Tobacco and cigarette-like products have been introduced recently that, under measurement systems such as the FTC smoking machine, result in decreased emission of some toxicants compared to conventional tobacco products. Currently available products include tobacco with reportedly reduced levels of some carcinogens and cigarette-like products that deliver nicotine with less combustion than cigarettes. Two classes of pharmaceutical products approved by the Food and Drug Administration (FDA) for short-term use in smoking cessation might also be used for harm reduction. These include nicotine products, such as in patch, gum, inhaler, and nasal spray preparations, and a nonnicotine product that reduces the craving for tobacco. These cessation drugs could be used long term to maintain cessation or concomitantly with continued but decreased use of conventional tobacco products (see Table 1).

These tobacco and pharmaceutical products could potentially result in reduced exposure to toxicants. The committee uses potentially, because whether exposure to tobacco toxicants is reduced depends on the user’s behavior, such as frequency and intensity of use. Reduced exposure, however, does not necessarily assure reduced risk to the user or reduced harm to the population. Therefore, and in order to avoid misinterpretation, the committee uses the generic phrase “potential reduced-exposure products,” or PREPs, when discussing the modified tobacco products, cigarette-like products (whether tobacco containing or not), or pharmaceutical products and medical devices (whether nicotine containing or not) used for their tobacco harm reduction potential. More such products are likely to be introduced in the near future, perhaps accompanied by claims that they are less harmful than conventional products.

The Institute of Medicine (IOM) convened a committee of experts to formulate scientific methods and standards by which PREPs (pharmaceutical or tobacco-related) could be assessed. Four questions were imbedded within the charge given to the committee by the Food and Drug Administration in December 1999. Where there are not yet answers, the committee was asked to outline the broad strategy by which the knowledge base might be assembled.

1. Does use of the product decrease exposure to the harmful substances in tobacco?

2. Is this decreased exposure associated with decreased harm to health?

Front Matter (R1-R20)

Executive Summary (1-18)

1 Introduction (19-37)

2 Principles of Harm Reduction (38-59)

3 Historical Perspective and Lessons Learned (60-81)

4 Products for Tobacco Exposure Reduction (82-139)

5 The Scientific Basis for Pres Assessment (140-179)

6 Surveillance for the Health and Behavioral Consequences of Exposure Reduction (180-200)

7 Implementation of a Science-Based Policy of Harm Reduction (201-230)

8 Principal Conclusions (231-240)

9 Nicotine Pharmacology (241-282)

10 Tobacco Smoke and Toxicology (283-308)

11 Exposure and Biomarker Assessment in Humans (309-366)

12 Cancer (367-469)

13 Cardiovascular Disease (470-499)

14 Nonneoplastic Respiratory Diseases (500-542)

15 Reproductive and Developmental Effects (543-559)

16 Other Health Effects (560-580)

Appendix A: Presentations and Submissions (581-585)

Appendix B: Committee Biographical Sketches (586-592)

Appendix C: Time Line of Tobacco Events (593-606)

Index (607-636)