FDA Prohibits PA Firm from Distributing Supplements Violating Good Mnf. Practices
On November 23, the Food and Drug Administration took 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 the…
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FDA by the U.S. Department of Justice, would stop the defendants (ATF Fitness Products Inc., Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti of Oakmont, Pa., owner and operator of both companies) from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act. According to the FDA, this is the first time it has taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations.