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Despite agreeing to shut down 20 months ago, Quality Formulation Laboratories Inc. (QFL) and American Sports Nutrition Inc. (ASN) continued to produce a variety of protein powder mixes and other dietary supplements sold in health food stores throughout the United States — a form of contempt that U.S. District Court Chief Judge Garrett E. Brown Jr. dubbed unique in its persistence and scope.
“After the FDA found egregious sanitation and manufacturing problems at the defendants’ facility, we obtained a court order requiring the defendants to clean up their act,” said Tony West, Assistant Attorney General of the Civil Division of the Department of Justice. “Instead of complying with that order, the defendants thumbed their nose at it and continued distributing product.
“The court’s appropriately stiff sentences in this case make clear the lesson: If you jeopardize the health and safety of the American people, we will hold you accountable.”
Brown sentenced owner Mohamed S. Desoky to 40 months in federal prison and three years of supervised release, along with a $60,000 fine.
The jude also sentenced manager Ahmad Desoky to 34 months, with three years supervised release and a $12,000 fine. Fellow manager Omar Desoky also got 34 months in prison and three years of supervised release.
Brown also ordered their companies to $1 million in fines and prohibited anyone connected with them from doing business in the dietary supplement industry during the periods of supervised release or probation unless they first obtained consent of the U.S. Food and Drug Administration and a federal judge.
Ahmad Desoky, an attorney, was barred from practicing law during his period of supervised release.
A March 16, 2010 consent decree that staved off more serious charges required that the defendants shut down their manufacturing operation and not reopen there or elsewhere without first correcting the violations and getting the FDA’s approval to reopen.
But they kept on going.
First they set up operations at a separate location in Congers, N.Y., where they took their employees and equipment — without notifying the government. They also “continued receiving, manufacturing and distribution operations at their Paterson. N.J., facility despite the court’s order,” an FDA complaint says. Jurors in June found the men and two others guilty of related charges in both cases.
The prosecution was handled by Department of Justice, Civil Division, Consumer Protection Branch Trial Attorneys David Sullivan and Patrick Runkle, and District of New Jersey Assistant U.S. Attorney Howard Wiener. The FDA Office of Chief Counsel Attorney Shannon Singleton supported the matter, which was investigated criminally by the FDA Office of Criminal Investigations, Jersey City Branch, and civilly by the FDA New Jersey District Office, according to a Department of Justice release issued late Wednesday afternoon.
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