on Commerce, Trade and Consumer Protection
Energy & Commerce Committee
Washington, DC 20515
    Dear Chairman Stearns and Ranking Member Schakowsky: I am writing 
today to clarify the record with regard to testimony offered by U.S. 
Smokeless Tobacco Company (USSTC) regarding its payments to the 
American Legacy Foundation as part of the Smokeless Tobacco Master 
Settlement Agreement. The testimony was offered during a hearing before 
the Subcommittee on Commerce, Trade and Consumer Protection of the 
Energy & Commerce Committee on June 3, 2003 entitled ``Can Tobacco Cure 
Smoking? A review of Tobacco Harm Reduction.''
    The American Legacy Foundation (Foundation) is an independent 
public health foundation that addresses the health effects of tobacco 
use on our nation through research, grants, technical training and 
assistance, youth activism, counter-marketing and grass roots outreach. 
Our mission is to build a world where young people reject tobacco and 
anyone can quit. The Foundation is a 501(c)(3) organization and was 
established in March 1999 as a result of the Master Settlement 
Agreement (MSA) between the attorneys general in 46 states and five 
U.S. territories and the tobacco industry. I serve as the Foundation's 
President and CEO.
    During the hearing, USSTC offered testimony regarding its company's 
smokeless tobacco products. In so doing, it sought to allay concerns 
members might have regarding the marketing of these products to youth 
by pointing to USSTC's support of the American Legacy Foundation. 
Specifically, USSTC testified that:
        `` . . . USSTC became the only smokeless tobacco company to 
        enter into the Smokeless Tobacco Master Settlement Agreement 
        (``STMSA'') with Attorneys General of various states and U.S. 
        territories. Pursuant to the STMSA, USSTC is providing up to 
        $100 million (plus an inflation adjustment), over a 10-year 
        period, to the American Legacy Foundation for programs to 
        reduce youth usage of tobacco and combat youth substance abuse, 
        and for enforcement purposes.'' (citations omitted)
    While we commend USSTC for entering into the STMSA, we would like 
the record to clearly reflect the history and underpinnings of the 
settlement agreement to which it refers.
    Along with the larger MSA reached with the cigarette manufacturers, 
the STMSA was the result of protracted litigation brought by the states 
to recoup the billions of dollars the states were forced to spend as a 
direct result of a wide range of illegal activities undertaken by the 
tobacco industry. It was the states, and not the tobacco companies, 
that introduced the concept of the Foundation into the settlement 
discussions. Moreover, it was the states that earmarked a portion of 
their recovery to create the Foundation. Indeed, the agreement 
specifically states that the payments are ``made at the direction and 
on behalf of Settling States.'' It also states that the manufacturers 
``do not undertake and expressly disclaim any responsibility with 
respect to the creation [or], operation . . .'' of the Foundation.
    Accordingly, while USSTC quite accurately represents that it 
entered into the settlement agreement and has made payments pursuant to 
that agreement, it is not accurate to state that USSTC is funding the 
American Legacy Foundation or to suggest that it is responsible for its 
successes in reducing youth smoking or that, because of its connection 
to the Foundation, members of Congress should not be concerned about 
smokeless tobacco products being marketed to America's youth.
    I would also like to take this opportunity to inform the 
Subcommittee of the American Legacy Foundation's successes in 
countering youth tobacco usage. Indeed, on June 4, Legacy was honored 
to receive both the Gold and Grand Prize EFFIE awards for its truth 
' campaign. The EFFIE Awards recognize advertising campaigns 
that deliver superior results in meeting the objectives they were 
designed to achieve. Legacy was just the second nonprofit organization 
to earn this top honor in the EFFIE's 35-year history.
    With its frank approach and blunt messaging, truth ' was 
specifically cited in a recent Monitoring the Future Report released by 
the National Institute on Drug Abuse as one of the reasons behind sharp 
declines in teen smoking. See Johnston, L.D., O'Malley, P.M. & Bachman, 
J.G. (2002), p. 126-127. Monitoring the Future national survey results 
on drug use, 1975-2001. (NIH Publication No. 02-5106). Bethesda, MD: 
National Institute on Drug Abuse. Indeed, a table presented during the 
release of a subsequent report shows a striking trend in the reduction 
of cigarette use among eighth, tenth and twelfth graders, which 
corresponds to the launch of our truth ' campaign, as well 
as other important tobacco control efforts including increases in 
cigarette prices, increased prevention activities in a number of 
states, efforts by the FDA in conjunction with states to reduce youth 
access to tobacco, and removal of certain types of advertising 
nationwide, such as billboards. See Johnston, L.D., O'Malley, P.M. & 
Bachman, J.G. (2002). Monitoring the Future national results on 
adolescent drug use: Overview of key findings, 2002. (NIH Publication 
No. 03-5374). Bethesda, MD: National Institute on Drug Abuse.
    Legacy has received what is likely to be its last payment for 
public education pursuant to the MSA, which could mean that we will 
forced to scale back or eliminate our truth ' campaign. 
States with award winning youth tobacco control and counter marketing 
efforts are also eliminating these programs because of budget woes. 
Increasingly, campaigns like truth ' and state counter 
marketing campaigns are being challenged in the courts by tobacco 
companies. Now, more than ever, we urge you and your colleagues to 
remain vigilant when it comes to our children's health.
    We respectfully request that the entire contents of this letter be 
included in the official record for the Subcommittee.
            Sincerely,
                                Cheryl G. Healton. Dr. P.H.
                                                    President & CEO
cc: Mr. Richard H. Verheij, USSTC
   Members, Subcommittee on Commerce, Trade and Consumer Protection,
   House Energy and Commerce Committee
                                 ______
                                 
                               Frontiers of Freedom
                                                Fairfax, VA
                                                       May 29, 2003
The Honorable Cliff Stearns
House Commerce, Trade and Consumer Protection Subcommittee
2125 Rayburn House Office Building
Washington, DC 20515
    Dear Chairman Stearns: Please accept the following testimony for 
the June 3rd Subcommittee hearing entitled, ``Can Tobacco Cure 
Smoking?--A Review of Tobacco Harm Reduction.''
    On behalf of Frontiers of Freedom I would also like to take this 
opportunity to applaud the Subcommittee for looking into this issue and 
encourage other parts of the government, including the Federal Trade 
Commission and the Department of Health and Human Services, to work 
together to explore this issue in further formal settings.
    The Frontiers of Freedom Institute has been on the forefront of 
promoting sound science in public policy. It is our belief that sound 
science must be the bedrock foundation for public policy decisions. 
This is particularly true when public health is involved. To divorce 
sound science from public policy is legislative and regulatory 
malpractice.
    The Institute has reviewed a wide array of studies and experts and 
it appears that the great weight of the evidence indicates that using 
smokeless tobacco instead of smoking tobacco provides a better, safer 
and healthier alternative. Many of these experts have a long history of 
speaking out against tobacco for health reasons.
    It is not our opinion that the use of tobacco in any form is 
healthy, but if sound science and medicine indicate that using 
smokeless tobacco instead of smoking cigarettes provides a significant 
reduction in health risks, the public has a right to know this 
important fact. This is useful information to those who currently smoke 
and want to reduce their health risks.
    Some argue against permitting the public to have this information 
and argue that people should simply stop smoking. However, in practice 
many people have been unsuccessful in their attempts to stop smoking. 
The adult smoking public should be made aware of their options. To 
prohibit consumers from having access to this knowledge is more than 
bad policy. It is malfeasance. In the corporate world, such a decision 
would expose executives to untold liability to those who would have 
benefited from this information but were denied it.
    Much has been made of the Enron scandal on grounds that employees, 
investors, and the public were not given access to the best and most 
accurate information about the company's financial health. Throughout 
recent history, there have been a wide variety of scandals when 
government or corporate officials withheld factually accurate 
information from the public. Congress should NOT place itself in the 
center of a future scandal by preventing the public from obtaining 
accurate and factual information that can help smokers improve their 
health. Political correctness is no substitute for factual correctness.
