ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Thursday, August 29, 1996 TAG: 9608290083
SECTION: NATIONAL/INTERNATIONAL PAGE: A-4 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Associated Press
AT LEAST 17 DEATHS in three years have been blamed on ephedrine-laced pills, tablets and teas, and the FDA wants to know what it should do about it.
Advisory panel members called for tougher regulation of diet supplements that supposedly increase strength, reduce weight and produce an ``herbal high,'' but they sent mixed signals on what precise action the Food and Drug Administration should take.
No formal vote was taken Wednesday, but E. Wayne Askew, acting chairman of the committee, said the panel members were in general agreement that FDA should tighten controls on the sale of dietary supplements that contain the drug ephedrine. Just how tough the new regulations should be, however, split the members.
``The committee is divided between those who believe there is no safe level for ephedrine in dietary supplements and those who believe a low dose would be OK,'' said Askew.
At least 17 people have died and 800 made ill by dietary supplements containing ephedrine since 1993, according to the FDA.
Ephedrine-laced pills, tablets and teas, packaged as dietary supplements, have been selling briskly at health food shops, convenience stores and workout parlors as aids to reducing weight and building muscle and endurance. FDA has called some preparations with high doses of ephedrine ``street drug alternatives.''
FDA officials organized the advisory committee to gather expert advice on how to respond to the growing number of people injured by dietary supplements containing the substance.
The key question before the committee was whether any dose of ephedrine was safe for dietary supplements, which can be purchased with few restrictions.
``My take on the committee is that a little more than half say there is not a safe level of ephedrine in diet supplements and a little less than half wanted to set a low level,'' said FDA Administrator David Kessler.
Kessler said the agency ``got good advice'' from the committee and He said the action could range from an outright ban on ephedrine-laced dietary supplement products to setting a low dose limit on the drug.
``Doing nothing is not an option,'' he said.
Even though the committee failed to unify on how much ephedrine should be allowed in dietary supplements, Kessler said, ``All of the dose levels claimed as safe [by some committee members] were much lower than what is available today.''
If the agency permits a low dose of ephedrine in dietary supplements, it also would mandate strict manufacturing standards, he said.
The 14-member advisory committee, made of up nongovernment scientists, consumer representatives and doctors, heard two days of reports and discussion on the use of ephedrine in so-called herbal products sold as dietary supplements.
Ephedrine is a compound extracted from plants and used for centuries by Chinese practitioners as a medicine. It also can be synthesized.
Patricia A. Negron, a stock analyst of the herbal product industry, said one top manufacturer reported about $30 million in sales of ephedrine-related products.
LENGTH: Medium: 64 linesby CNB