Originally expected earlier this year, FDA’s proposed overhaul of the Generally Recognized as Safe (GRAS) notification process has now been pushed to December 2026. While the timeline has shifted, the proposal itself remains very much alive—and manufacturers should not interpret the delay as a signal that reform is off the table.
Since dicentra published its April update on state-level GRAS disclosure bills, the federal conversation has continued to develop.
FDA’s updated Unified Agenda now identifies December 2026 as the anticipated publication date for the Notice of Proposed Rulemaking (NPRM) on substances Generally Recognized as Safe. At the same time, stakeholder meetings, written submissions, presentations, and recent FDA discussions have provided more detail about the issues likely to shape the proposal.
Taken together, these developments point toward a potentially significant change in how companies document, disclose, and communicate GRAS conclusions. The timing may have shifted, but the direction remains consistent: greater transparency, increased FDA visibility, and closer scrutiny of substances introduced through independently reached GRAS conclusions.
Under the current federal framework, companies generally have two pathways for establishing that the intended use of a food substance is GRAS:
A company reaches its own GRAS conclusion, generally supported by a scientific dossier, without submitting the conclusion to FDA. Rather the GRAS conclusion is reviewed for consensus agreement (if there is a basis to do so) by an independent expert panel that is appropriately selected according to FDA guidance.
A company submits a GRAS notice to FDA. Following its review, FDA may issue a “no questions” letter stating that the Agency has no questions at that time regarding the notifier’s GRAS conclusion.
Both pathways are expected to rest on the same underlying scientific foundation, including:
The key difference is transparency and FDA awareness. A self-affirmed conclusion may remain entirely outside FDA’s GRAS notice inventory, while an FDA-notified conclusion creates a formal submission record and a publicly available Agency response.
FDA’s planned proposal could substantially reduce that distinction by requiring notification for certain uses that may currently be supported through an independent GRAS conclusion.
According to the Unified Agenda, FDA is considering amendments to 21 CFR Parts 170 and 570 that would require submission of a GRAS notice for certain substances used in human or animal food.
The anticipated proposal would:
Under the current system, submitting a GRAS notice is voluntary. Under the contemplated framework, certain uses would be presumed by FDA not to be GRAS unless the mandatory notification requirement has been satisfied.
The Agenda also indicates that FDA is considering a time-limited, streamlined submission option for uses already introduced into commerce before the effective date of a final rule. That detail is especially important because it suggests the proposal may address not only future GRAS conclusions, but also at least some substances and uses already on the market.
However, the exact scope of the requirement, available exemptions, submission timelines, review process, transition period, and treatment of existing self-affirmed conclusions will not be known until the proposed rule is published.
The updated regulatory timetable lists publication of the NPRM for December 2026.
This is a proposed rule—not a final rule—and the December date is an anticipated publication target rather than a statutory deadline. Following publication, FDA would generally accept public comments, review stakeholder feedback, and determine whether and how to move toward a final rule.
For manufacturers, this means the immediate compliance framework has not yet changed. Self-affirmed GRAS remains a valid path to market under the existing federal regulations.
The delay should nevertheless be viewed as additional preparation time rather than a reason to postpone GRAS planning.
Since April, EO 12866 meetings and related stakeholder materials have illustrated the range of issues FDA and the Office of Management and Budget are being asked to consider.
Although stakeholders differ on how the rule should operate, the materials show broad recognition that any federal reform will need to address much more than the simple question of whether notification becomes mandatory.
Key themes include:
The Meat Institute’s May 2026 submission supported greater transparency and consumer confidence, while emphasizing the need for a strong, consistent national standard.
Its submission called for implementation that is:
The organization also encouraged FDA to consider a phased approach and to coordinate closely with the U.S. Department of Agriculture’s Food Safety and Inspection Service.
That coordination is important for meat and poultry products because FSIS regulates the safety and suitability of substances used in those products while relying in part on FDA’s scientific safety evaluations. Changes to the GRAS framework could therefore affect substances used across overlapping FDA and USDA regulatory systems.
The industry submission also highlighted the importance of post-market review. Rather than treating mandatory notification as a complete solution on its own, it encouraged FDA to pair reform with a science-driven system for verifying the continued safety of substances already in use.
Recent FDA discussions on dietary supplement innovation have also highlighted the relationship between GRAS conclusions and New Dietary Ingredient Notifications, or NDINs.
FDA officials stated that the Agency wants to understand how proposed GRAS changes could affect dietary supplement ingredients and how companies currently navigate the intersection between GRAS determinations and NDIN requirements. Since GRAS status supports the use of an ingredient in dietary supplements, its unclear how self-GRAS ingredients will be viewed in the context of their use in the format of tablets/capsules/soft gels etc. FDA also emphasized the need for a framework that protects public health while allowing safe innovative ingredients to enter the market without unnecessary restrictions.
This issue is particularly relevant for ingredients such as:
Participants noted that unclear boundaries between food, dietary supplement, NDI, and GRAS pathways can influence how companies bring new ingredients to market. Some stakeholders argued that a workable and sufficiently broader NDI pathway could reduce reliance on GRAS as an alternative route for novel supplement ingredients that are not currently in the food supply.
Other speakers raised concerns that certain probiotics and technologically modified substances may not fit neatly within historical definitions of a “dietary substance,” creating uncertainty over whether the appropriate route is GRAS, NDIN, or another regulatory pathway.