    For these reasons, the Institute appreciates the attention the 
Subcommittee is giving this subject, and urges Congress to continue to 
look into this issue and work to permit consumers to have access to 
information and scientific studies regarding the potential health 
benefits of using smokeless tobacco as compared to smoking tobacco.
            Sincerely,
                                            George Landrith
                                                          President
                                 ______
                                 
  Prepared Statement of Alliance for Health Economic and Agriculture 
                              Development
                            general comments
    The Alliance for Health Economic and Agriculture Development 
(AHEAD) appreciates the opportunity to submit this testimony to the 
House Committee on Government Reform as well as to the Subcommittee on 
Commerce, Trade and Consumer Protection ( House Committee on Energy and 
Commerce). AHEAD was formed shortly following the issuance of the 
historic report Tobacco at a Crossroad, which laid out a series of 
recommendations for policy changes affecting the production, 
manufacture and marketing of tobacco products.
    The Alliance is an informal coalition of individuals, 
organizations, business, churches and other interests working 
cooperatively to implement the principles and recommendations in the 
commission report. The Alliance builds on nine years of dialogue and 
discussion between tobacco producers, public health organizations and 
others and provides a neutral setting where non-traditional partners 
can resolve differences and work together to achieve mutual goals.
    Tobacco growers, the public health community and manufacturers are 
indeed at a crossroads. There are unique challenges and opportunities 
before us that are going to require that all parties set aside the 
rhetoric and to focus on substantive issues. On the one hand, the 
attitude that we have to change everything overnight or not at all is 
unrealistic. But the attitude on the part of some that nothing should 
change is not only unrealistic but irresponsible. Dogmatic views, 
entrenchment and an unwillingness to find solutions must be substituted 
with open dialogue, discussion and transparency. We need to be able to 
recognize and work through the things that represent legitimate issues 
and to circumvent those that are used merely to stall what is 
inevitable and necessary. The Alliance recognizes that no one party 
alone can solve the challenges confronting us from the use of tobacco.
    The future of tobacco and tobacco products will require a more 
integrated system that encompasses the production, processing, 
manufacturing, labeling, advertising, and marketing of tobacco. For 
example, the current tobacco program with its system of quotas must be 
a replaced with a new system of production controls that brings the 
growing of tobacco into the 21st century, taking into account 
technological opportunities and consideration of health and safety 
issues. These authorities should be based within the USDA and 
coordinated with the FDA. The future will require a more active 
research agenda, more effective monitoring and surveillance and an 
effective regulatory system (FDA) that is flexible enough to be able to 
deal with unforeseen issues and to take advantage of opportunities when 
they arise. It should involve incentives for tobacco growers, 
researchers and responsible manufacturers to develop new methods of 
production and new products that reduce exposure to tobacco toxicants 
and which have a reasonable prospect of reducing tobacco related 
disease. Government, public health organizations, researchers, tobacco 
growers and even industry must find a way to work constructively and 
cooperatively to address the challenges and to find meaningful, 
effective and workable solutions. What we do here in the United States 
could set an example for the rest of the world in light of the recently 
approved FCTC.
    Tobacco and tobacco products come in a variety of forms. For 
decades there has been a tendency to equate all tobacco and tobacco 
products as being equally harmful when in fact this is not the case. 
There are many types of tobacco leaf that go into making a tobacco 
product. These include such varieties as burley, flue-cured, dark-
fired, and oriental. As with any agricultural plant, most tobacco is 
treated with pesticides, and cured and processed in different ways. All 
of these things can and do affect the quality (including health and 
safety) and composition of the leaf. In addition, as much as 50% of the 
tobacco used in US manufactured cigarettes (both domestic and foreign 
export) comes from overseas where there are fewer regulatory controls 
in place. This alone can result in added and unforeseen risks. 
Similarly there are many types of manufactured tobacco products--
cigarettes, cigars, pipes, and smokeless. Each of these carries their 
own set of risks--some greater than others. And even within each of 
these categories there are and can be significant variations of risks. 
Risk will vary depending on whether the product is burned or not, what 
type of tobacco is used, how it is treated, where that tobacco came 
from, and what additives and chemicals are used in its manufacture. 
Lowering risks from tobacco will also depend on the development of new 
technologies that are based on science and not public relations 
gimmicks. The challenge that we face is how to best assess these risks 
so that the public and consumers of tobacco fully understand the 
consequences of using tobacco products and understand the relative 
risks that various products present.
   development of lower risk products and technologies to reduce risk
    The Alliance believes, as do most others, that risk reduction can 
be a viable and effective means in reducing the disease caused by the 
tobacco products currently on the market. Statements by the Surgeon 
General, the IoM, and other public health authorities all advocate that 
reducing toxins in tobacco products and ``encouraging the development 
of products that reduce consumer health risks or serve as less harmful 
alternatives'' should be done undertaken. There is enough science to 
begin to make changes and to recognize that there are technologies in 
existence that can reduce the levels of toxins that are known to be 
associated with disease. While clearly unique, tobacco products are 
consumer products and like other products in society where we consider 
``risks'' we can and should do the same with tobacco. The issue no 
longer seems to be whether scientifically based lower risk products 
should be developed and made available, the issue and challenge is how. 
Development of science-based tobacco products that can lower risk 
through both regulation and competition can also force the more toxic 
products off the market. We could see a significant shift in not only 
the development of new products but the removal or replacement of the 
older ones.
    As the Tobacco at a Crossroad noted:
          Given the number of Americans who use tobacco today, 
        prohibition would not protect the public health because it 
        would drive many smokers to use unregulated black market 
        products. Therefore, a statutory standard designed to promote 
        the `public health' rather than one that requires a tobacco 
        product to be ``safe'' best protects everyone's interests. It 
        also recognizes that the ``status quo'' for current products is 
        not in anyone's interest if it is possible to reduce the harm 
        that tobacco products cause (p.43).
          Independent science based decisions by FDA designed to 
        protect public health by taking reasonable steps to reduce the 
        harm of tobacco products now being sold and promote the 
        introduction of less harmful products will also create fair 
        standards and will provide predictability to farmers and to 
        industry. (p.43)
    The Institute of Medicine Report, Clearing the Smoke noted:
          For many diseases attributable to tobacco use, reducing risk 
        of disease by reducing exposure to tobacco is feasible. This 
        conclusion is based on studies demonstrating that for many 
        diseases, reducing tobacco smoke exposure can result in 
        decreased disease incidence with complete abstinence providing 
        the the greatest benefit.
    There are obviously many unknowns that will have to be addressed. 
For example, concerns have been raised that we may find ourselves 
making the same mistakes that were made in the development and 
marketing of low tar and low nicotine cigarettes. What was believed to 
be in the interests of public health turned out to be an abusive 
marketing tool for the tobacco companies. One of the primary reasons 
for this was the absence any kind of regulatory oversight. These kinds 
of mistakes (and others) can be resolved and avoided if the FDA is 
given the authority it needs to prescribe the labeling and marketing 
requirements for all tobacco products--including prescribing the manner 
in which claims can be made and preventing the use of claims that are 
false or misleading. A science-based regulatory structure can not only 
ensure that products are properly labeled and marketed, but it can also 
serve to stimulate competition to develop new technologies and products 
that will lower risks associated with tobacco use. These efforts 
however, must been carried out under an effective regulatory scheme and 
with greater transparency.
               the critical need for and role of the fda
    FDA will provide the level playing field under which all tobacco 
products should be regulated--governing their manufacture, sale, 
distribution, labeling and marketing.
    FDA's authority must be comprehensive but at the same time flexible 
enough to be able to deal with what will most likely be a rapidly 
changing environment. Issues related to risk reduction will be but one 
component of FDA's authorities. Other things that the agency will need 
to focus on include:

 Prohibiting and restricting advertising and marketing that is 
        misleading and deceptive(all tobacco products).
