WASHINGTON, D.C., April 26, 2002 - A six-month, randomized, placebo-controlled clinical trial on ephedra, conducted by Columbia and Harvard universities (Boozer et al.) and published yesterday in the peer-reviewed International Journal of Obesity, reaffirms the findings of a Dec. 2000 comprehensive science-based risk assessment performed by Cantox Health Sciences International. The Cantox Report on Ephedra concluded that the popular dietary supplement ephedra is safe, under recommended conditions of use, at a total daily dosage of 90 mg, divided into smaller doses of up to 30 mg.
According to John Cordaro, president and chief executive officer, The Council for Responsible Nutrition (CRN), "This newly-published study is an important aspect of the overall science base that we urge the Food and Drug Administration (FDA) to take into account as it considers establishing any regulatory action beyond those self-regulating steps already taken for ephedra by dietary supplement makers. Any regulatory policy established by FDA must be based on sound science, and our industry is committed to working with FDA to devise and implement those kinds of objective, scientifically appropriate actions." The Cantox Report on Ephedra, commissioned by CRN, evaluated all available data utilizing a risk assessment method developed by the U.S. National Academies' Food and Nutrition Board. The evidence reviewed included 19 clinical trials, including the data from the Boozer study that found ephedra both safe and beneficial for weight loss at the 90 mg per day dosage. Cantox Health Sciences International is a world-renowned, independent scientific consulting firm specializing in risk assessment.
"The publication of the Boozer et al. study in a peer-reviewed journal further confirms the validity and importance of the Cantox Report and the credible scientific evidence that shows that ephedra is a product that can be used safely and provide benefits for those for whom it is intended and when used according to label instructions," said John Hathcock, Ph.D., vice president, nutritional and regulatory science, CRN.
Dr. Hathcock further pointed out that since the Cantox Report was issued, four additional studies have been reported, providing further evidence that ephedra can be safely and effectively used for weight loss under recommended conditions of use.
Notes to Editor:
The Council for Responsible Nutrition (CRN) http://www.crnusa.org is one of the dietary supplement industry's leading trade associations representing ingredient suppliers and manufacturers. CRN members adhere to voluntary dosage level recommendations for ephedra that are consistent with findings from the Cantox Report, including dosage and serving limits, labeling, conditions of use, and adequate post-market surveillance. For specific recommendations go to .