FDA wants limits on ephedrine diet supplements
WASHINGTON (Reuter 6/02/97)

The U.S. Food and Drug Administration said Monday it wants to limit the amount of the natural stimulant ephedrine in dietary supplements, and to warn users about the compound's dangers.

"Consumers should be aware that just because a product is labeled 'natural' or from an herbal source it is not guaranteed to be safe," Dr. Michael Friedman, deputy FDA commissioner, said in a statement.

People with hypertension, heart conditions and neurologic disorders should avoid using ephedrine alkaloids, as should pregnant women, the FDA said.

The FDA does not seek to ban ephedrine alkaloids, the active ingredient in some dietary supplements aimed at increasing energy, losing weight and body-building.

However, after hundreds of reports of consumer illnesses and injuries, the agency sought to prohibit the sale of dietary supplements that contain eight milligrams of ephedrine or more per serving.

In addition, the FDA said it wanted to warn consumers on product labels not to use dietary supplements that contain ephedrine for more than seven days. Products that encourage excessive short-term consumption would be required to carry a label warning that "Taking more than the recommended serving may result in heart attack, stroke, seizure or death."

Usually derived from one of several species of herbs of the genus Ephedra, the substance is also known as Ma huang, Chinese Ephedra and epitonin.

Reported adverse effects associated with ephedrine ranged from episodes of high blood pressure, irregularities in heart rate, insomnia, nervousness, tremors and headaches, to seizures, heart attacks, strokes and death, the FDA said.