Alerts-At the Counter

Citing No Risk to Humans, FDA Revokes Authorization of Color Additive Red No. 3

January 16, 2025

Are duller candies headed to Americans in the next two years? Many consumers already try to avoid Red No. 3 food dye. Now, FDA has revoked authorization for the use of Red No. 3 as a color additive in food, dietary supplements, and ingested drugs. FDA took this step in response to a color additive petition submitted in late 2022 by the Center for Science in the Public Interest (CSPI) and several other consumer advocacy groups. Red No. 3 is often used to give candy, cakes, cupcakes, frozen desserts, frostings, and icings a bright red hue. FDA’s revocation follows widespread criticism of its slow action regarding the color additive, California’s ban of Red No. 3, other state proposals to ban the color additive, and criticism from Congress.

Why did FDA revoke authorization of Red No. 3?

Red No. 3 (erythrosine) is a color additive common to foods and certain ingested drugs. Outside of the United States, Red No. 3 is banned in Australia and New Zealand, and heavily regulated in Europe. In 2022, several advocacy groups filed a petition with FDA that requested revocation of Red No. 3’s color additive authorization due to safety concerns. The petition cited studies linking Red No. 3 with an increased cancer risk in rats.

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