FDA Bans Red No. 3
The FDA has officially banned the use of FD&C Red No. 3 in food and ingested drugs. The organization cited the Delaney Clause, which bans additives linked to cancer in humans or animals. Red No. 3 is a synthetic dye that is commonly used in food products such as candy, baked goods, frozen desserts and frostings. The synthetic dye must be phased out of food entirely by January 15, 2027. All ingested drugs containing the dye must be phased out by January 18, 2028.
The FDA decision to ban FD&C Red No. 3 stems from a 2022 petition by the Center for Science in the Public Interest (CSPI). The petition cited studies linking high levels of the dye to cancer in male rats. While the FDA noted that these effects are specific to rats, advocates, including CSPI, have long supported the ban, highlighting that the dye has been banned in cosmetics and topical drugs since 1990.
Industry groups, such as the National Confectioners Association, welcomed the FDA’s leadership. This emphasizes their confidence in the FDA’s commitment to food safety and in maintaining a consistent, science-based regulatory framework.
The transition timeline provides a critical opportunity for manufacturers to reformulate products and explore alternative color solutions well before the deadlines. Early action will ensure compliance with the FDA’s ban on Red No. 3 while maintaining consumer trust in an evolving regulatory landscape.
Stakeholders may submit objections or hearing requests regarding the ruling within 30 days of its FDA’s Official Federal Register publication which occurred today, January 16, 2025.
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