those of other tobacco constituents. Some have proposed that nicotine should be removed from tobacco products in order to prevent addiction (Henningfield et al., 1998), decrease tobacco use, and thereby decrease exposure to the most toxic constituents in tobacco. The marketability of a nonaddicting tobacco product, however, is thought to be low. Nicotine has pleasurable or rewarding effects, in addition to its addictive properties. However, societal views of addictions per se surround the controversy.

Retaining nicotine at pleasurable or addictive levels while reducing the more toxic components of tobacco is another general strategy for harm reduction (for a recent review of this issue, see Russell, in Ferrence et al., 2000). The tobacco industry reportedly would support some FDA regulation of cigarette products (Schwartz and Kaufman, 2000). Key to its acceptance is that there be no upper level for nicotine that is set so low as to effectively ban cigarettes (Schwartz and Kaufman, 2000). Experience with NEXT, a cigarette with extremely low nicotine levels that did not succeed in the marketplace, suggests that nicotine is one of the factors crucial to the success of a tobacco product.

PHARMACEUTICAL PRODUCTS

Modified tobacco and cigarette-like products are not the only potential strategies for harm reduction. Two classes of pharmaceutical products might provide an alternative to the less harmful cigarette for harm reduction. These two classes of drugs are nicotine products, of which there are several such as patch, gum, inhaler, and nasal spray preparations, and nonnicotine products. To date, only one product that does not contain nicotine has been approved by the FDA for tobacco cessation and is on the market—a slow-release bupropion preparation, Zyban. This has been approved by the FDA for short-term (up to six months) use for tobacco cessation and was subject to standard FDA review and approval. Chapter 4 includes a detailed description of such products and the FDA approval process.

Early speculation that these products might be used on a long-term or continuing basis to reduce exposure to tobacco toxicants was supported by the observation that some people use them far longer than indicated in the FDA labeling and continue to smoke as well. It is possible that these smokers might decrease their tobacco use to a level that is less harmful than their prior tobacco use. Some smokers might cease using tobacco but use the pharmaceutical products on a long-term basis to help ensure abstinence. Claims by the manufacturers of usefulness for harm reduction short of cessation or for long-term maintenance would require FDA review and approval for either new indications or as new products. To date,



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