On August 11, 2026, FDA published the long-anticipated Proposed Rule on Substances Generally Recognized as Safe (GRAS). If finalized, the rule would require submission of GRAS notices for substances self-determined to be GRAS under the conditions of their intended use in human or animal food, unless an exception applies. The exceptions cover substances FDA has already authorized by regulation or for which it has accepted successful GRAS notifications, among others. FDA proposes a “streamlined submission” for substances already in interstate commerce at the time a final rule goes into effect, which is essentially a notification about the facts and use of such substances, rather than the full notification that would be required for newly introduced substances. This proposal represents a fundamental shift from the current voluntary GRAS notification program to a mandatory framework. That said, FDA maintains that it is not proposing a pre-market approval requirement because substances may go to market before FDA’s review of the notification. Moreover, FDA does not assert that failure to submit a GRAS notice would render the food adulterated or otherwise in violation of the Federal Food, Drug & Cosmetic Act (FD&C Act). Rather, the Agency maintains that such failure would be a factor it considers in prioritizing food substances for post-market review and the modified GRAS framework would foster transparency and assist FDA in efficient enforcement of the food additive requirements of the FD&C Act. The details of the proposal are summarized below. Comments are due by December 9, 2026.
- If the Proposed Rule is finalized, a company must notify FDA of any substance it has self-determined to be GRAS before marketing it in human or animal food, unless an exemption applies. This applies to both direct food ingredients and food contact substances.
- Notably, the Proposed Rule would not establish a pre-market approval framework for GRAS substances (and FDA acknowledges that it lacks the authority to do so). Companies may continue to market self-determined GRAS substances before and while FDA reviews the GRAS notice.
- For substances already in the market at the time any final rule goes into effect based on a GRAS self-determination, FDA proposes a time-limited streamlined submission option. This would be a simplified notification (not a full GRAS notice) that includes basic information about the substance and its intended use. FDA would post streamlined submissions on a public list.
- The exempted categories do not include FEMA GRAS substances that are not the subject of an FDA “no questions” letter or other formal review by the Agency. As such, those substances would need a GRAS notification, but those already in commerce can be the subject of a streamlined submission.
- At this stage, the new framework is still only proposed. The mandatory notification program will not become effective unless and until the Agency issues a final rule. If finalized as proposed, the rule would take effect 60 days after publication of the final rule; mandatory notifications would be required 18 months after the effective date; and streamlined submissions for self-determined GRAS substances already on the market would be due within one year of the effective date.
Mandatory GRAS Notification Requirement
The Proposed Rule would require companies to notify FDA when they use or market a substance for use in human or animal food based upon a GRAS conclusion, unless an exception applies (as described below). This requirement would apply to both ingredients used directly in food (“direct” food substances) and food contact substances (“indirect” food substances).
The notification requirement would be satisfied upon FDA’s “filing” of a submission as a GRAS notice. FDA proposes a 45-day initial evaluation period for determining whether a submission is adequate to file. This initial review addresses only filing adequacy, not the substance’s actual GRAS status, which FDA evaluates after filing. If FDA ceases to evaluate a GRAS notice at the notifier’s request, the notification requirement would be considered unmet.
Importantly, FDA is not proposing to establish a pre-market review or approval program for GRAS substances. Consistent with the statutory exemption for GRAS substances from the food additive definition and approval process, a company may continue to market a substance it has independently concluded to be GRAS both before submitting a GRAS notice and while such a notice is pending before the Agency. FDA does not state that noncompliance with the mandatory notification requirement would, by itself, render a food adulterated or otherwise in violation of the FD&C Act. Rather, in the preamble to the Proposed Rule, FDA explains that noncompliance would be a factor the Agency considers in prioritizing food substances for post-market review.
Exceptions to the Mandatory GRAS Notification Requirement
The Proposed Rule would exempt from the mandatory notification requirement a food substance that:
(a) Is the subject of an existing FDA “no questions” letter that covers the substance under the conditions of its intended use.
(b) Is the subject of an FDA regulation listing or affirming the substance as GRAS under the conditions of its intended use.
(c) Is of natural biological origin that has been widely consumed for its nutrient properties in the U.S. prior to 1958, is subject only to conventional processing, and presents no known safety hazard.
(d) Has undergone FDA review through an established process, and documentation made publicly available by FDA through that process does not identify the need to submit a GRAS notice. Examples include FDA’s Voluntary Premarket Consultation or Voluntary Premarket Meeting for foods from new plant varieties developed through biotechnology, Animal Cell Culture Consultation for foods from cultured animal cells, and FDA’s Center for Veterinary Medicine’s Animal Food Ingredient Consultation process.
(e) Is the subject of an exemption under the threshold of regulation (TOR) process for food contact substances.
(f) Is the subject of an effective premarket notification (FCN) for a food contact substance which covers the substance under the conditions of its intended use. Note that this exemption is limited to the manufacturer or supplier identified in the FCN.
(g) Is the subject of the time-limited streamlined submission option described in the Proposed Rule (discussed further below).
