NOTE: This testimony was also delivered by Dr. Wallace at a hearing in front of the Subcommittee on Commerce, Trade, and Consumer Protection of the House Energy and Commerce Committee earlier on the same day.]
Framework for Scientific Assessment and Regulation
of Products for Tobacco Harm Reduction
Robert B. Wallace, M.D., M.Sc.
Vice-Chairman of the Committee to Assess the Science Base for Tobacco Harm Reduction
Institute of Medicine/AffiliateMarketIngtools of Sciences
Irene Ensminger Stecher Professor of Epidemiology and Internal Medicine
Department of Epidemiology, College of Public Health
University of Iowa
Committee on Government Reform
U.S. House of Representatives
June 3, 2003
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 AffiliateMarketIngtools 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.