FDA Proposal to Make GRAS Notices Mandatory (2026)

On Tuesday 11 August 2026 the U.S. Food and Drug Administration published a proposed rule, “Substances Generally Recognized as Safe,” at 91 FR 51834 (FR Doc. 2026-16296, Docket No. FDA-2025-N-3262). If it is finalized, any company that adds a substance to human or animal food on the basis of its own conclusion that the substance is “generally recognized as safe” (GRAS) would have to notify the FDA and explain the basis for that conclusion. Today such notification is voluntary. Public comments are open until 9 December 2026.

This page reports what the proposed rule and the accompanying Department of Health and Human Services (HHS) announcement say: what GRAS means, what would change, the exceptions and the one-year pathway for ingredients already on the market, what the proposal does not do, its estimated costs, its dates and legal status as of 11 October 2026, and how it fits more than sixty years of earlier FDA actions on food ingredients. Background on additives themselves is on the site’s Food Additives page.

Table of Contents

  1. What the FDA Proposed
  2. What GRAS Means and How the Current System Works
  3. What the Proposal Would Change
  4. The Exceptions to the Notice Requirement
  5. The One-Year Pathway for Ingredients Already on the Market
  6. What Falls Outside GRAS: Dietary Supplement Ingredients and Other Categories
  7. The Reasons the FDA Gives
  8. What the Proposal Does Not Do
  9. Estimated Costs and Effects
  10. Dates and Legal Status as of 11 October 2026
  11. The Same-Day Ultra-Processed Food Definition Step
  12. How the Proposal Fits Earlier FDA Actions on Food Ingredients
  13. Primary Documents
  14. Key Research Papers
  15. Connections
  16. Featured Videos

1. What the FDA Proposed

The document is a proposed rule, the stage of federal rulemaking at which an agency publishes the text of a regulation it is considering and invites public comment before deciding whether to adopt it. It appeared in the Federal Register, the U.S. government’s daily journal of agency rules and notices, on 11 August 2026 at volume 91, pages 51834–51881. Comments are collected in a public docket — an online file where the rule, supporting documents and every public comment are kept — numbered FDA-2025-N-3262. The rule carries Regulation Identifier Number (RIN) 0910-AJ02.

The rule’s summary states that the FDA “is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use.” It would amend two parts of the Code of Federal Regulations: 21 CFR part 170 (human food) and 21 CFR part 570 (animal food). The rule notes that “food substances” include both ingredients and substances that reach food indirectly, such as from food packaging.

HHS announced the proposal the day before, on 10 August 2026, in a press release titled “Secretary Kennedy Announces Landmark Food Policy Reforms to Advance President Trump’s MAHA Agenda.” The White House Office of Information and Regulatory Affairs has classed the proposal as an “economically significant regulatory action” under Executive Order 12866, the label given to rules expected to have an annual effect of $100 million or more or a material effect on a sector of the economy, public health or safety.

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2. What GRAS Means and How the Current System Works

The 1958 law. The Food Additives Amendment of 1958 created a premarket review and approval process for “food additives”: before such a substance can be added to food, the FDA must authorize it. In defining a food additive, however, Congress excluded substances that are “generally recognized as safe” by qualified experts under the conditions of their intended use. A substance that is GRAS for a particular use is therefore not subject to FDA premarket approval for that use. The rule describes this as a balance: Congress exempted GRAS uses from premarket approval but gave the FDA authority to review substances on the market, including those purported to be GRAS, to decide whether they are in fact food additives that need approval.

Self-GRAS, or “independent conclusions.” Under current regulations a company that concludes a use of a substance is GRAS “may, but is not required to, notify FDA of this conclusion.” A conclusion reached without telling the FDA is what the rule calls an “independent conclusion of GRAS status”; it is commonly called self-GRAS. The rule states that a company’s conclusion (or a claim that it has independently “certified” a substance as GRAS) “does not necessarily mean that such a use is GRAS,” and that the FDA may determine otherwise on the evidence.

