Regulatory Updates: GRAS Proposed Rule Clears OMB Review; FDA Sends UPF Whitepaper to OIRA
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Two topics of increasing regulatory scrutiny—the "Generally Recognized as Safe" (GRAS) rule and a federal definition of ultra-processed foods (UPFs)—have seen some movement at the U.S. Government's Office of Management and Budget (OMB), signaling progress on the Trump administration's food policy agenda.
OMB Completes GRAS Rule Review
First, the OMB's Office of Information and Regulatory Affairs (OIRA) has completed its review of the U.S. Food and Drug Administration's (FDA's) proposed rule, "Substances Generally Recognized as Safe," according to a notice posted to the OMB website on July 31, 2026 and an August 4 report by AgencyIQ by POLITICO. The rule was originally posted to the Unified Agenda in September 2025.
The proposed rule would amend the Code of Federal Regulations to enforce stricter GRAS oversight in several ways:
- Making FDA notification of GRAS submissions mandatory for most substances, with exemptions allowed only for substances already listed by FDA, substances that have a "no questions letter," or substances covered by a regulation
- Require FDA to maintain and update a public-facing GRAS notice inventory for all GRAS substance notifications and their conditions of intended use
- Clarify the process under which FDA would determine that a substance is not GRAS.
The proposed rule's publication in the Federal Register will be followed by a comment period, a review of comments received, and the eventual development of a final rule, which will include a transition period for industry to adjust to the new requirements before they go into effect.
FDA Sends Whitepaper on UPF Definition to OIRA
As previously reported, FDA and the U.S. Department of Agriculture (USDA) issued a joint Request for Information (RFI) in July 2025 for input on a statutory definition for UPFs. The RFI closed for comment on October 23, 2025, with mixed responses from food system stakeholders.
At present, there is no single, authoritative definition for ultra-processed foods for the U.S. food supply; however, the term is most commonly associated with the four-category NOVA food classification system, which defines Category 4 UPFs as "industrially manufactured food products made up of several ingredients (formulations) including sugar, oils, fats, and salt and food substances of no or rare culinary use."
Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has shifted the anticipated time line for the delivery of the UPF definition several times. Most recently, he said in March on the Joe Rogan Experience podcast that the definition would be coming in April.
On August 3, 2026, HHS and FDA sent a whitepaper titled, "Proposed Definition of Ultra-Processed Food," to OIRA, signaling that the definition is officially under review. As the UPF definition is a "proposed" action, there may be an opportunity for comment on the whitepaper before the definition is finalized.
Legally defining UPFs at the federal level could allow regulatory agencies like FDA and USDA to pursue specific rules and policies for the food category. However, according to a June 9 report by Bloomberg and analysis by AgencyIQ by POLITICO, the Trump administration may ultimately choose to utilize an established definition of UPFs in research rather than food regulation and policy—a decision that could enable the faster issuance of a definition.
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