FDA Proposes Revoking Brominated Vegetable Oil (2023)

Table of Contents

1. What the FDA Did
2. What BVO Is and How It Was Used
3. The Legal Terms: GRAS, Food Additive and Revocation
4. Why the FDA Acted: The New Animal Studies
5. What the Proposal Would Change
6. California and the Other Chemicals Under Review
7. The Planned Human Foods Program
8. The Docket and the Comment Period
9. What the Proposal Does Not Do
10. Dates and Legal Status as of October 18, 2026
11. How It Fits Earlier and Later FDA Actions
12. Primary Documents
13. Key Research Papers
14. Connections
15. Featured Videos

1. What the FDA Did

The FDA announced the step on November 2, 2023, in two documents: an FDA statement headed “FDA Proposes to Ban Food Additive, Continues Assessments of Additional Chemicals,” and a constituent update (a short notice the agency sends to industry, advocacy groups and other interested parties) headed “FDA Proposes Rule to Revoke Regulation Allowing the Use of Brominated Vegetable Oil (BVO) in Food.” Both state that the FDA “proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food.”

The formal document is a proposed rule titled “Revocation of Authorization for Use of Brominated Vegetable Oil in Food.” It appeared in the Federal Register (the U.S. government’s daily journal of rules, proposed rules and notices) on November 3, 2023, volume 88, pages 75523–75528, as FR Doc. 2023-24084. It is issued by the Food and Drug Administration within the Department of Health and Human Services, concerns Part 180 of Title 21 of the Code of Federal Regulations, and carries Regulation Identifier Number (RIN) 0910-AI81.

The rule’s summary reads: the FDA “is proposing to amend our regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food. This action is being taken because there is no longer a reasonable certainty of no harm from the continued use of BVO in food.”

The FDA statement says that the agency “concluded that the intended use of BVO in food 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 headline uses the word “ban”; in legal terms the document is a proposal to revoke a food additive regulation.

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2. What BVO Is and How It Was Used

The FDA describes BVO as “a vegetable oil that is modified with bromine,” a chemical element. Its job was physical, not nutritional: according to the FDA statement, it was authorized “for use in small amounts to keep the citrus flavoring from separating and floating to the top of some beverages.”

The FDA’s BVO program page adds that the authorized amount was “not to exceed 15 parts per million,” that it was used “as a stabilizer for fruit flavoring in beverages,” and that when used it had to be listed on the label as “brominated vegetable oil” or as the specific oil that had been brominated, such as “brominated soybean oil.” The same page says BVO had been used as a food ingredient since the 1920s.

By 2023 its use had already shrunk. The FDA wrote that “many beverage makers reformulated their products to replace BVO with an alternative ingredient, and today, few beverages in the U.S. contain BVO.” The constituent update added, in the FDA’s words: “Consumers who wish to avoid products that contain brominated vegetable oil may do so by looking for it by name in the ingredients list.”

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3. The Legal Terms: GRAS, Food Additive and Revocation

Three terms explain what kind of action this was:

• GRAS stands for “Generally Recognized as Safe.” The FDA’s program page says that in the late 1950s and early 1960s the agency considered BVO GRAS and placed it on its original “GRAS list” in the Code of Federal Regulations.
• Food additive regulation. On January 27, 1970, according to the same page, the FDA concluded that BVO in food was not GRAS “because of toxicity concerns under the conditions of use at the time.” Instead of removing it altogether, the agency limited it to a flavoring-oil stabilizer in fruit-flavored beverages at a reduced level, and from July 28, 1970, regulated it as a food additive “while additional safety studies were conducted.” The constituent update says the FDA “has regulated BVO as a food additive since” that 1970 removal. A food additive regulation is the rule that spells out which use of the substance is allowed and at what level.
• Revocation. Revoking that regulation removes the authorization. The proposed rule states that there are “no authorizations for other uses of BVO in food,” so revoking this one would leave BVO with no authorized use in food.

The standard the FDA applied is in the rule’s own phrase: whether there is a “reasonable certainty of no harm” from the use. The FDA concluded there no longer was.

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4. Why the FDA Acted: The New Animal Studies

The constituent update gives the reason for acting in 2023: the FDA “has recent data from studies it conducted that demonstrate adverse health effects in animals at levels more closely approximating real-world human exposure. Based on these data and remaining unresolved safety questions, the FDA can no longer conclude that the use of BVO in food is safe.”

It describes two findings:

• Bioaccumulation of bromine — bromine building up in the animals’ bodies.
• Toxic effects on the thyroid, which the update describes as “a gland that produces hormones that play a key role in regulating blood pressure, body temperature, heart rate, metabolism and the reaction of the body to other hormones.” The site describes the gland’s conditions on its Thyroid Disorders page.

