Buzz
It seems like an American norm that the FDA only bans a controversial ingredient after most companies have already discontinued it—that’s how things unfolded with trans fats and BPA in baby bottles. Now, brominated vegetable oil (BVO) is set to join the list. It was once an ingredient in Mountain Dew and can still be found in some citrus-flavored sodas today.
On Thursday, the FDA revealed its intention to withdraw the rule that considers BVO safe in small amounts. Currently, BVO can be used at concentrations of 15 ppm or below, pending the results of further toxicology studies the agency is supposed to review periodically. It appears that these reviews have ultimately shifted some perspectives.
So, what exactly is BVO?
Brominated vegetable oil is an emulsifier used in sodas with citrus flavors. Without it, the oil would separate from the drink, potentially creating a film or ring at the top, as the oil is less dense than water.
BVO gets its name from the addition of bromine to the oil molecules. This makes the oil denser, preventing it from floating and helping the tiny droplets of BVO and flavoring oils remain evenly dispersed throughout the beverage.
If you’ve heard that BVO is also used as a flame retardant, that’s somewhat misleading; there are brominated compounds used for flame retardation, but the BVO found in beverages is a different version.
Why is it being banned now?
Concerns about BVO’s safety have been around for decades, but sufficient research hadn’t been conducted to provide a clear answer. In 1970, the FDA decided that it could no longer classify BVO as “generally recognized as safe”; in 1977, after discussions with food manufacturers, they allowed it again, but at much lower doses (initially permitted at 150 ppm, it was reduced to a limit of 15 ppm in 1977).
Countries such as Australia, Japan, and various European Union members completely prohibit BVO in food and drinks. Manufacturers can substitute BVO with other ingredients like sucrose acetate isobutyrate (SAIB), glycerol ester of rosin (known as ester gum), and locust bean gum, all of which are allowed by FDA regulations.
In 2014, the FDA acknowledged that there was insufficient data to definitively determine BVO’s safety for continued use in the market. To address remaining concerns, they commissioned rat studies. The FDA now states that the results of these studies “do not support [the] safety of BVO used as a food ingredient.”
What are the issues with BVO?
One major concern is that bromine has a chemical structure similar to iodine, which is essential for thyroid hormone production in our bodies. There are worries that bromine could replace iodine in the thyroid, potentially causing thyroid problems. The latest FDA studies suggest that large amounts of BVO cause thyroid toxicity in rats, supporting earlier findings from studies conducted on rats and pigs.
Another concern is the possibility of bromine accumulation in our bodies over time. The recent FDA studies confirmed this issue. This presents a problem, not only because bromine may be toxic, but because its accumulation complicates safety research. Even if a person is given a set dose of bromine in a study, it’s difficult to know the actual amount in their body.
There are still many unanswered questions. Does BVO really cause thyroid toxicity at the levels typically found in orange soda? We don’t have a definitive answer. It might not. We also don’t know if BVO could potentially affect other organs or processes in the body. However, the FDA has stated that after reviewing the evidence on thyroid toxicity and bioaccumulation, it has no intention of conducting further safety studies.
Despite lingering safety concerns regarding the possibility of developmental and reproductive toxicity from dietary exposure to BVO, we believe that addressing these unresolved issues is unnecessary to conclude that there is no longer any reasonable certainty of harm from this substance. Consequently, we propose to revoke BVO's interim approval as a food additive.
In other words, BVO was permitted because it was initially assumed to be harmless to consumers. The FDA hasn’t declared it to be harmful, but it has decided to stop assuming BVO is safe. This is enough for the substance to be removed from the market.
Which sodas contain BVO?
In 2014, both Pepsi and Coca-Cola announced they would stop using BVO in their beverages. If you look at the labels of Mountain Dew (produced by Pepsi) or other popular sodas, you're unlikely to find it listed anymore.
Although the additive is still found in Sun Drop citrus soda, Giant’s store brand orange soda, and Walmart’s store brand version of Mountain Dew, Great Value Mountain Lightning, to name a few, it remains in use. If a soda contains BVO, the ingredients label will list 'brominated vegetable oil' (typically near the end, since it’s only in trace amounts).
When is the rule expected to be implemented?
The FDA has suggested a new regulation that would prohibit the use of the ingredient, and they are currently collecting public feedback on this proposal until January 17, 2024. There’s no set date yet for when the final rule will be issued.
Once the final rule is published, it will become 'effective' 30 days later, and manufacturers will have a year to stop selling products containing BVO. Therefore, the ban might take effect as early as 2025.
