FDA's Proposed GRAS Rule: What It Would Do — and What It Wouldn't

This article analyzes a proposed rule, not a final rule. The proposed amendments to 21 CFR parts 170 and 570 are not currently binding. Publication has opened an active federal rulemaking and comment process. Comments are due December 9, 2026, under Docket No. FDA-2025-N-3262 (RIN 0910-AJ02).

The analysis is based on the Federal Register publication at 91 FR 51834 (August 11, 2026). That rendition is not an official legal edition; legal researchers should verify against the official Federal Register PDF on govinfo.gov.

Three things that are often blurred together: a firm’s own GRAS conclusion, the duty to notify FDA, and FDA premarket approval. The proposal would change the second, but generally not convert the first into the third. Live status lives on the GRAS Reform Tracker.

Executive conclusion

The proposal would replace FDA’s current voluntary GRAS-notification system with a mandatory notification system for most covered human- and animal-food uses marketed under the GRAS provision of section 201(s) of the Federal Food, Drug, and Cosmetic Act. It would cover direct ingredients and indirectly added substances, including substances that migrate from food-contact materials.

The proposal would not create a conventional FDA premarket-approval system for GRAS uses. The responsible person would still make the initial conclusion that the use is GRAS, and FDA expressly says a company may introduce the substance into interstate commerce before submitting a notice and before FDA files it. The notification duty would nevertheless remain unsatisfied until FDA files the submission as a GRAS notice. Proposed 21 CFR 170.205(a), 170.265(a)(2), and parallel animal-food provisions are the core of that structure.

Self-conclusion would survive, but undisclosed self-conclusion would not. A company could continue to decide that a use is GRAS without prior FDA approval, but it could not indefinitely rely on a covered independent GRAS conclusion without bringing the basis for that conclusion into FDA’s notification system after the compliance obligation applies.

The five most important takeaways

1. Mandatory notification is not the same as premarket approval.
2. FDA filing — not mere transmission of documents — is the compliance event.
3. A no-questions letter is not an FDA GRAS affirmation and can later be revisited.
4. An insufficient-basis letter and a cease-to-evaluate letter have different legal consequences.
5. Legacy uses receive a temporary streamlined route, but public listing is essential and FDA can later require a full notice or food-additive petition.

What the proposal would do — and would not do

The rule’s critical legal mechanics

A mandatory notice, but not ordinary premarket approval

FDA expressly states that the proposed program generally would not establish a premarket review program for purportedly GRAS substances. A company could market before submitting and after submission but before filing. This does not mean the firm has complied; it means the proposal does not condition market entry on FDA’s advance permission. The firm still bears the risk that the use is not actually GRAS and the separate risk that the notification requirement has not yet been met. (91 FR 51851; proposed 21 CFR 170.205(a), 170.265(a)(2).)

Filing is not a safety decision

FDA would have 45 days after receipt to decide whether the submission is adequate to file. That preliminary review concerns completeness and filing suitability, not whether the use is GRAS. Filing would satisfy the act of notification, but would not establish that the substance is safe, generally recognized as safe, or lawfully marketed under all circumstances. (91 FR 51851, 51854; proposed 21 CFR 170.265(a).)

The three familiar response outcomes are legally different

• No-questions letter: FDA states that, based on the submitted and otherwise available information, it has no questions at that time. The notifier remains responsible for the GRAS conclusion, and FDA can later revisit the letter.
• Insufficient-basis letter: the notice does not provide a sufficient basis for the conclusion. The act of notification remains satisfied, but the response can inform a not-GRAS or unauthorized-food-additive assessment and post-market action.
• Cease-to-evaluate letter: if FDA grants the notifier’s request to stop, the notification requirement is no longer considered met. The use remains noncompliant with the notice requirement until FDA files a new notice or another exception applies.

Public disclosure has two layers

First, data and information in a GRAS notice become available for disclosure under 21 CFR part 20 as of FDA’s receipt, subject to applicable exemptions. Second, FDA would proactively place specified materials in its online inventory, including filed notices, substantive response letters, subsequent letters, and cease-to-evaluate letters. The proposal should not be read as requiring immediate proactive posting of every unfiled submission merely because FDA received it.

The time-limited legacy route is a listing mechanism, not a GRAS review

For eligible uses already in interstate commerce before the final rule’s effective date, the proposed subpart F pathway would accept a streamlined submission identifying the substance, conditions of use, evidence of prior market presence, and certain prior notice numbers. It would not initially require the full underlying safety dossier. FDA’s posting would not mean FDA reviewed or agreed with the GRAS conclusion. FDA could later demand a full notice or a food-additive petition.

