regulatory tool for any product, tobacco containing or not, that makes an explicit health claim and also meets the definition of a drug or device. In the 1950s the FDA exerted jurisdiction in two cases in which tobacco companies made explicit claims regarding the health benefits of their products. In 1953, the FDA classified Fairfax cigarettes as drugs when the manufacturer enclosed leaflets with language that implied effectiveness in preventing an array of diseases, and in 1959 (United States v. 354 Bulk Cartons Trim Reducing-Aid Cigarettes), the FDA successfully prohibited explicit claims of weight reduction by a cigarette. During the late 1970s, however, when Action on Smoking and Health (ASH) and others petitioned the FDA to assert jurisdiction over cigarettes as drugs and devices, the FDA denied the petition on the grounds that cigarettes did not fall under the statutory definition of a drug. The FDA asserted that evidence of consumer intent to use the product predominantly for the health effects or the effects on the structure or function of the body was not sufficient to infer a similar intent by the manufacturers. Tobacco manufacturers appeared to be free from more comprehensive regulation as long as they did not make explicit claims about health benefits or effects on body structure or function and if they complied with advertising and labeling restrictions enacted by Congress (Slade and Ballin, 1993; U.S. DHHS, 2000).

In 1988, the Coalition on Smoking or Health (CSH) and others petitioned the FDA to classify low-tar and nicotine products as drugs and to classify the new smokeless cigarette product by RJR, “Premier”, as an alternative nicotine delivery system and, hence, subject to regulation as a drug. CSH cited indirect claims made through advertising and marketing as evidence of the manufacturer’s intent to have the product used for the mitigation or prevention of disease (Slade and Ballin, 1993). Again in 1994, the FDA was petitioned by CSH to classify all cigarette products as drugs as defined in the FDCA. Later that year, the FDA Commissioner announced in a letter to CSH and later in congressional testimony that the FDA, in light of new evidence, would revisit the FDA’s authority to regulate tobacco products as drugs and devices as defined in the statute.

Following this investigation, the FDA asserted its jurisdiction and proposed regulation of certain tobacco products in the Federal Register in August 1995. The authority for such regulation was based on new evidence showing that cigarettes and smokeless tobacco products are nicotine-containing (i.e., drug-containing) devices as defined by the FDCA of 1938. The FDA determined that nicotine could be classified as drug based on the facts that (1) nicotine causes and sustains addiction, (2) nicotine produces other psychoactive (mood-altering) effects, and (3) nicotine controls weight. The definition of nicotine as a drug as defined by the FDCA includes an intent by the manufacturer for the product to be used as a drug in the bodies of their customers.

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