201 



D. FDA HAS ON NTAIEROLS OCCASIONS REGLXATED AS DRLGS 

 A.NT)/OR FOOD OTHER NICOTEST OR TOBACCO CONTATsTSG 

 PRODUCTS 



In addition to the legal authorities to regulate cigarenes as drugs under the FDC 

 Act. the FDA has also brought numerous actions against a number of nicotine 

 and/or tobacco containing products. 



In 1987 the Food and Drug Administration found that a cigarette-like product. 

 FAVOR, was a nicotine debvery system intended to satisfy a nicotine dependence 

 and to affect the structure of one or more functions of the body. The FDA 

 reached its decision to classify the product as a drug after reviewing promotional 

 materials filed with the Securities and Exchange Commission (SEC). 



In 1989 the FDA issued a regulatory letter against Masterpiece Tobacs . This time 

 the product was being sold as a chewing gum. The manufacturer had argued that 

 the product was outside the FDA's Jurisdiction because the product contained 

 tobacco. The FDA disagreed and ruled that because the product was a chewing 

 gum. it therefore fell under the jurisdiction of the FDA under the definition of 

 "foods. " Because the product contained a dangerous substance - tobacco - the 

 product was deemed to be adulterated and removed from the market place. 

 Arguments that the product was a tobacco product for "chewing pleasure only" did 

 not even enter the FDA's decision to remove the product from the marketplace. 



In 1989 the FDA issued a regulatory letter against C.A. Blockers, Inc. indicating 

 that a cigarene additive, "N-Bloctin," was a "diug" subject to regulation by the 

 FDA. "N-Bloctin" according to the regulatory letter, "is an alcohol containing 

 cigarette additive, the intended uses of which include, through action at the tissue 

 cells, to inhibit the accumulation in the lungs of nitrosamines present in 



