On July 3, 2026, the Office of Information and Regulatory Affairs (OIRA) released the 2026 Unified Regulatory Agenda, providing additional details and an updated timeline for the U.S. Food and Drug Administration's (FDA) publication of a proposed rule (RIN 0910-AJ02) that would, for the first time, mandate premarket notification for substances determined to be Generally Recognized as Safe (GRAS). The Agenda entry reveals significant changes from prior descriptions of the rule. Most notably, the scope more narrowly targets "certain uses of food substances," removes language covering indirect food substances such as food-contact materials, and introduces new concepts, including a "streamlined submissions" pathway and a "limited submission window." The entry also states that the FDA will presume that food substances subject to the mandatory notification are not GRAS unless the notification requirement is satisfied. Significant doubts remain regarding the FDA's legal authority to require GRAS notifications for food substances.
Background
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a substance is excluded from the statutory definition of "food additive" if it is "generally recognized, among experts qualified by scientific training and experience to evaluate its safety," as "adequately shown through scientific procedures … to be safe under the conditions of its intended use." As a result, GRAS substances are exempt, by definition, from the FD&C Act's premarket approval requirements for food additives. Since 1958, the GRAS exemption has been understood as resting on the general recognition by qualified experts that a substance is safe under the conditions of its intended use—not on FDA's review or approval. Over the years, the FDA has reviewed certain food substances and promulgated regulations that affirm or list specific uses of those substances as GRAS. However, those reviews were undertaken either on the FDA's own initiative or in response to voluntary stakeholder petitions, but they did not displace the industry's ability to make independent determinations that a food substance is GRAS under the conditions of its intended use.
In 1997, the FDA replaced its prior GRAS petition process with a voluntary notification program, codified in 21 C.F.R. Part 170, Subpart E, under which any person may, but is not required to, notify the FDA of a conclusion that a substance is GRAS under the conditions of its intended use. Companies that choose not to submit voluntary notifications engage in what is commonly known as "self-affirmed GRAS" or "self-determined GRAS." The FDA has long acknowledged the industry's reliance on GRAS self-determinations.
The current rulemaking effort to curtail or eliminate self-affirmed GRAS determinations for covered uses and require premarket GRAS notifications represents a significant shift in the FDA's historical interpretation and administration of the GRAS exemption. The proposed rule was submitted to the Office of Management and Budget (OMB) for interagency review on December 1, 2025, and cites 21 U.S.C. §§ 321, 342, 348, and 371 as its legal authority. It is classified as "Economically Significant," meaning that the rule may have an annual effect on the economy of at least $100 million or adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health, or safety.
The 2026 Unified Agenda Update: What Changed
A comparison of the Spring 2025 Unified Agenda entry with the 2026 Agenda entry reveals several material changes that narrow the rule's apparent scope while introducing novel regulatory concepts:
- Revised Publication Timeline to December 2026. The proposed rule is now anticipated for publication in December 2026. The Spring 2025 Agenda had indicated October 2025, and earlier timelines had suggested late spring or summer 2025. The continued slippage likely reflects the complexity of the rulemaking and extended OMB review.
- Scope Narrowed to "Certain Uses of Food Substances." The 2026 Agenda entry refers to mandatory notification for "certain uses of food substances," suggesting that not all GRAS uses will be subject to the requirement. This is a meaningful departure from the broader language in prior entries.
- Removal of Indirect Food Substance Language. The Spring 2025 Agenda entry explicitly included "substances added indirectly (such as from food packing)" within the rule's scope. This language does not appear in the 2026 Agenda entry, potentially excluding food-contact materials from the mandatory notification requirement.
- Streamlined Submissions Pathway. The 2026 Agenda entry introduces a concept of "streamlined submissions" that would be available before the final rule's effective date. This may signal the FDA's intent to reduce the regulatory burden on companies with existing GRAS determinations.
- Limited Submission Window. The 2026 Agenda entry references a "limited submission window" before the effective date, suggesting a defined period during which companies must bring existing self-affirmed GRAS substances into compliance.
- Presumption of Non-GRAS Status. Perhaps most significantly, the 2026 Agenda entry states: "Uses of food substances that are subject to the mandatory notification requirement will be presumed by FDA not to be GRAS unless the notification requirement has been met." This presumption effectively reverses decades of the FDA's interpretation of and industry's reliance on the FD&C Act's GRAS exemption and clearly signals the FDA's intended foreclosure of GRAS self-affirmation as a lawful pathway to establish the regulatory status of a food substance. Non-notified covered uses would be presumed non-GRAS and thus treated as unapproved food additives.