 Restricting the sale, advertising and promotion of tobacco 
        products to children and adolescents.
 Disclosing additives, toxins, ingredients, country of origin 
        and other information that adult users of tobacco are entitled 
        to have.
    The research and science base will need to be expanded by both the 
public and private sectors. Industry science must be held to the same 
level of standards and peer review and transparency that is required in 
other industries.
    Consideration should also be given to undertaking a major 
educational campaign designed to educate the public about the new 
regulatory authorities and to help them read and understand the 
warnings and labeling requirements (not unlike what was needed when 
food labeling reforms were instituted).
    In addition, there will be a need to have a monitoring and 
surveillance system in place that will allow governmental agencies to 
effectively track tobacco use by the public and to take the necessary 
corrective steps if certain goals and objectives are not being met.
    Some argue that existing authorities of the Federal Trade 
Commission are sufficient to ensure effective and proper regulation of 
tobacco products including lower risk products. We disagree. Although 
we believe that the FTC should retain its section 5 governing unfair 
trade practices, the FDA, as a science-based agency, is best suited to 
deal with the complex scientific and medical issues relating to tobacco 
``including reduced risk products.
    For a more detailed list of what the Alliance believes to be the 
``Core Principles'' of FDA regulation see attached.
                               conclusion
    Reducing risk associated with tobacco and tobacco use must move 
forward but it must do so carefully and with the full participation of 
all parties. We believe the Commission report Tobacco at a Crossroad 
represents a blueprint for change--change that must be made and 
accepted by all stakeholders. Preserving the ``status quo'', whether 
its on the part of manufacturers, tobacco growers and even public 
health is in the best interests of no one. The kind of open dialogue 
and discussion that resulted in the issuance of a set of Core 
Principles in 1998 between growers and health organizations as well as 
the commission report, Tobacco at a Crossroad (2001) must now be the 
model upon which we enter the final phase of ensuring effective but 
fair regulation of tobacco by the FDA.
                                 ______
                                 
  Prepared Statement of Nancie G. Marzulla on Behalf of Defenders of 
                            Property Rights
    Mr. Chairman, members of the subcommittee, thank you for allowing 
Defenders of Property Rights an opportunity to present testimony 
concerning the impact of communicating to American consumers important 
health-related information about tobacco risk reduction. I am Nancie G. 
Marzulla, President of Defenders of Property Rights, the only public 
interest legal foundation devoted exclusively to constitutionally 
protected property rights. Defenders of Property Rights was founded in 
1991 to counterbalance the governmental threat to private property as a 
result of a broad range of regulations. We believe that society can 
achieve important social objectives such as protection of our 
environment and our health while respecting fundamental constitutional 
rights like those of private property and freedom of speech. As such, 
we continue our efforts to protect victims of over-zealous regulations 
in court, to help government regulators better realize the limits on 
their power, and to work closely with elected representatives to ensure 
that property owners have a say in the laws that govern their ability 
to make use of their property.
    Mr. Chairman, we come before your Subcommittee today to remind you 
that commercial speech, like all other lawful expression in this 
nation, is constitutionally protected, a point which is often 
overlooked in the heat of debate over how best to protect the consumer 
against false or misleading advertising. We are here to underscore the 
fact that, just as a manufacturer may not disseminate false or 
misleading information about its product, neither may Congress prohibit 
the dissemination of truthful information by that same manufacturer. 
Because this commercial expression carries First Amendment protection, 
Congress bears the burden of making certain that any statement it 
prohibits is, in fact, untrue. If Congress cannot demonstrate, based on 
sound scientific evidence, that a particular statement is false or 
misleading, Congress cannot prohibit that statement consistent with the 
First Amendment.
    The Founders understood that the free exchange of commercial 
information makes free enterprise possible by enhancing competition and 
educating consumers. Indeed, the origins of our right to free 
expression are as much commercial as they are political for, in the 
end, our economic freedoms are the true source of our political 
freedoms as well. Judge Loren Smith of the Court of Federal Claims 
rightly observed that:
        Without extensive property rights, jealously defended, only the 
        government would have the resources needed to organize 
        political campaigns or parties of any size. Without property 
        rights, no individual would have a base to run for office other 
        than those who hold governmental power. Without property and 
        contract rights, litigation in the courts would be a very 
        limited and ineffective tool for protecting anything. The 
        judiciaries of every former socialist country are a stark 
        testimony to the weakness and ineffectiveness of a dependent 
        judiciary. Without the right to advertise profit-making 
        products, the free press and media necessary for effective free 
        speech, would be a mere illusion . . . Underlying all of our 
        political and intellectual freedoms which make for a civilized 
        society is a foundation of widely dispersed private property, 
        and all the attributes of that system that Madison so clearly 
        understood: freedom to contract, free markets, and personal 
        security. Without this foundation, political liberty and the 
        ability to exercise those rights guaranteed by the First 
        Amendment would be a mere sham.
Loren A. Smith, Allen Chair Symposium 1996: The Future of Environmental 
and Land-use Regulation: Essay: Life, Liberty & Whose Property?: An 
Essay on Property Rights, 30 U. Rich. L. Rev. 1055, 1060 (1996).
    For example, the Constitution places such a strong emphasis on 
protecting private property rights, among other economic freedoms, 
because the right to own and use property is critical to the 
maintenance of a free society. Properly understood, property is more 
than land. Property is buildings, machines, retirement funds, savings 
accounts and even ideas. In short, property is the fruits of one's 
labors. The ability to use, enjoy and exclusively possess the fruits of 
one's own labors is the basis for a society which individuals are free 
from oppression. Indeed, there can be no true freedom for anyone if 
people are dependent upon the state (or an overreaching bureaucracy) 
for food, shelter and other basic needs. Where the fruits of your 
labors are owned by the state and not by you, nothing is safe from 
being taken by a majority or a tyrant. As a government dependent, the 
individual is ultimately powerless to oppose any infringement of his 
rights (much less degradation of the environment) because the 
government has total control over them. People's livelihoods, possibly 
even their lives, can be destroyed at the whim of the state. Private 
property thus acts as a barrier to the arbitrary and tyrannical 
exercise of government power.
    With proper appreciation for this strong relationship between our 
economic and political freedoms, the Supreme Court recently stated 
that, ``so long as we preserve--a predominantly free enterprise 
economy, the allocation of our resources in large measure will be made 
through numerous private economic decisions. It is a matter of public 
interest that those decisions, in the aggregate, be intelligent and 
well informed. To this end, the free flow of commercial information is 
indispensable.'' See 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 
496-97 (1996) (citing Virginia State Board of Pharmacy v. Virginia 
Citizens Consumer Council, 425 U.S. 748, 765 (1976)). The Court further 
explained that ``a paternalistic assumption that the public will use 
truthful, nonmisleading commercial information unwisely cannot justify 
a decision to suppress it.'' See id. at 498. While government may have 
an interest in consumer protection, regulating truthful, non-misleading 
commercial information does not serve to protect that interest. Rather, 
protecting commercial speech empowers consumers to make informed 
decisions and allows business to compete effectively.
    Those who contend that commercial speech is not entitled to First 
Amendment protection rely on a two-page 1942 decision of the Supreme 
Court in which the Court disposed of commercial speech in one sentence. 
See Valentine v. Chrestensen, 316 U.S. 52, 54 (1942) (``We are . . . 
clear that the Constitution imposes no . . . restraint on government as 
respects purely commercial advertising''). As Judge Kozinski of the 
Ninth Circuit has pointed out in his penetrating law review article, 
this opinion ``cites no authority''. See Alex Kozinski and Stuart 
Banner, Who's Afraid of Commercial Speech?, 76 Va. L. Rev. 627, 627 
(1990) (``Without citing any cases, without discussing the purposes or 
values underlying the First Amendment, and without even mentioning the 
First Amendment except in stating Chrestensen's contentions, the Court 
found it clear as day that commercial speech was not protected by the 
First Amendment''). Realizing its folly, the Supreme Court reversed 
itself 34 years later in Virginia State Board of Pharmacy, 425 U.S. 
