That distinction follows the statute’s structure. Congress defined GRAS by reference to safety and general recognition, not by reference to filing a notice. FDA may have omitted the proposed presumption because it recognized that making notification a substantive condition of GRAS status would be harder to justify without legislation.
The proposed framework can therefore be summarized in the following manner: notification would be mandatory; FDA approval before marketing would not be; and failure to notify would increase scrutiny but would not automatically determine GRAS status. Those distinctions are likely deliberate. Whether a court agrees that FDA has remained within its authority is another question.
Not Premarket Approval but Perhaps a Commercial Equivalent
The legal distinction between mandatory notification and premarket approval is real. The commercial distinction may be much smaller.
Consider a supplier that completes an independent GRAS conclusion, files the notice, and begins marketing while FDA review is pending. Months later, FDA issues an insufficient-basis letter. That letter does not necessarily mean FDA has determined the substance is unsafe. It means the notice, based on the information submitted and otherwise available, did not provide an adequate basis for the claimed GRAS conclusion.
Customers and retailers may not wait for that nuance to be resolved. They may suspend purchases, delay product launches, request additional data, demand contractual protection, or reformulate. The supplier may need to supplement the scientific record, narrow the conditions of use, submit a new notice, or consider another regulatory pathway. FDA’s own economic analysis reportedly recognizes that insufficient-basis determinations may shift market share and revenue among manufacturers.
Companies that commercialize during review should therefore treat the issue as more than an FDA filing decision. It is also a supply chain and contract decision. Regulatory representations, warranties, indemnification, termination rights, inventory allocation, and responsibility for reformulation or withdrawal should be addressed before launch, not after an unfavorable letter arrives.
There is also litigation risk outside FDA. If notification becomes mandatory, plaintiffs’ lawyers will likely cite a failure to notify in consumer-protection and false-advertising cases. Whether those claims ultimately succeed will depend on the theory and facts, but noncompliance would supply another allegation that companies will have to defend.
The Streamlined Pathway Solves One Problem and Creates Another
FDA is not proposing that every existing self-GRAS use immediately undergo a full GRAS-notice review. Instead, substances already introduced into interstate commerce before the final rule’s effective date could qualify for a 1-time streamlined pathway. During the proposed 1-year window, the submitter would provide basic information, including the identity of the substance, conditions of use, food categories, use levels, technical purpose, and evidence of prior interstate commerce. The complete GRAS dossier would not initially be required.
The approach is understandable. Requiring thousands of full notices at once could overwhelm both FDA and industry. The agency reportedly anticipates approximately 6,000 streamlined submissions, and someone will still have to review those submissions, decide which warrant follow-up, and request additional information where appropriate.
But the pathway appears to require proof of commerce without clearly requiring proof that an independent GRAS conclusion existed. That creates a basic fairness and integrity problem.
Supplier A may have spent substantial resources developing a dossier, convening experts, and reaching an independent GRAS conclusion before marketing. Supplier B may have sold a competing ingredient for years without ever completing that work. Both may be able to produce invoices showing interstate commerce. As drafted, it is not clear how the streamlined submission distinguishes between them.
FDA should consider requiring the submitter to certify that, before the effective date, the substance was marketed under the identified conditions of use based on a completed independent GRAS conclusion and that supporting documentation existed. The submission could also identify the date of that conclusion. This would preserve the streamlined nature of the pathway without allowing proof of sales to substitute for proof of GRAS status.
In my opinion, industry should also consider whether 1 year is enough. Companies will need to inventory substances, locate historical files, reconcile current uses, collect commerce records, and coordinate with suppliers and customers. FDA’s own economic analysis reportedly discusses a longer period. Comments should address the time actually required with concrete operational evidence.
Reliance on Another Company’s Submission Will Be Harder Than It Sounds
The proposal recognizes that GRAS status is not proprietary. A company may not need to submit a new notice if an existing no questions letter covers the same substance under the same conditions of use. Once a streamlined submission appears on FDA’s public list, another company may also be able to rely on that listing for the same substance and conditions of use.
The principle makes sense. The implementation is difficult. Company B must determine whether Company A’s submission really covers Company B’s ingredient. A shared common name is not enough.
