FDA proposes mandatory GRAS notification program and expanded oversight of food ingredients

On August 11, 2026, the United States Food and Drug Administration (FDA) published a proposed rule that, if finalized, will fundamentally change the manner in which companies establish and communicate that a substance is generally recognized as safe (GRAS) for use in human or animal food. The proposal aligns with the Trump Administration’s Make America Healthy Again (MAHA) initiative and the increased scrutiny of ingredients in the food supply.

The proposed rule, if finalized, would end FDA’s existing voluntary GRAS notification program and require all substances purported to be GRAS under the conditions of their intended use to submit a notification to FDA, unless an exemption applies. This mandatory notification program would apply to substances, other than approved food additives, that are currently in the food supply and that are introduced after the rule becomes final. While the notification program is not a premarket approval program, it would provide FDA with information to support risk-based prioritization of post-market reviews and potential enforcement actions involving substances in the food supply.

Comments on the proposed rule are due by December 9, 2026.

Background

Under the Food, Drug and Cosmetic Act (FD&C Act), a food additive is any substance whose intended use results, or may reasonably be expected to result, directly or indirectly, in the substance becoming a component of human or animal food, unless the substance is GRAS. While food additives must be pre-approved through an FDA regulation, the current regulatory framework allows a company to either voluntarily submit a GRAS notification or independently conclude that a substance is GRAS under the intended conditions of use. This framework has allowed substances to be introduced into the food supply without FDA’s knowledge, which, according to FDA, can result in inadequate safety analyses and unapproved food additive uses. The agency stated that the proposed mandatory GRAS notification would increase transparency and provide FDA with information to more effectively and efficiently administer the FD&C Act and ensure a safe food supply.

Summary of the rule

If finalized, the proposed rule would:

• Convert the existing voluntary GRAS notification program into a mandatory notification program
  
  
• Establish exceptions, including a time-limited, streamlined option for substances already in the food supply
  
  
• Update and expand the Threshold of Regulation (TOR) exemption to the food additive definition

Mandatory GRAS submission

Under proposed 21 CFR § 170.205(a), any person introducing a substance into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act would be required to notify FDA of the basis for the conclusion that the substance is GRAS under its intended conditions of use. The requirement would apply to human and animal food substances, including both direct and indirect substances added to food, regardless of whether the substance is already in the food supply or is being introduced for food use for the first time.

The notification requirement would be satisfied when FDA files the submission as a GRAS notice based on a determination that the notification contains the required information, rather than on a substantive determination of safety. FDA proposes completing its initial evaluation of whether to file a submission within 45 days of receipt. Once filed, FDA would generally have 180 days to evaluate the notifier's GRAS conclusion, subject to two successive 90-day extensions, for a total potential review period of 360 days. Currently, FDA is only allowed to extend once for 90 days.

FDA’s review of submitted notices would result in three potential results:

• A “no questions” letter, indicating that FDA has no questions at that time regarding the notifier’s GRAS conclusion;
  
  
• An “insufficient basis” letter, stating that the notice does not provide a sufficient basis for a GRAS conclusion; or
  
  
• A “cease to evaluate” letter, granting the notifier’s request to cease FDA’s evaluation of the notice. If FDA issues a “cease to evaluate” letter, the notification requirement would no longer be considered satisfied until a new GRAS notice for that substance is filed.

Notably, failure to submit a required GRAS notice would not render a substance unlawful. Instead, FDA would consider non-compliance with the submission requirements when prioritizing substances for post-market review and when determining whether compliance action is needed, including when determining whether a food additive petition or regulation may be required. Industry may market a proposed GRAS substance before submitting a GRAS notice or after submitting a GRAS notice before it is filed by FDA.

Exceptions to mandatory notification

The proposed rule would also establish the following seven exceptions from the mandatory notification requirement:

1. Substances and conditions of use that have been the subject of a prior GRAS notification for which FDA issued a “no questions” letter
   
   
2. Substances affirmed as GRAS under the conditions of their intended use by regulation and listed in 21 CFR Parts 182, 184, or 186
   
   
3. Substances recognized as GRAS under the conditions of their intended use in accordance with 21 CFR § 170.30(d) (pre-1958 substances of natural biological origin) or proposed 21 CFR § 170.30(i)(1) (previously affirmed GRAS substances when there are no limitations on use other than good manufacturing practices)
   
   
4. Substances that are evaluated through an established FDA process, where FDA’s publicly available documentation does not identify the need for a GRAS notice. These include consultations and premarket meetings for biotech plants and animal cell-cultured products, as well as the Animal Food Ingredient Consultation (AFIC) process and substances listed in and used in accordance with the Association of American Feed Control Officials (AAFCO) 2024 Official Publication for animal food
   
   
5. Certain substances that qualify for FDA’s revised TOR exemption
   
   
6. Food-contact substances with an effective premarket notification, which covers the substance under conditions of its intended use, and where the substance originates from the manufacturer or supplier listed in the premarket notification
   
   
7. Substances already in interstate commerce under the conditions of their intended use pursuant to a self-GRAS determination before the effective date of a final rule, provided that the responsible party submits the required streamlined filing to FDA within one year after the effective date

Revision to TOR

FDA has also proposed to revise the TOR regulations that currently exempt food-contact substances from needing approval as food additives because the level of migration into a food is expected to be trivial. The proposed rule would revise FDA’s TOR exemption under § 170.39 to reflect current scientific guidance and expand its scope beyond food-contact substances to encompass both direct and indirect food uses.

