More than a year after U.S. Department of Health and Human Services (HHS) Secretary Kennedy directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to overhaul its longstanding regulations governing food-ingredient oversight—and specifically to eliminate the ability of companies to self-affirm that their ingredients are Generally Recognized as Safe (GRAS)—the federal government has issued a proposed rule (the 2026 GRAS Proposed Rule) that would significantly curtail—and may effectively displace—the decades-old self-affirmed GRAS pathway food ingredients. FDA formally unveiled the proposal on August 10, 2026, at HHS’s “Food Policy Celebration Rally,” where Secretary Kennedy and Acting FDA Commissioner Kyle Diamantas framed the action as closing the so-called “GRAS loophole,” alongside a related announcement that HHS, FDA and the U.S. Department of Agriculture (USDA) had submitted the federal government’s first proposed definition of ultra-processed foods (UPFs) to the Office of Management and Budget (OMB) for final interagency review. The 2026 GRAS Proposed Rule was then published in the Federal Register the following day, August 11, 2026 (Docket No. FDA-2025-N-3262), with comments due by December 9, 2026. Throughout the preamble, FDA states that its central aim is to increase transparency and strengthen regulatory oversight of the food industry.

The key provisions of the 2026 GRAS Proposed Rule are briefly summarized immediately below, with a more detailed discussion with our takeaways and recommended next steps to follow:

• Mandatory GRAS notifications. Subject to certain exceptions, the rule would convert the current voluntary GRAS notification program into a mandatory one. If the notification requirement is not met for a substance’s intended use, FDA would treat that as a factor in prioritizing the substance for post-market review.
• Transition pathway for existing ingredients. For substances already on the market based on industry self-GRAS conclusions, the proposal would create a time-limited (i.e., within one year after the effective date of the final rule), streamlined submission pathway for manufacturers to provide FDA with information on those existing uses.
• Extended review and initial evaluation timelines. FDA would add a 45-day pre-filing evaluation period and reserves the ability to extend its 180-day evaluation by 90 days up to two times (total potential: 360 days).
• Confidentiality. If a notifier does not identify data and information as exempt from Freedom of Information Act (FOIA) disclosure at the time of submission, FDA will consider such information non-exempt and any confidentiality claim waived. For non-public safety data claims as confidential, notifiers must explain how a GRAS conclusion can be supported notwithstanding that qualified experts lack access to such data.
• Effective Date and Compliance. If finalized, the rule would take effect 60 days after publication, with a compliance deadline set 18 months thereafter. That 18-month compliance window is designed to overlap with the separate one-year deadline for the streamlined submission pathway, giving FDA enough time to publish its public list of streamlined submissions before companies’ compliance deadline arrives.

Our Takeaways

1. Streamlined Submission Pathway

A notable feature of the proposal is the streamlined submission pathway for substances already in interstate commerce before the effective date of any final rule. FDA did not propose to require every legacy self-affirmed GRAS use to undergo full retrospective GRAS notice review in the first instance; instead, the agency proposed a time-limited option under which a person may submit specified information about the substance and its conditions of use instead of submitting a full GRAS notice. FDA explains that this pathway is intended to give the agency insight into substances already on the market while avoiding the administrative burden of requiring full GRAS notices for all legacy uses at once.

The streamlined submission requirements are notably limited. For human foods, the submission must include: the name and address of the submitter; the name of the substance, using an appropriately descriptive term; the intended conditions of use, including the foods in which the substance is used or in contact with, levels of use and purposes of use; evidence that the substance was present in interstate commerce before the effective date of the final rule; and, if applicable, the GRAS notice number for a prior GRAS notice for which FDA sent a cease-to-evaluate letter. The submitter may identify the statutory basis for its GRAS conclusion, but that information is optional. FDA is not proposing to require underlying safety data or information supporting the GRAS conclusion as part of the streamlined submission.

That limitation is important because it creates a gap between the proposal’s transparency rationale and what the streamlined pathway would actually disclose. The pathway would tell FDA and the public that a substance is on the market and describe how it is being used, but it would not necessarily disclose why the submitter believes the use is GRAS. FDA can ask questions about a streamlined submission and may later determine that a GRAS notice or food additive petition must be submitted for the intended use of the substance. But FDA also states that posting streamlined submission information on the public list does not mean FDA has reviewed the GRAS status of the substance’s conditions of intended use. For stakeholders, that means the streamlined pathway is best understood as a transitional disclosure mechanism, not an FDA safety review or endorsement.

