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This article was originally published in The Tan Sheet

Executive Summary

FDA DELAY IN ISSUING FINAL DIETARY SUPPLEMENT REGULATIONS URGED by Sen. Orrin Hatch (R-Utah) and Reps. Bill Richardson (D- N.M.) and Elton Gallegly (R-Calif.) in a Nov. 23 letter to HHS Secretary Donna Shalala. The letter was sent after negotiations in the House failed to produce an extension to the Nutrition Labeling & Education Act moratorium for dietary supplements beyond the one- year exemption provided by Hatch's Dietary Supplement Act of 1992, which expires on Dec. 15. The three members of Congress "strongly" urged Shalala "to make certain that FDA takes no action to implement the June 18 Federal Register notice" containing the agency's advance notice of proposed rulemaking on dietary supplements ("The Tan Sheet" June 21, pp. 1-11) "prior to Congressional approval of a dietary supplement bill." "Aware that the 'hammer' will fall on FDA's proposals and that they will become final if no final regulation is promulgated prior to June 1994," the three lawmakers told Shalala that they would "work to make certain legislation is enacted prior to that time." While Hatch, Richardson and Gallegly said they did not want final rules promulgated, they emphasized that their "intent would be that FDA proceed, however, with approval of health claims that are already in the pipeline, such as folic acid, which we hope FDA will process with all due speed despite its recalcitrance thus far." FDA "has consistently demonstrated an anti-dietary supplement bias over the past three decades," Hatch, Richardson and Gallegly charged. "Congress provided the one-year moratorium in anticipation that HHS and FDA would work with us to resolve the issues surrounding the treatment of dietary supplements within the NLEA framework," the letter states. "That dialogue, quite simply, never took place," they maintained, saying that FDA's June 18 Federal Register notice was a "[reissuance of] the previous proposal" made by the agency following the passage of NLEA. In addition, the three reiterated an Oct. 29 request that "the administration withdraw FDA's fatally flawed document, "Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace"" ("The Tan Sheet" Nov. 8, In Brief). The report was submitted by FDA Commissioner David Kessler to House Energy & Commerce/health subcommittee Chairman Henry Waxman (D-Calif.) as part of the record of a July 29 hearing on FDA regulation of dietary supplements. Hatch, Richardson and Gallegly asked Shalala to meet with them "to discuss" the report. Noting that the HHS secretary has not yet responded to their request to withdraw the report, the congressmen emphasized that they are "very serious" about the matter.

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