FDA has proposed — not finalized — a rule that would make GRAS notification mandatory for human and animal food and end marketing an ingredient on an un-notified, independent ("self-affirmed") GRAS conclusion; nothing changes today, and comments are due December 9, 2026. Every deadline in the proposal is pegged to a future final rule: notification would become enforceable 18 months after that rule's effective date, and ingredients already on the market would get a one-time, one-year window to be listed with FDA. There is no grandfathering — and no premarket approval either.
On Tuesday, August 11, 2026, the Food and Drug Administration published a proposed rule titled "Substances Generally Recognized as Safe" at 91 FR 51834 (FR Doc. 2026-16296; Docket No. FDA-2025-N-3262; RIN 0910-AJ02). It would amend 21 CFR part 170 for human food and 21 CFR part 570 for animal food, and it carries the signature of HHS Secretary Robert F. Kennedy, Jr. — who directed FDA on March 10, 2025 to explore ending the pathway that lets firms market purportedly GRAS ingredients without telling the agency.
For food and ingredient importers the document matters twice: if finalized, it would change which paperwork has to exist behind nearly every ingredient in the U.S. food supply, and the window to shape it is hard-edged — comments close December 9, 2026, and late comments will not be considered.
What FDA is proposing
The operative requirement is a single paragraph, proposed 21 CFR 170.205(a):
"Any person introducing a substance into interstate commerce under the GRAS provision of section 201(s) of the Act must notify FDA of the basis for their conclusion that the substance is GRAS under the conditions of its intended use, except as provided under paragraph (b) of this section."
Since the 2016 final rule (81 FR 54960), sending FDA a GRAS notice has been voluntary. Many ingredients instead entered the market on what press materials call "self-affirmed" GRAS — the rule's own term is "independent conclusion of GRAS status," meaning "a GRAS conclusion has been reached without submitting a GRAS notice." The proposal would make notification a requirement that "would include substances already in the food supply and those being marketed for food use for the first time," subject to seven exceptions discussed below.
One mechanical detail deserves early attention: compliance would turn on FDA filing the notice, not on the company submitting it. FDA proposes a 45-day filing evaluation, then a 180-day review clock with up to two 90-day extensions — and a granted cease-to-evaluate request has "the same effect as if we never received a GRAS notice." Notices would be filed electronically (a paper waiver is available), with foreign-language material accompanied by "an accurate and complete English translation."
What happens to ingredients marketed under an independent ("self-affirmed") GRAS conclusion
The word "grandfathering" appears nowhere in the proposal. Existing ingredients would instead get a one-time, time-limited disclosure option: proposed subpart F (§§ 170.305 and 570.305).
Within one year after a final rule's effective date, a company could submit the substance's identity, its conditions of use, and evidence that the substance was in interstate commerce before that date. No safety data would be required. FDA would post the information on a public list, and being on that list is what sustains the exception from filing a full GRAS notice.
The list is disclosure, not blessing: "The posting of this information does not mean that FDA has reviewed the GRAS status" of the use, and FDA could later "issue a determination that a GRAS notice or food additive petition must be submitted," removing the exception. The window is a hard cutoff — submissions "will not be accepted" after the one-year date — and it is closed entirely where a use previously drew an insufficient-basis letter or an FDA not-GRAS determination.
Companies holding a "no questions" letter from a previously filed GRAS notice fare better: those uses would be excepted outright. But the exception tracks the letter — same substance, same conditions of use — and FDA proposes new authority to rescind no-questions letters (proposed § 170.38(c)), which would revive the notice requirement.
The seven exceptions
Proposed § 170.205(b) lists seven situations where no GRAS notice would be required on the human-food side — each narrower than it first sounds.
| # | Exception (proposed § 170.205(b)) | What to watch |
|---|---|---|
| 1 | A no-questions letter "covers the substance under the conditions of its intended use" | Same conditions of use only; FDA proposes power to rescind letters (§ 170.38(c)) |
| 2 | Substance is listed or affirmed as GRAS in 21 CFR parts 182, 184, or 186 | Check that the listed use matches the actual use, not just the substance name |
| 3 | Substance is considered GRAS under existing § 170.30(d) or (i)(1) | Narrow provisions; confirm the cited paragraph actually reaches the use |
| 4 | Use already considered through an established FDA process (for example, biotechnology or animal cell culture consultations) | FDA's publicly available documentation must not identify the need for a GRAS notice |
| 5 | Threshold of Regulation (TOR) exemption under § 170.39 | Human food only; FDA also proposes expanding TOR beyond food-contact substances |
| 6 | An effective Food Contact Notification (FCN) covers the substance | Only where the substance "originates from the manufacturer or supplier listed in the effective FCN" |
| 7 | Subpart F submission included on FDA's public list | One-year window; FDA can override by ordering a GRAS notice or food additive petition |
Proposed § 570.205 mirrors the mandate for animal food, but the exception list differs: the codified-GRAS exception points to parts 582 and 584, there is an exception for uses vetted through an established animal food ingredient consultation process, and there is an exception for substances "listed in and used in accordance with" the feed-ingredient definitions chapter (Chapter 6) of the 2024 AAFCO Official Publication, incorporated by reference — unless the use is the subject of a public FDA statement of concern. There are no TOR or FCN exceptions on the animal-food side.
