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Ephedrine alkaloids

This article was originally published in The Tan Sheet

Executive Summary

FDA should build a "transparent basis for a new position on ephedra" by immediately releasing all new adverse event reports without an accompanying agency analysis, five dietary supplement industry groups say in a March 10 letter to Commissioner Jane Henney, MD. The agency also should "propose and make public in advance criteria for evaluation methods that will define the process that is appropriate for reviewing ephedra products in light of the new AERs and in the context of other necessary data, including consumption data," AHPA, CHPA, CRN, NNFA and UNPA say. On Feb. 25, FDA announced it was withdrawing the dosing and duration of use limits in its June 1997 proposed reg and would make publicly available all ephedrine alkaloid-related AERs received since the proposal's publication, along with an agency analysis of the AERs (1"The Tan Sheet" March 6, p. 9)
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