The findings of a recent OIG report on FDA inspections is, once again, reviving talk of a shifting of food inspections from the federal agency to the states.
With the report finding that FDA is conducting fewer food facility inspections annually than it did prior to the pandemic and not meeting its required numbers; had attempted to inspect thousands of facilities that were not in operation; and had not conducted timely follow-up inspections for a majority of significant violations observed, the OIG’s overarching takeaway in June was not much different than that of a similar report issued by the GAO in January, aptly titled FDA Should Strengthen Inspection Efforts to Protect the U.S. Food Supply.
It also has long been a known fact that FDA had not met its annual domestic and foreign inspection targets since fiscal year 2018, due primarily to having gotten behind during the pandemic, and that it has had long-standing workforce capacity challenges, making it problematic to not only meet the annual target but to catch up from the previous years. So, the OIG recommendation that FDA “increase the number of facilities inspected each year and ensure that all facilities are inspected within the required timeframes” is an unsurprising, even banal, conclusion. However, the implementation of such a recommendation requires a great deal more, as it must take into consideration the decrease in FDA funding and significant workforce cutbacks of 2025.
It is stating the obvious to say that a reduction in funding and a reduction in personnel will lead to a reduction in delivery of key functions – which for FDA is essentially doing inspections as a critical part of regulatory oversight. So no one should be surprised by these reports.
And that is where the state discussion comes back into play, as evidenced by Fiscal Year 2026 Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies Appropriations Act. Unanimously approved by the Senate Committee on Appropriations, the Act specifies that, of the total amount appropriated for the Human Foods Program and related field activities in the Office of Inspections and Investigations, no less than $116,000,000 shall be used for State and local programs. The appropriation was set due to the Committee’s concern that “food facilities are not inspected frequently enough to adequately identify and respond to risks.” And it is also based on the FSMA directive for the FDA to build an integrated national food safety system “in partnership with State and local authorities.”
It is not a new system by any means. The FDA currently works with 43 FDA funded Human Food Inspection contract states and Puerto Rico to conduct inspections, for which the emphasis is placed on determining significant violations to Good Manufacturing Practices (GMPs), Preventive Controls, unsanitary conditions, and practices that may render the food injurious to health. FDA oversight of the states includes audits of each state inspector who conducts FDA contract inspections twice in a 36-month period; annual reviews of the state inspector audits at the state program and national level; and annual reviews of the state programs performance criteria.
But increasing the extent of the state programs is the area making the news. While no official word has come down, “multiple health officials” have told media outlets that the FDA is drawing up plans that would end most of its routine food safety inspections work, outsourcing it instead to state and local authorities. While such a plan would likely need Congressional approval for funding, the “no less than” funding requirement in the 2026 appropriations act would certainly be a step in that direction. But how far that, or other funding would go is in question, as is the readiness, ability, and capability of the states to take over such a program.
Conducting inspections takes trained inspectors and an infrastructure to support them, such as follow up to Form 483a observations and warning letters. So do you put money into the FDA to do that, or do you push money out to the states to do that? Any idea that it will be cheaper in the long run to have states do inspections is wrong if we expect top-level inspections.
Currently, FDA is required to inspect more than 75,000 facilities, including approximately 22,000 high-risk facilities and 53,000 non-high-risk facilities. So even assuming that all 50 states would be included in the program, that leaves a high number of inspections per state, particularly when nearly a third are considered high-risk, thus subject to more frequent inspections. It also could take food safety backward a step if the states are not equitably funded or knowledgeable, with any resulting state issues apt to impact the entire nation due to the interconnection of the food supply chain.
There is a model of state inspections for FDA-regulated foods in the milk inspection programs (State Cooperative Milk Safety Cooperative Program). The program is successful, though complex, so it can be done. But it would require a great deal of funding, time, and training to be implemented across all FDA-regulated facilities.
There’s a lot to unpack, and a lot to pack into, a shift from federal to state inspections. That’s not to say it can’t, or even shouldn’t, be done; but it does mean that careful consideration needs to be taken, and adequate time allowed for a public health-beneficial outcome.
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