Federal officials moved Wednesday to ban a controversial bright red dye used in drinks and snacks that has been linked to cancer in animals.
The Food and Drug Administration’s action affects red dye No. 3, which was approved for permanent use in food and ingested drugs more than 50 years ago. The decision comes more than two years after advocates pressured the agency to ban the dye used in bubblegum, candy and fruit cocktail, arguing that it is safer to use natural coloring derived from plants such as beets and red cabbage.
Studies have shown that high doses could cause cancer in rats, prompting the FDA to decide to remove the artificial dye. But the agency maintains that there is no evidence that ingesting the cherry-red coloring causes cancer in humans.
The FDA’s decision comes at a crucial time for food policy in the United States. Robert F. Kennedy Jr., whom President-elect Donald Trump picked to lead the nation’s health department, has been critical of some chemicals and ingredients found in food and drinks. Social media influencers and lawmakers in both parties are also increasingly scrutinizing food and drinks sold in grocery stores, while the FDA pleads for more money from Congress to devote to chemical safety.
Red dye No. 3 must be removed from food by mid-January 2027, and excised from ingested drugs the following year. The FDA says its decision to ban red dye No. 3 was based on a federal law called the Delaney Clause, which prohibits additives found to cause cancer in humans or animals at any dose.
“The Delaney Clause is clear; the FDA cannot authorize a food additive or colour additive if it has been found to cause cancer in humans or animals,” Jim Jones, the FDA’s deputy commissioner for human foods, said in a statement. “Importantly, the way that … Red No. 3 causes cancer in male rats does not occur in humans.”
Opponents of red dye No. 3 – also known as erythrosine or FD&C Red No. 3 – have argued that the additive should have been banned decades ago, and scientists have long debated the safety of food additives. The nonprofit Center for Science in the Public Interest led a 2022 petition asking the agency to formally remove the dye from the list of approved colour additives in foods.
“We’re not surprised FDA has asserted that the risk is small, since it’s a chemical they failed to ban for years,” Peter Lurie, president of the Center for Science in the Public Interest and a former FDA official, said in a statement. “But the truth is Congress made plain decades ago that this was exactly the type of chemical – one that causes cancer in animals – it was trying to keep out of the US food supply.”
The FDA estimates that the artificial dye is not as widely used in food and drugs when compared with other colorings, adding that it is primarily used in products such as candy, cakes and frozen desserts.
The International Association of Color Manufacturers told The Washington Post last month that it stands behind the dye, saying it is “safe for its intended uses,” and that removing the additive would lead to higher costs for consumers.
In 1990, the FDA forbade use of the color additive in cosmetics, including lipstick and blush, because of studies linking it to cancer in rats. At the time, the agency said it would take steps to eliminate red dye No. 3 in food and other products, but it did not follow through.