Public availability of submissions, responses, and GRAS substances

FDA will maintain a publicly available list of 1) certain qualifying submissions and 2) substances and uses that qualify for an exception from the GRAS notification requirement or are otherwise exempt from regulation as food additives. Inclusion on the list would not constitute an FDA determination that a substance is GRAS, and FDA would retain authority to require a full GRAS notice or food additive petition where appropriate.

FDA’s public inventory would continue to include all categories of agency responses to GRAS notices, including “no questions” letters, notices deemed to provide insufficient bases for GRAS conclusion, and notices for which FDA ceased evaluation. Although the proposal generally preserves FDA’s existing Freedom of Information Act (FOIA) disclosure framework, it expressly requires submitters to identify information they consider exempt from disclosure at the time of submission; otherwise, FDA may treat the information as non-exempt from disclosure or deem any confidentiality claim to be waived.

Timeline

Comments on the proposed rule are due by December 9, 2026. FDA proposes that any final rule become effective 60 days after publication in the Federal Register, with compliance required 18 months thereafter to provide industry with sufficient time for the transition.

Key takeaways

• The proposed rule represents one of the most significant potential changes to the GRAS framework since FDA began receiving and evaluating GRAS notices nearly 30 years ago.
  
  
• Substances can continue to be marketed before and after submitting a GRAS notice, as stated above. However, non-compliance could subject the ingredient to scrutiny by FDA, state regulators, attorneys general, and the plaintiffs’ bar. Risk could further increase if FDA issues an “insufficient basis” letter for a notified substance or determines a substance is not GRAS under the conditions of intended use.
  
  
• The proposed rule emphasizes that GRAS status attaches to a substance under specified conditions of use rather than to the substance generally. Accordingly, any change in conditions of use for a codified or notified substance, such as differences in identity, manufacturing process, or specifications, or use in different food categories or at higher use levels may require a new GRAS notice.
  
  
• The proposed rule also clarifies that GRAS notifications and associated FDA actions are not specific to the original notifier. Any person may rely on an existing “no questions” letter or a substance’s inclusion on FDA’s public list for the same substance and conditions of use.
  
  
• Changes to the GRAS status of an ingredient resulting from a final rule could affect the need to submit a New Dietary Ingredient Notification, as the exemption under Section 413(a)(1) may no longer apply.
  
  
• Without federal legislation, there is no express pre-emption. Chemical ingredients will continue to be the subject of state legislation and regulation.
  
  
• Review of these notices will require significant FDA resources. It is unclear if and when FDA will have the staff, information technology, and other resources to review the required notices, as well as to increase any resulting post-market review of chemical substances, issue any new food additive regulations, or initiate any enforcement actions.

Next steps

Companies are encouraged to:

• Evaluate how the proposed rule will affect their businesses and provide comments individually or through trade associations.
  
  
• Review ingredients to determine the regulatory basis for their use in food (e.g., through food additive approval, a GRAS regulation, a prior GRAS notification, or a self-GRAS determination).
  
  
• Ensure ingredients are being used under GRAS permissible conditions of use. Differences in identity, manufacturing processes, or specifications, or use in different food categories or at higher use levels, may require a new GRAS notice. This includes reviewing any documentation and affirmation provided by suppliers of your ingredients.
  
  
• Strengthen and update GRAS dossiers. Ensure that supporting safety assessments are robust, current, and well documented, as mandatory notification will increase FDA scrutiny and make GRAS notices and FDA responses publicly available.
  
  
• Finalize any pending self-GRAS determinations for substances expected to enter interstate commerce before the effective date of a final rule. Doing so may allow use of the rule's time-limited streamlined submission process rather than requiring a full GRAS notification. Submissions under these streamlined procedures must be made within one year of the effective date of any final rule.
  
  
• Assess market-entry timing on a product-by-product basis. Companies are encouraged to weigh the commercial advantages of marketing a substance before FDA completes its evaluation against the potential costs and disruption of responding to an adverse FDA determination after launch.
  
  
• Review supply chain agreements to assess whether revisions are needed to allocate responsibilities for GRAS documentation, certifications, and related compliance obligations under the proposed rule, including with respect to ingredient conditions of use.
  
  
• Assess the potential impact of FDA’s public database on intellectual property, trade secrets, and making otherwise internal documents available for public review.
  
  
• Consider developing a standard operating procedure to track future notifications and FDA responses that affect ingredients.
  
  
• Consider support for current federal legislative proposals that would establish similar notification and other requirements while explicitly providing for pre-emption.

For more information, please contact the authors.