748, 770 (1976), when it then accorded First Amendment protection to 
commercial speech:
        Virginia is free to require whatever professional standards it 
        wishes of its pharmacists; it may subsidize them or protect 
        them from competition in other ways . . .  But it may not do so 
        by keeping the public in ignorance of the entirely lawful terms 
        that competing pharmacists are offering. In this sense, the 
        justifications Virginia has offered for suppressing the flow of 
        prescription drug price information, far from persuading us 
        that the flow is not protected by the First Amendment, have 
        reinforced our view that it is. We so hold.
The Court recognized that commercial expression belonged as much in the 
marketplace of ideas as did other forms of expression. Producers now 
convey and consumers now receive information about goods and services 
without fear of severe restrictions, strengthening the foundations of 
our free society and our free market economy.
    Advocates of regulating commercial speech blithely ignore the 
important role that commercial speech plays in a free society and in a 
free market, instead brandishing flimsy rationales for limiting First 
Amendment protection for commercial speech. None of these rationales 
withstand scrutiny. For example, the California Supreme Court in Nike 
v. Kasky, a case now pending before the United States Supreme Court, 
thought it had distilled from the Supreme Court's opinions three 
reasons for the commercial speech exclusion from full First Amendment 
protection: (1) that commercial speech was more easily verifiable by 
the speaker than news reporting or political commentary; (2) that 
commercial speech was hardier than noncommercial speech in the sense 
that commercial speakers, because they act from a profit motive, are 
less likely to experience a chilling effect from speech regulation; and 
(3) that governmental authority to regulate commercial transactions to 
prevent commercial harms justifies a power to regulate speech that is 
`linked inextricably' to those transactions.'' See Kasky v. Nike, 45 
P.3d at 252-53 (citing 44 Liquormart, Inc., 517 U.S. at 499; Virginia 
State Board of Pharmacy, 425 U.S. at 771-72 fn. 24)
    First, objective verifiability is not a characteristic unique to 
commercial speech. As Judge Kozinski of the Ninth Circuit also pointed 
out in his aforementioned law review article:
        [T]here are many varieties of noncommercial speech that are 
        just as objective as paradigmatic commercial speech and yet 
        receive full first amendment protection. Scientific speech is 
        the most obvious; much scientific expression can easily be 
        labeled true or false, but we would be shocked at the 
        suggestion that it is therefore entitled to a lesser degree of 
        protection. If you want, you can proclaim that the sun revolves 
        around the earth, that the earth is flat, that there is no such 
        thing as nitrogen, that flounder smoke cigars, that you have 
        fused atomic nuclei in your bathtub--you can spout any nonsense 
        you want, and the government can't stop you.
Kozinski, supra, at 635.
    Second, the notion that profit is a stronger motivation to speak 
than, e.g., religious, philosophical or political conviction, 
contradicts the history of this nation's founding and the sacrifices of 
our founding fathers themselves. George Washington and John Adams 
neglected their farming businesses to serve the revolution, while 
Benjamin Franklin, James Madison, Thomas Jefferson and the others 
risked hanging for treason as the price of signing the Declaration of 
Independence. Pasternak and Solzhenitsyn continued to write, and 
Shostakovich to compose, under the very real threat of being sent to 
the Gulag. Humankind throughout the ages has proved that it is not the 
love of money, but the love of truth and right that appears to be the 
strongest motivation of our race.1 See Kozinski, supra, at 
637 (``History teaches that speech backed by religious feeling can 
persist in extraordinarily hostile climates; sacred texts survive in 
places where dire consequences attend their possession, consequences 
that would easily overcome a mere profit motive. Artistic impulses can 
also cause expression to persist in the face of hostile government 
regulation'').
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    \1\ . . .
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    Third, although government may certainly act to prevent commercial 
fraud, restrictions on commercial speech often do not link the speech 
at issue to a proposed or completed fraudulent transaction. Were the 
speech so linked, First Amendment protections would certainly not 
obtain because it is the transaction, not the speech, which is 
unlawful. Restricting fraudulent or misleading speech with no 
connection to actual resulting fraud abandons the marketplace of ideas 
for the majesty of the courtroom, placing judges in the role of arbiter 
of the truth. Advocates of restricting the free flow of commercial 
information apparently consider the relative merits of laundry 
detergent or pickup tricks, for example, too important to be left to 
the consuming public.
    Having dispensed with these rationales, it is clear to see that 
there is no compelling rationale for restricting commercial speech. 
Indeed, any attempt to distinguish between commercial and noncommercial 
speech for the purposes of determining the ``appropriate'' level of 
First Amendment protection (and the ``appropriate'' degree of speech 
restriction) is bound for failure. Commercial motivations are 
invariably and inextricably intertwined with all forms of expression. 
See Loren A. Smith, supra, at 1062-63 (``The desire to make a buck and 
the desire to write a poem appear very similar''). Many motives, 
including profit, can prompt expression on any issue, and ``human 
motives cannot be separated by any objective test.'' See id. at 1062-
63. See also John O. McGinnis, The Once and Future Property-Based 
Vision of the First Amendment, 63 U. Chi. L. Rev. 49, 55 (1996):
        Moreover, research into our evolutionary heritage confirms that 
        the human faculty of speech evolved to improve economic well-
        being, both by facilitating the exchange of goods and by 
        creating another product for exchange--namely information 
        itself. Information production of all kinds is thus 
        increasingly seen as directed toward the acquisition of wealth 
        and status . . . Expressive man is economic man.
    Indeed, as I noted earlier, commercial speech has played a leading 
role in the establishment of our right to freedom of expression. In 
17th and 18th century England, printers faced loss of income when 
government suppressed publication. See McGinnis, supra, at 60 
(``Printers [who convinced Parliament to end the licensing system] . . 
. naturally sought to protect their interests and limit the 
prerogatives of government [to suppress publication]''). Accordingly, 
the printers relied on property rights arguments in their successful 
efforts to convince Parliament to end the licensing system and the 
general warrants by which government seized printed material. See id. 
at 61 (``The notion of information as property came naturally to 
printers and played a prominent part in their arguments for freedom''). 
In defending freedom of the press, these Whig printers couched their 
arguments in the language of economic rights, rightly understanding 
that economic motives often drive and enable the dissemination of 
information on matters political, commercial, and otherwise. See id. 
Accordingly, no court has held that there exists a commercial press 
exception to the Free Press Clause.
    Other forms of expression demonstrate a similarly close 
relationship between commercial motivations and the resulting 
expression. See Kozinski, supra, at 641 (providing example that fully 
protected music videos promote record sales). Newspapers and broadcast 
television, the heirs of the aforementioned Whig printers, disseminate 
information on political affairs with a view to increasing sales, 
attracting paying advertisers, and generating ratings. In these cases, 
profit motivation and economic transactions are essential to the 
transmission of the resulting expression. See McGinnis, supra, at 91. 
Excluding ``commercial speech'' from the ambit of First Amendment 
protection thus undermines the very foundations of free speech.
    Congress must therefore exercise the utmost caution in considering 
whether to regulate the transmission of commercial information about 
the health benefits and risks of smokeless tobacco. The First Amendment 
guarantees our freedom to give and receive information to ensure that 
we are a self-governing people. A well-informed basis for decision-
making, aided by the free exchange of information, is an essential 
ingredient of that self-government, both at the ballot box and at the 
supermarket. A well-informed basis for decision-making is even more 
essential when it comes to making decisions about one's health. Before 
taking action, Congress should keep in mind the importance of self-
government and the role that commercial speech plays in maintaining it.
