U.S. regulators have officially prohibited the use of Red 3, a food dye, as of Wednesday, marking an important step in food safety nearly 35 years after it was already banned in cosmetics due to cancer concerns.
The Food and Drug Administration (FDA) responded to a 2022 petition led by a coalition of food safety and health advocates who urged the agency to revoke the authorization for the dye that gives vibrantly red hues to candies, snack cakes, and maraschino cherries.
The FDA’s decision is viewed as a legal requirement after studies indicated that Red 3 is linked to cancer in laboratory rats. This action is grounded in the Delaney Clause, a law that mandates the agency to ban substances that have been shown to cause cancer in either humans or animals.
Referred to scientifically as erythrosine or FD&C Red No. 3, this ban takes the dye off the approved list for use in foods, dietary supplements, and orally consumed medications, including cough syrups. Since the FDA previously prohibited its use in cosmetics in 1990 due to similar findings, the recent decision reinforces the agency’s stance on public health and safety.
Jim Jones, the FDA’s deputy commissioner for human foods, explained, “The FDA is taking action that will remove the authorization for the use of FD&C Red No. 3 in food and ingested drugs. Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red 3; however, the mechanism causing this in rats does not apply to humans.” Food producers now have until January 2027 to eliminate the dye from their products, while the timeline extends to January 2028 for pharmaceutical makers. Although some other countries still permit the dye’s use, imported products must comply with U.S. regulations.
Consumer advocacy groups hailed this move as commendable but long overdue. Dr. Peter Lurie, who heads the Center for Science in the Public Interest, called it a long-awaited measure, emphasizing the inconsistency in its prior ban in cosmetics yet allowance in food products.
The possibility of legal challenges from food manufacturers is uncertain, especially due to the lack of conclusive evidence linking the dye to cancer in humans. At a congressional hearing, FDA Commissioner Dr. Robert Califf acknowledged this concern, suggesting that insufficient scientific backing may lead to legal pitfalls if a ban were challenged in court.
Historically, when the FDA banned Red 3 from topical products in 1990, it continued to permit its use in food products due to emerging evidence suggesting that its carcinogenic effects in rats do not translate to humans. Since then, health advocates have lobbied the FDA to review this position, culminating in the 2022 petition and subsequent congressional action that urged the agency to take decisive action to protect children, who may be more affected due to their higher consumption ratios compared to adults.
A recent poll indicates that a significant portion of the American public—approximately two-thirds—supports measures to limit or reformulate processed foods by eliminating additives like artificial sugars and color dyes. This sentiment is particularly heightened among individuals with a college degree or higher earnings.
Red 3 is already banned in several regions, including Europe, Australia, and New Zealand, with California set to impose a restriction beginning in January 2027. Additionally, separate measures are being proposed in states like Tennessee, Arkansas, and Indiana to restrict certain dyes in foods served in public schools.
The International Association of Color Manufacturers has defended the safety of Red 3, claiming its compliance with acceptable consumption levels for humans, citing research from the UN and the World Health Organization supporting the dye’s safety. Some food companies are proactively reformulating products, swapping out Red 3 for natural sources of coloring such as beet juice, carmine (derived from insects), and plant-based pigments from foods like purple sweet potatoes and radishes.
This development marks a significant shift in food safety regulations and reflects ongoing public concerns over artificial additives in the food supply.
