182 



I. PRELIMTWRY STATEMENT 



In 1906. the first Food and Drug Act was enacted into law. The statute banned 

 from interstate commerce any trafficking of adulterated and/or misbranded foods 

 or drugs. Since that time the Food and Drug Administration (FDA) has. under 

 statutory direction from the U S. Congress, continued to enforce the laws 

 designed to ensure that foods and drugs are safe and effective. The Act also now 

 governs cosmetics and medical devices. All of the products covered by the Act 

 are products that are either ingested by man, applied to the skin or implanted into 

 the body. Food and Drug Administration regulation of these products governs 

 the composition of the products and their sale, distribution, advertising and 

 promotion. 



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

 to ensure the protection of consumers from hazardous substances. There is one 

 product that has, although it has attributes similar to foods and drugs, 

 traditionally not been regulated by the FDA and has escaped regulation by 

 statutory exemption under the Consumer Product Safety Act, the Fair Labeling 

 and Packaging Act, the Toxic Substances Act and the Federal Hazardous 

 Substances Act; that product is tobacco. 



There can be no question by any person reviewing the health hazards posed by 

 cigarettes that this is a pirxluct that logically warrants regulation in the same 

 manner that foods, drugs and other harmful products are regulated. There can be 

 no question by anyone reviewing the medical literature on nicotine and its 

 addictive effects that this is a product that should be considered a dangerous drug. 

 As the Surgeon General has frequently stated, cigarette smoking is this nation' s 



