320 



77 



petition (uph«ld In ASH v. Harris 655 F.2d 236 O.C. Cir. 1980) then 

 Connlssloncr Donald Kennedy stated that petitioners had failed to 

 establish an intent on the part of the manufacturer to sell a product 

 which "affected the structure or function of the body." Specifically, 

 the Connlss loner wrote: 



"Statements by the Petitioners and citations in the 

 petition that cigarettes are i.sed by smokers to 

 affect the structure or functions of their bodies 

 are not evidence of such Intent by the 

 manufacturers or vendors as required under 

 provisions of the FOCA." 



In denying the petition, FDA did not say that cigarettes could not be 

 clissified as drugs under Sec. 201, the FOA merely said that In the case 

 of cigarettes in general , petitioners failed to provide sufficient 

 evidence to establish that manufacturers sell cigarettes with an 

 Intention of affecting the structure or functions of the body . 



This is not the case for low tar and nicotine cigarettes. Evidence 

 presented in the Statement of Factual Grounds demonstrates that 

 prlaarily because of the well established scientific evidence that 

 cigarettes cause cancer, emphysema, heart disease, etc., consumers have 

 soitgtit ways of either quitting or reducing their risks by smoking what 

 Is believed to be safer cigarettes. In order to meet this consumer 

 concern for health, tobacco companies have shifted their marketing 

 strategies by manufacturing increasing numbers of low tar and nicotine 

 cigarettes, which they have aggressively promoted in a manner, which 

 suggests to the public that the lower tar and nicotine cigarettes 



