Soda additive “no longer considered safe,” gets long-awaited FDA ban

After more than five decades of limbo, the Food and Drug Administration on Wednesday revoked the authorization of brominated vegetable oil (BVO) in food, banning an additive long known to have toxic effects that is already banned in Europe, Japan, Australia, New Zealand, and California.

BVO—simply vegetable oil that is modified with bromine—has been used in foods since the 1920s. It has often been used as a stabilizer for fruit flavorings, particularly in citrusy beverages, including sodas, to keep the citrus flavoring from separating and floating to the top. The FDA authorized the use of BVO just after gaining the authority to regulate food additives in 1958. By the early 1960s, the FDA had put BVO on its first inventory of food additives it deemed generally safe—designated "generally recognized as safe" or GRAS. But safety concerns quickly surfaced, and by the late 1960s, the FDA had already limited its use to a flavoring stabilizer and capped the amount that could be used to 15 parts per million.

That 15-ppm limit was authorized on an "interim basis," pending more safety studies. In 1970, the FDA revoked the GRAS designation for BVO, but continued to allow the 15-ppm limit—on an interim basis—given that safety studies "did not indicate an immediate health threat from the limited use."

“Disgraceful”

The interim safety limit stayed in place until now, as the FDA was waiting for more safety data. In the mid-2010s, following bans in Europe and Japan, the agency began to review BVO and commissioned its own studies. A resulting rat study, which the agency published in 2022, found that when rats were fed BVO at levels that mimicked humans' exposure at the 15-ppm limit, the animals developed abnormalities in their thyroids, alterations in their hormone signaling, and accumulation of brominated fatty acids in their hearts, livers, and fat.

The FDA proposed its ban in November 2023. At the time, the FDA's Deputy Commissioner for Human Foods, James Jones, hinted at the agency's inactions by noting that the proposed restructuring at the agency was intended to "develop a faster and more nimble process for evaluating chemicals in the food supply."

By then, most major soda makers had already phased BVO out of their citrusy sodas and other drinks amid public pressure. Coca-Cola pledged to remove BVO from its drinks in 2014, and PepsiCo confirmed in 2020 that it had removed it from its drinks, including Mountain Dew and Gatorade. The FDA reports that only a few beverages in the US still use the additive. Among the lingering users is Sun Drop, according to its product page.

Manufacturers have one year to reformulate their products, the FDA notes.

Consumer advocates chided the FDA while celebrating the ban. "The FDA’s decision to ban brominated vegetable oil in food is a victory for public health," Scott Faber, senior vice president of government affairs at the Environmental Working Group, said in a statement. "But it’s disgraceful that it took decades of regulatory inaction to protect consumers from this dangerous chemical."