324 



81 



cooBerce since FAVOR was a new drug within the meaning of the FDCA and had 

 not been approved for use by the FDA. 



In reaching its conclusion, the FDA reviewed numerous labeling and 

 pronotional materials, as well as registration material filed with the 

 Securities and Exchange Commission (SEC). The materials, said the FDA, 

 represent and sugcjcs t that F AVOR is a novel nicotine delivery system; that 

 each pouch of six will have a nicotine capacity intended to satisfy the 

 average number of conventional cigare'tes for an entire day, that th« 

 quantity of nicotine required to produce the effect on the nervous system 

 which most smokers are accustomed to in relation to the amounts of other 

 alkaloids regularly consumed by typical users, and that FAVOR Is an 

 alternative for conventinal cigarette smokers who desire nicotine 

 pleasure. 



In Its regulatory letter, FOA points out that the medical literature 

 clearly recognizes that nicotine is well absorbed from the lungs and that 

 " it has potent phanMcologic effects, including effects on the nervous 

 systea and th«t nicotine is a drug of dependence ." Upon that basis, the 

 FOA then rtachts the following significant conclusion: 



It is our position that FAVOR is a 

 nicotine delivering system intended to 

 satisfy a nicotine dependence and to" 

 affect the structure of one or more 

 functions of the body. (Food and Drug 

 Administration Regulatory Letter to 

 Advanced Tobacco Products, Inc., 

 February 9, 1987.) 



