Prior to 1996, the FDA played no role in the regulation of tobacco products, and was controlled through a combination of state and congressional regulation. Most state laws dealt with the sale of tobacco products, including the issue of selling to minors and licensing of distributors. By 1950, all states had laws prohibiting the sale of tobacco products to minors, which at the time, the purchase age differed in each state.
In 1964, Surgeon General Luther Terry issued a report on smoking and health saying that tobacco causes lung cancer and is a main contributor to bronchitis. Subsequently, in 1965, the US Congress passed the Federal Cigarette Labeling and Advertising Act (FCLAA), which required a health warning on all cigarette packs. In 1970, President Richard Nixon signed the Public Health Cigarette Smoking Act, which banned cigarettes ads on the radio or television. It also required an updated warning on the cigarette packages which read: "Warning: The Surgeon General has determined that cigarette smoking is dangerous to your health."
In 1996, the FDA issued the "FDA Rule," which asserted its authority over tobacco products and issued a rule intending to prevent and reduce tobacco use by children. The intended regulations included prohibiting non-face-to-face sales of tobacco products, prohibiting outdoor advertising of tobacco products near schools or playgrounds, imposing more stringent advertising regulations, and prohibiting brand name sponsorships, among other things.
After the regulations were issued in 1996, tobacco companies sued. In the 2000 Supreme Court case FDA v. Brown & Williamson Tobacco Corp., the court ruled that Congress had not given the FDA authority over tobacco and tobacco marketing.
As a result, Congress was forced to provide explicit FDA authority to regulate tobacco and this was finally accomplished via the passage of the Family Smoking Prevention and Tobacco Control Act in 2009.
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