FDA Moves on Self-Affirmed GRAS and Chemical Reviews (2025)

Table of Contents

1. 1. What HHS and the FDA Did
2. 2. Key Terms: GRAS, Self-Affirmation and Post-Market Review
3. 3. March 10, 2025: The Self-Affirmed GRAS Directive
4. 4. How GRAS Notification Became Voluntary
5. 5. May 15, 2025: A Systematic Post-Market Review Program
6. 6. June 18, 2025: The Proposed Ranking Method
7. 7. August 19, 2025: The Updated List of Chemicals Under Review
8. 8. What Officials Said
9. 9. What These Steps Do Not Do
10. 10. Dates and Legal Status (as of October 11, 2026)
11. 11. How the Steps Fit Earlier and Later Actions
12. 12. Primary Documents
13. Key Research Papers
14. Connections

1. What HHS and the FDA Did

The 2025 record is four separate announcements, none of them a rule published in the Federal Register:

• March 10, 2025 — HHS press release. The HHS Secretary directed the Acting FDA Commissioner “to take steps to explore potential rulemaking” to revise the FDA’s GRAS final rule and related guidance so as to eliminate the self-affirmed GRAS pathway. HHS also said it would work with Congress on legislation.
• May 15, 2025 — FDA press release. The FDA announced “a stronger, more systematic review process for food chemicals already on the market,” to be rolled out over the following months in three parts: a prioritization scheme (draft for comment), a final review process, and an updated list of chemicals under review.
• June 18, 2025 — FDA constituent update. The FDA released its proposed method for ranking chemicals in food for post-market assessment and opened Docket FDA-2025-N-1733 for comments until July 18, 2025.
• August 19, 2025 — FDA constituent update. The FDA updated its public “List of Select Chemicals in the Food Supply Under FDA Review,” adding BHA, BHT, azodicarbonamide (ADA) and six synthetic color additives, plus a review of opiate alkaloids on poppy seeds.

A constituent update is a short notice the FDA’s Human Foods Program posts for industry, advocates and the public. A Federal Register docket is the public file on regulations.gov where a document, its supporting material and the public comments are posted.

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2. Key Terms: GRAS, Self-Affirmation and Post-Market Review

• Food additive. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a substance added to food, directly or by migrating from packaging or equipment, is a “food additive” that needs FDA premarket review and approval, unless an exception applies. The FDA’s 2026 GRAS proposal traces this requirement to the Food Additives Amendment of 1958.
• GRAS (“generally recognized as safe”). The main exception. A use of a substance is GRAS if qualified experts generally recognize it, on the basis of scientific procedures (or, for substances used in food before January 1, 1958, common use in food), as safe under its intended conditions of use. A GRAS use is not a food additive and does not need FDA approval. The 2026 proposal notes that it is the use of a substance, not the substance itself, that is GRAS.
• GRAS notice. A company may send the FDA a notice explaining why it concluded a use is GRAS. The FDA reviews it and posts its response letter in a public inventory. HHS described the notice program as one the FDA “strongly encourages” but does not require.
• Self-affirmed GRAS. HHS used this term for a company concluding that a use is GRAS “without notifying the FDA.” The FDA’s regulations call it an independent conclusion of GRAS status.
• Post-market review. A fresh safety look at a chemical that is already allowed in food — a food additive, color additive, GRAS substance, food-contact substance or contaminant — in light of new information.

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3. March 10, 2025: The Self-Affirmed GRAS Directive

The HHS press release, titled “HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe,” states:

• The instruction. The Secretary directed the Acting FDA Commissioner to explore potential rulemaking to revise the agency’s “Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.” HHS said this would enhance the FDA’s oversight of GRAS ingredients and “bring transparency to American consumers.”
• The current system. “Currently, the FDA strongly encourages manufacturers to submit GRAS notices … but industry can self-affirm that the use of a substance is GRAS without notifying the FDA.”
• Program size. The FDA had “completed and published more than 1,000 GRAS notices” and evaluates an average of 75 notices a year. Notices, supporting data and the FDA’s response letters are available in a public inventory.
• What ending self-affirmation would mean. HHS wrote that it “would require companies seeking to introduce new ingredients in foods to publicly notify the FDA of their intended use of such ingredients, along with underlying safety data, before they are introduced in the food supply.”
• Congress. HHS said it was “committed to working with Congress to explore ways legislation can completely close the GRAS loophole.”

