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U.S. Department of Health and Human Services

About FDA

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How did the Federal Food, Drug, and Cosmetic Act come about?

En Español

The first comprehensive federal consumer protection law was the 1906 Food and Drugs Act, which prohibited misbranded and adulterated food and drugs in interstate commerce. Arguably the pinnacle of Progressive Era legislation, the act nevertheless had shortcomings—gaps in commodities it covered plus many products it left untouched—and many hazardous consumer items remained on the market legally.

The political will to effect a change came in the early 1930s, spurred on by growing national outrage over some egregious examples of consumer products that poisoned, maimed, and killed many people.

The tipping point came in 1937, when an untested pharmaceutical killed scores of patients, including many children, as soon as it went on the market. The enactment of the 1938 Food, Drug, and Cosmetic Act tightened controls over drugs and food, included new consumer protection against unlawful cosmetics and medical devices, and enhanced the government’s ability to enforce the law. This law, as amended, is still in force today.