Three New Jersey companies that manufacture and sell nutritional supplements and protein powders have just learned what happens when you do not follow health directives from the Food and Drug Administration. Attorneys for the agency are seeking a permanent injunction to “stop the companies and its officer from manufacturing and distributing the products until needed corrections are made,” according to an FDA press release. The complaint, filed in U.S. District Court in New Jersey, claims that companies “have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.”

The companies facing legal action are American Sports Nutrition Inc., Quality Formulation Laboratories, Inc. and Sports Nutrition International LLC, all in Paterson, N.J. The FDA says that Mohamed S. Desoky  manages all three companies. The FDA had warned Desoky in July 2007 that there were problems both with cleanliness in the Quality Formulation manufacturing plant and with unlisted ingredients in some products. Desoky has had a problem with inspectors in May 1998, according to FDA records.

The FDA complaint filed July 10 of this year says that management of the companies did not live up to promises to correct problems. In the latest inspection, “the company failed to clean processing equipment between batches and control allergens in the facility. FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.”

Gross. Attorneys for the FDA have asked the federal court for a permanent injunction that would halt manufacturing and distribution until all problems are corrected. In essence, the FDA wants a shutdown that could last weeks, even months depending on the amount of work needed to trap animals, disinfect equipment and eliminate unlisted ingredients.

Can a brand name survive such a scandal over the quality and safety of its products? Desoky and the three companies face that and other challenges. If the judge grants the FDA’s request, they will spends tens of thousands of dollars putting operations back in order. Responding to regulators’ legal actions will also be very costly. And customers and distributors may defect en masse.

The lesson for other manufacturers is that the FDA is getting tougher on food safety. While the agency gave Doseky two years to correct problems, when time ran out, the hammer came down. It is likely to strike again and again this year.

About 

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.

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