FDA, DOJ Take Action Against Three Protein Supplement Makers

NEWARK, N.J.Three New Jersey-based dietary supplement manufacturers are facing a government-mandated halt to operations until they come into regulatory compliance, following FDA enforcement action. The U.S. Department of Justice (DOJ), acting on the agencys behalf, filed a complaint on July 1 in U.S. District Court of New Jersey for permanent injunction against Quality Formulation Laboratories Inc., American Sports Nutrition Inc. and Sports Nutrition International LLC. The Paterson, N.J.-based firms manufacture dietary supplements and protein powders, which are distributed throughout the United States and sold internationally under private label brands.

FDA is seeking a court order to stop the companies from manufacturing and distributing products until it corrects manufacturing deficiencies noted during agency inspections of the operations. Among the cited concerns are failure to follow cGMPs (current good manufacturing practices), labeling problems including not disclosing major food allergens, and storage of food in filthy conditions.

In response to INSIDER's request for comment, Mohamad Desoky, CEO of Quality Formulation Laboratories, said the company has been working to resolve FDA's concerns and has been in negotiations with the agency for several months. He said he expects the company and FDA to reach a final settlement in the next few weeks.