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This article was originally published in The Tan Sheet

Executive Summary

AMINO ACIDS' CLASSIFICATION AS "DRUGS" URGED BY FDA TASK FORCE on dietary supplements in its final report, FDA said a June 19 Federal Register notice on the regulation of dietary supplements. "This recommendation was based, in part, on information presented indicating that the primary intended use of these products is for therapeutic rather than nutritional purposes," FDA explained. The agency stated that FDA's Task Force on Dietary Supplements "pointed to the wide marketing of amino acids for use in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure of the body through" such claims as: "Nature's Tranquilizer"; "stimulates the immune system"; "reduce craving for alcohol and sweets"; "used in the treatment of alcoholism"; and "used in the treatment of schizophrenia and senility." Apart from regulating amino acids as drugs, the task force report also suggested that amino acids in dietary supplements could be considered "food additives or GRAS [generally recognized as safe] substances with a DSL [dietary supplement limit] low enough to ensure safety, unless drug claims are made," FDA noted. If that regulatory option is adopted by FDA, the task force suggested that "a DSL for each amino acid would have to be established." A dietary supplement limit was defined by the task force as the maximum daily safe supplemental intake for a given vitamin or essential mineral. Based on the task force's conclusions, FDA said "it is clear that many amino acid products are being marketed in violation" of the law because "they are unapproved food additives and adequate scientific evidence to ensure their safe use does not exist, or because they are being marketed for therapeutic uses." FDA declared that it "intends to bring amino acid-containing supplements into compliance with the law" and is calling for the submission of data and information "on the safety and intended uses of amino acids, as well as support for claims being made for them." FDA also called for comments on the task force recommendations. FDA stressed that amino acid-containing supplements that are "marketed for use as drugs must comply" with the drug provisions of the FD&C Act. FDA will then "consider whether the drug uses of particular amino acids are so well established and widespread as to justify rulemaking to establish as a matter of law that these products are drugs." For amino acid supplements intended for nutritional use, FDA said that data or other information should be included "that provide a basis upon which these products can be legally marketed under the food provisions" of the FD&C Act. The agency said it will consider any data and comments submitted on amino acids "in forming its regulatory and enforcement strategy" on amino acid supplements. However, FDA "will continue to take regulatory action as appropriate to address safety or other consumer protection concerns," the agency emphasized. FDA explained that "products containing amino acids warrant special attention by the agency," particularly because of "a recent epidemic" of eosinophilia myalgia syndrome, "a serious disease associated with consumption of L-tryptophan supplement products." The agency pointed out that, to date, more than 1,500 cases including 38 deaths have been attributed to EMS. FDA asserted that "L-tryptophan-associated EMS was caused by several factors and is not necessarily related to a contaminant in a single source of L-tryptophan." The agency also is focusing on amino acids as a special area of concern due to the conclusions of a 1992 report by the Federation of American Societies for Experimental Biology (FASEB), which analyzed nutritional, physiological and pharmacological data on the 22 amino acids most commonly used as dietary supplements. The FASEB report determined that "the fragmentary nature of scientific data on amino acids precluded a definitive judgment on their safety," FDA said. The agency is soliciting comments on the FASEB report as well as "data that were not included in the report."

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