FDA Takes Action Against Lifeway Foods and Subsidiary

May 16, 2008
Regulatory agency says repeated violations prompt closure of certain processing lines. Company refutes allegations.

Citing inadequate labeling and safety and sanitation plans, the U.S. Food and Drug Administration on May 15 announced the shutdown of cream cheese and seafood operations at Lifeway Foods Inc. and its subsidiary, LFI Enterprises. The regulatory agency said a consent decree of permanent injunction was signed by both corporations and two of their top executives. Operations may resume only after the agency determines that the companies have achieved full compliance with all food safety requirements.

The FDA says its action follows the defendants' "extensive history" of violations of the Federal Food, Drug and Cosmetic Act. 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.

Lifeway reported May 16 that all of its production facilities remain open and operational. The company said the only product line affected is cream cheese spreads, which are produced by its wholly owned subsidiary. These products represent less than one-half of 1% of Lifeway's total revenue, the company says.

The company also refutes FDA's allegations. Lifeway Foods CEO Julie Smolyansky said in a statement, "We vigorously disagree with the allegations of the complaint. These same products have been produced for over 15 years for a very small and select group of customers in the Philadelphia area without one consumer complaint, and while we of course respect the government's position, we do not agree with their unfounded assertions. We know that we are and have been compliant as to any alleged violation asserted in the complaint. We would never place our customers at risk."

The decree does not include other products produced by Lifeway, including kefir, spreadable cheese products and farmer's cheese.

About the Author

Jill Jusko

Bio: Jill Jusko is executive editor for IndustryWeek. She has been writing about manufacturing operations leadership for more than 20 years. Her coverage spotlights companies that are in pursuit of world-class results in quality, productivity, cost and other benchmarks by implementing the latest continuous improvement and lean/Six-Sigma strategies. Jill also coordinates IndustryWeek’s Best Plants Awards Program, which annually salutes the leading manufacturing facilities in North America.

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