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Update: On September 21, 2012, Judge Laurel Beeler of the U.S. District Court for the Northern District of California entered a consent decree of permanent injunction in this case. Fujino Enterprises, Inc. and Eriko Fujino are now prohibited from processing and distributing articles of food, including fish and fish products, unless they comply with the Federal Food, Drug and Cosmetics Act, applicable FDA regulations and the terms of the consent decree.
For Immediate Release: March 29, 2012
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FDA pursues enforcement action against California fish processor
Fish may put consumers at risk of botulism and other food hazards
The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop the processing and distribution of fish products at a California company because of a risk of botulism and other food hazards.
If granted, the permanent injunction against Fujino Enterprises Inc., doing business as Blue Ocean Smokehouse, of Half Moon Bay, Calif., would stop the company from processing and distributing fish and fish products. Blue Ocean’s president Erika Fujino also is named in the government’s complaint.
Blue Ocean processes fresh and smoked fish and fish products including salmon, cod, halibut, Wild King Salmon Candy (a honey-glazed, cold-smoked salmon), hot-smoked tuna, sturgeon and hot-smoked fish cream cheese spreads. Blue Ocean receives fish for processing from outside California, including salmon from Washington state and sturgeon from Oregon.
“This company has ignored warnings by FDA and the California Department of Public Health by continuing to sell seafood that puts consumers’ health at risk,” said Dara A. Corrigan, associate commissioner for regulatory affairs. “We are taking this action, in part, as a result of collaborative enforcement actions with our state partner and as part of our joint efforts to protect the public health.”
The complaint alleges that the company’s fish and fish products are adulterated, because they are processed under conditions that do not comply with the agency’s Hazard Analysis Critical Control Point (HACCP) regulations. HACCP is a science-based system of preventive controls for food safety that is used by commercial seafood processors to identify potential food safety hazards and take steps to keep them from occurring.
The complaint also alleges that Blue Ocean’s fish are adulterated because the conditions under which they are prepared, packed, and held fail to conform to the Current Good Manufacturing Practice requirements for food established to ensure that food is processed in a safe and sanitary manner. An FDA inspection in October 2011 found poor employee sanitation practices and showed that the company’s facility was not maintained in a manner that protected against food contamination.
Blue Ocean’s vacuum-packaged hot and cold smoked fish products may pose a risk for the development of Clostridium botulinum toxin that can cause botulism, a rare but serious illness that may result in paralysis, inhibited respiration, and death. This toxin cannot be removed by cooking or freezing.
Investigators also found Listeria monocytogenes (L. mono) on food-contact and non-food-contact surfaces in the food processing areas of the company’s facility. Listeriosis, the illness caused by L. mono, can cause fatal infections in young children, the elderly, and individuals with weakened immune systems. Pregnant women may suffer miscarriages or stillbirths as a result of the infection.
In addition, Blue Ocean’s tuna products may pose a risk for the development of scombrotoxin (histamine), a toxin that also cannot be removed by cooking or freezing, and that can cause an illness known as scombrotoxin poisoning.
The company’s violations led to its voluntary destruction of almost 1,500 pounds of hot- and cold-smoked fish in October 2011, under the supervision of the FDA and the California Department of Public Health.
The complaint was filed on March 13, 2012, in the U.S. District Court for the Northern District of California.
No illnesses have been reported to date associated with Blue Ocean’s products. Illnesses or adverse events related to these products should be reported to the FDA: http://www.foodsafety.gov/report/index.html.
For more information:
FDA Warning Letter, November 19, 2010
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.