Source - Food & Beverage Litigation Update | Issue 754

FDA Sues Juice Supplier, Alleging Insanitary Conditions

The U.S. Food and Drug Administration (FDA) has filed a lawsuit seeking to enjoin Valley Processing Inc. from introducing adulterated food into interstate commerce. USA v. Valley Processing Inc., No. 20-3191 (E.D. Wa., filed November 6, 2020). FDA alleges Valley Processing’s juice products “have been found to contain inorganic arsenic and patulin, both toxins which pose a health risk to consumers.” The products were supplied to the U.S. Department of Agriculture’s school lunch program, “providing approximately 2,964,000 apple juice servings to schoolchildren every year.”

FDA allegedly found “grossly insanitary conditions” during inspections in 2016, 2017, 2018 and 2019, including barrels containing “grape juice concentrate that was several years old” and “contaminated by filth and mold, thus not suitable for human consumption.”

Investigators “also discovered that Defendants processed the ‘bottoms’ of stored grape juice concentrate. The ‘bottom’ of juice concentrate is the leftover sludge that accumulates at the bottom of the barrel, after Defendants open a barrel to pull product off the top, exposing all of the product in the barrel to possible contamination. Defendants diluted the ‘bottoms,’ likely to contain contaminants, to be blended with newer juice. Defendants mixed the juice concentrate from both the ambient barrels and the ‘bottoms’ with newer lots to hide the contamination.”

“Defendants have received ample notice that their juice processing operations violate the law and that continued violations could lead to regulatory action,” the complaint argues. “In response to the inspections, Warning Letter, and regulatory meeting, the Defendants repeatedly promised, both orally and in numerous letters to FDA, to bring their facility into compliance with regulatory requirements. Specifically, Defendants promised to suspend their violative practices of holding juice products outside and blending older juice product that had been subject to possible contamination with newer juice products, and to adequately implement their [Hazard Analysis  Critical Control Point] plans. The most recent FDA inspection showed that Defendants kept none of these promises. Although Defendants claimed to be interested in making necessary changes, compliance with the law has clearly not been a priority.”

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