Ephedrine Alkaloid AERs Release Without FDA Analysis Urged By SBA
This article was originally published in The Tan Sheet
Executive Summary
Release of a negative FDA analysis with recent adverse event reports on ephedrine alkaloid-containing dietary supplements "could eliminate the market for these products without FDA ever needing to continue its rulemaking," the Small Business Administration says in a March 17 letter to the agency.
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Ephedrine alkaloids
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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