The FDA says that based on recent study data, it can no longer conclude that brominated vegetable oil is safe. The agency is also reviewing the safety of FD&C Red No. 3.
On November 2, James Jones, the FDA's Deputy Commissioner for Human Foods, announced a proposed ban on brominated vegetable oil (BVO), a food additive used to stabilize citrus flavorings in some beverages. The move comes after California recently banned BVO and three other food additives, including Red Dye No. 3.
If finalized, the new rule would revoke previous regulations allowing brominated vegetable oil in food and drinks. The FDA says it issued the proposed rule after recent studies showed that BVO exposure at levels close to what humans would consume caused adverse health effects in animals.
"Results from these studies show bioaccumulation of bromine and toxic effects on the thyroid – a gland that produces hormones that play a key role in regulating blood pressure, body temperature, heart rate, metabolism and the reaction of the body to other hormones," the FDA said.
In light of this new data and other unresolved questions about the additive's safety, the agency says it can no longer consider BVO safe.
The FDA initially considered BVO as "generally recognized as safe" but removed that designation in 1970. However, due to manufacturers' requests, agency officials authorized BVO's use in limited amounts.
In a statement, Scott Faber, senior vice president for government affairs at Environmental Working Group (EWG), said, "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."
In 2014, PepsiCo and Coca-Cola removed BVO from their soft drinks. However, EWG says some food products still contain this harmful additive. "Especially in so-called off-brand products, including store-brand products and lesser-known, smaller brands that are sometimes sold regionally," Faber explained.
Faber says this proposed ban will ensure all consumers have access to food and drinks that are BVO-free.
People who wish to comment on the proposed ban can do so by visiting Regulations.gov and searching for docket number FDA-2023-N-0937. Comments must be submitted by January 17, 2024.
Will the FDA ban Red Dye No. 3?
In addition to the proposed rule on BVO, the FDA is also reviewing a variety of food additives, including compounds recently banned in California. Currently, the agency is evaluating the color additive regulations that authorize the use of Red No. 3 in ingested drugs, foods, and dietary supplements.
According to Jones' statement, a decision on proposed rules regarding Red Dye No. 3 is forthcoming.
- FDA. FDA Proposes Rule to Revoke Regulation Allowing the Use of Brominated Vegetable Oil (BVO) in Food.
- USA Today. Coke, Pepsi dropping controversial 'BVO' from all drinks.
- EWG. FDA proposes to ban use of brominated vegetable oil in food.
- FDA. FDA Proposes to Ban Food Additive, Continues Assessments of Additional Chemicals.