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Coalition on Smoking OR Health 

 February 25, 1994 

 Page 3 



This evidence, along with the growing body of data related 

 to new products proposed for the treatment of nicotine addiction 

 from smoking, suggests that cigarette vendors intend the obvious 

 — that many people buy cigarettes to satisfy their nicotine 

 addiction. Should the agency make this finding based on an 

 appropriate record or be able to prove these facts in court, it 

 would have a legal basis on which to regulate these products 

 under the drug provisions of the Act. 



A strict application of these provisions could mean, 

 ultimately, removal from the market of tobacco products 

 containing nicotine at levels that cause or satisfy addiction. 

 Only those tobacco products from which the nicotine had been 

 removed or, possibly, tobacco products approved by FDA for 

 nicotine-replacement therapy would then remain on the market. 



Given the widespread use of cigarettes and the prevalence of 

 nicotine addiction, such a regulatory action could have dramatic 

 effects on our society. One must consider the possible effects 

 of the loss of this source of nicotine on the health of some 

 people who are addicted to nicotine and the possible need for a 

 weaning period. It is also important to consider the potential 

 for a black market in nicotine-containing cigarettes. 



We recognize that the regulation of cigarettes raises 

 societal issues of great complexity and magnitude. It is vital 

 in this context that Congress provide clear direction to the 

 agency. We intend therefore to work with Congress to resolve, 

 once and for all, the regulatory status of cigarettes under the 

 Food, Drug, and Cosmetic Act. Few public health issues are more 

 important . 



David A. Kessler, M.D. 

 Commissioner of Food and Drugs 



Michael F. Heron, American Cancer Society 

 Fran Du Melle, American Lung Association 

 Matthew L. Myers, Asbill, Junkin, and Myers 



