The U.S. has officially banned Red Dye No. 3 from foods, beverages, and ingested drugs due to evidence linking it to cancer in laboratory rats. This decision by the FDA follows a long-standing debate, with the dye having been banned from cosmetics and topical drugs since 1990. The ban is enacted under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits any food additive found to cause cancer in humans or animals. Red Dye No. 3 is found in numerous products, including candies like Brach’s candy corn, Betty Crocker sprinkles, and strawberry Ensure, among others.
Food manufacturers have until January 15, 2027, to remove the dye from their products, while drug manufacturers have until January 18, 2028. This action aligns with restrictions or bans already in place in countries like Australia, Japan, and the EU. Despite the ban, the FDA notes that studies in humans and other animals do not show the same cancer-causing effects as seen in male rats, and thus, they do not raise significant safety concerns for human consumption. The move has been welcomed by consumer advocacy groups but has also sparked discussions on the dye’s safety profile and its impact on children’s health.
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