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The history of tobacco regulation includes quite a few episodes of bootleggers-and-Baptists coalitions in the 1960s and 1970s. While there were sporadic efforts to suppress tobacco use almost from the time it appeared in Europe-- James I of England published A Counter-Blaste to Tobacco in 1604, denouncing smoking as "a custom loathsome to the eye, hateful to the nose, harmful to the brain, dangerous to the lung, and the black stinking fume thereof, nearest resembling the horribly Stygian smoke of the pit that is bottomless"-- serious regulatory efforts appeared in the United States only in the 1960s. Prior to then, smoking was a widely accepted practice that government at all levels mostly ignored. Indeed, the federal Food and Drug Administration had been explicitly foreclosed from regulating tobacco when it was created by the 1906 Pure Food and Drug Act and the agency consistently foreswore any jurisdiction over smoking even after the 1938 Food, Drug and Cosmetic Act granted the agency powers over "articles (other than food) intended to affect the structure or any function of the body," a definition that arguably could have been read to include cigarettes as nicotine delivery devices. When confronted with proposed amendments to the food and drug laws to give the FDA jurisdiction, Congress repeatedly rejected such efforts.

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