November 15, 2019
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.
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.
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.
What is Scombrotoxin Fish Poisoning?
Scombrotoxin fish poisoning is caused by eating fish that has high levels of histamine, which is the result of not being properly refrigerated or preserved.
Symptoms typically develop within a few minutes to an hour after eating mishandled and decomposed fish. They usually resemble an allergic reaction and can include flushing of the face, headache, heart palpitations, itching, blurred vision, cramps, and diarrhea. Symptoms can be treated with antihistamines, but even without treatment, people usually get better within 12 hours.
People should consult their healthcare provider if they suspect that they have developed symptoms that resemble scombrotoxin fish poisoning.
Consumers can also submit a voluntarily report, a complaint, or adverse event (illness or serious allergic reaction) related to a food product.
Who to Contact
Consumers who have symptoms should contact their health care provider to report their symptoms and receive care.
To report a complaint or adverse event (illness or serious allergic reaction), you can
- Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to FDA.
Visit www.fda.gov/fcic for additional consumer and industry assistance.