The GRAS Rule Is Still at OMB — and the Timeline Just Moved Again

The GRAS rule delay in plain English

• The loophole: Today a company can decide on its own that a new food ingredient is safe and put it on the market — without ever telling the FDA. The agency wants to close that door.
• The hold-up: The rule that would close it has been parked at the White House budget office since December 2025, and its projected release date has slipped repeatedly. The current target — like the ones before it — is tentative.
• What would change: Companies would have to formally notify FDA before relying on a “generally recognized as safe” conclusion — and substances that migrate in from packaging would be covered too.
• Why it matters now: A court challenge is widely expected, several states are imposing their own reporting requirements rather than waiting for a federal rule, and FDA is already reassessing long-used additives through a separate post-market program. The GRAS Reform Tracker logs each of those developments as they happen.

FDA’s proposed rule to end the self-affirmed GRAS pathway — the mechanism by which a company can conclude on its own, without notifying FDA, that a food substance is generally recognized as safe — has been under review at the White House Office of Management and Budget since December 1, 2025. It has not yet published. On July 3, 2026, the administration’s 2026 Unified Regulatory Agenda gave the rule its third projected timeline in ten months: a tentative Federal Register publication date of December 2026.

The timeline, in order

The projection has moved twice already, which is itself the most instructive fact about this rulemaking. The Spring 2025 Unified Agenda (published September 4, 2025) targeted an October 2025 publication. The fall government shutdown intervened, and FDA submitted the proposed rule (RIN 0910-AJ02) to OMB on December 1, 2025. In February 2026, FDA’s director for food chemical safety told an industry conference the draft would be released in late spring or early summer 2026 and that OMB review would finish within weeks. That window has now closed without publication, and the July 3 agenda points to December 2026 — with the standard caveat that agenda timelines are projections, not commitments. A rule that has moved twice can move again, in either direction: OMB can clear a rule ahead of its agenda date, and December targets have a way of becoming next-year realities.

What the rule would do

The rule text is not public; what follows is drawn from FDA’s own agenda description. The proposed rule would amend 21 CFR parts 170 and 570 to require the mandatory submission of GRAS notices for human and animal food substances purported to be GRAS — replacing today’s system, in which notifying FDA is voluntary and many substances reach market on a company’s own self-affirmed conclusion. Two exemptions are described: substances listed or affirmed as GRAS by regulation, and substances that already hold an FDA “no questions” letter. FDA would maintain a public inventory of GRAS notices and clarify the process for determining that a substance’s use is not GRAS. Notably, the description covers substances added to food indirectly — including from packaging — so food-contact substances relying on self-affirmation are in scope, a dimension much of the coverage has missed.

Two questions the description does not answer will define the comment period. First, retroactivity: whether already-marketed self-affirmed ingredients would owe a notice, or whether the rule is forward-looking only. FDA has not clarified, and practitioner readings diverge. Second, authority: FDA stated in the 2016 GRAS Final Rule preamble that it lacks express statutory authority to require GRAS notices (81 Fed. Reg. 54981), and a 2021 federal court decision upholding the voluntary framework indicated that material changes to GRAS are for Congress to make. A finalized mandatory-notice rule is widely expected to draw a legal challenge on exactly this ground.

What happens on publication day

Publication in the Federal Register opens a public comment period — typically 60 to 90 days for a rule of this significance. That window is when the retroactivity question, the authority question, the treatment of dietary-supplement and animal-food ingredients, and the burden of re-papering decades-old self-affirmed dossiers will all be contested on the record. Congress is running a parallel track: at least four GRAS reform bills are pending, none of which preempts state law — so the state GRAS-reporting bills moving in New York (passed the state senate March 23, 2026), California, Pennsylvania, and New Jersey proceed regardless of the federal outcome.

Meanwhile, FDA is not waiting on the rule to scrutinize substances already in the food supply. The agency finalized its post-market assessment program on May 12, 2026, and has active reassessments running on BHA, BHT, and ADA. On July 10, 2026, FDA reopened the BHT comment period for an additional 30 days in response to stakeholder requests (the new deadline will be set in a forthcoming Federal Register notice); the ADA information request closed July 13, 2026, as scheduled.

The practical read

For regulatory-affairs teams and food-law practitioners, December-2026-tentative changes the pacing, not the picture. The questions the rule forces — which ingredients ride on self-affirmed GRAS, which would be exempt, and what the state overlay does regardless of FDA — are answerable now, before the comment clock starts. Law-firm alerts have consistently described the same preparation posture since the rule reached OMB: inventory self-affirmed determinations, review dossiers against the existing part 170 standards, and be ready to comment. The Regbase GRAS Reform Tracker logs every development in this rulemaking — OMB status, the congressional bills, the state overlay, and the post-market program — with the primary source attached.

Primary sources: Unified Agenda entry, RIN 0910-AJ02 (reginfo.gov) · 81 Fed. Reg. 54960 (2016 GRAS Final Rule) · FDA post-market assessment program announcement (May 12, 2026)