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.

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All labels observed (7)

Label	Occurrences
Federal Food, Drug, and Cosmetic Act canonical	20
Federal Food Drug and Cosmetic Act	3
FD&C Act	2
Food, Drug, and Cosmetic Act	2
Federal Food, Drug, and Cosmetic Act of 1938	1
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 ⓘ Food and Drug Administration ⓘ surface form: 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	Federal Food, Drug, and Cosmetic Act self-linksurface differs ⓘ surface form: FD&C Act FDC Act ⓘ
signedBy	President Franklin D. Roosevelt ⓘ surface form: Franklin D. Roosevelt
superseded	Pure Food and Drug Act of 1906 in major part ⓘ
titleNumber	Title 21 ⓘ surface form: Title 21 of the United States Code
triggeredBy	public concern after the 1937 Elixir Sulfanilamide disaster ⓘ
yearEnacted	1938 ⓘ

Referenced by (30)

Full triples — surface form annotated when it differs from this entity's canonical label.

Federal Insecticide, Fungicide, and Rodenticide Act → relatedTo → Federal Food, Drug, and Cosmetic Act ⓘ

Food and Drug Administration → legalBasis → Federal Food, Drug, and Cosmetic Act ⓘ

this entity surface form: Federal Food, Drug, and Cosmetic Act of 1938

Federal Food, Drug, and Cosmetic Act → shortName → Federal Food, Drug, and Cosmetic Act self-linksurface differs ⓘ

this entity surface form: FD&C Act

Public Health Service Act → relatedTo → Federal Food, Drug, and Cosmetic Act ⓘ

Pure Food and Drug Act of 1906 → amendedBy → Federal Food, Drug, and Cosmetic Act ⓘ

this entity surface form: Food, Drug, and Cosmetic Act of 1938

Pure Food and Drug Act of 1906 → replacedBy → Federal Food, Drug, and Cosmetic Act ⓘ

Center for Tobacco Products → legalBasis → Federal Food, Drug, and Cosmetic Act ⓘ

FDA traditional approval → legalBasis → Federal Food, Drug, and Cosmetic Act ⓘ

Title 21 → legalAuthorityFrom → Federal Food, Drug, and Cosmetic Act ⓘ

subject surface form: Title 21 of the Code of Federal Regulations

FDC Act → fullName → Federal Food, Drug, and Cosmetic Act ⓘ

FDC Act → abbreviation → Federal Food, Drug, and Cosmetic Act ⓘ

this entity surface form: FD&C Act

Kefauver–Harris Drug Amendments of 1962 → amends → Federal Food, Drug, and Cosmetic Act ⓘ

Medical Device Amendments of 1976 → amends → Federal Food, Drug, and Cosmetic Act ⓘ

this entity surface form: Federal Food Drug and Cosmetic Act

Medical Device Amendments of 1976 → amends → Federal Food, Drug, and Cosmetic Act ⓘ

this entity surface form: Food Drug and Cosmetic Act of 1938

Medical Device Amendments of 1976 → relatedTo → Federal Food, Drug, and Cosmetic Act ⓘ

this entity surface form: Federal Food Drug and Cosmetic Act

Drug Price Competition and Patent Term Restoration Act of 1984 → amends → Federal Food, Drug, and Cosmetic Act ⓘ

Food and Drug Administration Modernization Act of 1997 → amends → Federal Food, Drug, and Cosmetic Act ⓘ

Food Safety Modernization Act of 2011 → precededBy → Federal Food, Drug, and Cosmetic Act ⓘ

Food Safety Modernization Act of 2011 → amends → Federal Food, Drug, and Cosmetic Act ⓘ

Family Smoking Prevention and Tobacco Control Act of 2009 → amends → Federal Food, Drug, and Cosmetic Act ⓘ

Prescription Drug User Fee Act of 1992 → relatedTo → Federal Food, Drug, and Cosmetic Act ⓘ

this entity surface form: Food, Drug, and Cosmetic Act

Food and Drug Administration Amendments Act of 2007 → amends → Federal Food, Drug, and Cosmetic Act ⓘ

FDA v. Brown & Williamson Tobacco Corp. → relatedStatute → Federal Food, Drug, and Cosmetic Act ⓘ

21st Century Cures Act → amends → Federal Food, Drug, and Cosmetic Act ⓘ

Title 21 of the United States Code → contains → Federal Food, Drug, and Cosmetic Act ⓘ

Poison Prevention Packaging Act → relatedTo → Federal Food, Drug, and Cosmetic Act ⓘ

this entity surface form: Food, Drug, and Cosmetic Act

United States federal drug laws → includes → Federal Food, Drug, and Cosmetic Act ⓘ

this entity surface form: Federal Food Drug and Cosmetic Act

Office of Compliance → legalBasis → Federal Food, Drug, and Cosmetic Act ⓘ

Office of Tissues and Advanced Therapies → jurisdiction → Federal Food, Drug, and Cosmetic Act ⓘ

Office of Compliance and Biologics Quality → usesRegulatoryAuthorityFrom → Federal Food, Drug, and Cosmetic Act ⓘ