Not a ban, and not premarket approval
Two opposite misreadings are circulating: that FDA has banned self-affirmed ingredients, and that this is premarket approval in disguise. The rule's own text rejects both:
"[T]he proposed GRAS notification program generally, and proposed Sec. 170.205(a), do not establish a premarket review program for purportedly GRAS substances. ... Thus, a company may continue marketing a purported GRAS substance before submitting a GRAS notice or after submitting a GRAS notice before it is filed by FDA."
Failing to notify would not automatically transform an ingredient into an unapproved food additive. As proposed, noncompliance "would be a factor" in FDA's "prioritization of food substances for post-market review." The substantive question — whether the use really is GRAS — stays separate: an FDA letter finding an insufficient basis for a GRAS conclusion "would be relevant to our determination of whether a food substance is an unapproved food additive under its conditions of use and would inform any post-market action." The preamble's enforcement toolkit includes warning letters, seizure of adulterated foods, and import alerts.
The three clocks
Every deadline in the proposal is relative to a final rule that does not yet exist. FDA states its intent that a final rule "become effective 60 days after the date of the final rule's publication," proposes that the notification requirement carry "a compliance date of 18 months after the effective date of the final rule," and would close the subpart F listing window one year after the effective date.
| Clock | Proposed length | Starts from |
|---|---|---|
| Final rule becomes effective | 60 days | Publication of a future final rule (stated intent) |
| Mandatory-notice compliance date (§§ 170.205 / 570.205) | 18 months | The final rule's effective date |
| Subpart F window for existing ingredients | 1 year, hard cutoff | The final rule's effective date; late submissions "will not be accepted" |
No calendar dates exist for any of these clocks, and none can until a final rule publishes — any specific month or year attached to them is invented. Note the sequencing quirk: the subpart F window (one year) closes before the compliance date (18 months) arrives, so a company relying on the public-list exception for legacy ingredients would have to move early.
What this means for imported ingredients
Here precision matters, because the proposal is silent where importers most want an answer. It contains no importer-specific provisions and never mentions the Foreign Supplier Verification Programs rule or section 805 of the FD&C Act. The duty simply rides on "any person introducing a substance into interstate commerce under the GRAS provision." How that maps onto a U.S. importer buying a foreign-made ingredient — as opposed to the foreign manufacturer — is a question the rule does not answer. That silence is worth a docket comment, not an assumption.
What the document does show is that imported ingredients sit squarely in FDA's view. The preamble reports: "Of the more than 1,200 filed GRAS notices, 617 were submitted by foreign firms, and 503 of these were submitted by foreign firms located in countries where English is not the primary language" — hence the proposed English-translation requirement (§§ 170.220(c), 570.220(c)). Its enforcement history runs through the border: crude stevia leaf extracts under an import alert since 1991, one that currently recommends detention without physical examination; ashwagandha foods from firms on the Red List of Import Alert 99-45; palm-leaf dinnerware added to Import Alert 23-15.
The practical work right now is inventory, not filings. Questions worth putting to suppliers and your own product file:
- Which GRAS basis does each imported ingredient rely on? A no-questions letter with a GRN number, a codified listing in parts 182/184/186 (or 582/584 for feed), or an independent conclusion living only in a supplier's files?
- Can the supplier produce the basis document? If the answer is a marketing sheet rather than a dossier or letter, you have found the exposure.
- Who would notify FDA if notification becomes mandatory — the foreign manufacturer, or you? The rule does not assign this; your contracts eventually will.
- Which ingredients would need the subpart F window, and what evidence of pre-effective-date interstate commerce exists for them today?
