The New York City Health Department is investigating one confirmed and one suspect case of botulism, a rare but serious foodborne illness caused by an extremely potent toxin. Both patients are Chinese-speaking Queens residents and had recently purchased unrefrigerated fresh bulk tofu from the same store in Flushing.

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

The “Rely” Sardine Anchovies were sampled by a New York State Department of Agriculture Food Inspector during inspection. Subsequent analysis of the product by New York State Food Laboratory personnel confirmed that the “Rely” Sardine Anchovies were not properly eviscerated prior to processing.

The sale of un-eviscerated fish is prohibited under New York State Agriculture and Markets regulations because Clostridium Botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish. Uneviscerated fish have been linked to outbreaks of botulium poisioning.

This product may be contaminated with Clostridium botulinum spores, which can cause Botulism, a serious and potentially fatal food-borne illness. Symptoms of botulism include blurred or double vision, general weakness, poor reflexes, difficulty in swallowing and respiratory paralysis.

No illnesses have been reported to date in connection with this problem.

The affected product, Bos brand “Naturally Smoked Herring Fillets – Natural”, was sold refrigerated in various weight packages from Ramaker’s Imports, St. Catharines, ON without a Best Before Date applied to the package. The affected product was sold by Ramaker’s Imports from September 2011 to December 7, 2011.

Consumers who have purchased refrigerated Bos brand “Naturally Smoked Herring Fillets – Natural” from any other retailer without a Best Before Date on the package are also advised not to consume the product.

There have been no reported illnesses associated with the consumption of this product.

Food contaminated with Clostridium botulinum toxin may not look or smell spoiled. Consumption of food contaminated with the toxin may cause nausea, vomiting, fatigue, dizziness, headache, double vision, dry throat, respiratory failure and paralysis. In severe cases of illness, people may die.

The retailer, Ramaker’s Imports, St. Catharines, ON is voluntarily recalling the affected product from the marketplace.

Over at Outbreak Database, we have been keeping track of foodborne illness outbreaks – small and large – over the last 12 months.  Here is one of the more interesting Botulism Outbreaks:

Utah State Prison Pruno October 2011 – 12 Ill.  Inmates of a Utah State Prison developed botulism after drinking pruno. Pruno is a drink made from various fruit, potato, bread, water, table scraps, and sugar, which are then fermented to make alcohol. Making pruno in prison is a violation of prison rules. Most illnesses began on October 1. The last illness began on October 3. Health officials planned to test pruno samples to pinpoint the specific source. Three of the twelve who became ill were critically ill.

• Brand: Gentes Foods
• Product Information: Gordita Black Bean Tortillas
• UPC code: 618032102021
• Date code: 11-6-11 (printed on a white sticker found on the product packaging)
• Net weight: 10 ounces
• Packaging: 6 tortillas per vacuum-packed, clear sleeve container
• Label: white lettering on an orange background

It is important to note that some products under the same date code are not affected by the recall because these products were not exposed to the absence of refrigeration controls. Gentes Foods Gordita Black Bean Tortillas having the same date code sold in the following stores are included in the recall:

• Safeway #110 located at 1546 North Main,Salinas California
• Safeway #2840 located at2010 Freedom Boulevard,Watsonville California
• Safeway #3116 located at2255 Gellert Boulevard, SouthSan Francisco California
• Safeway #3125 located at3889 San Pablo Avenue,Emeryville California

C. botulinum contains neurotoxins related to the muscular paralysis often seen in botulism, a life-threatening condition.

The affected product is sold vacuum-packaged at various weights. All best-before dates and lot codes are affected.

The smoked trout filets have been distributed in Ontario.

There have been no reported illnesses relating to the consumption of the product, according to the CFIA.

Food contaminated with C. botulinum may not look or smell spoiled, but consumption could lead to nausea, fatigue, dizziness and double vision, and in severe cases, paralysis, respiratory failure and death.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

The following product has been recalled:

GENTES FOODS 10 OZ GORDITA BLACK BEAN TORTILLAS UPC 618032102021

Gentes Foods Gordita Black Bean Tortillas were distributed to the Safeway and Pak N Save stores in California listed below. The date code is on a white sticker applied to the packaging that reads “12 7 11.” This date code sold at other retail outlets has not been affected.

• SAFEWAY #1110 1546 N MAIN SALINAS CA
• SAFEWAY #2840 2010 FREEDOM BLVD WATSONVILLE CA
• PAK N SAVE #3116 2255 GELLERT BLVD S SAN FRANCISCO CA
• PAK N SAVE #3125 3889 SAN PABLO AVE EMERYVILLE CA

Gentes Foods Gordita Black Bean Tortillas are packed as 6 tortillas in a vacuum packaged clear sleeve. The package is approximately 10oz in size and an orange label is on a clear wrapper with white lettering.

