ATF Agrees to Injunction

PITTSBURGHATF Fitness, based in Oakmont, Pa., has entered a consent decree with the federal government, agreeing to cease manufacturing and destroy products that are adulterated or misbranded. The agreement, which was submitted to federal court in Pittsburgh by both ATF and the Department of Justice (DOJ), also stipulates ATF will take on an expert consultant to help the company to bring its quality control to standard, including complaint-handling, recordkeeping and other aspects of manufacturing.

FDA slammed ATF over cGMP (current good manufacturing practice) violations, including for substituting ingredients and products without noting the changes on the final product labels and failing to report serious adverse events (SAERs) associated with its products. On behalf of FDA, DOJ filed for an injunction against  ATF Fitness Products Inc., Manufacturing ATF Dedicated Excellence Inc. (MADE) and James G. Vercellotti, owner and operator of both companies, in U.S. District Court for the Western District of Pennsylvania on Nov. 23, 2011. It was the first time the agency had taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement GMPs. (Note: FDA spoke on the topic of GMP inspections and compliance at SupplySide West in November 2011; the video of the presentation is available online.)

This is a the latest episode in a long series between FDA and ATF.  In 2001, the company voluntarily recalled its BioPharm T-Cuts products only 10 days after hitting the market, after FDA found the product contained the thyroid hormone tiratricol, which can cause side effects such as nervousness, stroke or heart attack. ATF received a warning letter from FDA in early 2005 for supplements found to contain ephedra. The company said the products were exclusively for export, but FDA found no export documentation. Later in 2005, U.S.Marshals seized $13,000 worth of ephedra-containing products from ATF after months of talks. Then in early 2006, FDA seized $17,000 worth of ATF's Lipodrene supplement, including  five unlabeled boxes containing various quantities of 100-tablet Lipodrene bottles labeled with a recommended dose of 50 mg/d ephedrine alkaloids.