U.S. Food and Drug Administration

 FDA Talk Paper,  October 31, 2001

U.S. Marshals Seize Unapproved Drug in FDA Case

At the request of the Food and Drug Administration (FDA), the 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 drug, ephedrine HCl, but are labeled as a dietary supplement for use in weight loss. It is in violation of the law because drug ingredients are prohibited in dietary supplements.

FDA inspections of E'OLA revealed that the firm purchased raw materials and ephedrine HCl, had other firms produce Amp II Pro Drops on contract, and then ship the finished product back to E'OLA for distribution.

Ephedrine HCl has been approved as a drug by FDA since 1948 and, therefore, cannot be legally marketed as a dietary supplement.

In addition, E'OLA marketed AMP II Pro Drops as a treatment for obesity. Dietary supplements cannot be marketed to treat obesity, a disease.

These products are also misbranded because their labeling fails to bear adequate directions for use as is required of all drug products.

The text in this article was prepared by the FDA Office of Public Affairs.