FDA Revokes Brominated Vegetable Oil (BVO) in Food (2024)

Table of Contents

1. What the FDA Did
2. What BVO Is and How It Was Used
3. The Legal Steps: GRAS, Food Additives and Revocation
4. From the GRAS List to Fifty Years of “Interim” Use
5. The New Animal Studies Behind the Decision
6. How Much BVO People Were Estimated to Consume
7. What the Public Comments Said
8. What the Rule Does Not Do
9. Costs, Benefits and Who Was Most Exposed
10. Dates and Legal Status as of 11 October 2026
11. How the Rule Fits Other FDA Food-Chemical Actions
12. Primary Documents
13. Key Research Papers
14. Connections

1. What the FDA Did

The FDA constituent update of 2 July 2024, “FDA Revokes Regulation Allowing the Use of Brominated Vegetable Oil (BVO) in Food,” states that the agency “is revoking the regulation authorizing the use of brominated vegetable oil (BVO) in food,” and that it concluded the intended use of BVO “is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health (NIH) found the potential for adverse health effects in humans.”

The final rule appeared in the Federal Register on 3 July 2024, volume 89, pages 55040–55045, under 21 CFR Part 180 and Regulation Identifier Number (RIN) 0910-AI81. Its action line reads simply “Final rule.” It is dated 18 June 2024 and signed by Robert M. Califf, Commissioner of Food and Drugs. The operative text is one sentence: “Remove § 180.30.” That section, titled “Brominated vegetable oil,” was the only regulation authorizing BVO in food. The rule’s summary puts it this way: it “revokes the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. There are no authorizations for other uses of BVO in food.”

The FDA finalized the rule exactly as it had proposed it on 3 November 2023 (88 FR 75523); the final rule says the agency is “finalizing it without change.”

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2. What BVO Is and How It Was Used

The final rule describes BVO as “a complex mixture of plant-derived triglycerides that have been reacted to contain atoms of the element bromine bonded to the molecules.” Triglycerides are the ordinary fat molecules that make up vegetable oils. BVO had been made from several oils, including corn, cottonseed and olive; more recently, the rule says, it was often made from soybean oil and declared on labels as “brominated soybean oil.”

Its job was physical rather than nutritional. According to the rule, BVO was “used primarily to help emulsify citrus-flavored soft drinks, preventing them from separating during distribution.” The FDA’s program page puts it more plainly: it was used in small amounts, not more than 15 parts per million, “to keep the citrus flavoring from floating to the top.”

When it was used, it had to be named in the ingredient list, either as “brominated vegetable oil” or as the specific oil, such as “brominated soybean oil.” The FDA says that over time many beverage makers reformulated their products to replace BVO, and that “Few beverages in the U.S. contain BVO.” The rule adds that safe and authorized substitutes “are available and have long been in use for the same functions as BVO.”

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3. The Legal Steps: GRAS, Food Additives and Revocation

Three terms explain what kind of action this was:

• GRAS (“generally recognized as safe”). The Federal Food, Drug, and Cosmetic Act (FD&C Act), as quoted in the rule, defines a “food additive” as a substance that becomes a component of food if it is not generally recognized by qualified experts as safe under the conditions of its intended use. A substance that is GRAS for a use is outside that definition.
• Food additive regulation. A substance that is not GRAS needs an authorizing food additive regulation (or another exception in the law) before it may be used in food. After 1970, § 180.30 was BVO’s only such authorization. Part 180 of the regulations is titled “Food Additives Permitted in Food or in Contact With Food on an Interim Basis Pending Additional Study.”
• Revocation. The rule cites sections 409(i) and 701(a) of the FD&C Act. Section 409(i) provides that food additive regulations may be amended or repealed under a procedure the FDA prescribes by regulation; under 21 CFR 171.130(a) the FDA may propose repealing a food additive regulation; section 701(a) gives authority to issue regulations for efficient enforcement of the Act.

Because the FDA had already found in 1970 that BVO in food is not GRAS (35 FR 1049), removing § 180.30 left no legal basis for any use. The rule states that BVO “cannot be used in food without an authorizing food additive regulation or an applicable exception from regulation as a food additive.” Formally the action is a revocation of an authorization; in its response to public comments the FDA itself refers to the economic impact of “banning BVO.”

A Federal Register docket is the public file for a rulemaking. This one, FDA-2023-N-0937 on regulations.gov, holds the proposed rule, the public comments, the FDA memoranda cited as references, and the economic analysis.

