On January 15, 2025, FDA announced that it was revoking the regulatory approval of FD&C Red No. 3 (erythosine) under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is amending the color additive regulations to prohibit the use of FD&C Red No. 3 in foods and drugs in response to a 2022 color additive petition.

The Delaney Clause, enacted in 1960 as part of the Color Additive Amendments to the FD&C Act, prohibits FDA from approving a food additive or color additive if it is found to cause cancer in humans or animals. This is not the first time the agency has revoked a license based on the Delaney Clause. For example, in 2018, the FDA revoked the approval of several synthetic flavors based on the Delaney Clause in response to a food additive petition.

FD&C Red No. 3 is a synthetic food dye that gives foods and beverages a bright cherry red color. FDA estimates that FD&C Red No. 3 is not widely used in foods and drugs when compared to other approved colors based on information available in third-party food product labeling databases, food manufacturers’ websites, other publicly available information, and FDA certification data. FD&C Red No. 3 is primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, icings and frostings, and some ingested drugs

Manufacturers use FD&C Red No.3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028 to reformulate their products Food imported into the United States must comply with this requirement.

Please see original information in the link: https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs