FDA Proposes Major Overhaul of GRAS Framework: What Food and Feed Companies Need to Know Now

If finalized as proposed, the new rule would begin requiring notifications for many new ingredients and uses while creating a separate, time-limited streamlined pathway for certain GRAS ingredients already on the market. Companies developing innovative products, using novel or less common ingredients, or relying on proprietary ingredient suppliers will need to assess how this proposal could impact their business.

The Current GRAS Framework

Under the Federal Food, Drug, and Cosmetic Act (FDCA), any substance intentionally added to food is generally considered a “food additive” and subject to the FDA premarket review and approval, unless a statutory exception applies. One exception is the GRAS provision: a substance is not a food additive if qualified experts generally recognize, based on scientific procedures or other permitted evidence, that it has been adequately shown to be safe under the specific conditions of its intended use. Because a GRAS substance falls outside the definition of “food additive,” it does not require the FDA premarket approval for that use.

Under current regulations (21 C.F.R. §§ 170.205 and 570.205), companies may, but are not required to, notify the FDA of GRAS conclusions. The FDA’s rules allow companies to reach their own use-specific GRAS conclusion — often with an independent panel of qualified scientific experts — and market the substance without notifying the FDA. This is commonly called “self-affirmed GRAS” or “self-determined GRAS.”

If a company chooses to voluntarily notify the FDA of its GRAS conclusion, FDA will evaluate the notice and generally provide one of three responses.

• A “no questions” letter, meaning the FDA does not question the company’s GRAS conclusion at that time.

• An “insufficient basis” letter, meaning the notice does not support the GRAS conclusion.

• A “cease to evaluate” letter, issued at the notifier’s request.

Importantly, an ingredient’s GRAS status is use-specific, meaning that it is limited to specific conditions of intended use — including food categories, use levels, function, manufacturing specifications, and other relevant parameters. A change in supplier, manufacturing process, specifications, food category, function, or use level may require a new GRAS analysis.

Why the Current Administration Is Pushing for GRAS Reform

This proposal is part of the current Administration’s broader “Make America Healthy Again” (MAHA) initiative, and fits within a broader FDA-led food-chemical-safety campaign that includes post-market reassessments of chemicals such as beta hydroxy acid (BHA), phthalates, and propylparaben, as well as efforts to phase out petroleum-derived synthetic food colorants.

The FDA identified “GRAS reform” as a priority in its 2026 Priority Deliverables, describing it as “the biggest update to strengthen its food-additive oversight.” On March 10, 2025, US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., directed the FDA to explore rulemaking to eliminate the self-affirmed GRAS pathway that allows firms to market GRAS substances without notifying the FDA.

In the preamble to the proposed rule, the FDA contends that a mandatory notification process would address several perceived concerns with the current system, namely: the FDA currently lacks visibility into substances entering the food supply; companies are not required to disclose their GRAS conclusions or underlying evidence; and the agency may learn about potential safety problems only after an adverse public-health event occurs.

What the Proposal Would Change

If finalized, proposed 21 C.F.R. §§ 170.205 and 570.205 would require any person introducing a human or animal food substance into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act to notify the FDA of the basis for the GRAS conclusion, unless an exception applies. The proposal covers direct additions to food and indirect uses, including substances that may migrate from packaging or other food-contact materials. For covered food-contact uses, the FDA recommends the Food Contact Notification (FCN) process, and proposed § 170.205(a) would permit a manufacturer or supplier to submit an FCN instead of a GRAS notice.

Not Traditional Premarket Approval: If finalized as drafted, the proposal would not convert GRAS notices into  traditional FDA premarket approvals. Companies would be allowed to market a GRAS substance before submitting a notice or while the notice is being evaluated by the FDA; the proposal does not specify how soon after introduction the notice must be submitted. If the FDA later concluded that the use is not GRAS, however, the company could face enforcement for marketing a product with an unapproved food additive.

FDA Review and Response: Proposed § 170.265(a)(1) would give the FDA 45 days to conduct an initial evaluation of a submission to determine whether to file it as a GRAS notice. If the FDA were to decide to file the submission as a GRAS notice, the notification requirement would then be satisfied, unless the FDA later were to cease evaluating it. Filing would not mean that the FDA had evaluated the evidence or agreed that the substance is GRAS. The FDA would then have 180 days to respond, with up to two 90-day extensions. If the FDA were to respond with an “insufficient basis” letter, the notification requirement would still be satisfied, but the response would be relevant to the FDA’s determination whether the substance is an unapproved food additive and could inform post-market action.

Business Implications and Planning Priorities

The proposed mandatory notification requirements likely would have the largest impact on businesses that:

• Develop innovative products, use novel or less-common ingredients, or introduce new conditions of use for familiar ingredients;

• Rely on proprietary ingredient suppliers for safety support, GRAS conclusions, or regulatory status determinations; or

• Market products that emphasize new or alternative ingredients or use food-contact materials that rely on GRAS rather than an effective FCN or other established the FDA pathway.

