In the first move of its kind against a sizable dietary supplement manufacturer, the U.S. Food and Drug Administration (FDA) filed for the permanent injunction of two companies and their corresponding owner. Subsequently, the United States has entered a consent decree that would force ATF Fitness Products Inc., Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti to cease operations following numerous current good manufacturing practice (cGMP) violations.
While attending Penn State University in 1991, James Vercellotti established ATF Fitness Products. Since its induction into the dietary supplement industry, ATF Fitness Products has supplied consumers with approximately 400 products under trademarked names such as Sci-Fit and Nature’s Science. Their products benefit everyone from the competitive bodybuilder to the hard working mothers of America. As a result, the company has witnessed a success that has transformed them into an international dietary supplement manufacturer found in 13 countries.
Similar to that of ATF Fitness Products is another one of Vercellotti’s dietary supplement companies. Manufacturing ATF Dedicated Excellence, Inc. was established once ATF Fitness Products became a success. The satellite company simultaneously develops and markets dietary supplements for people in all walks of life.
However, recent months have witnessed each of Vercellotti’s companies become the subject of government action. On March 9, 2012, Judge Arthur Schwab in the Western District of Pennsylvania signed a consent decree of permanent injunction. The consent decree was in response to numerous cGMP violations. According to FDA inspectors, Vercellotti’s companies failed to do the following: clean manufacturing equipment, maintain proper records concerning the ingredients of their supplements and label their products correctly. In addition to the cGMP violations, the defendants also failed to notify officials at the FDA of possible adverse events involving consumers.
“Dietary supplements have a significant role in the public’s health,” said Dara Corrigan, associate commissioner for regulatory affairs. This “injunction reinforces our commitment to ensuring that these supplements meet the cGMP requirements the law establishes.”
According to an FDA News Release, The consent decree prohibits ATF Fitness Products and Manufacturing ATF Dedicated Excellence from manufacturing, preparing, packing, labeling or distributing any dietary supplement until they have completed FDA-approved measures to correct deficiencies and comply with the law. The company must also hire an outside quality control expert until FDA is satisfied that the company’s manufacturing procedures ensure a safe product. The firm may not resume operations until it receives permission to do so from the FDA.
Complicating the already ambiguous situation, is a history of violations at the defendant’s facilities. The FDA today took legal action against a dietary supplement maker and owner in 2011 for substituting ingredients and products without noting the changes on the final product labels. 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” their 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 reported experiencing a spike in blood pressure, hospitalization and a subsequent mild heart attack.
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