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FDA Issues First Injunction of its Product Safety Rule

FDA Issues First Injunction of its Product Safety Rule

The FDA’s action marks the first consent decree of permanent injunction against a firm or grower for violating public safety standards.

The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., an Illinois-based processor of sprouts and soy products. The permanent injunction was filed against the firm for violating public safety standards and comes more than two years after being sent a warning letter, Food Poisoning Bulletin reported.

Fortune Food Product did not respond to Xtalks’ request for comment.

The Product Safety Rule, which was part of the Food Safety Modernization Act (FSMA), gives the FDA the power to issue consent decrees of permanent injunction against corporations for violating safety standards. The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.


Related: FDA Announces Slow Phase-Out of Certain PFAS Chemicals Used in Food Packaging


The Produce Safety Rule 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 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 can carry a risk of foodborne illness if they are contaminated, and unlike other fresh produce, the warm, moist conditions required to grow sprouts are ideal for the rapid growth of bacteria, including Salmonella, Listeria, and E. coli. Many populations at higher risk for food poisoning complications are advised to avoid them completely unless they are fully cooked.

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.”

Fortune Foods can’t 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 unsanitary conditions showing that the sprouts and soy products “may have become contaminated with filthy water or may have been rendered injurious to health.”

No confirmed illnesses related to Fortune Food’s products have been reported to the FDA.