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FDA bans Red Dye No. 3 from foods

Written by Annie Gimbel | Jan 15, 2025

U.S.  —  U.S. regulators have banned Red Dye No. 3 from the food supply.

Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke authorization for the color additive that's made from petroleum. It gives some candies, snacks and maraschino cherries a bright red hue. Also referred to as erythrosine, the synthetic food dye is also found in some cupcakes, cookies, frozen desserts, and frostings and icings, and ingested drugs. 

The FDA revoked  authorization based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Delaney Clause was enacted in 1960 as part of the Color Additives Amendment to the FD&C Act. It prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals.

The FDA determined that the data presented in a 2022 color additive petition show that Red 3 causes cancer in male laboratory rats exposed to high levels of the additive because of a hormonal mechanism that occurs in the rodents.

Manufacturers who use Red No. 3 in food or medications will have until Jan. 18, 2028, to reformulate their products, and the ban applies to all internationally made products imported into the U.S., according to the FDA.