Texas Senate Bill 25 (89th Legislature, 2025) lists this substance among 44 ingredients that trigger a mandatory consumer warning label under Texas Health & Safety Code Sec. 431.0815. The label reads: "WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom." It applies to food labels developed or copyrighted on or after January 1, 2027. On February 11, 2026 the U.S. District Court for the Western District of Texas preliminarily enjoined enforcement against the plaintiff trade groups and their members; Texas appealed to the Fifth Circuit on March 5, 2026.
Named in Texas SB 25 (2025) among 44 ingredients requiring a consumer warning label: "not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom." The requirement applies to labels developed or copyrighted on or after Jan 1, 2027, and was preliminarily enjoined by a federal court (W.D. Tex., Feb 11 2026); Texas’s appeal is pending at the Fifth Circuit.
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.
On January 15, 2025 the FDA revoked its authorization for FD&C Red No. 3 in food, applying the Delaney Clause after studies showed cancer in laboratory male rats. Food makers must reformulate by January 15, 2027.
On January 15, 2025 the FDA revoked its authorization for FD&C Red No. 3 in food, applying the Delaney Clause after studies showed cancer in laboratory male rats. Food makers must reformulate by January 15, 2027.
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.