FDA Eases Up On Ephedra

WASHINGTON--The Food and Drug Administration (FDA) announced it would begin another round of ephedra analysis in order to revisit the potential health risks associated with it. In a letter to senators and House members dated Feb. 25, FDA associate commissioner for legislation, Melinda Plaisier, said the FDA was going to withdraw a portion of its 1997 proposed rule that would have limited dosages of ephedra to 8 milligrams (24 mg daily). It was also withdrawing the section of the rule that would have limited dosages to one week.

The rule was proposed in response to adverse reaction reports collected after the 1994 dietary supplement law was passed, 16 of which allegedly resulted in deaths from ephedra, also known as ma huang. The FDA announced the newly researched health risk report will be released March 31.

The FDA's proposed rule and adverse reaction data had been harshly criticized by a Government Accounting Office report. The FDA's treatment of ephedra has also been the subject of an ongoing investigation by the House Government Reform Committee.