The U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register that would fundamentally transform the existing voluntary Generally Recognized as Safe (GRAS) notification program into a mandatory one. According to the notice, the proposed rule would require any person who introduces a food substance into interstate commerce under the GRAS provision of the Federal Food, Drug, and Cosmetic Act to notify the FDA of the scientific basis for its GRAS conclusion.
The proposed rule represents a significant change to the GRAS regulatory framework. Since 2016, the FDA has maintained a voluntary program where companies could conduct independent safety evaluations and introduce substances into the food supply without informing the agency. As of March 2025, the FDA's Human Foods Program had filed over 1,200 GRAS notices, though the agency estimates that an additional 1,000 or more substances were subject to independent conclusions without notification.
This initiative follows a directive from HHS Secretary Robert F. Kennedy Jr. on March 10, 2025, to explore rulemaking to eliminate the pathway for firms to introduce purported GRAS substances into the market without notifying the FDA. The move aligns with the Administration's Make America Healthy Again priorities. The FDA cited several examples where mandatory notification could have improved public health protection, including tara flour, caffeinated alcoholic beverages, Delta-8 THC products, and stevia leaves and crude extracts.
The proposed rule would amend 21 CFR Parts 170 and 570 to require mandatory submission of GRAS notices for both human and animal food substances. However, several exceptions are proposed where mandatory notification would not be required. These include substances already covered by an FDA no questions letter, substances listed or affirmed as GRAS in 21 CFR Parts 182, 184, or 186, and pre-1958 natural substances. Other exceptions include substances reviewed through established FDA processes, such as biotechnology consultations, threshold of regulation exemptions, effective food contact notifications from the same manufacturer, and substances included on a public list via a streamlined submission option.
To address substances already in the marketplace without notification, the rule includes a time-limited streamlined submission pathway. This option is available only for substances that were in interstate commerce before the effective date of the final rule and is not available for substances that previously received an insufficient basis letter or a not GRAS determination from the FDA. These streamlined submissions must be filed within one year of the effective date of the final rule.
The comment period for the proposed rule closes on December 9, 2026. If finalized, the rule would become effective 60 days after publication in the Federal Register, with a compliance date set for 18 months after the effective date for certain sections. Food companies are advised to conduct GRAS inventories, assess exception eligibility, and prepare for potential streamlined submissions.