No illnesses have been reported to date.

These items have been recalled due to a lack of temperature control during the distribution process. UNFI inadvertently subjected the recall items to temperature ranges above those directed by the manufacturer.

The tainted olives were packed in 314ml glass jars, with a best before date of 09/2012. They were imported into Finland by Kespro as early as September 2010. The olives were sold in Finland to K-food stores KCM Big Apple (Espoo), KCM Jumbo (Vantaa) and KSM South Centre (Rovaniemi), and to a few restaurants.

According to a notice posted October 21, 2011 on the Rapid Alert System for Foods and Feeds (RASFF) and updated this morning (October 24th), these olives also were distributed to the United Kingdom and the USA. So far, neither the U.S. Food and Drug Administration nor Britain’s Food Standards Agency has issued a Consumer Alert or a public health advisory of any sort.

Department of Corrections spokesman Steve Gehrke confirmed Friday that the five prisoners had been released from an unspecified area hospital on Thursday; three inmates remained hospitalized in critical condition.

In all, 12 inmates were reported Oct. 5 to have become ill after consuming the brew, which had been mixed and fermented inside a plastic bag hidden in an inmate’s cell, according to the Salt Lake Valley Health Department.

Four inmates were treated at the prison medical facility, while the other eight were hospitalized with symptoms including nausea, vomiting, facial paralysis and blurry vision.

It is thought jars used for tapenade (black olive paste) had not been properly sterilised and further tests have found contamination in other products including dried tomatoes, sandwich spread, pesto and pastes made from anchovies, aubergines, peppers, chickpeas and artichokes.

Public health authorities are asking people not to eat jars of pastes made by the firm La Ruche, from Cavaillon, sold under the brands Les Délices de Marie Claire, Terre de Mistral and Les Secrets d’Anaïs.

It has also asked la Ruche to start withdrawing its products.

An official public health statement said: “Many jars are still in circulation, putting people who might eat them at a severe risk”, adding that as they are sold in popular tourist spots there is a risk that people from all over France and from abroad will have bought them.

On April 8, 2011, a Georgia resident, aged 41 years, was hospitalized after 4 days of progressive dizziness and dysphagia. The patient developed respiratory distress, required mechanical ventilation, and was treated with botulism antitoxin. On April 3, she had tasted potato soup purchased from a local grocer, noted a sour taste, and discarded the remainder. The soup, stored in a plastic container labeled "keep refrigerated" in letters 1/8 inch tall, had been purchased on March 16, but had been left unrefrigerated for 18 days. She was hospitalized for 16 days and then was transferred with residual weakness to a rehabilitation facility.

Botulism is caused by a paralyzing toxin produced by Clostridium botulinum bacteria. C. botulinum spores are present in soil and can be found on raw produce, especially potatoes and other root vegetables (1). If a low-acid food such as potato soup is stored unrefrigerated in an anaerobic environment (e.g., a sealed container), without a barrier to bacterial growth, spores can germinate, resulting in bacterial growth and botulinum toxin production (2). Because heating food to a temperature of 185°F (85°C) for 5 minutes inactivates the toxin, proper preparation also is an important safeguard (3).

Improper storage has been documented in previous botulism outbreaks associated with commercially produced, chilled foods. Since 1975, 19 U.S. botulism cases were linked to six such products. Demand for prepared, chilled foods is increasing (4). Labels advising refrigeration might be ignored or not noticed, and do not warn about the danger of consuming unrefrigerated food. The Food and Drug Administration is reexamining labeling requirements. Storage at an improper temperature also can occur before products reach consumers (5). To inhibit the growth of C. botulinum and other microbes, an acidifying agent or other microbial inhibitor, such as citric or phosphoric acid, can be added to prepared, chilled foods before they are sealed in a package. This procedure was used successfully to reduce the danger of botulism from commercial garlic-in-oil products after two outbreaks (6).

Reported by

Mandy P. Seaman, Alana C. Sulka, Gwinnett County, Georgia Board of Health. Melissa Tobin D'Angelo, Georgia Dept of Community Health. Mitchell A. Blass, St. Joseph's Hospital, Atlanta, Georgia. Randy L. Mills, Ohio State Univ Hospitals East, Columbus; Jane Carmean, Ohio Dept of Health. Carolina Lúquez, Susan Maslanka, Kelly A. Jackson, Barbara E. Mahon, Patricia M. Griffin, Div of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging and Zoonotic Infectious Diseases; Katherine A. O'Connor, Ethel V. Taylor, EIS officers, CDC. Corresponding contributor: Katherine A. O'Connor, kaoconnor@cdc.gov, 404-639-0195.

