On December 1, the U.S. Food and Drug Administration (FDA) sent its proposed Generally Recognized as Safe (GRAS) rule, which is expected to mandate submission of GRAS notices for human and animal food substances, to the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA). Given FDA’s long-standing approach to GRAS as a voluntary framework, such a change would dramatically alter the food regulatory landscape and raise difficult questions concerning statutory authority and agency policy. It has been 28 years since FDA determined that mandatory GRAS notifications were too resource-intensive for the agency to review and that it could instead exercise its post-market enforcement authority effectively to carry out its mission to protect public health. FDA has now taken the next step in a process that could reverse that decision.
Next Steps
OIRA will review the proposal for up to 90 days and then suggest any changes so that the rule complies with the 1980 Paperwork Reduction Act and Executive Order 12866. The purpose of this review is to ensure that significant agency rules are consistent with presidential policy and regulatory principles. The review period could be extended by up to 30 days.
You may request a meeting with OIRA during the 90-day review period, if you are an interested party, to provide input regarding the impact this proposal could have on your business. Since the text of the rule is not yet public, you may provide general comments.
FDA will then publish a Notice of Proposed Rulemaking (NPRM) after it has reviewed or incorporated OIRA’s suggestions. Given the uncertainty of these regulatory timelines, we expect that the earliest a proposed rule could be published is early to middle 2026.
Prepare for commenting on the proposed rule by gathering relevant data and talking to your stakeholders and supply chain about how this could affect them. Review Venable’s prior coverage on this matter and consider the impact that a mandatory GRAS requirement could have on your business. For example, in September, we discussed how, rather than pursuing potentially controversial regulatory changes that may not withstand a court challenge, the agency may be better served to consider whether existing enforcement mechanisms adequately address safety concerns while maintaining the integrity of the regulatory system.
Planning Ahead
- Analyze your existing GRAS positions to identify any ingredients that may raise questions under a mandatory notification system and any potential costs for new GRAS notifications
- Evaluate potential trade secret or confidential business information implications that mandatory submissions could create
- Review supply agreements to determine if suppliers will need to provide GRAS documentation or support mandatory notifications
- Begin mapping internal processes for creating GRAS dossiers
Please call us to discuss whether you are ready for a premarket review of your new food ingredients, and whether you would like to comment on the rule.
Please also review our other publications regarding the GRAS proposal:
- FDA Announces Notice of Proposed Rulemaking to Eliminate Self-Affirmed GRAS and Revise GRAS Review Criteria
- Exploring the Future of GRAS: HHS’s Recent Directive and Its Potential Impact on the Food Industry
- FDA’s Proposed Interim Animal Food Ingredient Consultation Process – Will the GRAS be Greener post-AAFCO Ingredient Definition Process?