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. Some preparations with high doses of ephedrine have been called “street drug alternatives” by the FDA.
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 ephedrine.
The key question before the committee was whether any dose of ephedrine was safe for dietary supplements, which can be purchase with few restrictions. Some members wanted all such products banned, while others said a low dose of the drug was acceptable.
“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.