The proposal leaves consequences and timing gaps

The proposal specifies filing and response deadlines but does not create a deemed result if FDA misses them. It also does not state a deadline for FDA to place a qualifying legacy submission on the public list, even though listing is necessary for the exception. Nor does the codified language state detailed criteria or a formal contest procedure for FDA’s later decision to require a full GRAS notice or food-additive petition.

Section-by-section analysis

Front matter: status, dates, comments, and confidentiality

The front matter identifies FDA, the affected CFR parts, the docket and RIN, the comment deadline, and the procedures for electronic, paper, and confidential comments. Electronic comments and attachments are posted publicly unchanged. A confidential submission must be made on paper in two copies: a complete confidential version and a redacted public version. The public rulemaking deadline is December 9, 2026.

What it does not do: the front matter does not create the substantive GRAS duties. It governs participation in the proposed rulemaking. A confidentiality label is not enough if the commenter fails to follow the prescribed process.

Section I — Executive Summary

The Executive Summary frames the proposal as a conversion from voluntary to mandatory notification, with defined exceptions, a temporary streamlined route for certain existing uses, and a revised human-food threshold-of-regulation procedure. It identifies sections 201, 402, 409, and 701 of the FD&C Act as the authority and emphasizes transparency, earlier identification of potentially unsafe uses, and improved FDA oversight.

What it does not do: it does not itself supply all operative exceptions or filing details. Those appear in the proposed regulatory text. It also does not amend the statutory definition of GRAS.

Section II — Abbreviations

This section supplies shorthand such as GRAS, FCS, FCN, TOR, HFP, CVM, PRA, and related terms. It is organizational. Legally operative definitions appear in the proposed CFR provisions.

Section III — Background and need

FDA recounts the 1958 Food Additives Amendment, the GRAS exclusion, the historical GRAS lists and affirmation process, the 1997 proposal, and the 2016 voluntary notification rule. FDA stresses that a private conclusion does not necessarily make a use GRAS or lawful.

FDA then identifies three recurring problems: inadequate or undocumented independent analyses; the ability to request a cease-to-evaluate letter and later market without telling FDA whether its questions were resolved; and broad information gaps concerning unnotified uses. Examples include crude stevia leaf extracts, caffeinated alcoholic beverages, delta-8 THC foods, tara flour, and ashwagandha. These examples support the policy rationale; the proposed rule itself is not a new adjudication of every example.

FDA also points to a changing food supply, globalized manufacturing, cumulative nutrient exposure, and novel food-contact materials. The calcium example is used to show why FDA values visibility into aggregate exposure. It is not a new calcium limit or a ban on packaging alternatives.

Section IV — Legal authority

FDA argues that sections 409(a) and 409(d) require or authorize the agency to identify uses that are food-additive uses requiring authorization, and that section 701(a) permits regulations for efficient enforcement. The proposal uses those existing powers as the legal basis for requiring information about purported GRAS uses.

What it does not do: it does not claim that Congress added an express statutory sentence directing every person with a GRAS conclusion to notify FDA. The proposal instead presents mandatory notification as an implementation and enforcement mechanism. Any observation about the significance of that distinction in litigation is legal analysis beyond the text of the proposal.

Section V.A — Definitions in 21 CFR 170.3

The proposal would modernize the definition of food and define FDA-related pronouns for part 170. These are terminology changes, not an independent expansion of statutory jurisdiction.

Section V.B — Eligibility under 21 CFR 170.30

The proposal removes an old recommendation to notify FDA about pre-1958 foreign common use because notification would become mandatory. It preserves detailed evidentiary conditions: foreign common-use evidence must be documented, corroborated by a second independent source, widely available in the country of use, and readily available to qualified U.S. experts. The animal-food version additionally addresses target-animal safety and human safety from edible tissues.

The proposal also clarifies that an existing GRAS affirmation covers uses that are not significantly different from the uses underlying the regulation. Materially different uses cannot simply rely on the existing regulation.

Section V.C — FDA determinations that a use is not GRAS

For uses already listed or affirmed in the CFR, FDA could initiate a public process, allow 60 days for review and comment, and amend or repeal the regulation if convincing GRAS evidence is lacking. For uses covered by a no-questions letter, FDA could ask new questions and update or rescind the letter. For other uses, FDA would make the basis for a not-GRAS determination public.

The absence of an FDA not-GRAS determination would not establish that a use is GRAS. FDA silence is not an approval or safe harbor.