The voluntary notification program. The FDA first proposed its GRAS notification program in 1997, ran it as an interim pilot (its human food center filed the first notice in 1998), and finalized it in a 2016 rule (81 FR 54960). When a notice is filed, the FDA evaluates whether the data support the company’s conclusion and generally answers in one of three ways:

The rule also states that under the current program there is no requirement that a company wait for the FDA’s response before selling the substance.

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3. What the Proposal Would Change

The rule’s executive summary lists its major provisions. If finalized, it would:

The HHS announcement adds that the proposal would expand the public inventory of submitted GRAS notices. The rule’s stated purpose is “greater transparency about substances that are added to food,” so that the FDA can more efficiently decide whether a use is in fact a food additive use that needs its approval.

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4. The Exceptions to the Notice Requirement

Proposed 21 CFR 170.205(b) lists seven situations in which no new GRAS notice would be required for human food, because, in the FDA’s words, a notice would be “unnecessary or unwarranted”:

  1. An existing “no questions” letter already covers the substance under the same conditions of use. The rule notes that a significantly different identity, manufacturing process or use (food categories, use levels, specifications) may fall outside the earlier letter.
  2. The substance is listed or affirmed as GRAS in FDA regulations (21 CFR parts 182, 184 or 186) for that use.
  3. Long-standing foods and affirmed substances: a food ingredient of natural biological origin widely consumed for its nutrients in the United States before 1 January 1958, conventionally processed, with no known hazard (21 CFR 170.30(d)); or a use not significantly different from one affirmed in part 184 or 186 with no limit other than good manufacturing practice.
  4. An established FDA consultation process has already considered the use — the voluntary premarket consultations for foods from new plant varieties developed through biotechnology, or the consultations for foods from cultured animal cells — and did not identify a need for a GRAS notice. Informal FDA advice does not qualify.
  5. A threshold-of-regulation exemption covers the use.
  6. An effective food-contact notification covers the use, for the manufacturer or supplier named in that notification only.
  7. A streamlined submission for an ingredient already on the market has been made and appears on the FDA’s public list, unless the FDA later determines that a full notice or a food additive petition is needed.

The animal food version (570.205(b)) does not include the threshold-of-regulation and food-contact exceptions, because there is no threshold-of-regulation exemption or food-contact notification program for animal food. It adds two exceptions of its own: uses already cleared through an established FDA animal food ingredient consultation, and feed ingredients listed in, and used according to, the ingredient definitions published by the association of state feed-control officials (2024 edition), where the FDA has not publicly raised a concern about their GRAS status.

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5. The One-Year Pathway for Ingredients Already on the Market

The rule acknowledges that “many persons have relied on” the current law to market substances on the basis of self-GRAS conclusions, and that requiring full notices for all of them “would likely overburden” the FDA’s review resources. It therefore proposes a new subpart F of part 170 with a shorter, one-time submission for substances introduced into commerce under the GRAS provision before a final rule takes effect.

Under proposed 21 CFR 170.305, a streamlined submission would have to include:

The submission would not have to include the underlying safety data. The pathway would be closed to uses the FDA has already found not GRAS and to uses that received an “insufficient basis” letter; those would need a full notice or a food additive petition.

Under proposed 170.305(c)(3), submissions must be made electronically within one year after the final rule’s effective date and “will not be accepted beyond one year.” The FDA would post the information on a public list and states that a listing “does not mean that we have reviewed the GRAS status” of the use. The agency could ask submitters questions and could decide that a full GRAS notice or a food additive petition is required for a listed use.

