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http://www.nytimes.com/2002/06/18/health/18SHEL.html

No Limit, for Now, on a Dieting Supplement

By REUTERS

ASHINGTON, June 17 (Reuters) — In a victory for the food supplement industry, the government has decided to wait for further studies of the popular weight-loss supplement ephedra before deciding whether to limit its use.

Makers of the popular supplement, also known as ma huang, praised the action while a consumer group said everyone involved in the decision should be fired.

But Tommy G. Thompson, secretary of health and human services, said it was not clear whether ephedra is dangerous.

"It is crucial that we have a full understanding of these dietary supplements," Mr. Thompson said in a statement.

He said that the RAND Corporation, a research organization, would finish a "comprehensive review" of the studies on ephedra and that this would be the basis for further study by the National Institutes of Health.

Makers of the supplement have insisted for years that their product is safe when taken as directed. Ephedra supposedly increases metabolism and can raise the heart rate. It is similar to the pseudoephedrine used in over-the-counter cough, cold and allergy products.

"As the F.D.A. has advised, adverse event reports alone regarding ephedrine-containing dietary supplements do not provide a scientific basis for assessing the safety of these products," Jan Strode, a spokesman for one maker of the supplement, Metabolife, said in a statement.

But Public Citizen, a consumer group that has tried for years to have the products taken off the market, expressed outrage. The announcement "not only fails to ban ephedra dietary supplements but also fails to seriously warn against the use of these products," said Dr. Sidney M. Wolfe, director of the group's health research arm. He added that officials "responsible for this dangerous cowardice" should be fired.

In January, Health Canada, Canada's equivalent of the Food and Drug Administration, expressed concern about excessive doses of ephedra, also known as ephedrine, and asked makers to recall products containing high doses.

The Mayo Clinic Proceedings published a study in January that reviewed reports from 1995 to 1997 about adverse reactions to ephedra and found some serious reactions even at recommended doses. The study found 11 sudden deaths, 16 strokes and 10 heart attacks in patients who took products containing ephedrine.

The Department of Health and Human Services said the F.D.A. was strengthening its system for encouraging doctors and consumers to report any health problems possibly related to a drug or supplement.

"These products are not for everyone," said Dr. Lester Crawford, deputy commissioner at the food and drug agency.

No one under 18 should take ephedra, nor should pregnant women, nursing mothers, people taking certain drugs or patients with diabetes, glaucoma or heart disease.

In 1997, the food and drug agency proposed limiting doses of ephedra and taking other steps to restrict its use. It withdrew the proposals in 2000 after industry groups and a Congressional audit said they were not supported by scientific evidence.

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