Section V.D — Threshold of regulation under 21 CFR 170.39

The proposal would expand the human-food threshold-of-regulation process beyond migration from food-contact articles to direct and indirect uses meeting very low exposure and safety criteria. The principal exposure benchmark would become 0.025 micrograms per kilogram of body weight per day. The proposal also retains an alternative for a substance already regulated for direct addition where exposure from the new use is at or below one percent of the acceptable daily intake. No significant adverse environmental impact is permitted.

The request would include identity, conditions of use, exposure data, toxicological information, impurity analysis, and environmental information. FDA must grant the exemption; a manufacturer cannot create it unilaterally. FDA may decline where available information indicates public-health risk and may later reevaluate an exemption when significant new information emerges.

Other proposed changes include removal of the current no-technical-effect criterion, removal of the triplicate-copy requirement, electronic submission through COSM with a waiver option, a public exemption list that omits trade names, and retention of reconsideration through the general administrative procedure in 21 CFR 10.33 even though the cross-reference in 170.39 would be removed.

Sections V.E and V.F — Definitions and mandatory notice

The proposal would define the online inventory and the no-questions letter, then establish mandatory notification in proposed 21 CFR 170.205. The duty applies to any person introducing a covered substance into interstate commerce under the GRAS provision unless an exception applies. Food-contact manufacturers or suppliers could submit an FCN instead, and FDA recommends that route because it is tailored to food-contact substances.

Sections V.G through V.I — Submission, translation, and FOIA

Human-food notices would be submitted through COSM unless FDA grants a paper waiver. Foreign-language material submitted or incorporated by reference would require an accurate and complete English translation. A notifier claiming FOIA protection would have to identify the specific information at submission. Failure to do so would be treated as non-exemption or waiver. For non-public safety information, the notifier would have to explain how a conclusion can be generally recognized when qualified experts lack access to the information.

Sections V.J and V.K — FDA review and public disclosure

FDA would conduct a 45-day filing review and send a filing or non-filing letter within two business days of its decision. The substantive review would ordinarily occur within 180 days of filing, with up to two 90-day extensions. FDA does not state that missing these periods produces a deemed result. A cease-to-evaluate letter would make the notice obligation unmet; an insufficient-basis letter would not.

Filed notices and specified letters would be placed in the inventory. Disclosure remains subject to 21 CFR part 20, including protection for qualifying trade secrets and confidential commercial information.

Section V.L — Obsolete petition transition

FDA would remove the provision governing GRAS affirmation petitions pending when the 2016 system began because FDA states none remain. This does not repeal completed GRAS affirmations or the existing GRAS regulations.

Section V.M — Temporary legacy pathway

An eligible use introduced into interstate commerce before the final rule’s effective date could use the streamlined pathway. The submission would identify the submitter, substance, conditions of use, prior market presence, and any prior GRN associated with a cease-to-evaluate letter. The statutory basis for the GRAS conclusion could be supplied voluntarily. The initial filing would not require the underlying safety dossier.

The route is unavailable for the same conditions of use covered by an insufficient-basis letter or an FDA not-GRAS determination. A prior cease-to-evaluate letter does not by itself disqualify the submission; instead, its file number must be identified. Any person could rely on public listing for the same conditions of use, but listing would not mean FDA reviewed or accepted the GRAS basis.

Submissions would be due within one year after the final rule’s effective date. The general notice compliance date would be 18 months after the effective date, creating a six-month gap between the end of the streamlined window and the general compliance date. FDA does not propose a deadline for agency listing decisions.

Sections V.N through V.P — Heading, plain language, and tables

FDA would rename part 170 to reflect both food additives and GRAS substances and would make plain-language edits such as replacing shall with must or will. These changes are described as non-substantive. The tables are crosswalks, not independent sources of legal obligation; the codified text controls.

Section V.Q — Animal-food provisions

The animal-food program largely mirrors the human-food program but uses CVM procedures and contains different exceptions. The legacy submission must identify target animal species, food uses, levels and purposes, and, for food-producing animals, potential human exposure to residues in edible tissues. Animal-food notices do not use the human-food FCN or TOR alternatives.

Animal-specific exceptions include an established consultation process such as AFIC when FDA publicly states it has no safety questions or concerns, and a limited exception tied to specified material in the 2024 AAFCO Official Publication when FDA has not publicly expressed a GRAS concern. The AAFCO exception is tied to the identified edition and conditions of use, not to every state-recognized feed ingredient or later edition.

Sections VI and VII — Alternatives and timing

FDA asks for burden-reducing alternatives that still improve transparency, help identify unsafe or unauthorized uses, and support public-health oversight. It specifically mentions streamlined submissions for all purported GRAS uses as an example. FDA proposes a final-rule effective date 60 days after publication, an 18-month compliance date for 170.205 and 570.205, and a one-year legacy submission window.

