food and drug law
Federal regulation of food production in the United States began in a limited scope in the mid-1800s. It was not until 1906 with the enactment of the Food and Drug Act (21 U.S.C. § 1 et seq.) and the Meat Inspection Act (21 U.S.C. § 601 et seq.) that significant national oversight began. The Food and Drug Act prohibited the shipment of misbranded or adulterated food, beverages, and drugs in interstate commerce. Though repealed, it established a federal role in consumer protection. Subsequent laws expanded and replaced its provisions.
The Food and Drug Administration (FDA) is a central enforcement agency for consumer safety in the United States. It became part of the Department of Health and Human Services in 1979. The FDA exercises jurisdiction over products representing a substantial segment of national consumer expenditures. The FDA oversees the safety and efficacy of food, drugs, biological products, medical devices, and cosmetics. Its mandate includes regulation of labeling, clinical trial oversight, advertising and promotional monitoring, and protection of the blood supply.
Several federal laws have extended and clarified the FDA’s authority. The Food, Drug, and Cosmetic Act of 1938 replaced the earlier 1906 statute and remains a foundational statute for federal food and drug law. The Food Additives Amendment of 1957 imposed premarket safety evaluation for new additives. The Delaney Clause of 1958 prohibited approval of carcinogenic substances in food. The Kefauver–Harris Drug Amendments of 1962 required scientific proof of drug effectiveness and safety prior to marketing. The Nutrition Labeling and Education Act of 1990 mandated standardized nutritional disclosures on packaged foods.
See: 21 U.S.C. and Title 21 C.F.R.
[Last reviewed in November of 2025 by the Wex Definitions Team]
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