What Company B Should Evaluate
Whether the substances are chemically and compositionally equivalent.
Starting materials, process steps, processing aids, and safety-relevant differences.
Purity, contaminants, microbiological limits, and impurity profile.
Food categories, use levels, target populations, and cumulative exposure.
Whether the intended function falls within the existing submission.
Whether the cited studies and exposure assumptions apply to Company B’s substance.
The problem is that Company B may not have access to the information necessary to perform that comparison. Company A may properly treat details of its process, composition, or impurity profile as confidential. Branded ingredient suppliers that invested in a GRAS notice may also resist competitors using the resulting letter as a shortcut.
FDA should specify the minimum information a relying company must compare, the information that must be publicly available, how companies should proceed when relevant information is confidential, and the records they should maintain to document the conclusion that a new notice was unnecessary. These questions exist today, but mandatory notification would make them much more consequential.
What Companies Should Do Now
The proposal may change, and its legal authority may be challenged. Neither possibility is a reason to wait. The most useful preparation work will remain valuable under almost any final rule. Companies should organize that work in 3 phases.
Phase One: Map the Portfolio
Build a GRAS inventory. List every substance for which the company relies on GRAS status and identify the precise basis: an independent conclusion, an FDA no questions letter, a GRAS regulation, a food-contact notification, or another exclusion or exception. Finished-product companies should identify where the answer depends on a supplier.
Locate the supporting record. Find the dossier, expert panel report, exposure assessment, safety studies, specifications, manufacturing information, and FDA correspondence. A conclusion without a retrievable file will be difficult to defend or submit.
Identify FDA history. Pull any cease-to-evaluate or insufficient-basis letters. They may affect eligibility for the streamlined pathway and will influence FDA’s interest in the substance.
Phase Two: Test Whether the Record Still Fits the Business
Compare the conclusion with current uses. Confirm that today’s food categories, use levels, technical effects, specifications, manufacturing process, and target population remain within the original conclusion. Commercial expansion can outgrow the regulatory file without anyone recognizing it.
Stress test older conclusions. Determine whether exposure has increased, new safety information has emerged, specifications have changed, or the original analysis contains material data gaps. Update the assessment or generate additional data where needed.
Evaluate third-party reliance. If the company relies on another notifier’s letter or listing, document why the substance and conditions of use are adequately equivalent. Do not rely solely on the ingredient name.
Review projects in development. For current self-GRAS projects, evaluate the entire commercialization timeline, including completion of the conclusion, launch, evidence of interstate commerce, notification, FDA review, and customer acceptance. The date the report is signed is only one part of the analysis.
Phase Three: Prepare for the Transition and Shape the Rule
Preserve proof of interstate commerce. Retain invoices, purchase orders, shipping records, and customer records for substances that may qualify for the streamlined pathway. Connect those records to the specific substance and conditions of use.
Review contracts and launch policies. Decide whether the company will commercialize during FDA review and allocate the consequences of delay, an information request, or an insufficient-basis letter. Suppliers and customers should not wait for a dispute to decide who bears the risk.
Develop comments from operational facts. Talk with regulatory, R&D, procurement, sales, and commercial teams. Quantify the time needed to inventory files, the cost of updating dossiers, confidentiality barriers, likely launch delays, and supply-chain effects. Work through trade associations on common issues, but consider separate comments where the company has unique facts or proposed solutions.
The Bottom Line
FDA’s proposal does not abolish self-GRAS. It changes the consequences of keeping an independent GRAS conclusion private. If finalized substantially as proposed, its largest effects may come from increased FDA visibility, greater customer diligence, reliance on other companies’ submissions, and the commercial consequences of FDA review. Companies could still market without waiting for FDA’s response, but customers and retailers may be reluctant to proceed while that review is pending.
The legal challenge will be whether Congress authorized FDA to impose the notification obligation. The business challenge is more immediate: companies must know what is in their portfolios, why each use is lawful, whether the supporting record still matches the product, and what will happen if FDA questions it.
The companies that start that work now will be better positioned to use any transition pathway, respond to customers, submit meaningful comments, and make informed launch decisions while the final framework takes shape.