Friday, May 16, 2008

FDA Puts Its Foot Down

When USDA's Food Safety and Inspection Service is faced with a contaminated food that is a clear and present danger to consumers, and a processor that refuses to act, the agency can threaten to withdraw its inspectors, effectively shutting down the processing plant.

FDA doesn't have that luxury. FDA inspectors must coax, cajole and convince a recalcitrant food processor to issue a voluntary product recall. As the Mars Petcare story clearly shows, this is not always a satisfactory solution.

Sometimes, a processor's breaches of safe food handling practices are so egregious that FDA has no choice but to seek a court injunction and shut down production until the company corrects its unsafe practices.

FDA announced today that it has shut down the operations of Hope Food Supply Inc., of Pasadena Texas, and has ordered the company to recall all of its products. The agency was able to take this unusual action because of a consent decree that Hope Food had signed when operating under a different name. Under the consent decree, the seafood manufacturer had agreed to develop and implement a HACCP plan, as required of it under the Food, Drugs and Cosmetic Act. It did not do so.

Hope is a producer of smoked catfish and smoked seafood, and distributes its products nationwide. It is under orders to recall everything produced and shipped since 2007. FDA is advising consumers who have purchased any smoked fish or smoked seafood to contact their retailer to determine their source, and to discard anything produced by Hope Food Supply, Inc.

FDA has also obtained a signed consent decree of permanent injunction against Lifeway Foods, Inc., and its subsidiary LFI Enterprises, Inc. The decree shuts down operations at the companies' production facilities in Skokie, IL and Philadelphia, PA. Lifeway and LFI process and distribute cream cheese and seafood products, such as cream cheese and lox spreads and whitefish salad.

According to the FDA news release, both facilities have been in violation of food safety and food labeling standards repeatedly since 2004. The consent decree specifies that operations may only resume at these facilities once FDA is satisfied that the locations are in full compliance with food safety standards, including the development and implementation of an appropriate HACCP program. The decree does not extend to Lifeway's other products that contain no seafood. There has been no product recall ordered as part of this consent decree.

The FDA news releases contained the following statement from Margaret O'K. Glavin, associate commissioner for regulatory affairs:
"We simply will not allow a company to put the public's health at risk by not implementing adequate procedures and plans to produce safe food. . . The FDA will take action against companies and against their executives who violate the law and endanger public health."
While it's encouraging to learn that FDA is prepared to take court action against egregious offenders of food safety requirements, we shouldn't lose sight of the fact that the agency had to jump through a series of hoops for four years before it could obtain a consent decree against Lifeway. And the decree only covered those products that contain seafood.

Isn't it time to strengthen FDA's ability to enforce the provisions of the Food, Drug and Cosmetic Act?

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