By Top Class Actions  |  November 8, 2023

Category: Legal News
Close up of vegetable oil in a bowl, representing the FDA brominated vegetable oil ban.
(Photo Credit: Africa Studio/Shutterstock)

FDA brominated vegetable oil ban overview: 

  • Who: The U.S. Food and Drug Administration proposed revoking a regulation that authorizes the use of brominated vegetable oil (BVO) as a food additive. 
  • Why: The FDA said the results of recent toxicology studies gave it “conclusive scientific evidence” to support removing a food additive authorization for BVO. 
  • Where: The agency’s proposal would affect consumers nationwide. 

The U.S. Food and Drug Administration (FDA) has proposed rescinding a regulation authorizing the use of brominated vegetable oil (BVO) as a food additive. 

The FDA said the results of recent toxicology studies done in collaboration with the National Institutes of Health gave it the “conclusive scientific evidence” needed to support removing a food additive authorization for BVO. 

BVO — vegetable oil that has been modified with bromine — is used as a beverage additive to keep citrus flavoring from separating and floating to the top of certain beverages, according to the FDA

Even under current rules, the agency only allows the use of BVO in small amounts. The FDA determined in 1970 that the BVO was no longer “Generally Recognized as Safe” and began overseeing its use at that time. 

Over the years many beverage makers reformulated their products to replace BVO with an alternative ingredient, and today, few beverages in the U.S. contain BVO,” the FDA said, in a statement. 

FDA determines thyroid is a ‘potential target organ of toxicity’ from oral exposure to brominated vegetable oil 

The BVO toxicology studies — which tested on Sprague Dawley rats — found the incidence of thyroid follicular cell hypertrophy in the male and female rats given a high dosage of the food additive. 

The FDA ultimately determined that oral exposure to BVO — based on the most current study and past observations in rats and pigs — is associated with “increased levels of inorganic and organic bromine.” 

The results of the study also led the FDA to believe the thyroid was a “potential target organ of toxicity” resulting from oral exposure to BVO. 

The proposal comes less than one month after California Gov. Gavin Newsom signed into law a bill banning the use of BVO, potassium bromate, propylparaben and red dye 3 that is set to go into effect at the beginning of 2027. 

The FDA, meanwhile, said it is “continuously reviving and reassessing” the safety of a variety of chemicals in food “to ensure the science and the law support their safe use in food,” noting that this included “all four ingredients that are part of the recent California law.” 

What are your thoughts on the FDA’s decision to revoke a regulation authorizing the use of BVO? Let us know in the comments! 


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