Excerpted from CNN, Friday, 14 June 2002.

HHS Cracks Down On Ephedra Sales

Washington, Saundra Young, CNN Medical Unit -- Health and Human Services Secretary Tommy Thompson announced plans Friday to study the controversial dietary supplement ephedra and to crack down on the illegal marketing of non-herbal synthetic ephedrine alkaloid products.

The department announced that it had recently funded a comprehensive review of the existing science on ephedra -- particularly those in diet supplements -- to be conducted by the RAND Corp. The review is expected to be finished by early fall and is intended to clarify what HHS knows about ephedra dosages, use, and possible harmful effects.

The National Institutes of Health will then use this information to guide an expanded research effort to better understand the safety of ephedrine alkaloids.

"It is crucial that we have a full understanding of these dietary supplements," Thompson said. "By increasing our breadth of knowledge about these supplements, we can give consumers the information they need to make informed decisions about these products."

Ephedra is commonly sold in the United States as a product to enhance weight loss, increase energy and enhance sports performance.

Ephedrine alkaloids are active chemicals found naturally in a number of plants, but can also be produced synthetically. Non-herbal synthetic ephedra compounds are illegal in the United States because they are not legal dietary supplements, but illegal drugs.

HHS also announced it sent six warning letters to companies unlawfully selling non-herbal ephedra products over the Internet as part of its new effort to cracking down on these drugs.

Last October, the FDA had U.S. marshals seize $2.8 million worth of a non-herbal synthetic ephedra, marketed as a dietary supplement.

"This action is yet another example of HHS's strong commitment to protecting the public from the dangers of unlawfully marketed drug products" Thompson said.

Last fall, Dr. Sidney Wolfe and his group, Public Citizen, filed a complaint with the FDA, charging that the product should be pulled from the market because of reports of adverse events related to the dietary supplements containing ephedra. Wolfe blasted the announcement Friday.

"Today's announcement by the Department of Health and Human Services, which not only fails to ban ephedra dietary supplements but also fails to seriously warn against the use of these, should result in the firing of all officials in HHS and the Food and Drug Administration who are responsible for this dangerous cowardice," Wolfe said.

But the FDA has said that the adverse event reports alone do not provide a basis for halting sales of the products, and they called for further scientific research.

Dr. Lester M. Crawford, deputy commissioner of the FDA, said consumers should read the labels carefully to ensure their proper use.

"Although warning labels appear on many of these products, adult consumers need to consult their health care provider if they have a history of high blood pressure, if they have current or previous history of high blood pressure, heart or thyroid disease, a seizure disorder, depression, diabetes, difficulty urinating, prostate enlargement, glaucoma, or are using any prescription drug," he said. Crawford warned pregnant or nursing women should not use these products.

Industry representatives applauded the FDA's action.

"We are pleased that the HHS is conducting additional scientific research of herbal ephedra-based products," said Jan Strode, a spokesperson for Metabolife, a dietary supplement used for weight control. "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."

Metabolife has been an advocate for regulation at the state and federal levels that includes safe serving limits, a ban on marketing and sales to minors and strong warning labels.

Excerpted from CNN, Friday, 14 June 2002.