References

Angulo FJ, Getz J, Taylor JP, et al. A large outbreak of botulism: the hazardous baked potato. J Infect Dis 1998;178:172--7.

Sheth AN, Wiersma P, Atrubin D, et al. International outbreak of severe botulism with prolonged toxemia caused by commercial carrot juice. Clin Infect Dis 2008;47:1245--51.

Sobel J. Botulism. Clin Infect Dis 2005;41:1167--73.

Peck MW. Clostridium botulinum and the safety of minimally heated, chilled foods: an emerging issue? J Appl Microbiol 2006;101:556--70.

Kalluri P, Crowe C, Reller M, et al. An outbreak of foodborne botulism associated with food sold at a salvage store in Texas. Clin Infect Dis 2003;37:1490--5.

Morse DL, Pickard LK, Guzewich JJ, Devine BD, Shayegani M. Garlic-in-oil associated botulism: episode leads to product modification. Am J Public Health 1990;80:1372--3.

The defendants receive their seafood products from outside Minnesota, including tilapia directly imported from China, bony fish shipped to defendants from New York and originating in the Ivory Coast, and croaker shipped to defendants from New Jersey and Florida and originating in Brazil, Uruguay, Guyana, and Argentina. The defendants sell their seafood products to consumers from their retail store, and process and distribute other seafood products wholesale.

"This company has ignored warnings by FDA and the Minnesota Department of Agriculture by continuing to sell seafood that puts the consumer's health at risk," said Dara A. Corrigan, the FDA's associate commissioner for regulatory affairs. "By taking this action, a result of collaborative enforcement efforts with our state partner, FDA is demonstrating its commitment to protecting the public health from the dangers of adulterated and misbranded food products."

The complaint alleges that the company and its officers, Stanley Jide, Adebayo Mafe, and Charles Chiefredo, market and distribute seafood products that are prepared, packed, or held under insanitary conditions under the Federal Food, Drug, and Cosmetic Act.

The FDA considers uneviscerated fish over 5 inches in length that are salt-cured, dried, or smoked, such as the bony fish sold by BCS African Wholesale, to be adulterated because they could contain Clostridium botulinum toxin. The toxin can cause botulism, a serious and sometimes life-threatening condition. The toxin cannot be removed by cooking or freezing. Smaller uneviscerated fish (those 5 or fewer inches long) can be salt-cured, dried, or smoked in a manner that prevents the toxin formation.

FDA says that BCS African Wholesale's bony fish, which are falsely labeled "Gutted Bony Fish," are also misbranded under the Act. FDA says the defendants' fish are also adulterated because the firm failed to comply with the Hazard Analysis and Critical Control Point (HACCP) regulations. HACCP is a science-based system of preventive controls for food safety that commercial seafood processors develop to identify potential food safety hazards and steps to keep them from occurring. The FDA Seafood HACCP program was designed to increase the margin of safety for U.S. consumers and to reduce illnesses to the lowest possible levels.

The FDA sent BCS African Wholesale a warning letter on July 20, 2010, after FDA and the Minnesota Department of Agriculture inspected the company's facility. In response to the warning letter, the defendants assured FDA that they were no longer selling uneviscerated fish. FDA and MDA jointly inspected the facility two months later and found that the defendants were still selling adulterated seafood, including uneviscerated bony fish that were also misbranded. After both inspections, MDA embargoed the potentially dangerous fish at BCS African Wholesale to prevent their distribution to the public.

The complaint was filed on May 31, 2011, in the U.S. District Court for the District of Minnesota.

It was on a Thursday night that Lavista Williams noticed her daughter's cry sounded different. By the next morning, even though Mya took her formula fine, her cry was "really, really weak. Her arms were floppy, her head fell back. She couldn't roll on her side." Alarmed at her daughter's condition called an ambulance to take her to a local emergency room. The doctor there ordered X-rays and blood work which revealed nothing. "She's OK, take her home," he advised. There was no pediatrician on staff in the emergency room.

Williams ignored the directive to go home, called ahead to the children's hospital and made the 40-minute drive to its emergency room. "Everything was immediately fast-paced," she says. "They took her vitals and ran three tests on her. By then her legs, which had been strong, stopped moving. Her cry was a whisper and her breathing was raspy." When the two doctors who treated her saw how weak she was, they called in a pediatric neurologist.

