The U.S. Food and Drug Administration (FDA) has announced a ban on the use of Red No. 3, a synthetic food coloring, in food products and ingested drugs. The dye, which has been in use since 1907, was previously banned from cosmetics and topical drugs in 1990 due to evidence of its carcinogenic properties. The use of Red No. 3 in food products is already prohibited or limited in Australia, Japan, and several European Union countries.
Red No. 3 is a common ingredient in a variety of candies, gums, and cookies, including popular products like Brach’s candy corn, Betty Crocker sprinkles, and strawberry Ensure. Food manufacturers have been given until January 15, 2027, to eliminate the dye from their products, while drug manufacturers have until January 18, 2028.
The decision to ban Red No. 3 is grounded in the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, enacted in 1960. This clause prevents the FDA from approving any food or color additive found to cause cancer. Jim Jones, the FDA’s deputy director for human foods, stated that there is evidence of cancer in male rats exposed to high levels of Red No. 3.
The ban was prompted by a petition from the Center for Science in the Public Interest and 23 other organizations. The petition included data showing that male lab rats exposed to high levels of Red No. 3 developed cancer. However, the FDA noted that studies in humans and other animals did not show the same effect, and stated that the available data does not raise safety concerns for humans.
Despite being banned in cosmetics and topical drugs for nearly 35 years, Red No. 3 has remained in food and ingested drugs. There have been ongoing public calls to restrict the use of food dyes, particularly Red No. 3, due to its prevalence in products marketed to children. Brian Ronholm, director of food policy for Consumer Reports, expressed concern about the widespread use of the dye, stating that it only serves to make food look more appealing.
The FDA had previously intended to ban Red No. 3 in food in 1992, but did not take action due to the resources that would be required to revoke its authorization. The federal ban follows the California Food Safety Act, which banned Red No. 3 and three other food additives in the state over a year ago. Other states, including New York, New Jersey, Pennsylvania, Maryland, West Virginia, Illinois, and South Dakota, have also introduced similar legislation.
The National Confectioners Association, which had previously criticized California’s law, expressed support for the FDA’s decision. The association emphasized that food safety is their top priority and that they will continue to comply with FDA’s guidance and safety standards.