In the first half of 2025, there have already been eight reported Food and Drug Administration (FDA) investigations stemming from foodborne illness outbreaks. This is already a significant increase from the yearly total of ten investigations in 2024 and nine investigations in 2023. In this “Food Foundations” series, NALC staff attorneys will break down a series of governmental activities relevant to our food system. This blog post, specifically, explains human food inspections by the FDA.
Jurisdiction of food supply
In the United States, the food supply is primarily regulated on the federal level by two agencies – the FDA and the United States Department of Agriculture (USDA). Specifically, the USDA regulates meat, poultry, catfish, and unshelled egg products, and the FDA regulates the other 80% of food. While USDA and FDA have tried to create consistency in various aspects of their regulation, i.e., in nutrition labeling, one of the biggest discrepancies between their regulation involves food inspections. In particular, the Federal Meat Inspection Act (FMIA), the legislation that authorizes USDA’s jurisdiction over food, requires the USDA to inspect every meat product that is sold commercially and ensure that it is safe, wholesome, and properly labeled. However, the FDA does not have the same requirements under the Food, Drug and Cosmetics Act (FDCA).
Current FDA food safety scheme
Contrary to the inspection scheme of USDA, the FDA does not inspect every food under its jurisdiction before it enters the food supply. While the FDA does conduct routine inspections to ensure compliance with laws, it also utilizes inspections to follow up on specific instances such as a foodborne illness outbreak. Further, the FDA may conduct inspections on its own, it also has a program for contracting with state and territorial government regulatory agencies.
Types of FDA inspections
The FDA specifically conducts three categories of inspections – surveillance, compliance follow-up, and for-cause. While the inspections themselves may be similar, each of these types of inspections are prompted by a different situation.
Surveillance inspections are those that are not necessarily prompted by a specific situation, but instead occur periodically and are meant to ensure continued compliance with regulatory requirements. Surveillance inspections can be broken down further into two categories, routine and targeted. For example, the Food Safety Modernization Act (FSMA) requires that domestic high-risk facilities be routinely inspected every three years, and non-high-risk facilities be inspected at least once every five years.
The classification of a facility as high-risk is based on known safety risk factors, including the compliance history of a facility and the known safety risks of the food. To learn more about the FDA’s determinations for high-risk or non-high-risk, click here. It is important to remember that the mandated three- or five-year inspection requirement is the minimum, and that facilities may be inspected more frequently if necessary.
The other category of “targeted” surveillance inspections is determined by specific food safety risks. For example, risk factors that may increase the risk of contamination (such as a history of Listeria in a lunch meat) or even the individual facility’s history of compliance may lead investigators to conduct a targeted inspection. Surveillance inspections, both routine and targeted, are broader in scope than other types of inspections, examining the facility’s overall compliance with applicable regulations rather than the safety of a specific issue or product.
Compliance Follow-up inspection verifies compliance and corrective actions following a violative inspection, violative food samples, or an official agency action. These inspections are typically narrower in scope and focus on confirming that specific corrective actions have been implemented and are effective. If deficiencies persist, FDA may take additional regulatory action.
The last type of inspection, called a “for-cause” inspection, is typically expedited and in response to a specific issue like a foodborne illness outbreak, a consumer complaint, or a product recall. Like compliance follow-up inspections, for-cause inspections are typically narrower in scope, and focus on identifying specific regulatory violations or safety issues.
Contract program
To meet the requirements of the routine surveillance inspections, the FDCA permits the FDA to “rely on inspections conducted by other Federal, State, or local agencies under interagency agreement, contract, memoranda of understanding, or other obligation.” 21 U.S.C. § 350j(a)(2)(E). Currently, FDA outsources certain inspections though its Human Food Inspection Contract Program. This program works with state regulatory agencies for their assistance in the inspection of food manufacturer/processor firms. Currently, the FDA has 48 contracts with state and territorial government regulatory agencies. Specifically, 43 states and Puerto Rico have been awarded contracts. Four of the states have two agencies with individual contracts – California, Iowa, South Carolina, and West Virginia. In November 2023, FDA stated that the current program funding was $13.6 million. During inspections under this program, the emphasis is placed on determining the violations to Good Manufacturing Practices, Preventive Controls, unsanitary conditions, and practices that may render the food injurious to health. Thus, the primary focus is for FDA’s surveillance inspections to be conducted by state actors where there is a contract.
