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Washington, D.C. — The United States has officially banned Red Dye No. 3, a widely used food and drug coloring linked to cancer in animals, marking a significant victory for public health advocates. The decision was announced on Wednesday by the outgoing Biden administration, decades after scientific evidence first raised alarm over the additive’s safety.
Known chemically as erythrosine, Red Dye No. 3 has been a staple in nearly 3,000 food products, including candies, snacks, fruit products, and even medications. Despite its pervasiveness, the additive has faced mounting criticism over its potential health risks. The ban will require manufacturers to reformulate products containing the dye by January 2027 for foods and January 2028 for medicines, according to the U.S. Food and Drug Administration (FDA).
A Long Road to Regulation
The decision comes in response to a 2022 petition by the Center for Science in the Public Interest (CSPI) and other advocacy groups. Citing the “Delaney Clause,” a federal provision that prohibits any food additive shown to cause cancer in humans or animals, the groups argued that the use of Red Dye No. 3 violated U.S. safety standards.
The health risks associated with the dye have been known for decades. In 1990, the FDA banned Red 3 from use in cosmetics after studies linked it to thyroid cancer in male rats. However, the additive continued to be used in food and drugs due to industry resistance. Manufacturers of products like maraschino cherries relied on the dye to maintain their vibrant appearance.
Lagging Behind Global Standards
The United States has faced criticism for its delayed action on Red 3 compared to other countries. The European Union banned the dye in 1994, followed by similar restrictions in Japan, China, the UK, Australia, and New Zealand. Critics have attributed the slow response in the U.S. to extensive lobbying by food and pharmaceutical industries.
“It’s hard to square the FDA’s mission of protecting American health with the prolonged delay in addressing this issue,” said Carl Tobias, a former FDA legal consultant and professor at the University of Richmond.
Broader Health Concerns
In addition to its carcinogenic risks, synthetic food dyes like Red 3 have been associated with neurobehavioral issues in children. A 2021 California government report highlighted evidence linking synthetic dyes to Attention-Deficit/Hyperactivity Disorder (ADHD) and other adverse outcomes. Animal studies have further suggested changes in brain structure and neurotransmitter systems caused by these additives.
“These dyes add no nutritional value or preservation benefits—they’re just there to make food look pretty,” said Thomas Galligan, a scientist with CSPI.
Moving Forward
Advocacy groups hailed the FDA’s decision as a critical step toward addressing harmful chemicals in food. They urged further action to regulate other toxic substances, including heavy metals like lead, arsenic, and cadmium, commonly found in children’s foods.
“This is a long-overdue victory for consumers, but it’s only the beginning,” said Galligan. “We need to push for broader reforms to ensure that all additives in our food supply are safe.”
As the U.S. takes its first steps in banning Red Dye No. 3, public health advocates hope the decision signals a broader shift toward prioritizing consumer safety over industry lobbying.
