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 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 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 ⓘ
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 ⓘ

How these facts were elicited

Referenced by (1)

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