Federal Food, Drug and Cosmetic Act

Federal Food, Drug, and Cosmetic Act

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Acts repealed	Pure Food and Drug Act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 March 5, 1938 Committee consideration by Committee on Interstate and Foreign Commerce Passed the House on June 1, 1938 (amended and passed) Passed the Senate on June 2, 1938 (disagreed) Reported by the joint conference committee on June 11, 1938; agreed to by the House on June 15, 1938 (agreed) and by the Senate on June 15, 1938 (agreed) 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 Safety and Health Act, 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

The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. 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. 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 a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form(see elixir sulfanilamide disaster). It replaced the earlier Pure Food and Drug Act of 1906.

The FDC Act has ten chapters:

The FD&C is perhaps best known by the consumer because of its use in the naming of food coloring additives, such as "FD&C Yellow No. 6." The Act made the certification of some food color additives mandatory. Some food colorings are generally recognized as safe (GRAS) by the FDA and do not require certification.

The FDA lists nine FD&C (Food, Drugs & Cosmetics) certified color additives for use in foods in the United States, and numerous D&C (Drugs & Cosmetics) colorings allowed only in drugs for external application or cosmetics. Color additives derived from natural sources, such as vegetables, minerals or animals, and artificial counterparts of natural derivatives, are exempt from certification. Both artificial and naturally derived color additives are subject to rigorous standards of safety before their approval for use in foods.

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