The U.S. Food and Drug Administration (FDA) has revoked a rule it made allowing for the use of brominated vegetable oil (BVO) in food.

Recent toxicology studies conducted by FDA in collaboration with NIH have yielded conclusive evidence that BVO can lead to toxic effects on the thyroid at levels which closely approximate real-world human exposure, the agency stated. It’s one of several ingredients that clean label advocates are calling for bans on, due to recent studies suggesting that real-world human exposure to them may be toxic. For instance, California recently enacted the California Food Safety Act, which placed bans on Erythrosine (Red Dye No. 3), BVO, Propylparaben, and Potassium Bromate.

FDA has regulated BVO as an additive since the agency first removed it from the list of generally recognized as safe (GRAS) substances in 1970. It was authorized for use in small amounts to keep citrus flavoring from floating to the top of beverages.

The rule is effective on August 2, 2024, at which point companies will have one year to come into compliance and reformulate, relabel, and deplete tehir inventory of BVO-containing products before FDA begins enforcing the rule in 2025.

“The FDA is taking this action as part of our regulatory authority over ingredients added to food, which includes reassessing previously evaluated food ingredients and addressing safety concerns,” the agency stated. “Reassessing the safety of food ingredients as new, relevant data become available, is a priority for the FDA and a key part of our food safety mission.”