Sections VIII through X — Economics, environment, and paperwork

FDA estimates ten-year present-value costs of about $89.6 million at a three-percent discount rate and annualized costs of about $10.5 million at that rate, with wide ranges. Benefits are described chiefly as increased information and transparency rather than monetized health outcomes. FDA finds a significant economic impact on a substantial number of small entities and says expenditures may meet the adjusted Unfunded Mandates threshold in at least one year.

FDA treats the rulemaking as categorically excluded from preparation of an environmental assessment or environmental impact statement. That is an assessment of the rulemaking, not a declaration that every submitted substance is environmentally safe.

The Paperwork Reduction Act discussion describes the content of a full notice and estimates roughly 180 hours per GRAS notice and 32 hours per streamlined legacy submission. The information-collection requirements would not become effective until a final rule is published, OMB approves the collection, and the rule goes into effect.

Sections XI through XIII — Federalism, tribes, and references

FDA concludes that the proposal does not have federalism implications requiring a summary impact statement and tentatively concludes that it would not have substantial direct tribal effects. FDA expressly invites tribal officials to identify potential impacts. The references support the preamble but generally do not create obligations unless incorporated by reference. The proposed AAFCO material is the principal incorporation-by-reference issue.

Human-food provisions and exceptions

Proposed 21 CFR 170.205(b) contains seven exceptions. Each is tied to the substance under particular conditions of use, not to a chemical name in the abstract.

1. Existing no-questions letter: Applies when the existing letter covers the substance and the same conditions of use. It is not necessarily limited to the original notifier, but a material change in identity, process, purity, specification, food category, use level, or technical effect may fall outside it. Rescission removes the exception.
2. Listed or affirmed GRAS use: Applies when the conditions of use are already covered by parts 182, 184, or 186. It does not authorize materially different conditions.
3. Uses regarded as GRAS under 170.30(d) or (i)(1): Covers specified traditional natural biological ingredients and uses not significantly different from unrestricted GRAS affirmations.
4. Established FDA process: Applies where a formal, standardized, public FDA process reviewed the intended use and the public documentation did not recommend a GRAS notice. Informal technical assistance and the Early Food Safety Evaluation Program do not qualify.
5. Threshold-of-regulation exemption: Applies only after FDA grants the exemption for the intended use.
6. Effective FCN: Applies only when the FCN covers the use and the substance comes from the manufacturer or supplier identified in the FCN.
7. Publicly listed legacy submission: Applies after a qualifying streamlined submission appears on FDA’s public list, unless FDA later requires a full notice or petition.

Uses that cannot be the subject of a GRAS notice

Proposed 170.205(c) excludes uses falling within the statutory categories in section 201(s)(1) through (6), including pesticide-related categories, color additives, prior-sanctioned uses, new animal drugs, and dietary-supplement ingredients described in section 201(ff) when used or intended for use in a dietary supplement. These are use- and category-specific exclusions; they should not be overstated as a statement that the chemical could never be evaluated under the GRAS provision in a different legally relevant use.

Animal-food differences

Every major ask, recommendation, and instruction

Unresolved questions and practical gaps

No consequence for missed agency deadlines. The text gives FDA deadlines but does not specify deemed filing, approval, a no-questions outcome, or another remedy if FDA misses them.

No listing deadline for legacy submissions. The exception requires public listing, yet the proposal gives FDA no express time limit for deciding or posting a qualifying submission.

No detailed standard for escalation. FDA may require a full notice or food-additive petition after a streamlined filing, but the codified text does not state a detailed evidentiary threshold or formal challenge process.

Marketing before compliance. FDA permits market entry before submission and filing, but the notice obligation remains unmet. The proposal does not define an acceptable interval between first marketing and filing.

Enforcement consequences are not exhaustively stated. Post-market prioritization is expressly described, but the proposal does not say it is the only possible response to violation of the notice regulation.

Scope of existing letters. Manufacturers must decide whether process, identity, specification, or use changes remain within a prior no-questions letter; consultation is possible, but no automatic abbreviated route is proposed.

Public disclosure and confidential safety data. The proposal forces a notifier to reconcile confidentiality claims with the requirement that the safety basis be generally available to qualified experts, but it does not eliminate all difficult line-drawing.

Transition sequencing. The legacy window ends at one year, while the main notice compliance date is eighteen months after the effective date. Firms seeking the streamlined route must act earlier than the general compliance deadline.

