Ephedra Hearing Inspires Comment From Industry

Ephedra Hearing Inspires Comment From Industry

WASHINGTON--The public hearings on ephedrine alkaloids held here Aug. 8 and 9 came to a close and drew comment from the industry. The meetings were not designed to discuss any regulatory changes; rather, they were a forum for those wishing to express views on both sides of the ephedra issue. They focused on determining the risk involved in using ephedra products.

Topics that were addressed included exploring ephedra's traditional medical use, using ephedra for weight loss and exercise enhancement and combining ephedra with other stimulants. In addition to the discussions, 140 new adverse event cases were reviewed by the panel.

It was said by some at the meeting that the Adverse Event Reports (AERs) brought before the panel may have been the result of consumers that either use ephedra products incorrectly or who have pre-existing medical conditions. Others noted that the total number of AERs considered by the panel [273] is small compared to the number of consumers using ephedra products [reportedly more than 3 billion doses annually]. "There is really no correlation between the serious side effects--I'm talking about death and stroke--that can be attributed solely to the ephedra-containing dietary supplement," said Dr. Norton Page, a spokesperson for the Ephedra Education Council (EEC), as well as a veterinarian and toxicologist.

Others took a different view. "Clearly, adverse effects of ephedrine alkaloids can be serious, and indeed, fatal," said Dr. George Ricaurte of the Johns Hopkins University School of Medicine.

The Consumer Healthcare Products Association (CHPA) cited several efforts underway to increase the knowledge base on ephedra, including studies conducted by Harvard Medical School, Columbia Presbyterian Hospital and the Council for Responsible Nutrition.

The EEC presented a number of its findings as well. It found no association between the use of dietary supplements containing ephedrine alkaloids and serious AERs. Page also stated that 73 percent of the 273 AERs are missing data that is essential for proving causality.

Several industry organizations, including the American Herbal Products Association (AHPA), made recommendations for regulation of ephedra. AHPA's recommendations were based on trade guidelines AHPA and its members adopted several years ago.

"We may finally have arrived at the time for finalizing the appropriate, science-based rulemaking for supplements that contain ephedra and extracts of ephedra," said Michael McGuffin, AHPA president. During the meeting, McGuffin offered testimony that explained the data and observations made by AHPA regarding ephedra supplements; it specifically detailed the Ephedra Survey that AHPA conducted earlier in the year.

For the full text of McGuffin's address, visitwww.ahpa.org.Visit www.chpa-info.org,www.nnfa.org, www.ephedrafacts.orgor www.fda.gov for additional information.