BVO
FDA proposes ban on potentially harmful ingredient found in some sodas
Kristen Rogers, CNN
Fri, November 3, 2023
The US Food and Drug Administration has proposed revoking its regulation authorizing the nationwide use of brominated vegetable oil, or BVO, as an additive in food.
The FDA’s decision comes after California banned the ingredient in October by passing the California Food Safety Act, the first state law in the United States to ban brominated vegetable oil. The additive is already banned in Europe and Japan.
“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 … found the potential for adverse health effects in humans,” said James Jones, the FDA’s deputy commissioner for human foods, in a statement.
Brominated vegetable oil — vegetable oil modified by bromine, a pungent, deep red oily chemical — is used as an emulsifier in citrus-flavored beverages to keep the flavoring from separating and floating to the top. Bromine is also commonly used in flame retardants.
It’s possible that dozens of products — mostly sodas — use brominated vegetable oil as an ingredient, according to the Eat Well Guide by the Environmental Working Group, a nonprofit research and advocacy group that focuses on consumer health, toxic chemicals and pollutants.
The low number of products containing this ingredient is due to past restrictions by the FDA.
“In 1970, the FDA determined BVO was no longer ‘Generally Recognized as Safe’ … and began overseeing its use under our food additive regulations,” Jones said in a statement. “Over the years many beverage makers reformulated their products to replace BVO with an alternative ingredient, and today, few beverages in the U.S. contain BVO.”
Additionally, a 2012 petition with more than 200,000 signatures also brought attention to health concerns, according to an EWG news release. It also said many companies eliminated it from consumer products due to market pressure.
How brominated vegetable oil could harm health
Brominated vegetable oil has been linked to health hazards including nervous system damage, headaches, skin and mucous membrane irritation, fatigue, and loss of muscle coordination and memory, according to the EWG. The ingredient can also accumulate in the body over time.
The studies motivating the FDA’s decision were conducted in animals, but the observed negative health effects were at levels closely approximating real-world human exposure, according to a news release. One harm some research found is toxic effects on the thyroid gland, which produces hormones critical for the regulation of blood pressure, heart rate, body temperature and metabolism.
“Today’s announcement will ensure everyone has access to products that don’t contain BVO,” Scott Faber, the EWG’s senior vice president for government affairs, said in a statement.
Jones of the FDA said the proposed ban “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.”
A final decision is yet to come — following reception of comments through January 17, 2024, and a review process — but if you want to avoid consuming brominated vegetable oil until then, check the ingredients lists of products before you buy them.
Jenny McGrath,Maiya Focht
Fri, 3 November 2023
Check the ingredients list for traces of brominated vegetable oil.Stefania Pelfini, La Waziya Photography / Getty Images / Amazon
The US Food and Drug Administration announced it wants to ban the additive brominated vegetable oil.
The product helps stabilize citrus flavor in some sodas and juices, but can build up in the body.
A final decision will be made in the coming year, but other countries have long since banned it.
This week, the US Food and Drug Administration proposed revoking a regulation that authorizes the use of brominated vegetable oil in food.
Food companies have used the additive BVO since the 1920s. For decades, manufacturers used it to keep fruit flavoring in a stable form that doesn't separate and rise to the top. It was used in some sodas, fruit juices, and other drinks with citrus oil.
"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," James Jones, the FDA's deputy commissioner for human foods, said in a statement released Thursday.
He noted that the move follows a recent ban on the ingredient in California. In October, California Gov. Gavin Newsom signed a law prohibiting the sale of food or drink items with BVO and other ingredients like red dye 3 and potassium bromate.
The FDA is accepting comments on its proposal through January 17, 2024.
How can you tell what drinks contain BVO?
In 1958, the FDA gained the authority to determine the safety of food ingredients. In the years following, it listed BVO as generally recognized as safe.
Over the years, new data showed potential health effects, and the FDA removed it from the GRAS list in the '60s. The agency limited its use to a stabilizer that couldn't exceed the level of 15 parts per million in the drinks.
The FDA notes that many beverage companies have since found alternative stabilizers. For example, in 2014, Coca-Cola announced it was removing BVO from Powerade drinks.
But you may still find BVO in some soft drinks or other fruit-flavored drinks.
