Ephedrine restrictions unsupported by FDA adverse event files, supplement firms maintain.
This article was originally published in The Tan Sheet
Executive Summary
EPHEDRINE ALKALOID RESTRICTIONS UNSUPPORTED BY FDA ADVERSE EVENT FILES, the Washington, D.C. firm Hyman, Phelps & McNamara states in an Oct. 3 letter to FDA Lead Deputy Commissioner Michael Friedman, MD. The agency's Center for Food Safety & Applied Nutrition relied "heavily" on the files for its proposal to establish serving limits and label warning requirements for dietary supplements containing ephedrine alkaloids, the firm notes. However, the files "do not support CFSAN's proposed restrictions," the firm maintains.
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