Drafting errors and internal inconsistencies

The proposal contains several apparent drafting defects. These do not necessarily alter the intended policy, but they should be corrected before any final rule because regulatory cross-references and incorporation-by-reference descriptions must be precise.

• Wrong CFR part reference: The animal-food preamble discusses current 21 CFR 570.38(d) and then says the proposal would remove 507.38(d). In context, 570.38(d) appears intended.
• Second wrong CFR reference: The discussion of proposed animal-food subpart F points readers to 507.305 even though the proposed provision is 570.305.
• AAFCO page-range conflict: The preamble identifies pages 367–549, while proposed 570.205(b)(6) identifies pages 354–549.
• AAFCO title variation: The document uses multiple formulations for the incorporated Chapter 6 material, including food ingredients, feed ingredients, and official feed terms/common names/definitions.
• Paperwork Reduction Act citation: The proposal cites 44 U.S.C. 3407(d). The PRA review provision appears to be 44 U.S.C. 3507(d).
• Grammar in proposed 170.30(d): The phrase “no known safety hazards exists” should use either singular hazard or plural exist.
• Definition spacing: Proposed 170.3(p) prints “our,us” without a space. This is minor but should be cleaned up.
• Official table cross-reference: The official PDF’s Table 2 reportedly maps proposed 570.265(a)(3) to 170.265(a)(5), although the parallel non-filing provision appears to be 170.265(a)(3). This should be checked and corrected in the final crosswalk.

Practical implications

For manufacturers and ingredient suppliers

The central operational change would be documentation discipline. A covered GRAS conclusion would need to be developed in a form that FDA can file, with attention to identity, manufacturing, specifications, exposure, safety evidence, general recognition, translations, and FOIA designations. Merely possessing an internal memorandum or sending an incomplete package would not satisfy the proposed duty.

For companies with legacy uses

The first task would be inventorying every condition of use currently supported by an independent GRAS conclusion and matching it against the proposed exceptions. A legacy use eligible for streamlined treatment would need proof that it was in interstate commerce before the final rule’s effective date. Because the streamlined window closes six months before the main compliance date, waiting for the general deadline could forfeit the lighter route.

For users of existing no-questions letters or GRAS regulations

Reliance should be mapped to the exact notified or regulated conditions: substance identity, manufacturing process, purity and specifications, foods, use levels, technical effect, and exposure. A prior letter or regulation is not a blanket authorization for the substance in all forms and uses.

For food-contact businesses

A company would need to choose among a GRAS notice, an FCN, and, where eligible, a TOR request. The FCN is manufacturer- or supplier-specific; a GRAS conclusion generally is not. TOR requires FDA to grant an exemption. The choice affects exclusivity, data package design, review pathway, and public disclosure.

For animal-food businesses

The analysis must include target-animal safety and, where relevant, human exposure to residues. AFIC and the AAFCO 2024 exception require close attention to the exact intended use and to FDA’s public statements. There is no proposed animal-food TOR or FCN alternative.

For public commenters

The strongest comments will identify a precise proposed provision, explain the operational or legal problem, supply data or concrete examples, and offer replacement language. Comments concerning the legacy-listing deadline, the consequences of missed FDA deadlines, standards for requiring a full notice, abbreviated notices, and the drafting inconsistencies are especially suited to specific regulatory text.

Conclusion and source references

The proposal is best understood as a mandatory transparency and post-market oversight system, not a wholesale conversion of GRAS into food-additive premarket approval. Its principal legal move is to make FDA filing of a notice mandatory for covered uses while leaving the responsible person to make the initial GRAS conclusion and generally allowing market entry before FDA acts. That design gives FDA far more information without making its no-questions letter equivalent to approval.

The proposal is also more conditional than a simple statement that “self-GRAS is eliminated.” Existing regulations, no-questions letters, formal FDA processes, TOR exemptions, FCNs, animal-food consultations, the AAFCO exception, and a temporary legacy list create multiple routes. Each route is use-specific, and several depend on public documentation or FDA listing rather than the company’s unilateral assertion.

The most important weaknesses are procedural: no automatic result for missed FDA deadlines, no listing deadline for legacy submissions, limited criteria for escalation from a streamlined filing, an unclear interval between marketing and completed notification, and several drafting defects. Those issues are central to understanding both what the proposal says and what it leaves for a final rule.

Primary sources: 91 FR 51834 (Aug. 11, 2026), Docket No. FDA-2025-N-3262, RIN 0910-AJ02 · Official govinfo PDF (document 2026-16296) · Regulations.gov docket FDA-2025-N-3262 · GRAS Reform Tracker