In a significant move to prioritize public health, U.S. regulators announced a ban on the use of the food dye known as Red 3, marking the end of its authorization in the nation's food supply. This decision comes nearly 35 years after the dye was prohibited from cosmetics due to its potential link to cancer.
The Food and Drug Administration (FDA) granted a 2022 petition spearheaded by two dozen food safety and health advocacy groups, including the Center for Science in the Public Interest (CSPI). The petition called for removing the dye—also known as erythrosine or FD&C Red No. 3—from products like candies, snack cakes, maraschino cherries, dietary supplements, and oral medications.
A "Matter of Law" Decision
The FDA cited findings from animal studies indicating that high levels of Red 3 exposure caused cancer in male lab rats. Under the Delaney Clause—a federal statute that mandates the banning of any additive shown to cause cancer in humans or animals—the agency said it had no choice but to act.
"The FDA is taking action that will remove the authorization for the use of FD&C Red No. 3 in food and ingested drugs," said Jim Jones, the FDA's deputy commissioner for human foods. While the cancer risk observed in rats does not apply to humans, Jones emphasized that the action was legally necessary.
Food manufacturers have until January 2027 to reformulate products without Red 3, while makers of ingested drugs, including cough syrups, must comply by January 2028.
A Long-Awaited Decision
Advocacy groups celebrated the move as a long-overdue correction. "This is a welcome but long overdue action from the FDA: removing the unsustainable double standard in which Red 3 was banned from lipstick but permitted in candy," said Dr. Peter Lurie, director of the CSPI, according to the AP.
Health advocates have pushed for years to remove Red 3 from food, citing its unnecessary risks. In November 2024, nearly two dozen members of Congress also urged the FDA to take swift action to protect children, a demographic heavily exposed to foods containing the dye.
The United States now joins Europe, Australia, and New Zealand, where the dye is banned mainly for food use, except in specific cases such as particular cherries. California will enforce its ban on Red 3 beginning in January 2027, and lawmakers in other states, including Tennessee, Arkansas, and Indiana, are pushing for similar school restrictions.
Industry Response
Some manufacturers have already abandoned Red 3, opting for natural alternatives such as beet juice, carmine (a dye derived from insects), and pigments sourced from purple sweet potato, radish, and red cabbage. Sensient Food Colors, a major supplier, has highlighted these options as viable replacements.
However, legal challenges from the food industry remain a possibility. FDA Commissioner Dr. Robert Califf acknowledged this risk during a congressional hearing in December, noting, "When we do ban something, it will go to court. And if we don't have the scientific evidence, we will lose in court."
A Step Toward Safer Food
The FDA's decision underscores growing pressure to scrutinize artificial additives in the U.S. food supply. Advocates argue that aesthetic considerations like the bright red hues in processed foods are not worth the potential risks. "No aesthetic reason could justify the use of a carcinogen in our food supply," stated the congressional letter.
With Red 3 now set for removal, the FDA's action reflects a broader shift toward prioritizing health over convenience in food production, offering a renewed focus on consumer safety and transparency.