326 



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8. KMimimiCM mcOTIW E CIGARETTES ARE MISBRAWOED UNDER SEaiOW 

 XU n) and SICTIOW 503 of th€ HJOO WlXi AW COSMf mrwrT 



The Food, Orug. and Cosmetic Act, Section 301 (b) makes it unlawful to 

 adulterate or misbrand any food, drug, device, or cosmetic in 

 Interstate comnerce. In determining if the product Is misbranded the 

 Food, Drug, and Cosmetic Act sets out specific statutory crlkerla. 

 Section 20I(n) of the Act states that in determining whether labeling 

 or advertising Is misleading: 



"there shall be taken Into account among other things, not only 

 representations made or suggested by statement, word, design, 

 device or any combination thereof but also the extent to which 

 the labeling or advertising falls to reveal facts material 1n 

 the light of such representations or material with respect to 

 the consequences which may result from the use of the article to 

 which the labeling or advertising relates under the conditions 

 of use prescribed In labeling or advertising thereof or under 

 such conditions of use as are customary or usual.* 



Section 502(a), (f) and (n) of the Act further state that a drug is 

 misbranded: 



*(a) If Its labeling Is false or misleading in any particular." 



* * • 



*(f) Unless its labeling bears (I) adequate directions for use; 

 and (2) such adequate warnings against use In those pathological 

 conditions or by children where Its use may be dangerous to 

 health, or against unsafe dosage or methods or duration of 

 administration or application. In such manner and form, as are 

 necessary for the protection of users: Provided, That where any 

 requirement of clause (1) of this subsection, as applied to any 

 drug or device, is not necessarily for the protection of the 

 public health, the Secretary shall promulgate regulations 

 exempting such drug or device fro« such requirement." 



