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DIETARY SUPPLEMENT SYSTEMATIC SAFETY REVIEW RECOMMENDED BY ATTORNEYS GENERAL

This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT SYSTEMATIC SAFETY REVIEW RECOMMENDED BY ATTORNEYS GENERAL from 11 states in recent comments to FDA. Noting that supplements should "pass sufficient scrutiny to allow the public to have confidence that all such products in the marketplace are safe for consumption," the AGs stated that "we agree with the FDA that there is a need to review vitamins and minerals on the market to determine at what levels they can be safely consumed." "Such a review could bring those marketing nutritional supplements into compliance with existing law," the AGs asserted, and "could prevent tragedies such as those that have occurred in the past with consumption of some supplements." In its June 18 advance notice of proposed rulemaking on the regulation of dietary supplements, FDA cited the need for a "comprehensive science-based evaluation of the potential toxicity of vitamins and minerals at various intake levels" ("The Tan Sheet" June 21, p. 1). A systematic review of currently marketed dietary supplements is included in dietary supplement legislation introduced by Rep. Cardiss Collins (D-Ill.) in August ("The Tan Sheet" Aug. 16, p. 4), and was cited by House Energy & Commerce/health subcommittee Counsel William Schultz as a key tenet for any successful supplement bill. The Center for Science in the Public Interest also has endorsed the idea. The AGs maintained that the "purpose" of the Nutrition Labeling & Education Act "cannot be fully carried out unless the protections of the NLEA apply fully to dietary supplements." At the National Association of Attorneys General summer meeting in July, NAAG adopted a resolution opposing misleading or inaccurate labeling and advertising for dietary supplements. The resolution also called on Congress to ensure that supplement manufacturers remain subject to FDA jurisdiction under the same standards as other FDA-regulated industries ("The Tan Sheet" July 26, p. 1). Regarding amino acid products, the state AGs also concurred with FDA's position. The group contended that "the industry should be required to establish (1) the safety of amino acids for their intended use; (2) maximum dosages of amino acids for safe use; and (3) the efficacy of amino acids for their intended use." In addition, the AGs recommended that a "prompt determination . . . be made whether any amino acid products could have potentially harmful effects" and that FDA prohibit the sale of amino acid products making drug claims that are not "generally recognized" by "qualified scientists" as being safe and effective. In addition, the AGs maintained "that many other dietary supplements and herbal products currently on the market pose significant health risks to consumers" due to unsubstantiated health claims. "We support the FDA's position that health claims cannot be made for dietary supplements without premarket approval," they concluded. "We also support the FDA's position requiring, at a minimum, significant scientific agreement before FDA approval of health claims," the AGs declared, adding that "if sellers go beyond approved health claims," dietary supplements should be regulated as drugs. "Due to limited resources, state and federal regulators are able to take action against only a limited number of individuals and businesses responsible for false claims," the state AGs noted. "Without premarket approval, perpetrators of false claims will simply sell their products by misleading the public and reap the profits until regulators and the courts stop them years later," they said. A health claim standard lower than requiring "significant scientific agreement" would "result in approval of health claims that are known to be false and that have support of only a fringe group of scientists, or are supported only by scientists with financial interests in the nutritional supplement industry," the AGs charged. Under industry-supported legislation introduced by Sen. Orrin Hatch (R-Utah), health claims would be allowed if substantial scientific evidence supporting them is available. Companion legislation by Rep. Bill Richardson (D-N.M.) would enable the use of health claims if FDA is notified of the claims within 30 days of their introduction. The state AGs also contended that drug claims should not be used for dietary supplements unless an NDA is approved for those claims. "Consumers should not be exposed to health risks resulting from taking worthless nutritional supplements sold as cures for disease where conventional treatment may be effective, but are not pursued because the 'cure' promised by an ineffective nutritional supplement is more attractive to consumers than more painful, costly or intrusive (but effective) conventional treatment," the letter to FDA states. The group also suggested that FDA step up good manufacturing practices inspections for supplement firms and supported the standardization of nutrient content claims under the NLEA.
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