HHS Proposes Mandatory GRAS Notification

A new rule proposed by the U.S. Department of Health and Human Services (HHS) on August 11, 2026, would make notification to the U.S. Food & Drug Administration (FDA) mandatory for use of substances in food based on a Generally Recognized as Safe (GRAS) determination. Mandatory notification would apply to food substances added directly to food (i.e., ingredients) as well as substances indirectly added to food as food contact substances (e.g., components in food packaging). The proposed rule would permit a streamlined submission pathway for a period of one year after the effective date of the rule for substances already in interstate commerce that have been marketed based on independent GRAS conclusions. The proposed rule is meant to modernize the existing GRAS framework and increase transparency around substances in the U.S. food supply, says HHS in its release.

The GRAS designation was established through the Food Additives Amendment of 1958 to the Food, Drug, and Cosmetic (FD&C) Act. The GRAS provision exempts uses of substances that are generally recognized by qualified experts as safe under their intended conditions of use from the premarket approval requirements applicable to food additives. GRAS status may be based on scientific procedures or, for substances used in food before 1958, on experience based on common use in food. FDA established a voluntary GRAS notification program in 1997 and finalized the notification procedures in 2016. For nearly three decades, manufacturers have been able to voluntarily notify FDA of their GRAS conclusions, while also having the option to reach an independent GRAS conclusion without notifying the agency. FDA's GRAS Inventory currently logs more than 1,300 GRAS notices since the notification program began.

What the proposed rule means for companies using new substances

Under the proposed rule, companies using new substances in foods for humans or animals under GRAS provisions of the FD&C Act would be required to submit a GRAS notice supporting their GRAS conclusion, unless an exemption applies. Under the proposed new rule, GRAS notice requirements remain unchanged.

While this proposed rule would make FDA notification mandatory, it would not require premarket approval for substances. Companies could still reach their own GRAS conclusions and market their substances but would be required to submit GRAS notices to FDA unless an exception applies. FDA would then review the GRAS notice under essentially the same process used for voluntary GRAS notices today and issue a response regarding the basis for the GRAS conclusion.

The proposal would also expand FDA's Threshold of Regulation (TOR) pathway. Currently used primarily for substances that migrate into food from food-contact materials at very low levels, the proposed rule would expand the TOR process to certain substances used directly in food. Uses that receive a TOR exemption would not also require a GRAS notice, providing an abbreviated regulatory pathway for qualifying substances associated with negligible dietary exposure.

What the proposed rule means for companies currently relying on self-determined GRAS conclusions

For certain substances already in interstate commerce before the effective date of a final rule and marketed based on an independent GRAS conclusion, FDA proposes a time-limited streamlined submission pathway. Rather than initially submitting a full GRAS notice, companies would provide basic information, including the identity of the substance, its intended conditions of use and purpose, and evidence that the substance was already in interstate commerce before the final rule's effective date. FDA states that underlying data or information supporting the GRAS conclusion are not required as part of the streamlined submissions. Following submission, FDA could subsequently require the submission of a full GRAS notice or a food additive petition for the intended use of the substance. Inclusion on FDA's public list would not constitute an FDA determination that the intended use of the substance is GRAS. 

When would this new rule take effect?

FDA is accepting comments on the proposed rule for 120 days (through December 9, 2026). The timing for issuance of a final rule has not been announced. If the rule is finalized as proposed, it would become effective 60 days after publication of the final rule, with companies generally required to comply with the new mandatory GRAS notification requirements 18 months after the effective date.

What should companies be doing now?

Companies that manufacture, supply, or use substances marketed on the basis of a self-determined GRAS conclusion should begin assessing the potential impact of the proposed rule on their products and regulatory processes. This may include reviewing existing independent GRAS conclusions, identifying substances that may be eligible for the proposed streamlined submission pathway, filing notices as needed, evaluating whether internal procedures are prepared for mandatory GRAS notification of future uses, and considering whether to submit comments to FDA before the deadline of December 9, 2026. Until a final rule is issued and becomes effective, the current voluntary GRAS notification framework remains in place.