Timing will matter. FDA proposes that any final rule become effective 60 days after publication, that proposed sections 170.205 and 570.205 have a compliance date 18 months after the final rule’s effective date, and that streamlined submissions be accepted only during a one-year window after the effective date. Companies with legacy self-affirmed GRAS positions should therefore begin inventorying substances, conditions of use, supporting records and prior GRAS notification history well before the final rule is issued.

2. Same Substance Reliance

FDA states that “[a]ny person could rely on the inclusion of the submission on a public list maintained by FDA for the same conditions of use of a substance.” The proposed “same substance reliance” concept is useful but underdeveloped. In practical terms, that means a company may be able to rely on another person’s streamlined submission if the substance and conditions of use are the same.

The difficulty is that the public list may not contain enough information for a third party to determine whether reliance is appropriate. The streamlined submission need not include underlying safety data, and FDA’s posting of the submission does not mean FDA has reviewed the GRAS status of the substance or its intended use. The proposed public information would include substance identity and conditions of use, but it may not include manufacturing details, specifications, impurity profiles or confidential commercial information that could be essential to determining whether another company’s substance is truly the “same” substance under the same conditions of use.

That concern is not merely theoretical. FDA’s 2016 GRAS Final Rule, and subsequent FDA guidance, emphasized that a GRAS conclusion based on scientific procedures generally must rest on publicly available and accepted scientific data, information or methods, and FDA advised that there could be no basis for a GRAS conclusion if trade secret or other non-public information is necessary for qualified experts to conclude that the substance is safe under the conditions of intended use. The 2026 GRAS Proposed Rule would also require a notifier that identifies non-public, safety-related information as exempt from disclosure to explain how there could be a basis for a GRAS conclusion despite the fact that qualified experts do not have access to that information. For the streamlined pathway, however, FDA is not proposing to require that kind of underlying safety showing up front. The result is a practical mismatch: FDA would allow reliance on a public listing, but the listing may not give downstream users enough information to responsibly determine whether their own substance and use are covered.

3. Public Disclosure, Confidentiality and Commercial Strategy

The proposal also has important disclosure consequences that companies should not overlook. This isn’t an entirely new concept: FDA’s current GRAS framework already treats general recognition as contingent on generally available and accepted information, with unpublished or non-public information playing, at most, a corroborative role rather than serving as the foundation for safety—indeed, current guidance already provides that there can be no basis for GRAS status if trade secret or other non-public information is necessary for qualified experts to reach the safety conclusion. What the 2026 GRAS Proposed Rule would add, however, is a more formalized and higher-stakes disclosure discipline. Under a mandatory-notification regime, companies would need to build out the public and confidential portions of the GRAS record from the outset. FDA proposes to clarify that if a notifier does not identify data and information as exempt from disclosure under FOIA at the time of submission, FDA will consider that information not exempt or the confidentiality claim waived. For non-public, safety-related data used in reaching a GRAS conclusion, the notifier would need to explain how a GRAS conclusion can exist even though qualified experts lack access to that information, particularly given the baseline principle noted above.

This may make GRAS strategy more closely resemble a combined regulatory, scientific and commercial disclosure exercise. Companies will need to decide not only whether they have a defensible GRAS basis, but also what information can be disclosed, what information must be protected and whether non-public safety-related information creates a vulnerability under the general recognition standard. In practice, stakeholders should pressure-test whether the publicly available record, standing alone, can support both safety and general recognition; identify any FOIA-exempt information with precision; and prepare a non-confidential explanation showing why any proprietary data are corroborative rather than essential. This will matter not only for new ingredients, but also for existing substances that may be swept into the proposed mandatory notice framework or the proposed time-limited streamlined submission pathway for substances already in interstate commerce—particularly for ingredient manufacturers, food-contact material suppliers and companies relying on proprietary manufacturing processes or specifications. For those companies, the proposed rule may require earlier coordination among regulatory, toxicology, manufacturing and business teams to decide whether that public record is sufficient for GRAS, and how to preserve trade secret protection without undermining the GRAS rationale.

