The FDA is implementing a major reorganization plan called “Simple Reform” on October 1, 2026
August 10 update to this article: Apparently, there has been some confusion when the Simple Reform info went out because it is not affecting food, according to Dr. Stephen Ostroff, in a follow up email. Also, Steven Mandernach, J.D. Executive Director of Association of Food and Drug Officials (AFDO) told FST, he spoke with his food program contacts at the FDA last week, and they confirmed that the Human Foods Program is not affected by Simple Reform.
Originally reported: 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.
“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.
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