FDA Safety Reassessments of BHA, BHT and ADA (2026)

Table of Contents

1. What the FDA Did
2. The Three Chemicals and Where They Are Used
3. How Each Chemical Is Authorized Today
4. The Background the FDA Gives for BHA
5. What Information the FDA Asked For
6. The Review Framework Finalized in May 2026
7. What Officials Said
8. What the Reassessments Do Not Do
9. Dates and Status as of October 11, 2026
10. What the Published Research Covers
11. How the Reviews Fit Earlier and Parallel FDA Actions
12. Primary Documents
13. Key Research Papers
14. Connections

1. What the FDA Did

The FDA took three related steps, each built around a request for information (RFI). An RFI is a notice in the Federal Register, the U.S. government’s daily journal of agency actions, that asks anyone with relevant data to send it in. Each RFI opened a public docket, a numbered online file at regulations.gov where the notice, its background documents and every public comment are kept.

• BHA, February 2026. The FDA press release “FDA Launches Assessment of BHA, a Common Food Chemical Preservative” is dated 10 February 2026. The notice “Butylated Hydroxyanisole (BHA); Request for Information” followed on 11 February 2026 (91 FR 6227–6229, FR Doc. 2026-02761, Docket No. FDA-2026-N-0302), with comments due 13 April 2026.
• BHT and ADA, May 2026. The press release “FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA” is dated 12 May 2026. Two notices followed on 13 May 2026: “Butylated Hydroxytoluene (BHT); Request for Information” (91 FR 27054–27056, FR Doc. 2026-09507, Docket No. FDA-2026-N-2526) and “Azodicarbonamide (ADA); Request for Information” (91 FR 27060–27062, FR Doc. 2026-09508, Docket No. FDA-2026-N-4126). Both comment periods were set to close on 13 July 2026.
• BHT comment period reopened, July 2026. A notice of 30 July 2026 (91 FR 48127–48128, FR Doc. 2026-15429) reopened the BHT comment period for 30 days, to 31 August 2026.

Each notice states the same purpose in nearly the same words: the FDA is conducting a post-market assessment of the chemical’s safety “considering the latest state of the science” (BHA) or “the most recent science” (BHT and ADA), and intends to use the information it receives to determine whether the chemical “remains safe under its current conditions of use” in food and as a food contact substance. A post-market assessment is a review of a substance that is already being sold, as opposed to the review done before a new additive is first allowed. All three notices are signed by Grace R. Graham, the FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs, and name staff of the Human Foods Program’s Office of Food Chemical Safety, Dietary Supplements, and Innovation as contacts.

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2. The Three Chemicals and Where They Are Used

• BHA (butylated hydroxyanisole, CAS No. 25013-16-5). The BHA notice describes it as an antioxidant used in food “to prevent the spoilage of fats and oils.” Food-grade BHA is a mixture made mostly of 3-tert-butyl-4-hydroxyanisole with varying amounts of 2-tert-butyl-4-hydroxyanisole. The February press release lists frozen meals, breakfast cereals, cookies, candy, ice cream and meat products among the foods in which it can be found.
• BHT (butylated hydroxytoluene, CAS No. 128-37-0). The BHT notice describes it as an antioxidant used in food to prevent the spoilage of fats and oils and as an antioxidant in food contact materials. It quotes the regulatory definition of an antioxidant: a substance used “to preserve food by retarding deterioration, rancidity, or discoloration due to oxidation.” The May press release lists breakfast cereals, frozen pizza, frozen meals, baking mixes, cookies, chewing gum and meat products.
• ADA (azodicarbonamide, CAS No. 123-77-3). The ADA notice describes it as “a whitening agent in cereal flour and as a dough conditioner in breadmaking” that also “has applications in manufacturing food contact materials.” Unlike the other two notices, it also asks about ADA’s decomposition products, “the chemicals formed when ADA breaks down, such as during breadmaking,” naming semicarbazide and ethyl carbamate.

A food contact substance is a material, or an ingredient of a material, used in packaging, processing equipment or other items that touch food, which is not meant to be part of the food but can move (migrate) into it in small amounts. All three notices cover both uses: as a food ingredient and as a food contact substance.

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3. How Each Chemical Is Authorized Today

Each notice explains that every use of a chemical in food or food packaging has to rest on a legal basis under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act: a food additive regulation (a rule the FDA issued after reviewing the substance), an effective food contact notification, or an exclusion from the food additive definition. The two exclusions the notices name are GRAS status (“generally recognized as safe” by qualified experts for the intended use) and a prior sanction (a use that the FDA or the U.S. Department of Agriculture approved before the 1958 Food Additives Amendment).

