On Wednesday, U.S. regulators announced the prohibition of Red 3, a dye used in food products, marking a significant move nearly 35 years after it was already banned from cosmetics due to cancer concerns. The Food and Drug Administration (FDA) officially approved a petition from a coalition of health advocates and food safety experts that sought to eliminate the dye, which is typically used to provide a vivid red color in various confections, snack cakes, and maraschino cherries.
The FDA’s decision comes in accordance with legal requirements, particularly referencing the Delaney Clause. This statute mandates that any additive known to cause cancer in humans or animals must be banned from use. Scientific studies have indicated that Red 3 can induce cancer in lab rats, prompting the action from the FDA to revoke its approval for use in food products, dietary supplements, and oral medications such as cough syrup. The dye, formally recognized as erythrosine or FD&C Red No. 3, has been under scrutiny for decades, having been previously banned in cosmetics and topical medications in 1990 due to similar health concerns.
Deputy Commissioner for Human Foods at the FDA, Jim Jones, stated that the evidence linking Red 3 to cancer in male rats supports the regulatory action. However, he emphasized that the mechanism by which the dye causes cancer in rats does not translate to humans. Manufacturers of food products will have a deadline until January 2027 to eliminate Red 3 from their offerings, while pharmaceutical manufacturers have until January 2028 to comply with these new regulations. Although other countries continue to permit some uses of this dye, any imported products into the U.S. must meet the new standards.
Consumer health advocates celebrated this decision as a crucial step forward, noting the discrepancy that allowed the dye in food products while prohibiting it in cosmetics. Dr. Peter Lurie, the head of the Center for Science in the Public Interest, which spearheaded the petition, remarked that this decision was both welcome and overdue. However, uncertainty looms regarding potential legal challenges from food manufacturers, especially since there isn’t a clear consensus that Red 3 is carcinogenic when ingested by humans. At a December hearing, FDA Commissioner Dr. Robert Califf had hinted that legal challenges are likely if sufficient scientific evidence was not provided.
In 1990, when the FDA prohibited Red 3 in cosmetics, the dye was still permitted in food and medications because earlier studies concluded that the cancer-causing effects seen in rats did not apply to human consumption. Health advocates had been advocating for a reevaluation of this stance for years, leading to the 2022 petition which garnered support from numerous congressional members, who echoed the sentiment that children, who might consume the dye more relative to their body weight, should be protected. They stressed the lack of justification for allowing a potentially harmful substance simply for aesthetic purposes in food.
Recent polling data indicates that about two-thirds of Americans support measures to restrict or reformulate processed foods by eliminating harmful ingredients, including added sugars or artificial dyes. The support for such actions is notably stronger among individuals with higher education levels and incomes. In particular, around 80% of voters holding college degrees favor reformulating processed foods compared to about 60% of those without such credentials.
While Red 3 is already banned in many areas, including the European Union, Australia, and New Zealand—with exceptions for certain cherry products—California’s regulations will enforce a ban on the dye starting January 2027. Additionally, some states like Tennessee, Arkansas, and Indiana are considering legislation to limit specific dyes in foods served in public schools.
The International Association of Color Manufacturers, however, defends the safety of Red 3, arguing that it poses no risk at levels typically consumed by humans. They cite studies conducted by scientific committees of the United Nations and the World Health Organization as evidence supporting the dye’s safety. Meanwhile, several food producers have started to reformulate their products to eliminate Red 3, opting for alternative colorants such as beet juice, carmine derived from insects, and natural pigments from vegetables like purple sweet potatoes, radishes, and red cabbage.
