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Dietary Supplement Seized Due to Use of Unapproved Drug

© Maggie Herman

At the request of the Food and Drug Administration (FDA), U.S. marshals have seized approximately 140,000 bottles of the dietary supplement Amp II Pro Drops manufactured by Nature's Energy, Inc., and distributed by Biogenics, Inc., doing business as E'OLA International.

According to the FDA the drops are manufactured with a drug called ephedrine hydrochloride (HCl). This ingredient makes the dietary supplement illegal for a handful of reasons. First, it is illegal for dietary supplements to contain drug components. Second, Amp II Pro Drops were marketed as a treatment for obesity, which is defined by the FDA as a disease. However, it is illegal for dietary supplements to be marketed as disease treatments. Finally, because the drops contain a drug, they are subject to FDA's labeling requirements. Thus, the products were misbranded because they did not bear adequate instructions required on drug products.

Ephedrine is an amphetamine-like stimulant that has been linked to various adverse side effects, including high blood pressure and hypertension, heart disease, and diabetes. In addition, although not part of the reasons for the FDA seizure, some experts believe that the risks associated with Amp II Pro Drops are exacerbated by certain ingredients in the drug, such as caffeine and dimethyl amino ethanol.

In February of 2001, an Alaska jury found E'Ola liable for producing an unreasonably dangerous product. Talbert v. E'Ola Prods. Inc., Alaska, Anchorage 3d Jud. Dist. Super. Ct., No. 3AN97-4046-CIVIL, Feb. 7, 2001. There, Talbert, a 34-year-old customer service representative, suffered a stroke after taking the dietary supplement for about two years. The stroke resulted in severe brain injury and Talbert now has sporadic, uncontrollable hand tremors. Talbert sued E'Ola and some of its corporate officers, alleging that the product was unreasonably dangerous because it contained ephedrine. Additionally, she asserted that the company and its officers made material misrepresentations by claiming the product was "all natural" when, in fact, the ephedrine was synthetic. Other charges included a claim that the defendants knew of the health risks but failed to provide appropriate customer warnings and an assertion that the defendants had been informed by state and federal health officials that the substance was dangerous. A jury awarded Talbert $13.3 million, including $12 million in punitive damages-damages that are given to punish defendants for wrongful conduct.

Additionally, the FDA reported that an investigation revealed that E'Ola was purchasing the raw materials used to manufacture Amp II Pro, including the ephedrine HCl. Then, the company contracted with other companies to produce the illegal products before the products were shipped back to E'Ola for distribution.