On August 11, 2026, the U.S. Food and Drug Administration (“FDA”) published a proposed rule that would significantly change how food manufacturers use the “Generally Recognized as Safe” (“GRAS”) process to permit them to add substances to human and animal food. If finalized, the rule would convert the FDA’s current voluntary GRAS notification program into a mandatory notification framework for many food substances that companies self-determine to be GRAS.

For food manufacturers, ingredient suppliers, co-packers, distributors, importers, and animal feed businesses, the proposal is important because it would increase FDA visibility into ingredients that historically may have entered the market without agency notification. The rule is still only proposed, but companies that rely on their own independent GRAS conclusions should begin assessing their ingredient portfolios now.

Legal Framework
The GRAS concept comes from the Food, Drug, and Cosmetic Act (FDCA)’s definition of “food additive.” Under the FDCA, a “food additive” generally includes a substance that becomes a component of food or otherwise affects a food’s characteristics. The law (FDCA § 201(s) and FDCA § 409) generally requires premarket approval for food additives, but it provides an exception for substances that are generally recognized by qualified experts as safe under their intended conditions of use.

The FDA’s current GRAS regulation at 21 C.F.R. § 170.30(a) provides that recognition of safety must be based on expert consensus and scientific evidence demonstrating a reasonable certainty of no harm under the intended conditions of use. A GRAS conclusion based on scientific procedures requires the same quantity and quality of evidence expected for a food additive approval, while a GRAS conclusion based on historical use must rely on food use before January 1, 1958. As a result, manufacturers have long been able to independently conclude that a substance is GRAS and market it without notifying FDA, provided the conclusion is supported by the requisite scientific evidence and expert review.

What Would Change?
The FDA’s current GRAS notification regulation at 21 C.F.R. § 170.205 is voluntary: it provides that “any person may notify [the] FDA of a view that a substance is not subject to the premarket approval requirements of section 409 of the FDCA based on that person’s conclusion that the substance is GRAS under the conditions of its intended use.”

The FDA’s August 2026 proposal would change that voluntary framework, while stopping short of creating a traditional premarket approval system. In the proposed rule, the FDA states that it is “proposing to require the submission of GRAS notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the FDCA.” For substances already in interstate commerce before the effective date of any final rule, the FDA proposes a time-limited “grandfathering” pathway under which manufacturers could submit a streamlined notice within one year, without providing underlying safety data or a full GRAS narrative. The proposal was published at 91 Fed. Reg. 51834 on August 11, 2026, and the FDA set a comment deadline of December 9, 2026.

Why This Matters for Food Businesses
Many food businesses rely on complex supply chains involving ingredient suppliers, contract manufacturers, private-label arrangements, imported ingredients, flavorings, processing aids, packaging components, and animal feed inputs. If the rule is finalized, companies may face greater documentation expectations, supplier due diligence needs, and customer questions about the regulatory basis for ingredients, even where they rely on supplier GRAS representations.

Practical Steps to Consider Now

• Inventory ingredients and food-contact substances: Identify substances relying on supplier assurances, GRAS determinations, FDA “no questions” letters, or other pathways.
• Review supplier documentation: Confirm available GRAS notices, safety dossiers, expert reports, specifications, and use limits.
• Assess contract responsibilities: Review agreements for compliance, notice submission, indemnity, and change-in-law obligations.
• Evaluate legacy substances: Flag substances that either may need a transition pathway under the final rule, or are “grandfathered”, and plan for making the “grandfathered” filings under proposed section 170.305 (c)(1)-(2) within one year.
• Consider submitting comments: Address burden, timing, confidentiality, supply-chain responsibilities, and implementation issues by December 9, 2026.

The proposed rule remains subject to public comment, but it signals a meaningful shift toward greater FDA visibility into GRAS ingredients. Manufacturers should also monitor the possibility of further legal challenges to the FDA’s rulemaking authority on this subject.

Barley Snyder’s Food & Agribusiness Industry Group will continue monitoring the proposal and its impact on regional food and agribusiness companies. For guidance on reviewing ingredient portfolios, assessing supplier GRAS documentation, or preparing for potential FDA notification obligations under the proposed rule, please contact attorneys Jinnie Lee, Catherine Begley, Tim Dietrich, or any member of Barley Snyder’s Food & Agribusiness Industry Group.