The U.S. Food and Drug Administration (FDA) has finalized a rule prohibiting the use of brominated vegetable oil (BVO) in food products, including diet sodas. This decision, effective August 2, 2024, marks the end of a century-long presence of BVO in the American food supply and addresses concerns about its potential health risks.
What is Brominated Vegetable Oil?
Brominated vegetable oil (BVO) is a complex mixture of plant-derived triglycerides that have been modified by atoms of the element bromine bonded to the fat molecules. BVO is a vegetable oil modified with bromine, a naturally occurring chemical element, according to the FDA. It is created when the element bromine (Br) is bound to fat molecules in vegetable oil - usually soybean or palm oils.
As authorized, it was used in small amounts, not to exceed 15 parts per million, as a stabilizer for fruit flavoring in beverages to keep the citrus flavoring from floating to the top. Brominated vegetable oil has been used to help emulsify citrus-flavored beverages, especially soft drinks, preventing them from separating during distribution. The additive keeps the flavoring suspended and evenly mixed throughout the beverage. BVO and new mixing substances keep citrus drinks tasting tangy. When used, BVO was required to be listed as an ingredient on the label as “brominated vegetable oil” or as the specific oil that has been brominated, such as “brominated soybean oil”.
BVO can be found in products including:
- Citrus-flavored sodas and sports drinks
- Energy drinks
- Fruit-flavored syrups
- Some baked goods
Careful control of the type of oil used allows bromination of it to produce BVO with a specific density of 1.33 g/mL, which is 33% greater than water (1 g/mL). As a result, it can be mixed with less-dense flavoring agents such as citrus oil to produce an oil which matches the density of water or other products. Alternative food additives used for the same purpose include sucrose acetate isobutyrate (SAIB, E444) and glycerol ester of wood rosin (ester gum, E445). Similar iodinated oils have been used as contrast agents and for goiter prophylaxis in populations with low dietary iodine intake.
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Regulatory History and the FDA's Decision
Initially, BVO was deemed generally recognized as safe (GRAS), a classification of ingredients that are considered safe for human consumption. The FDA first raised concerns about the safety of BVO 50 years before it finally banned it from the food supply.
Here’s a timeline of regulatory action:
- 1920s: BVO is first used as a food additive before the FDA could legally regulate food ingredients.
- 1950s to early 1960s: The FDA put BVO on its list of “generally recognized as safe” (GRAS).
- Late 1960s-1970s: FDA becomes aware of safety concerns and removes it from the GRAS list.
- 1970: On January 27, the FDA concluded that the use of BVO in food was not GRAS because of toxicity concerns under the conditions of use at the time. Studies performed by other regulatory agencies and research institutions on test animals that were fed BVO at levels that far exceeded estimates of most human consumption raised concerns about possible effects on the heart.
- July 28, 1970: The FDA began regulating BVO as a food additive while additional safety studies were conducted. The FDA lowered the amount of BVO allowed in beverages and began regulating it as a food additive.
- 2014: FDA scientists reassessed available information on the safety of BVO and identified areas where additional information on possible health effects was needed and worked to obtain this information.
- Between 2016 and 2020: The FDA published improved methods to more accurately measure the amount of BVO in commercial soft drinks on the market and to measure small amounts of fats in vegetable oil.
- May 16, 2022: The FDA published a study in the journal Food and Chemical Toxicology that evaluated potential health effects related to BVO consumption in rodents. The FDA measured the amounts of BVO present in the animal food and brominated fats in tissues from test animals. We also fed test animals amounts of BVO that simulate real-life exposure. The data from the study 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.
- November 2, 2023: The FDA issued a proposed rule that, if finalized, would revoke the regulation allowing the use of BVO in food.
- July 3, 2024: The FDA issued a final rule to revoke the regulation allowing the use of BVO in food. The rule is effective on August 2, 2024.
After a 1976 study found a correlation between BVO intake and damage to the kidneys, livers, and hearts of animals, FDA determined BVO was no longer safe and limited its use to concentrations currently present in citrus-flavored sodas. The agency stressed that the proposed Human Foods Program, a group of individuals within FDA dedicated to reviewing food ingredients’ health and safety risks, will help speed up the evaluation process. The program will streamline the review process for assessing evidence of potential public health risks of food ingredients by increasing collaboration with organizations that conduct scientific studies of products, such as NIH.
The FDA's decision to ban BVO came after reviewing numerous studies, including a 2022 study that found rats given BVO had the substance's derivatives accumulated in their heart, liver, and fat. 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.
