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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT GMP STANDARDS SUPPORTED BY AMA in Nov. 29 comments on FDA's June proposals to implement the Nutrition Labeling & Education Act for dietary supplements and the agency's advance notice of proposed rulemaking on the regulation of supplements ("The Tan Sheet" June 21, pp. 1-11). The American Medical Association said that there "is need for good manufacturing standards to ensure that supplement products contain the labeled components that are not adulterated, contaminated or impotent." Good manufacturing practices are "necessary for all products consumed by the public," AMA added. AMA generally supported FDA's role in "keeping unsafe products from being marketed to consumers," noting that "in the area of dietary supplements, consumers are far from assured that all the products being offered in the marketplace are safe . . . let alone effective." The association acknowledged the "value that some supplements may have" and underscored that it "does not advocate restricting safe products." AMA added that it "[sees] nothing in the FDA's authority or proposed regulations that would" allow dietary supplements to be "available only by prescription." AMA concurred with the agency's proposals to regulate health claims and nutrition labeling for dietary supplements in the same way it regulates conventional foods. Similar requirements "will be more useful for consumers, reduce consumer confusion, and ensure that information is readily observable and comprehensible to consumers," the group concluded. Regarding amino acids, AMA charged that existing labels on amino acid products "provide inadequate information." Amino acid supplements, according to the association, "warrant special concern because they are commonly used for therapeutic reasons and not for nutritional reasons." AMA claimed that the "danger of not regulating supplements which are used as drugs was realized with the outbreak of eosinophilia myalgia syndrome (EMS)" from dietary supplements containing L-tryptophan. The association supported the idea that subgroups of the population, such as pregnant women, lactating women and the elderly, should "only use dietary supplements containing amino acids under medical supervision." AMA also questioned FDA's proposal to "limit the highest RDA [Recommended Dietary Allowance] for a nutrient as GRAS" (generally recognized as safe). The RDAs "are not formulated to provide advice concerning intakes in excess of the recommended minimums," AMA said. "While it may be appropriate for the FDA to recommend that nutrients not exceed a certain amount," the group continued, "there should not be regulatory limits on the intake of nutrients."

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