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S. 784 (103rd): Dietary Supplement Health and Education Act of 1994

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111.

This summary is from Wikipedia.

Last updated Oct 11, 2018. Source: Wikipedia

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

10/7/1994--Passed House amended. 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.