On August 10, 2026, the US Department of Health and Human Services (HHS) announced two actions under the Trump administration’s Make America Healthy Again (MAHA) agenda. The US Food and Drug Administration (FDA), which falls under the purview of HHS, proposed making notifications for substances considered Generally Recognized as Safe (GRAS) mandatory. In addition, HHS and the US Department of Agriculture (USDA) submitted the federal government’s first proposed definition of ultra-processed foods (UPFs) for final review.
Proposed GRAS rule
Currently, companies can independently conclude that an intended use of a substance is GRAS and introduce it to the market without notifying FDA (FPF reported). The proposed GRAS rule would make notifying the FDA mandatory. “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply,” stated Acting FDA Commissioner Kyle Diamantas.
Companies would have to submit the same seven-part dossier currently used in FDA’s voluntary GRAS notification program. This includes information on the substance’s identity and manufacture, intended uses and dietary exposure, and a scientific narrative explaining why the substance is generally recognized among qualified experts as safe, together with the supporting evidence. The submission should include relevant unfavorable as well as favorable information. The FDA would not need to approve the GRAS conclusion before marketing; the notification requirement would be fulfilled once the FDA accepts the notice for filing.
For GRAS substances already on the market, FDA proposed a temporary streamlined reporting procedure. Companies could provide information including the substance identity, intended conditions of use, and evidence that the substance was already in interstate commerce.
Congress established the GRAS exemption in 1958. The exemption was meant to make it easier for companies to use substances like vinegar or other common products without the entire FDA approval for food additives. FDA formalized its current voluntary notification procedure in 2016 (FPF reported).
If the current proposal becomes official, the main mandatory notification requirements would come into effect 18 months later.
A comment period for the GRAS proposal is open until December 9, 2026.
Threshold of regulation
FDA additionally proposed changes to its threshold of regulation (TOR) procedure. Currently, FDA can exempt substances migrating from food contact articles from food additive regulation when dietary concentrations are at or below 0.5 parts per billion (equivalent to 1.5 µg/person/day), if the substance is not a known or suspected carcinogen, has no technical effect in the food, and meets other safety and environmental criteria.
Under the new proposal, FDA would expand TOR exemptions to substances used directly in food as well as food contact substances and make qualifying uses exempt from the proposed mandatory GRAS notification requirement. FDA also proposes replacing the 0.5 ppb threshold with a body-weight-adjusted exposure limit of 0.025 µg/kg body weight/day, updating the criterion for carcinogenic impurities to a lifetime cancer risk of no more than one in one million, and removing the requirement that a substance have no technical effect in food.
Ultra-processed food definition moves forward
Alongside the GRAS proposal, HHS and USDA announced that they had submitted the federal government’s first proposed definition of UPFs for final review. HHS has not yet publicly released the proposed definition. The department said the proposal incorporates input from thousands of industry representatives, consumer organizations, researchers, and members of the public.
The agencies began the process in July 2025 with a joint request for information seeking input on the characteristics and criteria to be used to define UPFs (FPF reported). HHS, FDA, and USDA said a common federal definition could improve consistency in nutrition research and provide a basis for future policy development.
MAHA
The measures are part of a wider reshaping of US food chemical policy under MAHA. The MAHA Strategy specifically listed defining ultra-processed foods, “closing the GRAS loophole,” improving food labeling, and removing harmful chemicals from the food supply among planned executive actions (FPF reported). FDA subsequently included mandatory GRAS notification, post-market food chemical assessments, research on microplastics and PFAS, and development of a UPF definition in its 2026 Human Foods Program priorities.
As part of MAHA, HHS has finalized its systematic post-market assessment framework, covering food additives, GRAS substances, food contact substances, color additives, and contaminants (FPF reported).
References
US Department of Health and Human Services (August 10, 2026). “Secretary Kennedy Announces Landmark Food Policy Reforms to Advance President Trump’s MAHA Agenda.”
US Food and Drug Administration (August 11, 2026). “Substances Generally Recognized as Safe.” Federal Register.
US Department of Health and Human Services (August 10, 2026). “Fact Sheet: HHS Announces Proposed GRAS Rule.”
US Food and Drug Administration (2026). “Human Foods Program 2026 Priority Deliverables.”