Additionally, the Spring 2025 Agenda entry had mentioned an exemption for ingredients already covered by regulation or FDA "no questions" letters. The 2026 Agenda entry is silent on this point, leaving uncertainty as to whether such exemptions will be maintained.
The 2026 Agenda entry also does not address how the FDA would handle confidential, trade secret, or otherwise proprietary information in mandatory GRAS submissions. Although FDA regulations permit the Agency to withhold confidential and trade secret information from disclosure, GRAS determinations are inherently based on chemical identities and substance use levels, which themselves may be considered proprietary by the notifier.
Timeline: A Proposed Rule Is Only the Beginning
Even if the FDA publishes its Notice of Proposed Rulemaking (NPRM) in December 2026 as anticipated, the path to a binding final rule remains lengthy:
- NPRM Publication (anticipated December 2026). The proposed rule will be published in the Federal Register, opening a public comment period.
- Comment Period (at least 60 days, but likely longer). Given the rule's economic significance and industry impact, a 90- to 120-day comment period is probable, over the typical 60-day comment period. Extensions may be requested.
- FDA Review and Response. The FDA will review and respond to public comments. For a rule of this magnitude and complexity, this process typically takes 12 to 24 months or longer.
- Final Rule Publication. Realistically, a final rule is unlikely before late 2028 or 2029 at the earliest, particularly given the legal challenges that are virtually certain to follow.
- Implementation Period. The final rule would likely include a transition period before mandatory compliance, potentially incorporating the "limited submission window" referenced in the Agenda entry.
Industry stakeholders should note that the rulemaking process is highly uncertain. Political transitions, litigation, resource constraints, and competing regulatory priorities could all affect the timeline. Moreover, the rule's classification as "Economically Significant" means it will receive heightened scrutiny from OMB and the current or future Administration.
Questions About the FDA's Statutory Authority
The most consequential question surrounding this rulemaking is whether the FDA possesses the legal authority to mandate GRAS notifications. Multiple sources, including the FDA, have raised significant doubts.
The FDA's Own Admission
In the preamble to its 2016 GRAS final rule, the FDA explicitly acknowledged that it "lack[s] express statutory authority to require companies to submit GRAS notices." 81 Fed. Reg. 54,981 (Aug. 17, 2016). The FDA further stated that "[t]he creation of this GRAS provision reflected Congress' determination that many substances intentionally added to food for a specific use do not need premarket review by FDA to ensure their safety." Id. The FDA also observed that Congress has had the opportunity to amend the FD&C Act to require premarket GRAS notification but has chosen not to do so. 81 Fed. Reg. at 54,982. While the FDA suggested it might possess implied authority to mandate notifications, it expressly declined to exercise such authority at that time. Id.
The Statutory Text
The statutory framework of the FD&C Act presents structural challenges for the FDA's authority claim:
- Section 201(s) (21 U.S.C. § 321(s)) is a definitional provision that establishes GRAS status based on expert consensus regarding safety. It does not prescribe any methodology for confirming that a substance meets the GRAS standard, let alone require FDA notification or concurrence.
- Section 409 (21 U.S.C. § 348) establishes the food additive approval process, but by definition, GRAS substances are excluded from the definition of "food additive" and thus fall outside Section 348's regulatory reach.
- Section 701 (21 U.S.C. § 371) provides the FDA with general rulemaking authority for the "efficient enforcement" of the Act. Whether this general provision can sustain a mandatory premarket notification regime for an entire category of substances that Congress specifically exempted from premarket review is an open and serious question.
- Section 409 of FDAMA (1997) (21 U.S.C. § 348) is instructive by negative implication. When Congress enacted the Food and Drug Administration Modernization Act, it mandated premarket notification for food-contact substances (21 U.S.C. § 348(h)) but conspicuously did not impose the same requirement on GRAS substances. This legislative choice suggests Congress knew how to mandate notification when it intended to do so.
The CRS Analysis
On July 2, 2026, the Congressional Research Service published a legal analysis (LSB11445) examining the FDA's statutory authority. The CRS report notes the FDA's own admission of lacking express authority and observes that the 2021 Southern District of New York decision in Center for Food Safety v. Becerra "does not squarely address whether FDA is authorized to require the submission of GRAS notices." The decision held only that the FDA was not required to mandate them. CRS further notes that the FDA's shift from affirmatively declining to exercise implied authority to now asserting it could receive less deference from courts under the Skidmore framework, under which "earlier and later pronouncements" made by an agency may diminish the persuasiveness of the FDA's new position.
