FDA Proposes Mandatory GRAS Notification, but Stops Short of Premarket Approval

August 11, 2026

When the U.S. Department of Health and Human Services (HHS) first announced plans to target the self-affirmed Generally Regarded as Safe (GRAS) pathway last year, a central question was how far the Food and Drug Administration (FDA) would go. Would the agency simply require companies to disclose their GRAS conclusions, or would it effectively transform GRAS into a premarket approval program?

FDA has now provided its answer.

In a sweeping proposed rule on substances Generally Recognized as Safe, FDA would require notification for most substances introduced into interstate commerce based on a GRAS conclusion. The proposal would largely eliminate the ability to make an independent GRAS determination without FDA ever knowing about it.

At the same time, FDA expressly declines to turn GRAS into a premarket approval system. Companies could continue marketing substances they have concluded are GRAS before submitting a notice and while FDA evaluates it.

That distinction is critical. The proposal would substantially increase FDA visibility, documentation requirements, and post-market oversight without eliminating the underlying statutory ability to market a substance based on a defensible GRAS conclusion.

From Voluntary to Mandatory Notification

Under the current framework, a company may independently conclude that a substance is GRAS under its intended conditions of use and introduce it into the food supply without notifying FDA. Companies can voluntarily submit a GRAS notice and obtain a “no questions” letter from the agency, but notification itself is not currently required.

As we discussed when HHS first announced plans to address the GRAS “loophole,” that lack of mandatory disclosure became a central target of the current Administration’s food policy agenda. Congress subsequently added its own pressure through multiple legislative proposals seeking greater GRAS transparency and oversight.

The new proposal would make notification the default.

Any person introducing a substance into interstate commerce under the GRAS provision would generally have to notify FDA of the basis for concluding that the substance is GRAS under its intended conditions of use, unless a specified exception applies.

FDA would have 45 days after receiving a submission to determine whether to file it as a GRAS notice. Importantly, submission alone would not satisfy the requirement. FDA would consider the notification requirement satisfied when it formally files the notice.

After filing, FDA would generally have 180 days to evaluate the notice, although the proposal would allow FDA to extend that period by 90 days as many as two times.

Mandatory Notification Is Not Premarket Approval

This is perhaps the most important feature of the proposal.

FDA expressly states that the proposed mandatory GRAS notification system would not establish a premarket review program.

A company that has reached a GRAS conclusion could continue to introduce the substance into interstate commerce before submitting its GRAS notice. Likewise, a company could continue marketing while FDA determines whether to file the notice and while the agency evaluates the underlying GRAS conclusion.

In other words, FDA would gain substantially more information about what is entering the food supply, but companies would not necessarily have to wait for an FDA “no questions” letter before commercialization.

The regulatory risk would instead shift toward the strength of the underlying GRAS determination. FDA says failure to satisfy the notification requirement would be a factor in prioritizing substances for post-market review. And once FDA has the notice, the agency will have the information necessary to evaluate whether the substance is actually GRAS or instead constitutes an unapproved food additive.

For companies accustomed to independent GRAS determinations, the practical change is significant. A GRAS analysis may still support immediate market entry, but it can no longer be treated primarily as an internal exercise.

FDA Creates a Transition Path for Existing Self-GRAS Substances

The treatment of substances already on the market is another major component of the proposal.

FDA recognizes that requiring full GRAS notices immediately for every substance previously introduced based on an independent GRAS determination could overwhelm both industry and the agency. It therefore proposes a temporary, streamlined pathway for qualifying existing uses.

For substances introduced into interstate commerce before the effective date of a final rule, companies could submit more limited information instead of a complete GRAS notice. The submission would generally identify:

The submitter;
The substance;
Its intended conditions of use, including relevant foods, use levels, and purpose;
Evidence that the substance was already in interstate commerce before the final rule became effective; and
Certain information about previous GRAS notices, where applicable.

Significantly, the streamlined submission would not require submission of the underlying safety data supporting the GRAS conclusion.

FDA would place qualifying submissions on a public list. Placement on that list would not constitute FDA agreement that the use is GRAS. FDA could subsequently require a full GRAS notice or determine that the intended use requires a food additive petition.

The streamlined pathway also would not be available where FDA previously issued an insufficient-basis letter covering the intended use or determined that the substance was not GRAS.

Companies would have only one year after the final rule’s effective date to use this pathway. That makes identifying existing independent GRAS positions one of the most important preparatory steps companies can take now.

