WASHINGTON -- A report issued Wednesday by a leading dietary supplement organization says dieters can take as much as 90 milligrams per day of the controversial herbal stimulant ephedra without significant adverse effects.
The report, funded by the Council for Responsible Nutrition, is the latest salvo in a long-running battle between supplement-makers and the Food and Drug Administration over a popular and powerful weight-loss aid that the FDA has linked to hundreds of cases of serious illness and at least 39 deaths.
The recommendation by Cantox Health Sciences International, an independent scientific consulting firm based near Toronto, is slightly less than the standard of 100 milligrams per day that is generally supported by the supplement industry but considerably greater than the 24 milligrams per day proposed by the FDA three years ago.
The 90-milligram recommendation matches that of an industry-sponsored study conducted by Columbia and Harvard universities. The council released both the Cantox report and some of the Columbia-Harvard results at a news conference. Under dietary supplement law, ephedra is not subject to dosage and other regulations imposed on prescription and over-the-counter drugs.
The FDA withdrew its 24-milligram recommendation in February after Congress discredited one set of reported cases the FDA said documented ephedra's dangers. A second set issued in March prompted widespread speculation that the FDA is readying another effort at regulating dosage.
Joseph Levitt, the FDA's director of Food Safety and Applied Nutrition, said the agency would review the Cantox report and "incorporate it into our decision-making process." But FDA officials said the agency has no plans to issue a new ephedra rule before the end of the Clinton administration.
Nevertheless, Rep. Dan Burton, R-Ind., chairman of the House Government Reform and Oversight Committee and a longtime ally of the supplement industry, has scheduled a hearing next week to ask FDA Commissioner Jane Henney about her intentions.
The Cantox report examined 19 ephedra studies, and while no single one was considered definitive, the council said the report used a methodology that allowed the daily dosage of 90 milligrams to emerge: "The totality of information showed a consistency that was compelling," said council President John Cordaro.
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