Regulation of tobacco by the U.S. Food and Drug Administration

Regulation of tobacco by the U.S. Food and Drug Administration began in 2009 with the passage of the Family Smoking Prevention and Tobacco Control Act by the United States Congress. With this statute, the Food and Drug Administration (FDA) was given the ability to regulate tobacco products.

Prior to 1996, the FDA played no role in the regulation of tobacco products, and regulations were 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, most states had laws prohibiting the sale of tobacco products to minors, which at the time, the purchase age differed in each state. In 1992 the federal government required states to set a minimum age of at least 18 years to purchase tobacco products, which was amended in all states by 1993.

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. Members of the Federal Trade Commission read the report the day it was released and quickly proposed a mandatory cigarette label that warned, "CAUTION: cigarette smoking is dangerous to your health and may cause death from cancer and other diseases." However, Congress intervened to block this warning label with language that was less dire. In 1965, the United States 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.

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