Federal Food, Drug, and Cosmetic Act of 1938

Federal Food, Drug, and Cosmetic Act of 1938

Long title	To prohibit the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics, and for other purposes.
Acronyms (colloquial)	FFDCA, FD&C Act
Enacted by	the 75th United States Congress
Citations
Public law	75-717
Statutes at Large	52 Stat. 1040
Codification
Acts repealed	Pure Food and Drug Act
Titles amended	21 U.S.C.: Food and Drugs
U.S.C. sections created	21 U.S.C. ch. 9 § 301 et seq.
Legislative history
Introduced in the Senate as S. 5 by Royal Copeland (D–NY) on January 6, 1937 Passed the Senate on March 9, 1937 (voice) Passed the House with amendment on June 1, 1938 (voice) Reported by the joint conference committee on June 10, 1938; agreed to by the Senate on June 10, 1938 (voice) and by the House on June 13, 1938 (voice) Signed into law by President Franklin D. Roosevelt on June 25, 1938
Major amendments
1951 Food, Drug, and Cosmetics Act Amendments, PL 82–215, 65 Stat 648 1962 Food, Drug, and Cosmetics Act Amendments, PL 87–781, 76 Stat 780 Fair Packaging and Labeling Act, PL 89–755, 80 Stat 1296 Medical Device Regulation Act, PL 94–295, 90 Stat 539 Radiation Control for Health and Safety Act of 1968, PL 90-602, 82 Stat 1173 Drug Price Competition and Patent Term Restoration Act of 1984, PL 98-471, 98 Stat 1585 Nutrition Labeling and Education Act (1990), PL 101-535, 104 Stat 2353 Safe Medical Device Amendments of 1990, PL 101-629, 104 Stat 4511 Food and Drug Administration Revitalization Act (1990), PL 101-635, 104 Stat 4583 Dietary Supplement Health and Education Act (1994), PL 103-417, 108 Stat 4332 Food Quality Protection Act of 1996 Food and Drug Administration Modernization Act of 1997, PL 105-115, 111 Stat 2296 Food and Drug Administration Amendments Act of 2007, PL 110-85, 121 Stat 823[1] Over-the-Counter Hearing Aid Act of 2017 Sunscreen Innovation Act Drug Quality and Security Act Microbead-Free Waters Act of 2015

The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford.^[2] A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York.^[3] In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.^[4] The act has been amended many times, most recently to add requirements about bioterrorism preparations.

The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was used to dissolve the drug and make a liquid form.^[5] It replaced the earlier Pure Food and Drug Act of 1906.