Agroson’s LLC refuses FDA request to voluntary recall of Cavi brand papayas

The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC), and state and local partners, are investigating a multistate outbreak of Salmonella Uganda illnesses likely linked to Cavi Brand whole, fresh papayas.

Total Illnesses: 71
Hospitalizations: 27
Deaths: 0
Last illness onset: June 16, 2019
States with Cases: CT (14), FL (1), MA (5), NJ (18), NY (27), PA (4), RI (1), TX (1)

The FDA has asked Agroson’s LLC, the exclusive distributor of this brand, to conduct a voluntary recall of Cavi brand papayas. Agroson’s LLC refused to initiate a recall. 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.  FDA is doing this to protect consumers as it pursues additional protective and regulatory actions.

For Consumers, Restaurants, and Retailers:

Consumers in all states should not eat any Cavi brand whole, fresh papayas and should throw them away. If consumers are unable to determine the brand of papayas, the product should be thrown away. Retailers, restaurants, and other food service providers in all states should not serve or sell whole, fresh papayas under the Cavi brand, which are distributed by Agroson’s LLC.

Consumers no longer need to avoid whole, fresh papayas, with the exception of Cavi brand papayas.

For Restaurants, Retailers, Importers, Suppliers, and Distributors in All States:

The FDA strongly advises importers, suppliers, and distributors, as well as restaurants, retailers, and other food service providers from all states to not sell or distribute whole, fresh papayas from Agroson’s LLC that are labeled under the Cavi brand.

Based on this new information, the hold FDA advised on June 28, 2019 for all imported Mexican papayas is no longer necessary.

Distributors don’t need to withhold Mexican papayas from distribution, with the exception of the Cavi brand.

Mandatory Recall Authority

In 2018, the U.S. Food and Drug Administration released a final guidance regarding the agency’s mandatory recall authority under the FDA Food Safety Modernization Act (FSMA).

The 2011 food safety law gave FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities, and that the food could cause serious illnesses or death. FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.

This final guidance follows a draft which was made available for public comment in 2015, and provides additional clarity including some modifications based on comments received. The guidance provides questions and answers on FDA’s mandatory recall process, explains what FDA considers when moving forward with a mandatory recall, and more.

Until today, the FDA has issued a mandatory recall order of a food product only once. In April 2018, FDA issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several products were found to contain Salmonella. In two other instances, FDA started down the path of using its mandatory recall authority under FSMA until the companies ultimately chose to voluntarily recall their product.

While FDA’s mandatory recall authority plays an important role in ensuring that potentially dangerous food products are removed from the marketplace, the agency remains committed to working with firms to facilitate the orderly and prompt voluntary removal of potentially dangerous products from the food supply.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.