The directive was an instruction to explore a rule, not a rule. The proposal it led to was published seventeen months later (see section 10).

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4. How GRAS Notification Became Voluntary

The background section of the FDA’s August 2026 proposed rule (91 FR 51834) sets out the history the 2025 directive was aimed at:

• 1950–1952. A House committee chaired by Representative James Delaney investigated chemicals in the food supply and reported that substances were being used “without adequate and sufficient testing of their possible long-range injurious effects.”
• 1958. Congress passed the Food Additives Amendment, requiring premarket approval of food additives, with a two-step definition that excluded GRAS uses.
• Before 1997. The FDA ran a GRAS affirmation process in which interested parties petitioned the agency to affirm a use as GRAS by rule. The 2026 proposal describes this framework as having “proved to be resource-intensive.”
• April 17, 1997. The FDA proposed replacing affirmation petitions with a voluntary notification procedure (62 FR 18938) and began an interim pilot; the first GRAS notice was filed in 1998.
• 2010. A U.S. Government Accountability Office (GAO) report noted that the FDA generally has no information about GRAS conclusions that are not submitted to the voluntary program.
• August 17, 2016. The FDA finalized the voluntary GRAS notification regulation (81 FR 54960), the “GRAS Final Rule” the 2025 directive referred to. Under it, a company “may, but is not required to,” notify the FDA.
• March 25, 2025. The 2026 proposal states that the FDA’s human foods program had filed over 1,200 GRAS notices by this date. (HHS’s March 10 figure of more than 1,000 refers to notices completed and published.)

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5. May 15, 2025: A Systematic Post-Market Review Program

The FDA press release “FDA Advances Robust, Transparent Post-Market Chemical Review Program to Keep Food Supply Safe and Healthy” announced three actions “over the coming months”:

1. A “modernized, evidence-based prioritization scheme” for reviewing existing chemicals, with a draft to be released for public comment.
2. A “final, systematic post-market review process shaped by stakeholder input.”
3. An updated list of chemicals under review, “including BHT, BHA, and ADA,” and steps to expedite reviews already under way of phthalates, propylparaben and titanium dioxide.

What it replaced. The FDA wrote: “Until now, the FDA has conducted post-market reviews on a case-by-case basis, often in response to citizen petitions or new scientific evidence. This new framework will be proactive, science-based, and built for long-term impact.” A citizen petition is a formal written request from any person or group asking the FDA to take or change an action.

Part of a larger initiative. The release placed the program alongside the April 2025 plan to phase out petroleum-based synthetic dyes and the March 2025 GRAS directive.

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6. June 18, 2025: The Proposed Ranking Method

The June 18 constituent update and the method document posted in Docket FDA-2025-N-1733 (“Tool for the Prioritization of Food Chemicals for Post-Market Assessment”) describe how the FDA proposed to decide which chemicals to look at first.

• The approach. The method uses Multi-Criteria Decision Analysis (MCDA): FDA scientists score each chemical against a fixed set of criteria, and the scores are combined into one number. The higher the total, the higher the chemical’s priority. The FDA said the approach is similar to one the U.S. Environmental Protection Agency uses for prioritizing chemicals, adapted to exposure from food.
• Four public health criteria. Toxicity (scored across seven data types, including cancer and genetic damage, developmental and reproductive effects, nervous-system effects, other organ effects, immune effects, and build-up in the body); change in dietary exposure since the last assessment; whether the chemical is found in food intended for susceptible groups such as infants; and new scientific information that could change an earlier conclusion.
• Three “other decisional” criteria. The level of outside attention (for example from Congress or national news coverage); whether other government agencies have acted on the chemical; and whether not assessing it could cause the public to lose confidence in the safety of the food supply.
• Scoring. Each criterion is scored on a scale using the values 1, 3, 5 or 9 depending on the criterion. In the draft, criteria within each group are weighted equally, and the public health total and the other-decisional total are weighted equally against each other; the document states the method “can accommodate non-equal weights.”
• What a score means. The document states that a chemical’s score and position on the list “is not an evaluation as to whether that chemical poses a public health risk”; it is a tool for deciding where to spend agency resources.
• Development. The FDA says it piloted a draft tool in 2023–2024, published a discussion paper in August 2024 and held a public meeting in September 2024 before this draft.
• Next steps. Comments closed July 18, 2025. The FDA said it would then send the method and the comments for review by external scientific experts, in line with the Information Quality Act.

