The United States has entered a consent decree against ATF Fitness Products Inc., Manufacturing ATF Dedicated Excellence Inc. (MADE), and the owner and president of both companies, James G. Vercellotti, the Justice Department announced today. The decree, filed in the Western District of Pennsylvania on March 9, 2012, enjoins the firms and Mr. Vercellotti from violating the Food, Drug and Cosmetic Act (FDCA) in connection with their business of manufacturing, packing and distributing over 400 dietary supplements.
The decree orders the defendants to cease operations unless and until the FDA re-inspects the businesses and determines they no longer violate the FDCA. Additionally, the decree requires the defendants to retain an independent expert to review their production and distribution of supplements to ensure their continued compliance with the law.
“Almost by definition, consumers purchase dietary supplements to enhance and improve their health,” said Stuart F. Delery, Acting Assistant Attorney General for the Civil Division. “The Department of Justice took this action because consumers must, at the very least, be assured that they are buying what they think they are buying, and that the products are safe.”
During an inspection last year by the Food and Drug Administration (FDA), FDA inspectors found numerous current good manufacturing practice (“cGMP”) violations. Inspectors determined that the defendants failed to clean manufacturing equipment, failed to maintain proper records concerning the ingredients of the supplements, and failed to label their products correctly. Additionally, the FDA determined that defendants failed to notify the FDA of possible adverse events involving consumers who used the defendants’ supplements.
“Through this consent decree, we will ensure that the public is protected from purchasing and consuming tainted supplements and misbranded products,” said David J. Hickton, U.S. Attorney for the Western District of Pennsylvania.
The FDA previously inspected the defendant’s facilities, and noted a history of violations and warnings dating to 2001. As a result of the FDA’s findings of recent violations, as well as its findings of a history of unheeded warnings, the Justice Department filed suit, seeking this permanent injunction.
Acting Assistant Attorney General Delery thanked the FDA for referring this matter for litigation, as well as U.S. Attorney Hickton for his office’s assistance with the litigation.