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... The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats.
On January 15, 2025, the FDA issued an order revoking authorization for FD&C Red No. 3 in food and ingested drugs under the Delaney Clause, because the dye causes cancer in male laboratory rats; manufacturers must reformulate food by January 15, 2027 and drugs by January 18, 2028.
Commencing January 1, 2027, a person or entity shall not manufacture, sell, deliver, distribute, hold, or offer for sale, in commerce a food product for human consumption that contains any of the following substances:... Red dye 3 (CAS no. 16423-68-0).
California's Food Safety Act (AB-418, signed October 2023) bans the manufacture, sale, and distribution of food products containing Red dye 3 (CAS 16423-68-0) in the state effective January 1, 2027, enforceable by civil penalties.
Lifetime toxicity/carcinogenicity study of FD & C Red No. 3 (erythrosine) in rats. At the highest dietary dose, male rats showed statistically significant increases in thyroid follicular cell hypertrophy, hyperplasia, and adenomas.
A peer-reviewed lifetime study in Food and Chemical Toxicology (1987) found that male rats fed high dietary levels of erythrosine (FD&C Red No. 3) developed statistically significant increases in thyroid follicular cell adenomas, the carcinogenicity evidence that underpins the regulatory ban.