BHA and BHT are each authorized through several of these routes at once, according to their notices:

• GRAS listing: each is listed as GRAS as an antioxidant in food generally, provided the total antioxidant content does not exceed 0.02% of the fat or oil content of the food (21 CFR 182.3169 for BHA, 21 CFR 182.3173 for BHT). The notices say these uses “also appear to be the subject of uncodified prior sanctions,” citing a citizen petition placed in each docket (dated 23 January 1987 for BHA and 23 December 1986 for BHT). Each is also listed as GRAS in animal food, but the notices state that the reviews focus on human food.
• Prior sanction for packaging: each may migrate from food packaging material as an antioxidant up to 0.005% of the food (21 CFR 181.24).
• Direct food additive regulations: BHA and BHT, alone or combined, in certain foods with specified limits (21 CFR 172.110 and 172.115); in chewing gum base, alone or with each other or propyl gallate, up to 0.1% total antioxidant of the gum base (21 CFR 172.615); and, for BHA, in flavoring substances up to 0.5% of the essential oil content (21 CFR 172.515).
• Food contact materials: both appear in regulations for defoaming agents, adhesives, label and tape adhesives used on poultry and produce, coatings, paper and paperboard, acrylic plastics, container closure gaskets, ethylene-vinyl acetate copolymers, animal glue production, machinery lubricants with incidental food contact, and polyethylene film (up to 1% of the polymer). The BHT notice adds resin-bonded filters, rubber articles for repeated use and polymer stabilizers (up to 5% of the stabilizer formulation).
• Standards of identity: both are listed in the USDA specifications for butteroil and in USDA and FDA standards for margarine; BHT is also an optional ingredient in enriched parboiled rice (21 CFR 137.350).

ADA rests on food additive regulations only. It is authorized as an aging and bleaching ingredient in cereal flour and as a dough conditioner in bread baking at no more than 0.0045% (45 parts per million, or 2.05 grams per 100 pounds of flour) (21 CFR 172.806), and it is an optional ingredient in the standards of identity for bread, rolls and buns, flour and whole wheat flour. As an indirect additive it is permitted in container closure gaskets, rubber articles for repeated use and foamed plastics. The ADA notice states that the FDA is “not aware of any prior sanctions or conclusions that the use of ADA is GRAS in food or for food contact use.”

All three notices add the same sentence: “While FDA previously concluded the authorized uses to be safe, new information may require reconsideration of the regulatory status or the safe uses of a substance in or on food.”

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4. The Background the FDA Gives for BHA

The February press release gives the most background of the three announcements, and all of it concerns BHA:

• Regulatory history. The FDA “listed BHA as Generally Recognized as Safe (GRAS) in 1958 and approved it as a food additive in 1961.”
• The cancer listing. The release states that the National Institutes of Health’s National Toxicology Program (NTP) lists BHA as “reasonably anticipated to be a human carcinogen” based on animal studies.
• Use trends. The release states that “packaged food label data indicate BHA use has declined in recent years,” but that it “remains present in many food products, including those marketed to children.”
• Why it was picked. The release says the FDA identified BHA as “a top priority for review” under the strengthened chemical-review program launched in May 2025, and that BHA was recommended for re-assessment in several comments to the public meeting docket on the FDA’s enhanced systematic process, which closed in January 2025.

The May press release gives no comparable background for BHT or ADA beyond their uses; the BHT and ADA notices describe how each is authorized (section 3) and what the agency wants to know (section 5).

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5. What Information the FDA Asked For

The three RFIs ask for the same kinds of information. Each says that data from food manufacturers on uses and use levels are “crucial,” invites aggregated submissions through trade groups, and says the FDA does not need individual product recipes, only use levels in general product categories. The notices explain why: without such data, the FDA estimates dietary exposure using “maximizing assumptions,” which “may lead to overestimation of dietary exposure that could impact authorizations for the chemical’s use.” The requests, as listed in each notice, cover:

1. the general food categories in which the chemical is used;
2. typical and maximum use levels in each category;
3. current food contact uses, including data on migration from packaging and equipment into food;
4. subpopulations with high dietary exposure or particular safety concerns;
5. other dietary sources, such as dietary supplements, natural occurrence in foods, residues in animal products, or contamination of food or drinking water;
6. the market share of foods and food contact materials formulated with the chemical;
7. biomonitoring data (measurements in people’s blood or urine) for the chemical or its metabolites;
8. updated market disappearance or poundage data (how much is sold or used);
9. chemically or pharmacologically related substances used in food;
10. safety data, “especially unpublished data”;
11. documentation of any GRAS conclusions or prior sanctions beyond those the notice describes;
12. information supporting a conclusion that the chemical is no longer used for one or more of its authorized uses.

