On August 11, 2026, the Food and Drug Administration (FDA) published a proposed rule that would amend 21 C.F.R. Parts 170 and 570 to require submission of Generally Recognized as Safe (GRAS) notices for the use of food substances purported to be GRAS under the Federal Food, Drug, and Cosmetic Act (FDCA).Substances Generally Recognized as Safe, 91 Fed. Reg. 51834 (Aug. 11, 2026) (to be codified at 21 C.F.R. pts. 170, 570). Comments are due by December 9, 2026.
As discussed in this Client Alert, the GRAS pathway has historically allowed manufacturers to introduce a substance into the food supply without notifying FDA if those manufacturers independently concluded that the substance was GRAS for its intended use. Under 21 C.F.R. § 170.205, which remains in effect, submission of a GRAS notice is voluntary — manufacturers may but are not required to notify FDA of a conclusion that a substance is GRAS under the conditions of its intended use.21 C.F.R. § 170.205 (providing that a person “may” notify FDA of a GRAS conclusion).
For substances already in interstate commerce under the GRAS provision, FDA proposes a time-limited option for a streamlined submission, which would require much less information than a standard GRAS notice. Streamlined submissions under this pathway would have to include: (1) the name and address of the submitter; (2) the name of the substance; (3) the intended conditions of use (including the foods in which the substance is used, levels of use, and purposes for use); (4) evidence of presence in interstate commerce before the effective date of any final rule; and (5) if applicable, the GRN number from any prior Cease-to-evaluate letter.Proposed § 170.305(c)(1)–(2). Unlike a standard GRAS notice, the streamlined submission would not require underlying safety data or a full GRAS narrative.91 Fed. Reg. at 51857.
FDA does not say that it will provide manufacturers with an evaluative response letter to streamlined submissions. Instead, FDA says that it may ask the submitter questions or issue a determination that a full GRAS notice or food additive petition must be submitted. FDA intends to post the information in a streamlined submission on a publicly available list, which would clarify that “[t]he posting of this information does not mean that FDA has reviewed the GRAS status of the substance’s conditions of intended use.”Proposed § 170.305(d).
Submitters of full GRAS notices may still receive a “No questions letter,” “Insufficient basis letter,” or “Cease to evaluate letter,” each of which FDA has now formally defined in proposed § 170.203 and 170.303, respectively. However, FDA says that these are not the only categories of response letters that it might send in response to GRAS notices — leaving open the possibility that FDA could develop additional response categories in the future.
Importantly, although the streamlined pathway would be optional, forgoing it is not without consequence. If a manufacturer does not submit the streamlined information within the one-year window, the substance will not qualify for the exception under proposed § 170.205(b)(7), and the manufacturer will be required to submit a full GRAS notice as if it were introducing a new substance into commerce.
Proposed § 170.205(a) would mandate GRAS notices for new food substances and new intended uses of GRAS substances. Any person introducing a substance into interstate commerce under the GRAS provision would thus be required to notify FDA of their conclusion that the substance is GRAS under the conditions of its intended use, as detailed in the GRAS notice. Compliance with this proposed provision would be required 18 months after the effective date of any final rule.
There are several enumerated exceptions from the mandatory notice requirement under proposed § 170.205(a), including: (1) substances already covered by a “No questions letter”; (2) substances listed or affirmed as GRAS in parts 182, 184, or 186; (3) substances regarded as GRAS under § 170.30(d) or (i)(1); (4) substances evaluated through an established FDA process; (5) Threshold of Regulation exemptions; (6) effective Food Contact Notifications; and (7) substances for which a streamlined submission has been posted on the public list.Proposed § 170.205(b)(1)–(7).
Critically, the proposed rule states that it “does not establish a premarket review program for purportedly GRAS substances.” FDA explains that “a company may continue marketing a purported GRAS substance before submitting a GRAS notice or after submitting a GRAS notice before it is filed by FDA.” Similarly, “a company may reach a GRAS conclusion about a new use of a substance and introduce the substance into interstate commerce before submitting a GRAS notice.”91 Fed Reg. at 51851.
FDA says that the purpose of the proposed GRAS notification program is to inform its post-market review of food substances, enabling the agency to determine whether substances are not GRAS and therefore require premarket approval as food additives.
