FDA Proposes Mandatory GRAS Notification Requirement

Introduction

On August 11, 2026, the U.S. Food and Drug Administration (FDA) published a proposed rule that would convert the currently voluntary Generally Recognized as Safe (GRAS) notification program into a mandatory requirement. If finalized, any person who introduces a substance into interstate commerce based on self-determined GRAS status would be required to notify FDA of the GRAS determination and provide supporting documentation. The notification requirement would apply to products currently on the market as well as products introduced in the future.

Critically, this is a notification requirement, not a premarket approval requirement. Companies would be able to continue marketing GRAS substances without waiting for any FDA response to a notification. However, as discussed below, the practical implications of this rule are significant and industry participants should carefully evaluate their GRAS portfolios and plans now.

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

Background

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a food additive is deemed “unsafe” unless it conforms to a regulation prescribing conditions for its safe use or is exempt from the definition of a food additive because it is GRAS.¹ GRAS substances that are generally recognized among qualified experts as having been adequately shown to be safe under the conditions of their intended use have historically occupied a unique regulatory space, given they can be marketed for use in food without prior FDA approval.

Since 1997, FDA has maintained a voluntary GRAS notification program, which was finalized in 2016. Under this system, a company may independently determine that a substance is GRAS and market it without notifying FDA. If a company chooses to submit a GRAS notice, FDA evaluates the notice and responds with one of three outcomes: (1) by indicating that it does not question the basis for the GRAS conclusion; (2) stating that the notice does not provide a sufficient basis for a GRAS determination; or (3) indicating that the agency granted a request by the notifier to cease its evaluation of the GRAS notice.²

Since 1998, FDA has formally filed over 1,200 GRAS notices.³ However, FDA estimates that 1,000 or more additional substances are marketed for use in human food based on independent GRAS conclusions without FDA notifications.⁴ This gap has drawn increasing regulatory and public scrutiny. On March 10, 2025, Health and Human Services Secretary Robert F. Kennedy Jr. directed FDA to explore rulemaking to eliminate the pathway for firms to introduce purported GRAS substances without notifying FDA. The proposed rule aligns with the administration’s “Make America Healthy Again” initiative and responds to several high-profile incidents that highlighted the risks of the current voluntary system.

For example, in 2022, tara flour — a food ingredient marketed under a self-determined GRAS conclusion — was associated with approximately 400 adverse event reports, yet FDA had never received a GRAS notice for the substance.⁵ Similarly, FDA took enforcement action against caffeinated alcoholic beverages that were alleged to be GRAS.⁶ Further, FDA has taken enforcement action against delta-8 THC-containing food products, stating that the agency was unaware of a basis to conclude that delta-8 THC is GRAS for use in conventional foods.⁷

Summary of the Proposed Rule’s Major Provisions

1. Mandatory GRAS Notification

Under proposed § 170.205(a), any person introducing a substance into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act must notify FDA of the basis for the GRAS conclusion.⁸ The requirement applies to substances in both conventional food (human food ingredients) and food contact substances (e.g., food packaging materials).

The notification requirement would be considered satisfied upon FDA’s filing of the submission, not upon mere submission.⁹ FDA would have 45 days to determine whether to file a submitted notice.¹⁰ However, this filing determination is limited to completeness. FDA’s substantive evaluation of the GRAS conclusion would occur afterward and could result in a “no questions” letter, an insufficient-basis letter, or a “cease to evaluate” letter.¹¹ None of these outcomes is a formal premarket approval or denial, and the proposed rule would not require a company to await FDA’s substantive response before marketing a substance under a GRAS conclusion.¹² Because filed notices and FDA response letters would generally be publicly available, however, companies may face greater practical exposure following an adverse FDA response. A submission that FDA does not file would not satisfy the notification requirement. Further, FDA has proposed to consider noncompliance with that requirement when prioritizing substances for post-market review.¹³

2. Exceptions From Mandatory Notification

Proposed § 170.205(b) would provide exceptions from the mandatory notification requirement for:

1. Substances already covered by an existing “no questions” letter from FDA
2. Substances listed or affirmed as GRAS in 21 CFR Parts 182, 184, or 186
3. Substances considered GRAS under § 170.30(d) (natural biological origin, widely consumed before 1958) or § 170.30(i)(1)
4. Substances considered through an established FDA process (e.g., Voluntary Premarket Consultations, Animal Cell Culture Consultations) where no need for a GRAS notice was identified
5. Substances subject to a Threshold of Regulation (TOR) exemption under § 170.39
6. Substances covered by an effective Food Contact Notification (FCN), limited to the manufacturer/supplier listed in the FCN
7. Substances for which a streamlined submission has been included on FDA’s public list (a time-limited transitional option, discussed below)

Notably, while the GRAS mandatory notification requirement bears some resemblance to the process for new dietary ingredients intended for use in dietary supplements, the two frameworks differ in important ways, and companies should not assume that a favorable GRAS conclusion for conventional food also resolves NDIN status for the same substance used in a dietary supplement, or vice versa. The two pathways have distinct statutory triggers and procedural requirements, and each use must be evaluated on its own terms.

