From Voluntary to Mandatory: FDA's Proposed GRAS Rule

The U.S. Department of Health and Human Services (HHS) on August 10, 2026, announced a proposed rule that would modernize how the U.S. Food and Drug Administration (FDA) oversees the use of food ingredients. The centerpiece of the proposed rule is a requirement for manufacturers to notify FDA when they have concluded a substance is Generally Recognized as Safe (GRAS) for specified conditions of use and introduce the substance into the market. Specifically, the proposed rule would amend 21 C.F.R. Parts 170 and 570 to require the submission of GRAS notices for any substance introduced into interstate commerce under the GRAS provision of Section 201(s) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

This Holland & Knight alert explains the regulatory history behind the rule, summarizes the proposed rule's key provisions and assesses its implications for food and beverage industry stakeholders.

Background

When the U.S. Congress enacted the Food Additives Amendment to the FD&C Act in 1958, it established a premarket review and approval requirement for "food additives," but carved out an exception for substances that qualified experts GRAS under the conditions of their intended use. Originally understood to cover common ingredients such as vinegar and flour, the GRAS exemption evolved over subsequent decades. In 1997, FDA proposed replacing an earlier GRAS affirmation petition process with a voluntary notification procedure, finalized in 2016, under which manufacturers could, but were not required to, notify FDA of their GRAS conclusions. As a result, FDA published the safety data to support marketing of an ingredient. Many manufacturers participated in the process and, as of March 2025, FDA's Human Foods Program had filed more than 1,200 voluntary GRAS notices.

However, because GRAS notification was optional, companies routinely introduced substances into the U.S. food market based on their own determinations that a substance was GRAS without informing FDA. As of 2011, at least 1,000 human food substances entered the market through this pathway, with no public disclosure of the underlying safety information. A 2010 U.S. Government and Accountability Office (GAO) report identified these persistent information gaps for FDA and the public as a result of the voluntary notification.

In the proposed rule, FDA points to several reasons for moving from a voluntary to a mandatory notification framework, including inadequate analyses supporting independent GRAS conclusions, products remaining on the market after the agency ceases to evaluate a GRAS notice and the lack of comprehensive safety information, which FDA argues has hindered the efficient administration of the FD&C Act.

The Political Context

The proposed rule is a flagship initiative of the Trump Administration's Make America Healthy Again (MAHA) strategy. In March 2025, HHS Secretary Robert F. Kennedy Jr. directed FDA to explore rulemaking to eliminate the pathway for firms to introduce purported GRAS substances without notifying the agency. (See Holland & Knight's previous alert, "HHS Explores Stronger FDA Oversight for Food Ingredients," March 12, 2025.) The GRAS proposed rule builds on FDA actions initiated earlier in the Trump Administration's tenure, including the initiative to phase out petroleum-based synthetic dyes and the rollout of a new post-market chemical review framework. (See Holland & Knight's previous alerts, "HHS Announces Actions to Phase Out Use of Food Additives," April 25, 2025, and "FDA Initiates New Post-Market Review Framework for Food Chemicals," May 22, 2025.) Additionally, the GRAS proposed rule offers the Trump Administration a consumer protection message with broader bipartisan appeal ahead of the midterm elections. However, stakeholders should note that the comment period for the proposed rule is 120 days, closing on December 9, 2026, leaving a long time period by which they can submit comments on the proposed rule, as well as provide answers to the various requests for information throughout the proposal (see further below).

The proposed rule also arrives amid an increasingly active state regulatory landscape. At least seven states have enacted their own food additive bans since 2023, and some, including California and New York, have gone further by enacting broader food safety framework laws that go beyond individual ingredient restrictions. This growing patchwork of conflicting requirements has complicated national food production and distribution. The FD&C Act contains no general preemption provision for food substance regulation, so the absence of a federal preemption clause in the proposed rule is not a policy choice FDA could have made differently; it reflects a statutory limitation. Federal preemption would require new legislation – a step that has proven politically difficult given opposition from the MAHA community and state lawmakers.

Separately, HHS and the U.S. Department of Agriculture submitted the federal government's first proposed definition of ultra-processed foods (UPFs) to the White House Office of Management and Budget for final interagency review, though details have not yet been released. Together, the GRAS proposed rule and UPF definition mark continued progress toward enhancing transparency on the ingredients in the U.S. food supply and addressing the potential drivers of chronic disease.

Key Provisions of the Proposed Rule

Mandatory GRAS Notification

The core of the proposed rule is straightforward: 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 their GRAS conclusion. This applies to both human and animal food substances, including food contact substances (FCSs) such as chemicals migrating from packaging into food. If an FCS is marketed under a GRAS conclusion rather than through a food contact notification (FCN) or food additive regulation, the proposed mandatory notification requirement would apply. Notices must be submitted electronically, unless the notifier is provided a waiver to submit in paper format.

