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S 784 - 103

Dietary Supplement Health and Education Act of 1994

Message on Senate action sent to the House.

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Affected Sectors

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Agriculture
2 evidence matches
Impact 100% Confidence 92%

Agriculture and Food

Dietary Supplement Health and Education Act of 1994 Message on Senate action sent to the House. Agriculture and Food

Education
1 evidence matches
Impact 83% Confidence 78%

Dietary Supplement Health and Education Act of 1994 Message on Senate action sent to the House. Agriculture and Food

Healthcare
1 evidence matches
Impact 81% Confidence 75%

Dietary Supplement Health and Education Act of 1994 Message on Senate action sent to the House. Agriculture and Food

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Summary

36 Passed House amended Jul 24, 2001

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.

35 Passed Senate amended Jul 24, 2001

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) intended to supplement the diet by increasing the total dietary intake that contains a vitamin, mineral, herb or botanical, amino acid, another dietary substance, or a concentrate, metabolite, constituent, extract, or combination of the above ingredients; and (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. Excludes a dietary supplement from the definition of the term "drug" (with exceptions) and the term "food additive." Authorizes an article that is approved as a new drug, certified as an antibiotic, or licensed as a biologic to be marketed as a dietary supplement based on a finding that the uses and dosages set forth in the labeling are lawful. Deems a dietary supplement adulterated if it presents a substantial and unreasonable risk of illness or injury, poses an imminent and substantial hazard to public health or safety, or contains an ingredient that renders it adulterated. Provides that an article, another publication, a chapter in books, or the official abstract of a peer-reviewed scientific publication that appears in the article and was prepared by the authors or editor of the 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 brand of supplement; (3) is displayed so as to present a balanced view of the available scientic information; and (4) is displayed physically separate from such supplements. Places the burden of proof on the United States in establishing that such matter is false or misleading. Sets forth conditions under which nutritional claims may be made with respect to such supplements. Deems a dietary supplement misbranded unless its labeling meets specified guidelines. Establishes the Commission on Dietary Supplement Labels. Authorizes appropriations. Authorizes the Secretary of Health and Human Services to prescribe good manufacturing practices for dietary supplements to be modeled after those for food. Establishes an Office of Dietary Supplements within the National Institutes of Health. Authorizes appropriations.

00 Introduced in Senate Jul 24, 2001

Dietary Supplement Health and Education Act of 1993 - Amends the Federal Food, Drug, and Cosmetic Act to define a "dietary supplement" as a food for special dietary use that includes a vitamin, a mineral, an herb, an amino acid, or another ingredient used to supplement the diet by increasing total dietary intake. Excludes a dietary supplement from the definition of the term "drug" and the term "food additive". Deems a dietary supplement adulterated if it presents a substantial and unreasonable risk of illness or injury. Deems a food misbranded unless the label lists the daily value of specified nutrients which shall reflect the daily intake of each nutrient that will promote optiomal health. Prohibits such value from being less than the U.S. Recommended Daily Allowance. Deems a dietary supplement misbranded unless it meets specified guidelines. Establishes an Office of Dietary Supplements within the National Institutes of Health. Authorizes appropriations.

Sponsors

Timeline

Dec 1, 1994

Message on Senate action sent to the House.

Oct 25, 1994

Signed by President.

Oct 25, 1994

Signed by President.

Oct 25, 1994

Became Public Law No: 103-417.

Oct 25, 1994

Became Public Law No: 103-417.

Oct 18, 1994

Presented to President.

Oct 18, 1994

Presented to President.

Oct 12, 1994

Message on Senate action sent to the House.

Oct 8, 1994

Resolving differences -- Senate actions: Senate agreed to House amendment by Voice Vote.(consideration: 10/7/1994 CR S14801)

Oct 8, 1994

Senate agreed to House amendment by Voice Vote. (consideration: 10/7/1994 CR S14801)

Oct 8, 1994

By Senator Hatch from Committee on Labor and Human Resources filed written report. Report No. 103-410. Additional views filed.

Oct 8, 1994

By Senator Hatch from Committee on Labor and Human Resources filed written report. Report No. 103-410. Additional views filed.

Oct 7, 1994

Committee on Energy and Commerce discharged.

Oct 7, 1994

Committee on Energy and Commerce discharged.

Oct 7, 1994

Mr. Waxman asked unanimous consent to discharge from committee and consider.

Oct 7, 1994

Considered by unanimous consent. (consideration: 10/6/1994 CR H11173-11179)

Oct 7, 1994

Passed/agreed to in House: On passage Passed without objection.

Oct 7, 1994

On passage Passed without objection.

Oct 7, 1994

Motion to reconsider laid on the table Agreed to without objection.

Oct 7, 1994

Message on House action received in Senate and at the desk: House amendment to Senate bill.

Aug 16, 1994

Message on Senate action sent to the House.

Aug 16, 1994

Received in the House.

Aug 16, 1994

Referred to the House Committee on Energy and Commerce.

Aug 13, 1994

Senate Committee on Labor and Human Resources discharged by Unanimous Consent.

Aug 13, 1994

Senate Committee on Labor and Human Resources discharged by Unanimous Consent.

Aug 13, 1994

Measure laid before Senate by unanimous consent. (consideration: CR S11708-11715)

Aug 13, 1994

Passed/agreed to in Senate: Passed Senate with an amendment by Voice Vote.

Aug 13, 1994

Passed Senate with an amendment by Voice Vote.

May 11, 1994

Committee on Labor and Human Resources. Ordered to be reported with an amendment in the nature of a substitute favorably.

Mar 3, 1994

Sponsor introductory remarks on measure. (CR S2319)

Nov 23, 1993

Sponsor introductory remarks on measure. (CR S17049)

Oct 21, 1993

Committee on Labor and Human Resources. Hearings held. Hearings printed: S.Hrg. 103-419.

Apr 7, 1993

Introduced in Senate

Apr 7, 1993

Sponsor introductory remarks on measure. (CR S4576-4578)

Apr 7, 1993

Read twice and referred to the Committee on Labor and Human Resources.

House Votes

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Amendments

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