On August 10, 2026, the U.S. Department of Health and Human Services (HHS) announced two proposed food policy actions that together signal an intention to take a more assertive federal posture toward ingredients in the U.S. food supply. First, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would convert its long-standing voluntary Generally Recognized as Safe (GRAS) notification program into a mandatory one. Second, HHS—together with the U.S. Department of Agriculture (USDA)—submitted for final review the federal government’s first ever proposed definition of ultra-processed foods (UPFs). Both are framed as part of the Administration’s Make America Healthy Again (MAHA) agenda. Read on for an overview.
The GRAS Proposed Rule: From Voluntary to Mandatory Notification
Background
The Federal Food, Drug, and Cosmetic Act (FD&C Act) generally requires that food additives receive FDA approval prior to use.[1] However, the FD&C Act excludes from the “food additive” definition any substance that qualified scientific experts generally recognize as safe (or GRAS) under its intended conditions of use based on scientific procedures or, in the case of a substance used in food prior to 1958, experience based on common use in food.[2] Such substances are therefore not subject to FDA’s premarket approval requirements. Under this framework, manufacturers have been permitted to reach their own conclusions that a substance is GRAS—often called “GRAS self-affirmation” or “self-GRAS”—and, while FDA has maintained a voluntary notification program, companies have not been required to notify the Agency when making those determinations.
What the proposed rule does
The proposed rule would replace the current voluntary notification program with a mandatory one, requiring any person introducing a substance into interstate commerce pursuant to a GRAS determination to notify FDA of the basis for its GRAS conclusion, absent an applicable exception. According to FDA, the rule would modernize the GRAS framework, expand the public-facing inventory of submitted notices, and give FDA greater visibility into ingredients entering the food supply to support post-market oversight.
A few features are worth highlighting:
- This is not premarket approval. FDA has been explicit that the proposal does not create a premarket approval regime. Companies may continue to market a substance before submitting a notice, while a notice is pending, and after FDA responds, and the proposed rule sets no deadline requiring a company to notify FDA a fixed period before the substance reaches the market. The Agency describes the rule as a transparency and information-gathering measure, and the underlying scientific standard for GRAS status—general recognition of safety among qualified scientific experts—would remain unchanged. Because the program does not require premarket approval, however, a substance already on the market is not insulated: if FDA ultimately concludes that a use is not GRAS, it can treat the substance as an unapproved food additive, rendering the food adulterated and exposing even a marketed product to enforcement, reformulation, or withdrawal.
- The GRAS notice need only provide the basis for the conclusion, not the full data set. A GRAS notice would not require the submitter to provide the underlying data behind its independent GRAS conclusion. Where a notifier relies on non-public, safety-related information that it treats as exempt from disclosure under the Freedom of Information Act (for example, as a trade secret), it must instead explain how a substance can be generally recognized as safe when qualified experts do not have access to that same information. The practical effect is a partial window: FDA would see which substances are entering the food supply and the stated rationale for each GRAS conclusion, but not necessarily the complete scientific record supporting it.
- A streamlined pathway for existing substances. For substances already in interstate commerce before the final rule’s effective date based on prior self-GRAS conclusions, FDA proposes a time-limited streamlined submission requiring only basic identifying information about the substance and its uses—not the underlying safety data. That submission window would remain open for one year after the effective date, though FDA reserves the right to later require a full GRAS notice or food additive petition.
- Exceptions. The proposal identifies several circumstances in which a notice would not be required, including uses already covered by an FDA “no questions” letter in response to voluntary GRAS notices, substances listed or affirmed as GRAS in FDA’s regulations, certain historical-use substances, uses reviewed through an established FDA process to evaluate the potential presence of unapproved food additives, threshold-of-regulation exemptions, and uses covered by an effective food-contact notification.
- Review timelines and disclosure. FDA proposes to make an initial filing determination within 45 days of receiving a submission—a threshold check of whether the submission is complete enough to file for review—and to respond substantively to the GRAS notice within 180 days of filing, with the ability to extend that period by 90 days up to two times.[3] FDA would respond to all filed notices, unless the Agency grants a notifier’s request to cease evaluation. Information in a GRAS notice would be subject to public disclosure under FDA’s information-access rules as of the date FDA receives the submission, and the Agency would post filed notices and its response letters in the public GRAS Notice Inventory.
- Consequences of non-notification. The proposal does not create new penalties. Rather, a failure to notify would be treated as a factor in FDA’s prioritization of substances for post-market review, against the backdrop of the Agency’s existing authority to treat unapproved food additives as adulterated.
Key dates
FDA will accept public comments on the proposed rule through December 9, 2026. Any final rule would take effect 60 days after publication, with a compliance date of 18 months after the effective date for the mandatory-notification requirement and a one-year window for streamlined submissions covering legacy substances.
If finalized, the notification process is very likely to face legal challenge for a multitude of reasons, most particularly because FDA may lack authority to impose a mandatory GRAS notification process through rulemaking alone. The argument is that such a requirement exceeds the Agency’s statutory authority under the FD&C Act—an argument strengthened by the reduced judicial deference now afforded to agencies’ interpretations of their own governing statutes.
The Ultra-Processed Foods Definition
The second action concerns the government’s effort to establish the first federal definition of “ultra-processed foods.” According to HHS, the absence of a standardized federal definition has limited the consistency of research into the relationship between high consumption of UPFs and preventable chronic diseases. The proposed definition is intended to provide a stronger scientific foundation for future nutrition policy and research.
The proposed definition is not yet public and remains subject to review by the White House Office of Management and Budget. We will continue to monitor this effort and will provide an update with details once published.
What These Actions Mean for Industry
- Companies should begin taking inventory of their ingredients now. Identify ingredients and uses that currently rely on self-GRAS conclusions without a filed notice, locate published safety studies supporting the intended use, and assess which uses may qualify for an exception or the streamlined pathway.
- Reassess confidentiality expectations. Because GRAS notices—and the information in them—would become publicly accessible through FDA’s inventory, companies that have treated self-GRAS determinations as competitively sensitive should factor that transparency into their planning.
- Mind the state landscape—and dietary supplements. Several states have begun adopting their own food-ingredient listing, notification, and disclosure requirements. Regardless of whether FDA finalizes this proposed rule, companies should begin taking stock of the regulatory status of their ingredients now. Dietary supplement and functional food makers that rely on GRAS conclusions for food uses should assess their exposure, as well.
- Consider commenting. The GRAS comment period, open through December 9, 2026, is a meaningful opportunity to shape the rule’s scope, exceptions, timelines, and practical implementation.
- Watch for the UPF definition. Companies whose products could be characterized as ultra-processed should monitor the release of any proposed definition and be prepared to evaluate the impact on labeling and marketing and to engage as any future research or rulemaking develops.
Please contact us with any questions about how these developments may affect your products or compliance program.
[1] See FD&C Act § 409, 21 U.S.C. § 348.
[2] See FD&C Act § 201(s), 21 U.S.C. § 321(s).
[3] This 180-day review clock mirrors the current voluntary GRAS notification timeline, though the proposal adds a second 90-day extension (the voluntary program allows only one).