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FDA proposes US ban on brominated vegetable oil, an additive found in sodas

The US Food and Drug Administration (FDA) has proposed a ban on brominated vegetable oil (BVO) in food and drink products, following a similar ban by the state of California, after scientific studies in animals found that the ingredient may be harmful to human health.

Research published in the Food and Chemical Toxicology journal last year found that oral exposure to BVO in rats and pigs was linked to increased levels of bromine in body tissue and potential thyroid damage. These studies show that BVO can be toxic to the thyroid and can lead to accumulation of bromine in the body at levels relevant to human exposure.

Given these findings, the FDA concluded in a statement released last week that the use of BVO in food and drink products is no longer safe.

“Although BVO has a long history of use in foods and was at one time considered GRAS [generally recognized as safe], we have continued to study it to understand any potential health impacts. Recent toxicology studies conducted in collaboration with the NIH have now given us conclusive scientific evidence to support our proposal to remove the FDA’s food additive authorization for BVO,” said James Jones, deputy commissioner for human foods at the FDA.

As many as 90 products could be affected by the ban

BVO, a vegetable oil that has been modified with bromine, is used as an emulsifier in citrus-flavoured drinks to prevent the flavours from separating.

In the late 1960s, the FDA removed the ingredient from its GRAS list and lowered the limit of BVO in food and drink products to 15 parts per million.

Since then, manufacturers such as have gradually been removing the additive from their ingredient lists. In 2014, food and drink giants Coca-Cola and PepsiCo took the decision to remove BVO from both ready-to-drink and fountain-machine formulas. Nevertheless, some 90 sodas and beverages still contain BVO, according to a database manged by the Environmental Working Group (EWG), a not-for-profit advocacy group for consumer health. These include various Mountain Dew sodas, Sun Drop sodas, and Food Lion juices and punches.

Various rodent-based studies have shown BVO exposure to cause neurological, thyroid, heart, and liver problems; as well as behavioural, developmental, and reproductive issues.

“The evidence is clear that brominated vegetable oil in sodas and other beverages poses an unacceptable risk to our health,” said Brian Ronholm, director of food policy at Consumer Reports. “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.”

Could Red Dye No.3 be next?

The announcement follows a move by the US state of California last October when it became the first state to ban the use of four food additives, including BVO and Red Dye No.3, in packaged foods due to safety concerns. The legislation is expected to come into force in 2027.

Scott Faber, senior vice president for government affairs at the Environmental Working Group, said in a statement that 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".

If approved, the US will join Europe and Japan on the list of countries in which the additive is banned from use in food and drink products. The proposed effective date for the rule is 30 days after publication, with a compliance date set for one year later to allow the food industry time to adapt.

The FDA is currently reviewing the four additives prohibited under the recent Californian law and are expected to provide an opinion on the Red Dye No.3 in ingested drugs and foods in future, according to Jones.