On August 11, 2026, FDA published a proposed rule (Docket No. FDA-2025-N-3262) that would replace the voluntary GRAS notification program with a mandatory filing obligation for animal food substances. Comments are due December 9, 2026. FDA has stated that late comments will not be considered.
We have prepared a detailed memorandum analyzing the proposed rule's implications for feed companies, pet food manufacturers, premix operations, and integrators, including its treatment of existing ingredient portfolios, the AAFCO and SRIS pathways, and potential industry comments. Below are the key takeaways.
Key Takeaways
- Voluntary becomes mandatory. Proposed 21 CFR 570.205(a) would require any person introducing a GRAS substance into interstate commerce to file a notification with FDA—eliminating the current optional pathway.
- Legacy portfolios are the primary exposure. The obligation is not limited to new substances. FDA expressly states it applies to ingredients "already in the food supply." Companies with established product lines may face the largest compliance burden.
- AAFCO recognition is partial, static, and conditional. FDA proposes to incorporate only the "Official Names and Definitions" section of the 2024 AAFCO Official Publication—frozen at that edition, excluding post-2024 ingredients, and subject to a "public statement of concern" condition that can eliminate the exception for a use.
- SRIS cannot automatically satisfy any exception. As drafted, novel ingredients reviewed through the AAFCO/K-State SRIS pathway still require a full federal GRAS notice—a potential bottleneck for the industry's primary non-FDA review mechanism.
- The streamlined pathway is narrow and time-limited. Subpart F offers a one-time, one-year window requiring data—including target species, use levels, and, for food-producing animals, quantities of residues to which humans may be exposed—that many companies may not have assembled.
- Enforcement discretion is not a strategy. Certain ingredients (including glucosamine and chondroitin in pet food) face threshold questions at the food/drug boundary that the proposed rule's disclosure mechanisms could bring to a head.
The Proposed Obligation
Proposed § 570.205(a) would require any person introducing a substance into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act to notify FDA of the basis for their conclusion that the substance is GRAS under its intended conditions of use. The word "any" is deliberate: the duty attaches to every party in the supply chain that introduces the substance into commerce, not merely to the manufacturer of the substance itself.
Critically, the obligation is not limited to new substances. FDA states expressly that the requirement "would include substances already in the food supply and those being marketed for food use for the first time." For companies with established ingredient portfolios, the legacy product line is therefore the larger exposure—not the innovation pipeline.
Noncompliance carries no direct penalty as drafted. FDA states only that it would consider noncompliance "a factor in FDA's prioritization of food substances for post-market review." But a mandatory federal filing obligation—once publicly verifiable—may become relevant to retailer qualification requirements, private-label specifications, competitor challenges, and consumer litigation.
Unique Animal Food Exceptions—and the Critical Gaps
Proposed § 570.205(b) lists seven circumstances in which a GRAS notice is not required. Two of these have no human-food counterpart and are the most consequential provisions in the rulemaking for the animal food sector:
The AFIC exception (§ 570.205(b)(5)): No notice is required if the intended use has been reviewed through an established animal food ingredient consultation process with FDA, and FDA has publicly posted a summary indicating no questions or concerns. FDA identifies AFIC (GFI #294) as an example. This exception runs to all persons marketing the substance for that use—the clearest substance-based (rather than person-based) statement in the proposal.
The AAFCO exception (§ 570.205(b)(6)): No notice is required if the substance is listed in and used in accordance with the incorporated portion of Chapter 6 of the 2024 AAFCO Official Publication (OP), and the use is not the subject of a public FDA statement of concern regarding GRAS status.
The AAFCO exception is one of the proposal's most significant animal-food provisions—FDA is proposing to make a fixed portion of the 2024 AAFCO OP determinative of whether a GRAS notice is required under this exception. That is a meaningful accommodation. But it is narrower than most industry summaries suggest.
