Texas ephedrine rules
This article was originally published in The Tan Sheet
Executive Summary
Written comments on Texas Board of Health proposed regulations for labeling of ephedrine-containing dietary supplements are due April 4. Published in the Texas Register Feb. 4, the proposed rule would require the FDA toll-free MedWatch number and a warning prohibiting sales to persons 17 or younger to appear on labeling (1"The Tan Sheet" Nov. 15, 1999, p. 3). Industry members, including reps from several trade associations, said the regs are unnecessary at a Feb. 23 hearing. The MedWatch number requirement would go into effect Sept. 1, 2001, giving FDA time to modify the adverse event reporting system; the warning regarding minors would become effective Jan. 1, 2001