FDA Announces Revocation of Authorization for the Use of FD&C Red No.3 in Food and Ingested Drugs, Despite Finding No Human Health Risk

On January 15, 2025, the U.S. Food and Drug Administration (FDA) issued an order to revoke authorizations for the use of FD&C Red No. 3 in food and ingested drugs. FD&C Red No. 3, also referred to as Red Dye No. 3, Red Dye 3, and erythosine, is a synthetic dye that gives foods and other products a bright, cherry red color. It has been primarily used in certain food products, such as candy, cakes, frozen desserts, frostings and icings, as well as certain ingested drugs. FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in these products in response to a 2022color additive petition by certain advocacy groups. Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028, respectively, to stop using this ingredient in these products. Other countries still currently allow for certain uses of FD&C Red No. 3, but foods imported to the U.S. must comply with U.S. requirements.

FDA's order is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals. FD&C Act sec. 721(b)(5)(B)(i). The 2022 color additive petition requested that FDA review whether the Delaney Clause applied to FD&C Red No. 3 and cited, among other data and information, two studies which showed cancer in laboratory male rats exposed to high levels of Red No. 3. Based on FDA's review of this data and information, FDA has concluded that the Delaney Clause applies because FD&C Red No. 3 has been found to induce cancer when ingested by an animal. Specifically, FDA acknowledges that "some in vivo studies have shown FD&C Red No. 3 can induce thyroid tumors in male rats." In its constituent update announcing its conclusion, however, FDA states plainly that the "way that FD&C Red No. 3 causes cancer in male rats does not occur in humans" and that "[s]tudies in other animals and in humans did not show these effects." The agency concludes that "claims that the use of FD&C Red No. 3 in food and ingested drugs puts people at risk are not supported by the available information." Despite no finding of a human health risk, the Delaney Clause renders FD&C Red No. 3 "unsafe" as a matter of law.

FDA's actions come in the context of a larger trend of increased scrutiny of food and color safety, including specifically for FD&C Red No. 3. On September 28, 2024, California enacted California Assembly Bill 418, the California Food Safety Act, which prohibits the manufacture, sale, or distribution of food products in California containing FD&C Red No. 3, as well as brominated vegetable oil ("BVO"), potassium bromate, and propylparaben. On November 2, 2023, FDA proposed to revoke BVO, and in a statement accompanying the proposed revocation, also provided an update on the agency's review of Red No. 3. In May 2023, FDA announced it was adopting a more modernized, systematic approach to reviewing food ingredient safety, with a focus on post-market review. FDA has been working to develop new approaches to mine emerging and existing data more efficiently and prioritize substances for in-depth review based on risk. 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.