FDA Releases the CORE 2022 Summary of Foodborne Outbreaks and Adverse Events in FDA-Regulated Human Foods

FDA Releases the CORE 2022 Summary of Foodborne Outbreaks 
and Adverse Events in FDA-Regulated Human Foods 
By Laurie Post, Ph.D. 

On January 8, the U.S. FDA Coordinated Outbreak Response & Evaluation (CORE) Network published its first annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA regulated human foods for the 2022 calendar year.

The FDA’s CORE Network was established in 2011 to coordinate FDA’s efforts to find, stop, and prevent  foodborne illness outbreaks.  These goals are met through disease surveillance, outbreak response, post-response activities, and collaboration with CDC and state and local public health agencies.  Since inception, CORE teams have identified 959 potential outbreaks, responded to 234 outbreaks potentially linked to FDA regulated food products, identified a specific food in 100 outbreaks, and warned consumers to avoid those foods through more than 400 public notifications. Closed investigations conducted in 2020 through 2023 are detailed on FDA’s Investigation website.   

In 2022, CORE evaluated 65 incidents, responded to 28, and issued advisories for 11.  These numbers show a slight increase in the number of incidents evaluated in recent years, with 59 incidents evaluated, 19 responses, and 10 advisories issued in 2021.  The investigations in 2022 included E. coli, Cronobacter, hepatitis A virus, Listeria monocytogenes, and Salmonella which were linked to a variety of products, including produce (37%), dairy (8%), fish (8%), nuts and seeds (8%), and multi-ingredient foods (8%).  A specific associated food was not identified in 31% of the investigations.

CORE investigations also resulted in numerous public health actions, including recalls, public health advisories, Warning Letters, FDA prevention strategies, a country-wide Import Alert, and a Consent Decree.

The 2022 annual report highlights several notable outbreaks including Listeria monocytogenes linked to enoki mushrooms, Salmonella linked to cantaloupe, and Salmonella linked to peanut butter.

Current information on outbreak-related activities and investigations can be found on the CORE Investigation Table, FDA’s Public Health Advisories, Outbreak Investigation Reports, and Publications. Information on outbreaks linked to products regulated by the USDA’s Food Safety and Inspection Service (FSIS) can be found on their website.  CDC also publishes annual summaries that include information on outbreaks related to both FDA- and USDA-regulated products.  

How FDA Investigates Foodborne Illness Outbreaks

Every year the FDA responds to dozens of foodborne outbreaks to determine the source of the foodborne illness outbreak and halt the progression of illness.  Updates on the outbreak and adverse event investigations managed by FDA’s CORE Response Teams are published weekly.  Investigation tables may report limited information while investigations are in progress, with more information available as investigations reach completion. 

A public health advisory is issued for investigations that have resulted in specific, actionable steps for 
consumers to take to protect themselves.

Outbreak and adverse event investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors.  Adverse event investigations rely on self-reported data. Although these reports may name a particular product, FDA will only indicate a product category in the Adverse Event table and will not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events.  FDA provides a summary of their findings if a cause and/or contributing factors are identified that could assist future prevention activities.

FDA investigates outbreaks of foodborne illness using a traceback approach where movement of certain products through the supply chain is traced from the end consumer back to  the farm or manufacturer.  In the early stages of an outbreak investigation, traceback is important in identifying the specific product causing illness.  Traceback is also used to determine the source and distribution of the product causing illnesses to allow efficient removal from the marketplace.  For additional information, see How the FDA Uses Traceback to Respond to Foodborne Illness Outbreaks.

The FDA provides an overview of the traceback process used to examine the complex pathway food travels through the supply chain in a video and infographic.  The video explores how the CDC works with public health authorities to conduct epidemiological investigations to identify a source and how the FDA investigates the cause of the outbreak, works with industry to remove any potentially contaminated product from the marketplace, and partners with the CDC, and local and state public health agencies to issue public warnings.