FDA’s Proposed GRAS Rule: Why Companies Should Prepare Now

FDA is proposing one of the most significant changes to the GRAS framework in decades, a proposed rule that could change what companies share about ingredient safety and who may access that information.

Many consumers assume FDA reviews food ingredients before they reach the marketplace. In reality, some ingredients may qualify as GRAS, short for “generally recognized as safe,” which allows companies to market them without going through FDA’s food additive approval process. GRAS substances can include familiar food ingredients as well as less familiar substances used for functions such as preserving food or providing texture. Companies typically develop scientific support for GRAS conclusions but are not required to notify FDA before marketing the ingredient. As a result, FDA may not learn of potential safety concerns until the ingredient is already on the market.  

FDA’s August 2026 proposed rule is intended to close that gap by giving the agency earlier access to the evidence supporting GRAS determinations and greater visibility into ingredients entering the food supply.

The rule is only a proposal and could change after FDA reviews public comments. If FDA finalizes it, the rule would take effect 60 days after publication, and companies would have 18 months after that to comply with the notice requirement.

Why FDA Is Taking Another Look at GRAS

FDA views mandatory notification as a way to identify potential safety questions earlier. 

Beyond identifying safety questions earlier, FDA cites broader changes in the food marketplace as support for the proposed rule. Today’s supply chains often involve multiple suppliers, manufacturers and distribution channels, making it harder to track ingredients as they move through the food supply. FDA believes earlier access to safety information would provide a clearer picture of ingredient uses, anticipated levels of consumption, and the scientific basis for concluding those ingredients are safe. 

What Would Change Under the Proposal?

FDA proposes the following changes for new ingredients and those already on the market:

• Most companies would need to notify FDA: Under the proposal, companies generally would need to tell FDA why they concluded an ingredient is GRAS, unless an exception applies. A GRAS notice would describe the ingredient, how it is made and used, how much of it people are expected to consume, and the scientific support for the GRAS determination. The proposed requirements would apply to both human and animal food, including certain substances that may migrate from packaging or other food-contact materials. 
• FDA would screen notices first: Sending a notice would not be enough on its own. Within 45 days, FDA would decide whether the notice includes the information FDA needs to begin its review. This step does not decide whether the ingredient is safe.   
• FDA review of a GRAS notice would not be required before an ingredient is marketed: Companies generally would need to submit a GRAS notice, but FDA would not have to review or approve the notice before the ingredient could be marketed as GRAS. Companies could keep selling the ingredient while FDA reviews the notice. The notice would give FDA an earlier opportunity to review the basis for the GRAS determination without changing the company’s role in making that determination. 
• Some ingredients could qualify for an exception: A notice generally would not be needed if FDA has already addressed the same use, such as through a prior FDA no questions letter or an existing FDA regulation. Narrower exceptions cover certain packaging materials cleared for a specific supplier and uses FDA has exempted because exposure is very low. 
• Ingredients already on the market would have a temporary pathway: For ingredients already on the market based on a company’s own GRAS review, FDA proposes a one-year period after a final rule takes effect to submit a streamlined filing. The filing would identify the ingredient and its use along with evidence that it was on the market before the final rule took effect. However, FDA could later request a full GRAS notice if it determines that additional information is needed to evaluate the GRAS determination. 
• GRAS notices and supporting safety analyses would be publicly available: FDA would post GRAS notices, response letters, and certain submissions for ingredients already on the market, including details about ingredient manufacture and use, anticipated consumption, and supporting safety analyses. Companies would need to identify confidential material or risk FDA treating it as public. 

What Companies Should Do Now

Comments on FDA’s proposed rule are due December 9, 2026, but companies can begin reviewing their GRAS programs now:

• Know where records supporting your GRAS determinations are located: Supporting materials may be spread across business units, consultants, suppliers, and other parties in the supply chain. Identify which ingredients and product applications rely on GRAS determinations, who maintains the underlying studies and analyses, and whether those materials can be readily accessed if FDA has questions.  
• Make sure GRAS reviews keep pace with product changes: Review whether manufacturing processes, specifications, suppliers, formulations, intended uses, or use levels have changed since the original GRAS assessment, and ensure those changes trigger a fresh review when needed. 
• Consider how the proposed rule could affect your business: The proposed requirements could affect recordkeeping, supplier relationships, product development, and the amount of ingredient safety information available to the public. Use the comment period to consider how those changes would work in practice and whether FDA should hear about any operational or business concerns.   

Conclusion

FDA’s proposal would leave companies responsible for their GRAS determinations while giving FDA and the public greater visibility into those decisions. Companies that understand where their GRAS records are and whether they still reflect current products will be better positioned however the final rule takes shape.