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FDA's ROLE AS "FIRST LINE" REGULATORY BODY FOR DIETARY SUPPLEMENTS QUESTIONED

This article was originally published in The Tan Sheet

Executive Summary

FDA's ROLE AS "FIRST LINE" REGULATORY BODY FOR DIETARY SUPPLEMENTS QUESTIONED by National Nutritional Foods Association Ex-Officio/Past President Martie Whittekin before Rep. Henry Waxman's (D-Calif.) House Energy and Commerce/health subcommittee on July 29. Whittekin, who testified on a panel of industry and consumer group representatives, asserted that "it's just not necessary or feasible to expect FDA to be the first line of defense against all possible mistakes [made by the dietary supplement industry]." She added: "We cannot afford the cost of that type of regulation." Rather, Whittekin suggested that the agency recognize industry attempts at self-regulation as a reliable "safety net," and shift its bureaucratic focus to those manufacturers who "slip through the industry system for policing itself." In her testimony, Whittekin pointed to the recent development of the TruLabel program and the Natural Products Quality Assurance Alliance manufacturing guidelines as two such industry initiatives ("The Tan Sheet" July 26, p. 4). "In fact, the supplement industry is . . . taking many . . . important self-regulatory steps to insure safety of product, accuracy of label, and integrity of ingredients," Whittekin maintained. These steps, she suggested, could provide an alternative regulatory framework to FDA's June 18 proposed regulation for supplements ("The Tan Sheet" June 21, p. 1). She claimed that the FDA proposals, if implemented, would "deal a crippling blow to the small businesses of the dietary supplement industry." Citing a suggestion voiced by National Organization on Rare Disorders Executive Director Abbey Meyers for dissolution standards for vitamins, Rep. Waxman asked the group if "anybody on this panel disagree[d] with that notion that there ought to be a dissolution standard." Waxman concluded that no one on the panel would "disagree with the idea." However, Council for Responsible Nutrition President J. B. Cordaro noted that CRN has been working with the U.S. Pharmacopeia "to develop appropriate standards" for supplement dissolution testing. "We would hope that FDA would rely on these several years of work, instead of trying to reinvent the wheel," Cordaro said. Cordaro also endorsed the creation of an independent panel to advise FDA on dietary supplements. "As FDA has said, they do not have the resources to have experts in all of these fields. They need to be able to draw those experts into the process and provide that kind of expert advice," he said. "We believe that we could live with whatever standard might be decided upon, as long as Congress makes it clear that Congress wants to see [that] consumers know about the product, the value and the benefit of the product, and that FDA is directed to open up the flow of information," Cordaro told Waxman. "There needs to be some mindset changes in FDA; we don't believe that's going to happen just by sitting across the table and talking. We believe that Congress is going to have to direct FDA." Waxman asked panel members if they had concerns that giving industry greater latitude would lead to a "catch me if you can" dilemma for FDA in trying to halt the sale of unsafe, mislabeled, or misrepresented dietary supplements on a case-by-case basis. Whittekin maintained that "it is very easy for the FDA, in most cases, to get a label change with simply a phone call or a letter" to either the trade association or the manufacturer directly, and referred to the recent voluntary withdrawal of comfrey products by most manufacturers in NNFA. She claimed that those approaches "do not require a lot of manpower or resources." One alternative to FDA enforcement propounded by several industry representatives would be the establishment of an independent review board. Whittekin said that such a regulatory framework would presume "that [the manufacturers] are innocent until proven guilty, which is not an un-American concept." Also testifying on behalf of the dietary supplements industry were Jerry Kessler, president of the Nutritional Health Alliance; and Sidney Tracy, president of Traco Labs, which was involved in two FDA import detainment cases concerning its evening primrose and black currant oil products in spring 1993 ("The Tan Sheet" April 12, In Brief). During the question-and-answer period, Center for Science in the Public Interest Legislative Affairs Director Bruce Silverglade suggested that the supplement debate was not solely about the question of freedom of choice in the marketplace. "The freedom to choose isn't worth much if it is biased by deceiving claims that the manufacturer puts on the product for marketing reasons. We want this to be a true choice, an educated choice," he said. American Association of Retired Persons National Legislative Counsel Member Lucretia Paschall echoed Silverglade, saying that AARP's "concern is with consumer protection. We want the consumer to be able to make wise choices, based on the label and the quality of the product." In addition, John W. Bode, legislative counsel for the National Food Processors Association, argued that giving dietary supplements a separate regulatory framework from foods would "undermine nutritional education" of consumers. Although studies have found that certain supplements are "particularly beneficial for older Americans," Paschall said that "supplement manufacturers have capitalized on these developments and on Americans' -- particularly older Americans' -- increased interest in health." She added that "surveys also indicate that [senior citizens] are more trusting of salespersons, and do less research than younger consumers. Put these factors together and you have consumers who are ripe for being defrauded." Paschall pointed to such products as "Bone-Up" and "Ocu Guard" as examples and called for a "comprehensible approach" to assure supplement safety. "Nobody wants prescriptions for vitamins and nutritional supplements," NORD's Meyers told the subcommittee. However, she recommended that since "the American people think that the FDA is monitoring these products . . . give them power to regulate it." Meyers also called for "close government regulation" of dietary supplements by FDA, recommending the establishment of good manufacturing practices; bioequivalency tests; side effect labeling; and safety caps. "It's not a civil rights issue. If people believe that health foods are helping them, they should demand the same quality that we are," Meyers told the subcommittee. She emphasized that potency and consumer safety were the main issues in supplement regulation. "FDA has to wait for dead bodies before it can act, and this is really what has to be changed," she stated.
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