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

How this entity was disambiguated

This entity first appeared as the object of triple T241101 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.

NED1 Entity disambiguation (via context triple) gpt-5-mini-2025-08-07

Target entity: Federal Food, Drug, and Cosmetic Act
Context triple: [Federal Insecticide, Fungicide, and Rodenticide Act, relatedTo, Federal Food, Drug, and Cosmetic Act]

A. Controlled Substances Act
The Controlled Substances Act is a U.S. federal law that regulates the manufacture, distribution, and possession of certain drugs by classifying them into schedules based on their medical use and potential for abuse.
B. Food and Drug Administration
The Food and Drug Administration is a U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other consumer products.
C. Federal Insecticide, Fungicide, and Rodenticide Act
The Federal Insecticide, Fungicide, and Rodenticide Act is a U.S. law that regulates the registration, distribution, sale, and use of pesticides to protect human health and the environment.
D. U.S. Securities Act of 1933
The U.S. Securities Act of 1933 is a landmark federal law that established strict disclosure requirements for securities offerings to protect investors and restore confidence in financial markets after widespread abuses revealed by the stock market crash and ensuing economic crisis.
E. Toxic Substances Control Act
The Toxic Substances Control Act is a U.S. federal law that regulates the manufacture, import, distribution, and use of chemical substances to protect human health and the environment.
F. None of above. chosen
G. Unsure - the case is ambiguous/there is not enough information to decide.

NED2 Entity disambiguation (via description) gpt-5-mini-2025-08-07

Target entity: Federal Food, Drug, and Cosmetic Act
Target entity description: 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.

A. Controlled Substances Act
The Controlled Substances Act is a U.S. federal law that regulates the manufacture, distribution, and possession of certain drugs by classifying them into schedules based on their medical use and potential for abuse.
B. Food and Drug Administration
The Food and Drug Administration is a U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other consumer products.
C. Federal Insecticide, Fungicide, and Rodenticide Act
The Federal Insecticide, Fungicide, and Rodenticide Act is a U.S. law that regulates the registration, distribution, sale, and use of pesticides to protect human health and the environment.
D. U.S. Securities Act of 1933
The U.S. Securities Act of 1933 is a landmark federal law that established strict disclosure requirements for securities offerings to protect investors and restore confidence in financial markets after widespread abuses revealed by the stock market crash and ensuing economic crisis.
E. Toxic Substances Control Act
The Toxic Substances Control Act is a U.S. federal law that regulates the manufacture, import, distribution, and use of chemical substances to protect human health and the environment.
F. None of above. chosen

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 ⓘ

How these facts were elicited

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 ⓘ

All labels observed (7)

How this entity was disambiguated Show

Statements (71)

How these facts were elicited Show

Referenced by (30)

How this entity was disambiguated

How these facts were elicited