Brominated vegetable oil (BVO) is a complex mixture derived from plant triglycerides modified by bromine atoms bonded to the fat molecules. It has been historically used as an emulsifier in citrus-flavored beverages, especially soft drinks, to prevent the separation of flavorings during distribution. However, due to mounting health concerns and regulatory actions, BVO's use has been significantly curtailed.
Function and Properties of BVO
BVO is created by carefully controlling the bromination of specific plant oils to achieve a density of 1.33 g/mL, which is 33% greater than water. This specific density allows BVO to effectively mix with less dense flavoring agents like citrus oil, creating an oil mixture that matches the density of water or other beverage components, thereby preventing separation.
Alternative food additives with similar emulsifying functions include sucrose acetate isobutyrate (SAIB, E444) and glycerol ester of wood rosin (ester gum, E445). Historically, similar iodinated oils have been used as contrast agents and for goiter prophylaxis in populations with low dietary iodine intake.
Regulatory Status and Bans
Historical Context
BVO's journey through regulatory scrutiny began in the late 1960s when the FDA removed it from the "Generally Recognized as Safe" (GRAS) list due to emerging safety concerns. This action permitted its use only on an "interim" basis, pending additional studies, making it one of the few additives in federal regulations with such a designation.
Global Bans
Several countries and regions have banned the use of BVO in food and beverages:
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- United Kingdom: Banned since the 1970s.
- India: Banned since 1990.
- European Union: Banned since 2008.
- Japan: Banned since 2010.
- Canada: Removed BVO from its list of permitted food additives in August 2024, with a compliance deadline for food manufacturers by the end of August 2025.
United States
The FDA's stance on BVO evolved over several decades. Initially, BVO was regulated as a food additive with usage limits, not exceeding 15 parts per million, as a stabilizer for fruit flavoring in beverages. The FDA required that products containing BVO list it as an ingredient, either as "brominated vegetable oil" or the specific brominated oil, such as "brominated soybean oil".
- 2023: The FDA proposed a rule to ban the use of BVO in food due to safety concerns identified in multiple studies.
- 2024: The FDA finalized the rule to revoke the regulation allowing the use of BVO in food, effective August 2, 2024. This decision was based on studies conducted in collaboration with the National Institutes of Health (NIH), which indicated potential adverse health effects in humans.
Beverage makers were given until August 2, 2025, to reformulate and relabel their products, and to remove any old inventory containing BVO from store shelves.
California's Ban
California passed a law (AB 418) in October 2023, prohibiting the use of BVO, among other additives, in foods sold in the state. Food companies have until 2027 to comply with this regulation.
Health Concerns and Toxicity
Potential Health Effects
Concerns about BVO stem from studies indicating that it can accumulate in body fat and organs such as the liver, heart, and brain. Excessive bromine accumulation in the body can lead to bromine toxicity, which may cause damage to the central nervous system, headaches, nausea, memory loss, and loss of coordination.
Rachel Gargano, chief registered dietitian at Live it Up in Contra Costa County, California, notes, "Research has indicated that when BVO is consumed, brominated fat molecules collect in fat tissue as well as organs like the heart and lungs. BVO can disrupt thyroid function as bromine competes with iodine, which is essential for proper thyroid function. This disruption can potentially create a hormonal imbalance affecting energy levels, weight, mood, and reproductive health."
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Bromine Toxicity
Bromine toxicity through food and beverage sources is rare, but consuming very high levels of BVO in a short period can be dangerous. There have been case reports of adverse effects associated with excessive consumption of BVO-containing products.
- One case involved a man who consumed two to four liters of cola containing BVO daily for a month. He experienced severe fatigue, headache, memory loss, and an inability to walk. His condition improved after dialysis treatment.
- Another case involved a man who developed skin sores after drinking eight liters of soda containing BVO daily for several months. He recovered after discontinuing the beverage and receiving drug treatment.