The ADA notice has thirteen items rather than twelve. It adds a request for actual or expected residual levels of ADA’s decomposition products, “including semicarbazide and ethyl carbamate,” in foods and food contact materials, and it extends the migration, exposure, biomonitoring and safety-data requests to those decomposition products.

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6. The Review Framework Finalized in May 2026

The May 12 press release announced that the FDA had finalized two documents that “will guide the FDA’s annual food chemical post-market assessment plan”:

• “Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food.” The release says it describes how the FDA will monitor and triage signals (information on hazards, use or exposure related to food chemicals), then prioritize chemicals for assessment, evaluate them and manage them in the food supply. Based on public feedback, the release says, the agency streamlined the process, added public engagement opportunities, and gave more detail on how it receives and identifies safety signals, how it triages them and how it will communicate its scientific assessments.
• “Post-Market Assessment Prioritization Tool.” The release says this tool helps identify priority chemicals for full scientific assessment “by focusing on potential risk to public health.” Based on public comment and external scientific peer review, the FDA changed its previously proposed ranking method, including streamlining the decision criteria and scoring to focus on public health outcomes.

The release says progress on ongoing assessments will be posted on the FDA’s “List of Select Chemicals in the Food Supply Under FDA Review,” and that both framework documents are published on the FDA’s post-market safety of chemicals in food webpage. All three RFIs describe the reviews as part of this systematic process and state that each assessment “supports the Make America Healthy Again Commission’s recommendation to implement an evidence-based systematic process for post-market assessment of chemicals in food.”

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7. What Officials Said

The press releases quote three officials. Their statements are reported here as quotations; they are the officials’ words, not findings of the reviews, which had not concluded.

• The Secretary of Health and Human Services, Robert F. Kennedy, Jr. (10 February): “BHA has remained in the food supply for decades despite being identified by the National Toxicology Program as ‘reasonably anticipated to be a human carcinogen’ based on animal studies. This reassessment marks the end of the ‘trust us’ era in food safety. If BHA cannot meet today’s gold-standard science for its current uses, we will remove it from the food supply and continue cleaning up food chemicals—starting where children face the greatest exposure.”
• The FDA Commissioner, Marty Makary, M.D., M.P.H. (10 February): “The scientific community has raised significant concerns about some chemicals currently in the food supply.” In the same statement the Commissioner said that once the BHA assessment is complete the agency expects to assess BHT and azodicarbonamide, which he described as “a chemical used in yoga mats and also used as a dough conditioner.” That description is the Commissioner’s; the ADA notice itself describes the chemical’s non-food role only as having “applications in manufacturing food contact materials.” In the event, the BHT and ADA reviews were opened on 12 May, three months later, while the BHA review was still under way.
• The Commissioner (12 May): “Americans want the FDA to take a fresh look at some of the chemical additives that have become widespread in our food supply… We will act swiftly based on our findings.”
• The Deputy Commissioner for Human Foods, Kyle Diamantas (10 February), called the BHA assessment part of the FDA’s “proactive approach to food safety,” and on 12 May (titled in that release as Deputy Commissioner for Food) said the finalized framework “provides Americans with confidence that the FDA is ensuring chemicals in the U.S. food supply remain safe as new scientific information becomes available.”

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8. What the Reassessments Do Not Do

• No ban or restriction. None of the three chemicals has been banned, restricted or found unsafe. Each notice frames the review as a question still to be answered: whether the chemical “remains safe under its current conditions of use.” Every authorization listed in section 3 remains in force.
• Not a proposed rule. An RFI collects information. It does not propose to change any regulation, and it does not start the rulemaking process that would be needed to revoke or narrow an authorization. Any such change would require a separate published action.
• No conclusion yet. The notices state the objective of each assessment; none states a result. The FDA’s earlier conclusion that the authorized uses are safe stands, with the notices adding that “new information may require reconsideration.”
• Animal food is outside the focus. The BHA and BHT notices say the reviews focus on human food, although both chemicals are also listed as GRAS in animal food.
• The framework is not a decision about any chemical. The two documents finalized in May describe how chemicals are prioritized and reviewed; they do not themselves change the status of any substance.