This suggests that the GRAS proposal may have consequences extending beyond conventional foods and animal food. Ingredient developers working in the dietary supplement sector should monitor not only the final scope of the rule, but also any related FDA guidance or policy clarification.
Despite substantial differences in the preferred level of oversight, several common themes emerge from the materials.
Greater Transparency Is Likely
Industry, advocacy organizations, and FDA all recognize the importance of improving visibility into substances used in food.
The central disagreement is not whether transparency matters, but how much information should be disclosed, when disclosure should occur, and how confidential information should be treated.
Existing Uses Will Be One of the Hardest Issues
The proposal is not limited to future product development.
The Unified Agenda refers to streamlined submissions for uses introduced before the effective date of a final rule. Consumer advocates are pressing for comprehensive retrospective notification, while industry is asking for feasible, risk-based implementation.
This makes the treatment of legacy substances and longstanding uses one of the most important issues to watch when the NPRM is released.
FDA Capacity Will Matter
Mandatory notification could generate a substantial increase in submissions.
Stakeholders have therefore raised questions about prioritization, review timelines, implementation phases, potential costs for the GRAS petitioners, and whether FDA has sufficient resources to process notices while maintaining its other food-safety responsibilities.
Even if a future rule requires only submission rather than affirmative premarket clearance, FDA will still need systems to receive, organize, publish, evaluate, and act on the information provided.
Post-Market Oversight Will Remain Important
Several materials emphasize that mandatory notification cannot replace post-market surveillance.
Scientific knowledge changes. Exposure patterns change. Manufacturing processes evolve. New evidence may alter the understanding of a substance’s safety under particular conditions of use.
A modernized GRAS framework may therefore include, or be accompanied by, stronger mechanisms for prioritizing substances for reassessment.
Specialized Categories May Not Fit a Single Model
Medical foods, animal food substances, meat and poultry ingredients, conventional foods, and dietary supplement ingredients are governed by overlapping but distinct regulatory frameworks.
FDA may need to establish exemptions, tailored submission routes, transition periods, or guidance to avoid applying the same compliance model in circumstances that present very different risks and market realities.
Our April article examined proposals in New York, Pennsylvania, New Jersey, and California that would increase state-level disclosure and oversight of GRAS substances.
Those bills varied in scope, but shared a common policy direction:
The federal proposal could eventually create a more consistent national framework. However, publication of an NPRM in December would only begin the formal notice-and-comment process. A final federal rule and its effective date could remain well in the future.
As a result, companies may continue to face a developing patchwork of federal proposals and state initiatives.
A federal rule could ultimately reduce the need for separate state reporting requirements if it creates a sufficiently comprehensive national inventory. It could also lead states to modify, expand, or redirect their legislative efforts.
Until the federal proposal is available, however, businesses should continue monitoring both levels of government.
For food manufacturers, ingredient suppliers, and brand owners, the most important takeaway is that the regulatory value of a complete, defensible, and submission-ready GRAS dossier continues to increase.
The expected proposal raises several practical questions:
Companies should also consider the commercial implications of public disclosure.
A mandatory notice inventory could make information about ingredient composition, manufacturing, intended uses, exposure assumptions, and supporting studies more accessible to customers, competitors, advocacy groups, and state regulators.
This does not necessarily mean that all confidential information would become public. The proposed rule will need to explain how FDA intends to distinguish protected information from the public basis for a GRAS conclusion.
Nevertheless, companies should begin reviewing their documentation with future disclosure in mind.
The delay to December gives companies additional time to prepare before the NPRM is published.
The good news is that a properly prepared GRAS dossier should already contain much of the information likely to be required under a future notification system.
A strong dossier should be:
For companies with older self-affirmed conclusions, now is an appropriate time to conduct a gap assessment.
That assessment should determine whether the original conclusion remains valid in light of:
Companies developing new ingredients should also consider whether pursuing an FDA-notified GRAS conclusion now may provide greater long-term certainty than relying exclusively on an internal conclusion.
The correct strategy will depend on the ingredient, intended use, available evidence, commercial timeline, confidentiality concerns, and the possibility that another regulatory pathway may apply.
dicentra supports companies at every stage of GRAS strategy, including:
As the framework evolves, companies that treat GRAS documentation as a long-term regulatory asset will be better positioned to manage mandatory notification, public disclosure, state requirements, and future reassessment.
The anticipated publication date may have moved to December 2026, but the pressure for GRAS reform has not disappeared.
The Unified Agenda continues to describe a system based on mandatory notification, a public-facing inventory, and clearer FDA authority to identify uses that do not qualify as GRAS.
Meanwhile, stakeholder meetings have brought the central implementation questions into sharper focus:
The final shape of the proposal remains uncertain. What is increasingly clear is that undocumented or submission-incomplete GRAS conclusions may become more difficult to defend in the regulatory environment ahead.
For companies relying on GRAS today, the best approach is not to wait for December. It is to identify affected substances, review the supporting science, close documentation gaps, and prepare for a system in which notification and transparency may become the federal expectation.
Reach out to dicentra to ensure your ingredient strategy is ready for what comes next.
Disclaimer: This is a developing regulatory matter. The December 2026 date is an anticipated date listed in the federal regulatory agenda and may change. The scope, requirements, exemptions, transition provisions, and implementation timeline will not be confirmed until FDA publishes the proposed rule. dicentra will continue monitoring federal and state developments and provide updates as more information becomes available.