196 



- 15 - 



most relevant to this petition. As the Coun in National Nutntional Foods noted 

 in finding that the FDA had failed to show any vendor intent: 



The main issue on this appeal is whether the evidence of the extensive 

 use of larger doses of Vitamins A and D to treat or prevent diseases and 

 the promotion of such usage by persons not associated with the 

 manufacturers or vendors establishes such widespread therapeutic use at 

 the regulated levels as to overcome the plaintiffs' claim of the lack of an 

 intended use to cure or prevent disease. . . . (p. 335) 



In the ASH case. Action on Smoking and Health (ASH) had contended that the 

 mere presence of nicotine in a tobacco produa coupled with the "intent" of the 

 consumLng public to buy these products to affect structure and function of the 

 body made these products "dnigs" subject to the FDC Act. FDA denied the 

 petition. In affinning the FDA's decision the District Court noted that ASH, by 

 failing to introduce any evidence of vendor's intent - whether based upon 

 subjective vendor claims or objective evidence such as labeling, promotion 

 material and advertising, placed itself in a position of having to meet the high 

 standards established in cases where sututory "intent" is derived from consumer 

 intent alone. Whether consumer intent is a "relevant source for these purposes 

 depends upon whether such evidence is strong enough to justify an inference as to 

 vendor's intent." 



Petitioners beUeve that there is far more than sufficient evidence now available 

 on vendor's intent (complemented by weU esUbUshcd consumer intent) to 

 warrant the FDA assuming jurisdiction over all cigarette products under Section 

 201(g)(1)(B) and (C). 