Pediatric neurologist Ralph Northam responded and ran a nerve conductivity test and a spinal tap, both of which came back fine. The final tip-off for the neurologist was that in addition to her saliva pooling from her difficulty swallowing, Mya had been constipated for a couple of days. "Her muscles were not getting the message from her nerves," he says. He admitted her to the intensive care unit where she stayed for 17 days, 12 of those on a ventilator.

Mya's recovery time was speeded up significantly — from several months to a few weeks — by the administration of a single dose of botulism immune globulin, better known as "BabyBIG," an antidote that had to be ordered from California. Administered by IV in a couple of hours, the single dose cost $45,300.

It's unclear what the spore source was for Mya's illness but she had reportedly not been fed honey.

A: Although botulism is a rare condition in the United States -- with about 110 cases reported annually -- it can and does occur worldwide.

Botulism is caused by a toxin made by the bacteria Clostridium botulinum, which is common and may be found in soil and untreated water throughout the world. The bacteria make spores which can survive for long periods of time, however, if the spores are heated to 250 degrees for at least five minutes they are destroyed, so proper food preparation (for example, for home canning) is important.

People get sick from botulism toxin in one of three ways:

* Infants may ingest the bacteria, most commonly from being given honey or corn syrup (sometimes on their pacifier). The bacteria may then take up residence in the intestines and produce toxin. Almost three quarters of the cases of botulism in the U.S. are in infants, with the highest incidence in Utah, Pennsylvania and California, where Clostridium botulinum spore counts in the soil are high. It is very unlikely for adults to get botulism in this way since most normal adults' intestines are resistant to colonization with this bacterium.

* The botulism toxin can be directly ingested from improperly prepared foods. In fact, there are occasional outbreaks of botulism from poorly prepared home-canned foods, improperly cured meats, smoked or raw fish, honey or corn syrup. About a quarter of the botulism cases in the U.S. are from this type of food poisoning. Although the toxin itself has no taste or smell, some (but not all) strains of Clostridium botulinum "spoil" the food, making it smell and/or taste bad and even causing the can it is stored in to bulge.

* A small number of cases of wound botulism -- where the toxin enters the body through a break in the skin -- are reported every year in the U.S. Once inside the body, the toxin enters the bloodstream and then binds to part of a specific type of nerve (the presynaptic terminal in cholinergic nerves). This binding permanently disrupts the function of these nerves; it takes months for them to produce new normally functioning synapses.

Since this is a poisoning and not an infection, there is no fever with this condition. If it occurs from ingestion of the toxin or the bacteria, gastrointestinal symptoms can occur.

The nerves affected can be those responsible for making the eyes move and the pupils dilate or constrict, so vision problems are common.

Other nerves -- such as those responsible for speech, swallowing or making the facial muscles move -- may be affected. As the toxin begins to involve the nerves going to the muscles, the patient develops paralysis.

This is a descending paralysis with the arms affected before the legs. When the muscles that allow the patient to breathe are affected, respiratory failure can occur.

Depending on the amount of toxin present in the patient's system, symptoms may progress from mild to severe (and life-threatening) over hours, days or even weeks.

The first step in diagnosing botulism is considering the possibility; a descending paralysis raises suspicion of this condition, as does respiratory failure in an otherwise healthy infant. The diagnosis is confirmed by demonstration of the toxin in the patient's blood. Even if this test is negative in infants, finding spores in their stool confirms the diagnosis. Finding the bacteria in a wound confirms the diagnosis in patients with wound botulism.

Since the disease can progress rapidly, treatment for botulism is initiated even without confirmatory tests when the suspicion is high.

* The first step is supportive care; patients with respiratory failure require intubation (a tube placed in their airway and a machine used to breathe for them).

* Although wound botulism may benefit from antibiotics, the other types do not and antibiotics are not indicated.

* Human antibody antitoxin is recommended for infants, and horse serum antitoxin for those over age 1. The antitoxins may prevent more nerves from being affected, but since the nerve damage is irreversible once it has occurred, the patient will need supportive care until the nerves repair themselves, often for months.

Less than 10 percent of treated adults die. The prognosis is even better in appropriately treated infants, with less than a 1 percent mortality rate. The milder the disease, the more likely the patient will completely recover back to their baseline.

In order to prevent botulism, do not give honey or corn syrup to infants. Be sure to prepare home-canned foods and home-cured meats correctly. Throw away spoiled foods. Seek emergency treatment if you develop symptoms suggestive of botulism poisoning.

