319 



- 76 



tongue 1n cheek, 1f not to display a most 

 extraordinary naivete." 178 F. Supp at 851. 



Applying this sane argument, to contend that advertising and promotion 



of low tar and nicotine cigarettes would not create in the mind of a 



health conscious purchaser the idea that use of these cigarettes are 



less ha2ardous in that they contain low levels of substances known to 



affect the structure or functions of the body 1s again to speak with 



tongue In cheek. If not to display an extraordinary naivete. 



In determining whether low tar and nicotine cigarettes should be 

 classified as drugs under Section 201 (a) (1) (C), two more recent 

 actions by the FDA are also worth reviewing. One deals with PDA's 

 denial of a petition by Action on Smoking and Health which sought to 

 classify all cigarette products as drugs because they contained 

 nicotine. The other concerns the marketing of FAVOR smokeless 

 cigarettes, "a cigarette like device consisting of a plug Impregnated 

 with a nicotine solution Inserted with a small tube - corresponding In 

 appearance to a conventional cigarette." 



In 1977, Action on Smoking and Health (ASH) and others, filed a petition 

 with tht Food and Drug Administration seeking to classify all cigarettes 

 as drugs undtr Section 201 (g) (C) as articles "Intended to affect the 

 structure or any function of the body of man or other animals." The 

 premise on which the petition was filed was that because all cigarettes 

 contain nicotine "they fait easily and squarely within the broad 

 language of the act" (Petition of a.S.h. at p. 13). In denying the 



