Revocation of Authorization for Use of Brominated Vegetable Oil in Food (Proposed Rule)

The proposed rule would, if finalized, amend FDA’s regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food. Specifically, the proposed rule would remove 21 CFR 180.30. We are taking this action because there is no longer a basis to conclude that this use is safe. BVO is a complex mixture of plant-derived triglycerides that have been reacted to contain atoms of the element bromine bonded to the molecules.  BVO is used primarily to help emulsify citrus-flavored soft drinks, preventing them from separating during distribution. 

We quantify benefits in terms of reduction in BVO exposure under the proposed rule relative to the baseline exposure associated with gradual voluntary reduction of BVO. Although studies suggest that excessive consumption of BVO may cause adverse events such endocrine and central nervous systems disruptions, and that bromine also accumulates easily in the body, Clinical data on adverse events in humans from consuming BVO are limited and there is a lack of published independent studies that estimate the change in health outcomes from removing BVO from the food industry. Because of the data limitations and absence of independent studies that quantify health benefits, we do not estimate the monetary value of the public health benefits of this proposed rule. We quantify the costs to industry of reformulating and re-labeling products currently manufactured with BVO relative to the baseline cost of gradual voluntary reduction of BVO. Because established alternatives to BVO already exist, and many manufacturers have already reformulated their products to replace BVO, we assume that there will be a minimal change to product properties. We estimate that the annualized reduction in BVO exposure over 20 years under the proposed rule relative to the baseline of gradual voluntary reduction would range from 0.01 to 0.03 million ounces (oz), with a primary estimate of 0.02 million oz. The annualized costs relative to the baseline of gradual voluntary reduction of BVO would range from $0.09 million to $0.23 million at a 7 percent discount rate, with a primary estimate of $0.15 million, and from $0.03 million to $0.08 million at a 3 percent discount rate, with a primary estimate of $0.06 million.

Regulatory Impact Analysis

Revocation of Authorization for Use of Brominated Vegetable Oil in Food (Proposed Rule) (PDF 478 KB)

Federal Register: 88 FR 75523
Publication Date: 11/3/2023 
Docket: FDA-2023-N-0937