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Studies also demonstrated nicotine’s psychoactive effects, another component of addiction. Brain mechanisms for behavioral reinforcement and compulsive use were characterized (IOM 2001). Epidemiological studies showing that large majorities of smokers had tried and failed to quit added to the evidence of addiction.

The 1988 Surgeon General’s report (DHHS 1988), Health Consequences of Smoking: Nicotine Addiction, detailed how nicotine meets the criteria for an addictive drug, concluding that smokers smoke because they are addicted and that nicotine is the addictive agent. A growing number of scientific and medical organizations, including the World Health Organization, the American Medical Association, and the American Psychiatric Association, declared nicotine addictive or dependence producing.

The medical consensus that nicotine is an addictive drug transformed the concept of smoking from a bad habit of weak-willed people to a patho-physiological process that produces compulsive behavior. Increasingly, scientific studies have documented the pharmacological and structural effects of nicotine on the nervous system, which ultimately leads to specifiable changes in the brain.

The highly addictive nature of nicotine undermines the tobacco industry’s longstanding position that smoking is a “free choice” and, by drawing attention to the similarities between tobacco addiction and addiction to other psychoactive drugs, establishes the empirical and ethical foundation for more aggressive regulation. Although the FDA regulates nicotine patches and other nicotine-containing products used as aids for smoking cessation, FDA commissioners had traditionally declined to assert any jurisdiction over cigarettes. In the late 1980s, Scott Ballin, director of the Coalition on Smoking OR Health, petitioned the FDA to regulate low-tar cigarettes and the new smokeless brand Premier on the basis of their implied health claims that these products are less harmful than ordinary cigarettes (Kessler 2000). In response to the petition, FDA Commissioner David Kessler decided to explore a broader regulatory approach than one based on the “implied health claims” associated with low-tar cigarettes. In 1991, he created a team of FDA lawyers, scientists, and policy makers to study the policy implications of the finding that nicotine is an addictive drug. In particular, they explored whether the FDA could regulate nicotine under the Federal Food, Drug, and Cosmetic Act (Kessler 2000).

The statutory definition of drugs under the FDA law refers to “articles (other than food) intended to affect the structure or any function of the body.” Kessler’s team would spend the next several years documenting both that nicotine affects the structure or function of the body and that the tobacco industry intends it to have that effect. The phrase “intended to” required evidence that nicotine was not merely an unavoidable component of tobacco but was also an ingredient that cigarette makers intended to

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