Consumer Group Asks FDA to Seize Synthetic Ephedrine 'Supplements'

Consumer Group Asks FDA to Seize Synthetic Ephedrine 'Supplements'

WASHINGTON--Ralph Nader's consumer group asked the Food and Drug Administration (FDA) to seize products labeled as dietary supplements that contain a synthetic form of ephedrine. Public Citizen (www.publiccitizen.org) sent a letter to Tommy Thompson, secretary of Health and Human Services, regarding 10 products containing synthetic ephedrine being marketed on the Internet by nine manufacturers as dietary supplements.

The letter asked FDA to seize the products as unapproved new drugs because they contain synthetic ephedrine alkaloids. FDA has taken action against these types of products before, most recently against E'Ola International. (For more on that story, seewww.naturalproductsinsider.com/articles/1c1govn4.html.)

In its letter to Thompson, the group noted using synthetic compounds in dietary supplements is expressly prohibited by FDA's Food, Drug and Cosmetic Act. The group also referenced a letter sent to Rep. Henry Waxman (D-Calif.) from Melinda Plasier, FDA's associate commissioner for legislation, that FDA has concluded products containing synthetic ephedrine alkaloids are not dietary supplements and should be regulated as drugs.

After the December E'Ola seizure, the American Herbal Products Association (AHPA) issued a reminder that "AHPA's long-standing ephedra trade recommendation prohibits the use of any synthetically derived ephedrine alkaloids in any dietary supplement product."

This echoes the position of other dietary supplement industry associations. Diane McEnroe, legal counsel for the National Nutritional Foods Association (NNFA), noted that the industry's ephedra guidance promotes the use of natural source ephedra from ma huang and not synthetically derived ephedrine alkaloids or their salts.