As reported by NutraIngredients-USA in November 2011, the Food and Drug Administration (FDA) filed for a permanent injunction against ATF Fitness Products Inc., Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti, owner and operator of both companies.
The injunction was the first of its kind against a dietary supplement manufacturer of this size for failure to comply with cGMPs. The companies manufacture, package and distribute over 400 dietary supplements.
The Justice Department announced Tuesday that the United States has now entered a consent decree against ATF, MADE, and Vercellotti to cease operations unless and until the FDA re-inspects the businesses and determines they no longer violate the Food, Drug and Cosmetic Act (FDCA).
“Almost by definition, consumers purchase dietary supplements to enhance and improve their health,” said Stuart 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.”
Violations
FDA inspectors found numerous cGMP violations, including a failure to clean manufacturing equipment, a failure to maintain proper records concerning the ingredients of the supplements, and a failure to label their products correctly. The defendants also failed to notify the FDA of possible adverse events involving consumers who used the defendants’ supplements, said the Agency.
“Through this consent decree, we will ensure that the public is protected from purchasing and consuming tainted supplements and misbranded products,” said David 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.