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4. From the GRAS List to Fifty Years of “Interim” Use

The final rule and the FDA’s BVO program page give this timeline:

• 1920s. BVO is used as a flavoring-oil stabilizer and emulsifier.
• 1958. The Food Additives Amendment to the FD&C Act gives the FDA specific authority to regulate food ingredients (program page).
• Late 1950s–early 1960s. The FDA considers BVO GRAS and places it on its original “GRAS list” in the Code of Federal Regulations.
• 27 January 1970. Citing toxicity concerns at the level then in use, about 150 parts per million in beverages, the FDA concludes BVO can no longer be regarded as GRAS and removes it from the list (35 FR 1049). The program page says animal studies at levels far above most human consumption had raised concerns about possible effects on the heart.
• 1970. A trade association of flavor manufacturers petitions for BVO to be approved as a food additive at up to 15 ppm. The FDA finds no immediate threat to health at 15 ppm but concludes that longer-term studies are needed to support that limit.
• 28 July 1970. The FDA authorizes BVO as a stabilizer for flavoring oils in fruit-flavored beverages, at no more than 15 ppm, on a three-year interim basis pending more data (35 FR 12062). The rule says the agency judged in October 1970 that this reduced level gave “an adequate margin of safety” on an interim basis.
• 8 October 1974. The interim authorization is extended for an indefinite period to allow further safety studies (39 FR 36113). The program page says these additional studies “resolved the safety concerns related to the heart.”
• 2014. As part of a reevaluation of food and color additives, the FDA reviews all available BVO data. It finds no evidence of a health threat from the limited permitted use, but notes that many studies “did not clearly establish safe levels of chronic use,” citing poor study design by modern standards, equivocal results and suboptimal dose selection, and concludes that new, high-quality studies are needed.
• 2016–2020. The FDA publishes improved methods for measuring BVO in soft drinks and small amounts of fats in vegetable oil, which it later used to measure brominated fats in animal tissues (program page).
• 2022. The new rodent studies are published (section 5).
• 3 November 2023. Proposed rule published (88 FR 75523); comments accepted until 17 January 2024.
• 2–3 July 2024. Final rule announced and published.

The rule also notes that BVO “is not permitted for use in beverages in some jurisdictions, including Australia, the European Union, Japan, and New Zealand,” and that some products had already been reformulated to be sold there.

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5. The New Animal Studies Behind the Decision

The studies were designed through a collaboration between the FDA’s Center for Food Safety and Applied Nutrition, its National Center for Toxicological Research (NCTR), and the Division of Translational Toxicology of the National Institute of Environmental Health Sciences (NIEHS), with the aim of addressing possible thyroid toxicity and bioaccumulation. They were published in 2022 in Food and Chemical Toxicology (Woodling and colleagues, listed under Key Research Papers). The final rule summarizes the findings:

• Thyroid. In a 90-day study in rats, the thyroid showed enlargement of the follicular cells (follicular cell hypertrophy) in males at all exposure levels and in females at the highest level, with abnormal findings in male thyroids rising with dose. The study also showed changes in hormone signaling along the hypothalamic–pituitary–thyroid axis, the brain-to-gland chain that controls thyroid hormone. The rule says these data “corroborate previous studies in rats and pigs that also reported thyroid toxicity.”
• Bioaccumulation. Bromine built up in the animals’ bodies. After 90 days the build-up had not levelled off, and brominated fatty acids accumulated in a dose-dependent way in the heart, liver and fat. The FDA estimated that these fatty acids could persist for up to 587 days after BVO was removed from the diet.
• Nervous system (earlier findings). The rule notes that bromine accumulation had previously been related to central nervous system effects (lethargy, ataxia and disorientation) in pigs fed BVO.

The FDA’s conclusion, in the rule’s words: “These studies demonstrated adverse effects in animals at all doses tested, and the test doses more closely approximated levels of dietary exposure to BVO in humans than many earlier studies. We could not derive a safe level of dietary exposure to BVO from these studies.” The rule adds that the build-up of lipid-bound bromine makes it hard to estimate cumulative exposure and to interpret older short-term studies that had reported no adverse effect.

The FDA program page describes the 2022 data somewhat differently, saying they “suggest that oral exposure to BVO is associated with increased tissue levels of bromine and that at high levels of exposure the thyroid is a target organ of potential negative health effects in rodents.” Both statements come from FDA documents; the regulatory finding is the one in the rule.

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6. How Much BVO People Were Estimated to Consume

To compare the animal doses with real life, the FDA used dietary data from the combined 2015–2018 National Health and Nutrition Examination Survey (NHANES), with the conservative assumption that every beverage labeled as containing BVO held the full 15 ppm. For the U.S. population aged 2 years and older it estimated:

• a mean intake of 5 milligrams of BVO per person per day (0.08 mg per kilogram of body weight, on a 60 kg basis);
• a 90th-percentile intake of 9 mg per person per day (0.15 mg/kg).

