What the FDA’s BVO Regulation Means for Food Manufacturers

As consumers seek cleaner, healthier food and beverage options, additives such as brominated vegetable oil (BVO) are being increasingly scrutinized. In this article, Kelly Magurany, Senior Manager of Toxicology at NSF explains what BVO is and how the Food and Drug Administration’s proposed nationwide regulation to revoke authorized use of the ingredient may impact food and drink manufacturers.

A: BVO is a vegetable oil (commonly based on soybean oil) that is treated with bromine gas (Br₂) to produce a saturated oil that is liquid at room temperature. Through this treatment, the higher density BVO dissolves, rather than floats, on water, making it easy to incorporate flavors into water-based beverages or food products. The US Food and Drug Administration (FDA) currently allows BVO additives to be used in certain fruit-flavored beverages at concentrations up to 15 mg/kg of the finished beverage. Based on this concentration limit, a person who consumes two liters of soda per day would have the potential to be exposed to about 30 mg of BVO, which is equivalent to 0.5 mg/kg-body weight (bw) per day for an adult weighing 60 kg-bw.

A: The US FDA has been monitoring health concerns associated with BVO for decades since its introduction in the 1920s. Although the FDA identified some evidence that consumers of BVO had higher bromine levels in their body and that very high levels of exposure (not relevant to humans) were shown to have health effects in animals, no health effect relevant to humans had been identified at the current levels of use until recently.

In 2022, the US FDA partnered with the US National Institute of Environmental Sciences (NIEHS) to fund and conduct a 90-day study in rodents (as a model for humans) to better understand the potential health effects of BVO after repeated exposure. The results indicated that at an exposure of about 300 mg/kg-bw per day in the rodent, there was clear toxicity to the thyroid gland. In addition, increased tissue levels of brominated fats were observed in the heart, liver and fat tissues even at the lowest dose level of ~1 mg/kg-bw per day. This suggests that even human-relevant exposures may result in increased tissue concentrations of bromine. Although health effects were not observed in the rodents at ~1 mg/kg-bw per day, based on the consideration for potential tissue exposure and uncertainty associated with human health effects after chronic exposure, the FDA has proposed revoking the food additive use of BVO, which is anticipated to be effective in early 2024. Specifically, referencing the US FDA Standard of Safety , there is not a “reasonable certainty of no harm.”

A: Based on the US FDA proposed rule to revoke BVO from use as a food additive, food manufacturers will be unable to use BVO in fruit-flavored beverages, in any form, 30 days after the proposed rule is finalized.

A: BVO is permitted for use in Canada consistent with the US FDA limitations but is not permitted for use in the EU or Japan.

A: Glycerol esters of rosin are an example of an additive used to replace BVO. Glycerol esters of rosin are permitted in citrus-flavored beverages by the US FDA and Canada and in the EU and UK as food additive number E445.

A: In the US, the use of BVO requires disclosure on a product’s label. If a consumer is trying to avoid BVO consumption and purchasing, its best to thoroughly read and review the label on the product’s package. Consumers can also consider purchasing items that are not flavored, such as unflavored water or sparkling water and iced tea.

A: NSF provides a range of services to help manufacturers avoid the use of certain ingredients and navigate their country’s regulations. Our services include consulting, formulation, raw ingredient and label reviews. We also offer a Specialist Market Insight tool, which uses technology to help clients make evidence-based decisions by scanning media coverage, regulations and other literature for applicable regulations and guidelines. This service is available globally.

For assistance avoiding BVO, please contact foodregulations@nsf.org.