Cigarette smoking remains the leading preventable cause of death in the United States, causing an estimated 438 000 deaths annually, including 38 000 deaths by exposure to secondhand smoke.1 However, regulating tobacco has been politically dangerous terrain, with the industry misleading the public, lobbying Congress, and portraying smoking as a personal responsibility.2 When the US Food and Drug Administration (FDA) tried to curtail the promotion and accessibility of cigarettes to children and adolescents in 1996, the US Supreme Court struck it down, reasoning that in the Food, Drug, and Cosmetic Act (FDCA), Congress intended to exclude tobacco from the FDA's jurisdiction.3
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