The studies, the update says, were conducted in collaboration with the National Institute of Environmental Health Sciences’ Division of Translational Toxicology (formerly the Division of the National Toxicology Program) “to assess unresolved toxicological questions.” The FDA statement calls them “conclusive scientific evidence to support our proposal.”

The FDA’s program page gives the background. In 2014 FDA scientists reassessed the available information and identified areas where more information on possible health effects was needed. Between 2016 and 2020 the FDA published improved methods to measure BVO in soft drinks and small amounts of fats in vegetable oil, which made it possible to detect brominated fats in the tissues of test animals. On May 16, 2022, the FDA published a rodent study in the journal Food and Chemical Toxicology (Woodling and colleagues, listed under Key Research Papers). The animals were fed amounts of BVO that “simulate real-life exposure.” In the program page’s words, the data “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.” The page adds that the agency also ran a study to identify the level of BVO in the body after it is consumed.

These are animal findings. The program page states the overall conclusion as: “Animal and human data, including new information from recent FDA-led studies on BVO, no longer provide a basis to conclude the use of BVO in food is safe.”

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5. What the Proposal Would Change

The proposed rule’s summary is specific: it “would revoke 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.”

In practice, if finalized, the change would mean that BVO could no longer be used in food in the United States. Because few beverages still contained it, the FDA’s documents present the change as closing out a use that had already declined, rather than removing a widely used ingredient. The program page describes the proposal as one that, “if finalized, would revoke the regulation allowing the use of BVO in food.”

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6. California and the Other Chemicals Under Review

The FDA statement placed the proposal in a wider context. It said: “We recognize that California recently took steps to ban the use of four food ingredients, including BVO, in that state.” It added that the agency is “continuously reviewing and reassessing the safety of a variety of chemicals in food to ensure the science and the law support their safe use in food, including all four ingredients that are part of the recent California law.” The FDA statement does not name the other three ingredients, and this page does not either.

The statement singled out one of them for the FDA’s own process: the agency was “currently reviewing the color additive regulations authorizing the use of FD&C Red No. 3 in ingested drugs and foods (including dietary supplements) under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act.” The statement explains the Delaney Clause as the part of the law that, “in relevant part, prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested.” It said: “A decision from the FDA is forthcoming.” That decision came in January 2025 and is reported on the site’s FDA Revokes Red No. 3 in Food and Ingested Drugs (2025) page.

The statement also describes how the FDA chooses what to review: the agency “prioritizes its review of chemicals in food based on risk, science, and regulatory authority,” and the BVO proposal is “an example of how the agency monitors emerging evidence and, as needed, conducts scientific research to investigate safety related questions, and takes regulatory action when the science does not support the continued safe use of additives in foods.”

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7. The Planned Human Foods Program

The FDA statement linked the proposal to a reorganization then under way: “While these reviews take time, one of the key reasons for the proposed Human Foods Program (HFP) transformation currently underway is to enhance our review of food chemical safety.”

It said the proposed Human Foods Program “would include the creation of the Office of Food Chemical Safety, Dietary Supplements and Innovation where we intend to develop a faster and more nimble process for evaluating chemicals in the food supply.” In November 2023 this was still a plan; the statement describes it as “proposed.”

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8. The Docket and the Comment Period

A proposed rule does not itself change what is allowed; the FDA’s program page describes this one as a rule that, “if finalized,” would revoke the regulation. Before deciding, the agency invited public comments. A Federal Register docket is the public file for a rulemaking, where the proposal and the comments submitted on it are kept. This one is Docket No. FDA-2023-N-0937.

The Federal Register record states: “Either electronic or written comments on the proposed rule must be submitted by January 17, 2024.” The constituent update directed electronic comments to Regulations.gov under that docket number. The comment window ran about ten and a half weeks, from November 3, 2023, to January 17, 2024.

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9. What the Proposal Does Not Do

• It did not end BVO use on its own. It was a proposal. BVO remained authorized under the existing regulation until a final rule took effect, which happened in 2024 (section 10).
• It concerns BVO only. The proposal addresses the single authorization for BVO; it does not act on other bromine-containing additives. Potassium bromate, for instance, is not part of it; the site describes that additive on its Potassium Bromate page.
• It does not decide the other California ingredients. The FDA statement says the agency was reviewing all four, but the proposal itself covers BVO alone; the Red No. 3 review was a separate proceeding.
• It does not rest on harm observed directly in people. The new data the FDA cites are animal studies; the finding is that there is “no longer a reasonable certainty of no harm,” not a count of human illnesses.

