Inspections, Compliance, Enforcement, and Criminal Investigations
June 2, 2011: Two New Jersey Dietary Supplement Companies and their Principals Found Guilty of Criminal Contempt
WASHINGTON – A Trenton, N.J., jury Wednesday found Paterson, N.J.-based dietary supplement companies Quality Formulation Laboratories Inc. and American Sports Nutrition Inc., as well as their owner, Mohamed S. Desoky, and managers Ahmad Desoky Esq. and Omar Desoky, guilty of multiple counts of criminal contempt of court for violating a consent decree, the Justice Department announced today. The decree was entered by the U.S. District Court for the District of New Jersey on March 16, 2010. The decree, which resolved a civil action filed by the Justice Department as the result of an investigation by the Food and Drug Administration (FDA), mandated Mohamed S. Desoky and the two companies shut down all manufacturing and distribution activities of food products.
The defendants’ businesses manufactured and distributed food products and supplements, including many varieties of protein powder mixes, as well as other powder mixes and dietary supplements. The products were distributed under the American Sports Nutrition brand and many other private labels to locations throughout the United States.
The complaint in the civil case that led to court order alleged that the defendants, which included Mohamed S. Desoky, Quality Formulation Laboratories Inc., and American Sports Nutrition Inc., adulterated food by manufacturing it without following FDA’s regulations regarding current good manufacturing practice (CGMP) requirements, and causing the adulteration of food by preparing it under insanitary conditions whereby it may have become contaminated with filth (as a result of rodent activity) or may have been rendered injurious to health (as a result of cross-contamination with a major food allergen).
The complaint alleged that the defendants caused misbranding of food because the food contained a major food allergen (milk) not declared on the product labels. The civil complaint went on to allege that defendants’ failure to have adequate sanitizing and cleaning operations and follow their own procedures for manufacturing products on dedicated equipment, may have led to food being contaminated with this major food allergen by virtue of "cross-contamination" or "cross-contact" in the manufacturing process. The civil complaint alleged that during an FDA inspection of the defendant’s facility in December 2008 and January 2009, FDA investigators observed a dead rodent - cut in half- on a blender motor platform; a dead rodent, surrounded by rodent excreta pellets in an area used to store near-finished product; and, on two occasions, a live rodent running through the blending room. Additionally, the complaint alleged that investigators observed bags of raw ingredients that were gnawed through by rodents and covered in rodent urine and excreta pellets.
The consent decree that settled the civil action required that defendants shut down their manufacturing operation and not reopen there or elsewhere without first correcting these violations and getting FDA’s approval to reopen. The criminal contempt charges alleged that Ahmad Desoky and Omar Desoky, with knowledge of the court’s order, assisted their father, Mohamed S. Desoky, in violating the order, and thus were criminally liable for the violations even though they were not named as defendants in the original civil case.
The petition for criminal contempt charged all five defendants with violating the decree almost immediately upon its entry by setting up operations at a separate location in Congers, N.Y., to which they transported their employees and equipment. In addition, the petition alleged that the defendants violated the decree by failing to notify FDA of this relocation of their operations. All five defendants were found guilty of these charges.
The petition also alleged that Quality Formulation Laboratories Inc., Mohamed S. Desoky, Ahmad Desoky and Omar Desoky continued receiving and manufacturing operations at their Paterson facility despite the court’s order. These defendants were found guilty of this charge as well.
Finally, the petition alleged that Quality Formulation Laboratories Inc., Mohamed S. Desoky and Ahmad Desoky received and distributed product at their Paterson facility between September 2010 and January 2011, in violation of the court’s order. The jury found these defendants guilty of this count.
“When those responsible for manufacturing and distributing food and nutritional supplements don’t follow the FDA’s standards, the health and safety of the American people are put at risk,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. “These defendants thumbed their noses at a court order to shut down and clean up their facility – a facility that was plagued with cross-contamination, living and dead rodents, and other unsanitary conditions. The jury’s verdict sends a strong message to those who seek to ignore court orders enforcing important food safety laws.”
The prosecution of these defendants was handled by the Trial Attorneys David Sullivan and Patrick Runkle of the Justice Department’s Office of Consumer Protection Litigation, and Assistant U.S. Attorney Howard Wiener of the District of New Jersey. Shannon Singleton, FDA Associate Chief Counsel for Enforcement, supported the matter, which was investigated criminally by the FDA Office of Criminal Investigations, New York Field Office, and civilly by the FDA’s New Jersey District Office.
Sentencing has been scheduled by the court for Sept. 7, 2011.