Time-Limited Streamlined Submission Option
For substances already marketed based on self-GRAS conclusions, the Proposed Rule would offer a time-limited streamlined submission option in lieu of mandatory GRAS notification. This option would be available only for self-determined GRAS substances already introduced into interstate commerce before the effective date of the final rule (if finalized). This option would not be available for any conditions of use of a substance that are the subject of an “insufficient basis” letter or an FDA determination that the substance is not GRAS under the conditions of its intended use.
Streamlined submissions would need to be made within one year of the final rule’s effective date. Required contents include:
- Name and address of the submitter;
- Name of the substance;
- Conditions of intended use (including the foods in which the substance is used or is in contact with, use levels, and purposes of use);
- Evidence that the substance was present in interstate commerce before the effective date; and
- If applicable, the GRAS notice file number if FDA previously ceased evaluation of a GRAS notice for the same conditions of intended use of the substance.
Notably, FDA clarifies that the streamlined submission would not require inclusion of the statutory basis for the conclusion of GRAS status for the conditions of intended use, though FDA recommends its inclusion. FDA further explains that it would use this information to help prioritize post-market review of substances used in food.
FDA would post streamlined submissions on a publicly available list. Inclusion on the list would not represent Agency review of GRAS status. FDA may ask the submitter questions about their submission, and FDA may subsequently determine that a GRAS notice or a food additive petition must be submitted for the intended use of the substance. Any such determination would be made publicly available.
Electronic Submission Requirement
FDA would require that all GRAS notices and streamlined submissions be submitted electronically through FDA’s Centralized Online Submission Module (COSM), though a waiver of the electronic submission requirement may be requested. Any material submitted in or referenced by a GRAS notice that is in a foreign language must be accompanied by an accurate and complete English translation.
FDA’s Evaluation Process and Timelines
FDA proposes the following evaluation timeline for GRAS notices:
- 45-day initial evaluation period to determine whether to “file” the submission as a GRAS notice (i.e., accept it for substantive review) or reject it. Filing decision letters will be issued within two business days of the filing determination.
- 180-day evaluation period following filing, during which FDA will conduct its substantive review.
- Two possible 90-day extensions if needed.
Threshold of Regulation (TOR) Exemption Updates
FDA proposes to expand its existing TOR exemption to include substances used in food, in addition to food contact substances, that meet the TOR criteria set forth in its regulations. FDA also would update the scientific terminology and approaches for assessing cancer risk of carcinogenic compounds under the TOR framework.
Animal Food Provisions
The Proposed Rule includes parallel revisions to 21 C.F.R. Part 570 for substances used in animal food. The proposed revisions largely mirror the proposed revisions to the human food regulations in 21 C.F.R. Part 170, with a few notable differences.
The proposed animal food provisions do not include FCNs as an alternate pathway for food contact substances nor do they reference the TOR exemption because the FCN program and TOR exemption are specific to human foods. With respect to the time-limited streamlined submission option, for substances intended for use in food for food-producing animals, FDA would require, in addition to the information described above for streamlined submissions for human food substances, the quantities of any residues that humans may be exposed to in edible animal tissues.
FDA also proposes an additional exception from the GRAS notification requirement for animal food ingredients that are listed in and used in accordance with the “Official Common or Usual Names and Definitions of Feed Ingredients” section of Chapter 6 of the “Official Publication” of the Association of American Feed Control Officials, Inc. (AAFCO), 2024 ed., and for which FDA has not publicly expressed a concern about the GRAS status of the use of the ingredient.
Under the FD&C Act, food additives require pre-market review and approval, but the statutory definition of food additive carves out GRAS substances. As noted above, in issuing the Proposed Rule, FDA does not claim authority to impose a pre-market review and approval requirement for GRAS substances. Instead, FDA maintains that mandatory GRAS notifications would help the Agency fulfill its statutory responsibility to prohibit the use of unapproved additives in food. FDA also cites its general rulemaking authority under the FD&C Act to issue regulations for efficient enforcement of the Act.
In explaining its rationale for mandatory GRAS notifications, FDA states that the current voluntary system has allowed some companies to market ingredients based on inadequately supported GRAS conclusions. The Agency points to examples involving stevia leaf extracts, caffeinated alcoholic beverages, Delta-8 THC, tara flour, and ashwagandha as cases where FDA learned of potentially unsafe or unlawful uses only after products had entered the market or adverse events occurred. According to FDA, its lack of visibility with respect to self-determined GRAS substances used in the food supply impedes its ability to efficiently carry out its statutory responsibilities.
Recognizing the limits of its existing statutory authority, the current Administration has also signaled interest in broader reform. At the event announcing the Proposed Rule, HHS Secretary Kennedy called on Congress to provide FDA with additional authority to build on the proposed mandatory notification framework. Acting FDA Commissioner Kyle Diamantas likewise indicated that the Agency would continue to work with Congress on further GRAS reform. Those statements come as Congress has shown increasing bipartisan interest in food policy reform. Several GRAS reform proposals have already been introduced in Congress. In recent months, the House Health Subcommittee held a hearing on “Healthier America: Legislative Proposals On The Regulation And Oversight Of Food” and the Senate Committee on Health, Education, Labor, and Pensions (HELP) has marked up food-related bills.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
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