FDA Takes More Action Against Captain's SelectJun 9, 2008 | Parker Waichman LLP The U.S. Food and Drug Administration (FDA) today filed a complaint for a permanent injunction against Minneapolis, Minnesota seafood processor Captain's Select Seafood, Inc. The complaint also names two of its top officers for violating the Federal Food, Drug and Cosmetic Act (FD&C Act).
The FDA’s action follows Captain’s Select extensive history of violating the FD&C Act and the agency’s Hazard Analysis Critical Control Point (HACCP) regulations. FDA’s HAACP regulations require all seafood processors develop and implement adequate plans that identify all food safety hazards likely to occur for each kind of seafood product and that such plans contain preventative measures the processor can implement to control those hazards. “We simply can’t allow a company to put the public’s health at risk by not having adequate procedures and plans to produce safe food,” said Margaret O’K. Glavin, associate commissioner for regulatory affairs. “Our warning letters should not be taken lightly. We will take action against companies and against their executives who violate the law and endanger public health.”
Captain’s Select Seafood makes a variety of fish and fishery products. The HACCP violations documented by the FDA pose a public health hazard because, without adequate controls, products made by Captain’s Select Seafood could harbor pathogenic bacteria, such as Staphylococcus aureus and Listeria monocytogenes. Food products with these kinds of pathogens can cause serious illnesses in people who eat them.
The complaint was filed by the U.S. Department of Justice in the U.S. District Court for the District of Minnesota and follows a February 2006 warning letter and other violations dating back to April 2004.
Consumers can call the FDA’s toll-free Food Safety Hotline at 1-888-SAFEFOOD, should they have any food safety questions and can report any problems to the FDA consumer complaint coordinator in their geographic area. Contact numbers may be found on-line at www.fda.gov/opacom/backgrounders/complain.html
Mike Bakeman, general manager of Captain's Select Seafood, says the FDA's action is related to record-keeping issues and that Captain’s Select conducts minimal processing and distributes seafood from FDA-approved vendors.
This was the second such move by the FDA in recent weeks. Last month the FDA announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., of Skokie, Illinois. A consent decree of permanent injunction—signed by both corporations and two top executives, defendants Julie and Edward Smolyansky—stops all cream cheese and seafood processing in facilities in Skokie, Illinois and Philadelphia, Pennsylvania and follows an extensive and ongoing history of violations of the FD&C Act that date back to at least 2004.
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.