If you want to avoid BVO, you should check the ingredients in sodas, fruit drinks, lemonade, and juices.
When used, BVO is 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 side effects
The FDA has been monitoring the effects of BVO since the 1970s, after a report showed that it could cause heart problems when taken in large doses, according to the agency's press release. In the decades since, sparse reports have emerged about its potential harms.
There are anecdotal reports of people visiting the hospital with telltale signs of bromine poisoning — headache, fatigue, memory loss, and problems walking. In one 1997 case, doctors determined that a patient had gotten the condition from drinking 2-4 liters of soda with BVO in it a day.
BVO can also hurt the parts of your body used in eating and drinking, Katherine Zeratsky, a registered dietitian at the Mayo Clinic, told Food Network. "Health concerns about BVO stem from one of its ingredients, bromine. Bromine can irritate the skin, nose, mouth" she said.
In a 2022 report published in the journal Food and Chemical Toxicology, the FDA found that BVO may build up in mice thyroids over time, becoming toxic. Though they conducted these tests in mice, not humans, the agency deemed its results were significant enough to recommend against the use of BVO in food.
In humans, thyroids help control blood pressure, temperature, heart rate, and metabolism. Thyroid damage can cause weight fluctuations, heart rate irregularity, decreased energy, poor bone health, and more.
The final results of the proposal won't be fully processed until 2024, CNN reported.
An ingredient once commonly used in citrus-flavored sodas to keep the tangy taste mixed thoroughly through the beverage could finally be banned for good across the US.
The FDA has proposed to revoke the registration of a modified vegetable oil known as BVO in the wake of recent toxicology studies that make it difficult to support its ongoing use.
"The proposed action 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," says James Jones, FDA deputy commissioner for human foods.
BVO, or brominated vegetable oil, has been used as an emulsifying agent since the 1930s to ensure citrus flavoring agents don't float to the top of sodas. Sticking a dozen bromine atoms to a triglyceride creates a dense oil that floats evenly throughout water when mixed with less dense fats.
Yet that's not BVO's only trick. Animal studies have strongly implied the compound can slowly build up in our fat tissues. With bromine's potential ability to prevent iodine from doing its all-important work inside the thyroid, health authorities around the world have been suspicious of the emulsifier's risks for decades.
In fact, BVO is already banned in many countries, including India, Japan, and nations of the European Union, and was outlawed in the state of California just last October with legislation due to take effect in 2027.
Yet the FDA has been slow to convince. In the 1950s, the agency regarded the ingredient as generally recognized as safe (GRAS); an official classification afforded items that have either been appropriately tested or – for ingredients in common use prior to 1958 – don't appear to be harmful.
That changed the following decade when questions were raised over its possible toxicity, prompting the FDA to overturn its GRAS classification for BVO and temporarily limit its use to relatively small concentrations of no more than 15 parts per million exclusively in citrus-flavored drinks.
Data on the risks posed by even these small amounts of BVO over time hasn't been easy to collect, relying heavily on long-term studies that re-evaluate health effects in a significantly-sized sample of people. Yet the evidence has been slowly mounting.
A UK study in the 1970s found bromine was building up in human tissues, with animal studies linking high concentrations of BVO with heart and behavioral problems.
It's taken time, and a number of further studies, but on the back of more recent animal studies based on relative concentrations of BVO humans are likely to ingest, the FDA is finally convinced there is sufficient evidence to ban its use altogether.
Most major soda drink companies are fortunately ahead of the game. PepsiCo and Coca-Cola Co. have been phasing the ingredient out of their products over the past decade.
"Over the years many beverage makers reformulated their products to replace BVO with an alternative ingredient, and today, few beverages in the US contain BVO," says Jones.
The ban could be a sign of more things to come, with Jones announcing the agency is reviewing regulations that authorize the use of certain food additives, with a view to automatically prohibit the approval of any food coloring agents found to cause cancer in humans or animals, making for a more nimble bureaucratic process.
A final call on the FDA's reclassification of BVO still needs to go through a lengthy review process that is unlikely to be completed before early 2024.
With suitable alternatives to BVO already being used to make citrus drinks around the world taste tangy down to the very last drop, the ingredient isn't likely to be missed.
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