A GRAS notice must include 1) signed statements and a certification of completeness/truthfulness, 2) the identity, method of manufacture, specifications, and physical or technical effect of the substance, 3) dietary exposure data, 4) a narrative providing the basis for the GRAS conclusion and 5) a list of supporting data and information.

Notably, however, the proposed rule does not require submitters to provide the underlying data supporting their independent GRAS conclusion. Where a notifier relies on nonpublic, safety-related data or information that it identifies as exempt from disclosure under the Freedom of Information Act, e.g., for trade secret purposes, the notifier must explain how there could be a basis for a conclusion of GRAS status even though qualified experts do not have access to such data. This is a meaningful limitation: FDA will have visibility into what is being added to the food supply and the basis for a manufacturer's GRAS conclusion but not necessarily the full scientific record supporting it.

No Premarket Approval Requirement

Critically, the proposed rule does not create a premarket approval framework. Companies may continue marketing a substance before submitting a GRAS notice or while a notice is pending with FDA. As Acting FDA Commissioner Kyle Diamantas stated: "What we're doing is requiring companies that utilize that pathway to notify us of their conclusions, so that we have greater visibility into those conclusions, and so that consumers have awareness."

This is an important distinction: The proposed rule is a transparency and information-gathering mechanism, not a new approval requirement. Companies, not FDA, would continue to make the GRAS determination, and there is no time limit on continued marketing; products can move to market before, during and after the notification process without restriction. In practice, mandatory notification would function as an additional administrative step running alongside, not ahead of, a company's go-to-market process.

It is worth noting, however, that FDA under previous administrations maintained it could not make GRAS notification mandatory without congressional action, and food regulatory attorneys have questioned how far the agency can go through rulemaking alone. The U.S. Supreme Court's elimination of Chevron deference reduced the deference courts give agencies when interpreting ambiguous statutory language. This could become central to the rule's legal viability by giving stakeholders a stronger basis to contest FDA's interpretation of its authority under the FD&C Act. Acting Commissioner Diamantas acknowledged that requiring formal premarket approval would have required an act of Congress. This indicates FDA's acknowledgment of the varying perspectives on mandatory notification, as well as the possibility for lawsuits. It also leaves open the door for FDA in the future to seek additional authorities from Congress related to GRAS changes.

Consequences for Noncompliance

The proposed rule does not create new penalties or sanctions for noncompliance. Instead, FDA would treat failure to comply with the notification requirement as a factor in its prioritization of substances for post-market review. That said, the FD&C Act already provides robust enforcement mechanisms for adulterated food, including seizure (Section 304), injunctions (Section 302) and criminal penalties (Section 303). If FDA determines through post-market review that a substance constitutes an unapproved food additive, the food containing it is deemed adulterated under Section 402(a)(2)(C)(i), triggering those existing remedies.

In practical terms, however, companies that do not participate may subject their products to greater FDA scrutiny. Substances marketed without a filed GRAS notice face potential FDA determinations that the substance constitutes an unapproved food additive subject to enforcement action under Sections 402(a)(2)(C)(i) and 409 of the FD&C Act. FDA also acknowledges that mandatory notifications could lead to determinations that certain substances lack sufficient basis for a GRAS conclusion, potentially forcing reformulation or market withdrawal. For companies with large ingredient portfolios, the calculus will likely favor compliance.

Streamlined Pathway for Legacy Substances

Recognizing that many substances are already on the market under prior self-GRAS determinations, the rule creates a new Subpart F in proposed Sections 170.303 and 170.305 offering a time-limited, abbreviated submission pathway. These "streamlined submissions" require only basic identifying information:

• name and address of the submitter
• name of the substance, using an appropriately descriptive term
• intended conditions of use (including foods, levels of use and purposes)
• evidence of presence in interstate commerce before the effective date of the final rule
• if applicable, the GRN No. of a prior GRAS notice that received a cease to evaluate letter

For companies with substances already on the market, this is a critical compliance pathway, and compliance is deliberately not burdensome. Unlike a full GRAS notice, a streamlined submission does not require any underlying safety data, scientific analysis or narrative justifying the GRAS conclusion. Companies need only provide the basic identifying information listed above. However, submissions must be filed electronically within one year of the final rule's effective date.

FDA would post the information publicly but expressly reserves the right to later require a full GRAS notice or food additive petition for any substance. Inclusion on the public list does not represent an FDA determination that the substance is GRAS or a food additive petition is not required.

