In a reorganization termed “Simple Reform,” the FDA is shifting its operations from having inspectors who are specialists in particular fields to having generalists who will conduct inspections across multiple industries. The change, which also includes the centralization of administrative functions across FDA’s nine centers, harkens back to the 2025 DOGE-era reorganization plan. But it has just recently been approved by the Trump Administration with plans for it to take effect October 1, 2026.
The announcement of the reorganization was made by FDA Deputy Commissioner for Operations and COO Melanie Keller in an internal memo acquired by NOTUS. Though it formalizes the changes that have been occurring since the beginning of the Trump administration, the reorganization is said to not result in any further job cuts.
The plan reverses the 2017 reorganization, which had shifted the focus of inspectors from generalization to specific areas of expertise. The goal, at that time, was to enable the agency to keep pace with scientific innovation, better implement the 2011 Food Safety Modernization Act, and ensure inspectors had deep technical expertise in the specific items, products, and areas they regulated.
In contrast, in this reversal back to generalization, investigators will inspect across multiple industries “merging food & beverage, medical devices and clinical research inspectorates into a mixed pool of generalists,” as stated by Food Safety Tech, which also reviewed the memo.
The late July announcement is already making waves on both sides, with both former FDA officials and experts weighing in on how the lack of specialization will impact the efficiency and effectiveness of inspectors, particularly in relation to today’s sophistication of FDA regulated products. The planned centralization of the agency’s administrative functions has also been criticized as actually being less efficient, as each center and its people operate as fits the facilities and products they regulate, and there can be a great deal of variation in even the administration of that.
On the other side, an August 3 FDA Voices column (published after the disclosure of the memo), seems intended to respond to the opposition. With a stated goal of “Strengthening Our Operations and Workforce to Advance Public Trust,” the column notes that the inspectional modernization is not a move to generalists, but has been “designed to deepen talent by expanding investigators’ capabilities” and provide “cross-functional development opportunities to ensure investigators can operate effectively across different product areas when needed.” However, that seems to reinforce the idea of generalist investigators rather than negate it.
There are also some comments that FDA’s thoughts on hiring or training inspectors as generalists rather than specialists could help with staffing challenges for inspection of both domestic and foreign facilities, particularly in the wake of the previous Trump Administration reductions in force, (which is supported by the FDA Voices comment on “managing finite inspectional resources”). However, we would see that as coming at the cost of in-depth inspections, with no assurance that an FDA investigator thoroughly understands the processes, products, or risks of the facility they are sent to inspect.
With the FDA being part of the executive branch subject to control by the current President, the agency faces the likelihood of organizational and prioritization shifts with each quadrennial election. With the shifts that have and continue to occur during this Administration being a prime example of this, they also reflect the all-too-frequent lack of historical perspective in making changes – or at least the lack of providing public disclosure of the why behind the what in making such a reversal. While it may be advantageous to have some generalists to help cover less risky facilities, having knowledgeable specialists who can provide an expert eye in an inspection is essential to ensuring food safety and limiting risk. Losing that expertise is not the way to strengthen operations or advance public trust.
Timing is everything, and these changes are coming as the public health system is suffering a loss of confidence due to several large outbreaks occurring this summer. FDA needs more funding and more personnel. Food safety is becoming much more complex, and as such, it is imperative that our regulatory bodies understand the science, risks and complexity around food safety. Creating generalists may expand the numbers of inspectors with some understanding of food safety, but it does not bode well for the regulatory structure to be optimized to manage today’s food safety risks and regulatory challenges.
In summary, the FDA is shifting its operations from having inspectors who are specialists in particular fields to having generalists who will conduct inspections across multiple industries. The plan reverses the 2017 reorganization, which had shifted the focus of inspectors from generalization to specific areas of expertise. The goal, at that time, was to enable the agency to keep pace with scientific innovation, better implement the 2011 Food Safety Modernization Act, and ensure inspectors had deep technical expertise in the specific items, products, and areas they regulated. The public health system is suffering a loss of confidence due to several large outbreaks occurring this summer. Creating generalists may expand the number of inspectors with some understanding of food safety, but it does not bode well for the regulatory structure to be optimized to manage today’s food safety risks and regulatory challenges.
