FDA Bans Red Dye No. 3 in Food Following Cancer Risk Evidence

The US Food and Drug Administration (FDA) has announced a ban on the use of red dye No. 3, a synthetic food colorant linked to cancer in laboratory animals. Food manufacturers have until Jan. 15, 2027, to reformulate their products, while ingested-drug makers must comply by Jan. 18, 2028. 

Red No. 3, also known as erythrosine, is derived from petroleum and has been widely used to impart a vibrant red hue to candies, cakes, and oral medications. Though the dye was banned in cosmetics over 30 years ago, its use in food persisted, a point of contention for consumer advocacy groups and health experts. 

“Why would you say something cannot 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,” said Linda Birnbaum, Former Director, National Institute of Environmental Health Sciences. 

The FDA cited animal studies demonstrating that high levels of exposure to Red No. 3 caused cancer in male rats. Jim Jones, Deputy Commissioner for Human Foods, FDA, emphasized that the agency cannot authorize any additive found to cause cancer in humans or animals. However, the regulator noted that other studies involving humans and different animals did not reveal the same risks.

In response to the ban, trade group National Confectioners Association stated: "Food safety is the No. 1 priority for US confectionery companies, and we will continue to follow and comply with FDA's guidance and safety standards."

In Mexico, Red No. 3 is commonly found in products such as candies, sodas, jellies, and certain processed foods. The country’s consumer protection agency, PROFECO, has warned about the risks of consuming artificial colorants, including cognitive and behavioral effects in children.

Mondelēz Snacking México, the owner of brands like Ricolino and Panditas, affirmed that its products do not contain Red No. 3. "Our products comply with the regulations and approvals of both national and international authorities," the company said in a statement.