October 5, 2020

FDA Issues the First Injunction Under the Produce Safety Rule

The FDA has issued its first injunction under the Produce Safety Rule against a company that makes sprouts and soy products. That Rule, which was part of the Food Safety Modernization Act of 2011 and was finalized on January 26, 2016, gives the FDA power to issue consent decrees of permanent injunction against corporations for violating safety standards.

FDA Issues the First Injunction Under the Produce Safety Rule

The Produce Safety Rules mandates that sprout operations take measures “to prevent the introduction of dangerous microbes into seeds or beans used for sprouting; test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens; test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes; and take corrective actions when needed.”

Sprouts are considered an inherently risky food, and many populations at higher risk for food poisoning complications are advised to avoid them completely unless they are fully cooked.

The injunction under produce safety was filed against Fortune Food Product, Inc., its majority owner Steven Seeto, and supervisor Tiffany Jiany. The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.

FDA Chief Counsel Stacy Amin said in a statement, “Manufacturing foods in violation of the Produce Safety Rule and Current Good Manufacturing Practice regulations places consumers’ health at risk.This action demonstrates the agency’s commitment to pursuing and taking swift action against those who repeatedly disregard these food safety standards and distribute adulterated foods.”

The company cannot grow, harvest, pick, pack, or hold sprouts and soy products at or from its facility, or any other facility, until corrective actions have been taken and the FDA has been notified. The FDA conducted multiple inspections at the facility and documented insanitary conditions showing that the sprouts and soy products “may have become contaminated with filthy or may have been rendered injurious to health.”

The FDA is not aware of any confirmed illness related to Fortune Foods’ products. If any consumers think they have suffered adverse reactions after consuming these products, they should see their doctor and report it to the FDA using their Consumer Complaint Coordinators.

 

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