This is the first time FDA has taken legal action against a dietary supplement manufacturer (ATF Fitness Products) of this size for failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations.
The cGMPs for dietary supplements went into effect in 2007, in a stepped process based on company size. ATF Fitness Products compliance date came into effect in 2010, and ATF Fitness Products did not meet the relevant cGMP requirements after that date.
The FDA requested the permanent injunction against ATF Fitness Products Inc. (ATF), Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti of Oakmont, Pa., owner and operator of both companies.
The bottom line?
The government’s complaint 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.
The company’s product lines and individual offerings are listed here.
John Russo, Jr., PharmD, is president of The MedCom Resource, Inc. Previously, he was senior vice president of medical communications at www.Vicus.com, a complementary and alternative medicine website.