Publication date: August 11, 2026
Category: FDA Regulatory News | Food Ingredients | GRAS
Suggested SEO title: FDA Proposes Mandatory GRAS Notifications for Food Substances
Suggested meta description: FDA has proposed replacing the voluntary GRAS notification program with mandatory notifications for certain substances used in human and animal food. Learn the scope, deadlines, transition pathway, and recommended next steps.

Key Takeaways

• FDA has proposed converting the current voluntary GRAS notification program into a mandatory system for certain substances used in human and animal food.
• The proposal covers direct food ingredients and indirect substances, including certain food-contact substances, when their legal status relies on an independent GRAS conclusion.
• This is a notification framework, not a new premarket approval requirement. However, FDA would not consider the obligation satisfied until it accepts a sufficiently complete notice for filing.
• Certain substances already in interstate commerce could qualify for a time-limited streamlined submission instead of an initial full GRAS notice.
• Comments are due by December 9, 2026, under docket FDA-2025-N-3262.

FDA Moves to End “Self-GRAS Without Notification”

The U.S. Food and Drug Administration (FDA) published a proposed rule on August 11, 2026, that would fundamentally change how companies rely on the Generally Recognized as Safe (GRAS) pathway.

Under the current framework, a company may independently conclude that a substance is GRAS under its intended conditions of use and may voluntarily submit a GRAS notice to FDA. If the proposed rule is finalized, a person introducing a human- or animal-food substance into interstate commerce based on an independent GRAS conclusion would generally be required to notify FDA of the basis for that conclusion, unless an exception applies.

FDA states that the proposal is intended to increase transparency and give the Agency better information about substances in the food supply. Importantly, the proposal does not eliminate the statutory GRAS exemption or change the scientific standard for establishing GRAS status. For GRAS conclusions based on scientific procedures, the evidence must continue to be of the same quantity and quality as the evidence required to support a food additive regulation, and safety must be generally recognized among qualified experts.

Mandatory Notification Is Not the Same as Premarket Approval

The proposed program would require notification, but it would not convert GRAS substances into food additives that must receive FDA approval before marketing.

Under the proposal, a company generally would not need to wait for FDA to complete its substantive review before introducing a purported GRAS use into interstate commerce. The notification obligation would be considered met when FDA accepts a sufficiently complete submission for filing. FDA proposes to conduct its initial filing review within 45 days of receipt.

Acceptance for filing would not mean that FDA agrees the use is GRAS. After filing, FDA would evaluate the notice and could issue a “no questions” letter, an insufficient-basis letter, or another applicable response. The proposed review period would remain 180 days, but FDA could use as many as two additional 90-day extensions when needed.

Failure to meet the notification requirement could also influence FDA’s decision to prioritize a substance for post-market review. In addition, if a notifier asks FDA to cease evaluating a filed notice and FDA grants that request, the proposed notification obligation would no longer be considered satisfied.

Which Substances Would Be Affected?

The proposal would apply to certain substances used in:

• human food;
• animal food; and
• indirect food uses, including certain substances that migrate or may be expected to migrate from packaging or other food-contact materials.

The requirement would generally target uses placed on the market based on an independent GRAS conclusion. FDA proposes several exceptions, including where the intended use is already covered by:

• an FDA “no questions” letter;
• an applicable GRAS regulation;
• certain other FDA-recognized GRAS categories or review processes;
• a Threshold of Regulation (TOR) exemption; or
• an effective Food Contact Notification (FCN), for material supplied by the manufacturer or supplier identified in that FCN.

For food-contact substances, companies could continue to use the FCN pathway where appropriate. Because an FCN is manufacturer- or supplier-specific, its exception would apply only to the listed manufacturer or supplier.

FDA also proposes expanding the TOR procedure beyond substances used in food-contact articles to cover qualifying substances used directly or indirectly in food when exposure is sufficiently low and the applicable safety criteria are met.

Streamlined Option for Existing GRAS Uses

The proposal includes a transitional pathway for certain substances already introduced into interstate commerce before the effective date of a future final rule.

Eligible companies could submit streamlined information identifying the substance, its conditions of intended use and use levels, and evidence showing that the substance was already in interstate commerce before the final rule’s effective date. A complete underlying safety narrative would not be required for this initial streamlined submission.

The option would be available for only one year after the effective date of a final rule. FDA would place submitted information on a public list, but listing would not mean that FDA had reviewed or agreed with the GRAS status. FDA could later request additional information or a full GRAS notice.

Proposed Timing and Comment Deadline

This proposal is not yet legally effective. FDA proposes that any final rule would:

• become effective 60 days after publication in the Federal Register;
• provide a one-year window after the effective date for eligible streamlined submissions; and
• establish a compliance date 18 months after the effective date for the mandatory-notification provisions.

Stakeholders may submit comments through Regulations.gov by 11:59 p.m. Eastern Time on December 9, 2026. Comments should reference docket FDA-2025-N-3262. Because electronic comments and attachments are generally posted publicly without change, companies should not include confidential business information in a public electronic submission.

Recommended Actions for Industry

Food manufacturers, ingredient developers, distributors, importers, animal-food companies, and suppliers of food-contact substances should begin preparing now:

1. Inventory independent GRAS conclusions. Identify every product and intended use currently marketed without an FDA GRAS notice.
2. Confirm the responsible party. Determine who introduces each substance into interstate commerce and who would be responsible for notification.
3. Assess available exceptions. Review existing no-questions letters, GRAS regulations, FCNs, TOR exemptions, and other applicable FDA determinations.
4. Preserve market evidence. Retain dated invoices, shipping records, product labels, specifications, customer records, and other evidence showing interstate commerce before any final rule’s effective date.
5. Evaluate dossier readiness. Confirm that safety data, exposure estimates, manufacturing information, specifications, and the general-recognition basis are current and adequately documented.
6. Review confidentiality strategy. Separate information appropriate for public disclosure from confidential commercial information.
7. Consider submitting comments. Evaluate the proposal’s practical effect on portfolios, supply chains, small businesses, imported ingredients, food-contact materials, and confidential information.

EZFDA Perspective

If finalized, the proposal would create a major compliance and transparency shift for the U.S. food and ingredient sectors. It would not abolish GRAS self-determinations, but it would largely remove the ability to rely on an undisclosed independent GRAS conclusion for covered uses.

Companies should not wait for the final rule to begin organizing their records. A well-documented inventory of GRAS uses, regulatory pathways, safety support, and market-entry evidence will help businesses determine whether a full notice, a streamlined submission, an FCN, a TOR request, or another pathway is most appropriate.

EZFDA can assist companies with GRAS gap assessments, dossier preparation, regulatory-pathway analysis, food-contact strategy, and preparation of comments on the proposed rule.

Official sources: Federal Register proposed rule | Submit comments at Regulations.gov

Disclaimer: This article is provided for general informational purposes and does not constitute legal advice. The requirements discussed are proposed and may change before any final rule is issued.