Lifeway Foods Shutdown by FDA Over Manufacturing ViolationsMay 16, 2008 | Parker Waichman LLP Today, the U.S. Food and Drug Administration (FDA) announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., of Skokie, Illinois. The shutdown will remain in effect until both companies are found compliant with food safety laws. A consent decree of permanent injunction—which was signed by both corporations and two of their top executives, defendants Julie and Edward Smolyansky—stops all cream cheese and seafood processing in facilities in Skokie, Illinois and Philadelphia, Pennsylvania. According to the FDA, conditions at the facilities made it more likely that products would become contaminated with bacteria that causes food poisoning.
The action follows an extensive an ongoing history of violations of the Federal Food, Drug, and Cosmetic Act that date back to at least 2004. The complaint was filed by the U.S. Department of Justice and—according to an FDA release—alleges that the Julie and Edward Smolyansky:
- “Labeled and distributed cream cheese products with inadequate labels, including labels that did not disclose major food allergens, trans fat levels, and complete ingredient lists;
- “Processed and distributed products with seafood, including whitefish salad, ground nova salmon, and lox cream cheese and lox cream cheese spreads, without adequate Hazard Analysis and Critical Control Point (HACCP) plans to ensure the safe and sanitary processing of seafood containing products; and
- “Failed to document that they monitored sanitation conditions to keep food contact surfaces clean, to prevent cross-contamination from unsanitary objects, and to maintain hand washing, hand sanitizing, and toilet facilities.”
"We simply can’t allow companies to put the public's health at risk by not having adequate procedures and plans to produce safe food and proper labeling," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "We will work to take action against companies and their executives that violate the law."
Under the decree, the FDA will only allow operations to resume when the FDA agrees that they are in full compliance with all food safety. As part of the decree, the defendants must hire seafood-processing expert to prepare an HACCP plan and to submit that plan to the FDA.
Without adequate controls and when HACCP violations occur, a serious public health hazard can take place. For instance, Lifeway Foods and LFI Enterprises’ seafood products could foster dangerous—often deadly—bacteria, such as Vibrio species, Salmonella, Escherichia coli, Campylobacter jejuni, Staphylococcus aureus, and Listereria monocytogenes. Food these pathogens can cause serious illnesses—sometimes death—for those who eat them. Also, foods sold with labels that do not disclose major food allergens and complete ingredient lists can cause severe and deadly allergic reactions in those allergic to the undisclosed allergens.
Meanwhile, according to a recent government report, despite efforts in the U.S. to contain food borne illness, there has been no reduction in the number of infections, as a matter-of-fact, food borne illness reports remained stable last year following a prior period of decline. The report issued by government researchers found no change in the rate of infections caused by Listeria, Salmonella, Shigella, E.coli O157, and several other bacteria in 2007 compared with the previous three years and showed an increase in Cryptosporidium—a parasite which causes diarrhea—levels in recent years.