Notably, the proposed rule does not specify a timeframe within which a manufacturer must submit a GRAS notice after beginning to market a substance. The mandatory notice requirement under proposed § 170.205(a) would take effect 18 months after the effective date of any final rule. After that compliance date, any person introducing a substance into interstate commerce under the GRAS provision “must” notify FDA — but the proposed rule does not specify how soon after commencing marketing that notice must be filed. FDA notes that for “uses of substances that are required to be the subject of a GRAS notice,” noncompliance with the notification requirement would be “a factor in its prioritization of food substances for post-market review.”Id.
When FDA finalized its voluntary GRAS notification regulations in 2016, it declined to require manufacturers to provide even basic information about their GRAS determinations, stating that it “lack[ed] express statutory authority” to do so.81 Fed. Reg. at 54981–82. A federal court subsequently rejected a challenge to FDA’s decision not to mandate notices, agreeing that the FDCA is “silent on whether GRAS notices must be mandatory” and “specifically exempts GRAS ingredients from the premarket review regime for food additives.”See Ctr. for Food Safety v. Becerra, 565 F. Supp. 3d 519, 536–38 (S.D.N.Y. 2021); 91 Fed Reg at 51835, 51845-46 (citing 21 U.S.C. §§ 321, 342, 348, and 371).
FDA now invokes its authority under various sections of the FDCA to justify requiring notification, framing it as a tool to help the agency efficiently carry out its responsibilities under § 409(a) and (d) to identify food additives that require approval. FDA relies in part on § 701(a) of the FDCA (21 U.S.C. § 371(a)) to require GRAS notices. This provision authorizes FDA to “promulgate regulations for the efficient enforcement” of the FDCA. The court in Ctr. for Food Safety v. Becerra identified this provision as a potential source of authority to require GRAS notices, even as it upheld FDA’s prior decision not to exercise it for this purpose. But because FDA took the position then that it “lack[s] express statutory authority to require companies to submit GRAS notices,” its reversal may be scrutinized under the “change-in-position” doctrine in administrative law. That doctrine requires federal agencies to provide a “reasoned explanation for [a] change,” display awareness that [they are] changing position,” and consider “serious reliance interests.”See Food and Drug Admin. v. Wages & White Lion Investments, 604 U.S. 542, 566 (2025).
FDA acknowledges the limits of its statutory authority to eliminate the GRAS pathway altogether via rulemaking. The Department of Health and Human Services (HHS) states that it is “committed to working with Congress to explore ways legislation can completely close the GRAS loophole.”HHS Press Release, “HHS Secretary Kennedy Announces Plan to Increase Oversight of Food Ingredients” (Mar. 10, 2025). Removing the GRAS pathway altogether — effectively requiring premarket review of all food substances — would likely require legislation. Although FDA has said that this proposed rule does not create such a regime, FDA may nevertheless be challenged for establishing a de facto premarket review requirement without statutory authorization, despite its efforts to characterize mandatory GRAS notices simply as a tool to facilitate its post-market review of the food supply.
FDA proposes to maintain a publicly available inventory, or online repository, where it will make public certain information related to GRAS notices. FDA notes that the name and location of the inventory could “evolve over time.”
FDA recognizes that requiring full GRAS notices for all existing uses would “likely overburden the administrative resources” it has to evaluate and respond to notices, which is a reason for the streamlined submission for substances marketed before the effective date.91 Fed. Reg. at 51855. The proposed rule estimates annualized costs to industry of $10.5 million (at 3%) and includes an additional 90-day extension (up to two times) of the 180-day evaluation period for notices — signaling anticipated strain on agency resources. FDA currently has over 1,200 filed GRAS notices and estimates it would receive 210 annual submissions (194 human food and 16 animal food) under the mandatory program.See 91 Fed. Reg. at 51843, 51868, 51870, and 51877 (Regulatory Impact Analysis estimating annualized costs of $10.5 million at 3% discount rate over 10 years; estimating 210 annual submissions).
FDA’s proposed rule represents a significant shift in the regulatory framework governing GRAS substances. By converting the voluntary GRAS notification program to a mandatory one, FDA is seeking to gain greater visibility into the substances being introduced into the food supply. At the same time, FDA acknowledges the limits of its statutory authority and the resource constraints it faces in evaluating GRAS notices. Manufacturers should carefully assess the proposed rule’s implications for their product portfolios and consider submitting comments during the 120-day comment period. Latham & Watkins will continue to monitor developments in this area.