DOJ Seeks Injunction in Adulterated Food Case
Acting on behalf of an apparently energized Food and Drug Administration (FDA), the Department of Justice (DOJ) has filed a complaint for injunction against a New Jersey company and its owner seeking to halt the manufacture and sale of their dietary supplement products, in part, for failure to comply with good manufacturing practice requirements. U.S. v. Quality Formulation Labs., Inc., No. 09-03211 (D.N.J., filed July 1, 2009).
The complaint alleges that the defendants have caused their protein powders and other dietary supplements to be adulterated “in that they 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).” The allergen at issue is milk.
The complaint also alleges that one of the defendants’ articles of food is adulterated “in that it contains a color additive that is unsafe . . . because it is not declared on the product label.” The additive at issue is FD&C Yellow No. 5. Another food item is allegedly misbranded because it contains an ingredient (whey) “whose common or usual name is not listed on the product labels.” According to DOJ, other products are misbranded with a “low calorie” claim that violates the law “because the caloric intake per serving exceeds the maximum calorie limit.”
The complaint details what FDA inspectors found in the plant on numerous occasions between 2007 and 2009. Evidence of a rodent infestation allegedly included live and dead rodents as well as rodent gnawing, excrement, urine staining, and tracks throughout the facility. The employees allegedly failed to clean or sanitize equipment to prevent cross-contamination of non-allergenic products with allergens.
The government seeks a permanent injunction to stop the defendants from manufacturing and distributing adulterated and misbranded food articles and seeks an order that defendants cease manufacturing any article of food until the plant is brought into compliance with the Food, Drug, and Cosmetic Act.
