FDA PANEL MEMBERS BACK LIMITS ON HERBAL STIMULANT EPHEDRINE.

Byline: Warren E. Leary The New York Times

Members of a Food and Drug Administration advisory committee Wednesday suggested that controversial and sometimes dangerous dietary supplements made with the natural stimulant ephedrine could probably stay on the market if made subject to new restrictions.

Ephedrine preparations, derived from the herb ephedra and sometimes mixed with other herbs and chemicals, are sold as aids for losing weight, relieving respiratory ailments and boosting energy. They have been linked to hundreds of reports of injury and at least 17 deaths, health officials said.

Other products using the herb are also being marketed as natural alternatives to illegal drugs like Ecstasy, with the promise of providing euphoria or hallucinogenic effects with no health or legal risks, they said.

Many of the outside experts on the agency's Food Advisory Committee said after spending two days discussing ephedrine that they did not believe there was a dose level that was absolutely safe. However, some said, banning legal use of the herb as a dietary supplement could encourage unregulated underground use.

The panel of more than a dozen experts in medicine, nutrition, health and other specialties did not take a formal vote on whether ephedrine, also known as ma huang or ephedra in its natural form, should remain available as a diet supplement in health food and nutrition stores.

But an informal poll taken at the meeting of members' opinions indicated that most favored allowing the product to remain available at greatly reduced recommended dose levels, with better labeling to highlight potential adverse effects, and with tighter quality control over manufacturing.

Dr. David A. Kessler, the commissioner of food and drugs, said the agency would consider the panel's recommendations, studies by its staff and other evidence before making a decision on whether ephedrine should remain on the market as a dietary supplement. Kessler said he expected the agency to act quickly on the matter, almost certainly before the end of the year.

``It's clear we will have to do something and that the option of doing nothing is not acceptable,'' Kessler said after hearing the committee discussion. The agency's options include prohibiting the herb's use as a diet supplement or finding some safe or acceptable dose level that would allow it to stay on the market, he said.

Kessler said that if ephedrine were allowed to stay on the market, the agency would require strict manufacturing standards to assure the quality and content of products containing it.

The agency already has begun action against the part of the ephedrine industry that markets the herb as a legal ``herbal high.'' Products sold under names like Herbal Ecstacy, Cloud 9 and Ultimate Xphoria have been advertised in magazines and on the Internet as alternatives to street drugs.

Last week, the Food and Drug Administration sent letters to six companies, accusing them of ignoring repeated warnings about the health risks associated with these products. Kessler said that if the companies do not comply soon with federal rules, the agency would take them to court and ask to shut down their operations.