FDA Seizes Synthetic Ephedrine Product 39821

FDA Seizes Synthetic Ephedrine Product

ST. GEORGE, Utah--On Oct. 31, U.S. marshals seized 140,000bottles of a product manufactured with ephedrine hydrochloride (HCl) fromBiogenics Inc. (d/b/a E'OLA International) and its contract manufacturer,Nature's Energy Inc., in Pleasant Grove, Utah. The Food and Drug Administration(FDA) requested the seizure, alleging the product was an unapproved andmisbranded new drug.

According to FDA, because ephedrine HCl has been approved as a drug, E'OLA'sAMP II Pro Drops, which contained the substance, could not be sold as a dietarysupplement. FDA's notice also stated that the product was marketed as atreatment for obesity, but "dietary supplements cannot be marketed to treatobesity, a disease."

E'OLA issued a statement about the seizure, noting that it had not been givenprior warning about the action despite two FDA inspections in the last year."We have certainly done nothing wrong and we resent the implication of theFDA's action that we have," said Eileen Harding, E'OLA's (www.eola.com)vice president of operations. "It appears at this point that FDA has chosento make some sort of statement at our expense."

This is the second time E'OLA has found itself--and its AMP II Pro Drops--inthe media this year. In February, a woman who suffered a stroke after taking theproduct was awarded $13.3 million in the highest award granted in an ephedra orephedrine lawsuit.

The American Herbal Products Association (AHPA) issued a letter to itsmembers about the seizure, encouraging any companies that have productscontaining ephedrine HCl to discuss the issue with legal counsel. Also,"any AHPA member who is marketing any product containing ephedrine HCl isreminded that AHPA's long-standing ephedra trade recommendation prohibits theuse of any synthetically derived ephedrine alkaloids, such as ephedrine HCl, inany dietary supplement product."