Ephedrine proposed rule 150-day comment period extension urged by supplement coalition.
This article was originally published in The Tan Sheet
Executive Summary
EPHEDRINE FDA GUIDANCE DOCUMENT IN LIEU OF RULEMAKING urged by the Dietary Supplement Safety and Science Coalition in Dec. 1 comments to the agency. Responding to FDA's proposed rule on ephedrine alkaloids in dietary supplements, the Denver, Colo.-based industry group "strongly recommends that the FDA terminate its rulemaking...and, instead, develop and issue a guidance document which incorporates the suggestions of the DSSSC." FDA's June 4 proposed rule would, among other things, limit ephedrine single-dose amounts to 8 mg ("The Tan Sheet" June 9, pp. 20-25). The comment period for the proposal ended Dec. 2.
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