Testimony on Tobacco Harm Reduction

Committee on Government Reform
United States House of Representative
June 3, 2003

Oral Testimony of
Dorothy K. Hatsukami, PhD
Professor of Psychiatry
University of Minnesota Medical School

Mr. Chairman, I want to thank you for the opportunity to present before this Committee. My name is Dorothy Hatsukami and I am a Professor at the University of Minnesota, Medical School. I have conducted research in the area of tobacco dependence for over 20 years. During the past 4 years, I have been funded by the National Institutes of Health to study approaches and measures for reducing tobacco toxin exposure. I also served on the Institute of Medicine (IOM) committee that examined the issue of tobacco harm reduction.

I have been asked to answer questions on the feasibility and acceptability of reduced exposure, reduced risk products as an alternative to smokers and the research challenges that are related to tobacco harm reduction.

At the present time, the feasibility or acceptability of reduced exposure/reduced risk products as an alternative for smokers unable to quit is simply unknown. It is important to keep in mind that assessment of these products and any claims of reduced exposure or risk involve examining their impact on the individual as well as the population at large. For example, individuals may show a reduction in tobacco toxin exposure. However, if more people start smoking or fewer people quit because they perceive these alternative products as safer, the total net harm may be increased. The following four steps should be taken to assure pubic health and to avoid public health disaster.

To date, quitting tobacco use is the only known way to reduce tobacco-related mortality and morbidity. Thus strong messages for tobacco prevention and cessation should continue to be the primary focus with the public. Furthermore, priority should be given to continued efforts to develop, promote and provide treatments for cessation. Currently, medicinal nicotine products yield a significantly better safety profile than any tobacco products. In our study, subjects assigned to the nicotine patch condition experienced significantly less carcinogen levels than those assigned to a reduced exposure smokeless tobacco or cigarette product. Therefore, the priority should be to provide and promote the safest products for our tobacco users and to increase the success rates for abstinence by improving on our existing treatment methods.
Second, a strong research agenda should be developed that addresses: 1) understanding tobacco addiction and developing the best treatments possible to achieve abstinence; 2) developing and testing biomarkers that measure tobacco toxin exposure and that are related to the development of disease states; 3) determining the extent of reduction in tobacco toxin exposure that will result in reduced risk for disease; 4) determining the absorption of tobacco toxins from these tobacco products in humans and understanding the reasons for individual differences in the degree of exposure and disease susceptibility; 5) determining how messages regarding these potential reduced risk products can be conveyed to the public so that prevention or cessation efforts are not compromised and 6) examining the prevalence and pattern of use of these reduced exposure products either alone or in combination with conventional tobacco products. To date, current knowledge in these areas is very limited.
Third, organizations independent of the tobacco industry should test and determine the impact of these products. These entities should test for toxins within the product itself and in the case of cigarettes, as it is burned. In addition, the uptake of tobacco toxins in these reduced risk products and the consequences of this exposure should be assessed. An independent organization could also be responsible for conducting post-marketing surveillance in order to assess for prevalence and pattern of use of tobacco products with purported reduced exposure.
Finally, regulatory authority over tobacco products is essential. An organization such as the FDA that can critically evaluate the evidence base for exposure reduction claims as well as regulate marketing efforts is crucial to protect public health. Without oversight, the public could not be assured of the validity of industry claims of reduced risk or informed about tobacco toxin constituents to which they are exposed, and therefore informed decisions could not be made. Tobacco companies need to be required to submit their novel products and claims to the FDA prior to the appearance of these products and claims regarding these products in the marketplace. The FDA should also be given the authority to establish manufacturing standards for all tobacco products, so that development of less toxic cigarettes or other tobacco products can become standard rather than the exception. To me, it is unconscionable that we currently have the technology to potentially reduce toxins in tobacco products and yet do not have a mechanism in place to require that all tobacco products meet these lower levels. Requiring the reduction of toxins in all tobacco products would be important should they be demonstrated to lead to potential reduction in risk for disease.

In summary, the answer to the questions regarding whether reduced exposure/reduced risk products are an alternative for smokers who are unable to quit depends on the effects of these products on the individual and the population at large, which are information that we do not yet have. Therefore, understanding the impact of these products on public health will require research. In addition, we need to develop the infrastructure and resources to conduct the necessary research and to evaluate these products at all levels. But to fully protect public health, we need FDA regulatory authority over tobacco products.

Thank you again for the opportunity to present to you.