The U.S. Food and Drug Administration (FDA) has officially banned the use of Red Dye No. 3 in food and beverages, citing its link to cancer in male rats. Food manufacturers must reformulate thousands of products, including candy, cereals, and baked goods, that use the petroleum-based synthetic coloring by January 15, 2027.
The move comes over 30 years after the FDA prohibited Red Dye No. 3 in cosmetics and topical drugs. The ban was influenced by advocacy from the Center for Science in the Public Interest (CSPI) and 23 other organizations and scientists, who petitioned for the removal of the dye in 2022.
Red Dye No. 3, originally approved for use in foods in 1907, is widely used for its vibrant red hue. The Environmental Working Group (EWG) identified the dye in nearly 2,900 branded food products, including candies, dessert toppings, and baking decorations. In 2021, over 200,000 pounds of the dye were used in the food and drug industries, according to the CSPI.
Although the FDA acknowledged that the way Red Dye No. 3 causes cancer in male rats does not directly apply to humans, Deputy Commissioner for Human Foods Jim Jones emphasized that the Delaney Clause prohibits the agency from authorizing any food or color additive found to cause cancer in humans or animals.
The dye has already been banned in several countries, including European nations where its use is restricted to specific cherries. In the U.S., states like California banned Red Dye No. 3 in foods in 2023, with at least 10 other states introducing similar legislation.
Consumer advocacy groups celebrated the FDA’s decision. Ken Cook, president and co-founder of EWG, called it a “monumental victory for consumer health and safety,” highlighting that the dye remained in food products for years despite evidence of health risks, particularly for children. CSPI President Peter G. Lurie also welcomed the ban, noting the inconsistency of allowing the dye in food while banning it in cosmetics.
The National Confectioners Association, representing the U.S. confectionery industry, expressed its commitment to food safety and compliance with FDA guidance. However, it criticized state-level bans, describing them as emotionally driven and lacking scientific basis. The association reiterated that the FDA is the appropriate authority to make national regulatory decisions.
As the industry transitions away from Red Dye No. 3, the ban underscores a broader trend of food companies shifting to clean-label ingredients in response to consumer demand and regulatory action.