FDA Takes Action against Cream Cheese Companies, Executives
Repeated federal violations and failure to correct drove action

The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws. A consent decree of permanent injunction, signed by both corporations and two of their top executives, Julie and Edward Smolyansky (the defendants), halts cream cheese and seafood processing in facilities in Skokie, Ill., and Philadelphia, Pa.

The FDA's enforcement action follows the defendants' extensive history of violations of the Federal Food, Drug, and Cosmetic Act dating back to at least 2004. The complaint, filed by the U.S. Department of Justice, alleges that the defendants:

• 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 consent decree, operations may resume only after the FDA determines that the defendants have come into full compliance will all food-safety requirements. The consent decree requires the defendants to hire a seafood-processing expert to prepare a HACCP plan and to submit the plan to the FDA.

The HACCP violations pose a public health hazard because, without adequate controls, the defendants' seafood products could foster dangerous bacteria, such as Vibrio species, Salmonella, Escherichia coli, Campylobacter jejuni, Staphylococcus aureus, and Listereria monocytogenes. Food products with these kinds of pathogens can cause serious illnesses for people who eat them. Further, foods sold with labels that do not disclose major food allergens and complete ingredient lists can cause severe or life-threatening allergic reactions in people who are allergic to the undisclosed allergens.

The decree does not include other products manufactured by Lifeway including kefir, Farmers cheese, and spreadable cheese products.

The decree was signed by Judge Wayne R. Andersen on May 15, 2008, in the U.S. District Court for the Northern District of Illinois.

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