How to comment before December 9
The DATES section is unambiguous: "Either electronic or written comments on the proposed rule must be submitted by December 9, 2026. Submit comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by December 9, 2026." One date covers both tracks. Electronic comments go through the regulations.gov filing system, which accepts submissions until 11:59 p.m. Eastern Time at the end of December 9, 2026 — reference Docket No. FDA-2025-N-3262. Mailed or hand-delivered paper comments must be received by that date. FDA's warning is blunt: "late, untimely filed comments will not be considered."
FDA is openly shopping for alternatives, "specifically seeking comments on potential alternatives to the proposed rule that could reduce regulatory burdens," and invites comment on the 45-day pre-filing period, the second 90-day extension, and the animal-food counterparts. This is an economically significant rulemaking — estimated present-value costs of roughly $89.6 million over ten years at a 3 percent discount rate, a significant impact on small entities, and no small-business exemption proposed — so comments backed by cost and operational data carry the leverage.
Which of your ingredient lines would this rule touch?
Send a commercial invoice, packing list, or product list from a recent or upcoming shipment. Greenwich runs a free Import Readiness Review and returns a per-line map of your exposure:
- Per-line FDA / CPSC / USDA flags
- Preliminary HTS classifications with confidence levels
- Document gaps in the entry file
- Prioritized next steps
Greenwich does not prepare GRAS notices, perform GRAS evaluations, or determine GRAS status — the review shows which product lines pull FDA into the entry so you know where to look.
Frequently asked questions
Did FDA ban GRAS self-affirmation?
No. The August 11, 2026 document is a proposed rule, and even as proposed it is not a ban. The GRAS pathway would survive. What would end, starting at a compliance date 18 months after a future final rule takes effect, is marketing an ingredient on an independent GRAS conclusion without notifying FDA. FDA states that the program would not establish premarket review and that a company may continue marketing a purported GRAS substance before its notice is filed. Nothing is required of anyone today.
When do comments on the GRAS proposed rule close?
December 9, 2026 — the same date applies to comments on the proposed rule and to comments on the Paperwork Reduction Act information collection. The regulations.gov electronic filing system accepts comments until 11:59 p.m. Eastern Time at the end of December 9, 2026, mailed paper comments must be received by that date, and FDA warns that late, untimely filed comments will not be considered. Reference Docket No. FDA-2025-N-3262.
What happens to ingredients already on the market under a self-affirmed GRAS conclusion?
The proposal contains no grandfathering. It offers a one-time subpart F option instead: within one year after a final rule's effective date, a company could submit the substance's identity, its conditions of use, and evidence it was in interstate commerce before that date — no safety data required — and FDA would post the information on a public list. Posting does not mean FDA has reviewed the GRAS status, FDA could still order a full GRAS notice or a food additive petition, and the option is unavailable for uses that drew an insufficient-basis letter or a not-GRAS determination.
Does the proposed GRAS rule cover animal food?
Yes. The proposed rule amends 21 CFR part 170 for human food and part 570 for animal food. The animal-food side carries different exceptions, including one for substances listed in and used in accordance with the feed-ingredient definitions chapter of the 2024 AAFCO Official Publication, and it has no threshold-of-regulation or food-contact-notification exceptions.
Are dietary supplements covered by the proposed GRAS rule?
No. Dietary supplement ingredients described in section 201(ff) of the FD&C Act are excluded from the food additive definition by statute, so they cannot be the subject of a GRAS notice under the proposal. The exclusion follows the use, though: the same substance used in conventional food would be in scope. Pesticide residues, color additives, prior-sanctioned uses, and new animal drugs are also outside the proposed rule.
The bottom line
This is a proposed rule. Nothing has to be filed today, no marketing has to stop, and every deadline inside it floats on a final rule that has not been written. But the direction is unmistakable: the HHS Secretary signed it personally, it is designated economically significant, and it converts the central voluntary act of U.S. ingredient regulation into a requirement.
Two moves cost little now. First, map every ingredient — imported lines first — to the GRAS basis it actually relies on, and get the basis documents out of your suppliers' files and into yours. Second, put anything you need changed into the docket by December 9, 2026. If a final rule lands, the shortest clock is the one-year subpart F window for legacy ingredients — and the companies that already know their GRAS bases will be the ones that make it.
Primary sources: FDA (HHS), "Substances Generally Recognized as Safe," proposed rule, 91 FR 51834 (August 11, 2026), FR Doc. 2026-16296, Docket No. FDA-2025-N-3262, RIN 0910-AJ02; FDA, "Substances Generally Recognized as Safe," final rule, 81 FR 54960 (August 17, 2016). Quotations are from the proposed rule as published. This is a pending rulemaking — confirm the current status of the docket and of any final rule before acting on it. This article is operational guidance for importers and is not legal advice.