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7. August 19, 2025: The Updated List of Chemicals Under Review

The FDA first published its list of select chemicals under review in July 2023 and updated it in March 2024. The August 19, 2025 update added dates for when each review began and for the latest risk-management action, and links for public input where available.

New to the list:

• Butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) — synthetic antioxidants used as preservatives.
• Azodicarbonamide (ADA) — a dough conditioner and flour-treatment agent.
• Six synthetic color additives: FD&C Blue No. 1, Blue No. 2, Green No. 3, Red No. 40, Yellow No. 5 and Yellow No. 6.
• Opiate alkaloids on poppy seeds.

Other changes. Lead as a food-contact substance was separated from lead as a contaminant and given its own entry. The FDA said it was taking steps to expedite reviews of chemicals listed earlier, such as phthalates, propylparaben and titanium dioxide, and that it intended to seek data and information from stakeholders on BHA, BHT and ADA “in the near future.”

The site’s background pages on these substances are BHA, BHT, Azodicarbonamide, Titanium Dioxide, Phthalates and Food Dyes.

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8. What Officials Said

• The HHS Secretary (March 10): “For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public.”
• The Acting FDA Commissioner (March 10): “The FDA is committed to further safeguarding the food supply by ensuring the appropriate review of ingredients and substances that come into contact with food.”
• The HHS Secretary (May 15): “No parent should ever worry about what’s in their child’s food.”
• The FDA Commissioner (May 15): “We are prioritizing our resources and leveraging gold standard science to create, for the first time, a systematic post-market review program that consumers can trust and rely on.”

The word “loophole” in public discussion of this action is the Secretary’s; the FDA’s regulations describe the same practice as an independent conclusion of GRAS status.

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9. What These Steps Do Not Do

• They changed nothing legally in 2025. No GRAS rule was proposed in 2025, self-affirmed GRAS remained lawful throughout the year, and no chemical was restricted or removed.
• A place on the review list is not a safety finding. The list records that the FDA is reviewing a chemical; it is not a conclusion that the chemical is unsafe. The ranking method states the same about a chemical’s priority score.
• The ranking method was a draft. It was released for comment and external peer review, not adopted, in 2025.
• The directive did not by itself bind the FDA to a result. It directed the agency to explore rulemaking; the content of any rule was left to the rulemaking process.
• They do not cover the dye phase-out. The separate April 2025 plan on petroleum-based dyes is covered on the Synthetic Dye Phase-Out Plan page.

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10. Dates and Legal Status (as of October 11, 2026)

• Self-affirmed GRAS: PROPOSED rule, open for comment. On August 11, 2026 the FDA published a proposed rule, “Substances Generally Recognized as Safe” (91 FR 51834, FR Doc. 2026-16296, Docket FDA-2025-N-3262), that would convert the voluntary GRAS notification program into a mandatory one. Comments close December 9, 2026. It is not in effect. Details: FDA Proposal to Make GRAS Notices Mandatory (2026).
• Post-market review program: framework FINAL; reviews OPEN. The review framework was finalized on May 12, 2026. The FDA opened a reassessment of BHA in February 2026 and of BHT and ADA in May 2026. Details: FDA Safety Reassessments of BHA, BHT and ADA (2026).

Timeline

• March 10, 2025 — HHS directs the FDA to explore rulemaking to eliminate self-affirmed GRAS.
• May 15, 2025 — FDA announces the systematic post-market chemical review program.
• June 18, 2025 — draft ranking method released; Docket FDA-2025-N-1733 opens.
• July 18, 2025 — comment period on the ranking method closes.
• August 19, 2025 — updated list of chemicals under review.
• February 2026 — BHA reassessment opened.
• May 12, 2026 — post-market review framework finalized; BHT and ADA reassessments opened in May.
• August 11, 2026 — mandatory GRAS notification proposed rule published.
• December 9, 2026 — comment deadline on the GRAS proposal.

