OTC ephedrine ban exceeds FDA's FD&C Act authority -- NDMA, Whitehall-Robins, Bayer.
This article was originally published in The Tan Sheet
Executive Summary
OTC EPHEDRINE BAN EXCEEDS FDA AUTHORITY UNDER FD&C ACT, NDMA, Whitehall-Robins and Bayer argued in recent comments on FDA's July 27 proposal to halt ephedrine use in OTC bronchodilators. The Nonprescription Drug Manufacturers Association noted in a Sept. 27 submission that FDA's proposal relies in part on the Drug Enforcement Administration's request to restrict OTC availability of ephedrine because of ephedrine diversion to the illegal production of controlled substances.