This report includes information on incidents investigated by the United States Food & Drug Administration’s (FDA) Office of Coordinated Outbreak Response, Evaluation, & Emergency Preparedness (CORE+EP), within FDA’s Human Foods Program (HFP), that were linked to FDA-regulated human food in the 2024 calendar year.
Note from the CORE+EP Director
In 2024, FDA’s Center for Food Safety & Applied Nutrition was part of the single largest reorganization in FDA’s modern history and became known as the Human Foods Program. With this reorganization, CORE expanded to become CORE+EP. While the CORE teams continue to safeguard public health by ensuring the safety and integrity of the nation’s food supply through continued outbreak detection, response, and aiding in prevention efforts, the EP side is focused on the management of food defense, traceability, and supply chain programs.
We managed several high-profile investigations throughout 2024, including a large outbreak of E. coli linked to carrots, a historical outbreak of illnesses associated with cheese that had stumped investigators since 2018, and a novel adverse events series linked to Diamond Shruumz-Brand Chocolate bars, cones, and gummies.
Beyond responding to outbreaks and certain adverse events, the information included in this report highlights just a few of the activities CORE+EP engages in outside of outbreak and adverse event investigations. I’m pleased to share with you some of our many achievements in this 2024 annual report.
2024 At A Glance
72 Incidents Evaluated:
Incidents evaluated included potential outbreaks, confirmed outbreaks, and adverse events that were analyzed by the CORE Signals and Surveillance (Signals) Team. Not all incidents evaluated by Signals are transferred to one of four CORE Response Teams for follow up.
26 Responses Initiated:
When an outbreak appears to be caused by an FDA-regulated food, information related to the incident is transferred to a Response Team to coordinate FDA’s response efforts.
10 Advisories Issued:
Public health advisories provide consumers with actionable advice to stay safe when an FDA-regulated food is linked to an outbreak.
Note: These categories above represent the number of activities that occurred during 2024. The lifespan of a single incident may include activities spanning multiple years.
CORE Activities, by Year, 2011 – 2024
Note: These categories are not direct subsets of each other but rather represent the number of activities in each category that occurred during 2024. The lifespan of a single incident may include activities spanning multiple years.
The Signals Team evaluates emerging outbreaks and disease surveillance trends in collaboration with CDC, other FDA offices, and state agencies. The team reviews data from food firms, including past inspections, sampling results, product distribution, and sourcing information. It also considers previous incidents involving similar pathogen and food pairs. This information can provide clues to understand emerging outbreaks. When an outbreak appears to be caused by an FDA-regulated human food, information related to the incident is transferred to a Response Team to coordinate FDA’s response efforts. The coordinated efforts often lead a Response Team to identify a specific ingredient or products that can be linked to illnesses and support preventative public health actions.
Not all evaluations conducted by Signals result in a transfer. For example, outbreaks that are linked to non-FDA regulated products, such as those regulated by USDA, are not transferred to a Response Team but are assigned to the proper regulatory agency for further coordination. Additionally, not all incidents transferred to a Response Team result in an advisory being issued. In most cases, this is because a vehicle is not identified while the outbreak is ongoing or at the end of an outbreak investigation.
Responses with Identified Product(s)* Linked to Illnesses, by Associated Food Category, 2024
Multi-ingredient: Frozen Shakes, Shrimp Salad**, Chocolates, Gummies & Cones, Bagged salad mix**
Nuts-Seeds: Organic Walnuts
Shell Eggs: Eggs
Dairy- Solid/Semi-Solid Dairy Products: Raw Cheddar Cheese, Queso Fresco and Cotija Cheese
Produce- Fruits: Mangoes**
Produce- Vegetables: Romaine Lettuce**, Spinach**, Imported Cucumbers, Domestic Cucumbers, Jalapeno Pepper**, Organic Carrots, Onions, Sprouts**, Alfalfa Sprouts**, Organic Fresh Basil, Imported Parsley**
*Products were categorized using Interagency Food Safety Analytics Collaboration (IFSCAC) criteria.
**Responses where a product(s) was linked to illnesses, but no Advisory was issued – this is typically due to a lack of specific actionable advice for consumers, including an identified product that is no longer available to consumers at the time of identification. Although an Advisory is not issued in these instances, confirmed vehicles are reported on the CORE Investigation Table.
The work conducted by CORE during and following investigations of foodborne illness outbreaks and certain adverse events culminate in actions that can drive the prevention of additional illnesses and future outbreaks. When investigators find the food source of a multistate foodborne illness outbreak, they can take public health actions, such as issuing a public health advisory or recommending that companies voluntarily recall products confirmed to be associated with an outbreak, which are powerful steps to protect public health. In some cases, FDA’s Office of Compliance & Enforcement can pursue additional compliance actions to further protect consumers from unsafe food, such as issuance of warning letters, seizure, injunction, and addition of firms to import alerts.
In 2024, FDA issued ten public health advisories: nine were related to multistate outbreaks of foodborne illnesses and one corresponded to an adverse event series.
Investigations coordinated by CORE also inform follow-up activities carried out by other offices and divisions of FDA. These include but are not limited to follow-up inspections, continued risk assessments, and the development of prevention strategies.
FDA Actions Related to Outbreaks in 2024*
| Pathogen or Cause of Illness | Product(s) Linked to Illnesses | FDA Advisories | Recalls | Legal and Other Action |
|---|---|---|---|---|
| Listeria monocytogenes | Queso Fresco and Cotija Cheese | Outbreak Advisory | Recall Announcement
| Consent Decree of Permanent Injunction |
| E. coli O157:H7 | Raw Cheddar Cheese | Outbreak Advisory | ||
| Salmonella Typhimurium | Organic Fresh Basil | Outbreak Advisory | Recall Announcement
| |
| E. coli O157:H7 | Organic Walnuts | Outbreak Advisory | Recall Announcement | |
| Salmonella Africana & Braenderup | Cucumbers | Outbreak Advisory | Recall Announcement | Warning Letter |
| Not Identified | Chocolate, Gummies, Cones | Advisory | Recall Announcement | |
| Salmonella Enteritidis | Eggs | Outbreak Advisory | Recall Announcement | Warning Letter |
| E. coli O157:H7 | Onions | Outbreak Advisory | Recall (Announcement in Advisory) | |
| E. coli O121:H19 | Organic Carrots | Outbreak Advisory | Recall Announcement
| |
| Salmonella Typhimurium | Imported Cucumbers | Outbreak Advisory | Recall Announcement | Country-wide Import Alert IA # 99-35 |
*Note: Some investigations listed in this table may have been initiated in 2023, but an advisory was not issued until 2024. This is not an exhaustive list of all FDA activities related to these incidents and additional activities may be ongoing.
Continue at: https://www.fda.gov/food/outbreaks-foodborne-illness/core-2024-annual-report
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