The United States has officially banned the use of Red No. 3, a synthetic food dye commonly found in candies, cakes, and certain oral medications, after evidence emerged linking the dye to cancer in laboratory rats.
The decision, announced on Wednesday by the U.S. Food and Drug Administration (FDA), comes more than three decades after Red No. 3 was prohibited in cosmetics.
Linda Birnbaum, former director of the National Institute of Environmental Health Sciences and the National Toxicology Program, expressed her approval of the ban, stating, “Why you would say something can’t be in cosmetics, but you can eat it makes no sense to me. I am very pleased that they finally have done what I think they should have done years ago.”
The ban follows years of advocacy from consumer groups, including a 2022 petition urging the FDA to review studies showing high exposure to Red No. 3 may cause cancer in male rats. The FDA maintains, however, that studies conducted on other animals and humans did not demonstrate similar harmful effects. Despite this, Jim Jones, deputy commissioner for Human Foods at the FDA, confirmed that food additives found to cause cancer in humans or animals cannot be approved.
Manufacturers using Red No. 3 in food products have until January 15, 2027, to reformulate their goods, while those using the dye in oral medications have until January 18, 2028, to comply with the ban.
The move comes amid heightened scrutiny over food safety, as lawmakers recently questioned FDA Commissioner Robert Califf about the continued use of food dyes. In response to the ban, the National Confectioners Association emphasized that food safety remains the top priority for U.S. confectionery companies, reaffirming their commitment to comply with FDA standards.
Robert F. Kennedy Jr., nominated by President-elect Donald Trump to lead the FDA, has long advocated for reducing chemicals in food, a stance that aligns with the agency’s recent decision.
