FDA Threatens Papaya Importer With Five-Year Debarment, Import Alert

The Food and Drug Administration threatened to ban a New York-based company from importing food for five years after a series of outbreaks and a purported lack of cooperation from the company. In a warning letter dated Aug. 26, FDA told Agroson’s that it has been connected to three outbreaks of salmonella related to imported papayas, and threatened to put Agroson’s on import alert or debar the company from importing if it doesn’t respond with actions it is taking to correct the violations.

According to FDA, the most recent outbreak occurred over the course of 2019, with Cavi brand papayas strongly implicated in the string of illnesses. Agroson’s imported Cavi papayas sold in four of the five stores that were identified in an FDA traceback investigation, and Cavi papayas were also sold in the fifth, the warning letter said.

But when FDA requested that Agroson’s conduct a recall, the company refused, FDA said. And after FDA released a public notice July 5 to inform consumers of the outbreak, Agroson’s “sent a letter to multiple customers stating that FDA’s statements were not factual and should be retracted,” the agency said. Agroson’s also “posted on its public Facebook page that FDA’s assertion that your papayas are the source of the recent Salmonella illnesses is false,” FDA said.

Agroson’s was also connected to an outbreak in 2017, when it conducted a recall of its imported papayas. The company also had shipments of papayas refused in 2011 that were sampled and found to contain salmonella.

“You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action,” including putting Agroson’s on import alert. “Furthermore, based on your pattern of importing or offering for import adulterated food that presented a threat of serious adverse health consequences or death to humans or animals, you and your firm may be subject to future regulatory action, including but not limited to, debarring you for a period of up to five years from importing articles of food or offering such articles for import into the United States,” FDA said.

FDA gave the company 15 days to respond to its warning letter. The agency noted that it also recently conducted an inspection related to Agroson’s Foreign Supplier Verification Program and received a written response from Agroson’s about the inspection’s findings. FDA “will follow up with our evaluation of your submission and compliance with FSVP requirements at a later date,” the agency told Agroson’s.

Also on Aug. 26, FDA wrote to the American Association of Exporters and Importers, the Express Association of America and the National Customs Brokers and Forwarders Association of America and the papaya industry about the outbreak. "Since 2011, FDA has noted a pattern of recurrent outbreaks tied to consumption of imported papayas from Mexico," the agency said in the letter. It noted that the FSVP "makes importers responsible for verifying that the foods they bring into the United States, including papaya, have been produced in a manner that meets applicable U.S. safety standards (e.g. the Produce Safety Rule)." The agency will "use all the tools and enforcement powers we have available to further strengthen safeguards and prevent contaminated papayas from being imported into the U.S.," it said.