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9. Dates and Status as of October 11, 2026

• 10 February 2026: BHA reassessment announced.
• 11 February 2026: BHA RFI published (91 FR 6227); comments open in Docket FDA-2026-N-0302.
• 13 April 2026: BHA comment period closed (11:59 p.m. Eastern Time for electronic comments). The notice states that late comments will not be considered.
• 12 May 2026: framework documents finalized; BHT and ADA reassessments announced.
• 13 May 2026: BHT RFI (91 FR 27054, Docket FDA-2026-N-2526) and ADA RFI (91 FR 27060, Docket FDA-2026-N-4126) published, each with a 60-day comment period.
• 13 July 2026: original close of both the BHT and ADA comment periods. The ADA period closed on this date.
• 30 July 2026: BHT comment period reopened (91 FR 48127). The notice says stakeholders had asked for more time, asserting that 60 days was not enough to develop “a complete and scientifically robust submission, particularly due to supply chain communications,” and that because the request came too late to extend the period before it expired, the FDA reopened it for 30 days.
• 31 August 2026: reopened BHT comment period closed.

Legal status on 11 October 2026: all three comment periods have closed, and all three post-market assessments are open. In the Federal Register documents reviewed for this page there is no proposed rule, final rule or published safety conclusion for BHA, BHT or ADA. Every current authorization remains in effect. Comments that were received are publicly viewable at regulations.gov under each docket number, or at the FDA’s Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday to Friday.

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10. What the Published Research Covers

The RFIs do not summarize the scientific literature; they ask for it. The peer-reviewed papers listed under Key Research Papers below were checked on PubMed for this page and show the kinds of questions the research has examined for each chemical. They are not documents cited in the FDA notices.

• BHA and the rodent forestomach. In a two-year feeding study, rats given BHA at 2.0% of the diet developed significantly more papillomas and squamous cell carcinomas of the forestomach, and both 0.5% and 2.0% raised the rate of forestomach hyperplasia; tumors in other organs were not significantly increased (Ito 1983). Later reviews describe the mechanism as non-DNA-reactive, involving cytotoxicity and increased cell proliferation, and point out that humans have no forestomach; one 1996 review concluded the rodent findings are “conditionally species-specific and not relevant to humans” (Whysner 1996). A 2021 review by authors from industry and a consulting firm discusses how the rodent tumor data led to BHA’s cancer-hazard classifications and argues for exposure-based risk assessment (Felter 2021).
• BHT. A 2002 cosmetic-ingredient safety assessment summarized animal data: liver and kidney effects at high oral doses in rats, liver and lung adenomas in some animal studies alongside studies showing tumor promotion or tumor inhibition depending on the organ and exposure, and mild skin irritation and sensitization at full strength. That panel concluded BHT is safe as used in cosmetics; it did not assess food use (Lanigan 2002).
• ADA and its breakdown products. FDA chemists reported that adding ADA at the U.S. maximum of 45 mg/kg of flour raised ethyl carbamate in commercially prepared bread by 1–3 micrograms per kilogram, with larger rises after toasting (Cañas 1997). Health Canada scientists found semicarbazide formed when ADA-treated flour was heated to 150–200 °C, reaching about 0.2 mg/kg, with similar levels in the crusts of bread made from such flour (Becalski 2004). These are the two decomposition products the ADA notice names.
• ADA in the workplace. A 1981 survey of 151 workers exposed to ADA dust during its manufacture found that 28 (18.5%) without previous asthma reported late-onset asthma after exposure (Slovak 1981). This concerns inhaled industrial dust, not ADA in bread. Background on the condition is on the Asthma page.

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11. How the Reviews Fit Earlier and Parallel FDA Actions

Before 2026. According to the February press release, comments to the FDA’s public meeting docket on developing an enhanced systematic process for post-market chemical assessment, which closed in January 2025, recommended BHA for re-assessment, and in May 2025 the FDA launched a strengthened program to review chemicals already in the food supply. The same release says the Make America Healthy Again Commission’s Strategy Report identified post-market review of food chemicals, including food additives, food contact substances, GRAS substances and color additives, as a key priority.

The 2026 sequence. BHA was the first chemical given a full RFI under the process in 2026. The framework was finalized three months later, on the same day the BHT and ADA reviews began. The BHT notice cross-refers to the BHA notice, since the two antioxidants are often authorized together in the same regulations.

The GRAS proposal. The February release notes that the FDA “has advanced draft rulemaking to reform its GRAS framework.” That rulemaking became a proposed rule in August 2026 that would make GRAS notification to the FDA mandatory, and its proposal lists a failure to notify as a factor in prioritizing substances for post-market review. It is described on the site’s GRAS proposal page.

