Scientific Review Sets Upper Limit for Ephedra

WASHINGTON--The Council for Responsible Nutrition (CRN) contracted the independent scientific laboratory, Cantox Health Sciences International, to do an analysis on the comprehensive science behind ephedra. The lab found that no adverse events were recorded at levels of 90 mg per day, which the Food and Drug Administration (FDA) said it would take under consideration when looking at the safety of ephedrine alkaloids in ephedra.

Cantox evaluated Information from nonclinical and clinical studies, published case reports, animal data and adverse event reports (AERs) from medical literature and as reported to FDA. Cantox's main aim was to find a "tolerable upper intake level," which is the maximum total chronic daily intake of a substance judged unlikely to pose a risk of adverse health effects.

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 "no adverse effect level" was identified as 90 mg of ephedrine alkaloids in ephedra per day for a generally healthy person. Also, a consumer should split the dosage into 30 mg or less preserving and should not be taken chronically for more than six months.

The industry recommendation for ephedra dosage is similar to the report's: 25 mg per serving, not to exceed 100 mg per day.

The report cautioned against taking ephedra for those who suffered from heart disease, diabetes, glaucoma, high blood pressure, thyroid disease, kidney impairment or an enlarged prostate. Also, people under 18 and women who are pregnant or nursing should not use ephedra products. In addition, the report identified that 150 mg is the lowest total daily dosage at which moderate adverse effects began to be observed.

"The information reported here today is a win for consumers, a win for regulators and a win for [the] industry," said Jon Cordaro, president and chief executive officer for CRN.

An FDA spokesperson said the agency would take the Cantox report into consideration. "We're looking at the overall safety of [ephedra]," the spokesperson said, adding that the administration has no firm stance on either regulating 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 an amphetamine, a "known metabolite of ephedrine." (For more information about this report, visit www.nejm.org.) The journal corrected the erroneous information when the study was formally published in the Dec. 21 issue.

However, in an editorial in the December journal, G. Alexander Fleming, M.D., from Chevy Chase, Md.-based Ingenix Pharmaceutical Services, stated that there is still the "possibility that even at the recommended levels of intake, the use of supplements containing ephedra alkaloids, perhaps in conjunction with vigorous exercise, may carry a risk." He went on to say that FDA should take steps to better regulate this dietary supplement.

For additional information about the CRN ephedra report, visit www.crnusa.org.