US Food and Drug Administration Publishes Proposed Rule on Substances Generally Recognized as Safe

The US Food and Drug Administration's (FDA, the Agency) highly-anticipated Proposed Rule on Generally Recognized as Safe (GRAS) substances used in human food and animal food is now published in the Federal Register.¹ The Rule, if finalized in its current form, will require the mandatory submission to FDA of GRAS Notifications for substances added to food, substances added to animal food, and food-contact substances that otherwise would meet the definition of a "food additive," as that term is defined under the Federal Food, Drug, and Cosmetic Act (the Act) that rely on a self-determination of general recognition of safety. In addition to proposing amendments to the existing, voluntary GRAS Notification procedures under 21 C.F.R. Part 170, Subpart E (for human food) and 570, Subpart E (for animal feed), FDA proposes to amend and expand its Threshold of Regulation (TOR) procedures at 21 C.F.R. § 170.39 – historically used to exempt the need for premarket authorization for food contact substances on the basis of low dietary exposure – to also include substances added directly to food. Comments on the Proposed Rule must be submitted to FDA by December 9, 2026.

The Proposed Rule purports to deliver on US Department of Health & Human Services Secretary Robert F. Kennedy Jr.'s pledge to refine the Agency's approach to GRAS substances, which are statutorily exempted from the "food additive" definition under the Act. FDA's regulation describing the eligibility for GRAS substances is found at 21 C.F.R. § 170.30 (Eligibility for classification as Generally Recognized as Safe). Under this regulation, general recognition of safety requires that there be "common knowledge" throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food that there is a reasonable certainty that a substance is not harmful under the conditions of its intended use. More specifically, Section 201(s) of the Act defines a GRAS substance as one that is "generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use."

Importantly, for substances not widely used in food prior to 1958, general recognition based on "scientific procedures" already requires the same quantity and quality of scientific evidence as is required to obtain a food additive regulation for the substance. The Proposed Rule, as currently drafted, does not seek to modify this long-established standard.

The Core Requirement: Mandatory Notification, Not Mandatory Approval

The centerpiece of the Proposed Rule is the significant proposed revision to 21 C.F.R. § 170.205(a), which would require any person introducing a substance into interstate commerce based on a self-determination of GRAS status to notify FDA of the basis underlying such determination. FDA explains in the Proposed Rule that the updated procedure is intended not as a premarket approval requirement, but instead, as a premarket notification requirement. As such, a company may continue to market a use of a substance as GRAS both before and after a mandatory submission is made to the Agency, including while FDA's review of such notification is ongoing. Thus, the Proposed Rule is positioned by the Agency as a disclosure obligation to inform FDA as to GRAS uses of a substance on—or soon-to-be-placed on—the market, as opposed to an imposition of a new premarket authorization requirement. Importantly, however, the Proposed Rule also states that FDA may treat a company's failure to comply with the GRAS Notification requirement as a factor that could increase the likelihood of prioritization of the substance for post-market assessment. Such assessment could ultimately lead to a determination by FDA that the notified use is not, in the Agency's view, GRAS (see US Food and Drug Administration, Substances Generally Recognized as Safe (proposed Aug. 11, 2026) (to be codified at 21 C.F.R. § 170.38).

Notably, FDA makes a further distinction between merely submitting a GRAS notification and satisfying the notification requirement by submitting a sufficient amount of information by which the Agency can potentially make an independent safety determination. The Agency specifies that the notification obligation is met when FDA accepts the submission for filing.  While FDA states that it intends to make a filing decision within 45 days of receipt and will notify the submitter of its decision to file within two business days of making that determination, in recent years it has been common for companies to wait five to six months before receiving a letter on the filing decision. 

Food-Contact Substances Within Scope of the Mandatory Notification Requirement – But Alternative Approaches Continue to Apply

The definition of "food additive" under the Act may–in certain instances–include food-contact substances (FCS):

Any substance the intended use of which results or may reasonably be expected to result—directly or indirectly—in its becoming a component [of] or otherwise affecting the characteristics of any food.

The definition further provides that food additives may include substances intended for "producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food." An FDA "clearance" for the intended use of an FCS can be achieved in one of three ways, by virtue of: (1) an applicable Food Additive Regulation in 21 C.F.R. Parts 170-186; (2) an effective Food Contact Notification (FCN); or (3) an applicable TOR exemption listing.²  Substances that are GRAS under their intended conditions of use are expressly exempted from the food additive definition under the Act. While the Proposed Rule does not modify the ability to make a self-determination of GRAS status for an FCS, it does impose the same mandatory reporting requirement as would be the case for "direct" food additives, unless the FCS is the subject of an FCN or a TOR exemption.

