Ephedrine proposal comment period "immediate" suspension requested in letter to FDA.
This article was originally published in The Tan Sheet
Executive Summary
EPHEDRINE PROPOSAL COMMENT PERIOD "IMMEDIATE" SUSPENSION REQUESTED by Starlight International and Nutraceutical Corp. outside counsel Hyman, Phelps & McNamara in an Oct. 3 letter to FDA Lead Deputy Commissioner Michael Friedman, MD. The firm is asking that the comment period on the agency's June 4 proposal establishing dosage restrictions and label warnings for dietary supplements containing ephedrine alkaloids be closed again immediately to allow the review of recent FDA changes to the administrative record.