Jeff Hersh, Ph.D., M.D., F.A.A.P., F.A.C.P., F.A.A.E.P

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

Product Description UPC Code Packaging Lot Number(s)

Mama Rose's Cilantro Con Queso 7 90648 09020 3 12oz jars All 6 digit Lots beginning with 260… & 270…

Mama Rose's Garlic Con Queso 7 90648 09010 4 12oz jars All 6 digit Lots beginning with 260… & 270…

Mama Rose's Viper Venom Con Queso 7 90648 09000 5 12oz jars All 6 digit Lots beginning with 260… & 270…

Mama Rose's Hopi Corn Salsa 7 906480 1070 6 12oz jars All 6 digit Lots beginning with 260… & 270…

Fred Harvey Hopi Corn Salsa 4 52030 16600 4 12oz jars All 6 digit Lots beginning with 260… & 270…

All Con Queso expiration dates of 01/10/12 and earlier and Salsa expiration dates of 01/06/13 and earlier located on a white sticker on the bottom of the jar are affected by this recall.

The listed Con Queso and Corn Salsa products were distributed in AZ and WA through retail stores and gift shops.

Consumers should not to use the product even if it does not look or smell spoiled. The sauce was manufactured by First Commercial Kitchen LLC.

Botulism, a potentially fatal form of food poisoning, may cause the following symptoms: general weakness, dizziness, double-vision, and trouble with speaking or swallowing. Difficulty in breathing, abdominal distension, and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

The Black Bean Sauce is sold in 12oz. glass jars and labeled as Barb's Local Style Black Bean Sauce or Ohana Flavors Black Bean Sauce. The UPC numbers on the product are 6-75981-42491-8 and 7-02003-72739-6. The recalled sauce was distributed on Oahu and Molokai.

No illnesses have been reported to date in connection with this problem. A routine inspection discovered the problem.

Hank J. Hagen and Milton S. Reid and their company, Mystical One LLC (also known as Mystical One Juice LLC), are charged with violating the Federal Food, Drug, and Cosmetic Act by failing to have a Hazard Analysis and Critical Control Point (HACCP) plan for certain juice products, such as the company's carrot juice products, and by failing to comply with current Good Manufacturing Practice (cGMP).

The FDA requires all juice processors to prepare and implement HACCP plans that identify and control food hazards associated with their juices, and it requires all food manufacturers to follow cGMP. The FDA is not aware of illnesses associated with Mystical One's juice products.

Among the violations observed by FDA investigators were failures to:

• adequately heat low-acid vegetable juices to destroy or prevent growth of dangerous microorganisms;

• properly clean food-contact surfaces; and

• maintain and monitor sanitation conditions at the manufacturing facility to prevent sources of possible food and water contamination.

Failure to identify and control food hazards could lead to the formation of Clostridium botulinum bacteria that can germinate in the carrot juice made by the company. The neurotoxin formed by these bacteria, when ingested in even very small amounts, could cause paralysis, difficulty breathing and death from asphyxiation. In 2006, six cases of botulism in the United States and Canada were linked to refrigerated carrot juice.

The complaint also charges Mystical One, Hagen and Reid with failing to conform to cGMP requirements for making, packing, or holding human food. Beverage products produced under conditions that do not comply with HACCP or GMP requirements are considered adulterated under the Act.

Violations cited by the FDA involved the following brands:

• Fresh Carrot Juice,

• Magnum Food Drink,

• Pineapple Ginger Drink,

• Sorrel & Ginger,

• Sea Moss, and

• Peanut Punch.

The company purchases ingredients, such as carrots, that originate outside of New York and sells products to food service establishments primarily in New York, Connecticut, and Pennsylvania.

The FDA's most recent inspection at the Mystical One facility in August 2010 found the same or similar violations observed during previous inspections of the company. The agency issued a warning letter to the company in October 2009 and the company agreed to bring its operations into compliance. However, Mystical One did not make the necessary changes.

"This action shows that FDA will take strong enforcement action against companies that fail to put the required preventive controls in place to protect their customers from foodborne illness," said Associate Commissioner for Regulatory Affairs Dara A. Corrigan. "Mystical One failed to adhere to food safety guidelines and we have stopped their operation."

The injunction was filed by the Office of Loretta E. Lynch, United States Attorney for the Eastern District of New York, together with the Department of Justice's Office of Consumer Litigation.

JFC International distributed the frozen capelin, a species of smelt, nationwide. The capelin is uneviscerated, meaning the digestive organs are intact, thus increasing the risk of contamination.

The capelin was imported from Vietnam and distributed on Styrofoam trays and wrapped in plastic wrap.