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FDA Investigation of Scombrotoxin Fish Poisoning Linked to Yellowfin/Ahi Tuna/gassed tuna

November 20, 2019 — The following was released by the U.S. Food and Drug Administration:

FDA and state health authorities are investigating incidents of scombrotoxin fish poisoning linked to yellowfin tuna, also sometimes called ahi tuna. As a result of this investigation, FDA has placed Truong Phu Xanh Co, LTD of Vietnam on Import Alert, which provides information to FDA field staff that they may detain the firm’s yellowfin tuna without physical examination. Detained product will not enter the United States unless the importer proves that it meets U.S. food safety standards.

FDA asked for the supplier of yellowfin tuna associated with most of the illnesses, Truong Phu Xanh Co., LTD of Vietnam, to initiate a voluntary recall of all of its imported yellowfin tuna with production dates from January 2019 to the present. At this time, the firm has not recalled any product.

As part of the investigation, FDA evaluated the firm’s Hazard Analysis and Critical Control Point (HACCP) Plans. A HACCP Plan details a firm’s management system to address food safety through the analysis and control of biological, chemical, and physical hazards. Since FDA’s evaluation of this plan identified deficiencies, we asked for Truong Phu Xanh Co., LTD of Vietnam to initiate a voluntary recall of all of its imported yellowfin tuna with production dates from January 2019 to the present.
 
The investigation has identified 47 illnesses of scombrotoxin fish poisoning that occurred between August 8, 2019 and October 15, 2019.
 
Throughout the investigation, FDA and states have also been collecting product samples for testing. Scombrotoxin fish poisoning occurs when fish begin to spoil, resulting in increased histamine levels. Therefore, product samples cannot be linked to case patient samples through Whole Genome Sequencing (WGS) or Pulsed-Field Gel Electrophoresis (PFGE) analysis like for other foodborne illnesses, e.g., Salmonella or Listeria. Instead, samples are tested for decomposition and/or histamine levels. Multiple samples have been collected and analyzed, with positive results for decomposition or high histamine levels in products imported from Truong Phu Xanh Co., LTD.
 
FDA and state partners collected epidemiologic and traceback information for reported illnesses. As additional epidemiologic and traceback information was collected, FDA and state partners were able to work with companies throughout the supply chain to voluntarily recall implicated product. While recalls were conducted at various points in the supply chain, there may be additional product still on the market that could cause illness.
 
Ultimately, the coordinated investigation was able to identify Truong Phu Xanh Co., LTD as the common supplier of tuna that was likely consumed by most of the ill people.
 
Because scombrotoxin fish poisoning causes temporary or medically reversible adverse health consequences this incident did not meet the threshold for the use of FDA’s mandatory recall authority.
 
It has been determined that the source of the tuna for the illnesses announced by Seattle-King County Public Health Department is not related to Truong Phu Xanh Co., LTD.
 
Recommendations
 
Yellowfin tuna from Truong Phu Xanh Co., LTD with a production date in 2019 should not be consumed because it may have the potential to cause scombrotoxin fish poisoning. Tuna from this supplier could have been sold thawed or frozen; and could have been sold as ground tuna meat, poke cubes, steaks, or loins; this product could still be within its shelf life.­­
 
Scombrotoxin fish poisoning occurs when fish is not properly chilled or preserved and begins to spoil, resulting in increased histamine levels. Histamine cannot be destroyed by freezing or cooking.
 
Importers, Suppliers, and Distributors:
 
Importers, suppliers, and distributors should not use and should discard or destroy any yellowfin tuna imported from Truong Phu Xanh Co., LTD with a production date in 2019.
 
Restaurants and Retailers:
 
Restaurants and retailers should contact their suppliers to confirm the source of their yellowfin tuna because not all product was distributed in packaging that identifies Truong Phu Xanh Co., LTD. Yellowfin tuna imported from this company with a production date in 2019 should not be used, served, repacked, or sold; and should be discarded.
 
Consumers:
 
While we expect restaurants and retailers will have removed yellowfin tuna with a production date in 2019 from the Vietnamese supplier Truong Phu Xanh Co., LTD, consumers should ask if the yellowfin tuna being served or sold was imported from the Vietnamese supplier Truong Phu Xanh Co., LTD and has a production date in 2019.

FDA panel endorses wider use of fish-oil drug to protect against heart problems

November 15, 2019 — A panel of experts unanimously recommended Thursday that the Food and Drug Administration allow wider use of a fish oil-based drug to treat people at high risk for heart attacks and strokes even when they are taking cholesterol-lowering drugs.

The 16-0 endorsement of the FDA advisory committee puts Dublin-based Amarin Corp. one step closer to widespread distribution of Vascepa, a drug the company has said could be worth billions of dollars annually. The FDA, which usually follows such guidance, could make a long-awaited final decision next month.

