• On November 9, 2020, the U.S. Food and Drug Administration (“FDA” or “the Agency”) filed a lawsuit in the Eastern District of Washington against Valley Processing, Inc. (“Supplier”) that manufactures single strength fruit juice and fruit juice concentrate, which it later supplies to the U.S. Department of Agriculture’s (USDA) school lunch program.  The Supplier provides approximately 2,964,000 apple juice servings to schoolchildren every year.
  • According to the lawsuit, FDA found inorganic arsenic, which is associated with cancer, lesions, neurotoxicity, and diabetes.  In addition, FDA found patulin in the juices, which can cause nausea, vomiting, and gastrointestinal disturbance.  The Agency concluded that this occurred because the Supplier failed to implement practices to control the level of arsenic and patulin in apple and pear juice, and did not do adequate testing to ensure the products were free of the substances, even after being warned by the Agency during previous inspections.
  • The complaint notes that FDA issued warnings to the Supplier following inspections in 2016 through 2019 and advised it how to follow good manufacturing practice.   By way of background, FDA’s food current good manufacturing practice (CGMP) regulations establish basic practices that must be followed, and conditions that must be maintained, by companies who receive, prepare, process, pack, hold, or distribute food.  The purpose of CGMP is to ensure that food is processed in a safe and sanitary manner.  In addition to CGMP, the Agency stated that the Supplier is subject to the juice Hazard Analysis and Critical Control Point (HACCP) regulation, which creates a system to prevent the occurrence of potential food hazards in juice.  Although the Supplier was aware of its responsibility under HACCP, FDA alleged that the Supplier’s failure to have and implement an adequate HACCP plan created insanitary conditions that may render the Supplier’s juice injurious to health.
  • The Agency’s complaint also noted that at several inspections over the last several years, the FDA found many violations, such as animal droppings on containers of juice, dead animals, leaks, and bruised and moldy fruits being used to produce the products.  Further, FDA alleged that the Supplier raised the limit on what level of core rot it would accept for apples, from less than 1% to less than 10%, despite FDA advising that core rot could lead to high levels of patulin.  Moreover, the complaint alleges that the Supplier mixed grapefruit concentrate dating back to 2011, which had been stored outside at ambient temperatures, with newer juice.
  • The Agency asked the court for an injunction stopping the company from placing its products into the stream of commerce until they are found to be in compliance with FDA regulations.  We will continue to monitor any developments.