As part of an increased focus on the safety of food additives, the U.S. Food and Drug Administration (FDA) has published its final rule revoking the authorization for the use of brominated vegetable oil (BVO) in food. The additive is currently only authorized for use in fruit-flavored beverages and sodas to prevent added citrus flavorings from floating to the top of the drink prior to consumption.
FDA’s changing approach to BVO
Beginning in 1958, the FDA designated BVO as generally recognized as safe (GRAS). It was removed from the FDA’s GRAS list in 1970 when questions were raised about its safety. Since then, the FDA has allowed the use of BVO as a food additive, but limits the concentration to 15 ppm. As more data have been collected over the past several decades to corroborate the safety risks of BVO, the FDA has re-evaluated BVO’s status as an allowed food additive.
The FDA cited “conclusive scientific evidence” from recent toxicology studies conducted in partnership with the National Institutes of Health (NIH) to support its decision to remove BVO’s food additive authorization. Most European countries banned BVO as a food additive in the 1970s and it was formally banned throughout the European Union through a 2008 Directive.
Ongoing evaluation of food additive safety
The FDA first added a proposed federal ban of BVO to its docket in early 2023, as indicated by the Spring 2023 Regulatory Agenda. The state of California took decisive action and passed legislation banning BVO in late 2023 and New York introduced a similar bill prohibiting certain food additives, including BVO. After the states took action, the FDA advanced its own plans for a federal ban. The FDA has set August 2, 2024 as the effective date for its final rule banning BVO, and the compliance date will be one year from this date.
The California law that banned BVO also prohibits three other food additives: potassium bromate, propylparaben, and red dye No. 3. Stakeholders across the food sector raised concerns about having to navigate different regulations in California compared to the rest of the U.S.
It would appear that red dye No. 3 is next on the FDA’s list and that a decision is “forthcoming” on whether the FDA will propose that the additive is banned. In a statement, James Jones, Deputy Commissioner for Human Foods at the FDA, shared that the FDA “is continuously reviewing and reassessing the safety of a variety of chemicals in food to ensure the science and the law support their safe use in food, including all four ingredients that are part of the recent California law.”
Looking ahead
Food additive safety will remain a priority for the FDA, especially with the creation of an Office of Food Chemical Safety, Dietary Supplements, and Innovation under the restructuring of the Human Foods Program (HFP). Businesses that use BVO, potassium bromate, propylparaben, red dye No. 3, or any other food additives that are the subject of bans from other regulatory bodies, such as state legislatures, should pay close attention to communications from the FDA for these products as well.
While the ban on BVO comes with a one-year transition period, companies should begin working now to achieve compliance. It is also never too soon to begin thinking about how to maintain compliance with what may be a patchwork of regulations as states and federal regulations on other food additive ingredients go into effect at different rates.
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