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The 103rd Congress enacted Public Law 103-417 on October 25th , 1994 and called it the Dietary Supplement and Education Act of 1994 (DSHEA). The purpose of the law was to amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes. Besides defining what is classified as a dietary supplement, a predominant “other purpose” of this act is to put the burden of proof as to the safety of dietary supplements on the Federal Drug Administration (FDA). The DSHEA defines a dietary supplement as “…a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient described...[above]…[and] is intended for ingestion…” (Section 3). The DHSEA ammended the Federal Food, Drug, and Cosmetic Act of 1908, an Act that had been frequently ammended prior to 1994 and has been amended since. In section 342, which addresses the issue of adulterated foods, the DSHEA added part (f) which addresses the safety of dietary supplements made available in the United States for ingestion by human beings and is in process to establish standards for manufacturing practices of these products, part (g). The later is stuck in a quagmire, as the dietary supplement industry fears a crushing financial burden being placed on it if REQUIRED to meet the proposed standards for current Good Manufacturing Guidelines. At present these standards are meerly a suggestion.-CITE-
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