Need to Know

• FDA’s newly proposed rule would replace voluntary GRAS notifications with mandatory filings for substances introduced into the U.S. food supply under the GRAS provision
• The proposal raises unresolved legal questions about FDA’s statutory authority to mandate GRAS notifications
• Mandatory notification would provide FDA greater marketplace visibility, but filing would not constitute premarket approval, confer GRAS status, or provide companies with regulatory certainty
• Ambiguities about who must file, whether notices cover downstream users, and what constitutes a “significantly different” substance could create compliance challenges and duplicative filings across supply chains
• Companies should use the comment period, which closes December 9, to document compliance costs and reliance interests, address operational concerns, and preserve evidence needed for the proposed streamlined pathway.

What the Rule Would Require

Any person introducing a substance into interstate commerce under the GRAS provision would be required to notify FDA. This is not premarket approval; companies could market before and during review. Filing—not FDA agreement—satisfies the obligation. Non-notification would not automatically make a substance non-GRAS or a food adulterant; FDA characterizes noncompliance as merely "a factor in FDA's prioritization of food substances for post-market review." FDA estimates each full notice at 180 hours of preparation, with filing and review extending up to 405 days. Limited exceptions cover existing no-questions letters, GRAS-listed or -affirmed substances, historical-use provisions, plant biotech or animal-cell-culture consultations, Threshold of Regulation (TOR) exemptions, and food-contact notifications.

The Legal-Authority Question

In the 2016 Final Rule on Food Ingredients that May Be "Generally Recognized as Safe" (GRAS final rule), FDA stated: "We agree that we lack express statutory authority to require companies to submit GRAS notices" (81 Fed. Reg. 54,960, 54,982). Simultaneously, FDA reserved the position that "such a requirement might be within our legal authority, even if not expressly required by the FD&C Act." That reservation is the foundation of FDA's current theory.

The real battleground is section 701(a)—authority to issue regulations for "efficient enforcement" of the statute. Second Circuit precedent (National Ass'n of Pharmaceutical Manufacturers v. FDA, 2d Cir. 1981; United States v. Nova Scotia Food Products, 2d Cir. 1977) supports binding rules under that provision. But those cases involved express statutory standards—Current Good Manufacturing Practice (cGMP) and insanitary conditions. GRAS is structurally different: a self-executing statutory exclusion defined by scientific status, not a standard Congress directed FDA to implement.

Congress created mandatory notice requirements elsewhere—food-contact notifications under § 409(h), New Dietary Ingredient (NDI) notifications under § 413, facility registration under § 415—but never for GRAS. After Loper Bright (2024), courts exercise independent judgment on statutory authority. FDA must also explain its reversal from the voluntary policy it defended in Center for Food Safety v. Becerra (2021)—under FCC v. Fox (2009), an agency changing policy must give good reasons, particularly where the prior policy generated serious reliance interests.

The Enforcement Gap

FDA's preamble examples undercut its information-deficit rationale. The agency identified delta-8 tetrahydrocannabinol (THC) as an unsafe food additive, and issued only warning letters. FDA placed ashwagandha on an import alert but pursued no domestic enforcement. Tara flour was associated with approximately 400 adverse events; the manufacturer voluntarily recalled the product. For delta-8 THC and ashwagandha, FDA already had sufficient information to identify the substance and reach a conclusion without mandatory notification. In the tara flour case, FDA says it found no indication that the firm had reached a GRAS conclusion. Mandatory notification would have provided earlier visibility only if a responsible actor relied on GRAS and complied. The FD&C Act provides injunction, seizure, and criminal authorities. Mandatory notification does not cure an enforcement deficit after FDA completes the analysis that a notification is supposed to facilitate.

Adverse Selection and No Affirmative Value

The proposal presents an adverse-selection problem. Companies with strong safety records and reputational exposure will comply. Those with the weakest safety evidence have every incentive to remain silent, particularly when the consequence is only increased priority for post-market review. FDA cannot apply that factor until it discovers the company, substance, and absence of a notice. By then, existing surveillance has already overcome the information gap.

Filing produces no affirmative value. A no-questions letter is not an affirmation of GRAS status and can be rescinded. Companies incur 180 hours and public disclosure without receiving regulatory certainty. Worse, FDA can issue an "insufficient basis" letter after 405 days of review. Commercial consequences are immediate—customers, retailers, and plaintiffs react—but FDA could argue that a letter is not final agency action, meaning it may not be challengeable in court. Congress made NDI petition decisions and food-contact notification objections expressly reviewable. GRAS has no comparable protection.

Capacity Constraints and the Structure/Function Precedent

FDA has experienced significant reductions in force. The agency itself proposes extending the maximum review from 270 to 360 days because of anticipated volume. It estimates 2,418 streamlined human-food submissions, 155 streamlined animal-food submissions, and 98 additional firms submitting notices annually.

There is instructive precedent. After FDA required structure/function claim notifications, the agency became overwhelmed and switched to a "maintain on file" standard—the notifications sit in a database, rarely reviewed. The same dynamic—a mandatory full-dossier submission FDA lacks staff to meaningfully process—is foreseeable here.

Supply Chain Confusion

Proposed section 170.205(a) applies to "any person" introducing a substance into interstate commerce under the GRAS provision, but does not identify whether the ingredient manufacturer, importer, distributor, or finished-food company is the notifier. It does not state whether one notice covers downstream users or define "significantly different" for determining whether one manufacturer's material falls within another's notice. That ambiguity could generate duplicative filings throughout supply chains or leave downstream companies unable to determine whether a supplier's filing protects them.

The Streamlined-Pathway Trap

The proposal offers a lower-burden streamlined pathway for substances already in commerce before the effective date. The window opens on the effective date and closes one year later; the full compliance deadline arrives six months later. A company that waits until the compliance deadline loses access to the streamlined pathway and faces the full submission burden for substances marketed safely for years.

What Companies Should Do Now

• File company-specific comments—not just trade-association submissions. Company-specific cost data, reliance evidence, and supply-chain complexity are what build an administrative record.
• Quantify actual costs and reliance. FDA estimates annualized costs of $10.5–$11.7 million. Actual expert, translation, and confidentiality costs may be materially higher.
• Propose alternatives. A basic registry separating marketplace visibility from full scientific review, with voluntary full notices earning a meaningful safe harbor, would achieve high compliance at lower cost.
• Force FDA to answer: Who is the responsible notifier? Can one notice cover downstream users? What defines "significantly different"? What prohibited act does bare non-notification constitute?
• Preserve evidence of pre-rule commerce and prepare for the streamlined window immediately.
• File in both channels. File a merits comment in both the FDA docket and a separate Paperwork Reduction Act (PRA) submission to the Office of Information and Regulatory Affairs (OIRA) challenging burden estimates.

The Window Is Open

The proposal creates no current duty to file. The opportunity to shape the final rule is time-limited. The legal-authority question is genuinely open; FDA advances a substantial section 701(a) argument, but remains contestable under the statutory text, structure, and the agency's 2016 acknowledgment. Operational questions—such as who files, what constitutes equivalence, what happens after an adverse letter—will determine whether this produces a workable registry or an expensive exercise that rewards inaction.

Comments close December 9, 2026. That is the lowest-cost opportunity to put your company's facts into the record.