    Thank you for the opportunity to address this important issue here 
today. I would be happy to answer any questions you may have.
                                 ______
                                 
Prepared Statement of Carl V. Phillips, Assistant Professor, University 
             of Texas School of Public Health 1
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    \1\ This statement is the scientific opinion of the author, and 
does not necessarily represent the views of the University of Texas 
School of Public Health, the University of Texas Health Science Center 
at Houston or the University of Texas system.
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    Cigarette smoking is widely described as the greatest preventable 
cause of morbidity and mortality. I have always found this a rather 
tortured definition of ``preventable''--after all, if it is so 
preventable, why do U.S. smoking rates remain high, with the total 
number of smokers in the world increasing? It is reasonable to say that 
smoking is theoretically preventable. But the current methods--
education, warning, regulating sales and advertising, prohibiting 
smoking in many places, and pharmaceutical nicotine replacements--
despite their effectiveness over the last half century, seem to have 
had most of the effect as they are going to. Even if those methods 
become even more effective at discouraging people from taking up 
smoking, the tens of millions of current smokers in the U.S. remain at 
risk.
    Last year, I was retained by U.S. Smokeless Tobacco Company to 
analyze and give my opinion on what the scientific research had to say 
about the health risks of using smokeless tobacco (ST). As a professor 
of public health (Assistant Professor, University of Texas School of 
Public Health and University of Texas Medical School) specializing in 
methods for interpreting data and study results, I had much to say 
about the science. As a public policy analyst (Ph.D. in public policy 
from Harvard University and Masters in Public Policy from the Kennedy 
School of Government at Harvard), I find myself particularly interested 
in the potential life-saving policy of harm reduction.
    Like most everyone who has not personally reviewed the science, I 
believed that ST was a major risk factor for life-threatening illness, 
perhaps not as risky as cigarettes, but of similar magnitude. It 
quickly became clear to me that the risk from smokeless tobacco was 
tremendously lower than that from cigarettes. Indeed, even for the one 
disease most commonly linked to ST, oral cancer, the evidence of any 
risk at all was highly equivocal. I was distressed that the public 
health community, a community I am part of, had perpetuated such 
misinformation. More than that, I was impressed by the potential to 
reduce the devastating health effects of cigarettes by encouraging 
smokers to switch to ST. I came to consider this one of the greatest 
untapped resources for improving the health of the U.S. population, and 
have made ST my major substantive area of academic research.
    Many areas of health research offer large speculative payoffs, but 
it is not clear what will really be discovered. Many potential 
interventions offer great health benefits in theory, but it is not 
clear they could really be implemented. ST has scientifically proven 
potential to reduce harm from cigarettes and a proven track record in 
Sweden, where ST consumption has increased while smoking has dropped 
dramatically. It is difficult to imagine any other policy as likely to 
further reduce the health costs of smoking in the U.S., if only policy 
makers and public health leaders will let it work. This would require 
no complicated and expensive intervention; it would probably be enough 
for the government to tell the truth about the risks or allow ST 
manufacturers to do so.
Much less harmful than cigarettes
    The potential of ST use to reduce harms from smoking follows 
immediately from its role as an alternative source of nicotine and its 
relative safety. Despite the popular belief to the contrary, there is 
no genuine scientific disagreement with the claim that ST is much less 
harmful than cigarettes. Biology and chemistry would tend to predict 
this (for example, ST does not produce carbon monoxide buildup or cause 
chemical insult to the lungs), but it is the study of actual results 
for actual people (the science of epidemiology) that makes it clear. Of 
the various cancers, cardiovascular diseases, and other life 
threatening diseases that smoking has been shown to cause, the only 
persistent claim about risk from ST is for oral cancer (OC). The 
elimination of clearly smoking-specific hazards--lung cancer and other 
lung diseases, fires, and environmental (``second hand'') tobacco 
smoke--alone reduce the risks by half. But there has also been no 
conclusive link to cardiovascular disease and most other cancers. Even 
for OC, which account for about 1% of deaths attributable to smoking, 
smoking is associated with greater risk than the worst plausible claims 
about the risk from ST.
    The bottom line is that a cigarette smoker who switches to ST 
reduces his risk of disease from tobacco use by more than 90%, and 
quite possibly more than 99%. There is legitimate scientific 
uncertainty about whether the reduction is 98%, 99.9%, or some other 
value, but it clear that it is better than 90%. The remaining 
uncertainty should not dissuade us from acting immediately. One of the 
most important points I teach my students in my health policy classes 
is that if you perform a careful scientific analysis of a proposed 
policy, you will often find that you do not need to resolve the 
remaining uncertainty about some values. Even though they are somewhat 
uncertain, you know enough to know that any plausible value leads to 
the same policy recommendation. In the case of ST, if the reduction in 
risk of life threatening disease was possibly as low as 50% or even 75% 
compared to cigarettes, the question might be more difficult. But our 
current information, that the risk of using ST is much less than 10% of 
that from smoking, is sufficient to show that telling the truth about 
ST is a promising harm reduction strategy
How do we know?
    The scientific literature fails to establish a link between ST use 
and any life threatening disease. Scientifically demonstrating that 
something does not exist, such as showing there is no substantial 
health risk from ST, is usually more difficult than demonstrating that 
it does exist. A common observation is that ``the absence of evidence 
is not evidence of absence.'' This is an important point when evidence 
is absent because there has been little attempt to find the evidence. 
But when researchers have looked hard for evidence of a health risk and 
have not found it, we have compelling evidence that the risk is close 
to zero. This is the case for ST. This does not mean that the risk from 
ST for any particular disease is exactly zero--such a thing can never 
be proven--but it does give the best possible evidence that it is 
either zero or very low.
    The active effort by many organizations and researchers in the 
health community to show that ST is unhealthy has created attitudes 
that are a barrier to the suggested harm reduction strategy. But that 
same active effort is very helpful for drawing scientific conclusions, 
because we can be confident that if there were any clear associations 
to be found, they would have been found. The health science literature 
contains only a few papers that look at risk of diseases other than OC 
from ST use. One reason for this might be that no one has looked for 
such associations. However, there are many well-studied datasets that 
would allow such analyses and there is huge demand for findings that ST 
is associated with disease. Given that there is demand and potential 
supply, we can conclude that the lack of findings is not for lack of 
trying to find something. It is not surprising that there are not a lot 
of published papers that show a lack of association, because such 
findings tend to not get published (the phenomenon is called 
``publication bias''). We can further conclude that if there was a 
large risk for a disease from ST, it would be noticed; large effects 
are difficult to miss. Finally, we can observe that the opponents of ST 
focus almost entirely on the risk of oral cancer, and energetic 
advocates can usually be counted on to come up with the strongest 
possible case for their claims, suggesting that even they do not think 
there is support for the claim that ST causes other diseases.
    But even the case for OC risk is not very strong. It is widely 
reported that there is a causal link between ST and OC, most notably in 
a Surgeon General's Report [1986]. There is evidence that smokeless 
products that contain other major ingredients (particularly betel nut 
in South Asia) are risk factors for OC. There is one large U.S. study 
[Winn et al., 1981], that found an association between the use of 
early- and mid-20th century dry snuff and oral cancer. (The Surgeon 
General Report conclusions hinged largely on this study.)
    But the dominant product in the industrialized world, modern moist 
snuff, has not been associated with OC. The two major published studies 
on the topic [Lewin et al., 1998; Schildt et al., 1998] did not find an 
association, and provide convincing evidence that there is no strong 
association. Furthermore, my own research (which I will present this 
June at the Society for Epidemiologic Research meeting, the major U.S. 
epidemiology meeting) shows that Winn et al. and most others of the few 
modern studies that purport to find an association of ST and OC have 
reported their results in ways that tend to exaggerate the association, 
or make it appear that there is an association in the data when there 
really is not. In particular, they picked out subgroups of their 
population (such as only reporting results for nonsmoking women, or 
certain individuals who had used ST for more than 50 years), and 
reported numbers for them, omitting numbers for other groups who had 
much lower association or even showed reductions in cancer rates. The 
conclusion from all this is not that modern American and Swedish ST is 
proven to not cause oral cancer, but there is clearly no proof that it 
does cause it.
