FDA Updates on Food and Color Additives

On November 2, 2023, the U.S. Food and Drug Administration (“FDA”) proposed to revoke the food additive regulation for brominated vegetable oil (“BVO”), based on FDA’s determination that there is no longer a basis to conclude that the approved use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages is safe. In a statement accompanying the proposed revocation, FDA’s Deputy Commissioner for Human Foods Jim Jones also provided an update on the agency’s review of other food and color additives, including Red Dye No. 3.

In his statement, Jones acknowledged the recent enactment of California Assembly Bill 418, the California Food Safety Act, which prohibits the manufacture, sale, or distribution of food products in California containing BVO, Red Dye No. 3, potassium bromate, or propylparaben.[1] Jones said that FDA is reviewing and reassessing the safety of each of these ingredients. For Red Dye No. 3, Jones indicated that FDA is reviewing safety under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits FDA from approving an additive that is found to induce cancer when ingested by man or animals under tests appropriate for the evaluation of additive safety. The clause has been the subject of debate over the last few decades, as some have argued that it does not appropriately take into account quantitative risk assessment nor whether the inducement of cancer in animals actually translates into an inducement in humans. Jones said FDA’s decision on Red Dye No. 3 is “forthcoming” but did not provide a timeline.

FDA’s actions come in the context of a larger trend of increased scrutiny of food and color additive safety. Under the proposed reorganized Human Foods Program, FDA will establish the Office of Food Chemical Safety, Dietary Supplements & Innovation, which is supposed to modernize and strengthen FDA’s oversight of food ingredient safety. In May 2023, FDA announced it was adopting a more modernized, systematic approach to reviewing food additive safety, with a focus on post-market review. FDA has been working to develop new approaches to mine new and existing data more efficiently and prioritize substances for in-depth review based on risk. Within the past year, FDA has also requested comments on a citizen petition to revoke the color additive regulation for titanium dioxide in foods.

With Jones, who has extensive experience in chemical safety, at the helm, and under a proposed reorganized Human Foods Program, reviews of food and color additives and decisions on whether to revoke their authorizations may come at a more brisk pace, though such developments will also likely depend upon funding and resources for these activities. More FDA engagement on food and color additives may be welcome news to those that prefer a more uniform, federal approach versus state-level bans, though stakeholders will want any agency actions to be based on rigorous scientific evidence and consistent with FDA’s authorities. Covington will continue to monitor these activities and keep our clients and contacts updated.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.