A federal court has announced the closure of a 51-year old juice manufacturer in the Washington State over contaminated products and unsanitary conditions. The FDA had filed a complaint alleging the company’s products contained inorganic arsenic and patulin toxins that could pose health risks to consumers.
According to the official communication from the U.S. District Court for the Eastern District of Washington, a consent decree was entered between the U.S. Food and Drug Administration (FDA) and Valley Processing, Inc. Sunnyside, Washington, along with the company’s owner and president, Mary Ann Bliesner. The company was ordered to stop distributing adulterated juice products until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in the consent decree.
Juice for Use in School Lunch Programs
In a complaint filed on behalf of the FDA on Nov. 6, 2020, the agency’s investigators observed that the defendants processed juice under grossly insanitary conditions and failed to adhere to relevant food safety standards. This included storing grape juice concentrate contaminated with filth and mold in off-site storage tanks and covered barrels outside for several years.
Despite the contamination, the defendants combined this juice concentrate with newer lots and distributed the mixture to consumers. This included the distribution of juice for use in school lunch programs. The complaint states that the defendants promised to discontinue using the contaminated juice. Still, a subsequent inspection by the FDA in 2019 showed the defendants continued to blend the older juice with newer juice for distribution. Judy McMeekin, Pharm.D., FDA’s Associate Commissioner for Regulatory Affairs, stated:
“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.”
Aflatoxins and Mycotoxins
The consent decree of permanent injunction prohibits Valley Processing Inc. from receiving, preparing, processing, packing, holding, labeling, and/or distributing FDA-regulated products unless and until it completes corrective actions. Under the consent decree, Valley Processing, Inc. must destroy any juice still in its possession. Before processing or distributing any juice or food in the future, the defendants first must notify the FDA in advance, comply with specific remedial measures outlined in the injunction, and permit the FDA to inspect their facilities and procedures.
Most people know about the dangers of heavy metals like lead and mercury in the food chain but are unaware of other equally poisonous compounds occurring in foods. These include aflatoxins and mycotoxins like patulin that can be found in apple juices. Mycotoxins are toxins that are produced by molds or fungi that grow on food in warm and humid conditions. For instance, patulin is a mold that grows on various foods like fruits, grains, and cheese.
Adverse Health Effects
Patulin is a problematic mold because it can contaminate processed food products like apple juice. Millions of people drink large quantities of pure apple juice, and apple juice concentrate is diluted and added to several other commercial juices made from less prolific and more expensive fruits like berries and granadilla.
Inorganic arsenic is a toxic substance, and prolonged exposure to high inorganic arsenic levels is associated with cancer, skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes in humans. Based on another FDA’s quantitative risk assessment, the agency established an action level for inorganic arsenic in single-strength apple juice of 10 ppb.
The analyzed sample contained levels of inorganic arsenic above ten ppb. Based on the level of arsenic in that sample and other data and information on the adverse health effects of arsenic at such levels, apple juice concentrate represented by this sample is adulterated within the meaning of Section 402(a) of the Act because it bears or contains an added poisonous or deleterious substance which may render the food injurious to health.