On the heels of its announced ban last month of the diet supplement ephedra, the Food and Drug Administration plans to become much more aggressive in gathering safety evidence about other dietary supplements it views as potentially harmful, FDA commissioner Mark McClellan suggested in a wide-ranging speech Tuesday.
McClellan, speaking at the University of Mississippi School of Pharmacy, named three ingredients in weight-loss products that are already being tracked: bitter orange, aristolochic acid and a lichen derivative called usnic acid.
The FDA announced last month that it plans to prohibit sales of ephedra, which has been promoted for weight loss, enhanced sports performance and increased energy. The stimulant has been linked to about 16,000 adverse reactions, including strokes, heart attacks and irregular heartbeats. The FDA said as many as 155 deaths also have been linked to ephedra. The ban should go into effect this spring; if it stands up to expected court challenges, it could provide a model for similar bans.
Bitter orange has been used as a replacement for ephedra in weight-loss products. Aristolochic acid, from the plant aristolochia, also has been included in weight-loss preparations. It is a potential carcinogen and has been associated with permanent kidney damage. Usnic acid is a component of Lipokinetix, a dietary supplement that has been associated with serious liver toxicity.
December's ephedra announcement was the first time FDA has moved against a supplement since a 1994 law was passed that holds supplements to a different standard than new drugs, which must go through large-scale safety and effectiveness studies. The law says the FDA can move to block sales of a supplement only if it can prove they ''present an unreasonable risk to health.''
But by later this year, ''the public will not be faced with 'buyer beware' any longer,'' McClellan said Tuesday.
In his speech at the University of Mississippi, McClellan said the agency plans to issue a rule that will lay out a framework for determining whether a dietary supplement presents such a risk. A senior FDA spokesman said the announcement might come as early as next week.
McClellan called for more partnerships with universities and researchers to create the science that will allow the FDA ''to take more effective steps to make sure that dietary supplements that people take are safe and have benefits that outweigh their risks.''
John Hathcock of the Council for Responsible Nutrition, a supplement industry group, says he is impressed with the steps McClellan is taking. ''It's also important to recognize that this is the first time ever that they are attempting to ban a dietary supplement, which says to us that dietary supplements are abundantly safe.''
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