FDA Seeks Injunction for GMPs Incompliance

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WholeFoods Magazine Staff
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In late November, the U.S. Department of Justice (on behalf of the U.S. Food and Drug Administration [FDA]) filed a permanent injunction request against a Pennsylvania supplement maker for failing to comply with its good manufacturing practices (GMPs) regulations. According to a press statement, this is the first time the agency has taken action like this against a supplement manufacturer of this size.

Injunctions are sought against ATF Fitness Products Inc. (ATF) and Manufacturing ATF Dedicated Excellence, Inc. (MADE) as well as their owner/operator James G. Vercellotti of Oakmont, PA. ATF is considered a small supplement maker, with fewer than 20 employees; this size supplement manufacturer was bound to comply with FDA’s GMP regulations by June 2010. According to FDA, the firm did not. It believes ATF/MADE products were adulterated and misbranded; the company also allegedly failed to file a serious adverse event report after a consumer experienced a mild heart attack after taking its product.

This incident is not the first of ATF’s/MADE’s troubles with FDA. In 2006, the agency seized five unlabeled boxes of Lipodrene bottles from ATF, which contained 50 mg of ephedrine alkaloids. FDA says these adrenaline-like substances pose a danger to the heart and cannot be used in legal dietary supplements.

ATF and MADE sell more than 400 products under the brands Sci-Fit, Nature’s Science and For Store Only.

Published in WholeFoods Magazine, January 2012