FDC Act

E165700

The FDC Act is a key United States law that authorizes the Food and Drug Administration to regulate the safety, efficacy, and labeling of food, drugs, cosmetics, and certain medical devices.

All labels observed (1)

Label Occurrences
FDC Act canonical 1

How this entity was disambiguated

Statements (51)

Predicate Object
instanceOf United States federal statute
abbreviation Federal Food, Drug, and Cosmetic Act
surface form: FD&C Act
amendedBy 21st Century Cures Act
Dietary Supplement Health and Education Act of 1994
Food and Drug Administration Amendments Act of 2007
Food and Drug Administration Modernization Act of 1997
Food and Drug Administration Safety and Innovation Act of 2012
Kefauver–Harris Drug Amendments of 1962
surface form: Kefauver–Harris Amendments of 1962

Medical Device Amendments of 1976
authorizesRegulationOf biological products
cosmetics
drugs
food
medical devices
radiation-emitting electronic products
containsSection Section 201 (definitions)
Section 301 (prohibited acts)
Section 402 (adulterated food)
Section 403 (misbranded food)
Section 501 (adulterated drugs and devices)
Section 502 (misbranded drugs and devices)
Section 505 (new drugs)
Section 510 (registration of producers)
Section 510(k) (premarket notification)
Section 512 (new animal drugs)
Section 515 (premarket approval of devices)
country United States of America
surface form: United States
enforcedBy Food and Drug Administration
establishesAuthorityFor adulteration standards
biologics licensing in part
clinical investigations of drugs and devices
current good manufacturing practice requirements
misbranding standards
new drug approval
postmarket safety surveillance
premarket approval of certain medical devices
premarket notification (510(k)) for devices
recall authority for certain products
risk evaluation and mitigation strategies
fullName Federal Food, Drug, and Cosmetic Act
legalCitation 21 U.S.C. § 301 et seq.
primaryFocus efficacy
labeling
safety
regulates color additives
dietary supplements
food additives
infant formula
over-the-counter drugs
prescription drugs
tobacco product labeling aspects via amendments

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Referenced by (1)

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