The U.S. District Court for the Eastern District of Washington entered a consent decree between the FDA and Valley Processing of Sunnyside, Washington to stop the company from distributing adulterated juice products until they comply with the Federal Food, Drug, and Cosmetic Act. The complaint, filed on November 6, 2020, states that Valley Processing juice products allegedly contained inorganic arsenic and patulin toxins at levels that can cause health problems. This juice was distributed for use in school lunch programs.
This consent decree prohibits Valley Processing from receiving, preparing, processing, packing, holding, labeling, and/or distributing FDA regulated products until it completes corrective actions. The company had stopped its juice processing activities, but they must destroy any juice still in its possession. And the defendants must first notify the FDA in advance and comply with remedial measures, before they start processing juice again.
In addition to containing inorganic arsenic, a carcinogen, and patulin, a mycotoxin that adversely affects human health, FDA investigators observed that the juice was processed under “grossly insanitary conditions” during an inspection. Inspectors noted that grape juice concentrate was allegedly stored in off-site storage tanks and covered barrels that were contaminated with filth and mold. The defendants allegedly combined this juice concentrate with newer lots and then distributed the mixture to consumers.
Valley Processing allegedly promised that they would stop using the contaminated juice, but and FDA inspection in 2019 shows that the defendants still blended the older juice with newer juice. The U.S. Department of Justice filed the complaint on behalf of the FDA.
Judy McMeekin, Pharm. D., FDA’s Associated Commissioner for Regulatory Affairs said in a statement, “Food processors who do not comply with FDA regulations can put consumers’ health and well-being in danger. With this consent decree, we’re taking action to protect Americans, including children in this case, from consuming foods that have been processed in violation of the law. The FDA is fully committed to taking appropriate measures against those who disregard food safety standards and distribute adulterated food to the public.”