The rule explains that, to allow for the uncertainty of applying animal results to people, the FDA typically requires a food additive to be shown safe in animals at exposures at least 100 times higher than probable human dietary exposure (21 CFR 170.22). Because the new studies found adverse effects at every dose tested, including doses closer to human exposure than in earlier work, no such safe level could be set.

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7. What the Public Comments Said

The FDA received more than 40 comments on the proposal, from individuals, a grocery chain, a consumer advocacy group and an environmental group. The rule reports that all of them supported revoking the authorization. Its responses, in summary:

• BVO in food generally. Some comments argued against BVO in any food. The FDA replied that § 180.30 covered only flavoring-oil stabilizers in fruit-flavored beverages, and that without it no use of BVO in food is authorized.
• Other substances. Several comments asked the FDA to “ban” other food and color additives and unspecified “poisons and toxins.” The FDA said the rulemaking and its record are specific to BVO, so those requests were outside its scope, while noting that reassessing the safety of substances in food is “an important part of our food safety mission.”
• All brominated oils. One comment asked that all brominated vegetable oils, including brominated soybean oil, be covered. The FDA answered that the term already includes any vegetable oil subjected to bromination, naming brominated soybean, corn, cottonseed, olive and sesame oil.
• Lower-income buyers. Two comments said BVO remained in store-brand, regional and “value” products sold in low-budget stores, so that people with limited income were more exposed. The FDA agreed (section 9).

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8. What the Rule Does Not Do

• It does not cover other bromine-containing additives. A request to evaluate brominated food additives as a group was answered as “outside the scope of this rulemaking.” Potassium bromate is not addressed in the rule; the site describes it on its Potassium Bromate page.
• It does not act on other food or color additives. Requests to ban other additives were likewise outside its scope.
• It does not rest on harm observed directly in people. The finding is that “there is no longer a reasonable certainty of no harm,” based on animal studies at doses relevant to human exposure and the absence of a derivable safe level. The rule’s own words are that there is “no longer a basis to conclude that this use is safe.”
• It did not end use overnight. The one-year compliance period gave companies time to reformulate, relabel and sell through existing stock before enforcement began.

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9. Costs, Benefits and Who Was Most Exposed

The rule’s economic analysis assumes that every product using BVO would be reformulated with another stabilizer. Its estimates, in 2023 dollars:

• First-year costs: about $6.6 million to $16.4 million (the executive summary gives the upper figure as $16.6 million), from reformulation, relabeling, substitute ingredients and possible changes in taste or texture.
• Annualized costs (2 percent discount rate, beyond the baseline of gradual voluntary phase-out): $0.02 million to $0.06 million per year, primary estimate $0.04 million.
• Benefit: reduced exposure to BVO, roughly 0.02 million ounces per year relative to that baseline, over the 2026–2045 horizon. For the rule to be cost-effective, the table states, it would have to prevent more than $2 worth of illness per ounce of reduced exposure each year.

The Office of Information and Regulatory Affairs determined that the rule is not a “significant regulatory action” under Executive Order 12866, and the FDA certified that it would not have a significant economic impact on a substantial number of small businesses, estimating that it would affect at most 2.5 percent of small businesses in beverage manufacturing.

On who was most exposed, the FDA wrote that BVO-containing beverages “are often sugar-sweetened beverages,” that some studies show low-income consumers may drink more of them and so may be disproportionately exposed, and that years of news about manufacturers dropping BVO may have led consumers to stop checking labels, creating “an information asymmetry where consumers incorrectly believe that their food no longer contains BVO.”

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10. Dates and Legal Status as of 11 October 2026

• Proposed: 3 November 2023 (88 FR 75523, FR Doc. 2023-24084); comment period closed 17 January 2024.
• Signed: 18 June 2024.
• Announced: 2 July 2024 (FDA constituent update).
• Published: 3 July 2024 (89 FR 55040).
• Effective: 2 August 2024. The removal of § 180.30 from the Code of Federal Regulations took effect on that date.
• Compliance (enforcement) date: 2 August 2025, one year after the effective date.

Status as of 11 October 2026: final and in force. The compliance date has passed, so the FDA’s enforcement period has begun. A check of the Federal Register through 11 October 2026 found no later FDA document on brominated vegetable oil — no stay, delay, amendment or withdrawal of the rule.

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11. How the Rule Fits Other FDA Food-Chemical Actions

The documents present the BVO rule as part of the FDA’s reassessment of ingredients already in the food supply. The constituent update states that “Reassessing the safety of food ingredients as new, relevant data become available, is a priority for the FDA and a key part of our food safety mission,” and the final rule points readers to the agency’s description of its new approach to reviewing chemicals added to food. In the BVO case the sequence ran from a 2014 review that identified data gaps, through purpose-built animal studies published in 2022, to a proposal in 2023 and a final rule in 2024.