One-Year Abbreviated Notification Process for GRAS Substances Already on the Market

The mandatory reporting requirement for GRAS substances, as it appears in the Proposed Rule, would be both retroactive and prospective. Recognizing that companies have historically relied on the GRAS exemption process for many years, however, and to minimize potential disruption to the marketplace, FDA includes in the Proposed Rule a transitional period of one year (following the effective date of the Final Rule) within which companies already relying on a GRAS self-determination for the use of a food ingredient or FCS may submit an abbreviated filing to FDA in lieu of a full GRAS Notification. The abbreviated filing would require the submitting entity to identify the substance, its intended uses and use levels, and evidence that the substance was placed into interstate commerce prior to the effective date of the Final Rule.  Notification for these grandfathered substances would not need to include the underlying safety basis or information supporting the self-determined GRAS determination but would still provide FDA with the opportunity to be made aware of existing uses of GRAS substances in interstate commerce.

Although the abbreviated submission requirements for existing GRAS uses of substances would be less onerous than a full GRAS Notification for prospective GRAS uses of substances, FDA would still maintain a public listing of the aforementioned information and reserve the right to later require a full GRAS Notification, food additive petition, or other applicable process if the Agency identifies potential safety concerns.

Additional Administrative Requirements and Provisions

In addition to the mandatory notification requirements described above, the Proposed Rule includes the following additional noteworthy provisions:

• GRAS Notifications would need to be submitted electronically through the Agency's Centralized Online Submission Module (COSM) system. Paper submissions would require an advance waiver of this requirement by FDA.³
• FDA proposes to preserve its existing 180-day review period for GRAS Notifications following filing but would allow up to two 90-day extensions – the current regulations for (voluntary) GRAS Notifications permit up to one 90-day extension.
• The Proposed Rule, if finalized, would take effect 60 days following publication, with an expected 18-month compliance timeframe for the Mandatory GRAS Notification provision.
• The Proposed Rule envisions that the Agency would receive GRAS Notices for flavors that already have been determined to be GRAS by the Flavor Extract Manufacturers Association (FEMA).
• The proposed amendments to the animal food GRAS Notification regulations would align with the proposed amendments to GRAS Notifications for human foods. 
• The Proposed Rule is effectively silent with regard to potential interaction between the recommendations contained therein and existing or proposed state initiatives regarding GRAS substances in food (other than a statement that the Proposed Rule "does not contain policies that have federalism implications.").

Concluding Thoughts

The Proposed Rule arrives against a backdrop of heightened public interest in and attention to ingredient safety and transparency. The Proposed Rule, while suggesting the imposition of additional procedural requirements related to uses of GRAS substances, neither eliminates the statutorily defined GRAS exemption pathway, nor alters the longstanding requirement that a self-determination of GRAS status be based on the same quantity and quality of scientific evidence that would otherwise be required to obtain a food additive regulation.

Stakeholders should consider both the potential impacts of the new requirements under the Proposed Rule (including a detailed review of those substances for which they are currently relying on a self-determination of general recognition of safety), and the available alternative regulatory pathways for establishing a suitable FDA status for the intended use of a substance without the need to submit a GRAS Notification. In the case of food-contact substances in particular, FDA highlights the existing and highly successful FCN Program as a suggested alternative even where a self-determination of GRAS status (and potential mandatory reporting requirements) may otherwise soon apply.

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We are available to assist companies in evaluating existing GRAS determinations, assessing eligibility for the streamlined transition pathway, and preparing and submitting comments on the Proposed Rule. Additional resources are available on our website at: www.steptoe.com and, for food-contact substances, in our StepLadder Series of publications, available at: www.steptoe.com/stepladder.

¹ See 91 Fed. Reg. 51834 (Aug. 11, 2026). 

² See 21 C.F.R. § 170.39 ("Threshold of regulation for substances used in food-contact articles"). This rule, first promulgated in 1995, permits the Agency to exempt substances from the need for a specific regulatory clearance on a case-by-case basis if certain criteria are met. 

³ Steptoe has successfully filed a number of Food Contact Notifications (FCNs) for clients via the COSM online submission system.