“There’s a definite need for additional therapeutic approaches,” said Kenneth D. Burman, chief of the endocrine section at MedStar Washington Hospital Center, who chaired the panel. Despite some side effects, he said, “this seems a very useful new agent for addition to the armamentarium for the treatment of these patients.”

The drug, a purified version of the Omega-3 fatty acid found in fish, is aimed at some of the more than 40 million people in the U.S. who take statins to control their LDL, or “bad” cholesterol, and have adopted lifestyle changes, yet remain at risk of cardiovascular problems because of elevated triglyceride levels.

Triglycerides are another type of fat in the blood. When their levels are too high, generally more than 200 milligrams per deciliter of blood, the result can be deaths, heart attacks, strokes, unstable angina or the need for cardiac surgery.

A landmark 2018 study, led by a researcher at Brigham and Women’s Hospital and sponsored by Amarin, showed that patients who took four grams of Vascepa daily fared 25 percent better in staving off those events than those given a placebo. The researchers spent more than six years following more than 8,000 middle-aged and older patients in 11 countries who had coronary artery disease or diabetes and at least one other risk factor, such as high blood pressure.

Read the full story at The Washington Post

FDA warns about eating Kroger yellowfin tuna after illnesses

September 9, 2019 — The U.S. Food and Drug Administration is warning consumers not to eat raw yellowfin tuna steaks from several Kroger stores after some consumers became ill with scombroid poisoning.

On 4 September, the FDA became aware of multiple scombroid poisoning cases in individuals who consumed tuna steaks purchased from three separate Kroger retail locations in Ohio, the agency said in a press release.

Read the full story at Seafood Source

US lieutenant governors call for more inspections on imported seafood

July 24, 2019 — Lieutenant governors in the United States have put their weight behind a resolution sponsored by Lt. Governor Billy Nungesser (R-Louisiana) calling for additional inspections of imported seafood.

The resolution was approved at the National Lieutenant Governors Association annual meeting, which took place last week in Wilmington, Delaware. It calls on the U.S. Food and Drug Administration and the U.S. Department of Agriculture to “take immediate measures” to inspect foreign seafood, both at the point of harvest and when it enters the country.

Nungesser’s resolution was supported by Lt. Governor Susan Bysiewicz (D–Connecticut), Lt. Governor Bethany Hall-Long (D–Delaware), Lt. Governor Kate Marshall (D–Nevada) and Lt. Governor Kevin Meyer (R–Alaska).

The resolution calls on the creation of an inspection fee in the range of USD 0.05 (EUR 0.04) to USD 0.10 (EUR 0.09) per pound. Seafood caught by American fishermen and sent overseas for processing would be exempt from the inspection process.

Read the full story at Seafood Source

Groups praise updated US government seafood guidance

July 9, 2019 — U.S. seafood groups are lauding an updated government guidance that encourages pregnant and breastfeeding women and children to eat more seafood.

The U.S. Food and Drug Administration is updating its 2015-2020 Dietary Guidelines for Americans, released in 2017, which recommends that Americans eat at least eight ounces of seafood per week, based on a 2,000-calorie diet. While FDA did not increase the amount of seafood adults should eat, it is emphasizing the nutritional benefits – particularly to pregnant and breastfeeding women as well as children – of eating at least eight ounces of seafood weekly.

The agency also aims to help consumers who should limit their exposure to mercury choose from the many types of fish that are lower in mercury – “including ones commonly found in grocery stores, such as salmon, shrimp, pollock, canned light tuna, tilapia, catfish and cod,” the FDA said in a press release.

However, “it is important to note that women who might become pregnant, or who are pregnant or breastfeeding – along with young children – should avoid the few types of commercial fish with the highest levels of mercury listed on the chart,” FDA said.

Read the full story at Seafood Source

FDA study finds “forever chemicals” in grocery-store seafood

June 4, 2019 — The U.S. Food and Drug Administration has released the results of a wide-scale study investigating the presence of so-called “forever chemicals” in U.S. supermarket food.

The FDA found levels of per- and polyfluoroalykyl (PFAs) and other fluorocarbon resins – which are grease-proofing agents used in non-stick cookware, fast food wrappers, microwave popcorn bags and numerous other foodservice and food retail applications in many foods, including seafood – in market basket sampling done at grocery stores and supermarkets in three undisclosed U.S. cities in the mid-Atlantic region.

The FDA found PFAs at levels ranging from 134 parts per trillion to 865 parts per trillion in tilapia, cod, salmon, shrimp, and catfish, as well as numerous meat products, according to an FDA presentation at the Society of Environmental Toxicology and Chemistry in late May, the Associated Press reported.

FDA spokesperson Tara Rabin told the AP that her agency rated PFAs as “not likely to be a human health concern,” but the levels of chemical contamination found in the seafood tested were more than double the FDA’s recommended 70-parts-per-trillion limit for safe drinking water.