The rule also illustrates what “interim” meant in practice: Part 180 permits additives “on an Interim Basis Pending Additional Study,” and BVO’s three-year interim authorization of 1970 was extended indefinitely in 1974 and remained in place until 2024.

Later FDA actions on food chemicals are reported on their own pages: FDA Revokes Red No. 3 in Food and Ingested Drugs (2025), FDA Moves on Self-Affirmed GRAS and Chemical Reviews (2025), FDA Proposal to Make GRAS Notices Mandatory (2026) and FDA Safety Reassessments of BHA, BHT and ADA (2026). Other 2024 food actions include the PFAS food-packaging phase-out and the lead alerts on ground cinnamon.

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12. Primary Documents

1. Food and Drug Administration, HHS (2024). Revocation of Authorization for Use of Brominated Vegetable Oil in Food; Final Rule. Federal Register 89:55040–55045, 3 July 2024. Docket No. FDA-2023-N-0937; RIN 0910-AI81 — FR Doc. 2024-14300 (official PDF, govinfo.gov)
2. U.S. Food and Drug Administration (2024). FDA Revokes Regulation Allowing the Use of Brominated Vegetable Oil (BVO) in Food. HFP Constituent Update, 2 July 2024 — fda.gov constituent update
3. U.S. Food and Drug Administration. Brominated Vegetable Oil (BVO). Food Additives & Petitions program page, content current as of 2 July 2024 — fda.gov BVO page
4. Food and Drug Administration, HHS (2023). Revocation of Authorization for Use of Brominated Vegetable Oil in Food; Proposed Rule. Federal Register 88:75523–75528, 3 November 2023. Docket No. FDA-2023-N-0937 — FR Doc. 2023-24084
5. Public docket FDA-2023-N-0937 — regulations.gov FDA-2023-N-0937

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Key Research Papers

1. Woodling KA, Chitranshi P, Jacob CC, Loukotková L, Von Tungeln LS, Olson GR, Patton RE, Francke S, Mog SR, Felton RP, Beland FA, Zang Y, Gamboa da Costa G (2022). Toxicological evaluation of brominated vegetable oil in Sprague Dawley rats. Food and Chemical Toxicology 165:113137 — PubMed PMID: 35588981
2. Farber TM, Ritter DL, Weinberger MA, Bierbower G, Tanner JT, Friedman MH, Carter CJ, Earl FL, van Loon EJ (1976). The toxicity of brominated sesame oil and brominated soybean oil in miniature swine. Toxicology 5(3):319-336 — PubMed PMID: 944471
3. Vorhees CV, Butcher RE, Wootten V, Brunner RL (1983). Behavioral and reproductive effects of chronic developmental exposure to brominated vegetable oil in rats. Teratology 28(3):309-318 — PubMed PMID: 6665731
4. Horowitz BZ (1997). Bromism from excessive cola consumption. Journal of Toxicology. Clinical Toxicology 35(3):315-320 — PubMed PMID: 9140329
5. Chitranshi P, Gamboa da Costa G (2016). Simple and rapid quantification of brominated vegetable oil in commercial soft drinks by LC-MS. Food Chemistry 213:567-570 — PubMed PMID: 27451219
6. Rafson JP, Beekman CR, Carlos K (2026). Improved analysis and characterization of brominated vegetable oil in multiple beverages using LC-MS/MS and LC-HRMS. Journal of Agricultural and Food Chemistry 74(35):27978-27985 — PubMed PMID: 42715947

The first paper is the 2022 rat study cited as reference 4 in the final rule. The 1976 swine study and the 1983 rat study are earlier animal work on brominated oils; the 1997 paper is a single case report of bromide poisoning (bromism) in a person who drank large daily volumes of a BVO-containing soft drink; the 2016 and 2026 papers describe FDA laboratory methods for measuring BVO in beverages.

PubMed Topic Searches

1. PubMed: brominated vegetable oil
2. PubMed: brominated vegetable oil and the thyroid
3. PubMed: bromism

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Connections

• FDA Actions of 2024
• FDA and Regulation
• Brominated Vegetable Oil (BVO)
• Food Additives
• Potassium Bromate
• Food Additives Banned in Other Countries
• United States vs European Union: Food Safety
• Iodine and Halide Displacement
• PFAS Food Packaging Phase-Out (2024)
• Lead in Ground Cinnamon (2024)
• “Healthy” Claim Final Rule (2024)
• Red No. 3 Revocation (2025)
• GRAS and Chemical Reviews (2025)
• Mandatory GRAS Notices Proposal (2026)
• BHA, BHT and ADA Reassessments (2026)

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