4. Compliance Paradox

The 2026 GRAS Proposal also creates a potential compliance paradox. FDA describes the notification requirement as mandatory, but the proposed rule states that the GRAS notification program “generally” does not establish a premarket review program and that a company may continue marketing a purported GRAS substance before submitting a notice, or after submitting a notice but before FDA files it. Likewise, a company may independently conclude that a new use of a substance is GRAS and introduce the substance into interstate commerce prior to submitting a GRAS notice. FDA further states that noncompliance with the notification requirement would be considered as a factor in prioritizing food substances for post-market review, rather than automatically rendering the food adulterated. At the same time, FDA would treat the notification requirement as satisfied only if, after its 45-day initial evaluation, FDA files the submission as a GRAS notice, and if FDA ceases to evaluate the notice, the requirement would not be met. The result may be a regime that is arguably mandatory in name only: as proposed, noncompliance would trigger no automatic bar on marketing or adulteration finding, only an increased risk of being flagged for post-market scrutiny.

Potential for Litigation

FDA’s proposed move from a voluntary GRAS notification program to a mandatory notification framework was heavily telegraphed, but the proposed text—including FDA’s discussion in the preamble—still raises a significant statutory authority question: whether FDA has express authority to convert a statutory exemption from premarket food additive approval into a mandatory agency notification requirement. FDA grounds the 2026 GRAS Proposed Rule in Sections 201, 402, 409 and 701 of the federal Food, Drug and Cosmetic Act (FDCA) and argues that Sections 409(a) and 409(d), read together, give FDA responsibility to identify substances that may be food additives requiring premarket review and to initiate food additive rulemaking where appropriate. That framing is materially different from FDA’s 2016 position noted in the 2016 GRAS Final Rule, where the agency stated: “We agree that we lack express statutory authority to require companies to submit GRAS notices.” Whether that 2016 statement reflected a definitive legal conclusion or a policy-driven interpretation—and whether FDA may lawfully revise that view—are questions likely to be contested in any litigation. In that same 2016 GRAS Final Rule, FDA emphasized that Congress had amended Section 409 of the FDCA to create a mandatory food-contact notification program but had not amended Section 409 to require a premarket GRAS notification procedure, whether voluntary or mandatory.

The 2026 GRAS Proposed Rule does not squarely grapple with FDA’s 2016 statement that it lacked express statutory authority to mandate GRAS notice submissions. Instead, the proposal acknowledges the voluntary framework established in 2016, describes persistent information gaps under that framework, and reframes mandatory notification as a tool to help FDA efficiently carry out its responsibilities under Sections 409(a) and 409(d) and its efficient-enforcement authority under Section 701(a). That omission is likely to be a focal point in comments and, if the rule is finalized as proposed, in litigation.

The 2021 Southern District of New York (SDNY) opinion in Center for Food Safety v. Becerra is helpful to FDA in some respects, but its value to the government should not be overstated. The court upheld the 2016 GRAS Final Rule, found that FDA had not unlawfully subdelegated its authority and concluded that the rule did not exceed FDA’s statutory authority or conflict with the FDCA. But the opinion repeatedly addressed a voluntary notification regime, not a mandatory one. The quoted sentence in the opinion—“the FDCA does not impose mandatory GRAS notification on manufacturers or require FDA to review industry GRAS conclusions in advance of marketing”—appears in the court’s discussion as the government’s position, which the court credited in rejecting the subdelegation challenge. The court also noted that “it remains unclear under the statute whether FDA even has the authority to make GRAS notifications mandatory” and stated that “[t]he remedy Plaintiffs seek lies with Congress, not me.”

The agency likely recognized the post-Loper Bright litigation risk. The SDNY decision expressly applied Chevron deference and held that FDA’s voluntary-notification rule survived deferential review because FDA’s construction of the FDCA was reasonable and supported by a reasoned explanation. After Loper Bright, courts no longer defer to an agency’s statutory interpretation under Chevron, which might make FDA’s shift from “we lack express statutory authority” in 2016 to “mandatory notification is authorized by Sections 409(a), 409(d), and 701(a)” in 2026 more vulnerable than it would have been under the pre-Loper Bright framework.

The public remarks at HHS’s August 10, 2026 “Food Policy Celebration Rally” underscore that point, to a certain extent. Secretary Kennedy stated that HHS is “doing everything that we can do within our legal power” and that “Congress needs to give FDA the additional tools that it needs to keep pace with a changing food supply and protect the American people.” Acting Commissioner Diamantas similarly said that the proposal “advances and improves the agency’s oversight of food safety via regulation, while respecting the limitations of our authority under the statute,” and that the administration would “continue working with Congress on legislative options to further address and advance GRAS reform.”