The incorporation covers only the "Official Common or Usual Names and Definitions of Feed Ingredients" section of Chapter 6, not the entire OP and not even all of Chapter 6. Moreover,
it is frozen at the 2024 edition. Incorporation by reference under 1 CFR part 51 requires a fixed edition—the Office of the Federal Register does not permit dynamic or future-dated references. The exception therefore cannot track future OP editions without new rulemaking. The exception is expressly tied to the 2024 edition. FDA states that ingredients listed and used in accordance with other editions of the AAFCO OP would not qualify under § 570.205(b)(6). Later editions therefore would not be captured automatically.
The "public statement of concern" condition gives FDA substantial discretion to switch off the exception for a particular use. The proposal does not specify the evidentiary standard for such a statement, where FDA must publish it, whether affected parties would receive advance notice, or any procedure for responding before the exception ceases to apply. Companies relying on the incorporated AAFCO list therefore could face uncertainty about when an ingredient has lost the benefit of the exception.
The exception relieves only the notification duty. It does not confer GRAS status and is not an authorization to market.
The Post-2024 Gap and SRIS
SRIS is the Scientific Review of Ingredient Submissions pathway created by AAFCO and Kansas State University after FDA withdrew from the AAFCO process in October 2024. Although used by industry to review the safety of new animal food ingredients, SRIS review, standing alone, would not satisfy any of the seven exceptions as the rule is drafted. An SRIS-reviewed ingredient adopted by AAFCO and published only in a post-2024 OP edition would not qualify for the AAFCO exception; unless another § 570.205(b) exception independently applies, a GRAS notice would be required.
This gap is structural, not incidental. It will widen mechanically with each new OP edition. FDA's own preamble acknowledges that the exceptions were designed to "take into account the unique circumstances of how animal food has historically been regulated by States and FDA"—yet the architecture as drafted excludes the successor pathway the industry and state regulators built to replace the collaboration FDA terminated. The full-length, detailed memorandum identifies several potential comment approaches to address the post-2024 gap, including possible revisions to the regulatory text.
The Streamlined Pathway Trap
Proposed subpart F of part 570 offers a one-time, time-limited alternative for legacy substances: a streamlined submission to CVM by email within one year after the effective date of the final rule. But it is not an exemption. Four qualifications matter:
- The exception does not attach on submission—it attaches only when FDA includes the submission on a public list, and FDA may later determine that a full notice or petition is required.
- Animal-food submissions must include target animal species, use levels, purposes, and—for food-producing animals—the quantities of residues to which humans may be exposed in edible animal tissues. The target-species and human-exposure elements have no human-food counterpart.
- The window closes approximately 6 months before the 18-month compliance date. A company that waits to see the final rule's terms before acting may find the inexpensive pathway closed while the obligation remains open.
- Animal-food submissions would be made to CVM by email. The proposed rule does not establish a separate electronic portal or specify a deadline or formal procedure for FDA's determination that a submission meets the requirements for placement on the public list.
Ingredients at the Food/Drug Boundary
Certain ingredients face a threshold question that precedes the notification framework. Glucosamine and chondroitin—widely used in pet foods for joint-support purposes—lack any form of FDA/CVM concurrence. Their commercial use has rested on state-level acceptance (principally from the Texas Office of the State Chemist) and CVM's enforcement discretion. They do not appear in the 2024 AAFCO Official Publication, are not listed in 21 C.F.R. Parts 582 or 584, and have no AFIC consultation or no-questions letter on file. Indeed, CVM has historically declined to entertain food-additive petitions or GRAS notifications for ingredients whose functional benefit is unrelated to a recognized technical or functional effect—and the agency reads "functional effect" narrowly. Where the claimed benefit is a health benefit, CVM has insisted that the effect be tied to the ingredient's nutritive value in the targeted species. In practice, this has meant that the ingredient must be an essential or semi-essential nutrient, or at minimum a substance whose nutritive contribution is consumed in the normal course of the species' diet and is merely being isolated or concentrated. The agency has shown little appetite for accepting dual-purpose characterizations of specialized ingredients. A highly standardized turmeric extract, for example, might facially qualify as a flavor source—but CVM may look behind that characterization to determine the extract's real intended purpose, which in turn creates the risk that the agency will simply declare the ingredient ineligible for treatment as a food ingredient altogether.