The FDA expects that the proposal would have a significant economic impact on a substantial number of small entities. The main costs would include reviewing the rule, revising procedures, preparing notices or streamlined submissions, and maintaining supporting scientific and legal documentation. The practical impact would vary with each company’s ingredient portfolio, supplier arrangements, and product-launch schedule.

Existing GRAS Substances Already on the Market: A Time-Limited Streamlined Pathway

The proposed rule would also create a time-limited streamlined submission pathway for substances that were introduced into interstate commerce under the GRAS provision before the final rule’s effective date. For qualifying existing uses, a company could use the pathway instead of initially submitting a full GRAS notice, and the FDA would post streamlined submissions on a public list. A streamlined submission would need to:

• Be submitted within one year of the final rule’s effective date. 

• Identify the submitter the substance, and its conditions of use.

• Include evidence that the substance was present in interstate commerce before the effective date.

• If FDA previously issued a “cease to evaluate” letter, identify the applicable prior GRAS Notice (GRN) or Animal GRAS Notice (AGRN) file number.

Appearing on the FDA’s public list of streamlined submissions would not constitute FDA clearance, approval, or confirmation that the substance is GRAS. The FDA could later require a full GRAS notice or food additive petition. If the FDA questioned the substance’s GRAS status, the company could face regulatory and commercial consequences — including enforcement action, product withdrawal or recall, reformulation, supply disruption, and potential product-liability or class-action exposure.

Recommended Action Steps

Although the proposal is not final, companies can prepare themselves by doing the following:

• Inventory the regulatory status of ingredients and food-contact substances. Record each substance’s conditions of use — including food categories, use levels, function, manufacturing specifications, and supplier — identify the legal basis for marketing, such as an FDA regulation, effective FCN, GRAS notice that received a “no questions” letter, independent GRAS conclusion, or another established pathway, and distinguish uses introduced before the final rule’s effective date from new uses and market introductions.

• Work with suppliers. For each ingredient, confirm whether the supplier or manufacturer has reached an independent GRAS conclusion and what evidence supports it; whether a GRAS notice was submitted and, if so, FDA’s response; whether the substance was introduced into interstate commerce before the final rule’s effective date; and the supplier’s plans for notice, confidentiality, and recordkeeping. Ask whether changes in supplier, manufacturing process, specifications, food category, or use level could take the use outside an existing exception.

• Evaluate the underlying GRAS support. Confirm the specific conditions of use, statutory basis, and whether qualified experts could access and accept the evidence. For conclusions based on scientific procedures, the evidence must match the quantity and quality required for food-additive approval. A streamlined submission would not cure a weak GRAS conclusion; assess whether a full GRAS notice, food additive petition, or FCN may ultimately be needed.

• Build a compliance and launch timeline. If finalized as proposed, the rule would provide 18 months after the final rule’s effective date to comply, while the streamlined pathway would only be available for one year. Align product launches, supplier contracts, data collection, and legal review to those windows.

• Consider submitting comments. Companies affected by the proposed rule may wish to submit comments by December 9, 2026, including implementation, the scope of the exceptions, and the proposed disclosure requirements. ArentFox Schiff can assist with preparing and submitting comments.

• Plan for public disclosure. Under the proposed rule, data and information submitted to FDA in a GRAS notice generally would be available for public disclosure, subject to the Freedom of Information Act (FOIA) exemptions, including trade secret and confidential commercial information protections. Identify claimed protections at submission, coordinate with suppliers before filing, and do not assume unmarked information will remain confidential.

What the Proposal Does Not Change

The proposal would not change the underlying question in every GRAS analysis: whether the specific conditions of intended use are supported as GRAS or require an FDA-authorized food-additive pathway. It would change notification obligations, not the need for a rigorous, use-specific safety assessment.

Potential Legal Challenges

The proposal is likely to face legal challenges over whether the FDCA authorizes mandatory GRAS notifications. In the preamble to its 2016 GRAS notice rule, the FDA acknowledged that it “lack[s] express statutory authority to require companies to submit GRAS notices,” while courts have upheld the voluntary system in light of US Congress’s longstanding inaction. That more than 70-year interpretive history, together with draft legislation that would expressly grant the FDA such authority, could make statutory authorization a central issue in any challenge.

Looking Ahead

The FDA’s proposed GRAS overhaul could materially affect how companies document and commercialize ingredients, but the final rule may differ. If finalized as currently drafted, the proposed 18-month compliance period and one-year streamlined-submission window would begin running on the effective date. Companies that use the comment period to assess their ingredient portfolios, engage with suppliers, evaluate disclosure issues, and identify potential launch issues will be better positioned to manage implementation risk. Our team is monitoring the rulemaking and can help assess its impact on products, supply relationships, and regulatory strategies.

ArentFox Schiff’s Food, Drug, Medical Device & Cosmetic group includes attorneys, regulatory advisors, and scientists with experience in independent GRAS conclusions, including toxicology, safety-data review, and expert-panel coordination. For questions, please contact the authors or your regular ArentFox Schiff attorney.