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This article was originally published in The Tan Sheet

Executive Summary

VITAMIN AND MINERAL MAXIMUM LEVELS OPPOSED BY LEDERLE in a Nov. 24 letter to FDA on the agency's June 18 advance notice of proposed rulemaking on the regulation of dietary supplements. In response to FDA's call for comments on the establishment of maximum daily intake levels -- or a "dietary supplement limit (DSL)" -- for all vitamins and minerals, Lederle declared that it "does not support this view." Vitamin and mineral "safety is well established with well-known documented exceptions," the company maintained. Lederle recommended that FDA "devote its activities in this area to these exceptions." While acknowledging that "there may be some special issues that may require a closer look at specific nutrients," Lederle suggested that "the limited resources of the FDA would be better utilized by focusing on those few and appropriate exceptions rather than trying to force a consensus on a potentially controversial establishment of an arbitrary safe limit representing the majority of cases." The establishment of maximum limits by FDA, Lederle warned, "may impede the study and recommendation of vitamin and mineral levels crucial to optimal health." The company pointed out that evidence was presented at a June meeting on Recommended Dietary Allowances sponsored by the National Academy of Sciences that showed "the levels of several vitamins and minerals needed to achieve optimal health may be at 10 to 15 times the present U.S. RDA values." Lederle recommended that "FDA evaluate and regulate problem levels present in dietary supplements on a case-by-case basis." In addition, "rather than set dietary supplement limits," Lederle suggested that FDA "work with industry to educate consumers about the need to avoid high doses of those vitamins which might cause adverse effects." Citing a table compiled by the company from the medical literature on ingredient levels associated with adverse effects, Lederle maintained that the adverse effect levels for each nutrient "are far in excess of U.S. RDA or estimated safe and adequate daily dietary intakes." For minerals for which there is no RDA, the company said "there are no reports showing adverse effects from amounts used in major nutritional supplements." Lederle also submitted a copy of the Council for Responsible Nutrition's voluntary dosage level recommendations, which are followed by all CRN members, according to the firm. "The adherence of dietary supplement manufacturers to such safety standards would appear to make the regulation of supplement limits . . . unnecessary," Lederle asserted. In the June 18 ANPR, FDA noted that its Task Force on Dietary Supplements recommended that the agency establish a "maximum daily safe supplemental intake for a given vitamin or essential mineral called a dietary supplement limit," and solicited comments on the idea ("The Tan Sheet" June 21, p. 1). At a CRN meeting later that month, FDA Deputy Commissioner for Policy Michael Taylor said the agency believes a DSL is warranted by the few nutrients that pose toxicity concerns at higher levels but that FDA had not yet decided how it would formulate a DSL ("The Tan Sheet" July 5, p. 8).

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