Federal Food, Drug, and Cosmetic Act (FD&C Act)

The Federal Food, Drug, and Cosmetic Act was enacted in 1938 following the sulfanilamide disaster that killed over 100 people. It established the FDA's authority to regulate the safety of food, drugs, devices, and cosmetics in the United States. The Act defines "cosmetic" as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.

For cosmetics specifically, the original FD&C Act was remarkably permissive compared to other product categories — it did not require pre-market approval, facility registration, or product listing. The primary prohibitions were against adulteration (containing harmful substances) and misbranding (false or misleading labeling).

The Modernization of Cosmetics Regulation Act (MoCRA), enacted in December 2022 as an amendment to the FD&C Act, addressed this regulatory gap by adding new Sections 607 through 616 to the Act. These sections establish the modern regulatory framework including facility registration, product listing, safety substantiation, adverse event reporting, and GMP requirements.

The FD&C Act is codified primarily in Title 21 of the United States Code, and FDA's implementing regulations are found in Title 21 of the Code of Federal Regulations (21 CFR), with cosmetics-specific regulations in Parts 700-740.