• promotion, advertising and labeling of these products are firmly regulated to prevent false or misleading claims, explicit or implicit;

  • health effects of using PREPs are monitored on a continuing basis;

  • basic, clinical, and epidemiological research is conducted to establish the potential use of PREPs for reducing risks for disease in individuals and for reducing harm to the population as a whole; and

  • harm reduction is implemented as a component of a comprehensive national tobacco control program that emphasizes abstinence-oriented prevention and treatment.

The 7 chapters of the committee’s report that precede this and the extensive reviews found in Section II provide the documentation for the following principal conclusions regarding the four questions posed within the charge, as outlined in Chapter 1. Specific recommendations can be found within the body of the report.

Conclusion 1. For many diseases attributable to tobacco use, reducing risk of disease by reducing exposure to tobacco toxicants 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 greatest benefit. Key to this conclusion is the assumption that compensatory increase in exposure does NOT occur with the use of these products.

Conclusion 2. PREPs have not yet been evaluated comprehensively enough (including for a sufficient time) to provide a scientific basis for concluding that they are associated with a reduced risk of disease compared to conventional tobacco use. (One exception is the use of nicotine replacement therapy for maintenance of cessation in the Lung Health Study. See Chapters 13 and 14.) Carefully and appropriately conducted clinical and epidemiological studies could demonstrate an effect on health. However, the impact of PREPs on the incidence of most tobacco-related diseases will not be directly or conclusively demonstrated for many years. Tobacco use causes very serious morbidity and mortality due to several different diseases. Cancer (e.g., of the lung, oral cavity, esophagus, and bladder), cardiovascular disease, chronic obstructive pulmonary disease, and low birthweight are all well-established effects of tobacco use. The conditions can be diagnosed, the natural history of the diseases is reasonably well understood, and scientifically appropriate studies of tobacco users who switch to PREPs could be designed. See Chapters 4 and 1116 for supporting material.

However, such research will be difficult. For example, tobacco users may not use a particular PREP for long enough to see health impact; tobacco PREPs will undoubtedly change substantially over

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