FD&C Red No. 3, also referred to as Red Dye No. 3, Red Dye 3, and erythrosine, is a synthetic food dye that gives certain foods and drinks a bright, cherry-red color, and is found in certain candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, and ingested drugs. Like other color additives, its uses must be approved by the FDA, and it is used in small amounts. The FDA requires manufacturers to list FD&C Red No. 3 in the statement of ingredients when added to food.
Regulatory Information
The FDA will no longer allow for the use of FD&C Red No. 3 in food and ingested drugs. On January 15, 2025, the FDA issued an order to revoke these authorizations. 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 reformulate their products. Consumers could see FD&C Red No. 3 as an ingredient in a food or drug product on the market past the effective date in the order if that product was manufactured before the effective date.
The FDA is revoking the authorization for the use of FD&C Red No. 3 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.
To learn more about the new regulation, please go to: FDA
