Red dye No. 3 is found in some candy, food and beverage products. Miguel Sotomayor/Moment RF/Getty Images/File
The US Food and Drug Administration (FDA) has officially banned the use of red dye No. 3 in food, beverages, and ingested drugs, effective Wednesday, January 15, 2025. This decision comes over three decades after scientists linked the synthetic color additive to cancer in animal studies. The ban marks a significant victory for public health advocates who have long campaigned for the removal of the dye.
Red dye No. 3, also known as erythrosine, is a petroleum-derived chemical that imparts a bright cherry-red hue to various products. It has been widely used in candies, beverages, and certain medications despite ongoing concerns over its safety. Advocacy groups like the Center for Science in the Public Interest and the Environmental Working Group (EWG) have been instrumental in pushing for this change, submitting a petition in November 2022 that highlighted the dye’s carcinogenic potential.
California paved the way for this decision by banning red dye No. 3 in October 2023, setting a precedent for federal action. The FDA’s announcement requires manufacturers to stop using the additive in food and beverages by January 15, 2027, and in ingested drugs by January 18, 2028. Imported products containing the dye will also need to comply with these regulations.
Red dye No. 3 has been a common ingredient in numerous candies and drinks, though some major brands have already phased it out. For example, Ferrara, the maker of Brach’s candies, began removing the additive in early 2023, with fewer than 10% of its products now containing it. Similarly, the makers of PEEPS discontinued the dye’s use after Easter 2024.
While some companies have turned to red dye No. 40 as an alternative, this substitute has not been free from controversy. California recently banned red dye No. 40 in public schools due to its potential links to behavioral and attention issues in children. Studies have suggested that the dye may contribute to immune system tumor growth in mice, and it contains benzene, a known carcinogen.
The FDA’s decision to ban red dye No. 3 reflects growing scrutiny of synthetic additives in food and medicine. Dr. Jerold Mande, a nutrition expert from Harvard University, praised the move as a “long-overdue step” and a sign of progress in consumer protection. Ken Cook, co-founder of the EWG, called the ban a “monumental victory” and credited decades of advocacy for bringing about this change.
Despite these developments, some scientists and regulatory officials maintain that red dye No. 3 poses minimal risk to humans. The FDA noted that studies linking the dye to cancer in animals involved high doses unlikely to be encountered in typical human consumption. However, under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, any additive shown to cause cancer in animals or humans must be banned from the food supply.
The Delaney Clause had already led to the dye’s ban in cosmetics and topical drugs in 1990. However, its continued presence in food and ingested drugs highlighted regulatory gaps that critics have long decried. Public health advocates like Dr. Jennifer Pomeranz of New York University argue that the FDA’s latest action fulfills its legal obligation under the clause.
The ban on red dye No. 3 underscores the importance of reevaluating long-standing food safety standards. In 2012, research reinforced concerns about artificial food colorings, linking them to cancer in animals and potential behavioral impacts in children. While red dye No. 3 is just one of many additives under scrutiny, its removal signals a broader shift toward prioritizing consumer health and safety.
With this landmark decision, the FDA has taken a significant step in addressing public concerns over harmful additives. Manufacturers now face the challenge of reformulating their products to comply with the new regulations while maintaining the vibrant colors consumers expect. For advocates and experts alike, the ban represents a hard-fought victory and a hopeful precedent for future regulatory actions.
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