Federal Food, Drug, and Cosmetic Act

E31160

United States federal statute public health law

The Federal Food, Drug, and Cosmetic Act is a key U.S. law that authorizes the Food and Drug Administration to regulate the safety, labeling, and marketing of food, drugs, medical devices, and cosmetics.

Aliases (3)

FD&C Act ×1
Federal Food, Drug, and Cosmetic Act of 1938 ×1
Food, Drug, and Cosmetic Act of 1938 ×1

Statements (71)

Predicate	Object
instanceOf	United States federal statute → public health law →
administeredBy	Food and Drug Administration → U.S. Food and Drug Administration →
amendedBy	Drug Price Competition and Patent Term Restoration Act of 1984 → Family Smoking Prevention and Tobacco Control Act of 2009 → Food Safety Modernization Act of 2011 → Food and Drug Administration Amendments Act of 2007 → Food and Drug Administration Modernization Act of 1997 → Kefauver–Harris Drug Amendments of 1962 → Medical Device Amendments of 1976 → Orphan Drug Act of 1983 → Prescription Drug User Fee Act of 1992 →
appliesTo	interstate commerce in regulated products →
containsProvision	adulteration provisions → clinical investigation requirements for drugs and devices → good manufacturing practice requirements → labeling requirements for cosmetics → labeling requirements for drugs → labeling requirements for food → labeling requirements for medical devices → misbranding provisions → new drug approval requirements → postmarket surveillance requirements for certain devices → recall authority for certain products →
country	United States of America →
dateEnacted	June 25, 1938 →
definesTerm	adulterated → cosmetic → device → drug → food → misbranded → new drug →
enactedBy	United States Congress →
enforcementMechanism	administrative actions by FDA → civil penalties → criminal penalties → injunctions → product seizures →
jurisdiction	federal law of the United States →
language	English →
legalCitation	21 U.S.C. § 301 et seq. →
primaryPurpose	regulation of cosmetics → regulation of drugs → regulation of food safety → regulation of labeling of regulated products → regulation of marketing of regulated products → regulation of medical devices →
regulates	animal drugs → biological products in coordination with the Public Health Service Act → color additives → cosmetics → dietary supplements → food → food additives → human drugs → medical devices → tobacco products through later amendments →
requires	adequate directions for use on drug labeling → pre-market approval for new drugs → premarket notification or approval for many medical devices → truthful and non-misleading labeling →
sector	health regulation →
shortName	FD&C Act → FDC Act →
signedBy	Franklin D. Roosevelt →
superseded	Pure Food and Drug Act of 1906 in major part →
titleNumber	Title 21 of the United States Code →
triggeredBy	public concern after the 1937 Elixir Sulfanilamide disaster →
yearEnacted	1938 →

Referenced by (7)

Subject (surface form when different)	Predicate
Center for Tobacco Products → Food and Drug Administration ("Federal Food, Drug, and Cosmetic Act of 1938") →	legalBasis
Federal Insecticide, Fungicide, and Rodenticide Act → Public Health Service Act →	relatedTo
Pure Food and Drug Act of 1906 ("Food, Drug, and Cosmetic Act of 1938") →	amendedBy
Pure Food and Drug Act of 1906 →	replacedBy
Federal Food, Drug, and Cosmetic Act ("FD&C Act") →	shortName