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Touted as safe for over a century, the U.S. Food and Drug Administration (FDA) on Nov. 2 proposed banning a potentially harmful food additive once widely used in popular drinks like Gatorade and Mountain Dew after studies showed the ingredient could cause adverse health effects in humans. 

Patented by chemical companies as a flame retardant and banned in food throughout Europe and Japan, brominated vegetable oil (BVO) has been used in North America since the 1920s as an emulsifier in fruit-flavored beverages.

BVO is derived from soybean or corn and contains bromine atoms that keep citrus oils from floating to the top of the drink—or, in the case of flame retardants, restrict the chemical reactions that cause a fire.

Evidence Confirms The Toxicity of This Food Additive

Recent toxicology studies conducted in collaboration with the NIH [National Institutes of Health] have now given us conclusive scientific evidence to support our proposal to remove the FDA’s food additive authorization for BVO,” FDA deputy commissioner for human foods, James Jones, said in a statement

Toxicological studies in rats found that BVO is associated with increased tissue levels of inorganic and organic bromine and targets the thyroid—a vital gland that plays a significant role in regulating blood pressure, heart rate, metabolism, and growth. 

According to the Environmental Working Group, BVO may cause nervous system disorders and accumulate in the body. Drinking large amounts of beverages containing BVO over time can lead to headaches, skin irritation, fatigue, loss of muscle coordination, and memory problems.

Other peer-reviewed studies have linked BVO to neurological problems, thyroid, heart, and liver problems, as well as behavioral, developmental, and reproductive issues.

“Toxic additives like BVO that have been shown to pose toxic risks to the thyroid and other chronic health problems should not be allowed in our food,” Brian Ronholm, director of food policy at Consumer Reports, said in a statement. “We’re encouraged that the FDA has re-examined recent studies documenting the health risks posed by BVO and is taking action to prohibit its use.”

A final decision will not be made until after Jan. 17, 2024, so that the public can submit comments and the FDA can conduct a review process. If the ban is approved, the agency will give the beverage manufacturers at least one year to reformulate or relabel their products. Until then, consumers must check the ingredients listed on product labels.

FDA Didn’t Restrict Use of Bromated Vegetable Oil Despite Concerns

In the late 1960s, the FDA removed BVO from the “generally regarded as safe” list but didn’t feel there was enough data to restrict its use overall. In 1977, the FDA said BVO could be safely used in the interim as a stabilizer in fruit-flavored beverages as long as BVO levels stayed under 15 parts per million.

Soda makers and industry groups in 2011 said they were not concerned about the safety of BVO because their products met all government standards. They assured consumers their products were safe.

It wasn’t until 2014 that Coca-Cola Co and PepsiCo announced they were removing BVO from their soft drinks. The announcement came amid public pressure and a campaign amassing more than 200,000 signatures asking PepsiCo to remove BVO from Gatorade products.

Both companies said they had removed BVO from their products, with Coca-Cola saying it would replace BVO with sucrose acetate isobutyrate and glycerol ester of rosin—equally toxic ingredients. Yet, reports from as recently as 2020 and current product labels show BVO is still in Mountain Dew.  

Today, BVO is used in about 70 sodas and beverages, or about 10% of sodas in the U.S., according to Consumer Reports, citing the Environmental Working Group.

FDA Changes Course After New California Law Bans Controversial Additives

People for decades have asked the FDA to ban the use of BVO in food, and despite their awareness that the ingredient is potentially harmful, they’ve failed to do so. So why is the agency suddenly acknowledging that BVO isn’t safe to consume?

According to an FDA press release, the agency is changing its ways after California passed the “California Food Safety Act” in October, prohibiting the manufacture, sale, or distribution of food products in the state containing red dye No. 3, potassium bromate, BVO, and propylparaben beginning in 2027. 

The FDA “has known for decades that brominated vegetable oil is harmful to human health. While we’ve waited for federal action on this toxic chemical, states—like California—and some major beverage companies have stepped up to remove BVO from their products and get it off grocery store shelves,” Scott Faber, senior vice president for government affairs at the Environmental Working Group, said in a news release.

The FDA is also reviewing color additive regulations authorizing FD&C Red No. 3 for use in drugs and foods due to its potential to cause cancer. The agency, for years, has maintained that color additives are safe when used in accordance with FDA guidelines. 

Many food additives allowed in the U.S. are prohibited in Europe or must accompany a warning label. Critics say it should be easy for U.S. manufacturers to remove harmful ingredients from their products as many already offer versions of the same products in Europe without harmful ingredients.

Megan Redshaw

Megan Redshaw

Megan is an attorney and journalist with additional expertise in natural health. She has a flare for breaking down complex and controversial topics into easy-to-synthesize and entertaining pieces that empower others to make informed decisions.


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