A (so far) missed opportunity for harm reduction
    Even if we accept the main finding from the Winn et al. study about 
OC risk, the worst case scenario there is any evidence to support, and 
allow for some small risk of others diseases (so small that it has not 
been detected), the risk from ST is only about 1% of that from smoking. 
Our current scientific knowledge allows us to be fairly confident that 
ST has about 99% less risk of life threatening disease than smoking. We 
are as confident as is ever possible in health research that the 
reduction is greater than 90%. The implication of that is clear: Anyone 
who uses ST rather than cigarettes will be much safer, eliminating 
almost all the risk of life-threatening disease from his or her tobacco 
use.
    Having learned this in the last year, I have found myself thinking 
about my grandmother, a lifelong smoker, who died a few years ago 
following a series of smoking-related cancers. She tried to quit using 
tobacco and failed. The message from the public health community to her 
and to current smokers was ``quit or die.'' She could not quit. As an 
Appalachian woman of her age group, the use of ST would not have been 
unusual or socially unacceptable. Had she gotten the message that she 
would have been so much safer using ST rather than cigarettes, she 
might be alive today.
    Health authorities in other countries are starting to come around. 
Most notably, the United Kingdom's oldest medical organization, the 
Royal College of Physicians [2002], issued a report on tobacco 
regulation that acknowledged that ST is ``10-1000 times less hazardous 
than smoking'' and suggested that a harm reduction strategy might be 
appropriate. Many public health advocates and researchers are speaking 
up in favor of using ST as part of a harm reduction strategy. The 
changes in policy attitudes will come too late for millions who have 
already died, but millions of others can be saved.
Misleading the public
    Why did my grandmother never learn that ST offered such a huge 
reduction in risk? Why do tens of millions of literate and well-
informed smokers not know it now? Why did I, a well-read expert in 
public health not know this a year and a half ago? The consistent 
message from public health authorities, including state and federal 
government agencies, advocacy groups, and medical organizations, is 
that ST is as unhealthy as cigarettes. Sometimes this claim is stated 
in so many words, despite being clearly false. More often, the message 
is that ST is not a safe alternative to cigarettes. When this message 
is presented without further qualification, people tend to assume that 
the two products have comparable levels of risk, making the claim 
clearly misleading.
    My colleagues and I just completed a review of the over four 
hundred public-service-oriented Web sites that were found with a Google 
search for statements about the health risk from ST. Less than 1% of 
these say anything about ST offering a major risk reduction compared to 
smoking or acknowledge that it has not been shown to be very harmful. 
Many sites contain specific numbers that make their claims more 
misleading, while giving the appearance of greater accuracy. A fairly 
common claim is that ST ``can lead to a 50-fold increase in oral cancer 
risk.'' This result traces to one number reported in Winn et al., for 
extremely high exposure among a small subgroup of the population, and 
is not meaningful out of context. This number, the largest reported in 
the paper for any subgroup or exposure definition, clearly does not 
summarize the results from Winn et al. Furthermore, having re-analyzed 
the original unpublished Winn data, I found that the specific 
statistical choices used to produce that number appear to have been 
chosen to produce the largest number possible, which is a 
scientifically invalid method of analysis.
    Our major finding from our analysis of the Web sites (which we will 
also be presenting at the epidemiology meetings) is that most of them 
repeat the same overstated or false claims, reporting the same few 
numbers from Winn and the Surgeon General, and ignoring the substantial 
scientific literature that contradicts these claims. When they 
attribute their claims to any source, they cite the Surgeon General, 
the American Cancer Society, and a few other sources, all of which 
trace their claims primarily to pre-1980 research, which is not up to 
modern methodologic standards and studies people who used a different 
product from modern moist snuff. Furthermore, with the exception of two 
Web sites that deal with harm reduction, the sites that showed up in 
our search provide no absolute risk number that would allow readers to 
realize that, even the worst case scenario, ST is tremendously safer 
than smoking. What looks like a huge amount of mutually-confirming 
information about substantial risk turns out to be a lot of groups 
citing each other and repeating the same small body of misleading and 
often incorrect information.
    Given these patterns of systematic misinformation, it is not 
surprising that when people learn the truth about the risk of ST, they 
are almost always extremely surprised. Of the hundreds of people, 
usually highly educated and often health professionals, that my 
colleagues and I have told this information to, only one (my dentist) 
already knew the truth. It is little wonder that the harm reduction 
message, as strong as it is, has not taken off on its own.
Attempts to justify the misinformation
    The health advocates who defend the misinforming of the public 
offer several arguments, all of which seem difficult to defend. No one 
who hopes to preserve any credibility will deny that using ST rather 
than cigarettes leads to a dramatic risk reduction. Instead, other 
arguments are usually offered. They turn out to be equally 
unconvincing, but more subtly so.
    Advocates sometimes argue that honest information about ST should 
be denied to the public because it might cause tobacco nonusers to take 
up ST, and their increased risk could exceed the benefit experienced by 
smokers switching to ST. Simple arithmetic shows this to be wrong. If 
ST offers a 99% reduction compared to smoking, it would be necessary 
for 99 tobacco nonusers to take up ST for every smoker who switches. 
Even if the reduction were as little at 90%, it would require 9 for 
every 1. It is implausible that such a large increase in tobacco use 
could occur.
    An occasional retort to this arithmetic is that there is an ethical 
concern when one person experiences a benefit (the smoker who switches 
to ST) and another suffers a health cost (the nonuser who takes up ST 
upon learning it is relatively safe--assuming, of course, that ST does 
create some risk). But a much clearer ethical argument is that it is 
unacceptable in a free society for public officials to filter 
information to protect people from their own free choices, especially 
when someone else (the smoker who never learns the value of switching) 
pays a high price for it.
    A second argument used to justify the misinformation is that even 
though it is arithmetically implausible that increased ST use could 
directly cause an increase in the total health impact of tobacco, 
honest information about ST would lead to more tobacco users, and some 
of them would take up smoking. If this phenomenon--that ST would act as 
a ``gateway'' to smoking--did occur, the net benefits would indeed be 
reduced. However, even though this possibility can be stated, there is 
no reason to believe it would actually occur. Several studies have 
attempted to show that there is a tendency to switch from ST to 
cigarettes, but they have merely shown that many of the same people who 
might use one form of tobacco might use another, just as we would 
expect. But even if a pattern of switching from ST to cigarettes does 
exist in the U.S. currently, it would say nothing about what would 
happen if people had good information. Believing that the two products 
are comparably unhealthy, people might be equally likely to switch in 
either direction. But when people learn that ST is much less harmful, 
they will increase their switching from cigarettes to ST and decrease 
their switching from ST to cigarettes. To claim otherwise is to say 
that tobacco users do not care about their health, which is clearly not 
the case.
    Furthermore, the logic of the gateway argument is fundamentally 
flawed. The argument requires that there is a group of tobacco nonusers 
who are avoiding tobacco because of health concerns, but who would 
start using ST if they knew it was not very risky. But then, these same 
people--who were originally motivated to avoid tobacco due to health 
concerns--somehow decide to switch to cigarettes, which they know are 
much less healthy. Thus, since honest information about ST would tend 
reduce the switching from ST to cigarettes, and it is difficult to 
imagine any new ST users switching to smoking, honest information about 
ST would tend to decrease any role that ST plays as a gateway to 
smoking. Anyone concerned with the gateway effect should be in favor of 
honest information about the lower risk from ST.
