FDA CHALLENGED ON PREMATURE JUDGEMENT OF EPHEDRA SUPPLEMENTS
URGES FDA TO WAIT FOR CANTOX AND COLUMBIA/HARVARD STUDY

---

WASHINGTON, D.C., August 8, 2000—The Council for Responsible Nutrition (CRN) today challenged the Food and Drug Administration (FDA) on its premature rush to judgement of ephedra supplements. The Council urged consideration of two significant studies. The first is a risk assessment by Cantox Health Sciences International (Cantox) commissioned by CRN, and the second is a clinical trial by Columbia and Harvard universities. These studies are important, and should be received and subjected to science-based scrutiny in a public meeting.

"The Cantox study will be the first risk assessment carried out with procedures and guidelines developed by the U.S. National Academy of Sciences, principally funded by the FDA. The Columbia/Harvard trials are one of the largest and longest duration clinical trials conducted on ephedra," said John Cordaro, President and CEO of CRN. "I encourage the FDA to thoroughly analyze these unique scientific bodies of evidence to reach sound public policy."

The Council for Responsible Nutrition has been actively involved with the FDA, other associations, and the scientific community in the evaluation of the scientific evidence and policy options on ephedra. Over the last two years, efforts to resolve issues on the safety, dose and duration have been bogged down, coming to a head with the General Accounting Office (GAO) report criticizing FDA’s procedures in the evaluation of ephedra.

"In the end, sound and responsible science is the essential component to resolving this complex problem," Cordaro added.

CRN will deliver the following two statements at a public meeting on the Safety of Dietary Supplements Containing Ephedrine Alkaloids on Tuesday and Wednesday, August 8-9, 2000 at the Wilbur J. Cohen Auditorium at the Department of Health and Human Services.