State of the current system
In June 2025, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report evaluating the FDA’s efforts in inspected domestic food facilities. In this report, OIG reported to have found “gaps” in FDA’s inspection process. Specifically, the OIG report states that the FDA has conducted fewer inspections of food facilities compared to before the pandemic; FDA did not inspect many facilities within the required 3 or 5 year timelines and at its current inspection rate will not meet timelines in the future; FDA inefficiently used resources by attempting to inspect facilities that were no longer in operation; FDA’s identification of significant violations has decreases steadily over time with only 1 to 2 percent of facilities inspected each year having significant violations; and FDA did not conduct timely follow up inspections for the majority of significant violations. Additionally, OIG offered the following recommendations to FDA – increase the number of facilities inspected each year and ensure that all facilities are inspected within the required timeframes; improve methods for identifying facilities that are not in operation to make better use of resources; assess reasons for the decrease in number of facilities inspected by FDA with significant violations and take action as appropriate; and conduct timely follow up inspections of facilities with significant violations. The FDA has concurred with the report’s four recommendations; however, the agency does not believe that the report “accurately represents the agency’s timeliness in conducting follow-up inspections.” To read the full report, click here.
The OIG report follows a January 2025 report from the U.S. Government Accountability Office (GAO) that focused on FDA strengthening its inspection efforts to protect the U.S. food supply. GAO similarly concluded that FDA has not met the required timelines for food facility inspections since fiscal year 2018. In this report, GAO states that FDA identified a “limited workforce” as its primary challenge to meeting food safety inspection targets. Listed as an example of the limitations on FDA’s workforce is the agency’s need to prioritize resources to respond to emergencies rather than conduct routine inspections. Additionally, the report highlights the resources used in attempting to inspect facilities that are no longer operational. In its recommendations, GAO suggests implementing procedures to ensure the agency decreases those types of incidences. Further, GAO recommends FDA create a formal performance management process to assess the agencies progress in achieving its goals. To read the full report, click here.
The Proposed Ideas
Though both the GAO and OIG reports highlight some of the procedural challenges of FDA’s domestic food facility inspection process, neither report specifically mentions the idea of outsourcing all inspections to state and territorial actors. However, this idea is one that has been floating around for several years now. Though there has been no formal proposal or policy document published, there are reports that the Trump administration is seriously considering it. Earlier this year, in a leaked internal document from the White House Office of Management and Budget (OMB) it was proposed that the budget eliminates FDA’s direct role in routine inspections, and contract with state agencies to cover 100 percent of all routine inspections. However, once OMB sent its actual budget proposal to the Senate Committee on Appropriations, such a provision was not included.
CBS News has reported though that the FDA is working to create a similar plan to end its routine inspections work and outsource the job to state and local actors. Per CBS, the plans are not finalized but would keep the routine inspections of infant formula and foreign food facilities under the FDA’s jurisdiction. Additionally, FDA would handle inspections tied to outbreaks or ongoing noncompliance from a facility. Further CBS reports that the plan would be similar to FDA’s Grade A Milk Safety Program – where states are responsible for facility inspections, but FDA trains the state staffs and conducts audits. It was also recently reported in Agri-Pulse (behind a paywall) that the transition to state oversight might be phased in through the introduction of “pilot programs.” While no formal plan has obviously been announced yet, this might begin with a few states transitioning at first then more following in a phased roll out.
The funding challenges for the ideas
While FDA likely has the authority from the FDCA to create this plan on its own, it would probably need help from Congress to fund a full transition. The Senate recently passed its Agriculture and FDA Appropriations bill, and $1,171,319,000 was appropriated to the FDA’s Human Foods Program for activities including inspections. The House appropriations bill for Agriculture and FDA has passed committee but has not yet received a floor vote. In the House version, the FDA would be appropriated $1,232,115,000 for activities included inspections. The bills from both chambers are an increase from previous years, however it would still likely not be enough to support the transition to complete state routine inspection oversight. Thus, if FDA does propose this plan, then it will more than likely need Congress to pass additional appropriations to fund it. If FDA proposes to roll out the transition in phases, utilizing tools like “pilot programs” and transitioning by a few states at a time, the FY2026 appropriations might be sufficient.
Conclusion
The FDA, in contrast with USDA, does not inspect every food item under its jurisdiction before it enters the marketplace. Instead, FDA is required to conduct routine inspections once every 3 years for a high-risk domestic food facility and one every 5 years for a non-high-risk facility. However, as reported by the GAO and OIG, the FDA has repeatedly failed to inspect facilities in alignment with that mandated timeline. To combat this, some believe the FDA should transition to outsourcing its routine inspection through partnerships with state or local authorities. While the Trump administration and the FDA have not yet made any official announcements about a transition of that nature, unofficial remarks have been made that indicate a plan could be in the works at the agency.
To learn more about FDA’s regulation of foodborne illness outbreaks, click here to read NALC article, “The Adulterating Foodborne Pathogens: The Other 78% of the Food Supply.”
To learn more about FDA and USDA’s recall authorities, click here to read NALC article, “Food Recalls: What are They and How do They Work?”