    When the preceding arguments are shown to not hold up, anti-tobacco 
advocates sometimes offer a third argument that does not depend on 
logic or science: the goal of our society should be to eliminate all 
tobacco use, and telling the truth about ST is not compatible with this 
goal. It is not clear exactly whose goal this is and what justification 
they have for imposing it on the rest of society. The legitimate goal 
of health advocates is to improve health, and denying people a great 
harm reduction opportunity clearly does not do this. It is certainly 
true that eliminating all tobacco use would improve health (almost all 
the gain coming from eliminating cigarettes), but this goal, whether 
legitimate or not, will be unrealistic for many decades.
Conclusions
    Advocating the use of ST to reduce the harm from cigarettes is a 
minority position in the U.S. But scientific truth and ethical duties 
are not decided by counting votes. The science is clear: ST is much 
less harmful than cigarettes, and there is no realistic scenario that 
leads to any increase in health risks by telling the truth. In my 
opinion, health officials have an affirmative ethical duty to make the 
truth known, both because it is the truth and because it would save 
lives. It is difficult to justify keeping the truth from people, even 
when it might be harmful; it is clearly unjustified when it would be 
beneficial. In other countries these points have been appreciated at 
the highest levels in the health community. And many other American 
health researchers, notably including Professor Lynn Kozlowski of Penn 
State University, who has presented the ethical arguments in greater 
detail than I can here, have come to the same conclusions.
    It is not clear whether those who would prevent this harm reduction 
strategy are motivated by an unrealistic vision of eliminating all 
tobacco use in the short term or by something else. Whatever their 
motives, there should be a strong burden on them to present some 
logical argument, based on realistic scientific claims and clearly 
stated ethical positions, that we should deny people truthful 
information that could save their lives. In my extensive studies of the 
scientific and popular literature, I have found no such argument. We 
are not faced with a need for more scientific information. We have 
enough information to know that the harm reduction strategy responds to 
a huge health problem, has the potential for substantial reduction of 
risks, is likely to be implementable, and has not been shown to be 
costly or likely to have major unintended consequences. It is difficult 
to imagine a more compelling case for harm reduction.

                               References

    Lewin F, Norell SE, Johansson H, Gustavson P, Wennerberg J, 
Biorklund A, Rutqvist LE. Smoking tobacco, oral snuff, and alcohol in 
the etiology of squamous cell carcinoma of the head and neck; a 
population-based case-referent study in Sweden. Cancer. 1998;82:1367-
1375.
    Royal College of Physicians. Protecting smokers, saving lives; the 
case for a tobacco and nicotine regulatory authority. London: Royal 
College of Physicians, 2002
    Schildt EB, Eriksson M, Hardell L, Magnuson A. Oral snuff, smoking 
habits and alcohol consumption in relation to oral cancer in a Swedish 
case-control study. International Journal of Cancer. 1998;77:341-346.
    Surgeon General's Advisory Committee on the Health Consequences of 
Using Smokeless Tobacco. The health consequences of using smokeless 
tobacco. U.S. National Institutes of Health Publication No. 86-2874. 
Washington: United States Public Health Service, 1986.
    Winn DM, Blot WJ, Shy CM, Pickle LW, Toledo A, Fraumeni JF. Snuff 
dipping and oral cancer among women in the southern United States. New 
England Journal of Medicine. 1981;304:745-749.
                                 ______
                                 
    Prepared Statement of David W. Eisele, Chairman, Department of 
     Otolaryngology-Head and Neck Surgery, University of California
    With this letter, I would like to provide you and your committee 
with a clinical perspective on the issue of tobacco harm reduction, an 
issue that is presently being debated amongst public health experts, 
dentists, and other health care professionals. The scientific 
information regarding the relative health risks of various tobacco 
products is important information, which should be made available to 
tobacco consumers, the public, and the health care community. 
Dissemination of this information will assist individuals who use 
tobacco products to make informed decisions regarding tobacco use.
    On this issue, I offer you the perspective of a head and neck 
cancer surgeon with significant experience with the clinical problems 
encountered by patients who use tobacco products. I am an academic 
clinician-educator and I presently serve as Professor and Chairman of 
the Department of Otolaryngology--Head and Neck Surgery at the 
University of California, San Francisco. I also direct the Head and 
Neck Oncology Program at the UCSF Mt. Zion Cancer Center, an NCCN 
Comprehensive Cancer Center. Formerly, I founded and directed the Johns 
Hopkins Head and Neck Cancer Center at the Johns Hopkins School of 
Medicine. A copy of my curriculum vitae is attached.
    My postgraduate training consisted of residency training in General 
Surgery and Otolaryngology--Head and Neck Surgery. My clinical practice 
consists of the care of patients afflicted with head and neck cancer as 
well as other tumors of the head and neck. I have cared for such 
patients in three geographically distinct regions of the United States 
including the Pacific Northwest, the Middle Atlantic region, and the 
San Francisco Bay Area. These regions of the United States have varied 
tobacco product usage patterns. It is my understanding that, in 
particular, the use of smokeless tobacco is especially prevalent in the 
Pacific Northwest.
    In order to supplement my personal clinical experience and 
perspective, I have reviewed the body of epidemiological literature 
regarding smokeless tobacco and oral cancer. In addition, I have 
examined literature relevant to the issue of the potential role of 
smokeless tobacco in the context of harm reduction. My experience of 
nineteen years in the care of head and neck cancer patients has 
demonstrated that approximately 80% to 90% of patients with head and 
neck cancer are present or former smokers of cigarettes. A smaller 
proportion are cigar or pipe smokers. On numerous occasions, I have 
observed benign reversible oral lesions (hyperplasia) in users of 
smokeless tobacco. To date, however, I have never seen a patient with 
an oral cancer that can be attributed to the use of smokeless tobacco.
    The medical literature supports my clinical observations. The 
literature clearly demonstrates significant differences in the relative 
risks for the development of head and neck and other cancers for 
different tobacco products. Of notable importance is the markedly 
diminished risk for the development of cancer of the head and neck and 
the elimination of the risk of cancers in other body locations for 
smokeless tobacco compared to cigarettes. The medical literature 
provides clear and undebatable data indicating that smokeless tobacco 
is a safer form of tobacco use relative to cigarettes.
    There is general consensus that physicians and public health 
authorities have an obligation to inform patients and tobacco consumers 
regarding the adverse health risks associated with the use of the 
various tobacco products. Because the health risks associated with 
tobacco use vary according to their form, this information is 
additionally relevant and important information that should be 
disseminated. Patients must have this information in order to make an 
informed decision regarding tobacco product usage and product choices. 
In my practice, patients demonstrate interest in understanding these 
relative risks. For example, cigar smokers will often inquire about the 
relative risk of smoking cigars compared to smoking cigarettes.
    An analogous practice by physicians already exists. Physicians 
already advise patients regarding the comparative risks of drinking 
alcoholic beverages. All reasonable physicians acknowledge that 
excessive consumption of alcohol is deleterious to one's health. Recent 
data, however, show that alcohol use in moderation has beneficial 
health effects. A physician can only be effective in the care of a 
patient who consumes alcohol if the physician understands and transmits 
this information about alcohol. In addition, those of us in academic 
medicine have an obligation to our students and trainees regarding the 
unbiased transmission of this relevant information.
    In addition, physicians must understand the data relating to 
relative risk of tobacco forms in order to fully educate patients 
regarding tobacco use risks and smoking cessation. Presently, the 
general public health message to consumers has been that all tobacco 
products are hazardous to one's health. Although this dictum is 
generally correct, the various forms of tobacco carry with them 
significant risk difference with regard to health. These relative risks 
should be known by patients, physicians, and other health care 
providers. Public health authorities should disseminate this 
information to the public so that consumers of tobacco products can 
make informed, personal decisions.
