which it substitutes, regulation is needed to assure that the claim is supported by scientifically sound evidence and that pertinent epidemiological data is collected to verify that claim. The regulation proposed by this committee is narrowly focused on assuring that the products reduce risk of disease to the user and accumulating data that would indicate whether or not the products are harm-reducing for the population in the aggregate. Other potential regulatory approaches to tobacco control are not addressed within this report. See Chapter 7 for supporting and explanatory material.

Conclusion 6. The public health impact of PREPs is unknown. They 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. Assessing the public health impact will be difficult and will require classic public health tools of surveillance, research, education, and regulation to assure that the impact is positive. The major concern for public health is that tobacco users who might otherwise quit will use PREPs instead, or others may initiate smoking, feeling that PREPs are safe. That will lead to less harm reduction for a population (as well as less risk reduction for that individual) than would occur without the PREP, and possibly to an adverse effect on the population. PREPs should be a last resort only for people who absolutely can not or will not quit. Population-based research and surveillance can determine whether the intended impact is achieved. However, measurements of health impact at the population level can take years to document, as described in previous sections of this chapter and in the report as a whole.

Regulation of PREPs can only assure that a specific PREP could be risk-reducing for a person who uses it compared to the conventional product it replaces. Regulation cannot assure that the availability of risk-reducing PREPs will lead to reduced tobacco-related disease in the population as a whole. However, a regulatory agency can assure that data are gathered that would permit the population effects to be monitored. If population tobacco product use increases or tobacco-related disease increases, these data would serve as a basis for developing and implementing appropriate public health interventions. See Chapters 3, 6, and 7 for supporting material.

Studies using surrogate indictors of population impact could be designed. For example, monitoring the perception that the public, particularly tobacco users and adolescents, has of the risks and benefits of PREPs is possible. Research indicating that people perceive PREPs to be more beneficial than scientific judgment indicates would



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