Scientific Review Sets Upper Limit for Ephedra 40688

Scientific Review Sets Upper Limit for Ephedra

WASHINGTON--The Council for Responsible Nutrition (CRN) contracted theindependent scientific laboratory, Cantox Health Sciences International, to doan analysis on the comprehensive science behind ephedra. The lab found that noadverse events were recorded at levels of 90 mg per day, which the Food and DrugAdministration (FDA) said it would take under consideration when looking at thesafety of ephedrine alkaloids in ephedra.

Cantox evaluated information from nonclinical and clinical studies, publishedcase reports, animal data and adverse event reports (AERs) from medicalliterature and as reported to FDA. Cantox's main aim was to find a"tolerable upper intake level," which is the maximum total chronicdaily intake of a substance judged unlikely to pose a risk of adverse healtheffects.

In addition to lab animal studies, 19 studies that were conducted on adult,obese participants were selected and reviewed based on a study's design,duration, number of subjects and endpoints. It was determined that a "noadverse effect level" was identified as 90 mg of ephedrine alkaloids inephedra per day for a generally healthy person. Also, a consumer should splitthe dosage into 30 mg or less per serving and should not be taken chronicallyfor more than six months. The industry recommendation for ephedra dosage issimilar to the report's: 25 mg per serving, not to exceed 100 mg per day.

The report cautioned against taking ephedra by those who suffer from heartdisease, diabetes, glaucoma, high blood pressure, thyroid disease, kidneyimpairment or an enlarged prostate. Also, people under 18 and women who arepregnant or nursing should not use ephedra products. In addition, the reportidentified that 150 mg was the lowest total daily dosage at which moderateadverse effects began to be observed. "The information reported here todayis a win for consumers, a win for regulators and a win for [the] industry,"said Jon Cordaro, president and chief executive officer for CRN. For additionalinformation about the CRN ephedra report, visit www.crnusa.org.

An FDA spokesperson said the agency would take the Cantox report intoconsideration. "We're looking at the overall safety of [ephedra]," thespokesperson said, adding that the administration has no firm stance on eitherregulating or banning the supplement.

In related news, the editors at the New England Journal of Medicine (NEJM)have corrected the ephedra story the journal "prepublished" on Nov. 6.The study stated that ephedra, when broken down by the body, turned into anamphetamine, a "known metabolite of ephedrine." (For more informationabout this report, visit www.nejm.org. ) Thejournal corrected the erroneous information when the study was formallypublished in the Dec. 21 issue.