This posture raises a threshold question that the proposed rule does not resolve: Does CVM have the authority to restrict GRAS-eligible functional health benefits to "nutritive value" alone, and—if so—is "nutritive value" truly limited to defined essential or conditionally essential nutrients, or does it encompass other physiologically important substances that animals can safely consume as part of their diets—whether or not those substances are part of their diets today? Novel probiotic strains that support companion-animal health, for instance, may have no historical presence in the species' conventional diet yet could be safely incorporated into it with demonstrable benefit. If CVM's narrow reading prevails, manufacturers will face a regulatory dead end for an entire class of functional ingredients—chilling investment in research, product development, and science-backed differentiation across the pet food sector.
Under the proposed rule, if these substances are marketed under a GRAS theory, the notification duty applies and no exception covers them. Importantly, if CVM determines that a particular substance's impact on the structure or function of the body is unrelated to its nutritive value in the targeted species, the agency will likely exclude it from the GRAS-notification framework under Section 201(s)(5) of the FD&C Act and proposed § 570.205(c). Either way, the proposed rule's disclosure mechanisms—requiring companies to state the "purposes for which the substance is used" in a federal submission—could bring to a head an ambiguity that enforcement discretion has long deferred, potentially stymieing innovation that would promote the overall health of companion animals, livestock, and exotic species alike.
Why the Comment Period Is Uniquely Consequential
This is not a generic reminder to file comments. Several features of this proposal make the comment period particularly important for companies seeking changes before the framework is finalized:
- The static incorporation locks in. If the final rule retains the 2024 OP as the operative list, later AAFCO editions would not be captured automatically; FDA would need to amend the regulatory framework to bring later editions within the exception—a process that takes years. Every OP edition published in the interim would widen the gap.
- The streamlined pathway will not reopen. Subpart F is time-limited by design.
- Burden estimates must be challenged now. FDA estimates that 16 firms will submit animal-food GRAS notices annually, including 12 firms already submitting voluntarily and only four additional animal-food firms attributable to the rulemaking, and estimates 155 total streamlined animal-food submissions. Companies should assess whether those assumptions reflect the number of affected entities, ingredients, conditions of use, and potential filing obligations in the existing animal-food market. Contrary company-specific burden data should be placed in the administrative record now; concrete evidence can inform FDA's final analysis and may be important to any later review of the final rule.
- Company-specific evidence is irreplaceable. Association comments cannot supply your portfolio count, your preparation hours, your supply-chain structure, or your small-entity revenue data.
- Enforcement discretion is not a strategy. GFI #293 is nonbinding and revocable. If finalized, the proposed notification requirements would be binding. A favorable enforcement policy layered on an unfavorable regulation provides comfort without legal protection.
How We Can Help
Our full-length, detailed memorandum—available on request—provides detailed analysis of the proposed rule's requirements, exception architecture, legal vulnerabilities, and recommended comment strategy. We are prepared to assist with:
- Comment preparation. Company-specific comments to Docket FDA-2025-N-3262 and a separate PRA submission to OMB/OIRA, with proposed regulatory text for the post-2024 exception gap
- GRAS exposure assessment. A fixed-scope portfolio review mapping each ingredient-species-use combination against the seven § 570.205(b) exceptions
- Pathway strategy. SRIS, AFIC, GRAS notice, and/or food additive petition sequencing for pipeline ingredients
- Subpart F preparation. Streamlined submission drafting, confidentiality protocols, and evidence-of-commerce documentation
- Supply agreement review. Identifying representations, cooperation obligations, indemnity, and change-of-process notification provisions that need updating
To request the full-length, detailed memorandum or discuss how this proposed rule affects your operations, please contact your regular firm counsel or any member of our Food and Drug Law practice.
Docket: FDA-2025-N-3262 | RIN 0910-AJ02 | FR Doc. 2026-16296
Comment Deadline: December 9, 2026