In early August, the U.S. Department of Health and Human Services (HHS) announced a proposed rule that would require manufacturers to notify the U.S. Food and Drug Administration (FDA) when they conclude that a substance added to human or animal food is generally recognized as safe (GRAS).
The proposed rule was published to the Federal Register on Aug. 11, 2026, as Docket No. FDA-2025-N-3262 (RIN 0910-AJ02). Comments are due Dec. 9, 120 days after publication, and FDA has said late comments will not be considered.
Acting FDA Commissioner Kyle Diamantas said the proposal is intended to give the agency more insight into ingredients entering the food supply.
"By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply," Diamantas said.
Since Congress established the GRAS exemption in 1958, manufacturers have been permitted to determine independently that certain substances are generally recognized as safe under their intended conditions of use. FDA has operated voluntary notification programs, but companies have not been required to report those determinations to the agency.
Voluntary reporting 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. The obligation is not limited to new substances. FDA stated that the requirement would include substances already in the food supply, meaning companies with established ingredient portfolios, rather than new product pipelines, may face the largest compliance burden.
For substances already on the market based on manufacturers' independent GRAS conclusions, the proposal would create a one-time, time-limited streamlined submission pathway. Companies would provide the FDA with information about the substance's name, its intended use and evidence it has been marketed and crossed state lines but would not need to submit the underlying safety data and testing that led to the original GRAS conclusion. The agency said this would allow it to prioritize post-market safety evaluations while limiting additional regulatory burden.
That window would open for one year after the effective date of a final rule but close approximately six months before the 18-month compliance deadline — meaning companies that wait to see the final rule's terms before acting could find the streamlined pathway closed while the underlying obligation remains open.
Animal food submissions would also need to include target species, use levels and, for food-producing animals, the quantities of residues to which humans may be exposed in edible tissue — elements with no counterpart in the human food side of the rule.
Noncompliance carries no direct penalty as drafted; FDA noted it would instead be "a factor in FDA's prioritization of food substances for post-market review." But industry attorneys have noted that a mandatory federal filing obligation, once publicly verifiable, could still become relevant to retailer qualification requirements, private-label specifications, competitor challenges and consumer litigation.
AAFCO flags a gap around newer ingredient reviews
The Association of American Feed Control Officials (AAFCO) said it is reviewing the proposed rule and outlined its early concerns ahead of submitting formal comments.
According to AAFCO, FDA proposed recognizing the 2024 AAFCO Official Publication (OP) by reference in federal regulation, under 21 CFR 570.205(b)(6), exempting ingredients listed there from mandatory GRAS notification. AAFCO called the provision a significant federal recognition of its ingredient-definition process, but noted the exemption as written applies only to the 2024 OP and does not extend to ingredient definitions developed afterward — including those reviewed through AAFCO's Scientific Review of Ingredient Submissions (SRIS) pathway, created by AAFCO and Kansas State University after FDA withdrew from the AAFCO process in October 2024.
That gap means an ingredient favorably reviewed by SRIS and adopted by AAFCO's membership could still require a separate FDA GRAS notification if the rule is finalized as written. The gap is structural rather than incidental, explained AAFCO: it will widen with each new OP edition, since incorporation by reference requires a fixed edition and cannot automatically track future editions without new rulemaking. FDA's proposal also does not specify the evidentiary standard, publication method or advance-notice procedure for the "public statement of concern" that could switch off the exception for a given use.
AAFCO said it is focused on collaboration with FDA as it develops formal comments, noting the SRIS pathway was built to meet the same rigor FDA already recognizes in the 2024 OP and Animal Food Ingredient Consultation (AFIC) exceptions, including expert review, conflict-of-interest controls, public comment and a full membership vote. AAFCO said its comments will encourage FDA to:
- Make the 2024 Official Publication exception permanent and ongoing rather than frozen to a single edition.
- Explicitly recognize the AAFCO SRIS process as qualifying for the exception.