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6. What Falls Outside GRAS: Dietary Supplement Ingredients and Other Categories

The law excludes six categories from the definition of “food additive,” and the rule explains that because they are not food additives, they cannot be the subject of a GRAS notice and are not eligible for GRAS classification (proposed 170.205(c)):

  1. pesticide chemical residues in or on raw or processed food;
  2. pesticide chemicals;
  3. color additives, which have their own separate approval process;
  4. substances used under a sanction or approval granted before 6 September 1958;
  5. new animal drugs;
  6. ingredients described in section 201(ff) of the Federal Food, Drug, and Cosmetic Act in, or intended for use in, a dietary supplement.

The last point means that ingredients in dietary supplements are governed by the separate supplement law, not by this GRAS rule. The FDA’s separate 2026 public meeting on what counts as a dietary ingredient is described on the dietary ingredient page.

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7. The Reasons the FDA Gives

The Secretary’s directive. The rule states that on 10 March 2025 the Secretary of Health and Human Services, Robert F. Kennedy Jr., directed the FDA to explore rulemaking “to eliminate the pathway for firms to introduce purported GRAS uses of substances into the market without notifying FDA,” and that this aligns with the Administration’s Make America Healthy Again initiative.

Information gaps. The FDA writes that the voluntary program leaves gaps in what both the agency and the public know about substances added to food. It cites a 2010 U.S. Government Accountability Office (GAO) report, “Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to be Generally Recognized as Safe (GRAS),” which found that the FDA generally has no information about GRAS determinations not submitted to it, described one company that made about five such determinations a year without notifying the FDA, and recommended a strategy to require basic information on every GRAS determination.

Scale. The rule cites estimates that, as of January 2011, more than 10,000 additives were used in food, including about 1,000 human food substances for which companies had claimed independent GRAS conclusions. By its own count, the FDA’s human food program had filed over 1,200 GRAS notices as of 25 March 2025, and its veterinary center 75 notices as of 28 March 2025.

Timing of safety action. The FDA states that companies “are introducing substances into food without publicly disclosing the underlying safety information,” and that it “sometimes becomes aware of the need to take action regarding unsafe substances in food only after adverse public health events occur.” It compares the present to the years before 1958, when “numerous substances with unknown safety profiles” were being added to food, and says that today “an unknown number of substances” enter the market under the GRAS provision.

The benefits it expects. A mandatory program, the rule says, would give the FDA, state regulators, consumers, industry and consumer groups more information, help the FDA confirm that GRAS conclusions have a scientific basis and are documented, and allow earlier engagement with companies when questions arise.

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8. What the Proposal Does Not Do

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9. Estimated Costs and Effects

The rule’s preliminary economic analysis estimates the present value of costs at about $89.6 million over 10 years (range $34.9 million to $210.0 million), discounted at 3 percent in 2024 dollars, or about $82.3 million at a 7 percent discount rate. Annualized, that is about $10.5 million a year at 3 percent (range $4.1 to $24.6 million) and $11.7 million at 7 percent.

For companies, the listed one-time costs are reading the rule, revising internal procedures and, for those who choose it, preparing streamlined submissions for ingredients already on the market (including translation costs for manufacturers abroad). Recurring costs are preparing notices for new uses that would previously have been self-GRAS. For the FDA, costs are reviewing the one-time submissions and evaluating the ongoing stream of notices.

The FDA also notes possible shifts of market share between manufacturers: if a notice leads to a finding that there is an insufficient basis for a GRAS conclusion, products using that substance could be affected. The agency says it cannot estimate the size of such effects. The benefits it describes are informational — more knowledge for the FDA and the public about substances in human and animal food — and the rule says it is intended in part to “strengthen public confidence in FDA’s ability to oversee the safety of the U.S. food supply.”

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10. Dates and Legal Status as of 11 October 2026

The FDA also asks for comment on alternatives that could reduce burden — for example, allowing streamlined submissions for all purported GRAS substances — provided they still meet its goals of preventing unsafe additives and increasing transparency.

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11. The Same-Day Ultra-Processed Food Definition Step

The HHS release of 10 August 2026 paired the GRAS proposal with a second step: HHS and the U.S. Department of Agriculture submitted the first proposed federal definition of ultra-processed foods for final review. The definition itself was not released.

