The FDA’s assertion that cigarettes and smokeless tobacco products may be defined as nicotine delivery devices was based on findings that (1) the effects of nicotine are so widely known that it is foreseeable to a reasonable manufacturer that these products will cause addiction and other pharmacological effects and will be used by the consumers for these effects and to sustain the addiction; (2) consumers use tobacco products mainly to sustain addiction, for the mood-altering effects, and for weight loss; (3) manufacturers of tobacco products know that nicotine has pharmacological effects and that consumers use their products primarily to obtain the pharmacological effects of nicotine; (4) manufacturers design their products to provide consumers with a pharmacologically active dose of nicotine; and (5) as a consequence, consumers keep using cigarettes and smokeless tobacco to sustain their addiction to nicotine (U.S. DHHS, 1995). The agency disclosed new evidence from industry documents of product engineering, nicotine delivery manipulation, and industry research in support of its contention that tobacco products are intended to change the structure or function of the body. This provided the rationale for the FDA’s proposed new rules on the advertising, marketing, and sale of tobacco. Many of the proposed actions were directed toward limiting the access of minors to tobacco products and stopping cigarette advertising and promotion targeted at adolescents.

Specifically, the new regulations imposed a ban on the sale of tobacco products to minors; required vendors to check for proof of age; banned cigarette vending machines, banned billboard or other advertisements easily accessible to youth; restricted all advertising to black and white text (except in publications read primarily by adults); banned tobacco manufacturer sponsorship of sporting and entertainment events; banned promotional items displaying a brand name, logo, or free samples; and required tobacco industry financial support for antitobacco education for children (U.S. DHHS, 2000).

On August 28, 1996, after soliciting public comment, the FDA published its final rule, modified only in that adult-only businesses were exempted from certain restrictions. The FDA was met by legal action from the tobacco industry, advertising industry, and tobacco vendors to block implementation of these rules. The case was initially heard by the federal district court in Greensboro, North Carolina (April 1997), which upheld the FDA’s regulatory authority over tobacco products and supported the FDA definition of tobacco products as combination drug and drug delivery devices. The court, however, ruled that the FDA had no statutory authority to regulate tobacco advertising or promotion.

The decision was appealed by both sides in August 1997, and in August 1998, the Fourth Circuit overturned the district court decision and revoked FDA’s proposed authority to regulate tobacco products. The



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