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 has drafted a rule that would make notification mandatory for every GRAS ingredient, including substances that reach food from packaging. It is still under White House review, with tentative Federal Register publication in December 2026 (per the July 3, 2026 Unified Agenda).
• The two open fights: whether the rule reaches ingredients already on the market, and whether FDA has the legal authority to require notices at all — the agency itself once said it doesn’t, 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

According to the Unified Agenda entry (RIN 0910-AJ02), the proposed rule would amend 21 CFR parts 170 and 570 to require the mandatory submission of GRAS notices for the use of human and animal food substances purported to be GRAS. The description 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. The rule text has not been released; everything above is drawn from the agency’s own agenda description.

What would be exempt

Per the agenda description, substances that are listed or affirmed as GRAS for the intended use by regulation, or for which FDA has already issued a “no questions” letter on its GRAS notice inventory, would be exempted from the mandatory-notice requirement.

The retroactivity question

The single most consequential unresolved issue is whether the rule would apply to self-affirmed ingredients already on the market. The agenda description does not say whether the rule would be forward-looking only or would also require notices for existing GRAS conclusions. Law-firm analyses have flagged the ambiguity from the outset, and practitioner commentary is divided: some read the exemption structure as signaling relief for existing FDA-reviewed substances only, leaving already-marketed self-affirmed ingredients exposed; others consider it more likely that existing ingredients would face a future listing or notification obligation rather than removal from market. FDA has not clarified. For comparison, S. 3122 in Congress takes the harder line — no grandfathering, with a two-year window for existing self-affirmed substances to file.

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). 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 new deadline will be set in a forthcoming Federal Register notice. 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 preparing to comment once the rule publishes. 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 will the proposed rule publish? Unknown. The 2026 Unified Agenda (July 3, 2026) tentatively targets December 2026, but the projection has slipped twice already and the rule could publish sooner or later. It has been under OMB review since December 1, 2025. Publication in the Federal Register opens a public comment period.

Would it apply to ingredients already on the market? Unresolved. The agenda description is ambiguous on retroactivity, and FDA has not clarified. See “The retroactivity question” 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; 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. Substances with such letters would be exempt from the proposed mandatory-notice requirement.

Changelog

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