FDA Moves to End Use of Brominated Vegetable Oil in Food | Sheppard Mullin Richter & Hampton LLP

Within a month of California becoming the first state in the nation to ban manufacturing with, selling, or distributing food items that contain brominated vegetable oil (BVO), FDA has proposed to revoke the regulation authorizing the use of BVO in food as an additive. 

BVO is authorized for use in foods in small amounts (not to exceed 15 parts per million) as a stabilizer for fruit flavoring in beverages to keep the citrus flavoring from floating to the top. While many companies have already formulated away from using BVO, it is still used in some nationally sold beverages, and also in smaller or more regional beverage brands. When it is used, BVO must be listed as an ingredient on the label as “brominated vegetable oil” or as the specific oil that has been brominated, such as “brominated soybean oil”.

The safety of BVO has long been questioned: until the 1960s, FDA considered it to be generally recognized as safe (GRAS) and placed the ingredient on the FDA GRAS list. FDA then removed BVO from the GRAS list in the late 1960s after safety questions arose. However, the data available at the time did not support a total ban on the ingredient, and therefore FDA limited the ingredient to use as a flavor stabilizer. 

Over the last decade, FDA has increasingly scrutinized BVO. In 2014 it identified additional areas about which research was needed on the safety of the additive. Between 2016 and 2020, FDA published improved methods for measuring BVO in beverages. And in 2022, the FDA published a study in the journal Food and Chemical Toxicology that evaluated potential health effects related to BVO consumption in rodents.

The European Union has long banned BVO. The EU previously reached the conclusion that BVO contributes to an increased risk of cancer, behavioral issues in children, harm to reproductive organs, and can harm the immune system. California’s ban was in part premised on the EU’s earlier conclusions about BVO.

FDA’s recent action is the result of more recent studies that show bioaccumulation of bromine and toxic effects on the thyroid. The studies were conducted in collaboration with the National Institute of Environmental Health Sciences’ Division of Translational Toxicology.

FDA is accepting comments on the proposed rule through January 17, 2024.