                                 ______
                                 
                                                      June 20, 2003
The Honorable Cliff Stearns
Chairman
Subcommittee on Commerce, Trade, and Consumer Protection
Committee on Energy and Commerce
U.S. House of Representatives
Washington, D.C. 20515
    Dear Mr. Chairman: Thank you for your invitation to testify on June 
3 before the Subcommittee on Commerce, Trade, and Consumer Protection. 
I appreciate the opportunity to address the Subcommittee regarding the 
dangers of allowing the tobacco industry to make ``reduced risk'' 
health claims absent comprehensive and meaningful regulation of all 
tobacco products by the Food and Drug Administration (FDA).
    We at the Campaign for Tobacco-Free Kids are also grateful for the 
hard work and many efforts of Committee staff, especially Counsel Kelly 
Zerzan, to assist us in preparing for the hearing. Below are the 
answers to the questions submitted by Representative Whitfield for my 
response.
    Q1. Do you believe that as your press release strongly suggests, 
Marlboro cigarettes are more dangerous than other American blend 
brands? Then foreign brands?
    The first question does not accurately represent what we said in 
response to the important new study conducted by scientists at the 
Centers for Disease Control (CDC). I have attached our actual statement 
on the study and would request that it be included as an attachment to 
this letter. The study conducted by the scientists from the CDC found 
that Marlboros have higher levels of nitrosamines than do the most 
local popular brands in most countries sampled. In response, we said 
that while most people assume that cigarettes from highly sophisticated 
manufacturers, such as Philip Morris are ``better'' than other 
cigarettes, this may not be true because of the presence of high levels 
of certain known carcinogens in Marlboro. The thrust of our statements 
is that consumers should be wary of tobacco manufacturers' 
representations in the absence of concrete, objective and independent 
information about the actual levels of the many known toxins in tobacco 
and tobacco smoke. Without this information neither consumers, nor the 
public health community can know for sure whether one brand is more 
harmful than others.
    The study shows that knowledge of tar levels tells us little about 
the relative harm of different products. There have been 69 different 
known carcinogens and hundreds of other harmful substances identified 
in tobacco smoke. We need to know about the level of each of these 
harmful substances. We do know that Philip Morris possesses the 
technology to reduce the level of nitrosamines in Marlboro cigarettes, 
has had the technology to do so for many years, and should have done so 
long before now. The real lesson from this study is that consumers will 
receive accurate and complete information about the different levels of 
harmful substances in tobacco products only through comprehensive and 
meaningful regulation of tobacco products by the FDA. Similarly, the 
study shows that companies such as Philip Morris can be counted on to 
reduce the level of toxic substances only when their failure to do so 
becomes public knowledge.
    Q2. Keeping in mind that I know your advice is to quit smoking, 
would you recommend to people who don't quit that, instead of Marlboro, 
they switch to Winston? To Newport? Camel? Kool? Let me move to some 
international brands that don't contain much American tobacco, would 
you recommend that smokers switch to Gauluoise from France? To 555 from 
the UK? Mild Seven from Japan? Are any of these brands less dangerous 
than Marlboro?
    The lesson of the study described above and our experience with 
light and low tar is that it has not been shown that any of the tobacco 
products now on the market significantly reduce the risk of tobacco-
caused disease. The recommendations that we would make to a smoker are 
to quit or to switch to a scientifically proven smoking cessation aid 
that has been reviewed and approved by the FDA. We do not recommend 
that Marlboro smokers switch to Winston or that Winston smokers switch 
to Marlboro. Both are deadly. The same is true with regard to foreign 
brands.
    Q3. How would you feel if you learned that a consumer read your 
press release, or the misleading headlines that it generated, and 
switched to another brand from Marlboro, having been convinced that 
they were making a good decision by switching to a less risky product?
    I do not believe that any smoker, based on our press release, would 
take the course of action implied by the question. Our message is 
clear: Marlboro and other cigarettes kill one in two long-term users. 
Smokers concerned about their health should quit in the absence of 
scientific proof that any alternative dramatically reduces their risk 
of disease. Anyone concerned about providing smokers who cannot quit a 
real alternative should endorse the kind of government regulation that 
we have proposed. Meaningful FDA regulation of tobacco products, 
including tobacco products claiming to be less harmful, is essential to 
protect consumers looking for less harmful alternatives. In the 
interim, we recommend that smokers discuss their individual situations 
with their doctors.
    Q4. Your release concludes by saying that ``no company should be 
free to make a claim that a product is safer simply by reducing a 
single poison.'' I agree. By the same token, having just put out a 
release with the headline of ``Marlboro Shows Higher Levels of Key 
Carcinogens,'' do you think that advocacy groups such as yours should 
be able to claim that a product is more dangerous simply because of 
increased levels of a single poison? If you don't think smokers will 
take away that message and that there won't be any confusion, why would 
you have a problem with claiming that a single poison had been reduced?
    We agree that no company should be free to make a claim that a 
product is safer simply by reducing a single poison in it. The Campaign 
has not stated that one tobacco product is more harmful than others. In 
fact, the Campaign for Tobacco-Free Kids makes no claims regarding the 
relative dangers posed by the cocktail of lethal chemicals found, in 
varying combinations, in currently marketed tobacco products. For 
decades consumers have assumed that tobacco products low in tar reduce 
their risk of tobacco-caused disease. New studies show that this 
assumption was not correct, perhaps in part because some or all of the 
low-tar products had higher levels of specific toxic substances, such 
as nitrosamines. The new study by the CDC, combined with our 
experiences with low-tar should be a caution that without knowing the 
levels of other toxic substances we cannot assume that the removal of 
one known harmful substance alters the overall health impact of the 
product. It also makes clear that we need to know the levels of all of 
the toxic substances in these products before we will have any reason 
to believe that we can assess relative risk. Thus, even if Philip 
Morris lowers the levels of nitrosamines in Marlboros, we will not know 
if consumers are exposed to fewer toxic substances without knowing the 
levels of the other toxic substances in the cigarette and its smoke. 
Our earnest hope is that the takeaway message of our press release is 
that if Congress is concerned about ensuring that consumers get the 
information they need to make rational decisions, Congress should enact 
comprehensive and meaningful regulation of tobacco products by the FDA 
immediately.
    Q5. Finally, you have been the leading advocate in Washington for 
unlimited Food and Drug Administration authority over tobacco products, 
and have repeatedly characterized any effort by members to respond to 
those of us who are skeptical of this initiative, and concerned about 
its consequences, by crafting some kind of compromise approach as 
``worse that nothing.'' Your ``my way or the highway'' approach has 
significantly contributed to the stalemate on this issue for over five 
years now; according to you, on every day in each of those years, 
another 3,000 kids have started to smoke. If this problem is in such 
urgent need of resolution, how can you justify remaining so inflexible? 
Which is more important to you resolving this issue, or keeping it 
alive?
    We have supported repeatedly, and in various forms, compromise 
legislation to grant FDA meaningful authority to regulate tobacco 
products. We have also stated that the enactment of legislation that 
only provides the illusion of meaningful regulation of tobacco products 
would indeed be worse than no regulation because it would remove the 
pressure on Congress to act. Unfortunately, it is our assessment and 
the assessment of every other major organization in the public health 
community that the FDA bills supported by Philip Morris would do more 
harm than good because they are riddled with loopholes that would make 
it impossible for the FDA to protect consumers effectively. They do not 
represent a step forward. Instead, they simply remove the pressure for 
Congress to act. We continue to be willing to work with any member of 
Congress interested in enacting legislation that will give FDA 
effective authority over all tobacco products. Progress has been 
stymied by the unwillingness of the tobacco industry to endorse such 
legislation.
    Mr. Chairman, thank you again for the opportunity to address these 
issues so important to the nation's, and particularly our children's, 
health.
            Respectfully,
                                           Matthew L. Myers
                          President, Campaign for Tobacco-Free Kids
Enclosures
cc: The Honorable Edward Whitfield


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