FDA GRAS Reform Tracker

General overview

• The gap: Under current law, a company can conclude on its own that a food ingredient is “generally recognized as safe” and take it to market — without ever notifying the FDA. Nobody, including the agency, knows how many ingredients entered the food supply this way.
• The fix in motion: FDA’s proposed rule making notification mandatory for every GRAS ingredient — including substances that reach food from packaging — published in the Federal Register on August 11, 2026 (91 FR 51834). The public comment period is open through December 9, 2026.
• One open fight settled, one remaining: the published text answers the retroactivity question — ingredients already on the market are covered, with a one-year streamlined-submission window. Still contested is whether FDA has the legal authority to require notices at all — the agency itself once said it doesn’t, now argues it does, and a court challenge is widely expected if the rule is finalized.
• Meanwhile, the landscape is moving anyway: several states are advancing their own GRAS-reporting requirements, reform bills are pending in Congress, and FDA is separately reassessing long-used additives (BHA, BHT, ADA) through its new post-market program.

What is GRAS?

GRAS — “generally recognized as safe” — is a category created by Congress in the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. A substance whose intended use is generally recognized among qualified experts as safe is excluded from the statutory definition of “food additive,” and therefore from FDA premarket review and approval. The safety standard for a GRAS substance is the same as for an approved food additive; what differs is who evaluates it and when.

What is self-affirmed GRAS?

Under the current framework (21 CFR parts 170 and 570, per the 2016 GRAS Final Rule), a company has two paths. It can voluntarily submit a GRAS notice to FDA; if the agency does not object, it issues a “no questions” letter, and the conclusion appears in FDA’s public GRAS notice inventory. Or it can conclude on its own — typically via an expert panel reviewing publicly available safety data — that the substance is GRAS for its intended use, without notifying FDA at all. The latter is “self-affirmed” (more precisely, self-concluded) GRAS. FDA officials have publicly acknowledged that the agency cannot say how many self-affirmed substances are currently in the food supply.

What the proposed rule would require

The published rule (91 FR 51834) would amend 21 CFR parts 170 and 570 to require any person introducing a substance into interstate commerce under the GRAS provision of FD&C Act section 201(s) to first submit a GRAS notice to FDA, unless an exception applies — proposed §§ 170.205(a) for human food and 570.205(a) for animal food, retitling the current “Opportunity to submit a GRAS notice” provisions into a requirement. The scope covers both ingredients and substances added to food indirectly, such as from packaging. FDA would maintain and update a public-facing GRAS notice inventory for all substances subject to mandatory notice, and the rule would clarify the process by which FDA determines that a substance’s use is not GRAS. As proposed, a final rule would take effect 60 days after its publication, with compliance required 18 months after the effective date.

What would be excepted

Proposed § 170.205(b) lists the exceptions to the notice requirement. The two the agenda description had previewed are there: uses covered by an existing FDA “no questions” letter, and substances listed or affirmed as GRAS for the intended use by regulation (21 CFR parts 182, 184, or 186). The published text adds more: foods of natural biological origin widely consumed before 1958 under § 170.30(d), uses with a granted threshold-of-regulation exemption under § 170.39 (a program the rule would expand), and substances appearing on the public list built from subpart F streamlined submissions (below). The no-questions-letter exception has edges worth noting: it stops applying if FDA rescinds the letter, and it does not cover a use whose identity, manufacturing process, or conditions of use differ significantly from what the original notice described.

The retroactivity question — answered

The published text resolves what this page had tracked as the single most consequential open issue: the rule does reach self-affirmed ingredients already on the market. Rather than requiring a full GRAS notice for every existing ingredient at once — which FDA concedes would overwhelm its own review capacity — proposed subpart F (§ 170.305) creates a time-limited streamlined submission: for substances introduced into interstate commerce before the final rule’s effective date, a person may submit information about the substance and its conditions of use in place of a full GRAS notice, for one year from the effective date. FDA would post the submissions to a public list, and substances on that list would be excepted from the notice requirement (proposed § 170.205(b)(7)). The streamlined path is closed in two situations: where FDA has issued an insufficient-basis letter for the use, or has determined the use is not GRAS — those require a full new GRAS notice or a food additive petition. For comparison, S. 3122 in Congress takes a similar no-grandfathering line with a two-year window; the proposed rule’s window is one year.

The statutory-authority question and litigation outlook

Whether FDA can require mandatory GRAS notices at all is contested. In the preamble to the 2016 GRAS Final Rule, FDA itself stated that it lacks express statutory authority to require companies to submit GRAS notices (81 Fed. Reg. 54981). The published proposal confronts that history head-on: FDA now grounds the requirement in FD&C Act sections 201, 402, 409, and 701, arguing chiefly that sections 409(a) and (d) — which task the agency with identifying food substances that may require food-additive review and initiating that review on its own initiative — carry with them the authority to require the information needed to do the job (the preamble cites Southeastern Minerals, Inc. v. Harris, 622 F.2d 758 (5th Cir. 1980), among others). On September 30, 2021, the U.S. District Court for the Southern District of New York upheld the 2016 rule’s voluntary framework, concluding the FD&C Act can reasonably be read to permit a voluntary notification program — and indicating that material changes to the GRAS framework are for Congress, not the courts, to decide. Practitioner commentary widely anticipates that a finalized mandatory-notice rule would face a statutory-authority challenge. This page will track any litigation from the date of filing.

