FDA plans more scrutiny of supplements

January 21, 2004

http://edition.cnn.com/2004/HEALTH/diet.fitness/01/20/fda.supplements/

From Scott SpoerryCNNfn

Wednesday, January 21, 2004 Posted: 1520 GMT (11:20 PM HKT)

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WASHINGTON (CNN) -- The Food and Drug Administration is planning to move beyond its recent actions on ephedra and step up its scrutiny of the health effects of various other herbal supplements, a top federal health official said Tuesday.

In a speech in Mississippi, FDA Commissioner Mark McClellan said new manufacturing and labeling regulations for dietary supplements will be released later this year.

"When these regulations are finalized later this year, the public will not be faced with 'buyer beware' any longer," McClellan said.

McClellan cited substances called bitter orange, aristolochic acid and usnic acid, which are ingredients in weight-loss products.

According to McClellan, the three products have been associated kidney and liver problems.

In his speech, McClellan said most supplements are probably safe in reasonable doses, but he said he is concerned about a number of supplements on the market.

McClellan said the FDA intends to look closer at a number of such supplements.

The new ephedra rules, which will published in coming weeks, will serve as a model for evaluation of other supplements, according to McClellan's speech.

The pending ban on products containing ephedra, announced December 30, marks the first time U.S. officials have blocked the sale of an over-the-counter nutritional supplement. (Full story)

Unlike drugs, dietary supplements do not have to be proved safe before going on the market, but federal authorities can act to take them off the shelves if they are shown to be unsafe.

Ephedra is an herbal supplement found in various over-the-counter products designed to help people lose weight or increase their energy, and has long been the subject of criticism.

In February, a medical examiner said an ephedra supplement was linked to the death of Baltimore Orioles pitcher Steve Bechler.

A study commissioned by the National Institutes of Health also called into safety the use of ephedra, saying it was associated with higher risks of heart palpitations, tremors and insomnia.

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