Todd Harrison published “New Details Emerge on FDA's GRAS Rulemaking,” in Food Processing,” examining the latest developments in the FDA's anticipated rulemaking on the Generally Recognized as Safe (GRAS) framework. The following is an excerpt:
On July 3, the federal Office of Information and Regulatory Affairs released the 2026 Unified Regulatory Agenda, offering fresh details and an updated timeline for an FDA proposed rule that would, for the first time, mandate premarket notification for substances treated as Generally Recognized as Safe, or "GRAS." The FDA now hopes to publish the proposed rule by the end of this year.
The new entry signals meaningful changes: The rule now targets only "certain uses of food substances," drops earlier language covering indirect substances such as food-contact materials and introduces a "streamlined submissions" pathway and a "limited submission window."
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.
For the full article, click here.