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Herbals to get closer look from FDA.

WASHINGTON -- In the wake of his decision to ban the weight-loss supplement ephedra, Food and Drug Administration Commissioner Mark McClellan has vowed that the agency will increase its scrutiny of the herbal supplements business.

"While most supplements are probably safe in the close people take them, we are concerned about a number of dietary supplements that are currently on the market," McClellan said in a speech in Mississippi late last month. "And we intend to do more to take a closer look at them."

He noted that the FDA will examine the health benefits of several supplements and would release new manufacturing and labeling regulations later this year.

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

Many of the substances the FDA is expected to pay close attention to are being suggested as possible substitutes for ephedra.

Included among the products that will almost surely face increased scrutiny are bitter orange, or citrus aurantium; usnic acid; and aristolochic acid. All three have been used as weight-loss aids, while aristolochic acid has also been used to alleviate gastrointestinal and other health problems.

Among the steps that the FDA will take, McClellan indicated, is more aggressive gathering of the data it needs to determine if a supplement poses serious health risks.

He noted that the agency will go beyond the anecdotal evidence it has relied on in the past and seek out data from other sources, including pharmacological and clinical evidence and long- and short-term studies.

McClellan's speech was praised by many in the supplements industry who say that the weeding-out of poorly manufactured items and suspect ingredients will benefit the business and ensure consumers' safety.

"The FDA's action will be a real benefit," says Greg Andrews, director of Pharmavite Corp.'s Nature Made division. "Ensuring that only safe, quality-made supplements reach the market will only strengthen the industry."

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Title Annotation:Vitamins/Nutrition
Comment:Herbals to get closer look from FDA.(Vitamins/Nutrition)
Publication:Chain Drug Review
Geographic Code:1USA
Date:Feb 16, 2004
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