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10. Dates and Legal Status as of October 18, 2026

• November 2, 2023: FDA statement and constituent update announce the proposal.
• November 3, 2023: proposed rule published, 88 FR 75523 (FR Doc. 2023-24084; Docket No. FDA-2023-N-0937; RIN 0910-AI81).
• January 17, 2024: comment period closes.
• July 3, 2024: final rule published, 89 FR 55040 (FR Doc. 2024-14300; same docket). Its summary states that it “revokes the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages.”
• August 2, 2024: final rule effective.
• August 2, 2025: compliance date. The FDA program page says the compliance date is one year after the effective date, “to provide the opportunity for companies to reformulate, relabel, and deplete the inventory of BVO-containing products before the FDA begins enforcing the final rule.”

Status as of October 18, 2026: the 2023 proposal was finalized. The revocation is final and in force; the program page now states that “The FDA no longer allows for the use of brominated vegetable oil (BVO) in food.” A check of the Federal Register API through October 18, 2026, found only two documents on brominated vegetable oil since January 2023 — this proposed rule and the July 2024 final rule — and no stay, delay, amendment or withdrawal. The final rule is reported on the site’s 2024 BVO revocation page.

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11. How It Fits Earlier and Later FDA Actions

The FDA program page sets out a long timeline: BVO in use since the 1920s; the 1958 Food Additives Amendment, which gave the FDA specific authority to regulate food ingredients; BVO on the original GRAS list in the late 1950s and early 1960s; its removal from that list on January 27, 1970; regulation as a food additive from July 28, 1970, while longer-term studies were done (studies that, the page says, “resolved the safety concerns related to the heart”); the 2014 reassessment; new measurement methods from 2016 to 2020; the 2022 rodent study; the 2023 proposal; and the 2024 final rule.

The constituent update describes the proposal as “part of our regulatory authority over ingredients added to food, which includes reassessing previously evaluated food ingredients and addressing safety concerns,” and 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.”

Later FDA food-chemical actions are reported on their own pages: the 2024 BVO final rule, the 2024 PFAS food-packaging phase-out, the 2025 Red No. 3 revocation, the 2025 moves on self-affirmed GRAS and chemical reviews, the 2026 proposal to make GRAS notices mandatory, the 2026 reassessments of BHA, BHT and ADA and the FDA food dye actions of 2026. Other 2023 food actions are collected on the FDA Actions of 2023 page.

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12. Primary Documents

1. Food and Drug Administration, HHS (2023). Revocation of Authorization for Use of Brominated Vegetable Oil in Food; Proposed Rule. Federal Register 88:75523–75528, November 3, 2023. Docket No. FDA-2023-N-0937; RIN 0910-AI81 — FR Doc. 2023-24084
2. U.S. Food and Drug Administration (2023). FDA Proposes to Ban Food Additive, Continues Assessments of Additional Chemicals. FDA statement, November 2, 2023 — fda.gov statement
3. U.S. Food and Drug Administration (2023). FDA Proposes Rule to Revoke Regulation Allowing the Use of Brominated Vegetable Oil (BVO) in Food. HFP Constituent Update, November 2, 2023 — fda.gov constituent update
4. U.S. Food and Drug Administration. Brominated Vegetable Oil (BVO). Food Additives & Petitions program page, content current as of July 2, 2024 — fda.gov BVO page
5. Food and Drug Administration, HHS (2024). Revocation of Authorization for Use of Brominated Vegetable Oil in Food; Final Rule. Federal Register 89:55040, July 3, 2024. Docket No. FDA-2023-N-0937 (later status) — FR Doc. 2024-14300
6. 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. 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
3. 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
4. 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
5. Carroll JE, Norris BJ, Villadiego A, Wheeler SD (1984). Brominated vegetable oil myopathy: inhibition at multiple sites. Muscle & Nerve 7(8):642-646 — PubMed PMID: 6242313
6. Horowitz BZ (1997). Bromism from excessive cola consumption. Journal of Toxicology. Clinical Toxicology 35(3):315-320 — PubMed PMID: 9140329

The first paper is the 2022 FDA rodent study the program page describes; the second is one of the FDA laboratory methods for measuring BVO in soft drinks. The 1976 swine study, the 1983 rat study and the 1984 muscle 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 volumes of a soft drink.

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 2023
• FDA and Regulation
• BVO Revocation Final Rule (2024)
• Brominated Vegetable Oil (BVO)
• Food Additives
• Potassium Bromate
• Food Additives Banned in Other Countries
• United States vs European Union: Food Safety
• Thyroid Disorders
• Iodine and Halide Displacement
• Red No. 3 Revocation (2025)
• GRAS and Chemical Reviews (2025)
• FDA Food Dye Actions (2026)
• Lead in Cinnamon Applesauce Pouches (2023)
• Sesame Becomes the Ninth Major Allergen (2023)
• Infant Formula Safety Letters (2023)
• Plant-Based Milk Labeling Draft (2023)

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