FDA, Industry Argue Safety of Herbal Stimulant Ephedra

Manufacturers and regulators sparred Tuesday over whether people risk serious harm when they consume the herb ephedra, a stimulant used in scores of dietary supplements sold for weight loss and boosting energy.

Officials with the Food and Drug Administration, which previously tried to restrict ephedra use, said they had attributed 17 reports of serious side effects to the herb. The problems included one death from abnormal heart rhythms, two cases of heart attacks and one seizure.

“Use of ephedra continues to be a serious public health concern,” said the FDA’s Dr. Lori Love.

An industry-funded panel of experts vigorously attacked the FDA’s analysis, saying the reports voluntarily submitted to the agency by consumers and doctors were an unreliable way to gauge ephedra’s safety.

Many reports do not contain enough information to draw conclusions or could be explained by other circumstances such as underlying heart conditions, panel members said.

Even by conservative estimates, the rate of heart attacks, strokes and seizures in people taking ephedra were no higher than in the general population, said Dr. Stephen Kimmel, a University of Pennsylvania epidemiologist who chaired the panel.

“We’re looking for a dramatic increase, and we don’t see that,” Kimmel said, adding that no serious problems were seen when consumers took the products as directed.

Ephedra products have been growing in popularity since 1996. Millions of Americans take them, and makers say they can be an effective, over-the-counter alternative for treating one of the nation’s leading health problems: obesity.

Ephedra, also listed on labels as ephedrine or ma huang, suppresses appetite and boosts metabolism. Critics say it can dangerously speed up heartbeats and blood pressure in some people.

In 1997, the FDA proposed limiting ephedra doses and taking other steps to restrict its use. The agency withdrew the proposals in March after industry groups and a congressional audit said they were not supported by scientific evidence.

Now the FDA says it is listening to various views before it proceeds with new regulatory action. The agency also sought opinions from outside experts to avoid criticism that it was biased against ephedra.

Dr. Raymond Woosley, head of Georgetown University’s Department of Pharmacology, said he does not believe there is enough evidence to show that ephedra works to justify risking any harm.