According to press reports, the FDA is suing Valley Processing of Sunnyside, Washington because the company allegedly is not monitoring for toxic heavy metals in its juice products and producing under insanitary conditions. Valley Processing supplies juices to the national school lunch program. Three million servings of the company’s juice products were distributed every year to the federal school lunch program.
The lawsuit was filed November 6, 2020 in the U.S. District Court of Eastern Washington. The lawsuit states that the company allegedly ignored years of notifications from inspectors about issues that put kids at risk of consuming products that were “injurious to health.” The company has agreed to a consent decree.
The lawsuit states, “Defendants’ juice products are adulterated … in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health.” It also states, “Defendants have an extensive history of processing juice under grossly insanitary conditions.”
In a warning letter from the FDA to Valley Processing that was sent in June 2016, inspections revealed “serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (Title 21, Code of Federal Regulations (CFR), Part 120) and the Current Good Manufacturing Practice (CGMP) regulations for foods (21 CFR Part 110).”
During inspection, the FDA collected samples of apple juice concentrate which revealed inorganic arsenic levels at 88.1 nanogram per gram (ppb) in single-strength or ready-to-be consumed product, which makes the juice adulterated within the meaning of the law. The FDA’s action level for inorganic arsenic in single-strength apple juice is 10 ppb.
Inorganic arsenic is a toxic substance. Prolonged exposure to this heavy metal is associated with cancer, skin lesions, cardiovascular disease, developmental effects, neurotoxicity, and diabetes.
In addition, the letter alleges that the company’s Fruit Sorting critical control point was not adequate to control the food hazard of patulin, which may be a carcinogen, that comes from rotten, moldy, and damaged apples. The firm said they only monitor the top visible layer of incoming apple bins, which is “not an adequate sorting method,” according to the warning letter. And the company purchases “cull apples,” which may contain decay, worm holes, and internal breakdown. Any damaged, rotten, moldy, or bruised fruit should be culled from production.
And the firm did not hold raw materials in manner to prevent the food from becoming adulterated, apples were stored outside without atmospheric or temperature controls, and the company was not controlling for metal debris as a significant hazard. Finally, inspectors documented “live and dead animals, including mice, rats, squirrels, and birds, thoroughly various buildings used for both storage and manufacturing.”
