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March 25, 1994 Page 29 



manufacturers reveal their intention to sustain addiction to 

 nicotine in their nicotine dependent customers. 



Discussion 



Cigarettes are intended to affect the structure or function 

 of the body. The manufacturers have developed technologies which 

 permit them to precisely control the dose of nicotine so it is 

 predictable, neither too much nor too little, from cigarette to 

 cigarette. The intended use of cigarettes involves inhaling the 

 cigarette smoke. Inhalation has nothing to do with taste and 

 flavor; inhalation has everything to do with the rapid delivery 

 of nicotine to the central nervous system. The intended effects 

 of cigarette smoking include relaxation, stimulation, the 

 provision of satisfaction, and the promotion of physiologic 

 equilibrium. Any one of these intended effects is sufficient' to 

 trigger application of the Food, Drug and Cosmetic Law to 

 cigarettes, but in fact, all four effects, as well as others, are 

 intended. 



In other words, although the cigarette makers do intend to 

 sustain nicotine addiction among many of their customers, there 

 are also other intended pharmacologic effects of smoking which 

 also should result in the Food a.nd-Drug. Administration exerting 

 its regulatory authority over this industry. 



Objections from cigarette makers that sales weighted 

 nicotine deliveries have been falling over the years are not 

 persuasive that cigarettes are not intended to affect the 



