On January 15, 2025, the Food and Drug Administration (FDA or Agency) issued an order to revoke the authorization for the use of FD&C Red No. 3 (Red No. 3) in food and ingested drugs in response to a 2022 color additive petition. Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. According to FDA, it has been used primarily in candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs.
Manufacturers who use Red No. 3 in food and ingested drugs will have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products. Consumers, however, may still see Red No. 3 as an ingredient in a food or drug product on the market past the effective date of the FDA order if that product was manufactured before the effective date. Currently, other countries still allow certain uses of Red No. 3 (called erythrosine outside the United States). However, foods imported to the United States must comply with FDA's order.
FDA is revoking the authorization for the use of Red No. 3 based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. The Delaney Clause prohibits FDA authorization of a food or color additive if it has been found to induce cancer in humans or in animals.
Upon reviewing data presented in the petition and other available information, FDA concluded that the information provided in the petition and other publicly available data show that Red No. 3 causes cancer in male laboratory rats exposed to high levels of Red No. 3. Under the Delaney Clause, this finding of carcinogenicity renders the color additive "unsafe" as a matter of law, although FDA believes that Red No. 3 meets the required safety standard for a color additive (a reasonable certainty of no harm).
FDA's action takes place in an environment of increased scrutiny of food and color additive safety. As we have previously reported, states have become increasingly active in this space. For example, in October 2023, California became the first state to ban the manufacture and sale of products containing Red No. 3 when Governor Newsom signed the California Food Safety Act. In September 2024, Governor Newsom signed the California School Food Safety Act, prohibiting California public schools from serving school meals containing any of the following synthetic food dyes, because of health-related concerns: Red 40; Yellow 5; Yellow 6; Blue 1; Blue 2; and Green 3. FDA, however, still permits the six dyes to be used in foods.
FDA's newly reorganized Human Foods Program is prioritizing post-market chemical safety reviews. In September 2024, the Agency held a meeting to share its enhanced systematic process for post-market assessment of chemicals in food and hear stakeholder perspectives on this proposal.