- Preserve FDA's authority to flag safety concerns and require a GRAS notice when warranted.
A legal scholar's perspective
Laurie J. Beyranevand, Pescosolido Professor of Food and Agricultural Law and Policy and director of the Center for Agriculture and Food Systems at Vermont Law and Graduate School, said the rule's streamlined pathway is designed to ease, but not eliminate, the burden on companies that never notified FDA of self-affirmed GRAS conclusions.
"The proposed rule applies to both human and animal foods and proposes that for self-affirmed GRAS substances (i.e., those where industry has made its own GRAS conclusion and hasn't notified FDA) would be subject to a streamlined process whereby they would submit information about the name of the substance, its intended use, and evidence it was being used in the food supply and crossing state lines, but would not have to submit all the safety data and testing information that led to the GRAS conclusion," Beyranevand said.
Asked whether the rule adds burden without improving safety, or closes a genuine blind spot, Beyranevand came down on the side of traceability.
"The rule provides the important function of enabling FDA to track substances in the food supply,” she explained. “Without the notification process, FDA didn't have the information about what substances were approved as GRAS and couldn't track safety outcomes. Providing notification of the GRAS determination is a relatively small burden for industry that provides traceability for the agency.”
She also noted FDA recognizes that the proposal could weigh more heavily on smaller companies.
"FDA acknowledged that the proposed rule has the potential to disproportionately impact smaller businesses who want to bring new GRAS substances to market given the notification requirements,” Beyranevand said. “The agency is, however, asking for alternatives and suggestions to help reduce some of those barriers.”
Beyranevand feels the proposal fits a broader regulatory pattern rather than a one-off action.
"Generally, I think this reflects what we've been seeing already with some of the phase outs for certain color additives on the human foods side, reflecting a push for stronger oversight of the ingredients in the food supply," she said.
Beyranevand said this proposed rule might help strike the balance FDA has long struggled with between oversight and burden.
"This has been a long time coming,” she said. “FDA has struggled with how to address these types of substances in a way that provides oversight but doesn't unduly burden industry if the substances have been generally recognized by qualified experts as safe, which essentially requires scientific consensus.
“The law starts with a presumption that additives are unsafe, which is why they are required to undergo premarket safety testing and approval by FDA,” she added. “GRAS substances were created as a carve out from premarket approval to recognize things we'd used in the food supply commonly like salt, citric acid, etc. This proposal doesn't require premarket approval, but it does enable the agency to review the information that led to the GRAS conclusion and keep track of what substances are in the food supply to meet its mandate.”
What companies should do now
Attorneys Todd A. Harrison and Thomas Smith of Venable LLP said in a memorandum analyzing the proposed rule that pet food manufacturers, premix operations, feed companies and integrators should not wait for a final rule to assess their exposure.
Among the firm's key takeaways:
- Legacy portfolios are the primary exposure. The notification obligation is not limited to new substances. “FDA expressly states it applies to ingredients ‘already in the food supply,’” wrote the attorneys. “Companies with established product lines may face the largest compliance burden.”
- AAFCO recognition is partial, static and conditional. FDA's proposal incorporates only the "Official Names and Definitions" section of the 2024 AAFCO Official Publication, frozen at that edition and excluding post-2024 ingredients, and subject to a "public statement of concern" that can eliminate the exception for a given use.
- SRIS cannot automatically satisfy any exception. As drafted, novel ingredients reviewed through the AAFCO/Kansas State University SRIS pathway still require a full federal GRAS notice. “This is a potential bottleneck for the industry's primary non-FDA review mechanism,” they noted.
- 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, they wrote.
Venable said noncompliance carries no direct statutory penalty as drafted, but a mandatory, publicly verifiable federal filing requirement could still surface in retailer qualification standards, private-label specifications, competitor challenges and litigation — making early preparation, rather than reliance on enforcement discretion, the best course for companies evaluating their ingredient portfolios ahead of the Dec. 9 comment deadline.