Color additives. In the same year the FDA acted separately on food colors, including revoking the authorization for Orange B in July 2026 on the ground that the use had been abandoned and proposing to revoke Citrus Red No. 2. Those actions are on the FDA Food Dye Actions in 2026 page. The RFIs for BHA, BHT and ADA each include a request for information showing that a chemical “is no longer used for one or more of its authorized intended uses,” the same kind of evidence on which the Orange B revocation rested.

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12. Primary Documents

1. U.S. Food and Drug Administration (2026). FDA Launches Assessment of BHA, a Common Food Chemical Preservative. FDA News Release, 10 February 2026 — fda.gov press announcement
2. Food and Drug Administration, HHS (2026). Butylated Hydroxyanisole (BHA); Request for Information. Federal Register 91:6227–6229, 11 February 2026. FR Doc. 2026-02761, Docket No. FDA-2026-N-0302 — federalregister.gov 2026-02761
3. U.S. Food and Drug Administration (2026). FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA. FDA News Release, 12 May 2026 — fda.gov press announcement
4. Food and Drug Administration, HHS (2026). Butylated Hydroxytoluene (BHT); Request for Information. Federal Register 91:27054–27056, 13 May 2026. FR Doc. 2026-09507, Docket No. FDA-2026-N-2526 — federalregister.gov 2026-09507
5. Food and Drug Administration, HHS (2026). Azodicarbonamide (ADA); Request for Information. Federal Register 91:27060–27062, 13 May 2026. FR Doc. 2026-09508, Docket No. FDA-2026-N-4126 — federalregister.gov 2026-09508
6. Food and Drug Administration, HHS (2026). Butylated Hydroxytoluene (BHT); Request for Information; Reopening of Comment Period. Federal Register 91:48127–48128, 30 July 2026. FR Doc. 2026-15429, Docket No. FDA-2026-N-2526 — federalregister.gov 2026-15429

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Key Research Papers

1. Ito N, Fukushima S, Hagiwara A, Shibata M, Ogiso T (1983). Carcinogenicity of butylated hydroxyanisole in F344 rats. Journal of the National Cancer Institute 70(2):343-352 — PubMed PMID: 6571941
2. Whysner J, Williams GM (1996). Butylated hydroxyanisole mechanistic data and risk assessment: conditional species-specific cytotoxicity, enhanced cell proliferation, and tumor promotion. Pharmacology & Therapeutics 71(1-2):137-151 — PubMed PMID: 8910953
3. Felter SP, Zhang X, Thompson C (2021). Butylated hydroxyanisole: Carcinogenic food additive to be avoided or harmless antioxidant important to protect food supply? Regulatory Toxicology and Pharmacology 121:104887 — PubMed PMID: 33556417
4. Lanigan RS, Yamarik TA (2002). Final report on the safety assessment of BHT. International Journal of Toxicology 21(Suppl 2):19-94 — PubMed PMID: 12396675
5. Cañas BJ, Diachenko GW, Nyman PJ (1997). Ethyl carbamate levels resulting from azodicarbonamide use in bread. Food Additives and Contaminants 14(1):89-94 — PubMed PMID: 9059587
6. Becalski A, Lau BP, Lewis D, Seaman SW (2004). Semicarbazide formation in azodicarbonamide-treated flour: a model study. Journal of Agricultural and Food Chemistry 52(18):5730-5734 — PubMed PMID: 15373416
7. Slovak AJ (1981). Occupational asthma caused by a plastics blowing agent, azodicarbonamide. Thorax 36(12):906-909 — PubMed PMID: 7336369

Each citation was checked against its PubMed record (title, authors, journal, year) on 11 October 2026. None is cited in the FDA notices themselves.

PubMed Topic Searches

1. PubMed: butylated hydroxyanisole carcinogenicity
2. PubMed: butylated hydroxytoluene toxicity
3. PubMed: azodicarbonamide, semicarbazide and bread
4. PubMed: synthetic phenolic antioxidants and human exposure

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Connections

• FDA and Regulation
• FDA Proposal to Make GRAS Notices Mandatory (2026)
• FDA Food Dye Actions in 2026
• BHA (Butylated Hydroxyanisole)
• BHT (Butylated Hydroxytoluene)
• BHA and BHT: Preservatives in Food
• Azodicarbonamide (ADA)
• Food Preservatives
• Food Additives
• United States vs European Union: Food Safety Regulation
• News, 28 September 2026: Food Preservatives and High Blood Pressure
• Asthma

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