The congressional bills

At least four bills would reform GRAS by statute — which would moot the authority question — but none has advanced beyond committee, and none includes federal preemption, meaning the state patchwork continues regardless of what Congress does. S. 2341 (Sen. Markey) would mandate notices, including for currently marketed self-affirmed substances, within two years, and appears to sunset the GRAS pathway for new substances. S. 3122 (Sen. Marshall, the “Better Food Disclosure Act of 2025”) would deem a GRAS substance adulterated unless FDA lists it or it is under review, with a two-year compliance window for existing self-affirmed substances and no grandfathering provision. On the House side, H.R. 4306 (the “Food Chemical Reassessment Act of 2025,” Rep. Schakowsky) would require FDA to reassess at least ten food substances or classes every three years, and H.R. 7291 (the “GRAS Oversight and Transparency Act,” Rep. Lawler) would establish a review board within HHS to reexamine pre-2000 self-affirmed GRAS determinations and recommend revocation where safety has not been shown. All four bills remain in committee.

The state GRAS-reporting overlay

Bills in New York, California, Pennsylvania, and New Jersey would each require manufacturers relying on self-affirmed GRAS to report supporting information to the state, to be made publicly available online; failure to report would render the additive unlawful for use in that state. Pennsylvania’s and California’s bills would require the same information as a federal GRAS notice. New Jersey’s applies prospectively to new uses only; the New York, Pennsylvania, and California bills appear to reach existing self-affirmed substances. New York’s bill passed the state senate on March 23, 2026 — the only one to clear a legislative chamber this session. Because no federal proposal preempts state law, these requirements would operate independently of whatever FDA finalizes.

FDA’s parallel post-market review program

Separately from the GRAS rule, FDA finalized its proactive post-market assessment program for chemicals in food on May 12, 2026, releasing two framework documents: an enhanced systematic process for identifying and prioritizing chemicals for review, and a prioritization tool. The program’s scope includes GRAS substances, food additives, color additives, food-contact substances, and contaminants. Active reassessments: BHA (RFI published February 11, 2026), and BHT and ADA (RFIs published May 13, 2026, at 91 Fed. Reg. 27054 and 27060). On July 10, 2026, FDA announced it would reopen the BHT comment period for an additional 30 days in response to stakeholder requests for more time to compile data and scientific information. The operative Federal Register notice published on July 30, 2026 (Docket No. FDA-2026-N-2526) and set the deadline at August 31, 2026 — a twenty-day gap during which the reopening had been announced but no new deadline legally existed, and the safe course was to treat the original date as binding. FDA did not reopen the parallel ADA period, reporting no such requests, and that comment period closed July 13, 2026 as originally scheduled. Even ingredients untouched by the proposed GRAS rule can be re-examined through this channel.

How companies are preparing

Law-firm alerts widely describe the same low-regret posture: inventorying which ingredients are on the market via self-affirmed GRAS determinations, reviewing existing dossiers against the standards in 21 CFR part 170 subpart E, and commenting now that the rule has published — the docket (FDA-2025-N-3262) is accepting comments through December 9, 2026. Trade associations in the most self-GRAS-dependent categories — dietary supplements and animal food among them — have indicated they will engage in the comment period. Regbase reports these observable postures; it does not advise on them.

FAQ

When did the proposed rule publish, and when do comments close? The proposed rule published in the Federal Register on August 11, 2026 (91 FR 51834). Comments — electronic or written — are due December 9, 2026, via Docket No. FDA-2025-N-3262 at regulations.gov.

Would it apply to ingredients already on the market? Yes. Substances already in interstate commerce when a final rule takes effect are covered; the proposal offers them a streamlined submission (lighter than a full GRAS notice) for one year from the effective date, after which the full notice requirement applies. See “The retroactivity question — answered” above.

Does it cover animal food? Yes — the agenda description expressly covers substances in human and animal food (21 CFR parts 170 and 570).

Does it cover food packaging? Yes — the description covers substances added to food indirectly, such as from food packaging, meaning food-contact substances relying on self-affirmed GRAS are in scope.

Can FDA legally require mandatory GRAS notices? Contested. FDA said in 2016 that it lacks express authority to do so; the published proposal now asserts authority under FD&C Act §§ 201, 402, 409, and 701. A 2021 federal court decision upholding the voluntary framework suggested changes are for Congress. A challenge to a finalized rule is widely anticipated.

Do the state bills depend on the federal rule? No. None of the federal bills or the proposed rule would preempt state law; the NY/CA/PA/NJ reporting bills would operate independently.

