Most striking, FDA would presume that covered food substances are not GRAS unless the notification requirement is met.
Under the Federal Food, Drug, and Cosmetic Act, a substance is excluded from the definition of “food additive” if qualified experts generally recognize it as safe for its intended use. Since 1958, that exemption has rested on expert recognition, not FDA approval. In 1997, FDA replaced its GRAS petition process with a purely voluntary notification program, allowing companies to make independent “self-affirmed GRAS” determinations.
The current effort to curtail self-affirmation and require notifications marks a significant departure from decades of practice. The proposed rule, submitted to the Office of Management and Budget on Dec. 1, 2025, is classified as “Economically Significant,” meaning it may affect the economy by at least $100 million annually.
The new presumption of non-GRAS status effectively reverses FDA’s longstanding interpretation and forecloses self-affirmation as a lawful pathway; non-notified covered uses would be treated as unapproved food additives. The agenda is silent on earlier exemptions for ingredients already covered by regulation or “no questions” letters, and does not address how confidential or trade-secret information would be protected.
The central question is whether FDA even has the legal authority to mandate GRAS notifications. In the preamble to its 2016 GRAS final rule, FDA acknowledged that it “lack[s] express statutory authority to require companies to submit GRAS notices” and declined to exercise any implied authority at that time.
The statute reinforces those doubts: GRAS substances are excluded from the food-additive approval process, and when Congress mandated premarket notification for food-contact substances in 1997, it conspicuously declined to do the same for GRAS substances.
A July 2 Congressional Research Service analysis notes FDA’s own admission and warns that its reversal could draw reduced judicial deference under the Skidmore framework. The Supreme Court’s decision in Loper Bright Enterprises v. Raimondo (2024), which overruled Chevron, further weakens FDA’s footing, since courts must now exercise independent judgment on statutory interpretation. Legal challenges appear virtually certain.
On a parallel track, Senator Roger Marshall’s Better Food Disclosure Act of 2025 (S. 3122) would statutorily require GRAS notifications, create a public listing, establish post-market review and grant a two-year transition period—potentially providing the authority FDA now lacks.
Even if FDA publishes its proposed rule this December, a binding final rule is unlikely before late 2028 or 2029, given a lengthy comment period, FDA’s response process and near-certain litigation.
Companies should not wait. Prudent steps include conducting a GRAS inventory and gap analysis, assessing existing determinations, preparing substantive comments, and monitoring both the regulatory and legislative tracks — since the outcome may turn on whichever advances first.
FDA’s proposed rulemaking could reshape food-ingredient regulation, but it faces substantial legal headwinds, and the narrowing of scope may reflect the agency’s own recognition of those constraints.
Todd Harrison, co-chair of Venable’s FDA Group, guides clients through the myriad government regulations associated with food and drug labeling and marketing. He is based in the law firm’s Washington, D.C. office (www.venable.com). Email him at [email protected].