The FDA has postponed its planned rule requiring premarket notification for food substances classified as Generally Recognized as Safe until December 2026. The updated regulatory agenda released this month confirmed the new timeline.
The delay marks the second postponement for the proposed rule, known as RIN 0910-AJ02. Earlier projections had targeted October 2025, following an initial estimate of late spring or summer 2025.
Scope narrowed, new compliance pathways added
The latest agenda entry also reduces the rule’s reach, according to attorneys Todd Harrison and Thomas Smith of Venable LLP. The updated language now refers only to “certain uses of food substances,” removing broader references to indirect food substances like food-contact materials.
Two new concepts appear in the revision: a “streamlined submissions” process and a “limited submission window” for companies to bring existing self-affirmed GRAS substances into compliance before the final rule takes effect. The FDA would presume that substances subject to the mandatory notification are not GRAS unless the requirement is met, treating non-notified substances as unapproved food additives.
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Harrison said the agenda entry shows major changes from earlier versions. The scope now targets specific uses of food substances and removes language covering indirect food substances. It also introduces the streamlined submissions pathway and limited submission window.
Uncertainty persists over whether the rule will exempt ingredients already covered by existing regulations or FDA “no questions” letters. The 2026 agenda does not address this issue, nor does it explain how the agency would handle confidential or trade secret information submitted in GRAS notifications.
Legal challenges loom over FDA’s authority
The proposed rule, classified as “economically significant,” could affect the economy by at least $100 million annually. Its legal foundation remains in dispute.
Harrison pointed out that the FDA’s authority to mandate GRAS notifications is not settled. In the preamble to its 2016 GRAS final rule, the agency stated it lacked express statutory authority for such requirements. The Congressional Research Service repeated those concerns in a July 2 legal analysis.
The 2024 Supreme Court decision in Loper Bright Enterprises v. Raimondo eliminated Chevron deference, requiring courts to interpret statutes independently rather than deferring to agencies. This change may influence legal challenges to the FDA’s authority.
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Even if the FDA publishes the proposed rule in December 2026, Harrison said a final rule is unlikely before late 2028 or 2029. The timeline could shift due to political changes, litigation, resource limits, or other regulatory priorities.
Current regulations allow companies to voluntarily notify the FDA of GRAS determinations but do not require it. Many manufacturers use independent, or “self-affirmed,” assessments instead. The proposed rule would change that system, though its final form and legality remain unclear.
The rule’s development reflects broader tensions in food regulation, where agencies balance scientific standards with industry flexibility. Previous efforts to tighten GRAS oversight faced opposition over cost, feasibility, and legal questions. This latest delay shows the FDA is still adjusting its approach while lawmakers and courts weigh in.
The agency sent the proposed rule to the Office of Management and Budget for interagency review in December 2025, a step that usually precedes public release. For now, the food industry waits for clarity on a rule that could alter how ingredients enter the market.