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11. How the Steps Fit Earlier and Later Actions

• 1958. Food Additives Amendment creates premarket approval for food additives and the GRAS exception.
• 1997 and 2016. GRAS affirmation petitions replaced by voluntary notification, proposed in 1997 and finalized in 2016.
• July 2023 and March 2024. The FDA publishes, then updates, its list of select chemicals under review.
• August–September 2024. FDA discussion paper and public meeting on an enhanced systematic post-market assessment process.
• January 15, 2025. The FDA revokes Red No. 3 in food and ingested drugs under the Delaney Clause (Red No. 3 Revocation).
• March–August 2025. The four steps on this page.
• April 22, 2025. HHS and the FDA announce a plan to phase out petroleum-based synthetic dyes (Synthetic Dye Phase-Out Plan); the August 19 list then added six synthetic dyes to the chemicals under review.
• 2026. The review framework is finalized, BHA, BHT and ADA reassessments open, and the mandatory GRAS notification rule is proposed (section 10). Later dye steps are on FDA Food Dye Actions in 2026.

How U.S. food-chemical rules compare with Europe’s is covered on United States vs European Union: Food Safety Regulation Compared.

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12. Primary Documents

1. U.S. Department of Health and Human Services (2025). HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe. Press release, March 10, 2025 — hhs.gov press release (archived copy)
2. U.S. Food and Drug Administration (2025). FDA Advances Robust, Transparent Post-Market Chemical Review Program to Keep Food Supply Safe and Healthy. Press release, May 15, 2025 — fda.gov press release
3. U.S. Food and Drug Administration (2025). FDA Seeks Input on a New Method for Ranking Chemicals in Food for Post-market Assessments. Human Foods Program Constituent Update, June 18, 2025. Docket No. FDA-2025-N-1733 — fda.gov constituent update
4. U.S. Food and Drug Administration (2025). Tool for the Prioritization of Food Chemicals for Post-Market Assessment (method document for public comment). Docket No. FDA-2025-N-1733 — regulations.gov PDF; public docket: regulations.gov FDA-2025-N-1733
5. U.S. Food and Drug Administration (2025). FDA Update on Post-market Assessment of Chemicals in the Food Supply. Human Foods Program Constituent Update, August 19, 2025 — fda.gov constituent update
6. U.S. Food and Drug Administration. List of Select Chemicals in the Food Supply Under FDA Review (program page) — fda.gov list
7. Food and Drug Administration, HHS (2026). Substances Generally Recognized as Safe. Proposed rule. Federal Register 91:51834, August 11, 2026. Docket No. FDA-2025-N-3262 — FR Doc. 2026-16296 (official PDF, govinfo.gov)

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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. 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
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. 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
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) — 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
8. Palmont P, Membré JM, Rivière G, Bemrah N (2023). Risk ranking of chemical hazards in foods: comparison of aggregating methods using infant formula as an example. Food Additives & Contaminants. Part A 40(2):193-201 — PubMed PMID: 36602446

The first paper describes the GRAS exception and its history; papers 2–5 and 7 examine the U.S. food-additive and GRAS systems; paper 6 is a policy statement on food additives and children; paper 8 compares methods for ranking chemical hazards in food, the kind of task the FDA’s 2025 ranking method addresses.

PubMed Topic Searches

1. PubMed: GRAS and food regulation
2. PubMed: U.S. food additive safety assessment
3. PubMed: risk ranking of chemical hazards in food

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Connections

• FDA Actions of 2025
• FDA and Regulation
• FDA Proposal to Make GRAS Notices Mandatory (2026)
• FDA Safety Reassessments of BHA, BHT and ADA (2026)
• Synthetic Dye Phase-Out Plan (2025)
• Red No. 3 Revocation (2025)
• Ultra-Processed Foods Definition (2025)
• The GRAS Loophole (News)
• Food Additives
• BHA
• BHT
• Azodicarbonamide (ADA)
• Titanium Dioxide
• Phthalates
• US vs EU Food Safety

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