FDA Seizes Synthetic Ephedrine ProductFDA Seizes Synthetic Ephedrine Product
November 2, 2001
ST. GEORGE, Utah--On Wednesday, Oct. 31, U.S. marshals seized 140,000 bottles of a product manufactured with ephedrine hydrochloride (HCl) from Biogenics Inc. (dba 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 and misbranded new drug.
According to FDA, because ephedrine HCl has been approved as a drug, E'OLA's AMP II Pro Drops, which contained the substance, could not be sold as a dietary supplement. FDA's notice also stated that the product was marketed as a treatment for obesity, but "dietary supplements cannot be marketed to treat obesity, a disease." An FDA spokeswoman said that because the case is still open, the agency could not answer further questions about it.
E'OLA issued a statement about the seizure, noting that it had not been given prior warning about the action despite two FDA inspections in the last year. "We have certainly done nothing wrong and we resent the implication of the FDA'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 chosen to make some sort of statement at our expense."
This is the second time in recent weeks that FDA (www.fda.gov) has taken some action against dietary supplements containing drug ingredients. In mid-October, FDA sent warning letters to two manufacturers for including acetaminophen in their products. This is also the second time E'OLA has found itself--and its AMP II Pro Drops--in the media this year. In February, a woman who suffered a stroke after taking the product was awarded $13.3 million in the highest award granted in an ephedra or ephedrine lawsuit.
The American Herbal Products Association (AHPA) issued a letter to its members about the seizure, encouraging any companies that have products containing ephedrine HCl to discuss the issue with legal counsel. Also, "any AHPA member who is marketing any product containing ephedrine HCl is reminded that AHPA's long-standing ephedra trade recommendation prohibits the use of any synthetically derived ephedrine alkaloids, such as ephedrine HCl, in any dietary supplement product."
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