FDA GRAS rule timeline pushed to December 2026

The Office of Information and Regulatory Affairs released the 2026 Unified Regulatory Agenda on July 3, providing an updated timeline for the FDA's proposed rule, known as RIN 0910-AJ02, that would require premarket notification for substances determined to be Generally Recognized as Safe, or GRAS. 

Todd Harrison and Thomas Smith of Venable LLC detailed the changes in a blog post, "New Details Emerge on FDA's GRAS Rulemaking: Updated Timeline, Narrower Scope, and Open Questions on Statutory Authority."

The proposed rule is now expected to publish in December 2026, according to the attorneys, following earlier projections of October 2025 and, before that, late spring or summer 2025.

Under current law, codified in 21 C.F.R. Part 170, Subpart E, companies may voluntarily notify the FDA that a substance is GRAS but are not required to do so. Many manufacturers rely instead on independent, or "self-affirmed," GRAS determinations. The proposed rule would change that framework by mandating notification for certain uses of food substances, according to Harrison and Smith.

Scope narrowed in 2026 update

The 2026 agenda entry narrows the rule's scope compared with the Spring 2025 version, the attorneys wrote. The new entry refers only to "certain uses of food substances," rather than a broader category, and no longer includes language covering indirect food substances such as food-contact materials. The entry also introduces new concepts, including a "streamlined submissions" pathway and a "limited submission window" for companies to bring existing self-affirmed GRAS substances into compliance before a final rule takes effect, according to the blog post.

“The agenda entry reveals significant changes from prior descriptions of the rule," said Harrison. "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 agenda 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, Harrison and Smith wrote. Non-notified substances would be treated as unapproved food additives under that presumption.

The Spring 2025 agenda had referenced a possible exemption for ingredients already covered by regulation or FDA "no questions" letters, but the 2026 entry does not address that issue, leaving uncertainty about whether such exemptions will remain, according to the attorneys. The entry also does not address how the FDA would handle confidential or trade secret information submitted as part of GRAS notifications.

The proposed rule was submitted to the Office of Management and Budget for interagency review on Dec. 1, 2025, and is classified as "economically significant," meaning it could have an annual effect on the economy of at least $100 million.

Legal authority questioned

Harrison noted that questions remain about the FDA's legal authority to mandate GRAS notifications. 

"While the FDA's proposed GRAS rulemaking represents a potential paradigm shift in food ingredient regulation, it faces significant legal headwinds," said Harrison. "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.”

In the preamble to its 2016 GRAS final rule, the agency stated it lacked express statutory authority to require companies to submit GRAS notices, according to the blog, citing the Federal Register. The Congressional Research Service published a legal analysis on July 2 examining the same authority question, noted the attorneys.

The blog post also pointed to the 2024 Supreme Court decision in Loper Bright Enterprises v. Raimondo, which overruled Chevron deference and requires courts to exercise independent judgment on statutory interpretation rather than deferring to agency views. That shift could affect legal challenges to the FDA's GRAS authority, according to Harrison and Smith.

Separately, Sen. Roger Marshall introduced the Better Food Disclosure Act of 2025, S. 3122, on Nov. 6, 2025, with co-sponsors Sens. Rick Scott and Katie Britt. The bill would amend the Federal Food, Drug, and Cosmetic Act to require mandatory GRAS notifications, establish a public listing of GRAS substances, create a post-market review process and provide a two-year transition period for existing self-affirmed GRAS substances, according to the blog post. The bill does not include a preemption provision.

Harrison also cautioned industry stakeholders that the rulemaking process is highly uncertain, and the timeline could be affected by political transitions, litigation, resource constraints and competing regulatory priorities.

"Even if the FDA publishes its proposed rule in December 2026 as anticipated, a final rule is unlikely before late 2028 or 2029, factoring in a public comment period and the FDA's review and response process," Harrison wrote.

Read the full analysis on Venable's website.