The FDA is implementing a major reorganization plan called “Simple Reform” on October 1, 2026

The Trump administration approved FDA’s reorganization proposal, according to an internal agency announcement. In the announcement, Melanie Keller, the FDA’s deputy commissioner for operations and chief operating officer, said the reorganization proposal known as “Simple Reform” will go into effect on Oct. 1 of this year.

The FDA’s “Simple Reform” reorganization primarily changes internal agency administration rather than regulatory standards, meaning current compliance rules and quality system requirements remain legally unchanged for industry facilities. However, shifting to a generalist inspectorate heavily reshapes how inspections will play out in practice.

Under the revised structure, individual centers like the Human Foods Program (HFP) will no longer conduct their own administrative affairs like human resources, finance and information technology services. Instead, the agency will operate under a “shared service” model in which the FDA Office of Operations controls those functions across the agency.

The agency will end deep technical specialization for field inspectors, merging food & beverage, medical devices and clinical research inspectorates into a mixed pool of generalists. Investigators will handle inspections across multiple industries instead of focusing exclusively on one narrow technical product field.

The food and beverage industry should expect a shift in audit dynamics, meaning audits will likely focus less on highly specific, niche technical processes and more on foundational, broad-spectrum quality systems.

In 2017, FDA moved to place inspectors within specific programs of expertise, rather than requiring them to work across multiple programs. Simple Reform will reverse that.

Food Safety Tech reached out to Dr. Stephen Ostroff, who was the Deputy Commissioner for Foods and Veterinary Medicine at FDA a position he assumed in May 2016.

Rick Biros: “Steve, I’m curious to learn your opinion on Simple Reform and the impact you think it will have on food safety. I’ve reached out to Mike and Frank as well.”

Steve Ostroff: “I was  the Acting Commissioner of FDA when Program Alignment was finalized after several years of work.  I recall celebrating in Chicago (after your conference) at the district office downtown.  Program alignment was an effort to better vertically and horizontally align inspection activities – vertically within the inspectorate and horizontally between the Office of Regulatory Affairs inspectors and the headquarters programs.  It recognized that having generalist inspectors was inefficient and failed to take into account how technically sophisticated FDA regulated products had become (and were rapidly becoming).  It wasn’t possible for an inspector to be technically proficient in medical devices, gene therapies, regenerative medicine, infant formula, synthetic foods, etc. etc.  It also wasn’t helpful to have an inspector principally working on foods be supervised by someone with expertise in medical devices.  It was an effort that recognized the need for specialization and it was right then and it continues to be right.

The idea that inspectors would return to being generalists is a step in the wrong direction.  The significant loss of inspectors since early 2025 may in part explain why this is being proposed.  But this won’t solve that problem and won’t address the significant backlog of inspections in the food program, especially international inspections.  It’s more likely to exacerbate it.

As for centralizing administrative functions like HR, finance and IT, this is like a pendulum that swings back and forth.  It’s been tried over the years and there’s little evidence that it works or helps.  In addition, given the resource imbalances at FDA between the medical products programs and the food program, it’s a recipe for the interests of the food program and needs of the food program to end up at the back of the line.  As is so often the case, unfortunately. “

Frank Yiannas, who followed Dr. Ostroff as the next Deputy Commissioner for Food at FDA added “Don’t think it will achieve better results.”

“Simple Reform” will go into effect on Oct. 1 of this year. Dr. Donald A. Prater, Acting Deputy Commissioner for Food, U.S. Food and Drug Administration (FDA) will be presenting at the Food Safety Consortium Conference. October 21-23, 2026 in Washington DC. More info at FoodSafetyConsortium.org.