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REP. DURBIN TO MEET WITH FDA, INDUSTRY ON DIETARY SUPPLEMENT REGS

This article was originally published in The Tan Sheet

Executive Summary

REP. DURBIN TO MEET WITH FDA, INDUSTRY ON DIETARY SUPPLEMENT REGS April 21 as a follow-up to an April 1 hearing of the House Appropriations/agriculture subcommittee. Rep. Richard Durbin (D- Ill.), chairman of the subcommittee, asked to meet with the agency and the National Nutritional Foods Association after NNFA urged the subcommittee to consider legislation prohibiting FDA from using fiscal 1994 appropriations to implement the Nutrition Labeling & Education Act regulations on dietary supplements. The publication of final regs to implement the dietary supplement provisions of the NLEA were postponed by Title II of last year's FDA user fee legislation to no earlier than Dec. 15 and not later than Dec. 31. Proposed regs are due for publication by June 15. NNFA Legislative Director Richard Meyers argued at the hearing that if dietary supplement bills introduced by Rep. Bill Richardson (D-N.M.) and Sen. Orrin Hatch (R-Utah) (see stories, pp. 6-8) are not passed before Dec. 31, it would be "necessary for Congress to delay the implementation of the FDA's regulations for one more year." The subcommittee should "consider legislation that would preclude the [HHS secretary] from using fiscal year 1994 appropriated funds to finalize or implement the NLEA regulations as they apply to dietary supplements," Meyers declared. Meyers pointed out that FDA "will not have had time to take into consideration" the General Accounting Office's report on dietary supplements, "which, although due by April 30, 1993, apparently will not be ready by June." GAO was mandated by Title II of the 1992 FDA user fee law to conduct an investigation of how the agency uses its resources to regulate dietary supplements. Meyers claimed that FDA's implementation of the dietary supplement portions of NLEA "will deny millions of Americans the dietary information they need to improve their health" and will "cost the nation millions of dollars in health care expenditures which could have been saved through disease prevention." FDA "has not followed the original intent of Congress in promulgating" regs for NLEA, Meyers asserted, adding that "consumers were outraged that the proposed regulations did not allow substantiated health claims for supplements so that American consumers could make better decisions about how to maintain their health." Based in Costa Mesa, Calif., NNFA is a trade association representing the "natural products" industry including herbal and dietary supplement manufacturers.

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