Guest guest Posted March 2, 2000 Report Share Posted March 2, 2000 Acuman1 wrote: > Tuesday February 29 10:02 PM ET > > FDA to withdraw portions of ephedra proposal > > NEW YORK, Feb 29 (Reuters Health) -- The Food and Drug Administration (FDA) > has told members of the House and Senate that it intends to withdraw portions > of a 1997 proposed rule that would cap individual ephedra doses. > > The herb ephedra is the source of ephedrine, a dietary supplement that is > sold over-the-counter with claims that it can induce weight loss or boost > energy and athletic performance. Ephedrine has amphetamine-like effects, > including stimulant effects on the heart and nervous system. > > The FDA's decision follows a report from the General Accounting Office (GAO) > last August that recommended that the FDA withdraw the cap because it did not > have enough evidence of adverse effects. The GAO said that the FDA had made > its proposed rule based on unreliable evidence that did not prove whether or > not ephedrine had caused reported adverse reactions. > > At the time of the proposed regulation, the FDA had said that ephedrine could > cause serious reactions that could lead to heart attacks, strokes and, in > some cases, death. The agency recommended a limit on ephedrine levels in > dietary supplements and suggested warnings against consuming products > containing ephedrine for more than 7 days. > > In a letter to members of Congress dated February 25, 2000, FDA Associate > Commissioner for Legislation Melinda K. Plaisier wrote, ``In light of GAO's > conclusions, comments from others on the proposed rule, and having further > considered the issues, FDA plans to withdraw these provisions (regarding > dosing levels and duration of use) from the proposed rule.'' > > The FDA said that it would release data on adverse events associated with > ephedra use and make available its analysis of these reports and related > information. The agency also intends to hold a public forum to seek input on > the new information, which will serve partially as the basis for future FDA > action on ephedra. [This message contained attachments] Quote Link to comment Share on other sites More sharing options...
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