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DIETARY SUPPLEMENT DATABASE BALANCING NUTRIENT DEFICIENCY AND TOXICITY

This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT DATABASE BALANCING NUTRIENT DEFICIENCY AND TOXICITY is suggested by the American Heart Association in August comments on FDA's June 18 proposed rule implementing the nutrition labeling provisions of the Nutrition Labeling & Education Act for dietary supplements. "As a matter of priority," AHA urged FDA to consider "the necessity to establish a valid scientific database for evaluating competing risks of nutrient deficiency and toxicity" at various levels of intake. As part of developing the database, AHA said, "some experimental data followed by good clinical data will be needed." Such a database is needed, AHA explained, because "the concentration of one substance in a supplement may cause an imbalance in another such as a negative effect on the absorption of one or the other." For instance, "an excess of vitamin C may mask an elevated glucose level, or too much folate may mask pernicious anemia," the association stated. The potential for folic acid consumption to complicate the diagnosis of pernicious anemia has been cited as a problem that would arise if FDA goes ahead with allowing folic acid health claims and fortification of the food supply -- concepts that are expected to be proposed by FDA in the upcoming months. At a recent meeting, officials from the Centers for Disease Control and Prevention grappled with how to establish a surveillance system to detect folic acid-related adverse events such as the potential for folic acid to mask the hematologic manifestations of vitamin B[12] deficiency ("The Tan Sheet" Aug. 23, p. 8). "While it would not be adequate in and of itself," AHA added, "reported incidences of adverse reactions from dietary supplements could provide additional useful information to any good database." In more general comments on dietary supplement regulation, AHA argued that both amino acids and herbs should be regulated by FDA as drugs. "Herbal dietary supplements, because of the wide variability in composition of each herb and the potential for toxicity, are of even greater concern from the standpoint of safety to the American public," AHA asserted. Therefore, "because many herbs contain pharmacologically active substances," AHA recommended that they be "treated as drugs and [be] subject to the same rigorous standards." In addition, AHA suggested that herbal product labels "should bear warning messages regarding possible toxic effects" and "FDA should establish specifications and good manufacturing practices to assure the safety of herbal products." With regard to amino acids, AHA argued that they be regulated as drugs because "their intended use is for therapeutic purposes as opposed to nutritional purposes." FDA, in its June 18 advanced notice of proposed rulemaking on the regulation of dietary supplements, noted that it plans to call for data on the safety and intended uses of amino acids and claims made for the products ("The Tan Sheet" June 21, p. 8). The agency also called for comments on a report by its Task Force on Dietary Supplements, which recommended that amino acids be classified as drugs, and requested safety data on herbals. Among the association's suggestions, AHA recommended to FDA that it establish an "Office of Dietary Supplements" within the agency's Center for Food Safety and Applied Nutrition. Currently, supplements are handled by CFSAN's Office of Special Nutritionals. The Office of Dietary Supplements, AHA continued, would be "specifically charged with reviewing over a period of time all dietary supplements on the market." AHA suggested that the review should "focus first on supplements considered potentially unsafe." The concept of a comprehensive review of all dietary supplements has also been supported by Rep. Cardiss Collins (D- Ill.), who included such a review in recently introduced legislation ("The Tan Sheet" Aug. 16, p. 4). The Center for Science in the Public Interest also has supported the idea. In addition, AHA recommended that FDA establish an advisory committee specifically devoted to dietary supplement issues and that the agency "be given full enforcement authorities to remove a product . . . found to be unsafe" from the market. "The burden should remain on the manufacturer to establish that a product believed to be unsafe is in fact safe when used as intended. Any products appearing on the market after a specific date, which contain new or modified dietary supplements, should be subject to a petitioning review process designed to establish safety and efficacy," the association urged.
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