A Utah company has agreed to a federal settlement prohibiting it from making or selling drugs containing ephedrine in the guise of dietary supplements.
U.S. marshals raided E’Ola International’s offices last fall and seized $2.8 million worth of the company’s AMP II Pro Drops. The product, advertised as a weight-loss aid, contained ephedrine hydrochloride, a chemical long regulated by the Food and Drug Administration as a drug.
Federal law prohibits drugs from being sold as dietary supplements; nor does the Food and Drug Administration allow supplements to be marketed as obesity treatments.
Ephedra, also known as ma huang, is the herbal form of the chemical ephedrine, a stimulant sometimes used in decongestants. Ephedra-containing dietary supplements are popular but highly controversial because of concern that certain doses may cause heart attacks and other side effects.
The FDA hasn’t taken action against straight-herbal ephedra.
But Monday’s consent decree with E’Ola “is a big signal” that companies cannot sell synthetic ephedrine in the guise of herbal ephedra, said John Taylor, FDA’s enforcement chief.
“People have masqueraded behind the claim that their product was a pure ma huang product,” he said. “It’s a signal … that we indeed are concerned about products that are promoted as dietary supplements that are actually unlawfully marketed drug products.”
Officials with the St. George, Utah, company did not return calls seeking comment. The consent decree gives FDA the authority to order E’Ola to quit marketing and recall any ephedrine products sold as supplements. Also, E’Ola will destroy the AMP II Pro Drops seized last fall, the FDA said.