Jim Jones, FDA Deputy Commissioner for Human Foods, emphasized that the prohibition is an “example of how the agency monitors emerging evidence,” especially regarding safety. He points out that the agency is currently reviewing the health impacts of the other ingredients banned by California’s Food Safety Act, including Red Dye No. 3.
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Health Concerns and Potential Side Effects
Brominated vegetable oil can accumulate in the body and has been linked to health hazards, according to the EWG. Those include nervous system damage, headaches, skin and mucous membrane irritation, fatigue and loss of muscle coordination and memory. 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. BVO interferes with the body’s absorption of iodine, a mineral found in fish and salt that promotes the synthesis of hormones in the thyroid. This interference can result in reduced production of essential hormones, leading to metabolic disturbances.
Even though the NIH study focused on the effects of BVO consumption in animals, researchers predict comparable health outcomes in humans because the mechanism of thyroid hormone regulation is similar in both species. In fact, studies show that BVO can also build up in human tissues. The additive can also cause skin rashes and neurological disturbances, such as severe headaches, memory loss, and impaired sleep.
Bromine toxicity through food and beverage sources is very rare. But consuming BVO at very high levels in a relatively short time span can be dangerous. Researchers report a man who drank 2-4 liters of cola containing BVO daily over a month had to go to the hospital. His symptoms included serious fatigue, headache, and memory loss. He even lost his ability to walk. The man improved after dialysis treatment. Another case involves skin sores in a man who drank 8 liters a day of soda that had BVO in it over several months. The man stopped drinking the beverage and was given drug treatment. He got better in four months.
Global Regulations and Market Pressure
BVO has been banned for decades in countries such as Japan, India, and the United Kingdom. Nations and regions with BVO bans in place include:
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- United Kingdom, since the 1970s
- India, since 1990
- European Union, since 2008
- Japan, since 2010
- Canada removed it from its “list of permitted food additives with other accepted uses” in August 2024. But companies were given until the end of August 2025 to get food containing BVO off the shelves.
In the United States, California passed the Food Safety Act, becoming the first state to outlaw the production and sale of products containing BVO and Red Dye No. 3, a common carcinogen found in foods and cosmetics.
Speaking in support of the proposed ban, Scott Farber, Vice President of Government Affairs at the Environmental Working Group, noted that major beverage companies, such as PepsiCo and Coca-Cola, adapted to calls to eliminate BVO as an ingredient faster than FDA. Following a 2012 Change.org petition that obtained 200,000 signatures, the companies replaced BVO with a non-toxic food additive found in chewing gum.
Which Sodas Still Contained BVO?
Although some beverage companies have replaced BVO, most store-brand sodas, including Walmart’s Great Value brand, and sodas from companies including Keurig Dr. Pepper, still contain BVO. market contain BVO.
Examples of products that contained BVO before the ban include:
- Sun Drop, made by Keurig Dr Pepper.
- Dr. Orangette orange soda, sold at Walmart.
- Store-brand orange sodas sold at Giant and HEB.
What to Expect After the Ban
The rule that no longer allows BVO in food will go into effect on August 2, but companies will have one year after that date to reformulate and relabel their products as well as deplete their BVO inventory, according to the FDA statement. Food and beverage makers have until Aug. 2, 2025, to reformulate and relabel products and get rid of old inventory. The agency set an enforcement date of Aug. 2, 2025.
If FDA outlaws the ingredient, beverage brands that continue to use BVO would have to reformulate their products. Supporters of the agency’s ban claim that replacing the ingredient would not be burdensome to beverage companies as there are many comparable alternatives, both in price and quality, currently on the market.
FDA’s proposal is scheduled to be issued as a final rule sometime in 2024. Public comments on the proposed ban note that most sodas containing BVO disproportionately expose low-income consumers to health risks because they are more likely to purchase store-brand soda. In addition, the agency estimates $9 million in public health savings associated with reduced BVO exposure.
How to Identify Products Containing BVO
To determine whether a soda contains BVO, Galligan suggests first looking at the ingredient list, which is required to state if the drink contains BVO. It will say "brominated vegetable oil" or "brominated" and a specific type of oil, such as soybean.
Some other things to look out for to avoid soda with BVO, according to Galligan:
- It's most common in citrus-flavored drinks.
- If the drink looks cloudy throughout the bottle, it may contain BVO.
- Generic, off-brand sodas are more likely to have BVO than name brands.
- If you're drinking fountain soda in a restaurant, they usually carry name brands, so the risk of it having BVO is lower, but ask a restaurant worker about the brand and ingredients if you're concerned.
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