December 21, 2000 WASHINGTON (AP) - Challenging a prestigious medical journal report that a popular herbal stimulant can kill, the dietary supplement industry disclosed its own review Wednesday that contends ephedra is safe for most people, in the proper dose.
Up to 90 milligrams of ephedra a day, taken in three 30-milligram doses, cause no serious side effects, said the industry report, sent Wednesday to the Food and Drug Administration.
The report acknowledged that certain people, such as those with heart disease, diabetes and a list of other ailments, shouldn't take ephedra.
The report is the latest round in a three-year controversy over the largely unregulated dietary supplement used by millions of Americans for weight loss and bodybuilding. Some people also use large doses for an "herbal high."
The FDA has received about 1,000 reports of complications among ephedra users, including 54 deaths, since the mid-1990s. And a study in last month's New England Journal of Medicine concluded ephedra can cause heart attacks, strokes, seizures and death in otherwise healthy young people.
The FDA proposed restrictions on ephedra including slashing the legal dosage but backed off those plans last year under industry pressure. The agency is debating whether to order ephedra warning labels, which it had planned to decide by year's end.
FDA officials didn't return calls seeking comment Wednesday. The industry's Council for Responsible Nutrition hired a scientific consulting firm, Cantox Health Sciences, to review 19 medical studies of ephedra and FDA's death-and-injury reports.
Wednesday, the council sent FDA the report that concluded 90-milligram daily doses were safe for most people. Deep in the report, Cantox listed people who shouldn't take the herbal stimulant: people with heart disease, diabetes, glaucoma, high blood pressure, thyroid disease, kidney impairment or enlarged prostates; anyone under age 18; or pregnant or nursing women. The report recommends ephedra be labeled with such warnings.
Copyright 2000 The Associated Press. All rights reserved.
