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On August 10, 2026, the U.S. Department of Health and Human Services ("HHS") announced the Food and Drug Administration's ("FDA") proposed new rule to change the way food substances are regulated. Food substances include food ingredients (such as salt and citric acid) and substances added indirectly to food via packaging components like adhesives and resins.
Typically, new food substances may only be used if they receive premarket approval by FDA or are Generally Recognized as Safe (“GRAS”). Currently, companies may self-certify that a new food substance is GRAS without notifying FDA. The new rule would make GRAS notifications to FDA mandatory. Under the proposed rule, a company introducing a new food substance based on its determination that the substance is GRAS would be required to notify FDA of the basis for its conclusion that the substance is GRAS under the conditions of its intended use.
The proposed rule would also apply to food substances that are already on the market under a GRAS self-certification. For these substances, a company would be allowed to submit information regarding the substance and the conditions of its use to FDA instead of submitting a GRAS notice. The submission would need to include basic information about the substance, including its name and use, along with information about any prior GRAS notices for the substance that received a “Cease to Evaluate” letter from FDA.
The proposed rule would contain exceptions for certain substances, including substances already listed or affirmed by FDA as GRAS and substances for which FDA has already issued a “No Questions” letter, unless the substance’s identity, manufacturing process, or conditions of use are significantly different from those for which the No Questions letter was issued.
The proposed rule is part of an existing trend toward changing the GRAS system. The New York legislature has already passed the Food Safety and Chemical Disclosure Act, which has not yet been signed into law. This law would prohibit a company from using a self-certified GRAS food substance in the state unless it notifies the New York Department of Agriculture and Markets. A similar law is working its way through the California legislature.
The public comment period for the proposed federal rule will remain open until December 9, 2026. We will continue monitoring state and federal developments related to the GRAS system.
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