Exceptions from the Mandatory Notification Requirement

The proposed rule enumerates seven circumstances in which a GRAS notice would not be required:

1. Existing "No Questions" Letter. A "no questions" letter is FDA's response to a GRAS notice indicating that, based on the information provided, the agency has no questions at that time regarding the notifier's conclusion that the substance is GRAS under its intended conditions of use. Where such a letter already covers the substance, a new GRAS notice would not be required. However, this exception does not apply if the identity of, manufacturing process for or conditions of use of the substance are significantly different from those discussed in the GRAS notice that received the no questions letter; for example, a manufacturing process change that introduces new impurities. In such cases, the manufacturer is obligated to demonstrate that the substance remains GRAS and may consult with FDA. FDA invites comment on additional scenarios that could qualify for an abbreviated GRAS notice submission or be considered covered by an existing no questions letter.
2. Listed or Affirmed GRAS. The substance is listed or affirmed as GRAS under the conditions of its intended use in 21 C.F.R. Parts 182, 184 or 186.
3. Natural Biological Origin Substances. The substance is considered GRAS under Section 170.30(d) (natural biological ingredients widely consumed for nutrient properties before 1958) or proposed Section 170.30(i)(1) (substances affirmed as GRAS with no limitation other than good manufacturing practice, where conditions of use are not significantly different).
4. Established FDA Process. The intended use has been evaluated through an established FDA process (e.g., voluntary premarket consultation for biotech-derived foods), and FDA documentation does not recommend or identify the need for a GRAS notice.
5. Threshold of Regulation (TOR) Exemption. The intended use is the subject of an exemption under the TOR process in Section 170.39.
6. Effective FCN. An effective FCN covers the substance under the conditions of its intended use, and the substance in commerce originates from the manufacturer or supplier listed in the FCN. Note that this exception is manufacturer- and supplier-specific: Other companies marketing the same FCS under a GRAS conclusion would still need to file a GRAS notice.
7. Streamlined Submission for Legacy Substances. Information has been submitted under proposed Section 170.305 and included on the public list maintained by FDA, unless FDA later determines that a full GRAS notice or food additive petition is required.

These exceptions could spare many companies from having to prepare full GRAS notices for significant portions of their ingredient portfolios. Regulatory and research and development teams should work together to evaluate which substances fall within these categories, as the analysis will be fact-specific, particularly with respect to whether an existing no questions letter covers a substance under its current conditions of use. Companies that have modified manufacturing processes, expanded use levels, changed suppliers or introduced ingredients into new food categories since receiving a no questions letter should take a particularly close look.

Animal Food Substances

The proposed rule applies to human food substances as well as substances used in animal food (Part 570), with parallel amendments. FDA proposes an exception from notification for animal food ingredients listed in the 2024 Association of American Feed Control Officials "Official Publication" for which FDA has not publicly expressed concern about GRAS status.

FDA Review Timelines and Procedures

The proposed rule introduces new timing parameters for FDA's evaluation process:

• Initial Evaluation. Within 45 days of receiving a submission, FDA will determine whether to file it as a GRAS notice. This is a preliminary adequacy check, not a substantive GRAS review.
• Filing Notification. FDA will notify the submitter within two business days of its decision. The notification requirement is considered met only upon filing. Mere submission is not sufficient.
• Substantive Review. Within 180 days of filing, FDA will respond by letter, with the option to extend by 90 days up to two times, for a potential total of 360 days.
• Cease to Evaluate. If FDA ceases its evaluation, the notification requirement will not be considered met.

A practical note: The 45-day initial evaluation period is framed as a goal, not a hard requirement, and the proposed rule does not address how FDA intends to meet this timeline given well-documented reductions in Human Foods Program staffing. Companies with product launch timelines that depend on GRAS notice filing should build in an additional buffer and consider weighing in during the comment period.

Public Disclosure

All data and information in a GRAS notice will be available for public disclosure as of the date FDA receives the submission, in accordance with 21 C.F.R. Part 20. Information about purported GRAS uses of substances would be "accessible to the public within a few weeks of filing" through the agency's GRAS Notice Inventory, but no specific timeline is defined for "within a few weeks of filing" – a notable omission. For companies, this is a significant competitive consideration. Proprietary ingredient strategies, use levels and the bases for GRAS conclusions will become publicly accessible and visible to competitors, consumer advocacy groups and plaintiffs' counsel alike. Companies that have historically relied on the confidentiality of self-GRAS determinations as part of their competitive advantage should factor this transparency into their compliance planning.

Requests for Comment

The proposed rule includes numerous requests for information and comment, and stakeholders should pay careful attention to these. In addition, stakeholders should carefully weigh whether to provide responses to the individual questions, taking into account FDA has asked for data to substantiate potentially alternative responses to be provided. FDA seeks comment on:

• alternatives to the proposed rule that could reduce regulatory burdens while still meeting FDA's goals of prohibiting the use of unsafe food additives and increasing transparency; FDA seeks data and other information to support any suggested alternatives
• the 45-day pre-filing evaluation period and ways to reduce potential delays between receipt of a submission and filing
• scenarios qualifying for abbreviated procedures (e.g., where a substance differs from one covered by an existing no questions letter, or where there has been a change in manufacturing process)
• procedures for animal food substances already in the GRAS notice inventory

It is worth noting that the responses FDA receives during the comment period may inform not only the final rule but also the agency's future enforcement priorities and post-market review strategies.

