On Wednesday, U.S. authorities announced a ban on the dye known as Red 3 from the food supply, almost 35 years after it was prohibited in cosmetics due to potential cancer risks.
The Food and Drug Administration (FDA) acted in response to a petition filed in 2022 by a group of food safety advocates, who pressed the agency to revoke the approval of this dye, which imparts a vivid red color in various candies, snack cakes, and maraschino cherries.

The FDA stated that this decision was made as a “matter of law,” pointing to studies showing that Red 3 led to cancer in laboratory rodents.
Regulation stipulates that the FDA must ban any food additive linked to cancer in humans or animals under the Delaney Clause.
Known scientifically as erythrosine or FD&C Red No. 3, the dye is now removed from the list of allowable color additives for food, dietary supplements, and oral medications, including cough syrups.
Previously, in 1990, the FDA had already denied permission to use Red 3 in cosmetics and topical medications due to a study revealing a cancer link in rats.

Jim Jones, the FDA’s deputy commissioner for human foods, remarked, “The FDA is taking steps to rescind authorization for FD&C Red No. 3 in food and ingested pharmaceuticals. Evidence indicates cancer in male rats after exposure to high levels of this dye.” He emphasized, however, that the mechanism through which Red 3 induces cancer in rats does not occur in humans.
Food producers will be required to remove Red 3 from their products by January 2027, while manufacturers of ingestible drugs have until January 2028 to comply with the ban.
Although some other countries still permit certain applications of this dye, foods imported into the U.S. must abide by the new regulations.

Consumer protection advocates have welcomed the FDA’s decision.
Dr. Peter Lurie, director of the Center for Science in the Public Interest (CSPI), which spearheaded the petition, stated, “This is a long-overdue action from the FDA, eliminating an inconsistent standard that allowed Red 3 in candies but banned it from cosmetics.”
There is uncertainty regarding whether food manufacturers might contest the ban legally, as existing evidence does not definitively link the dye to cancer in humans.
At a congressional hearing in December, FDA Commissioner Dr. Robert Califf acknowledged the possibility of facing legal challenges, mentioning, “If we lack scientific evidence when we implement a ban, we may lose in court.”

The FDA had previously permitted Red 3 in foods and ingestible medications while prohibiting its use in cosmetics, believing that the cancer mechanism observed in rats didn’t apply to humans, leading to no action against its use in food.
Health advocates, including CSPI, have persistently urged the FDA to reassess this decision. In November, numerous lawmakers sent a letter advocating for a ban on Red 3, emphasizing the importance of protecting children, who tend to ingest more food dyes relative to their body weight compared to adults.
“The FDA must act swiftly to shield our youth from this harmful dye added solely for aesthetics,” stated the lawmakers, stressing that no visual appeal could justify including a carcinogen in our food supply.

Worldwide, Red 3 is prohibited in food products across Europe, Australia, and New Zealand, aside from certain types of cherries.
In California, this ban will take effect in January 2027, and proposals have been introduced in Tennessee, Arkansas, and Indiana aimed at restricting specific dyes in food served in public schools.
The International Association of Color Manufacturers, however, defends the safety of Red 3, arguing that it is safe within typical human consumption levels.
The organization references a 2018 review by lauded scientific committees from the United Nations and the World Health Organization that reaffirmed its safety in food products.

Some food companies have preemptively reformulated their products, opting for alternatives like beet juice, carmine (an insect-derived dye), and naturally sourced pigments from purple sweet potatoes, radishes, and red cabbage, as per Sensient Food Colors, a St. Louis-based supplier of food coloring and flavoring agents.