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FDA Files Permanent Injunction Against Pennsylvania Supplement Company

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By: Sean Moloughney

Editor, Nutraceuticals World

FDA has taken legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The permanent injunction, filed on behalf of FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act.

This is the first time FDA has taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement current Good Manufacturing Practice (GMP) regulations. The GMPs for dietary supplements went into effect in 2007, in a phased process based on company size. This company’s compliance date came into effect in 2010, and it did not meet the relevant GMP requirements after that date, according to FDA. The agency requested the permanent injunction against ATF Fitness Products Inc. (ATF), Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James Vercellotti of Oakmont, PA, owner and operator of both companies. The GMP regulations require manufacturers to ensure quality in their dietary supplements by controlling all aspects of their processes and procedures.

MADE makes more than 400 dietary supplements, including vitamins and minerals, under the brands “Sci-Fit,” “Nature’s Science” and “For Store Only.” ATF purchases dietary supplements exclusively from MADE and distributes them throughout the U.S. The government’s complaint, filed Nov. 23, 2011, in the U.S. District Court for the Western District of Pennsylvania, alleges that in addition to “adulterating” and “misbranding” final products, the manufacturer and its owner failed to report serious adverse events associated with their products. In one case an individual who consumed one of the products reportedly experienced a spike in blood pressure, hospitalization and a subsequent mild heart attack.

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