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I. PRELIMINARY STATEMENT 



In 1906, the first Food and Drug Act was enacted Into law. That statute 

 banned from Interstate comnerce any trafficking of adulterated and/or 

 niisbranded foods or drugs. Since that time the Food and Drug 

 Administration has, under statutory dlre-^tlon from the U.S. Congress, 

 continued to enforce the laws designed to ensure that not only are foods 

 and dpjgs safe and effective but the Act also now governs cosmetics and 

 ffledlcal devices. All of the products covered by the Act are products that 

 are either Ingested by man, are applied to the skin, or implanted Into tht 

 body. Food and Drug Administration regulation of these products not only 

 governs the composition of the products but also their sale, distribution, 

 advertising and promotion. 



The underlying purpose of the Food, Drug, and Cosmetic Act (FDCA) has and 

 continues to be to ensure tht protection of consumers from hazardous 

 substances. There is however, one product that, although it has 

 attributes slalltr to foods and drugs, has escaped regulation not only 

 undtr tlw Food, Oru). and Cosmetic Act but also the Consumer Product 

 Saftty Act, tho Fair Labeling and Packaging Act, the Toxic Substances Act. 

 and tho Federal Hazardous Substances Act. That product is of course 

 tobacco. FOA has assumed Jurisdiction over tobacco products under 

 situations in which a health claim has been made or implied about the 

 product. But, the the FDA has not taken action against tobacco products 

 as long as they are sold only for smoking pleasure. 



