The U.S. Food and Drug Administration has formally prohibited Red Dye No. 3 (erythrosine) in food and oral medications due to cancer risks indicated by animal studies. The choice arrives almost 35 years after this pigment was banned in cosmetics and topical applications for comparable reasons. The ban follows a petition started by health advocates in 2022, requesting the agency to revoke its endorsement of the additive over potential cancer risks.
The FDA’s press release issued on Wednesday was grounded in the Delaney Clause, which requires the ban of any additives that are detected or known to cause cancer in humans or animals. It was therefore determined that Red Dye No. 3 causes cancer in male rats in large amounts; however, according to the agency, the process of developing cancer in rats is not applicable to humans.
“This action removes FD&C Red No. 3 from the list of approved color additives in food and ingested drugs,” said Jim Jones, FDA deputy commissioner for human foods. By January 2027, U.S. manufacturers of food will get a head start on the new elimination of all artificial coloring in products before pharmaceutical companies, who have until January 2028 to do likewise.
Typically, the pigment has been used in candies, pastries, snack cakes, bright-red maraschino cherries, and cough syrups. Consumer advocacy groups, such as the CSPI, praised the ban. “This is a belated action to remove a double standard where Red 3 was prohibited in lipstick but permitted in candy for children,” stated CSPI director Dr. Peter Lurie.
Despite the ban, food manufacturers may challenge the decision in court. FDA Commissioner Dr. Robert Califf acknowledged this possibility, stating that strong scientific evidence is critical to defending the agency’s actions.
The FDA previously declined to ban Red 3 in food in 1990, despite barring it in cosmetics, due to a lack of evidence linking its cancer-causing effects in animals to humans. However, renewed pressure from lawmakers and health advocates led to a reassessment. A 2022 letter from nearly two dozen members of Congress cited the Delaney Clause and emphasized the need to protect children, who are disproportionately exposed to artificial dyes due to their diets.
Red 3 has been banned for food use in Europe, Australia, and New Zealand, except for specific applications, such as in certain cherries. California will enforce its own ban on the dye starting in January 2027, with similar proposals under consideration in other states.
In response to growing concerns, some manufacturers have already begun reformulating products, replacing Red 3 with natural alternatives like beet juice, carmine (derived from insects), and pigments from vegetables like radishes and red cabbage.
The International Association of Color Manufacturers continues to defend Red 3, arguing that the dye is safe at levels typically consumed by humans. However, public support for removing harmful additives is strong. A recent AP-NORC survey discovered that about two-thirds of Americans support limitations or modifications of processed foods to remove artificial dyes and additives.
This choice represents a crucial advancement in improving food safety, especially for children, and promotes manufacturers to embrace healthier, natural options.