Animal Studies
A 2022 FDA study on rodents found that exposure to BVO was associated with increased tissue levels of bromine. At high levels of exposure, the thyroid gland was identified as a target organ for potential negative health effects. In this study, rats fed BVO at levels similar to what some people might consume through food and beverages showed significant increases in bromide in their blood and elevated levels of brominated triglycerides in their heart, lung, and fat tissue. Changes in thyroid hormone levels and impacts on the thyroid gland were also observed.
FDA's Rationale for the Ban
The FDA's decision to ban BVO was driven by concerns over long-term exposure and accumulation in fat tissues. Maura Harrigan, a certified specialist in oncology nutrition at the Yale School of Public Health and Yale Cancer Center, explains that the FDA could not determine a safe level of exposure, leading to the ban.
Products That Contained BVO
Historically, BVO was found in various products, particularly citrus-flavored sodas and sports drinks. Some examples include:
- Citrus-flavored sodas and sports drinks.
- Energy drinks.
- Fruit-flavored syrups.
- Some baked goods.
Major brands like Pepsi and Coca-Cola had already removed BVO from their products before the FDA ban. However, some smaller brands and store brands may have continued to use it until the enforcement date. Examples of products that may have contained BVO include:
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- Multiple flavors of D&G Genuine Jamaican Soda.
- Sun Drop.
- Several store-brand soft drinks, such as HEB Orange Burst and Giant Orange Soda.
- Citrus-flavored juice beverages like Borden’s Pineapple Orange Sun Burst.
What the BVO Ban Means for Consumers
With the FDA's ban on BVO, consumers can expect that most major beverage products will no longer contain this additive. The beverage industry has been phasing out BVO for years, particularly in response to regulations like California's ban. Companies that rely on California sales are likely to reformulate their products to comply with the new regulations, and these BVO-free versions will likely be sold across all 50 states.
Checking Labels
Consumers can ensure they are not consuming BVO by checking the ingredient labels of fruit-flavored beverages and avoiding those that list "brominated vegetable oil" or "brominated soybean oil." Additionally, choosing water instead of sugary sodas is a healthier option.
Impact on the Beverage Industry
The ban on BVO necessitates that beverage manufacturers find alternative emulsifiers or reformulate their products. While this may require some adjustments to production processes, many companies have already successfully transitioned to BVO-free formulations.
Alternatives to BVO
The food and beverage industry has several alternative emulsifiers available to replace BVO. Some of the most common include:
- Sucrose Acetate Isobutyrate (SAIB, E444): A synthetic food additive used as a stabilizer in beverages.
- Glycerol Ester of Wood Rosin (Ester Gum, E445): Derived from pine trees, this additive is used to increase the density of citrus oils in beverages.
These alternatives perform similar functions to BVO, helping to keep flavorings evenly distributed in beverages and preventing separation.
Historical Timeline of Regulatory Action
The FDA's actions regarding BVO have unfolded over several decades:
- 1920s: BVO is first used as a food additive before the FDA had the legal authority to regulate food ingredients.
- 1950s to early 1960s: The FDA places BVO on its list of "generally recognized as safe" (GRAS) substances.
- Late 1960s-1970s: The FDA becomes aware of safety concerns and removes BVO from the GRAS list. The agency lowers the amount of BVO allowed in beverages and begins regulating it as a food additive.
- 1970: Studies raise questions about potential harm to the heart from BVO.
- 2022: The FDA publishes data from a study on rodents that showed potential danger to thyroid function, raising concerns about human health.
- 2023: The agency proposes a rule to ban the use of BVO in food based on studies showing it was not safe.
- 2024: The rule is finalized and effective on August 2. Food companies are given a year to reformulate their products and remove old inventory containing BVO.
The Role of the FDA
The FDA plays a crucial role in ensuring the safety of food additives. The agency continuously evaluates scientific data and research findings to determine whether additives are safe for human consumption. The FDA's recent actions on BVO reflect its commitment to reassessing previously evaluated food ingredients and addressing safety concerns based on the latest scientific evidence.
Jim Jones, the deputy commissioner for the FDA's Human Foods Program, stated that the "removal of the only authorized use of BVO from the food supply was based on a thorough review of current science and research findings that raised safety concerns."
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