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June 25, 1938legislationpublic healthpharmaceutical regulationconsumer protectionpublic healthfederal regulationpharmaceutical safety

FDR signs Federal Food, Drug, and Cosmetic Act after 107 sulfanilamide deaths

President Roosevelt signed the Federal Food, Drug, and Cosmetic Act on June 25, 1938, replacing the 1906 Pure Food and Drug Act. The law required manufacturers to prove a drug is safe before it goes to market — the first time the federal government imposed pre-market safety review. The legislation was a direct response to the Elixir Sulfanilamide disaster of 1937, in which S.E. Massengill Company used diethylene glycol — an industrial solvent — as a carrier, killing 107 people, including many children.