FDA Urges Court To Restore Ephedra Ban

May 10, 2006 7:00 a.m. EST

Nidhi Sharma - All Headline News Contributor

Denver, CO (AHN) – The Food and Drug Administration has argued that a federal judge who lifted the ban on dietary supplements containing low doses of the weight-loss aid ephedra has misunderstood the law and the ban should be restored.

Ephedra, which was banned two years ago, is linked to deaths and reports of health problems such as heart attack or increased blood pressure in addition to presenting an unreasonable risk of illness or injury at any dose.

U.S. District Judge Tena Campbell in Salt Lake City ruled last year the ban could not be enforced against supplements containing doses of ephedra up to 10 milligrams. Nutraceutical Corp. has challenged the ban.

The representator of the FDA, Christine Kohl, has told the judges that Campbell did not understand the law or the FDA's duties in regulating dietary supplements. She also said Campbell “essentially ignored scientific information on ephedra's effects on the body.”

According to the Associated Press, the Federal judge ruled that the FDA improperly required Nutraceutical to prove there was some benefit to ephedra use.

Instead, Kohl said the FDA should have had to prove harm.

The FDA based its ban in part on work by a doctor who studied the intake of various substances similar to ephedra rather than on use of ephedra itself.

As per FDA, since the substance is defined under the law as a dietary supplement rather than a drug, there was little or no scientific data available on its effectiveness or safety because manufacturers aren't required to conduct such studies.

If the ban is restored, it would essentially give the FDA license to ban any product it believes can cause harm, even if the harm comes only at extremely high doses.