FDA

FDA bans synthetic dye Red No. 3 in food and drugs

January 16, 2025

FDA announced a ban on FD&C Red No. 3, a synthetic dye used in foods, drinks, and drugs. The decision follows a 2022 petition that cited studies linking high levels of the dye to cancer in male rats. Although these effects aren’t observed in humans, the Delaney Clause in FDA's Federal Food, Drug, and Cosmetic Act mandates prohibition if a substance induces cancer in animals.

This regulatory shift highlights increased vigilance in food and drug safety. Red No. 3 is already banned or restricted in many countries, including Australia, Japan, and the European Union. California also passed a law to ban Red No. 3, effective in 2027.

Manufacturers must reformulate their food products by January 2027, while drugmakers will have an additional year.

Source:

(2025, January 15). FDA. FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs. https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs