FDA food regulation combines incident response, facility inspections, import oversight, laboratory surveillance, and coordination with state and local agencies. Recent figures from FDA reports show the scale of that system, from 72 incidents evaluated by the FDA Coordinated Outbreak Response and Evaluation (CORE) team in 2024 to more than 710,000 bacterial genome sequences collected through GenomeTrakr.
Contents
- 2024 incident response
- Products and outbreak investigations
- FDA funding and inspection activity
- Domestic and state-level oversight
- Imported food and foreign suppliers
- Traceability, laboratories, and chemical hazards
2024 incident response
The FDA CORE 2024 Annual Report recorded 72 incidents evaluated by the CORE team. During the same year, FDA initiated 26 responses involving FDA-regulated food incidents. These figures describe different stages of the response system: an evaluated incident is not necessarily the same thing as an initiated response.
FDA issued 10 advisories in 2024. Nine of those advisories related to multistate outbreaks, while one corresponded to an adverse-event series. The report’s 2024 outbreak-action table likewise listed nine outbreak advisories and one adverse-event advisory.
The advisory count is therefore a focused measure of public communication rather than a count of every incident evaluated. The broader 72-incident total includes the activity considered by CORE, while the 26 responses identify incidents for which FDA began a response. Keeping these measures separate helps avoid treating evaluation, response, and advisory publication as interchangeable stages.
The FDA CORE 2024 Annual Report also provides a product breakdown for responses where the product was identified. Produce and vegetables represented 55% of those responses, equal to 11 responses. Multi-ingredient foods represented 20%, or 4 responses. Dairy solid or semi-solid dairy products represented 10%, or 2 responses.
The remaining listed categories were each 5% of identified-product responses: fruits accounted for 1 response, shell eggs accounted for 1 response, and nuts and seeds accounted for 1 response. These percentages describe the identified-product response group in the report; they are not estimates of the share of all foodborne illness or all food products in commerce.
Products and outbreak investigations
One 2024 investigation illustrates how epidemiological interviews, environmental sampling, recalls, and legal action can connect within a food-safety response. In the queso fresco and cotija investigation, FDA and the Centers for Disease Control and Prevention interviewed 22 people. Sixteen of the 22 people, or 73%, reported eating queso fresco, cotija, or similar cheeses.
Two environmental samples collected during the on-site inspection tested positive for Listeria monocytogenes. The associated Cotija/queso fresco recall ultimately affected 19 brands. The FDA CORE 2024 Annual Report identified a consent decree of permanent injunction against Rizo-Lopez Foods dated October 8, 2024.
These measurements belong to a specific investigation and should be read with its dates and scope. The interview count is not a prevalence estimate for cheese consumption, and the two positive environmental samples are not a national contamination rate. Similarly, the 19-brand recall figure describes the reach of that recall rather than the number of brands routinely affected by food regulation.
The incident figures can be summarized as follows:
| 2024 FDA CORE measure | Reported figure |
|---|---|
| Incidents evaluated | 72 |
| Responses initiated for FDA-regulated food incidents | 26 |
| Advisories issued | 10 |
| Advisories related to multistate outbreaks | 9 |
| Advisory corresponding to an adverse-event series | 1 |
| People interviewed in the queso fresco/cotija investigation | 22 |
| Interviewees reporting queso fresco, cotija, or similar cheeses | 16 (73%) |
| Positive environmental samples for L. monocytogenes | 2 |
| Brands affected by the recall | 19 |
FDA funding and inspection activity
The FDA FY2024 Justification of Estimates requested $1.7 billion for human food, animal food, nutrition, and cosmetics work. The same budget justification listed a $4.6 billion request for medical product safety activities. The food-related request and the medical-product request cover different program areas, so they should not be treated as two parts of a single food-regulation total.
The FY2024 budget reflected a $371.9 million increase in direct discretionary budget authority. FDA described that increase as 10.4% above FY2023 enacted levels. The dollar increase and percentage increase are budget measures, not measures of the number of inspections or enforcement actions.
The budget justification reported 13,000 inspections, site visits, and sample collections conducted by FDA and state partners in FY2022. About 700 of these were human-food preventive-controls inspections. Because the 13,000 figure combines inspections, site visits, and sample collections, it is broader than the preventive-controls inspection count and should not be used to calculate a share without additional detail about the combined activities.
FDA awarded 199 cooperative agreements and/or grants. The awards went to all 50 states and to 12 stakeholder associations. FDA also signed 6 new Domestic Mutual Reliance Partnership Agreements, bringing the total number of those agreements to 13.
