On Jan. 15, 2025, the U.S. Food and Drug Administration revoked its authorization for the use of Red Dye No. 3 in food and ingested medications. Red Dye No. 3, chemically known as erythrosine, is a synthetic color additive made from petroleum that is used to give foods and beverages a bright cherry-red color. Food manufacturers that use Red Dye No. 3 have until Jan. 15, 2027, to reformulate their products, and drug manufacturers that use the dye in ingested drugs have until Jan. 18, 2028.
The FDA stated there is no evidence that Red Dye No. 3 causes cancer in humans, but data presented in a 2022 color additive petition showed that high levels of the dye caused cancer in male laboratory rats.
As noted in a previous McGuireWoods alert, Gov. Gavin Newsom signed the California Food Safety Act (CFSA) into law on Oct. 7, 2023, making California the first state to ban the manufacture, sale, distribution or delivery of food products containing four food additives commonly used in popular candies, snacks and drinks, including brominated vegetable oil (BVO) and Red Dye No. 3. The CFSA ban goes into effect on Jan. 1, 2027.
Several other states, including Illinois, followed California’s lead and introduced legislation seeking to ban Red Dye No. 3, though no other bills have passed to date. The FDA followed California’s lead and revoked its authorization for use of BVO on July 3, 2024, giving manufacturers until Aug. 2, 2025, to reformulate, relabel and deplete inventory before the FDA begins enforcement.
Food and drug manufacturers, distributors and retailers should understand how these bans and future regulation may impact their operations going forward.