Loper Bright and the Post-Chevron Landscape
The Supreme Court's decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024), which overruled Chevron deference, significantly alters the legal landscape. Courts must now exercise independent judgment on questions of statutory interpretation rather than deferring to an agency's reasonable construction of ambiguous statutory text.
This development has direct implications for the FDA's GRAS authority. The 2021 Center for Food Safety decision upheld the FDA's voluntary GRAS notification scheme under Chevron Step Two (deference to an agency's reasonable interpretation of a statute). That reasoning is now substantially weakened. GRAS-related challenges may have a greater chance of succeeding in a post-Chevron world. Moreover, eliminating the self-affirmed GRAS pathway altogether would likely require legislation; otherwise, it may not withstand legal challenge under the APA. The FDA will have to defend itself under the Loper Bright decision, which denies it any deference in its interpretation of the FDCA.
In sum, the statutory provisions cited by the FDA in the 2026 Agenda entry may not provide adequate authority to mandate GRAS notification, and eliminating the self-affirmation pathway will likely result in legal challenges.
Congressional Activity: The Better Food Disclosure Act
Running on a parallel track, Senator Roger Marshall introduced the Better Food Disclosure Act of 2025 (S. 3122) on November 6, 2025, with co-sponsorship from Senators Rick Scott and Katie Britt. The bill would amend the FD&C Act to:
- Require mandatory GRAS notifications to the FDA;
- Establish a public listing of all GRAS substances;
- Create a post-market review process; and
- Provide a two-year transition period for existing self-affirmed GRAS substances.
Notably, S. 3122 does not contain a preemption provision. The bill's existence may reflect legislative recognition that the FDA may lack the authority to accomplish these objectives through rulemaking alone. If enacted, the legislation would provide a clearer statutory basis for mandatory notification than what the FDA currently claims under existing law, potentially mooting legal challenges to the proposed rule.
Strategic Considerations for the Industry
Although a binding final rule remains years away, companies should begin preparing now:
1. Conduct a GRAS Inventory and Gap Analysis
- Identify all substances marketed on a self-affirmed GRAS basis.
- Assess the quality and completeness of existing GRAS determinations and supporting documentation.
- Determine which substances may qualify for any exemptions or streamlined pathways.
- Evaluate whether voluntary submission of GRAS notifications now may be strategically advantageous.
2. Prepare for the Comment Period
- Develop substantive comments addressing scope, implementation timelines, exemption criteria, the streamlined submission pathway, and the treatment of confidential, trade secret, and otherwise proprietary information.
- Consider coordinating with trade associations to amplify industry-wide concerns.
- Engage scientific experts to address the technical evidentiary standards for GRAS determinations, including the quantity and quality of scientific evidence necessary to demonstrate general recognition of safety.
3. Monitor and Assess Litigation Risk
- Track legal challenges to the proposed rule, which are virtually certain given the statutory authority questions.
- Evaluate whether to participate in or support such challenges.
- Assess exposure to enforcement risk in the interim period between NPRM publication and final rule issuance.
4. Monitor Both Regulatory and Legislative Tracks
- The outcome may ultimately be determined by whichever track advances first—either FDA rulemaking or congressional legislation.
- Companies should engage with Congress to ensure any legislative mandate appropriately balances transparency objectives with practical implementation concerns.
Conclusion
The FDA's proposed GRAS rulemaking represents a potential paradigm shift in food ingredient regulation, but it faces significant legal headwinds. The agency's own prior acknowledgment of its lack of express statutory authority, the structural logic of the FD&C Act's GRAS exemption, and the Supreme Court's elimination of Chevron deference collectively create substantial uncertainty about whether the proposed rule will survive judicial review. The narrowing of scope evident in the 2026 Agenda entry may reflect the FDA's recognition of these constraints.
Industry stakeholders should use the remaining months before the NPRM's anticipated publication to conduct thorough gap analyses, prepare substantive comments, and develop strategic positions on both the regulatory and legislative fronts. We will continue to monitor these developments and provide updates when the proposed rule is published. Please contact a member of the Venable Food and Drug Law team with any questions.
For more information, please contact your regular firm contact or any member of the Food & Beverage Regulatory practice group.