In August 2026, the Food and Drug Administration proposed a new rule to strengthen regulation of substances added to food that are classified as Generally Recognized as Safe (GRAS). A substance is GRAS if qualified experts generally recognize its safety under its intended conditions of use, based on scientific evidence or common use in food before 1958.
Since 1958, manufacturers have been able to determine GRAS status on their own, without notifying the FDA. The proposed rule would convert that voluntary program into a mandatory notification requirement, under whichmanufacturers would have to notify FDA of new GRAS substances before marketing them, with limited exceptions.
Currently, there are two pathways to GRAS certification. The first is a voluntary GRAS notification, and the second is aself-affirming GRAS notification. In a voluntary notification, the company submits a GRAS dossier to the FDA containing a literature review, toxicological data, and a dietary exposure assessment. The FDA will respond with either a “No Questions Letter,” indicating GRAS approval, or it may request supplementary information.
The second pathway, which the proposed rule seeks to eliminate, is the self-affirming GRAS notification. A self-affirmed GRAS notification is conducted internally and consists of a scientific evaluation, a toxicological review, and an expert panel consensus. A self-affirmed notification requires no participation from the FDA. While eliminating self-affirmed GRAS determinations could benefit the public by ensuring that manufacturers’ GRAS conclusions are backed by an appropriate scientific basis and documented safety analysis, it remains unclear whether the rule’s implementation would deliver those benefits.
Experts on the matter believe that the FDA lacks the resources to implement the rule without additional funding, and that the rule could slow food innovation in the United States. After budget cuts and mass layoffs, the FDA may lack the resources to handle an inevitable surge of notifications. In 2025, over 3,500 FDA employees were laid off, accounting for roughly 20% of the workforce. Now, the FDA may be required to review thousands of submissions for substances already in use. The expected cost of compliance with new GRAS regulations is an estimated $89.6 million in present-value dollars. This unfunded mandate would be imposed on top of a $271.0 million loss in overall funding compared to 2025. Some experts speculate that absent a substantive increase in funding from Congress, the FDA will need to reconsider how it allocates its resources to absorb the new workload.
With a diminished workforce, the FDA faces a formidable task in addressing the fifty-year gap left by self-affirmed GRAS determinations. The current estimate of unreviewed food additives is about 3,000, with roughly 1,000 being self-affirmed and the remainder affirmed via industry trade association panel. Because the list of substances with GRAS certification is incomplete, the FDA lacks a baseline for comparing new substances against those already recognized as safe.
FDA’s legal authority to require GRAS notification has also been called into question.
Because GRAS substances are excluded from the statutory definition of a food additive, they fall
outside FDA’s premarket approval authority. In its 2016 GRAS rule, the agency itself acknowledged that it lacks expressstatutory authority to require GRAS notices. Companies have also reportedly marketed new ingredients even after the FDA questioned them during the notification process. Some predict that if the rule is finalized, congressional actionwould be needed to make it enforceable.
Beyond internal obstacles at the FDA, the proposed rule is likely to face resistance from the food industry. The most significant concerns from corporations are increased compliance burdens, disrupting the supply chain, and delayed market entry. An FDA member cautioned that the food industry does not want to be regulated and will happily capitalize on a different market if the U.S. becomes too burdensome. The new rule would encourage food companies to outsource food contract manufacturing to U.S. competitors, costing the U.S. market jobs, weakening the supply chain, and increasing quality control risks.
Overall, although better health outcomes and greater transparency in the food industry are worthwhile goals, the proposed GRAS rule may fall short of delivering them in practice.