Key Dates and Compliance Timeline

• Comment Period: Stakeholders have 120 days from the Federal Register publication of the proposed rule (scheduled for August 11, 2026) to file comments; this means the rule will not be finalized until 2027, at the earliest
• Effective Date of Final Rule: 60 days after publication of the final rule; at the earliest, 2027
• Compliance Date for Mandatory Notifications (Sections 170.205 and 570.205): 18 months after the effective date
• Streamlined Submission Window (Subpart F): One year from the effective date for legacy substances

What Comes Next

The proposed rule represents the most significant structural reform to the GRAS framework since its creation in 1958, but it is more evolutionary than revolutionary. It layers a disclosure mandate onto the existing self-certification system without granting FDA new premarket approval authority. Notably, following the 120-day public comment period and FDA's review of the comments received, the final rule will take effect within 60 days of issuance, setting a quick timeline for stakeholders to prepare for any changes to compliance or research regimes to acclimate to changes that may take effect in 2027.

The proposed rule's ultimate impact will depend on several factors:

• FDA Enforcement Posture. How aggressively will FDA use its post-market review authority against non-notifiers? The agency's new post-market chemical prioritization tool and the broader review framework it has been building suggest a more active posture than in prior decades.
• Congressional Action. Secretary Kennedy has publicly called on Congress to pass legislation giving FDA "additional tools that it needs to keep pace with a changing food supply." Congress has been responsive on both sides of the aisle, with members leading on the following bills with the same goal of enhanced transparency, but varying perspectives on how to achieve that goal:
  • Roger Marshall's (R-Kan.) Better Food Disclosure Act (S. 3122) would go further than the proposed rule by deeming any GRAS substance adulterated unless included on a new FDA-maintained listing, and it notably omits a federal preemption provision, leaving the growing patchwork of state food additive bans intact. U.S. Senate Democrats have introduced a competing bill, the Ensuring Safe and Toxic-Free Foods Act (S. 2341), which would require FDA to affirmatively review all GRAS additives.
  • In the U.S. House of Representatives, the Committee on Energy and Commerce's Subcommittee on Health is considering competing approaches, including legislation from Ranking Member Frank Pallone (D-N.J.) that would require premarket notification with supporting scientific evidence, and a narrower bill from Rep. Kat Cammack (R-Fla.) that would establish mandatory notification while preserving exemptions for commonly consumed ingredients. (See Holland & Knight's previous alert, "Congress Takes Up Slate of FDA Bills Aimed at Reforming Food Regulations," April 28, 2026.)
  • Absent federal preemption, a lack of swift action from Congress is significant: States have increasingly pursued their own restrictions on food additives as well as some sweeping food safety measures, and manufacturers have warned that a state-by-state patchwork could create conflicting requirements and complicate national food production and distribution.
  • Though not a legislative proposal introduced by a member of Congress, FDA in its fiscal year 2027 budget included as a legislative proposal – requesting Congress take specific action – to "Ensure FDA Access to Industry Data to Strengthen Food Chemical Safety." The legislative request would authorize FDA to require premarket authorization from FDA for food additives considered GRAS, a notable provision missing from the proposed rule.
• Agency Capacity. Whether FDA has sufficient funding and staffing to meaningfully review thousands of expected submissions remains an open question. Acting Commissioner Diamantas has acknowledged that FDA already faces a GRAS backlog with limited staff and resources, and the proposed rule would significantly increase that workload.

Food and beverage companies and ingredient suppliers that have relied on independent GRAS conclusions should begin assessing their portfolios now. Specifically, companies should:

• Inventory their ingredients, including direct additives and any food-contact substances marketed under GRAS, to identify which currently rely on independent GRAS conclusions and would require a notice under the proposed rule.
• Map exceptions to determine which ingredients may qualify for one of the seven enumerated exceptions, reducing the compliance burden.
• Prioritize the streamlined pathway for legacy substances already in commerce, keeping in mind the one-year submission window and the lighter data requirements.
• Evaluate competitive exposure from the public disclosure of GRAS notice information. Though underlying safety data need not be submitted, the identity of the substance, method of manufacture, specific food applications and use levels all become publicly accessible within weeks of filing.
• Engage in the comment process. The 120-day comment period provides a critical opportunity to shape the final rule's scope, particularly around the definition of the exceptions, processing timelines, FDA capacity and the practical mechanics of the streamlined submission pathway.

Holland & Knight's Healthcare, Life Sciences and Agriculture & Food Policy teams will continue to monitor these developments and provide updates as more details emerge. For questions about how these changes may impact your business or compliance program, please contact the authors.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.