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FDA Slams ATF for cGMP Violations
November 23, 2011
2 Min Read
WASHINGTONThe U.S. Department of Justice filed a permanent injunction against ATF Fitness Products Inc., Manufacturing ATF Dedicated Excellence Inc. (MADE) and James G. Vercellotti, owner and operator of both companies, for substituting ingredients and products without noting the changes on the final product labels. The injunction, filed on behalf of FDA, would stop ATF from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act.
The government's complaint, filed Nov. 23, 2011, in the U.S. District Court for the Western District of Pennsylvania, alleged that in addition to adulterating" and misbranding" 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.
FDA this is the first time the agency has taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement cGMP(current good manufacturing practice) regulations. However, this is not the first time ATF has faced regulatory issues.
In January 2001, ATF voluntarily recalled a product it was distributing that contained tiratricol, a thyroid hormone that may cause insomnia, nervousness, sweating, diarrhea, stroke or heart attacks. The product, BioPharm brand T-Cuts, was only on the market for 10 days before the Food and Drug Administration (FDA) asked ATF to issue the recall.
In January 2005, FDA issued a warning letter to ATF regarding dietary supplements containi/ng ephedra, which the company claimed were exclusively for export; however, the agency claimed there was no export documentation available and requested ATF inform the agency of how it intends to dispose of the products.
In March 2005, U.S. Marshals seized $13,000 worth of ephedra-containing products from ATF, following an FDA investigation that involved numerous discussions between the agency and ATF for a few months after the warning letter.
In January 2006, FDA, in conjunction with the U.S. Attorney Generals Office in western Pennsylvania, authorized the seizure of the dietary supplement Lipodrene from ATF. The raid involved five unlabeled boxes containing various quantities of 100-tablet Lipodrene bottles labeled with a recommended dose of 50 mg/d ephedrine alkaloids. According to FDA, the total amount seized was valued at approximately $17,000.
MADE currently makes more than 400 dietary supplements, including vitamins and minerals, under the brands Sci-Fit," Natures Science" and For Store Only." ATF purchases dietary supplements exclusively from MADE and distributes them throughout the United States.
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