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FDA LISTS OVER 500 DIETARY SUPPLEMENTS MAKING UNSUBSTANTIATED CLAIMS

This article was originally published in The Tan Sheet

Executive Summary

FDA LISTS OVER 500 DIETARY SUPPLEMENTS MAKING UNSUBSTANTIATED CLAIMS in a report timed to be released during a July 29 hearing convened by Rep. Henry Waxman's (D-Calif.) House Energy and Commerce/health subcommittee. The list of products includes herbals, amino acids, glandular products, minerals and vitamins and cites product claims for a wide spectrum of conditions, including, for example, AIDS, cancer, herpes, hypertension, high cholesterol, diabetes, hepatitis, arthritis and cerebral palsy. FDA noted that each of the products "makes at least one unsubstantiated claim; most make several" and that "only products with printed claims have been included in this list." The claims, the report states, "range from treatment of such chronic diseases as cancer, emphysema and multiple sclerosis to the elimination of such disorders as incontinence and varicose veins." Some promise prevention, FDA reported, and other promise cures. "They range from the general ('infection' and 'senility') to the specific ('ringworm' and 'impetigo')," FDA said. FDA said it is issuing the report, entitled "Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace," so that "consumers have accurate information about the dietary supplement marketplace." The agency maintained that the report "demonstrates the pervasiveness of unsubstantiated claims currently being made for dietary supplements in the U.S. marketplace." The report also is likely to be used as additional ammunition by the agency in its lobbying efforts to convince Congress that FDA needs more authority over the regulation of dietary supplements, and not less authority as is proposed in the bills introduced by Sen. Orrin Hatch (R-Utah) and Rep. Bill Richardson (D-N.M.). In testimony before Rep. Waxman's subcommittee, FDA Commissioner David Kessler repeatedly cited the report to support the agency's position that a portion of the dietary supplements industry is making unsubstantiated health claims. Based on the report, Kessler estimated that about 80% of the dietary supplement marketplace consists of vitamins and minerals that are marketed at reasonable potencies and make no unsubstantiated claims. However, the report suggests that products in the other 20% of the marketplace "present safety concerns or make unsubstantiated claims." "Thousands of unsubstantiated claims are being made about hundreds of dietary supplements," the report asserts. In addition, the report observes that "some ingredients marketed as dietary supplements have demonstrated serious and even life-threatening hazards." The report maintains that, as a result, "millions of Americans are spending billions of dollars every year on dietary supplement products, many of which have shown little or no evidence of either safety or effectiveness" and that valid claims "are currently indistinguishable from invalid claims." FDA also describes in the report a recent survey of health food stores by agency inspectors which found that of 129 requests for information based on specific disease conditions, "120 resulted in recommendations of specific dietary supplements." In only three instances, store employees declined to make recommendations, and on six occasions "employees merely provided references from reading material on dietary supplements," FDA said. The report suggests that the "oral representations of dietary supplements demonstrate the pervasiveness of unsubstantiated claims for serious diseases being made for these products across the nation." The findings of the report, FDA said, suggest that the success of the agency's "rather modest enforcement actions of the past few years has been limited." FDA said that the samples it collected, "along with oral representations of uses for dietary supplements, show that in nearly all cases unsubstantiated claims are moving off the product label and into catalogues, brochures, and oral sales pitches." The agency concluded that the "bottom line" is that the dietary supplement marketplace "has changed little over the years despite FDA's efforts." FDA asserted that "if anything, unsubstantiated claims are becoming more exaggerated, more products of unknown effect are available, and their use is escalating." The report also lists nine herbal ingredients, two amino acids, four vitamin and mineral ingredients and germanium, a nonessential element, for which "serious" adverse reactions have been documented. The herbals include chaparral, comfrey, yohimbe, lobelia, germander, willow bark, Jin Bu Huan, Stephania and Magnolia, and Ma huang. The amino acids cited are L-tryptophan and phenylalanine, and the vitamins include vitamins A and B[6], niacin and selenium.
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