On January 16, 2025, the U.S. Food and Drug Administration (FDA) released an amendment to its color additive regulation (CFR Title 21, Chapter I, Subchapter A, Part 74). This amendment revokes the authorization for FD&C Red No. 3 in foods (including dietary supplements) and ingested drugs.
This decision follows a 2022 petition citing two studies that observed cancer in male rats exposed to high levels of FD&C Red No. 3. Although these effects have not been observed in humans, the Delaney Clause, a strict provision prohibiting approval of additives linked to cancer in humans or animals, mandates revocation.
FD&C Red No. 3, a synthetic dye known for its bright cherry-red color, has been primarily used in specific food products, including candy, cakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs. The dye is also referred to by other names, including erythrosine, Colour Index (C.I.) Acid Red 51, C.I. No. 45430, and C.I. Food Red 14. According to FDA regulations, all batches of FD&C Red No. 3 must be certified for compliance before use.
While less commonly used compared to other certified colors, FD&C Red No. 3 remains in some niche products. To comply with the updated regulation, manufacturers must:
Reformulate food products by January 15, 2027.
Reformulate ingested drugs by January 18, 2028.
Products imported to the U.S. must also comply with these regulations, even if FD&C Red No. 3 is permitted in other countries.