Dietary Supplement Health and Education Act of 1994
E642115
The Dietary Supplement Health and Education Act of 1994 is a U.S. law that defines and regulates dietary supplements as a category of food, setting labeling and safety standards while limiting the FDA’s pre-market approval authority.
Observed surface forms (1)
| Surface form | Occurrences |
|---|---|
| Dietary Supplement Health and Education Act provisions | 1 |
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
United States federal law
ⓘ
dietary supplement regulation ⓘ |
| administeredBy |
Federal Trade Commission
NERFINISHED
ⓘ
U.S. Food and Drug Administration NERFINISHED ⓘ |
| amends | Federal Food, Drug, and Cosmetic Act NERFINISHED ⓘ |
| authorizes |
FDA to establish good manufacturing practices for dietary supplements
NERFINISHED
ⓘ
FDA to take action against adulterated dietary supplements ⓘ FDA to take action against misbranded dietary supplements ⓘ |
| citationInUSCode | 21 U.S.C. § 321(ff) ⓘ |
| classifiesDietarySupplementsAs | food ⓘ |
| country |
United States of America
ⓘ
surface form:
United States
|
| createsCategory | new dietary ingredient ⓘ |
| criticizedFor | weak pre-market oversight of dietary supplements ⓘ |
| definesCategory | dietary supplement ⓘ |
| definesDietaryIngredientToInclude |
amino acid
ⓘ
concentrate, metabolite, constituent, extract, or combination of dietary ingredients ⓘ dietary substance used to supplement the diet ⓘ herb or other botanical ⓘ mineral ⓘ vitamin ⓘ |
| disclaimerTextPrototype | This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. ⓘ |
| enactedBy | 103rd United States Congress NERFINISHED ⓘ |
| establishes | definition of dietary ingredient ⓘ |
| limitsAuthorityOf | U.S. Food and Drug Administration NERFINISHED ⓘ |
| newDietaryIngredientCutoffDate | October 15, 1994 ⓘ |
| objective |
to ensure consumer access to dietary supplements
ⓘ
to provide information to help consumers make informed choices ⓘ |
| permits | structure or function claims on dietary supplement labels ⓘ |
| placesBurdenOfProofForUnsafeProductsOn | U.S. Food and Drug Administration NERFINISHED ⓘ |
| preMarketApprovalRequired | false ⓘ |
| prohibits | disease treatment claims without FDA approval ⓘ |
| publicLawNumber | Public Law 103-417 NERFINISHED ⓘ |
| regulates |
dietary supplement labeling
ⓘ
dietary supplement manufacturing practices ⓘ dietary supplement safety ⓘ |
| requires |
disclaimer for structure or function claims
ⓘ
evidence of reasonable expectation of safety for new dietary ingredients ⓘ ingredient list on dietary supplement labels ⓘ name and place of business of manufacturer, packer, or distributor on labels ⓘ net quantity of contents on dietary supplement labels ⓘ notification to FDA for new dietary ingredients ⓘ nutrition labeling for dietary supplements ⓘ statement of identity on dietary supplement labels ⓘ |
| sectorImpacted | dietary supplement market in the United States ⓘ |
| shortName | DSHEA NERFINISHED ⓘ |
| signedBy | Bill Clinton ⓘ |
| signingDate | October 25, 1994 ⓘ |
| supportedBy | dietary supplement industry ⓘ |
| yearEnacted | 1994 ⓘ |
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.