This is interesting.

Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, are pushing back against the U.S. Food & Drug Administration (FDA).

The federal government last Thursday (5/15/08) ordered Lifeway to shutdown its cream cheese and seafood operations.  FDA said:

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 Smolyanskys did not see it that way.   On the Manufacturing Business & Technology website, they weighed in with separate statements.

Julie Smolyansky, CEO commented, "The Consent Decree has absolutely no impact or affect upon Lifeway’s products or production facilities. 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."

Edward Smolyansky, CFO commented, "Lifeway and LFI filed an answer to the complaint denying all material allegations. Lifeway will continue to produce and ship all of its products including its kefir, farmer’s cheese, and spreadable cheese products without any interruption. As our most recent quarterly report filed on May 15, 2008 exhibits, our core product lines continue to grow at a tremendous pace, and we have never been more confident about the future of our business as a whole."

Here’s more of what FDA said about why it was closing them down.

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."

More from FDA here.