Brominated Vegetable Oil (BVO): FDA Revocation, State Bans, and What It Means for Beverage Companies

What Is Brominated Vegetable Oil?

Brominated vegetable oil (BVO) is a synthetic food additive created by reacting vegetable oil — typically soybean or corn oil — with bromine, a heavy halogen element. The bromination process increases the density of the oil so that it closely matches the density of water, which makes it useful as an emulsifier in citrus-flavored beverages. Without a weighting agent like BVO, the flavoring oils in drinks such as citrus sodas and sports drinks would float to the top, creating an unappealing ring of oil at the surface.

Property	Value
Chemical Name	Brominated vegetable oil
CAS Number	8016-94-2
UNII	93WH4D2435
Former CFR	21 CFR 180.30 (revoked)
Former Max Level	15 ppm in finished beverage

BVO appeared on ingredient labels of household-name products including Mountain Dew, Fanta, Sun Drop, Squirt, Fresca, and various Gatorade formulations. From a chemical standpoint, BVO is a complex mixture of brominated triglycerides. The bromine atoms that give BVO its density-matching properties are the same atoms that ultimately raised safety concerns — bromine bioaccumulates in human tissue, and the body eliminates it extremely slowly.

For most of its commercial life, BVO occupied a regulatory gray zone. It was technically authorized for use, but only under an "interim" designation that was never finalized. That interim status persisted for over fifty years — until the FDA acted decisively in 2024.

FDA Regulatory Status

As of March 2026, brominated vegetable oil is no longer authorized for use in food in the United States. The FDA published a final rule on July 3, 2024 (89 FR 55040), revoking the regulation at 21 CFR 180.30 that had permitted BVO as a stabilizer for flavoring oils in fruit-flavored beverages at concentrations not exceeding 15 parts per million (ppm) in the finished beverage.

The rule became effective on August 2, 2024. The compliance date — the date after which the FDA would begin enforcement — was August 2, 2025. That deadline has now passed. Any food or beverage product manufactured, distributed, or sold in the United States that contains BVO is in violation of federal food safety law.

This revocation is historically significant. BVO is the first food additive whose authorization the FDA has formally revoked in decades. The agency's action signaled a broader willingness to revisit long-standing food additive approvals, and it set the stage for the subsequent revocation of FD&C Red No. 3 in early 2025.

The Interim Food Additive Framework

BVO was regulated under 21 CFR Part 180, which covers "Interim Food Additives." This part of the Code of Federal Regulations was created specifically for substances that were once considered Generally Recognized as Safe (GRAS) but lost that status based on emerging safety data. Substances placed in Part 180 were authorized for continued use on a temporary basis while additional safety studies were conducted.

The revocation removed Section 180.30 from the CFR entirely. There is no longer any federal authorization for BVO in food, regardless of concentration.

The 54-Year Timeline: From GRAS to Revocation

1958: GRAS Designation

When the Food Additives Amendment of 1958 established the modern framework for food additive regulation, BVO was classified as Generally Recognized as Safe (GRAS). It entered widespread commercial use in citrus-flavored soft drinks.

1969–1970: Safety Concerns Emerge

In 1969, the Canadian Food and Drug Directorate published toxicity studies indicating that BVO caused organ damage in test animals, particularly affecting the heart, liver, and kidneys. Bromine from BVO was found to accumulate in fatty tissues.

The FDA removed BVO from the GRAS list in 1970. Rather than banning it outright, the FDA established an interim food additive regulation on July 28, 1970 (35 FR 12062) authorizing continued use under strict conditions: only as a stabilizer for flavoring oils in fruit-flavored beverages, at no more than 15 ppm. This authorization was explicitly temporary — granted for three years while additional safety data were gathered.

1974: The Indefinite Extension

When the three-year interim period expired without resolution, the FDA extended BVO's authorization indefinitely on October 8, 1974 (39 FR 36113). This extension would last for the next fifty years.

2012–2014: Public Pressure Builds

A petition on Change.org calling on PepsiCo to remove BVO from Gatorade gathered over 200,000 signatures in 2012. In January 2013, PepsiCo announced it would remove BVO from Gatorade, replacing it with sucrose acetate isobutyrate (SAIB). In May 2014, both Coca-Cola and PepsiCo pledged to remove BVO from all products.

2022: The NIH Studies

Studies from a collaboration between FDA's CFSAN, the National Center for Toxicological Research (NCTR), and NIEHS examined dietary BVO exposure in rats at doses approximating real-world human consumption. The findings were definitive:

• Thyroid toxicity: Statistically significant increases in thyroid follicular cell hypertrophy. Elevated serum TSH, decreased serum T4 — indicating disruption of the hypothalamic-pituitary-thyroid axis.
• Bromine bioaccumulation: Brominated fatty acids accumulated in heart, liver, and fat tissue. Estimated persistence of up to 587 days after BVO removal from diet.
• Dose relevance: Adverse effects occurred at exposure levels relevant to consumers who regularly drank BVO-containing beverages.

2023: Proposed Rule

On November 3, 2023, the FDA published a proposed rule to revoke BVO authorization (Docket No. FDA-2023-N-0937). The comment period ran through January 17, 2024. All public comments supported revocation.