3. Time-Limited Streamlined Submission Option

Recognizing that many substances are already marketed under self-determined GRAS conclusions, the proposed rule includes a time-limited streamlined submission option in proposed Subpart F, § 170.305. This option would create an exception from the GRAS notice submission requirement if certain information about the conditions of use of the substance is submitted to FDA and the submission is included on a public list maintained by FDA, unless FDA issues a determination that a GRAS notice or a food additive petition must be submitted for the intended use of a substance.

This transitional pathway would apply only to substances already in interstate commerce before the effective date of the final rule, and submissions must be made within one year after that effective date.¹⁴ The information required for submission must include (1) the submitter’s name and address; (2) the substance name; (3) intended conditions of use; (4) evidence that the substance was in interstate commerce before the effective date; and (5) if applicable, where FDA sent a cease to evaluate letter in response to a notifier’s previous GRAS notice (GRN or AGRN), provide that file number (GRN No. or AGRN No.) as part of the submission.¹⁵

The streamlined option is not available for substances that have received an “insufficient basis” letter or a “not GRAS” determination from FDA.¹⁶ FDA will post qualifying submissions on a public list, but may subsequently ask questions or determine that a full GRAS notice or food additive petition is required.¹⁷

The proposed notification requirement applies to “any person introducing a substance into interstate commerce” under the GRAS provision.¹⁸ The preamble further explains that “[a]ny person could rely” on inclusion of a streamlined submission on FDA’s public list “for the same conditions of use” of a substance.¹⁹ Thus, a downstream food manufacturer may be able to rely on a qualifying streamlined submission where it covers the same substance and conditions of use; the proposal does not require each manufacturer using that substance to submit separately. Similarly, an existing “no questions” letter may excuse a new GRAS notice if it covers the substance under the same conditions of use.²⁰ Companies should nevertheless confirm that their ingredient is materially the same as the ingredient covered by the submission or letter. FDA cautions that differences in identity, manufacturing process, specifications, or conditions of use may mean that an earlier GRAS conclusion does not apply, in which case a separate GRAS analysis and potentially a new notice may be necessary.²¹

Although the proposal does not prescribe which supply-chain participant must make a submission, it is likely that ingredient manufacturers or suppliers will often be best positioned to prepare and maintain the underlying GRAS support. Downstream food manufacturers, however, should not assume that a supplier’s submission automatically covers their products. They should confirm that any applicable streamlined submission or “no questions” letter covers the ingredient as manufactured and the relevant conditions of use in their finished foods. Companies may also wish to address these issues in supplier diligence and contractual arrangements, including responsibility for maintaining GRAS support and providing notice of any material changes to the ingredient, its manufacturing process, or its intended uses.

4. Electronic Submission and English Translation Requirements

The proposed rule would require that all GRAS notices be submitted electronically through FDA’s Collaboration, Submission, and Messaging (COSM) system.²² A waiver process would be available for filers unable to submit electronically.²³ Additionally, all foreign language materials included in a submission would need to be accompanied by an English translation.²⁴

5. Revised FDA Review Timelines

Under the proposed rule, upon receipt of a submission, FDA will conduct an initial evaluation to determine whether to file it as a GRAS notice and will inform the submitter of the filing decision within two business days.²⁵ Once filed, FDA will respond to the submitter within 180 days of filing based on its evaluation of the notice, with the possibility of up to two 90-day extensions (increased from one extension under the current program).²⁶ FDA will inform a notifier in writing of this second extension as soon as practicable, but no later than the end of the initial 90-day extension.²⁷

6. Expansion of Threshold of Regulation (TOR) Exemption

The proposed rule would expand the TOR exemption program to include substances used in food generally, not just food contact articles.²⁸ Thus, if a food-contact or processing substance already qualifies for a TOR exemption (i.e., where dietary migration is less than 0.5 ppb and poses negligible health risk), a company does not need to submit a separate mandatory GRAS notice for that use.

