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.
All labels observed (4)
How this entity was disambiguated
This entity first appeared as the object of triple T7110782 — 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: Dietary Supplement Health and Education Act of 1994 Context triple: [FDC Act, amendedBy, Dietary Supplement Health and Education Act of 1994]
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A.
Food and Drug Administration Modernization Act of 1997
The Food and Drug Administration Modernization Act of 1997 is a U.S. law that overhauled FDA regulatory procedures to speed the approval of drugs and medical devices while enhancing patient access to experimental therapies and modernizing agency operations.
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B.
Federal Food, Drug, and Cosmetic Act
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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C.
Kefauver–Harris Drug Amendments of 1962
The Kefauver–Harris Drug Amendments of 1962 are U.S. federal regulations that strengthened drug safety and efficacy requirements, mandating proof of effectiveness and stricter oversight of pharmaceutical marketing and manufacturing.
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D.
Food and Drug Administration Amendments Act of 2007
The Food and Drug Administration Amendments Act of 2007 is a U.S. law that expanded the FDA’s authority over drug and device safety, clinical trials, and post-market surveillance, while enhancing transparency and user fee programs.
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E.
Food and Nutrition Act of 2008
The Food and Nutrition Act of 2008 is a U.S. federal law that governs and authorizes major food assistance programs, including what is now known as the Supplemental Nutrition Assistance Program (SNAP).
- 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: Dietary Supplement Health and Education Act of 1994 Target entity description: 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.
-
A.
Food and Drug Administration Modernization Act of 1997
The Food and Drug Administration Modernization Act of 1997 is a U.S. law that overhauled FDA regulatory procedures to speed the approval of drugs and medical devices while enhancing patient access to experimental therapies and modernizing agency operations.
-
B.
Federal Food, Drug, and Cosmetic Act
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.
-
C.
Kefauver–Harris Drug Amendments of 1962
The Kefauver–Harris Drug Amendments of 1962 are U.S. federal regulations that strengthened drug safety and efficacy requirements, mandating proof of effectiveness and stricter oversight of pharmaceutical marketing and manufacturing.
-
D.
Food and Drug Administration Amendments Act of 2007
The Food and Drug Administration Amendments Act of 2007 is a U.S. law that expanded the FDA’s authority over drug and device safety, clinical trials, and post-market surveillance, while enhancing transparency and user fee programs.
-
E.
Food and Nutrition Act of 2008
The Food and Nutrition Act of 2008 is a U.S. federal law that governs and authorizes major food assistance programs, including what is now known as the Supplemental Nutrition Assistance Program (SNAP).
- F. None of above. chosen
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
United States federal law
ⓘ
dietary supplement regulation ⓘ |
| administeredBy |
Federal Trade Commission
ⓘ
U.S. Food and Drug Administration ⓘ
linked to:
Food and Drug Administration
|
| amends | Federal Food, Drug, and Cosmetic Act ⓘ |
| authorizes |
FDA to establish good manufacturing practices for dietary supplements
ⓘ
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
ⓘ
linked to:
United States of America
|
| 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 ⓘ |
| establishes | definition of dietary ingredient ⓘ |
| limitsAuthorityOf |
U.S. Food and Drug Administration
ⓘ
linked to:
Food and Drug Administration
|
| 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
ⓘ
linked to:
Food and Drug Administration
|
| preMarketApprovalRequired | false ⓘ |
| prohibits | disease treatment claims without FDA approval ⓘ |
| publicLawNumber | Public Law 103-417 ⓘ |
| 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 ⓘ |
| signedBy | Bill Clinton ⓘ |
| signingDate | October 25, 1994 ⓘ |
| supportedBy | dietary supplement industry ⓘ |
| yearEnacted | 1994 ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Dietary Supplement Health and Education Act of 1994 Description of subject: 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.
Referenced by (4)
Full triples — surface form annotated when it differs from this entity's canonical label.
Title 21 of the United States Code
→
contains
→
Dietary Supplement Health and Education Act provisions
ⓘ
linked to: Dietary Supplement Health and Education Act of 1994
linked to: Dietary Supplement Health and Education Act of 1994
Dietary Supplement Health and Education Act of 1994
→
authorizes
→
FDA to establish good manufacturing practices for dietary supplements
ⓘ
linked to: Dietary Supplement Health and Education Act of 1994