The federal regulatory review website lists the item as “White Paper: Proposed Definition of Ultra-Processed Food,” RIN 0910-ZD60, from HHS/FDA, received on 3 August 2026 for review under Executive Order 12866, at the stage “Notice.” As of 11 October 2026 it is a pending white paper, not a proposed or final rule, and its text is not public. What the research literature says about these foods is on the site’s Ultra-Processed Foods page.

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12. How the Proposal Fits Earlier FDA Actions on Food Ingredients

The rule’s background section traces the following history:

The same year brought other FDA steps on food chemicals, described on the food dye actions and BHA, BHT and ADA reassessments pages. How U.S. additive rules compare with Europe’s is covered on the US vs EU Food Safety page, and the August announcement was reported in the site’s news article of 10 August 2026.

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13. Primary Documents

  1. Food and Drug Administration, HHS (2026). Substances Generally Recognized as Safe; Proposed Rule. Federal Register 91:51834–51881, 11 August 2026. Docket No. FDA-2025-N-3262; RIN 0910-AJ02 — FR Doc. 2026-16296 (official PDF)
  2. Public docket FDA-2025-N-3262 — regulations.gov FDA-2025-N-3262
  3. U.S. Department of Health and Human Services (2026). Secretary Kennedy Announces Landmark Food Policy Reforms to Advance President Trump’s MAHA Agenda. HHS press release, 10 August 2026 — hhs.gov press room
  4. Office of Information and Regulatory Affairs (2026). White Paper: Proposed Definition of Ultra-Processed Food. HHS/FDA, RIN 0910-ZD60, received 3 August 2026, EO 12866 review pending, stage: Notice — reginfo.gov review record
  5. U.S. Food and Drug Administration (2026). Webinar: FDA’s Generally Recognized as Safe (GRAS) Proposed Rule, 15 October 2026 — fda.gov webinar page

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Key Research Papers

  1. Burdock GA, Carabin IG (2004). Generally recognized as safe (GRAS): history and description. Toxicology Letters 150(1):3-18 — PubMed PMID: 15068820
  2. Neltner TG, Alger HM, O'Reilly JT, Krimsky S, Bero LA, Maffini MV (2013). Conflicts of interest in approvals of additives to food determined to be generally recognized as safe: out of balance. JAMA Internal Medicine 173(22):2032-2036 — PubMed PMID: 23925593
  3. Neltner TG, Alger HM, Leonard JE, Maffini MV (2013). Data gaps in toxicity testing of chemicals allowed in food in the United States. Reproductive Toxicology 42:85-94 — PubMed PMID: 23954440
  4. Maffini MV, Alger HM, Olson ED, Neltner TG (2013). Looking back to look forward: a review of FDA's food additives safety assessment and recommendations for modernizing its program. Comprehensive Reviews in Food Science and Food Safety 12(4):439-453 — PubMed PMID: 33412683
  5. Maffini MV, Neltner TG, Vogel S (2017). We are what we eat: regulatory gaps in the United States that put our health at risk. PLoS Biology 15(12):e2003578 — PubMed PMID: 29261673
  6. Trasande L, Shaffer RM, Sathyanarayana S; Council on Environmental Health (2018). Food additives and child health. Pediatrics 142(2):e20181410 — PubMed PMID: 30037972
  7. Matouskova K, Neltner TG, Maffini MV (2023). Out of balance: conflicts of interest persist in food chemicals determined to be generally recognized as safe. Environmental Health 22(1):59 — PubMed PMID: 37670318

These papers are independent academic and professional-society analyses of the GRAS system and of U.S. food additive oversight; they are not cited in the proposed rule’s reference list.

PubMed Topic Searches

  1. PubMed: generally recognized as safe and food regulation
  2. PubMed: food additive safety assessment and the FDA
  3. PubMed: food additives and child health

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Connections

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