• On July 31, 2026, the White House Office of Information and Regulatory Affairs (OIRA) completed its review of FDA’s proposed rule addressing GRAS substances.  
  • The OIRA review included the following noteworthy topics:
    • “Consistent with Change” designation: OIRA cleared the proposal as “Consistent with Change,” indicating that revisions were made during interagency review or will be incorporated by FDA before publication, though the substance of those changes is not yet publicly available.
    • Major Rule designation: OIRA classified the proposal as a “major rule” under the Congressional Review Act.  This designation is generally reserved for rules expected to have significant economic impacts, such as annual economic effects exceeding $100 million or other substantial impacts on industry, competition, costs, or investment.
    • Unfunded Mandates Reform Act (UMRA): OIRA changed the proposal’s UMRA status from “Undetermined” to “Private Sector.”  This suggests FDA anticipates the rule could impose significant compliance costs on private-sector stakeholders and will likely need to include additional economic analyses when the proposal is published.
  • There is currently no firm timeline for when FDA will publish the proposed rule.  However, the completed OIRA review marks a major step before a Notice of Proposed Rulemaking (NPRM) is transmitted for publication in the Federal Register.  Also, its earlier than expected completion has prompted speculation that FDA could release the proposal sooner than the December 2026 publication date originally projected in the Administration’s July 2026 Unified Agenda.
  • The Department of Health and Human Services (HHS) has scheduled an event for August 10, 2026, featuring Secretary Kennedy, Acting FDA Commissioner Kyle Diamantas, and other senior officials, to announce two new food policy initiatives.  Although no details have been released, the event comes shortly after completion of the OIRA review of the GRAS proposal and during OIRA review of a white-paper proposed federal definition of ultra-processed foods, making both topics potential candidates for discussion.
  • Keller and Heckman will continue monitoring developments on these matters.