Federal Food, Drug, and Cosmetic Act of 1938
GPTKB entity
Statements (52)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:alsoKnownAs |
gptkb:FD&C_Act
|
| gptkbp:amendedBy |
gptkb:Kefauver_Harris_Amendment
gptkb:Medical_Device_Amendments_of_1976 gptkb:Drug_Price_Competition_and_Patent_Term_Restoration_Act |
| gptkbp:appliesTo |
animal drugs
color additives dietary supplements interstate commerce |
| gptkbp:basisFor |
regulation of cosmetics
regulation of medical devices regulation of veterinary products regulation of over-the-counter drugs regulation of prescription drugs regulation of food additives regulation of tobacco products (after later amendments) modern drug approval process regulation of bottled water regulation of infant formula |
| gptkbp:citation |
21 U.S.C. § 301 et seq.
|
| gptkbp:dateEnacted |
June 25, 1938
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| gptkbp:enforcedBy |
gptkb:FDA_Office_of_Regulatory_Affairs
|
| gptkbp:establishes |
standards for cosmetic labeling
standards for drug labeling standards for food labeling |
| https://www.w3.org/2000/01/rdf-schema#label |
Federal Food, Drug, and Cosmetic Act of 1938
|
| gptkbp:influencedBy |
gptkb:Elixir_Sulfanilamide_disaster
|
| gptkbp:prohibits |
adulterated or misbranded products
|
| gptkbp:providesFor |
criminal penalties for violations
injunctions against violators seizure of unsafe products |
| gptkbp:purpose |
to ensure safety of food, drugs, and cosmetics
|
| gptkbp:regulates |
gptkb:food
cosmetics drugs medical devices biological products |
| gptkbp:relatedTo |
gptkb:Public_Health_Service_Act
gptkb:Food_and_Drug_Administration_Modernization_Act_of_1997 gptkb:Food_Safety_Modernization_Act |
| gptkbp:replacedBy |
gptkb:Pure_Food_and_Drug_Act_of_1906
|
| gptkbp:requires |
pre-market approval of new drugs
|
| gptkbp:section |
Section 505 (New Drug Application)
Section 801 (Imports and Exports) Section 501 (Adulteration) Section 502 (Misbranding) |
| gptkbp:signedBy |
gptkb:Franklin_D._Roosevelt
|
| gptkbp:bfsParent |
gptkb:Pure_Food_and_Drug_Act_of_1906
gptkb:1906_Pure_Food_and_Drug_Act |
| gptkbp:bfsLayer |
7
|