FDA considers ‘regulatory actions’ against papaya distributor

FDA considers ‘regulatory actions’ against papaya distributor

(CORRECTED July 22) In response to a distributor’s refusal to recall Mexican papayas implicated in a salmonella outbreak, the Food and Drug Administration has alerted all of its customers and is pursuing other actions.

The FDA released an update July 19 on the Salmonella Uganda outbreak it has linked to Cavi brand whole papayas distributed by Agroson’s LLC, Bronx, N.Y.

“FDA contacted wholesale customers of Agroson’s LLC to ensure the fruit was no longer available for sale, has been discarded, or not further processed or frozen,” according to the notice. “FDA is doing this to protect consumers as it pursues additional protective and regulatory actions.”

No Cavi brand papayas have tested positive for pathogens, said Scott Davidson, a trade consultant with Miami-based Davidson Law Group, which has Agroson’s as a client. He said the July 19 update is a punishment to for refusing to recall “clean product.”

Davidson said FDA inspectors have approved Cavi papayas for entry into the U.S. after the agency contacted the company in early July.

“Since the agency has not found any trace of salmonella, Agroson’s should not be expected to issue a recall,” Davidson said in an e-mail. “We have confidence in FDA’s sampling practices, and trust that FDA’s lab technicians are reporting accurate results. Since FDA’s lab technicians have not identified any health threat in Cavi brand Papayas, we do not see any valid reason for issuing a voluntary recall.”

FDA spokesman Peter Cassell has said a positive test linking a company or food product to an outbreak is just one of three ways investigators can identify the source. Traceback and epidemiological evidence are the other two.

Cassell said it’s not uncommon for recalls or consumer alerts, even when there are no positive tests.

The Food Safety Modernization Act gives the FDA the power to force a product recall. Cassell said the process includes appearing before a judge, where the FDA and the company will present evidence.

In the July 19 update, the FDA again asserted that consumers should not eat whole, fresh Cavi brand papayas, and if they are unable to determine the brand, to throw it away. The agency also said retailers, wholesalers and foodservice providers should not sell or serve Cavi papayas.

All other brands of papayas are OK to distribute, according to the notice.

The number of consumers who became ill in the outbreak is 71, the same number from a July 5 FDA update. The last illness reported in connection with the outbreak was on June 16.


DeLauro demands action

Rosa DeLauro, D-Conn., a frequent critic of the FDA in the wake of foodborne outbreaks, said the FDA should use its mandatory recall authority against Agroson’s.

In a July 19 statement, DeLauro said Congress gave the FDA the power to force a recall because “too often corporations fail to act in the public’s interest.”

“But the passive approach it has taken in response to this salmonella outbreak has threatened people and their families. That is unacceptable,” she said in the statement. “FDA must immediately employ its mandatory recall authority and send a strong message that this uncooperative behavior will not be tolerated.”

Note on correction: Scott Davidson's title in the original article was incorrect.

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