Dietary supplement trade associations have applauded the 'strong action' of the FDA and the Department of Justice for finding New Jersey-based dietary supplement companies guilty of criminal contempt of court relating to GMP violations.
NJ-based 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, were found guilty of multiple counts of criminal contempt of court for violating a consent decree.
The complaint in the civil case that led to the court order alleged that the defendants adulterated food by manufacturing it without following FDA’s regulations regarding current good manufacturing practice (cGMP) requirements.
“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,” added West.
The announcement was applauded by the various dietary supplement trade associations.
Harry Rice, PhD, VP regulatory & scientific affairs for the United Natural Products Alliance (UNPA), told NutraIngredients-USA that the defendants’ actions demonstrate a blatant disregard for the regulations which have been put in place to safeguard consumers.
“Hopefully, this recent turn of events will send a strong message to other offenders that they better clean up their act or be prepared to suffer the consequences.
“The Interim Final Rule (published May 5 and effective July 3) related to the Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption will help in situations like this.
“That is, as of July 3, the FDA will have the power to prevent potentially harmful food from reaching U.S. consumers by detaining it for suspicion of adulteration or misbranding,” he added.
Rice’s comments were echoed by Cara Welch, PhD, VP regulatory & scientific affairs for the Natural Products Association (NPA), who commended the “strong actions” of FDA and the Justice Department.
“GMPs are serious business and people should know that this is the law. These companies were found to not be implementing GMPs and an example needed to be made,” she added.
Steve Mister, President of the Council for Responsible Nutrition (CRN), said the news was a “reminder to industry that FDA has teeth.
“As for the violations, we’re not even talking about testing the identity of your raw materials or batch analyses, we’re talking basic sanitation.
“FDA needed to show that there are consequences for violating fundamental consumer trust. It has done that and we applaud it,” he added.
During an FDA inspection of the facility in December 2008 and January 2009, FDA investigators reportedly observed a dead rodent - cut in half- on a blender motor platform; another dead rodent was observed surrounded by rodent feces in product storage area; and a live rodent was observed running through the blending room on two occasions.
The results of the FDA inspections led to a civil action that required the defendants shut down their manufacturing operation and not reopen there or elsewhere without first correcting these violations and getting the thumbs up from FDA. The defendants consented to this.
However, the criminal contempt charges alleged that all three Desoky’s knowingly violated the order, and were therefore criminally liable for the violations even though they were not named as defendants in the original civil case.
The petition for criminal contempt charges all five defendants with violating the decree almost immediately – the defendant transported employees and equipment to a separate location in Congers, NY, and restarted operations. The defendants allegedly failed to notify FDA of this relocation of their operations.
The defendants were also found guilty of continuing to receive, manufacture and distribute product at their Paterson facility
Sentencing will occur on September 7, 2011.
The website for Quality Formulation Laboratories Inc. is active but filled with gibberish: http://www.qualityformulations.com/contact_qfl.html , while contact email addresses for American Sports Nutrition Inc. do not work. As such nobody from the companies was available for comment prior to publication.