The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, is calling on a federal district court to impose a permanent injunction against three Paterson, New Jersey nutritional supplements companies and the executive who oversees their production.
The FDA claims Quality Formulation Laboratories, American Sports Nutrition, Sports Nutrition International and Mohamed S. Desoky are making supplements without following proper procedures.
The complaint, filed earlier this month in U.S. District Court in New Jersey, says the manufactures of protein powder mixes and dietary supplements must be prevented from introducing products into the market that are misbranded and contaminated. The lawsuit claims an investigation found unsanitary operations, mislabeled products, products improperly mixed and improper storage of ingredients. The FDA found that a number of the companies' products contained milk ingredients not declared on the product labels, and processing equipment was not cleaned in between batches to control allergens.
"The defendants adulterate articles of food by manufacturing them in a manner that fails to conform to current good manufacturing practices," the suit alleges. "(The products) have been prepared, packed, or held under insanitary conditions whereby they 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."
Desoky, who is the president of one company and CEO and an executive in the second and third, said all the issues have been corrected and he expects to settle the case without going to court. He added that those retailers who buy his products "empathize" with his situation and he has not received any cancellations.
"The FDA found some labels that did not carry the allergen statement, which we corrected all the way," he said. "We also did a lot of sanitation to meet their regulations. We are complying 100 percent, but we have not accepted all the allegations as being true."
Desoky said this is the first time in 29 years the government has filed a complaint against the plant operations. He said the companies recently experienced a significant increase in business and some of the quarters became cramped. He has since added a second floor, hired a pest control company and constructed a tracking system.
But the FDA says the companies have repeatedly failed to comply. Following three inspections, the manufacturers promised to make changes, but not to FDA satisfaction.
"This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so," Michael Chappell, the FDA's acting associate commissioner for regulatory affairs, said in a prepared statement on July 10. "The FDA will not tolerate companies that fail to provide adequate safeguards."
Because the matter is now in litigation, FDA spokeswoman Siobhan DeLancey said the administration will no longer comment on the case.
The companies' powder mixes and dietary supplements are sold throughout the United States. The three manufacturers also export products for sale by private label customers. The plants employ about 70 people. Desoky estimated annual revenues between $25 million and $30 million.