In a major move, the U.S. Food and Drug Administration (FDA) has announced a ban on the use of red dye No. 3 in food, beverages, and ingested drugs, responding to long-standing concerns over its potential cancer risks.
The decision, announced on Wednesday, January 15, comes more than three decades after scientists first linked the synthetic color additive to cancer in animal studies.
Known chemically as erythrosine, red dye No. 3 is a petroleum-based additive used to give foods and drinks their bright, cherry-red color.
It has been found in a wide variety of products, including candies, snacks, and drinks.
Despite evidence linking the dye to cancer in animals, it has continued to be used in food products, though its use has been prohibited in cosmetics and topical drugs since 1990 under the Delaney Clause, which prohibits any color additive shown to cause cancer in humans or animals.
The recent ban follows a petition submitted by advocacy organizations, including the Center for Science in the Public Interest and the Environmental Working Group, in November 2022.
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Their efforts highlighted animal studies showing the dye’s carcinogenic effects, prompting the FDA to take action. California had already banned red dye No. 3 in 2023, setting a precedent for the federal government.
Manufacturers will have until January 15, 2027, to remove the dye from food products, with a later deadline of January 18, 2028, for drugs. Imported goods will also have to comply with the new regulations.
Although the FDA maintains that human exposure levels are typically much lower than those that caused cancer in animal trials, critics like Dr. Jerold Mande, a nutrition expert at Harvard University, argue that the ban is long overdue.
Meanwhile, many food companies, like Ferrara, the maker of Brach’s candies, had already started phasing out the dye, using alternatives like red dye No. 40, which has not been linked to similar cancer risks.
The decision marks a significant step in addressing public health concerns, following years of debate over the safety of red dye No. 3.
