FDA Issues First Injunction Under Produce Safety Rule Shutting Down an Illinois Food Processor

The FDA issued the first injunction against a firm or grower for violating the Produce Safety Rule enacted under FSMA.  The Illinois processor  of sprouts and soy products has stopped production until it undertakes corrective action and comes in compliance with the regulations.  This comes after FDA had conducted multiple inspections where they documented insanitary conditions showing that sprouts and soy products had been produced in insanitary conditions.

The company had been issued a Warning Letter in July in which identified violations where significant evidence of rodent activity and insanitary conditions and practices throughout the farm mixed-type facility. Based on these findings, FDA determined that the mung bean sprouts, tofu products, and soybean noodle products were adulterated.  They noted employees shoveling product back up off the floor, product getting hung up in equipment, poor water handling systems, an inadequate Listeria control program,  extensive rodent infestation, inadequate handwashing facilities,  inadequate allergen labeling, etc.


FDA News Release
https://www.fda.gov/news-events/press-announcements/fda-issues-first-injunction-under-produce-safety-rule-illinois-based-food-manufacturer-repeated-food
FDA issues first injunction under Produce Safety Rule to Illinois-based food manufacturer for repeated food safety violations

For Immediate Release:
September 15, 2020

The U.S. Food and Drug Administration announced today that Fortune Food Product, Inc., an Illinois-based processor of sprouts and soy products, has agreed to stop production until it, among other things, undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.

2 cases of botulism linked to tofu

Tofu, sold in NY City, has been linked to 2 cases of botulism. The tofu was purchased by a couple in a NY City store. The tofu was displayed in a non-refrigerated, water filled bin. This is the first cases of botulism in NYC in more than 15 years.

‘Tofu is made by coagulating soy milk and pressing the resulting curds. The process begins by soaking, grinding, boiling and straining dried or fresh soybeans. Coagulation of the protein and oil (emulsion) suspended in the boiled soy milk is the most important step in the production of tofu. This process is accomplished with the aid of coagulants. Two types of coagulants (salts and acids) are used commercially. The third type of coagulant, enzymes, is not yet used commercially but shows potential for producing both firm and "silken" tofu’. (adapted from Wikeapedia).

Clostridium botulinum spores would survive the boiling and then be able to grow in the non-refrigerated product (in the absence of a secondary inhibitor. Tofu products vary greatly, even in terms of inclusion of antimicrobial parameters.) The spores will germinate and grow in the protein rich, non-refrigerated product. The product sitting in water would ensure a sufficient water activity as well as help support an anaerobic environment, both essential for C. botulinum. As C. botulinum grows, it produces a neurotoxin. If ingested, the neurotoxin enters the bloodstream and shuts down muscle function, potentially leading to death through the inability of the victim to breath.

Tofu is a considered a potentially hazardous food (TCS food) and thus requires refrigeration during distribution, at retail, and by the consumer.

 Tofu suspected of giving botulism to two people in QueensBotulism is a rare but potentially fatal foodborne illness

By Kerry Wills / NEW YORK DAILY NEWS 

Saturday, March 31, 2012, 2:18 AM
Read more: http://www.nydailynews.com/new-york/queens/tofu-suspected-giving-botulism-people-queens-article-1.1053799#ixzz1qtIZYyHM

Two people got botulism - a rare but potentially fatal foodborne illness - after buying tofu at a store in Flushing.