Read the full story at Seafood Source

Cell-based seafood faces labeling fight in US

June 3, 2019 — Those who remember the introduction of surimi to the U.S. in the early 1980s might still recall a fight that rose to the federal level involving what it would officially be named.

“Sea Legs,” “King Krab,” “Crab Shapes,” and “crab sticks” were all put forward as options. Eventually, the U.S. Food and Drug Administration required – but did not have the manpower to enforce – the term “imitation crab.” Finally, it agreed in 2006 to the long-winded “Crab-flavored seafood, made with surimi, a fully cooked fish protein.”

Previously, the U.S. government oversaw a protracted fight by the dairy industry against “oleomargarine.” The fight involved questions over classification of the product for tax purposes and a mishmash of state laws, some of which included a requirement to sell margarine in its original pale grey color – the yellow dye to be physically mixed in by the consumer – to avoid deception.

Now the scene is playing out for cell-based meats, if that is what they will finally be called.

“Cell-based meat,” “cell-cultured meat,” or “lab-grown meat,” are all terms referring to artificially cultured muscle or organ cells of animals. The Good Food Institute (GFI), which lobbies for and promotes the plant-based meat analog and cell-based meat industries, promotes the term “clean meat.”

“Rather than obtaining meat from animals raised on environmentally destructive factory farms and slaughtered in filthy slaughterhouses, clean meat is produced by taking a small sample of animal cells and replicating them in a culture outside of the animal. The resulting product is 100 percent real meat, but without the antibiotics, E. coli, salmonella, or waste contamination – all of which come standard in conventional meat production,” the organization explains on its website.

Read the full story at Seafood Source

Rash of catfish recalls caused by agency confusion

March 7, 2019 — The rash of wild and farmed catfish recalls in the United States since the beginning of this year may be caused by confusion over which regulatory agency oversees catfish inspections.

More than a year after a controversial regulation shifting inspections of all siluriformes (catfish) from the U.S. Food and Drug Administration to the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) went into effect, many catfish importers – and some domestic suppliers – remain unaware of the change, sources told SeafoodSource.

In addition, FSIS “discovered a lesser known species of siluriformes fish (sheat) in commerce without FSIS inspection, resulting in a recall,” Buck McKay, public affairs specialist with FSIS, told SeafoodSource.

“Working with our federal partners at Customs and Border Patrol (CBP) and the FDA, FSIS identified additional recent shipments of this fish imported by other companies resulting in two additional recalls,” McKay said.

FSIS identified a fourth product in commerce while performing effectiveness checks for one of the recalls.

As a result, five importers were forced to recall thousands of pounds of catfish that were not presented for re-inspection by FSIS. The agency did not find a food safety risk with the catfish.

Read the full story at Seafood Source

Trump’s signature gives 26% boost to imported seafood inspections

February 19, 2019 — Don’t be surprised to see more scrutiny by the US Food and Drug Administration (FDA) of imported seafood over the next few months thanks to the inclusion of Senate language in the final fiscal year 2019 appropriations bills signed by president Donald Trump on Friday.

The legislation retains language earlier argued for by Louisiana Republican senators John Kennedy and William Cassidy that requires FDA spend at least $15 million on its inspections of imported seafood during the fiscal year, a $3.1m, or 26%, increase over fiscal 2018.

The US government’s fiscal year ends on Sept. 30, meaning the impact could be felt shortly.

The Senate voted, 83-16, on Thursday afternoon to approve a legislative package that included seven spending measures, and the House followed suit with a 300-128 vote later in the evening. Trump’s signature on Friday ended the months-long budget standoff tied to his efforts to secure funding for a wall on the southern border, though a battle now is expected to begin over his much-reported national emergency declaration.

Read the full story at Undercurrent News

Agreement to end government shutdown brings relief to US seafood industry

January 28, 2019 — Workers at NOAA Fisheries and other federal agencies returned to their jobs Monday, 28 January, for the first time in more than a month, thanks to an agreement reached Friday between the U.S. Congress and the administration of President Donald Trump.

However, the resumption could be short-lived, as the deal to fund several government agencies lasts for only three weeks. That means another shutdown could happen next month if lawmakers and President Trump cannot finalize spending priorities for the 2019 fiscal year or approve another temporary bill.

While the talks hinge on whether the president gets funding for a border wall, numerous other policies and initiatives have been affected by the impasse. That includes some tied to the seafood industry.

For example, while the Food and Drug Administration maintained inspecting foreign seafood imports during the shutdown, funding for additional inspections remains in limbo.

Last July, the Senate passed a bill that would add more than USD 3 million (EUR 2.6 million) in funding for such inspections. However, the House failed to pass the bill, which would increase inspection funding by 26 percent, before Congress’ term ended at the beginning of this month.

Since the new Congress convened, the House has passed a bill that includes the funding, first proposed by U.S. Sen. John Kennedy (R-Louisiana). That bill has yet to pass in the Senate.

Read the full story at Seafood Source

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