From AFOA General Counsel, Olsson Frank Weeda (OFW):

On August 10, 2026, during the HHS Food Policy Celebration, the FDA released its much-anticipated proposed rule, “Substances Generally Recognized as Safe” which was published in the Federal Register today.

If finalized, the proposed rule would replace the current voluntary GRAS notification process with a mandatory notification and submission requirement for substances intended for use (including food-contact substances) in human and animal food. The proposed rule would apply to both new and existing GRAS substances, with a streamlined pathway for products already on the market. FDA states the rule is intended to increase premarket oversight and visibility into food substances; however, questions remain regarding the agency’s statutory authority to require GRAS notifications. Comments on the proposed rule are due December 9, 2026.

OFW’s memorandum on the proposed rule can be found here.