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DIETARY SUPPLEMENT SYSTEMATIC SAFETY REVIEW IS NOT NECESSARY, NDMA ARGUES

This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT SYSTEMATIC SAFETY REVIEW IS NOT NECESSARY, NDMA ARGUES in an Oct. 29 statement provided to Sen. Orrin Hatch (R-Utah). Alluding to suggestions by FDA officials that a systematic safety review of all supplements currently on the market would be helpful, the Nonprescription Drug Manufacturers Association asserted that a "systematic review of all nutritional supplements is not needed at this time. Safety reviews should be undertaken and reasonable safety margins established on a case-by- case basis only where FDA has determined a problem will exist or has been demonstrated under the usual conditions of use." At an Oct. 21 hearing of the Senate Labor & Human Resources Committee, of which Hatch is a member, FDA Commissioner David Kessler asked the committee to consider a systematic safety review of all currently marketed dietary supplements ("The Tan Sheet" Oct. 25, p. 1). The idea also has been supported by a group of attorneys general in comments to FDA ("The Tan Sheet" Oct. 11, p. 8) and has been included in dietary supplement legislation introduced by Rep. Cardiss Collins (D-Ill.). NDMA also maintained that "safety should be defined in terms of whether or not the ingredient is likely to result in injury under the conditions for use defined by its labeling, in the context of a reasonable safety margin, as determined through the available scientific evidence and/or prevailing medical opinion - not on an arbitrary 'cut-off' standard" such as the Recommended Dietary Allowance. NDMA's opposition to a systematic safety review for dietary supplements was part of a general NDMA statement "pertaining to legislative issues for multivitamin/mineral combination products" that was provided to Hatch along with an Oct. 29 letter. In the letter to Hatch, NDMA voiced its support for Hatch's dietary supplement bill, S 784, "in the context of our industry's narrower interests in vitamin/mineral dietary supplements." The letter, signed by NDMA President James Cope, notes that NDMA members market "all of the major brandname multivitamin/mineral supplements." The association told Hatch that it believes dietary supplement regulations proposed by FDA in June have "raised new issues which we think should be addressed by legislation." NDMA said it planned to contact Hatch later "to discuss those issues and to make ourselves available as a source of information on the subject of the manufacture of vitamin/mineral dietary supplements." Prior to the Oct. 29 letter to Hatch, NDMA had not expressed an option publicly on the dietary supplement debate. NDMA said that its government affairs committee is planning to meet on Nov. 8 to discuss whether the association should offer proposed language for dietary supplement legislation. Reportedly, Sen. Hatch is pushing for a markup of his legislation as early as the week of Nov. 8. In addition to commenting on safety issues, NDMA maintained that "nutritional supplements and OTC drugs (e.g., those containing fiber and calcium), as appropriate to the product's ingredients, should be allowed to bear the same health claims as foods." Health claims, NDMA continued, "should be established in a way that assures open, unbiased scientific debate with determinations based on case-by- case, weight-of-the-evidence findings of significant scientific agreement for health/nutrient relationships." Significant scientific agreement, NDMA explained, "implies a claimed relationship is recognized by a public health organization that is accepted as a credible source and/or significant number of qualified experts agree that publicly available peer-reviewed studies adequately substantiate the claimed relationship." NDMA also suggested: that vitamin and mineral supplements "should not be regulated as food additives"; that dietary intake standards "should be defined in the context of optimal health and not just for prevention of nutrient deficiency-related conditions"; and that the definition of dietary supplements should include all vitamins and minerals "found in conventional foods or recognized by an official compendia such as the U.S. Pharmacopeia or the Food & Chemical Codex III."
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