195 



intended use of a product may be determined from its labeling. accompanMng 

 labeling. oromotionaJ materia!, advenising. or anv other relevant source . ' 

 (emphasis added) The court notes that ' intent " has been established m 

 statements made in a disclaimer lener. magazine testimonials, as well as lectures, 

 and in "Class Notes on Health and Nutrition. ' Obviously the manner in which 

 intent can be established and ascertained is very broad and flexible. The coun 

 continues (citing Hohensee . Fairfax , and Trim ) finding that "regardless of the 

 actual physical effect of a product, it will be deemed a drug for purposes of the 

 Act where the labeling and promotional claims show intended uses to bring it 

 within the drug definition. "" .Ajid finally the court discusses the issue "by what 

 standards are these claims to be evaluated? Or to put it another way, what degree 

 of sophistication or vulnerability is to be ascribed to the hypothetical consumer in 

 order to understand how these claims are understood by the buying public?" 

 Citing U.S. v. Donerwich , the court states that, "Considering the remedial 

 purposes of the Act and particularly of the 1938 amendments, the Supreme Court 

 declared: 'The purposes of this legislation thus touch phases of the lives and 

 health of people which - in cirmnu iUnces of modern industrialism, are largely 

 bevond self-protection. Regard for these purposes should infuse construction of 

 the legislation if it is to be treated as a working instrument of government and 

 not mereiv as a coUection of English words. Accepting this admonition, we 

 conclude that the purposes of the Act will best be effected by postulating a 

 consuming public which includes the ignorant, the unthinking and the 

 credulous...'.' (p. 277) (Emphasis added.) 



The cumulative legal basis upon which "intent" and paniculariy "vendor intent" is 

 required to be established was again summarized and confinned in both National 

 Nutritional Foods Association s v. Mathews. 557 F.2d 325 2d Cir. (1977) and in 

 ASH v Harris . 655 F.2d 236 (1980), the latter case being direcUy related to and 



