On August 11, 2026, the U.S. Food and Drug Administration (FDA) will publish in the Federal Register a proposed rule, “Substances Generally Recognized as Safe” (Docket No. FDA-2025-N-3262), that would fundamentally restructure how food ingredients reach the U.S. market. The proposal would convert FDA’s longstanding voluntary GRAS notification program into a mandatory process: any person introducing a human or animal food substance into interstate commerce on the basis of a “generally recognized as safe” (GRAS) conclusion would be required to notify FDA of the basis for that conclusion, with limited exceptions. The rule would amend 21 CFR parts 170 (human food) and 570 (animal food) and would effectively end the practice commonly known as “self-affirmed GRAS” – marketing an ingredient based on an independent GRAS conclusion without informing FDA.

Comments are due 120 days after publication – December 9, 2026 – via regulations.gov under Docket No. FDA-2025-N-3262.

You can read the proposed rule here.

Background

Under the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic (FD&C) Act, a substance added to food is a “food additive” requiring FDA premarket approval unless, among other exceptions, it is generally recognized as safe among qualified experts under the conditions of its intended use. Since FDA finalized its GRAS notification regulation in 2016, companies have been able – but never required – to submit GRAS notices to FDA. FDA has filed more than 1,200 GRAS notices since 1998, but the agency has cited a 2011 estimate that more than 10,000 additives are in use in food, including roughly 1,000 human food substances marketed under independent (“self-affirmed”) GRAS conclusions that were never shared with the agency.

The proposal carries out HHS Secretary Robert F. Kennedy Jr.’s March 10, 2025 directive that FDA explore rulemaking to eliminate the self-affirmation pathway, a priority of the Administration’s Make America Healthy Again (MAHA) initiative. In the preamble, FDA points to a 2010 GAO recommendation that it collect basic information on all GRAS determinations, to enforcement episodes involving substances marketed without adequate GRAS support (caffeinated alcoholic beverages, Delta-8 THC edibles, tara flour, stevia leaf, ashwagandha, and palm leaf dinnerware), and to survey data showing declining public confidence in federal food safety oversight (from 68 percent in 2019 to 57 percent in 2024). The rule was signed by Secretary Kennedy himself, underscoring its political salience.

What the Proposed Rule Would Do

Mandatory GRAS notices. Any person introducing a substance into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act – whether the substance is new to the market or already in the food supply – would be required to notify FDA of the basis for the GRAS conclusion (proposed §§ 170.205 and 570.205). “Food substances” include both direct ingredients and indirect additions such as substances migrating from food packaging. For food contact substances, a manufacturer could submit a food contact notification (FCN) instead.

Seven exceptions. A GRAS notice would not be required where: (1) an existing FDA “no questions” letter covers the substance under the same conditions of use (any person could rely on it, not just the original notifier); (2) the substance is listed or affirmed as GRAS in FDA regulations (21 CFR parts 182, 184, or 186 for human food; parts 582 or 584 for animal food); (3) the use is covered by § 170.30(d) or (i)(1) (certain pre-1958 natural ingredients and affirmed-GRAS substances used under materially unchanged conditions); (4) FDA reviewed the use through an established consultation process (e.g., biotechnology or cultured-cell food consultations) without flagging the need for a notice; (5) the use holds a threshold of regulation (TOR) exemption; (6) an effective FCN covers the use, for the manufacturer listed in that FCN; or (7) the use is covered by a timely transition submission, described below.

A one-year transition window for products already on the market. New “Subpart F” would let firms whose substances entered interstate commerce before the final rule’s effective date make a streamlined submission – identity of the substance, conditions of use, and evidence of marketing, but no underlying safety data – in lieu of a full GRAS notice. FDA would post these submissions on a public list; inclusion is not an FDA endorsement, and FDA could later require a full GRAS notice or food additive petition for any listed use. Submissions would be accepted only for one year after the effective date, a hard cutoff. Firms whose prior GRAS notice drew an “insufficient basis” letter, or whose use FDA has determined is not GRAS, could not use this pathway.

New review timelines. FDA would decide whether to file a submission as a GRAS notice within 45 days of receipt and inform the notifier within two business days of its filing decision. The notification requirement is “met” upon FDA’s filing – not upon submission – and a notice later withdrawn at the notifier’s request (a “cease to evaluate” letter) would not count. FDA would retain its 180-day substantive review clock but could extend it by 90 days up to twice (360 days total).

An expanded low-exposure off-ramp. The TOR exemption in § 170.39, today limited to food contact articles, would expand to cover substances used in food generally, with an updated exposure benchmark (0.025 micrograms per kilogram of body weight per day) that normalizes safety across subpopulations. A granted TOR exemption would excuse a use from the GRAS notice requirement.

Administrative modernization. GRAS notices, TOR requests, and transition submissions would have to be filed electronically through FDA’s Centralized Online Submission Module (with waivers available); foreign-language materials would require complete English translations; and data not identified as FOIA-exempt at submission would be treated as disclosable. FDA would also codify its authority to send follow-up questions after issuing a no questions letter and to update or rescind such letters if new information calls a GRAS conclusion into question.

Animal food parallels. Part 570 changes largely mirror part 170, with animal-food-specific exceptions for ingredients reviewed through FDA’s Animal Food Ingredient Consultation process and for ingredients listed in and used in accordance with Chapter 6 of the 2024 AAFCO Official Publication (absent a public FDA safety concern).

What the Proposed Rule Would Not Do

The proposal would not create a premarket approval system for GRAS substances. Companies could still market a substance before submitting a notice and would not have to await FDA’s response. Instead, FDA would treat noncompliance as a factor in prioritizing substances for post-market review – and an insufficient-basis response would inform potential enforcement, since food bearing an unsafe, unapproved food additive is adulterated under the FD&C Act. Firms would also remain free to reach their own GRAS conclusions; the change is that those conclusions, and the data behind them, must be shared with FDA and the public.

Key Dates

  • August 11, 2026 – Publication in the Federal Register.
  • December 9, 2026 – Comments due (120 days), including on the information collection provisions.
  • Effective date – 60 days after publication of any final rule.
  • Effective date + 1 year – Subpart F transition window closes; streamlined submissions no longer accepted.
  • Effective date + 18 months – Compliance date for the mandatory notification requirement.

Next Steps

FDA has expressly invited comment on alternatives that would reduce burden – including allowing streamlined submissions for all purportedly GRAS substances rather than only those already on the market – as well as on the 45-day filing timeline, the second 90-day review extension, mechanisms for incorporating previously submitted data into new notices, and its paperwork burden estimates.

Clients with ingredients marketed under self-affirmed GRAS conclusions, pending or planned GRAS notices, food contact substances, or animal food ingredients should begin assessing their exposure now, including which exceptions may apply to existing product lines and whether the one-year transition window would cover current uses.