U.S. to Expand Research on Ephedra as Weight-Loss Supplement

A new effort to expand research on the safety of ephedrine alkaloids (ephedra) used in weight loss supplements, and to aggressively pursue the illegal marketing of non-herbal synthetic ephedrine alkaloid products, has been announced by Tommy G. Thompson, Secretary of the U.S. Department of Health and Human Services.

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

The RAND Corporation, on behalf of HHS, will conduct a comprehensive review of the existing science on ephedrine alkaloids including those used in dietary supplements. The review is slated to be complete by early fall 2002. The National Institutes of Health (NIH) will use this information to conduct expanded research to better understand the safety of the supplement.

Herbal ephedra is marketed in the United States in weight loss, energy and sports supplements. The supplement is made from active chemicals found naturally in a variety of plants, including the Ephedra species, but can also be produced synthetically.

Adverse effects from ephedra have been reported to the U.S. Food and Drug Administration, raising questions about the safety of the products. However, the FDA has advised that these adverse event reports do not provide a scientific basis for assessing the safety of the products and there is a need for more research.

"I urge manufacturers to include FDA's 1-800-MEDWATCH telephone number on their product labels," said Thompson. "Consumers can use the Medwatch number to report adverse events."

Thompson also announced new efforts to aggressively go after the illegal marketing of non-herbal ephedra supplements. The FDA has sent six warning letters to companies unlawfully selling non-herbal ephedra-containing products over the Internet.

Six letters also went to manufacturers of products that contain the drug ephedrine or norephedrine hydrochloride (a synthetic version of ephedra) labeled as dietary supplements for use in weight loss and suppression of appetite. These products violate the law as they are not legal dietary supplements and are illegal drugs.

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

Other sources: U.S. Department of Health and Human Services