Recommended Next Steps for Stakeholders

For companies, the immediate planning questions are practical and strategic. The comment period closes on December 9, 2026, and any final rule would become effective 60 days after publication, with proposed compliance dates and transition windows running from that later effective date. At the same time, FDA officials have publicly acknowledged bipartisan interest in GRAS reform and indicated that the administration will continue working with Congress on legislative options to further advance GRAS reform. Stakeholders therefore should monitor both the rulemaking docket and parallel legislative developments, because Congress could alter the GRAS framework on a different timeline than FDA’s rulemaking (see also our related post regarding the Congressional GRAS Reform Bills).

In the interim, stakeholders should consider taking the following steps:

• Inventory current GRAS positions. Identify each ingredient, food-contact substance and condition of use currently marketed on the basis of an independent GRAS conclusion, and determine whether the use would fall within one of the proposed exceptions or the time-limited streamlined submission pathway for legacy substances.
• Assess the public evidentiary record. For each GRAS conclusion, determine whether the safety basis rests on generally available and accepted scientific data, information or methods, and flag any conclusion that depends materially on trade secret, confidential commercial or other non-public safety-related information.
• Engage suppliers early. Where a company relies on supplier assurances, specifications, manufacturing controls or prior GRAS positions, it should confirm the basis for lawful marketing and evaluate whether the available information is sufficient to support the company’s own use, particularly where the proposed “same substance” reliance concept may not reveal manufacturing details, specifications or confidential information needed to confirm equivalence.
• Prepare for disclosure decisions. Companies should identify what information can be submitted publicly, what information should be claimed as exempt from disclosure under FOIA and whether any non-public safety-related information creates a vulnerability under the GRAS general recognition standard.
• Use the comment process strategically. Substantive comments on burden, review timelines, the one-year streamlined submission window, the proposed 45-day filing determination, the 180-day review period with up to two 90-day extensions, supplier reliance and the proprietary-data problem may help shape the final rule.
• Monitor state-level developments. Stakeholders should also track state ingredient restrictions and bans, as well as emerging state-level GRAS transparency legislation, such as New York’s pending “Food Safety and Chemical Disclosure Act,” which would impose a first-of-its-kind state mandatory reporting regime for self-affirmed GRAS substances used in food; from a compliance standpoint, these state initiatives matter because they may require stakeholders to assess regulatory risk on two fronts—federal and state—and to prepare disclosure, substantiation and supplier-diligence workstreams before FDA’s federal rulemaking is finalized.

Stakeholders should also pay close attention to the agency-capacity assumptions underlying the proposal. Converting a voluntary notification program into a mandatory one will likely substantially increase the number of submissions FDA receives, particularly during the proposed transition period for existing ingredients. The proposal, however, does not appear to be accompanied with any meaningful discussion concerning increase in funding, staffing, or reviewer capacity. As a result, an open question is whether FDA will have the practical ability to process what could be a significant influx of notices while still reasonably meeting the proposal's stated review timeframes. That issue may warrant particular attention during the comment process, as implementation challenges could affect both regulatory predictability and the pace of review.

The legal risk is equally important. Until challenged and decided by a court, FDA has a plausible argument that the proposed mandatory notification helps it carry out its post-market responsibilities under Sections 409(a) and 409(d) of the FDCA and its efficient-enforcement authority under Section 701(a). But FDA’s 2016 statement that it lacked express statutory authority to require GRAS notices, the SDNY court’s observation that mandatory-notification authority remained unclear, the aforementioned compliance paradox, and the post-Loper Bright end of Chevron deference all create meaningful litigation vulnerability if the rule is finalized substantially as proposed. The bottom-line message for stakeholders is therefore not that the rule is certain to be invalidated, but that companies should plan now for both implementation and litigation uncertainty.

If you have questions, would like to discuss how these changes may affect your business or sector, or are interested in engaging thoughtfully with the evolving GRAS framework, we would be pleased to continue the conversation. A webinar on this issue is forthcoming; to receive the invitation, as well as other food-related regulatory updates, please sign up for our Food & Beverage mailing list. Please contact any of the authors listed.