PITTSBURGH (Legal Newsline) - The Department of Justice announced Tuesday that it has entered a consent decree against a dietary supplement firm requiring it to cease operations until the Food and Drug Administration inspects the company's operations again.
ATF Fitness Products Inc., of Oakmont, PA., and affiliate Manufacturing ATF Dedicated Excellence Inc., as well as the owner and president of both companies, James G. Vercellotti, were enjoined from manufacturing, packaging and distributing over 400 dietary supplements. The companies have allegedly violated the Food, Drug and Cosmetic Act.
The decree was filed in the U.S. Court for the Western District of Pennsylvania in Pittsburgh on Friday. It orders the defendants to "cease operations unless and until the FDA re-inspects the businesses and determines they no longer violate the FDCA."
The decree also requires the defendants to hire an independent expert who will periodically review the company's operations to ensure compliance with the federal regulations.
"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."
The FDA determined there were multiple violations of manufacturing practice standards after an inspection last year. The company allegedly failed to clean manufacturing equipment, did not maintain proper records concerning the ingredients of the supplements, and did not correctly label products. The company also failed to notify the FDA of any adverse reactions to their 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.
ATF had a history of violations and warnings dating to 2001. Because of this history and the current alleged violations, the DOJ asked and received the permanent injunction.
Representatives of ATF did not respond to requests for comment.