Utah Co. Settles Diet Drug Case

Source: The Associated Press

According to an Associated Press article, a Utah company has agreed to a federal settlement prohibiting it from making or selling drugs containing ephedrine in the guise of dietary supplements.

According to an October 2001 FDA talk paper, United States Marshals seized unapproved drug products from Biogenics Inc., of St. George, Utah, doing business as E'OLA International, and at its contract manufacturer, Nature's Energy, Inc., of Pleasant Grove, Utah. About 140,000 bottles of AMP II Pro Drops valued at $2.8 million was seized.

The United States Marshals seized finished drug products, known as AMP II Pro Drops, and the bulk ephedrine hydrochloride (HCl) used in its manufacture. The finished products contain a regulated drug, ephedrine HCl, but were labeled as a dietary supplement for use in weight loss, a violation of the law since drug ingredients are prohibited in dietary supplements. Full text of the FDA talk paper can be found at:

Federal law prohibits drugs from being sold as dietary supplements, and the FDA does not allow supplements to be marketed as obesity treatments.

Ephedra, also known as ma huang, is the herbal form of the chemical ephedrine, a stimulant used in decongestants. Ephedra-containing dietary supplements are popular but controversial and very much in the media spotlight.

Although the FDA hasn't taken action against straight-herbal ephedra, there are fears and signs that some action may be forthcoming.

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