FDA Bans Red No. 3 in Food & Drugs

The FDA has officially prohibited the use of FD&C Red No. 3 in food and ingested drugs, citing the Delaney Clause, which bans additives linked to cancer in humans or animals. The synthetic dye, commonly used in food products such as candy, baked goods, frozen desserts, and frostings, must be phased out by January 15, 2027. All ingested drugs containing the dye must be phased out by January 18, 2028.

The decision stems from a 2022 petition by the Center for Science in the Public Interest (CSPI), which cited studies linking high levels of the dye to cancer in male rats. While the FDA noted that these effects are specific to rats and do not occur in humans at typical exposure levels, 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, emphasized their commitment to food safety and welcomed the FDA’s leadership 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 and maintain consumer trust in an evolving regulatory landscape.

Stakeholders may submit objections or hearing requests regarding the ruling within 30 days of its Federal Register publication which occurred today, January 16, 2025.

 

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