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Executive Summary

OTC SMOKING DETERRENT PRODUCT CLAIMS FOR SMOKING REDUCTION NEED MORE DATA to be allowed as a monograph claim, FDA said in a tentative final monograph, published in the July 3 Federal Register. Although noting that some evidence has been accumulated to indicate that a reduction in smoking, or "controlled smoking," results in health benefits to the individual, the agency concluded: "Even so, there is insufficient evidence to show that a significant reduction in smoking will lead to cessation or that reduction will lower the health risks associated with smoking." The agency "is aware that recent reports in the literature have indicated that reduction in smoking, or controlled smoking, should be considered as an alternative to abstinence because of the generally disappointing outcomes of traditional abstinenceoriented smoking-treatment studies." The authors of one study, FDA said, "concluded that abstinence and reduction are not necessarily different points on the same continuum, but rather that abstinence and smoking reduction should be treated as two potentially discrete treatment outcomes." Individuals can reduce smoking by either decreasing the number of cigarettes smoked or by switching to low nicotine/low tar cigarettes, FDA said. However, the agency added, "evidence on the effects of controlled smoking on the health of the individual smoker has been contradictory." FDA said that "should sufficient data regarding reduction claims become available before the publication of the final monograph, the agency will consider including reduction in smoking claims in the final monograph." In the tentative final monograph, FDA proposed that the only indication for such products should be: "A temporary aid to those who want to stop smoking cigarettes," or "A temporary aid to breaking the smoking habit." The agency classified all but two of the 13 active ingredients reviewed by the Miscellaneous Internal Panel into Category II, or non-monograph status. Silver acetate and lobeline (in the form of lobeline sulfate or its pharmacological equivalent as natural labelia alkaloids or Lobelia inflata herb) were the only Category III active ingredients. In addition, the agency said that povidone-silver nitrate, not classified by the panel, was a new drug.

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