Some Existing FDA Reviews Would Satisfy the New Framework

FDA is also proposing several exceptions intended to avoid duplicative review.

For example, a new GRAS notice generally would not be required where an existing FDA “no questions” letter covers the substance under the same conditions of intended use. Other exceptions would cover certain substances already listed or affirmed as GRAS in FDA regulations, uses addressed through specified FDA review processes, qualifying threshold-of-regulation exemptions, certain food-contact notifications, and substances included through the temporary legacy pathway.

However, companies should be careful before assuming that an existing “no questions” letter resolves the issue. FDA specifically notes that a prior GRAS conclusion may no longer cover a substance if there have been significant changes to its identity, manufacturing process, specifications, food categories, use levels, technical effect, or other conditions of use.

That makes the exact scope of historical GRAS notices increasingly important. Companies relying on older notices should compare the conditions FDA previously evaluated against the substance and use actually being marketed today.

The Proposal Also Raises Confidentiality Questions

Greater FDA visibility also means greater public visibility.

The proposal would require companies submitting GRAS notices to identify information they consider exempt from disclosure under the Freedom of Information Act at the time of submission. If they do not, FDA proposes to treat the information as non-exempt or consider the confidentiality claim waived.

The rule also highlights a more fundamental issue inherent in GRAS determinations. Where a company relies on non-public safety information, it would have to explain how there can be “general recognition” of safety among qualified experts when those experts do not have access to the information.

Companies preparing GRAS notices will therefore need to consider their disclosure and confidentiality strategy alongside the scientific merits of the submission.

The Burden Could Be Significant

FDA itself acknowledges that the proposal would impose meaningful costs, particularly on smaller businesses. The agency concludes that the proposed rule would have a significant economic impact on a substantial number of small entities.

The operational burden may extend beyond the preparation of new GRAS notices. Ingredient manufacturers and food companies will need to identify historical GRAS determinations, determine which existing FDA reviews remain applicable, collect evidence supporting legacy use, evaluate supplier documentation, and establish procedures for future notification.

The proposal also arrives amid broader scrutiny of the food industry. As we recently discussed in connection with San Francisco’s lawsuit targeting ultra-processed foods, ingredient choices, formulation decisions, safety substantiation, and marketing practices are increasingly being examined through regulatory, legislative, and litigation frameworks that extend beyond traditional FDA compliance.

What Food Companies Should Be Doing Now

The rule is still proposed, but companies that rely on GRAS determinations should not wait for a final rule to understand their exposure.

Food and ingredient companies should consider:

Inventorying existing GRAS positions. Identify substances and intended uses supported by independent GRAS conclusions and determine which have previously been submitted to FDA.
Comparing current uses with prior FDA reviews. Confirm that existing “no questions” letters or other FDA actions actually cover current manufacturing processes, specifications, use levels, and intended uses.
Identifying legacy substances. Determine which independently concluded GRAS uses could qualify for the proposed streamlined pathway and begin assembling evidence of existing interstate commerce.
Reviewing underlying safety files. FDA could ultimately require a full GRAS notice even for a substance initially placed on the streamlined public list. Older scientific analyses should be reviewed for continued adequacy.
Evaluating confidentiality. Determine what information may require protection and whether existing GRAS files rely on non-public safety information.
Considering comments on the proposal. FDA is specifically requesting input on alternatives that could reduce regulatory burdens while maintaining greater transparency and safety oversight.

If the proposed rule is finalized substantially as written, the era of undisclosed independent GRAS determinations will largely come to an end. What will remain is an important distinction: GRAS would continue to provide a pathway to market without affirmative FDA preapproval, but companies relying on that pathway would generally have to tell FDA what they are doing and be prepared to defend the scientific basis for it.

The proposed rule was published in the Federal Register on August 11, 2026. The 120-day comment period thus closes on December 9, 2026.

How Gardner Law Can Help

Gardner Law advises food and ingredient companies on GRAS determinations, food additive requirements, ingredient safety, FDA submissions, and related compliance matters.

Companies relying on independent GRAS conclusions should begin evaluating how the proposed framework would affect existing products, future ingredient introductions, supplier relationships, supporting safety documentation, and potential public disclosures. Gardner Law can help companies assess existing GRAS positions, determine whether proposed exceptions or the streamlined legacy pathway may apply, evaluate the adequacy of supporting documentation, and prepare comments addressing provisions of the proposed rule that may materially affect their operations.