FDA Proposes Brominated Vegetable Oil Ban Due to Health Risks

Concerns about potential risks of BVO have existed for decades, but recent toxicology reports established that the food additive is a threat to human health.

Federal food safety regulators are proposing a ban for brominated vegetable oil (BVO), which is a controversial food additive that was once commonly found in products like Gatorade, Mountain Dew and other fruit-flavored drinks, but has been found to not be safe for human consumption.

The U.S. Food and Drug Administration (FDA) announced the proposed brominated food vegetable oil (BVO) ban on November 2, after an evaluation of scientific evidence concluded the chemical may cause serious side effects.

Brominated vegetable oil (BVO) is vegetable oil modified with the chemical bromine, which in its liquid state is corrosive to human tissue and toxic via inhalation. BVO is currently authorized by the FDA for use in small amounts, to keep citrus flavoring from separating and floating to the top of some beverages.

BVO Health Risks

According to the agency’s findings, bioaccumulation of bromine can lead to 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 chemical was once commonly used in many consumer food products, from bakery products and pasta to beverages, especially among large national brands, including Gatorade, Orange Fanta, and Mountain Dew.

BVO has been slowly phased out over the last 10 years, after health studies indicated the chemical caused liver, heart, and brain damage. Beverage makers formulated their products to replace BVO with an alternative ingredient, but some brands continue to use of the food additive.

It is still found in generic brands, many breads, Orange Fanta, and regional beverages like Sun Drop citrus-flavored soda.

The European Union and Japan have already banned the use of the ingredient due to health side effects. Last month, California Governor Gavin Newsome signed a bill banning four food additives in California, including BVO and Red Dye No. 3.

California is the first state to ban the chemical in the U.S., even though the FDA continues to allow the use of it in food products.

Proposed BVO Ban

The FDA issued the proposed ban after reviewing recent scientific research that indicated BVO is no longer “generally recognized as safe” or GRAS, an FDA determination allowing ingredients for use in foods.

In 1970, the FDA determined BVO was no longer GRAS and began overseeing its use under food additive regulations, but did not ban the use of the ingredient in food products. However, it took decades for the FDA to propose a ban.

However, the agency indicates recent toxicology studies provided “conclusive scientific evidence” to remove the food additive’s authorization.

Following California’s move to ban four food additives, the FDA is also reviewing regulations authorizing the color additive Red No. 3 for use in drugs and foods, including dietary supplements.

Under the Delaney Clause of the FDA Cosmetic Act, the FDA is prohibited from approving a color additive that is ingested if it causes cancer in animals or humans.

If the proposed rule on BVO is approved, the agency will give food and beverage makers one year to reformulate or relabel products before enforcing the ban.

The FDA will accept public comment on the rule until January 17, 2024. Comments can be submitted electronically at regulations.gov to docket number FDA-2023-N-0937.