7. FOIA and Confidentiality Clarifications

The proposed rule clarifies that data and information not identified by the submitter as exempt from disclosure under the Freedom of Information Act will be considered non-exempt from public disclosure.²⁹ Submitters should carefully designate confidential commercial information at the time of submission.

8. Animal Food Provisions

The proposed rule further includes parallel provisions in Part 570 for animal food, mirroring the Part 170 requirements for human food with appropriate modifications.³⁰ Notably, the animal food provisions include an exception for ingredients listed by the Association of American Feed Control Officials.³¹

Key Timelines and Compliance Dates

If the rule is finalized as proposed, the following timeline would apply:

• Comment Period: 120 days, currently ending December 9, 2026
• Effective Date: 60 days after publication of the final rule
• Compliance Date for Mandatory Notification: 18 months after the effective date
• Streamlined Submission Window: One year from the effective date

FDA estimates the present value of costs associated with the proposed rule at approximately $89.6 million with a lower bound of $34.9 million ad an upper bound of $210.0 million, discounted at a 3% discount rate over 10 years, with annualized costs of approximately $10.5 million.³² The agency acknowledges that the rule may have a significant economic impact on small entities.³³

Key Takeaways

FDA’s proposal would change the current food ingredient regulatory landscape by converting the current voluntary GRAS notice process into a mandatory notification framework for covered human and animal food uses. Although the proposal is not an FDA premarket approval requirement and does not require a company to await FDA’s substantive evaluation before marketing, it would substantially expand FDA’s visibility into self-determined GRAS uses, and likely result in greater public scrutiny of the use of GRAS ingredients more generally.

Because companies may market a substance immediately after filing, without waiting for FDA’s substantive review, there is an identifiable risk in going to market before FDA weighs in. If FDA later issues an insufficient basis letter or a not-GRAS determination, the company will already be in the marketplace when that adverse finding becomes public, unlike today’s voluntary regime, where declining to submit avoids creating any public record at all. A post-market adverse determination can trigger immediate scrutiny from customers, retailers, and supply-chain partners already relying on the product, and heightens exposure to enforcement. Companies should weigh the benefit of early market entry against the cost of unwinding distribution or responding to customers after an adverse public determination.

Beyond the risk of adverse action while already on the market, the notification requirement itself increases what becomes visible to FDA and the public. A submitted GRAS notice would give FDA (and potentially the public) access to the company’s safety rationale and supporting information, and the proposal states that failure to meet the notification requirement may be considered in FDA’s prioritization of substances for post-market review. Accordingly, companies should ensure that each GRAS conclusion is supported by a thorough, scientifically sound, and well-documented analysis — including with respect to the general recognition of the ingredient’s safety by experts, before relying on the GRAS pathway.

In anticipation of a final rule, companies may wish to consider the following:

• Inventory and classify GRAS uses. Companies should identify substances currently marketed under self-determined GRAS conclusions, confirm the relevant conditions of use, and determine whether an exception may apply.
• Strengthen GRAS dossiers. The quality and completeness of the underlying safety assessment will become more consequential. Companies should review existing files for the scientific evidence, expert analyses, and generally available information needed to support a GRAS conclusion.
• Plan for legacy substances. For eligible substances already in interstate commerce, companies should evaluate whether to use the proposed one-year streamlined-submission pathway or prepare a full GRAS notice. That decision will require consideration of the applicable exception, the available documentation, and potential disclosure implications.
• Assess market-timing risk. Companies should decide, on a case-by-case basis, whether to market a substance immediately upon filing or to wait for a more favorable indication from FDA, weighing the commercial benefit of early entry against the risk of having to respond to an adverse determination after the product is already in the marketplace.
• Address disclosure and supply-chain issues. Because GRAS notices and streamlined submissions may become publicly accessible, companies should carefully identify information that may warrant confidential treatment. Companies should also coordinate with suppliers and customers to determine who will assume responsibility for any notification and whether the available supporting documentation is sufficient.

* * *

The proposed rule is open for public comment until December 9, 2026. Companies and trade associations should consider submitting comments, particularly regarding the scope of the exceptions, the adequacy of the streamlined submission pathway, and the compliance timeline.

We will continue to monitor FDA developments relating to the proposed mandatory GRAS-notification rule. If you have any questions about the proposal, please reach out to one of the authors of this Advisory or to your existing Arnold & Porter contacts.

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.