Federal Lawsuit Alleges Federal School Lunch Program Apple Juice Supplier Sold Apple Juice Containing High Levels of Arsenic and Patulin
The FDA and Federal Government allege the company sold juice that was “unfit for human consumption.”
According to online news reports from KXTY.com and NYtimes.com, a federal lawsuit is alleging that a juice supplier for a school lunch program sold juice products that contained high levels of toxic substances such as patulin (mycotoxin) and inorganic arsenic. The lawsuit also asserts that the former Sunnyside fruit processing company had an extensive history of “processing juice under grossly insanitary conditions” and repeatedly violated food safety standards. The lawsuit also contends that a group of Food and Drug Administration inspectors stated in their inspection report that they witnessed moldy fruit being stored outside for several months, and they found dead rodents inside the processing plant.
The former Sunnyside fruit processing plant sold its juice concentrate and juice products to businesses nationwide. The businesses then packaged, distributed, and sold the juice products directly to consumers and a federal school lunch program —which provided approximately three million servings per year.
In September, the former Sunnyside fruit processing plant, known as “Valley Processing,” was sold to Milne Fruit Products, Inc. The plant is located in Sunnyside, Washington, and was one of the biggest, privately owned, wholesale juice manufacturing plants in the country.
The U.S. Attorney’s Office filed the federal lawsuit last Friday in the U.S. District Court for the Eastern District of Washington. The complaint alleges the company neglected to investigate unsafe levels of arsenic found in its fruit juice products. Additionally, the FDA documented 14 food safety standard violations at the Valley Processing facilities during yearly inspections conducted between 2016 and 2019. According to the FDA, the Defendants regularly promised to correct their facilities to comply with all regulatory requirements. However, the FDA stated in the lawsuit that a recent FDA inspection revealed that Defendants did not keep their promises.
Particularly, the federal lawsuit maintains that the company neglected to “comply with the Hazard Analysis and Critical Control Point (HACCP)” regulations for juice products as well as the Current Good Manufacturing Practice (CGMP) regulations for food product manufacturing.
According to the federal lawsuit, FDA inspectors first discovered the high levels of arsenic in Valley Processing juice products while conducting an annual inspection of the plant back in January 2016. The FDA found in one specimen of “ready-to-consume apple juice” inorganic arsenic levels as high as 88.1 parts per billion, which is almost nine times the FDA’s tolerable limit of 10 ppb. On October 25, 2018, the company recalled about 14,800 gallons of apple juice concentrate, which was already distributed both in the U.S. and internationally due to unsafe levels of inorganic arsenic.
Arsenic is a naturally existing toxin that is found in soil and can be absorbed by trees; however, inorganic arsenic comes from manmade sources such as pesticides. Arsenic is toxic at high levels or with continued exposure.
The Dangerous Side Effects of Arsenic Consumption and Exposure in Children
According to FDA inspectors, inorganic arsenic has been linked to causing cancer, developmental effects, neurotoxicity, skin lesions, diabetes, and cardiovascular disease in humans. Health officials are uncertain if or how many schoolchildren consumed the apple juice containing high inorganic arsenic levels. Health officials warn that arsenic has a far greater health impact on children, whose systems cannot process harmful chemicals such as Arsenic and Patulin, as well as adults. Researchers have discovered that when children are exposed to arsenic over some time, the side effects include impaired brain development, a lower I.Q., breathing problems, growth problems, an unhealthy immune system, and cancer later in life.
Unsanitary Conditions Caused Dangerous Levels of a Dangerous Mycotoxin Called Patulin
According to the federal government’s lawsuit, inspectors for the FDA also frequently detected patulin inside the plant. Patulin is a dangerous mycotoxin that is produced by some classes of molds that grow on pears, apples, and other foods. Exposure to unsafe levels of patulin over time can lead to serious health hazards in humans, such as vomiting, nausea, and gastrointestinal disturbances. On June 28, 2019, the apple juice manufacturer recalled over 11,000 gallons of its apple juice because the juice contained a patulin level greater than 50 ppb, the FDA’s allowable limit. According to the lawsuit, FDA officials blame the high patulin levels on the manufacturer’s unsafe method of storing fruit outside in uncovered wooden bins for months without temperature or atmospheric controls.
The federal lawsuit also asserts that the company promised the FDA to test and investigate the unsafe levels of patulin levels, yet failed to do so. Further, the FDA investigators witnessed in a ten-minute period, 46 apples passed inspection and were prepped for making juice, although those apples were “visibly deteriorated with mold and rot.” The lawsuit asserts that the company actually “lowered its quality control standards” to permit a higher number of moldy and rotten apples to pass inspection and be turned into juice products.
The FDA asserts in the lawsuit that the company attempted to conceal contamination levels by mixing in expired juice concentrate and ‘leftover sludge’ with new juice products. The FDA states that several of the juice concentrates used was “several years old, with some lot codes dating back to 2008.” The FDA took samples and confirmed that the juice concentrate in some barrels was “contaminated by mold and filth, and was not suitable for human consumption.” The Defendants allegedly pledged to stop these unsafe practices, but FDA investigators affirmed these practices continued on an inspection of the plant in June 2019.”
The federal lawsuit is seeking a permanent injunction to prevent Valley Processing from reopening, ordering the destruction of any leftover juice products, and ordering the company to reimburse the FDA investigation costs.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Did your child become ill or tragically pass away due to contaminated juice provided by his or her school?
Parker Waichman LLP is reviewing cases of Arsenic and Patulin poisoning caused by contaminated fruit juice. Parker Waichman LLP helps individuals and families recover financial compensation from those who willfully and negligently caused harm. Trust your legal claim to our experienced product liability attorneys. For a free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation