FDA bans Red Dye No. 3 amid growing health concerns

The U.S. Food and Drug Administration (FDA) has officially banned the use of FD&C Red No. 3, a synthetic food coloring linked to cancer in laboratory animals, marking a significant step in addressing public health concerns. This decision comes after decades of research and advocacy, as well as a growing push for stricter food safety regulations.

Red Dye No. 3, also known as erythrosine, has been widely used in food, drinks, candies, and medications to create a bright red hue. However, studies dating back to the 1980s revealed its potential to cause cancer in male rats, leading to a ban on its use in cosmetics in 1990. Despite this, the dye continued to be used in consumables, sparking public outcry and petitions for its removal.

Why Was Red Dye No. 3 Banned?

The FDA’s recent decision was influenced by the Delaney Clause, a provision that prohibits the authorization of food additives found to cause cancer in humans or animals. The ban, announced on January 17, 2025, requires manufacturers to eliminate Red Dye No. 3 from foods and drinks by January 2027, with drugmakers given until January 2028 to comply.

Jim Jones, the FDA’s deputy director for human foods, stated, “The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals. Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.”

Health Concerns Linked to Red Dye No. 3

While there is no direct evidence linking Red Dye No. 3 to cancer in humans, its potential health risks have long been debated. Research suggests that synthetic food dyes, including Red No. 3, may contribute to hyperactivity and behavioral issues in children.

“The ban is a step in the right direction,” says Dr. Sheela Sathyanarayana, a professor of pediatrics at the University of Washington. “It reflects growing awareness of the need to protect consumers, especially vulnerable groups like children, from unnecessary health risks.”

What Products Contain Red Dye No. 3?

Despite some companies voluntarily phasing out Red 3, it remains prevalent in various products, including:

• Seasonal candies like cherry cordials, candy corn, and ring pops
• Maraschino cherries, often used in fruit cocktails
• Strawberry-flavored milk, sodas, ice creams, and desserts

Advocates hope this ban will encourage manufacturers to adopt safer, natural alternatives such as beet juice or paprika extract.

Global Implications of the Ban

The FDA’s decision aligns with stricter food safety regulations in other regions, such as the European Union, which has long maintained tighter controls on synthetic additives. Experts believe this move may pave the way for further evaluations of other controversial additives, including Red Dye No. 40 and Yellow 5.

Kate Donelan, a registered dietitian, emphasizes the need for more comprehensive regulations. “This is just the beginning. The FDA must reevaluate outdated safety data and address environmental contaminants in food processing and packaging.”

Conclusion

The FDA’s ban on Red Dye No. 3 is a critical milestone in improving food safety standards and protecting public health. While the transition may take time, it underscores the growing demand for safer and healthier food options. As awareness continues to rise, consumers and regulators alike must work together to eliminate potentially harmful additives from the global food supply.