2024: Final Rule

The final rule was published on July 3, 2024 (89 FR 55040), removing 21 CFR 180.30 from the CFR. The FDA concluded that "there is no longer a basis to conclude that this use is safe."

Key Deadlines

Date	Event	Status
November 3, 2023	FDA proposed rule published	Complete
October 7, 2023	California AB 418 signed into law	Complete
July 3, 2024	FDA final rule published (89 FR 55040)	Complete
August 2, 2024	Final rule effective	Complete
August 2, 2025	FDA compliance deadline — BVO no longer permitted	Passed
January 1, 2027	California AB 418 enforcement begins	Upcoming

California AB 418: The State-Level Catalyst

Governor Gavin Newsom signed AB 418, the California Food Safety Act, on October 7, 2023. The law prohibits the manufacture, sale, or distribution of food products containing four substances in California:

1. Brominated vegetable oil
2. Potassium bromate
3. Propylparaben
4. Red Dye No. 3 (FD&C Red No. 3)

The California ban takes effect on January 1, 2027. While the FDA's federal revocation of BVO technically renders the California BVO provision redundant at the federal level, AB 418 remains significant:

• Independent enforcement pathway: California's law creates state-level enforcement with its own penalties, separate from FDA enforcement.
• Precedent for state action: AB 418 demonstrated that states would not wait for the FDA to act, accelerating federal action.
• Broader scope: The law covers three additional substances beyond BVO.

As of early 2026, over 140 food additive bills have been introduced across 38 states following AB 418's template.

International Status

The United States was a latecomer to restricting BVO. Most major jurisdictions banned it years or decades earlier:

Jurisdiction	Status	Year
United Kingdom	Banned	1970
India	Banned	1990
European Union	Not authorized (Regulation EC 1333/2008)	2008
Japan	Banned	2010
Canada	Banned	2024
United States	Revoked (21 CFR 180.30 removed)	2024 (compliance 2025)

The EU uses a "positive list" approach under Regulation (EC) No 1333/2008, where only food additives explicitly listed may be used. BVO does not appear on these lists, meaning it is effectively prohibited. Canada moved to ban BVO in August 2024, shortly after the FDA's final rule.

Affected Product Categories

BVO's use was limited to stabilizing flavoring oils in fruit-flavored beverages:

• Citrus-flavored soft drinks: Mountain Dew, Sun Drop, Squirt, and various citrus sodas
• Fruit-flavored sports drinks: Certain Gatorade and Powerade formulations
• Citrus-flavored energy drinks: Some energy drink products
• Store-brand and regional citrus beverages: Private-label citrus sodas were among the last to reformulate

Industry Reformulation Status

By the time of the FDA's 2024 final rule, most major brands had already reformulated:

• PepsiCo: Removed from Gatorade (2013), Mountain Dew (~2020)
• Coca-Cola: Removed from Fanta, Fresca, Powerade (2014-2016)
• Keurig Dr Pepper: Sun Drop reformulation completed by end of 2024

The American Beverage Association reported broad industry compliance ahead of the August 2025 deadline. Smaller regional brands and store-label products were the last to transition.

Replacement Ingredients

• Sucrose acetate isobutyrate (SAIB): Authorized under 21 CFR 172.833. EU-approved as E444.
• Glycerol ester of wood rosin (ester gum): Authorized under 21 CFR 172.735. EU-approved as E445.

Both alternatives perform the same weighting function without bromine-related safety concerns.

What Companies Should Do

Immediate Actions

1. Verify BVO-free formulations. Audit all products including legacy formulations, seasonal products, limited editions, and co-manufactured products. The compliance deadline has passed — any product containing BVO is in violation.

2. Review supplier certificates. If you use pre-blended flavor systems or emulsion concentrates from third-party suppliers, confirm BVO is not present. There is no de minimis exception.

3. Check labeling. Ensure current labels do not list BVO. Replace older label stock still in circulation.

Ongoing Compliance

4. Monitor state legislation. California AB 418 creates an independent enforcement mechanism effective January 1, 2027. New York and other states are pursuing similar legislation covering additional substances.

5. Document reformulation. Maintain records of when BVO was removed, replacement ingredients used (SAIB, ester gum), and the safety basis for replacements.

6. Supply chain communication. Ensure contract manufacturers and co-packers have updated their formulations.

Strategic Considerations

7. Prepare for broader additive scrutiny. The BVO revocation is part of a larger trend. The FDA has signaled increased willingness to revisit long-standing food additive approvals, as evidenced by the subsequent Red No. 3 revocation and the BHA review process.

8. Track the state patchwork. Over 140 food additive bills across 38 states are creating a complex compliance landscape that requires systematic monitoring.

Regulatory Intelligence

Policy Canary tracks regulatory developments affecting brominated vegetable oil and other food additives across FDA, state legislatures, and international bodies. Subscribe to receive alerts when new regulatory actions affect your products.

BVO is one of four substances covered by California AB 418. For information on the other three, see our pages on potassium bromate, propylparaben, and Red No. 3.