The Food and Drug Administration (FDA) announced its decision to ban the use of Red No. 3, a synthetic food dye widely used to create a vibrant cherry-red color in various food and drink products. This dye has been linked to cancer in animal studies, prompting concerns from health advocates and lawmakers.
Red No. 3 is currently found in thousands of food items, including popular products like candies, cereals, fruit cocktail cherries, and strawberry-flavored milkshakes. According to the Center for Science in the Public Interest (CSPI), a food safety organization that filed a petition in 2022 to eliminate the dye, over 9,200 products contain Red No. 3. Despite the ban on this specific dye, the FDA has not extended the restriction to other synthetic dyes, such as Red No. 40, which has been associated with behavioral issues in children.
The FDA’s ruling marks a significant win for consumer safety groups and certain U.S. lawmakers who have long called for the removal of Red No. 3. They cite substantial evidence linking the dye to cancer risks and behavioral changes in children. Dr. Peter Lurie, president of the CSPI, applauded the decision, emphasizing the inconsistency of allowing Red No. 3 in food products while banning it in cosmetics since 1990 under the Delaney Clause—a federal regulation prohibiting additives that induce cancer in humans or animals.
Food manufacturers now face a deadline of January 15, 2027, to reformulate products containing the dye. Companies producing ingestible drugs, including dietary supplements, will be granted an additional year to comply.
“The FDA cannot approve a food or color additive if it has been proven to cause cancer in humans or animals,” said Jim Jones, the FDA’s deputy director for human foods. “Research has demonstrated cancer development in male laboratory rats exposed to high doses of FD&C Red No. 3.”