The same FDA FY2024 Justification of Estimates said FDA and its partners inspected thousands of produce farms through grantees. “Thousands” is a quantified scale description, but it does not provide an exact farm count. It is therefore useful evidence of program reach while remaining distinct from the exact counts reported for agreements, inspections, and samples.
Domestic and state-level oversight
FDA’s inspection schedule varies by facility risk. According to FDA’s Inspections to Protect the Food Supply, FDA and states generally perform routine surveillance inspections at least once every 3 years for domestic high-risk facilities. For domestic non-high-risk facilities, FDA generally performs routine surveillance inspections at least once every 5 years.
The Food and Drug Administration Reauthorization Act (FDORA) mandated annual inspections of infant formula manufacturers. This requirement is a specific annual frequency for that category and should not be generalized to every domestic food facility.
Food regulation also depends on a large network of state, local, and tribal agencies. FDA reported that more than 3,000 such agencies regulate retail food and food-service industries. Those agencies oversee more than 1 million food establishments.
The agency counts show why federal inspection totals do not represent the entire retail food regulatory system. The federal government works alongside thousands of other agencies, and the more-than-1-million-establishment figure covers the establishments overseen by those state, local, and tribal bodies. These are national system-scale figures, not a count of establishments inspected in a particular year.
The inspection frequency figures also describe general routine surveillance schedules. They do not say that every high-risk facility is inspected exactly once every three years or every non-high-risk facility exactly once every five years. The wording “at least” indicates a minimum general interval, while additional circumstances can affect actual inspection activity.
Imported food and foreign suppliers
The FDA FY2024 Justification of Estimates reported 1,827 Foreign Supplier Verification Program (FSVP) inspections as of November 16, 2022. Of those inspections, 1,621 were remote and 206 were on-site. The date matters: this is a count as of November 16, 2022, presented in a later FY2024 budget document.
For foreign food manufacturers in high-security-risk countries, FDA reported oversight of 267 manufacturers. That oversight included 95 rapid response assessments, 11 FSVP inspections, 5 import seafood Hazard Analysis and Critical Control Point (HACCP) inspections, and 169 targeted samples.
These activities are different oversight tools. A rapid response assessment is not the same as an FSVP inspection, an import seafood HACCP inspection, or a targeted sample. The figures should therefore be read as a profile of the oversight performed for the 267 manufacturers, not as interchangeable inspections or as a single rate.
FDA also received 6 applications for the Voluntary Qualified Importer Program (VQIP) during the 2022 application cycle. An application count measures participation in that voluntary program; it does not represent the number of foreign suppliers inspected or the volume of imports cleared.
FDA issued Import Alert 99-48 on March 20, 2024, addressing food products with detectable chemical contaminants, including per- and polyfluoroalkyl substances (PFAS). The alert covered a broad range of chemicals, including benzene, dioxins, polychlorinated biphenyls (PCBs), and PFAS. The date identifies when the alert was issued, while the chemical list describes its scope.
Traceability, laboratories, and chemical hazards
FDA published the Food Traceability Final Rule in November 2022. FDA’s Tracking and Tracing of Food materials state that section 204 of the Food Safety Modernization Act requires FDA to establish pilot projects for rapid and effective food tracking and tracing.
Those pilot projects were completed, and FDA released a report in March 2013. FDA later issued a Report to Congress on the pilot projects in November 2016. The sequence shows that the pilot-project work and its reporting occurred years before publication of the Food Traceability Final Rule. These are milestone dates, not annual performance counts.
Laboratory surveillance provides another large-scale measure. FDA’s FY2024 Justification of Estimates reported that the GenomeTrakr network had collected more than 710,000 whole bacterial genome sequences. More than 390,000 of those sequences were Salmonella sequences. Both figures are cumulative “more than” counts, so they should not be read as exact totals or as the number collected in one year.
The GenomeTrakr figures also describe sequences, not confirmed illnesses, outbreaks, or contaminated products. They indicate the size of a genomic surveillance resource. Connecting a sequence to a specific incident requires additional epidemiological, laboratory, and traceability evidence that is not quantified in these figures.
Finally, the FDA-TRACK Reportable Food Registry Data Dashboard covers entries submitted across Years 1–15, from September 8, 2009, through September 7, 2024. This measurement window is essential context for the dashboard’s coverage: it spans 15 reporting years and ends on September 7, 2024, rather than representing a single calendar year.
Together, the incident-response, inspection, import, traceability, and laboratory measures show several different ways to understand FDA food regulation. Some figures are counts for a defined year or date, some are cumulative totals, and some describe general requirements or minimum inspection intervals. Reading each statistic with its source, measurement period, geography, and unit keeps the comparisons meaningful.