FDA moves to revoke approval for brominated vegetable oil in food amid safety concerns

03 Nov 2023 --- Brominated Vegetable Oil (BVO) may no longer be authorized for use in food in the US, as the FDA looks to revoke its regulations. This decision to propose a revocation follows new evidence of its harmful effects found in studies conducted by the FDA National Center for Toxicological Research, Center for Food Safety and Applied Nutrition and Toxicologic Pathology Associates, US.

BVO is a vegetable oil modified with bromine, authorized by the FDA for use in small amounts to prevent citrus flavoring separation in certain beverages.

The FDA has made the decision to further the ban based on risk assessment, scientific evidence, and regulatory authority. 

A number of previous studies raised concerns about potential toxicities associated with BVO consumption. These were confirmed by the recent paper published in Science Direct, which suggests that BVO exposure is linked to increased tissue levels of inorganic and organic bromine, highlighting the thyroid as a potential target organ for toxicity.

Reason for the decision
The FDA’s decision to revoke authorization for BVO in food was based on a 90-day dietary exposure study conducted in rats, which involved varying concentrations of BVO in their diet.BVO’s intended use in food and beverages is no longer considered safe, as studies have found potential adverse health effects in humans.

Key findings from the study included increased serum bromide in high-dose groups, thyroid follicular cell hypertrophy observed in both male and female rats, elevated serum thyroid-stimulating hormone (TSH) levels and decreased serum thyroxine (T4) levels in males. 

Additionally, the research established a clear dose-response relationship in di- and tetra-bromo stearic acid levels in heart, liver, and inguinal fat tissues. 

These results indicate a connection between BVO exposure and elevated levels of both inorganic and organic bromine in tissues, emphasizing the thyroid as a potential organ susceptible to toxicity.

It’s worth noting that BVO is rarely used in beverages in the US, and all other applications of BVO were overseen under food additive regulations after it lost its “Generally Recognized as Safe” (GRAS) status in 1970.

Other regulations
The FDA’s choice follows California’s recent ban on BVO and three other ingredients in food. According to the FDA statement, the organization is examining various chemicals in food, including color additives, to guarantee their safety, encompassing the three ingredients already prohibited in California.

The planned Human Foods Program (HFP) transformation seeks to improve food chemical safety by establishing a streamlined evaluation process for substances in the food supply. 

The HFP envisions establishing the Office of Food Chemical Safety, Dietary Supplements, and Innovation. The goal is to craft a swifter and more adaptable method for assessing chemicals within the food supply, emphasizing efficiency and agility in the evaluation process.

Earlier this year, the European Food Safety Authority announced that it is seeking input on its draft opinion warning that polybrominated diphenyl ethers, a type of brominated flame retardants that are prevalent in animal-derived food, could pose reproductive and nervous system risks.

By Milana Nikolova