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DIETARY SUPPLEMENT FDA/INDUSTRY FORUM REQUESTED

This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT FDA/INDUSTRY FORUM REQUESTED by Council for Responsible Nutrition President J. B. Cordaro to discuss issues related to the regulation of dietary supplements. Testifying at a July 20 hearing of the House Government Operations/human resources and intergovernmental relations subcommittee, Cordaro told subcommittee Chairman Edolphus Towns (D-N.Y.) that "if there is anything that this subcommittee can do, it can find a locus or a forum where we can sit down and get that rational discussion going." Acknowledging the diverging views of FDA and the dietary supplement industry on how these products should be regulated, Cordaro added: "I think [a forum] is going to do more to solve real problems than whatever legislation might be passed." Industry-supported legislation on dietary supplements was introduced by Rep. Bill Richardson (D-N.M.) and Sen. Orrin Hatch (R-Utah) in April ("The Tan Sheet" April 12, p. 6). Towns is a cosponsor of the House bill. Cordaro emphasized that the reason he was interested "in taking part in this hearing was to ask you all to encourage the industry and the Food and Drug Administration to sit down and to find a way to resolve our problems . . . without resorting to eight-second sound bites on the evening news." Responding to Cordaro's request, subcommittee member Donald Payne (D-N.J.) told Towns that he hoped an FDA/industry forum to discuss supplement issues "is noted and perhaps you might be able to recommend this and take it a step further." Towns staffers indicated that the New York Democrat is considering Cordaro's proposal as an option to follow-up on the hearing. FDA Center for Food Safety and Applied Nutrition Director Fred Shank signaled at the hearing a willingness to work with the supplement industry in formulating regulatory policies. "Clearly it is important that we have a good dialogue with all professionals as we move forward in the development of these policies," Shank offered. The FDAer noted that he has "heard the criticism that we have not paid enough attention" to the opinions of the supplement industry, adding that "we do want to reach out and get the advice from all of those that can contribute to this process." Subcommittee member Bernard Sanders (I-Vt.) specifically asked Shank whether FDA has consulted with the "alternative medicine community" in devising its regulatory policies. Shank assured Sanders that FDA is "trying to reach out to more of these groups as we attempt to build policies for the future." At a June 30 conference sponsored by CRN, FDA Deputy Commissioner for Policy Michael Taylor urged members of the supplement industry to submit serious and scientific comments on the agency's regulatory proposals on dietary supplements ("The Tan Sheet" July 5, p. 9). Shank also emphasized to the subcommittee that FDA has been trying to allot more of its resources toward overseeing dietary supplements. "There are more people at FDA dedicated to the general food supply than there are for dietary supplements," he said, "but I can assure you that in the recent period of time we have allocated more resources than we traditionally have" for supplements. At present, FDA "uses only 15 to 20" of its approximately 3,000 employees "per year to look at the enforcement of dietary supplements," Shank reported. The CFSAN director was accompanied by former subcommittee staffer Mitch Zeller, who currently serves as special assistant to Deputy Commissioner for Policy Michael Taylor; CFSAN Clinical Research and Review Staff Director Laurie Love; and CFSAN Senior Associate Director Robert Lake. Towns noted that he convened the July 20 hearing to evaluate the dissonant views on the regulation of dietary supplements and to discover whether "FDA is striking the right regulatory balance." In his opening statement, Towns declared that "it is time to cut through the regulatory fog surrounding dietary supplements." He also indicated that the hearing was, in part, a follow-up to a subcommittee investigation on L-tryptophan that was initiated in 1991 by former subcommittee chair Ted Weiss (D-N.Y.), who died in September 1992. Beginning in the late 1980s, consumption of the amino acid supplement L-tryptophan was associated with over 1,500 cases, including 38 deaths, of eosinophilia myalgia syndrome, according to FDA estimates. Referring to a 1991 hearing convened by Weiss on L-tryptophan, Esther Sternberg, MD, chief of the neuroendocrine immunology and behavior unit at the National Institutes of Mental Health, told Towns that she was asked at that time, "what can we do to prevent this from ever happening again." She declared: "It is frightening to me now that I am once again before this committee not to answer that question but to answer the opposite question: That is, should we make food supplements more available to in order to provide the public with greater freedom of choice." In the June 23/30 issue of the Journal of the American Medical Association, the Centers for Disease Control and Prevention acknowledged that questions still remain on the EMS epidemic and L-tryptophan. In response to a letter to the editor of JAMA, CDC noted that "only certain tryptophan brands were implicated in EMS, supporting that some tryptophan contained an EMS-causing contaminant." CDC concluded that "until that substance, the etiologic agent of EMS, is clearly identified and tryptophan can be screened for its presence, we believe that use of tryptophan for anything other than the most clear-cut and compelling medical indications would be imprudent." The July 20 session was the first of a series of Capitol Hill hearings on dietary supplements slated for the summer and early fall ("The Tan Sheet" July 19, p. 11). On July 29, Rep. Henry Waxman's (D-Calif.) House Energy and Commerce/health subcommittee is scheduled to consider the dietary supplements issue, while Sen. Edward Kennedy's (D-Mass.) Senate Labor and Human Resources Committee is said to be considering holding a supplements hearing in September. The hearings are expected to address the Richardson/Hatch legislation as well as proposed regulations on dietary supplements issued by FDA in June ("The Tan Sheet" June 21, pp. 1-11).
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