FDA Proposes to Ban Brominated Vegetable Oil in Food

November 23, 2023By Sophia R. Gaulkin & Riëtte van Laack

For any of our readers seeking recommendations on which drinks pair well with turkey this Thanksgiving, certain fruit-flavored beverages may be off the table.  Earlier this month, FDA issued a proposed rule that would revoke 21 C.F.R. § 180.30, its interim authorization of the use of brominated vegetable oil (BVO) in in fruit-flavored beverages.

BVO is a complex mixture of plant-derived triglycerides that have been reacted to contain atoms of the element bromine bonded to the molecules.  As authorized, BVO is used in small amounts as a stabilizer and emulsifier for flavoring oils in fruit-flavored beverages, primarily to keep the citrus flavoring from separating and floating to the top of the beverage during distribution.

BVO has been used as a flavoring oil stabilizer and emulsifier since the 1920s, and it was generally recognized as safe (GRAS) for this use by FDA.  Fast-forwarding half a century, in 1970, FDA removed BVO from the codified list of GRAS substances due to toxicity concerns at a level of approximately 150 parts per million (ppm) in beverages.  The Flavor and Extract Manufacturers Association responded by submitting a food additive petition to FDA, requesting approval to use BVO in beverages at a maximum use level of 15 ppm.  Based on the data available at the time and the historical use of BVO in food without an immediate threat to health, FDA determined that there would be an adequate margin of safety for BVO in beverages at the use level of 15 ppm on an interim basis while additional, longer-term safety studies were conducted.  FDA subsequently established an interim food additive regulation, codified at 21 C.F.R. § 180.30, which authorizes the use of BVO as a stabilizer for flavoring oils in an amount not to exceed 15 ppm in the finished fruit-flavored beverage.  Since then, FDA has evaluated new information on BVO’s possible health effects as it became available.

As described in the preamble to FDA’s proposed rule, recent toxicology studies in cooperation between FDA and the National Institutes of Health have provided “conclusive scientific evidence” for FDA to remove its authorization for BVO.  FDA asserts that the studies demonstrate that BVO consumption has the potential for adverse health effects in humans, including but not limited to thyroid toxicity.  Once the rule is finalized, companies will have one year from the effective date to reformulate, relabel, and deplete their inventory of BVO-containing products.

Some may wonder what took FDA so long.  Australia, the European Union, Japan, and New Zealand have already banned BVO use in beverages.  Moreover, California recently enacted the California Food Safety Act, prohibiting the manufacturing, selling, delivering, distributing, or holding food that contains BVO, with a $5,000 civil penalty for first violations, as of January 1, 2027.  In addition, New York introduced a similar bill prohibiting certain food additives, including BVO.

Before any reader starts hoarding certain citrus-flavored beverages, rest assured: apparently safe substitutes for BVO are available and have long been used for the same functions as BVO (e.g., ester gum, locust (carob) bean gum, and sucrose acetate isobutyrate).  Over the past decade, beverage manufacturers have already reformulated their products to replace BVO with these alternatives.

Comments on the proposed rule can be submitted here until January 17, 2024.