Food and Drug Administration Publishes Unified Regulatory Agenda

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FDA Releases Unified Agenda, Intends to Prioritize GRAS, FOP, and Dietary Ingredients

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Friday, September 12, 2025

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On September 4, 2025, FDA published its Unified Regulatory Agenda, which describes regulations currently under development or recently completed, providing a preview of the Agency’s top regulatory priorities. The agenda includes three significant regulations that could affect food and dietary supplements: a proposed generally recognized as safe (GRAS) substances rule; a final front-of-package (FOP) labeling rule; and a proposed rule finding a specific ingredient is not excluded from the dietary supplement definition.
The proposed GRAS rule would amend FDA’s regulations in 21 CFR parts 170 and 570 to “require the mandatory submission of GRAS notices” for substances purported to be GRAS for use in human or animal food. Substances that are currently subject to a GRAS regulation or a “no questions letter” in FDA’s GRAS inventory would be exempt from the rule. The proposed rule would also clarify that FDA maintain a public GRAS notice inventory, as well as the process to determine that a substance is not GRAS. As we previously blogged, FDA recently submitted a collection for information relating to the GRAS notification process, and in early 2025, the Agency was directed to explore a rulemaking to revise the GRAS final rule and related guidance to eliminate the self-affirmed GRAS pathway. The proposed rule is scheduled to be published in October 2025, though this is subject to change.
The FOP final rule would require the front labels on food packages to display certain nutrition information to help consumers make more informed dietary choices. FDA issued the proposed FOP rule in January 2025, later extending the comment period to July 15, as we previously blogged. At a high level, the rule would require the inclusion of a Nutrition Info box on the principal display panel of most foods that would display interpretive information on the amount of saturated fat, sodium, and added sugars in the product. FDA received more than 13,000 comments on the proposed rule. The final rule is scheduled to be published in May 2026, though this is subject to change.
Finally, the proposed rule related to a dietary supplement ingredient “would find that a specific ingredient would not be excluded from the dietary supplement definition.” Thus, products containing the ingredient could be lawfully marketed as dietary supplements, assuming they otherwise meet the dietary supplement definition. This may be related to nicotinamide mononucleotide, which is the subject of a citizen petition seeking regulatory clarity on its use as a dietary ingredient. The proposed rule is scheduled to be published in January 2026, though, once again, this is subject to change.