What is a “no questions” letter? FDA’s response to a voluntary GRAS notice indicating the agency does not question the notifier’s GRAS conclusion. Uses covered by such letters would be excepted from the proposed mandatory-notice requirement — unless FDA rescinds the letter, or the use differs significantly from what the letter reviewed.

Changelog

• September 2, 2026 — The reopened BHT comment period closed August 31; the GRAS comment period is unchanged. The reopened Request for Information on BHT (Docket No. FDA-2026-N-2526) closed on August 31, 2026 as scheduled — no further reopening or extension notice has published (checked against the Federal Register API). Both post-market RFIs — BHT and ADA — are therefore closed, and the reassessments move to FDA’s review. Re-verified with no change: the proposed GRAS rule (91 FR 51834, document 2026-16296; Docket No. FDA-2025-N-3262) remains the only document in its docket, with comments due December 9, 2026 per the Federal Register record. Note on reginfo.gov: the OIRA review row for RIN 0910-AJ02 has been updated since publication to show the review concluded July 31, 2026 “Consistent with Change” — a procedural housekeeping change that neither alters the published rule nor the comment deadline.
• August 13, 2026 — The proposed GRAS rule published on August 11, 2026; comments are due December 9, 2026. The Federal Register published “Substances Generally Recognized as Safe” (91 FR 51834–51881, document 2026-16296; Docket No. FDA-2025-N-3262) eleven days after OMB clearance. Verified against the FR API, the published rule text, and the regulations.gov docket (open for comment). The published text answers this page’s headline open question: already-marketed self-affirmed ingredients are covered, via a one-year streamlined-submission window (proposed subpart F, § 170.305) with a public list backing a new exception at § 170.205(b)(7). Proposed timeline: final rule effective 60 days after final publication; mandatory-notice compliance 18 months after the effective date. FDA now asserts statutory authority under FD&C Act §§ 201, 402, 409, and 701 — its answer to the 2016 preamble statement this page has tracked. Note for readers of the same-day trade coverage: FDA announced a separate ultra-processed-foods definition action on August 11; it is a different document and is not part of RIN 0910-AJ02.
• August 7, 2026 — The proposed rule cleared OMB on July 31, 2026. The reginfo.gov review record for RIN 0910-AJ02 shows OIRA concluded its review “Consistent with Change” on July 31 — eight months after the December 1, 2025 submission, and well ahead of the December 2026 agenda target. “Consistent with Change” is the disposition OIRA records when a rule was revised during its review; the revised text stays non-public until publication. No Federal Register publication as of August 7 (checked against the FR API). Publication, which opens the comment period, is now FDA’s move alone. Checked with no change: BHT comments due August 31, 2026 (Docket No. FDA-2026-N-2526); the ADA period remains closed; the BHA reassessment is unchanged.
• July 30, 2026 — The BHT reopening notice published; comments are due August 31, 2026. FDA announced the reopening on July 10, but the operative Federal Register notice did not appear until July 30 (Docket No. FDA-2026-N-2526; the original RFI published May 13, 2026 at 91 FR 27054). For twenty days there was an announced reopening with no new deadline in force — this page said so, and now records the date. The parallel ADA period remains closed as of July 13, 2026, with no reopening. Re-verified with no change: the proposed GRAS rule (RIN 0910-AJ02) is still under OMB review, submitted December 1, 2025 and not yet published, with the 2026 Unified Agenda (July 3) still targeting December 2026; the BHA reassessment is unchanged.
• July 13, 2026 — FDA reopened the BHT comment period; the ADA period closed on schedule. On July 10, 2026, FDA announced it will reopen the Request for Information on butylated hydroxytoluene (BHT) — in human food and as a food-contact substance — for an additional 30 days, citing stakeholder requests for more time to compile data and scientific information; the new deadline will be set in a forthcoming Federal Register notice. The parallel RFI on azodicarbonamide (ADA) was not reopened — FDA reported no extension requests — and its comment period closed on July 13, 2026, as originally scheduled. Both RFIs published May 13, 2026 under the post-market assessment program (BHT docket FDA-2026-N-2526). Also in this update: congressional bill details verified against congress.gov (H.R. 4306, Schakowsky; H.R. 7291, Lawler — both in committee); plain-English summary section added.
• July 7, 2026 — Page launched. Current status: proposed rule under OMB review since December 1, 2025; the 2026 Unified Regulatory Agenda (released July 3, 2026) tentatively schedules Federal Register publication for December 2026. Parallel developments logged: FDA post-market assessment program finalized May 12, 2026, with BHT/ADA RFI responses due July 13, 2026.

Primary sources: Proposed-rule analysis · Proposed rule, 91 FR 51834 (Aug 11, 2026) · Comment docket FDA-2025-N-3262 (regulations.gov) · Unified Agenda entry, RIN 0910-AJ02 (reginfo.gov) · OMB review record for RIN 0910-AJ02, concluded July 31, 2026 (reginfo.gov) · FDA post-market assessment program announcement (May 12, 2026) · 81 Fed. Reg. 54960 (2016 GRAS Final Rule)