November 15, 2019
“Based on our traceback investigation of recent cases of Scombrotoxin fish poisoning, the FDA is warning all sectors of the supply chain to discard certain tuna supplied by Truong Phu Xanh Co., LTD of Vietnam and advising consumers not eat any of this product. Additionally, the FDA has placed the company on Import Alert, which provides information to FDA field staff that they may detain the company’s yellowfin tuna without physical examination from entering U.S. borders. Detained product will not enter the U.S. unless the importer proves that it meets U.S. food safety standards. We have asked for a recall but the company to date has not taken that action, so we are issuing this public warning,” said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas. “Previous voluntary recalls of this tuna product by certain sectors of the supply chain that were initiated early on in our investigation removed some affected product from the market. However, after further traceback we identified Truong Phu Xanh Co., LTD as the common supplier of yellowfin tuna that was likely consumed by most of the ill people. We became concerned that additional product that could cause illness may be available to consumers and is why we are issuing this warning and Import Alert.”
The U.S. Food and Drug Administration, along with state and local partners, is announcing an investigation of several cases of Scombrotoxin fish poisoning linked to yellowfin tuna, also sometimes called ahi tuna, supplied by Truong Phu Xanh Co., LTD of Vietnam. Consumers, importers, suppliers, distributors, retailers and restaurants are being warned to immediately discard tuna from this supplier with production dates from January 2019 to the present.
To date, this investigation includes 47 illnesses of Scombrotoxin fish poisoning linked to yellowfin tuna. The last known illness traced to this product occurred on Oct. 15. Throughout the investigation, the FDA and states have been collecting product samples for testing. When Scombrotoxin fish poisoning occurs, 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. The FDA and state partners also collected epidemiologic and traceback information for reported illnesses.
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. 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.
Because Scombrotoxin fish poisoning causes temporary or medically reversible adverse health consequences, this incident did not meet the threshold for the use of the FDA’s mandatory recall authority. That said, the FDA has asked that the company initiate a voluntary recall of all of its imported yellowfin tuna with production dates from Jan. 2019 to the present. This request was based on the long shelf life of the product, the convergence of our traceback investigation on this supplier, positive product samples, and the review of the firm food safety plans. At this time the firm has not recalled any product.
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.