News Briefs: U.S. marshals seize unapproved drug for FDA
December 1, 2001
News Briefs: U.S. marshals seize unapproved drug for FDA
Under orders from the Food and Drug Ad-ministration (FDA), U.S. marshals seized unapproved weight-loss supplements containing ephedrine hydrochloride from Biogenics Inc. of St. George, UT, doing business as E’OLA International and at its contract manufacturer, Nature’s Energy Inc. of Pleasant Grove, UT.
About 140,000 bottles of AMP II Pro Drops, valued at $2.8 million, were seized. The finished products contain ephedrine HCl, classified as a drug, and were labeled as a dietary supplement for use in weight loss. FDA officials say this is in violation of the law because drug ingredients are prohibited in dietary supplements. The FDA said its 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 shipped the finished product back to E’OLA for distribution.
Ephedrine HCl has been approved as a drug by the FDA since 1948, and the agency said it cannot be marketed legally as a dietary supplement. Also, E’OLA marketed AMP II Pro Drops as a treatment for obesity, contrary to regulations that prohibit the marketing of dietary supplementary supplements to treat a disease, the FDA said in a written statement. These products also are misbranded because their labeling fails to bear adequate directions for use as is required of all drug products, according to the FDA.
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