Last Updated: 2002-06-17 9:58:46 -0400 (Reuters Health)

By Maggie Fox

WASHINGTON (Reuters) - In a victory for the food supplement industry, the US government said on Friday it would delay limiting the use of the popular weight-loss supplement ephedra until more studies on its safety were in.

Makers of the popular supplement, also known as ma huang, were quick to praise the action while one consumer group said everyone involved in the decision should be fired.

But Health and Human Services Secretary Tommy Thompson said it was not clear just how dangerous, if at all, ephedra is.

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

"By increasing our breadth of knowledge about these supplements, we can give consumers the information they need to make informed decisions about these products."

He said the RAND corporation, a think-tank, would finish a "comprehensive review" of the studies on ephedra and this would be used as the basis for further study by the National Institutes of Health.

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

"As the FDA 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 spokesperson for one of the makers, Metabolife, said in a statement.

But Public Citizen, which has battled for years to have the products taken off the market, was outraged.

"Today's announcement by HHS, which not only fails to ban ephedra dietary supplements but also fails to seriously warn against the use of these products, should result in the firing of all officials in HHS and the FDA who are responsible for this dangerous cowardice," Dr. Sidney Wolfe, who heads the group health research arm, said.

"By now, there have been well over 100 deaths reported to the FDA in people using ephedra-containing products and, as described in our Sept. 5, 2001, petition to ban these products, there are more reports of death, stroke, arrhythmia, heart attacks, chest pain, seizures and hypertension for ephedra than for all other dietary supplements combined."

If there had been this many problems with a prescription drug, Wolfe said, it would have been taken off the market.

CANADA WORRIED ABOUT EPHEDRA'S SAFETY

In January Health Canada, Canada's equivalent of the FDA, expressed worry about excessive doses of ephedra, also known as ephedrine, and asked makers to voluntarily recall products containing high doses of the supplement.

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

HHS said the FDA was strengthening its adverse event reporting system, under which doctors and consumers are urged to call in with any health problems that could be related to taking a drug or supplement.

The FDA took care to warn that ephedra can be dangerous.

"These products are not for everyone," Deputy FDA Commissioner Dr. Lester Crawford said. "Consumers should read the labels carefully to ensure their proper use."

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

In 1997, the FDA proposed limiting the allowable 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.

HHS also said it would "aggressively pursue" makers of non-herbal synthetic ephedrine products. "As part of these efforts, FDA today sent six warning letters to firms unlawfully selling non-herbal ephedrine-containing products over the Internet," the HHS statement said.

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