HHS To Investigate Ephedra Safety, Efficacy

WASHINGTON--On June 14, Secretary of Health and Human Services (HHS) Tommy Thompson reported the department will expand its research efforts on ephedrine alkaloids while aggressively pursuing the illegal marketing of non-herbal synthetic ephedrine products.

"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."

The Food and Drug Administration reportedly advised HHS (www.hhs.gov) that adverse event reports (AERs) would not provide a good enough scientific basis for assessing the safety of ephedra products, and there is a need for further research. HHS announced it recently contracted the RAND Corp., based in Santa Monica, Calif., to conduct a comprehensive review of the existing science behind ephedra, especially in dietary supplements. The meta-analysis is expected to be completed by early fall, according to HHS, at which point the National Institutes of Health will use this information to expand its research efforts in better understanding ephedra.

In mid-May, acting deputy director of the HHS, Yvonne Maddox, submitted an HHS 2002 fiscal budget request to President Bush asking for $232.1 million, part of which was earmarked for the Office of Dietary Supplements and other federal centers conduct an evidence-based review on the safety and efficacy of ephedra. HHS also reported that it planned to nominate ephedra to be studied by the National Toxicology Program at the National Institute of Environmental Health Sciences.

One surprising comment made by HHS was that FDA had begun a major effort to strengthen its AER system by incorporating existing reporting systems into a new, unified one to better monitor the safety of all dietary supplements, including ephedra.

"This is interesting news and the first I've heard about it," said Michael McGuffin, president of the American Herbal Products Association (www.ahpa.org). He added that the present system for reporting AERs--the Special Nutritionals Adverse Event Monitoring System, also known as SN/AEMS--does not work, especially since the system allows for nothing more than entering AERs. It does not allow re-entry into the system if the wrong company or even ingredient is attributed to an AER.

In the June statement, Thompson not only encouraged FDA to continue with its plans to improve the current AER system, but also for manufacturers to label ephedra products in a way that would better protect consumer health. "I urge manufacturers to include FDA's 800-MEDWATCH telephone number on their product labels," he advised, adding that this number is an opportunity to support FDA's AER system.

"Sec. Thompson's statement is . commendable for moving the policy discussion on ephedra's safety to a more advanced level," said Wes Siegner, general counsel and spokesperson for the Washington-based Ephedra Education Council (www.ephedrafacts.com). "For too long, this important public safety issue has been stuck in first gear and has looked only at the collected AERs."

In addition, HHS reported that six warning letters were sent June 14 by FDA to companies illegally selling products promoting weight loss, suppressed appetite and enhanced libido containing non-herbal ephedrine or norephedrine hydrochloride over the Internet. FDA also sent a letter to a company for unlawfully promoting an ephedrine product as an alternative street drug. The companies must inform FDA within 15 days about how they will correct these violations. Because the letters were just sent, the companies' names were not disclosed.

"We have long advocated for the removal of synthetic ephedrine [in dietary supplements] and illegal products promoted to children as street drug alternatives, such as those marketed as herbal ecstasy, magic mushroom and primal rush," Siegner said.

According to San Diego-based Metabolife, a manufacturer of weight-loss products containing ephedra, Thompson's words today were a positive message for the industry. "We are pleased the HHS is conducting additional scientific research of herbal ephedra-based products . to add to those studies that have been done, showing that when taken as directed, these products are safe and effective for weight loss."

AHPA commended HHS's announcement as a positive and informed response to the current issues surrounding ephedra. "It's satisfying to see the government is essentially saying that the stand the industry has taken is sound," McGuffin said.