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AMINO ACIDS AND OTHER DIETARY SUPPLEMENTS NEED FDA REGULATION

Executive Summary

AMINO ACIDS AND OTHER DIETARY SUPPLEMENTS NEED FDA REGULATION and pre-market approval to ensure safety, the National Organization for Rare Disorders recommends. NORD Executive Director Abbey Meyers asserted at a Feb. 4 meeting of FASEB's Life Sciences Research Office that her organization "would like manufacturers of medical foods to get their products approved by the FDA: to ensure safety, to assure that it has the medical effect that it is being marketed for, even if that medical condition is not on the label, [and] to prohibit dosages that are unsafe or possibly toxic." Specifically, Meyers suggested that manufacturers of dietary supplements "engaging in marketing practices that even hint at unproven medical claims should be prosecuted." Labeling on these products "should explicitly state that they should not be used for medical purposes." When sales reps promote these supplements for prevention and treatment of illnesses, "state law enforcement authorities should prosecute them for practicing medicine without a license," Meyers said. The Life Sciences Research Office of the Federation of American Societies for Experimental Biology held the public forum to provide an opportunity for presentations of scientific information on the safety of free amino acids and related products as dietary supplements. The LSRO will consider the information in preparing a report for FDA that will be publicly available by October of this year. FDA's Center for Food Safety and Applied Nutrition contracted with LSRO in November 1990 to provide a scientific review of the usage and safety of amino acids and similar products. Part of the impetus for the study was the outbreak of disease in November 1989 from contaminated L-tryptophan. Contamination of the amino acid dietary supplement produced an outbreak of eosinophila-myalgia syndrome that led to approximately two-dozen reported deaths and more than 1,000 cases of illness as well as a large-scale nationwide recall. Meyers pointed to the health consequences resulting from contaminated L-tryptophan as "the most recent, visible and deadly example of what can happen when we allow these chemicals to be promoted and sold to an unsuspecting public as if they were harmless drugs." Meyers told the meeting that she hopes the LSRO study "will lay the foundation for much-needed reforms in this area." FDA and the public "need to know about the quality of the manufacturing process, the purity and potency of the products, their shelf-life, their bioavailability and bioequivalence, the instruction given for their use, and, above all, how it is that people are led to make therapeutic use of these nominal food substances." Another approach to the regulation of medical foods -- the creation of a "nutraceutical" category -- is being promoted by the Foundation for Innovation in Medicine. The non-profit educational group, in recent press releases, proposed that a "Nutraceutical Commission" be established for the regulation of nutritional products with medical benefits. FIM maintains that current food and drug regulations do not cover development of these products and their medical claims. The orphan drug regs were suggested by the group as a model for the regulation of "nutraceuticals" in that these products could undergo fewer clinicals than traditional drugs and receive seven years of marketing exclusivity. Also, the commission would review products on a case-by-case basis instead of through set guidelines, and outside experts would be chosen as primary reviewers. In a separate presentation during the Feb. 7 meeting, Sigma- Tau Pharmaceuticals U.S. Marketing & Sales Director C. Kenneth Mehrling suggested that FDA "restrict the availability of L- carnitine to prescription use only." He warned about the risks of consumer use of the nutritional supplement version of L-carnitine versus the prescription drug product Carnitor, which Sigma-Tau markets for carnitine deficiency. Mehrling noted that manufacturers of dietary supplements do not have to obtain FDA approval, or "meet a prescription drug's strict manufacturing and packaging requirements." He added that use of L-carnitine without medical supervision can be dangerous to persons with glucose abnormalities and undiagnosed metabolic disorders.
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