FDA proposes mandatory notices for food ingredients labeled GRAS

The Food and Drug Administration has proposed replacing its voluntary notification system for certain food ingredients with a mandatory notice requirement, giving regulators and the public more information about substances introduced into food under the “generally recognized as safe,” or GRAS, exemption.

The proposed rule was published August 11, 2026, as Federal Register document 2026-16296 under docket FDA-2025-N-3262. Public comments are due December 9, 2026.

The proposal would change reporting and oversight. It would not ban food additives, and it would not require the FDA to preapprove every GRAS use before a product reaches the market.

What the proposal would change

If finalized, the rule would generally require any person introducing a covered substance into interstate commerce under the GRAS provision to notify the FDA of the basis for concluding that the substance is GRAS under its intended conditions of use.

A notice would identify the substance, explain how it would be used and describe the scientific information supporting the GRAS conclusion. The proposed definition of food substances includes ingredients added directly to food and some substances added indirectly, such as materials that migrate from food packaging.

The proposal would apply to substances used in both human and animal food. FDA says the additional information would help it determine whether a substance is properly covered by the GRAS exemption or instead is an unapproved food additive subject to FDA review.

How the current GRAS system works

Under the current framework, companies and other responsible parties may voluntarily submit GRAS notices to the FDA. After reviewing a notice, the agency may issue a “no questions” letter when it does not question the notifier’s conclusion based on the information submitted.

A company may also reach an independent GRAS conclusion without submitting a notice. That conclusion, a voluntary notice and an FDA no-questions letter are separate from a formal FDA determination that a substance is safe for every possible use.

FDA rules say a substance can qualify as GRAS only under specific conditions of intended use. A conclusion about one use does not automatically cover different foods, amounts or exposure conditions.

What the public could see

The proposed rule would continue public disclosure of filed GRAS notices and related FDA correspondence through the agency’s GRAS notice inventory, subject to protections for trade secrets and confidential commercial information.

FDA says broader disclosure would give regulators, researchers and the public more information about substances entering the food supply. It also says notices could support post-market review and enforcement when the agency identifies a safety concern or concludes that a use does not qualify for the GRAS exemption.

The proposal would not automatically trigger a retrospective FDA safety review of every ingredient already on the market. It also would not turn an FDA no-questions letter into blanket approval for uses beyond those described in the notice.

Who could be affected

Ingredient suppliers, packaged-food manufacturers, animal-feed companies and other businesses introducing covered substances into interstate commerce could face new documentation and electronic submission duties if the rule is finalized.

The proposal includes exceptions and a time-limited streamlined submission pathway for certain GRAS uses already in interstate commerce before a final rule takes effect. FDA proposes making that pathway available for one year after the final rule’s effective date. Eligibility requirements and exceptions could change during the rulemaking process.

Timeline, cost and next steps

Comments on the proposed rule and its information-collection burden are due December 9, 2026. Electronic comments submitted through Regulations.gov must be filed by 11:59 p.m. Eastern time at the end of that day.

FDA proposes that any final rule become effective 60 days after publication in the Federal Register. It also proposes an 18-month compliance period for the core mandatory-notification provisions. Those dates are not final.

FDA’s preliminary analysis estimates the proposal’s present-value costs at about $89.6 million over 10 years, with an estimated range of $34.9 million to $210 million, using a 3% discount rate. The estimate could change after public comments and further rulemaking.

For consumers, there would be no immediate change in store products because this is only a proposed rule. The immediate public action is the comment period. The main issues to watch are whether FDA changes the scope of covered uses, the exceptions, the streamlined pathway, the cost estimates or the proposed compliance schedule before issuing a final regulation.

Sources

• Federal Register: Substances Generally Recognized as Safe, 91 FR 51834
• FDA: Generally Recognized as Safe
• Associated Press: New FDA rule may require food manufacturers to disclose new additives

Look for updates to this story

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