A bill to amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes.
Dietary Supplement Health and Education Act of 1994 - Amends the Federal Food, Drug, and Cosmetic Act to define a "dietary supplement" as a product: (1) other than tobacco, intended to supplement the diet that contains a vitamin, mineral, herb or botanical, dietary substance, or a concentrate, metabolite, constituent, extract, or combination of the above ingredients; (2) that is intended for ingestion, is not represented as food or as a sole item of a meal or diet, and is labeled as a dietary supplement; (3) that includes an article approved as a new drug, certified as an antibiotic, or licensed as a biologic and that was, prior to such approval, certification or licensure, marketed as a dietary supplement or food, unless the conditions of use and dosages are found to be unlawful; and (4) excludes such articles which were not so marketed prior to approval unless found to be lawful. Deems a dietary supplement to be a food. Excludes a dietary supplement from the definition of the term "food additive."
(Sec. 4) Deems food to be adulterated if it is a dietary supplement or contains a dietary ingredient that: (1) presents a significant or unreasonable risk of injury; (2) is a new dietary ingredient for which there is inadequate information to provide assurance that such ingredient does not present such risk; (3) poses an imminent hazard to public health or safety; or (4) contains an ingredient that renders it adulterated.
(Sec. 5) Provides that a publication shall not be defined as labeling when used in connection with the sale of dietary supplements when it: (1) is not false or misleading; (2) does not promote a particular manufacturer or brand of supplement; (3) is displayed so as to present a balanced view of the available scientic information; (4) is displayed physically separate from such supplements; and (5) does not have appended to it any information by sticker or other method. Places the burden of proof on the United States in establishing that such matter is false or misleading.
(Sec. 6) Sets forth conditions under which nutritional claims may be made with respect to such supplements.
(Sec. 7) Deems a dietary supplement misbranded unless its labeling meets specified guidelines.
(Sec. 8) Deems a dietary supplement which contains a new dietary ingredient adulterated unless: (1) such supplement contains only ingredients which have been present in the food supply as articles used for food in a form in which the food has not been chemically altered; or (2) there is a history of use or other evidence of safety regarding such supplement.
(Sec. 9) Authorizes the Secretary of Health and Human Services to prescribe good manufacturing practices for dietary supplements to be modeled after those for food.
(Sec. 12) Creates the Commission on Dietary Supplement Labels. Authorizes appropriations.
(Sec. 13) Establishes an Office of Dietary Supplements within the National Institutes of Health. Authorizes appropriations.
Committee on Energy and Commerce discharged.
Committee on Energy and Commerce discharged.
Mr. Waxman asked unanimous consent to discharge from committee and consider.
Considered by unanimous consent. (consideration: 10/6/1994 CR H11173-11179)
Passed/agreed to in House: On passage Passed without objection.
On passage Passed without objection.
Motion to reconsider laid on the table Agreed to without objection.
Message on House action received in Senate and at the desk: House amendment to Senate bill.
Resolving differences -- Senate actions: Senate agreed to House amendment by Voice Vote.(consideration: 10/7/1994 CR S14801)
Senate agreed to House amendment by Voice Vote. (consideration: 10/7/1994 CR S14801)
By Senator Hatch from Committee on Labor and Human Resources filed written report. Report No. 103-410. Additional views filed.
Enacted as Public Law 103-417
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By Senator Hatch from Committee on Labor and Human Resources filed written report. Report No. 103-410. Additional views filed.
Message on Senate action sent to the House.
Presented to President.
Presented to President.
Signed by President.
Signed by President.
Became Public Law No: 103-417.
Became Public Law No: 103-417.
Message on Senate action sent to the House.