Federal Food, Drug, and Cosmetic Act (FDCA) | Practical Law

Federal Food, Drug, and Cosmetic Act (FDCA) | Practical Law

Federal Food, Drug, and Cosmetic Act (FDCA)

Federal Food, Drug, and Cosmetic Act (FDCA)

Practical Law Glossary Item 7-503-3134 (Approx. 3 pages)

Glossary

Federal Food, Drug, and Cosmetic Act (FDCA)

Also known as the FFDCA, FDC Act, and FD&C Act. The federal statute giving the Food and Drug Administration (FDA) the authority to regulate foods, drugs, medical devices, cosmetics, and tobacco products.
The FDCA authorizes the FDA to, among other things:
  • Approve new drugs, certain medical devices, and food and color additives.
  • Inspect establishments where foods, drugs, devices, cosmetics, and tobacco products are manufactured, processed, packed, or held.
  • Regulate advertising for prescription drugs and certain medical devices.
  • Issue regulations for product labeling and claims, such as:
    • nutrition information found on food packaging; and
    • nutrient content and health claims for foods and dietary supplements.
  • Recall or seize, or both, certain products it determines are unsafe or not FDCA-compliant.
(21 U.S.C. §§ 321, 334, 343(q) and (r), 350a(e)-(g), 350l, 352, 355, 360e, 360h, 360bbb-8d, 379e, 387h(c).)
For more information about the Federal Food, Drug and Cosmetic Act, see Practice Note, Advertising: Overview: The Food, Drug, and Cosmetic Act.
The full text of the FDCA is available on the FDA's website.