238 



III. STATOCirr OF LISAL GROUNDS 



A. LOM Tar and Low Nicotine Cigarettes are 'Drugs* within the 

 waning of the Federal Food, Drug, and Cosaetic Act. 



1. The Food and Drug Administration has asserted 



jurisdiction over tobacco products where claims related to 

 the treatment, cure, mitigation or prevention of disease 

 have been indicated and where the tobacco product has been 

 Shown to be intended to affect the structure or function of 

 the body. 



2. Low tar/low nicotine cl'jarettes are Mrketed with the 

 intent of creating in the mind of the public the idea that 

 t?iey will "mitigate," or "prevent" the onset of disease 

 associated with the SBo^cng habit, thus meeting the 

 definitional requirements of "drugs." 



3- Comparative advertising and promotion activities which 

 distinguish varying levels of nicotine and tar demonstrate 

 the intent of the cigarette manufacturers to market these 

 products as products intended to affect the structure or 

 functions of the body thus meeting the definitional 

 requirements of 'drugs.' 



B. LoM Tar and Low Nicotine Cigarettes are alsbranded under 

 Section 201 (n) and Section 502 of the Food Drug and Coswtic Act. 



1. Low Tar and Low Nicotine cigarette labeling, advertising 

 and promotion falls to disclose that these products contain 

 chemical additives and other constltutents which are harmful 

 and may Increase risks to health. 



2. Low Tar and Low Nicotine cigarette labeling, advertising, 

 and proaotlon falls to disclose contraindications, 

 effectiveness, side effects, etc. 



3. Low Tar and Low Nicotine cigarette labeling falls to 

 provide directions for use and adequate labeling, including 

 warnings that cigarettes are addictive. 



C. Cigarette ainufacturers have failed to sect the re<|u1reaents 

 of Section SOS of the Food. Drug, and Coswtlc Act, "New Drugs.* 



IV. CONCLUSION 



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