FDA Proposes Closing GRAS Loophole as Ultra-Processed Food Definition Slips Again
The US Food and Drug Administration on August 10, 2026, submitted to the Federal Register a proposed rule requiring food manufacturers to notify the agency of all ingredients brought to market under the Generally Recognized As Safe (GRAS) pathway, closing a loophole that allowed use of ingredients proven safe through scientific research or common use The Guardian. If finalized, the rule would transition the GRAS framework from a voluntary program to a mandatory notification system, applying both to new ingredients and to all substances already on the market under GRAS. The proposal was listed among the FDA Human Foods Program's 2026 priority deliverables FDA.
The GRAS framework dates to 1958, when it was intended as an exemption from formal food additive review. Over decades, it became the primary mechanism by which new substances entered the US food supply, outpacing the food additive petition pathway. Manufacturers could self-determine that an ingredient met the GRAS standard, often relying on their own experts or published studies, without submitting a notification to the FDA. The proposed rule upends that self-determination model.
Acting FDA commissioner Kyle Diamantas leads the agency under Health and Human Services secretary Robert F. Kennedy Jr., who has made food-system reform a central pillar of his tenure. The GRAS proposal carries legal questions that differ from the voluntary system the FDA already operates. In 2021, a federal judge ruled that the FDA had authority to create a voluntary GRAS notification system, but a mandatory system would be legally distinct, and the agency's rulemaking will need to navigate that distinction.
The GRAS rule arrives as the Trump administration has again postponed defining 'ultra-processed foods,' promising additional information at a later date The Guardian. HHS and the US Department of Agriculture did submit a proposed definition aimed at 'creating a stronger foundation for future federal nutrition research,' but no final definition has been issued. Kennedy promised a definition of ultra-processed foods by April 2026. In April 2026, Diamantas acknowledged the difficulty, saying 'a definition for ultra-processed foods is really hard' The Guardian.
The delay is rooted in a lack of scientific consensus on what ultra-processed foods are, and whether they have negative health effects remains difficult to ascertain. In academic literature, ultra-processed food is defined as industrial formulations of food substances never or rarely used in kitchens, such as high-fructose corn syrup NIH. Health experts describe them as a class of food or drink made using processing techniques, additives, and industrial ingredients, mostly containing little whole food Reuters. An estimated 70% of packaged products in the US food supply are foods often considered ultra-processed FDA.
The FDA and USDA have been working on the definitional question for over a year. On July 25, 2025, the agencies issued a Request for Information seeking data to help develop a uniform definition Federal Register. The regulatory landscape has moved on other food-chemical fronts. The FDA recently extended by 30 days the public comment period for its review of select chemicals in the food supply, with comments now accepted through July 26, 2026 FDA. In February 2026, the FDA said it would consider a petition to revoke the safety status of dozens of processed refined carbohydrates Reuters. On July 22, 2026, the FDA issued a final order revoking the authorized use of Orange B as a color additive in food and proposed to revoke other outdated color additive authorizations FDA.
The broader context here is a regulatory architecture under active revision, where some pieces move and others stall. The GRAS proposal is concrete: it targets a specific legal mechanism with a specific remedy. The ultra-processed food definition, by contrast, confronts a taxonomic problem before it becomes a regulatory one. Without a settled definition, mandates to label, restrict, or tax ultra-processed products lack a target. The FDA's own regulatory agenda lists a proposed 2026/2027 rulemaking to provide by regulation that an ingredient is not excluded from the dietary supplement definition FDA, indicating the scope of food-ingredient rulemaking under this administration extends well beyond GRAS.
For manufacturers, the GRAS rule, if finalized, would impose retroactive notification obligations on ingredients already in the supply chain, a compliance burden that could surface previously undisclosed safety data. The mandatory system would also give the FDA a comprehensive inventory of GRAS substances for the first time. Whether the agency has the resources to evaluate that volume of notifications is a question the proposal itself does not answer. The 2021 judicial ruling affirming the voluntary system's legality means the mandatory framework will likely be tested in court once finalized, and the legal theory distinguishing the two systems will be central to any challenge.
