In a historic move, the U.S. Food and Drug Administration (FDA) has banned the use of red dye No. 3 in food and ingested drugs, following decades of health concerns, including evidence linking the synthetic colorant to cancer in animals. The FDA announced the decision on Wednesday, responding to a petition filed in November 2022 by consumer advocacy groups, including the Center for Science in the Public Interest and the Environmental Working Group. The ban marks a pivotal moment in the fight for food safety, which had seen many push for stricter regulations after studies revealed the dangers of the petroleum-derived additive.
Red dye No. 3, chemically known as erythrosine, has been a staple in food coloring since the 1960s, often used to give products a vibrant, cherry-red hue. However, despite animal studies indicating that the dye could cause cancer, it remained in use for over 30 years, raising questions about the FDA’s regulatory processes. The decision comes after California’s move to ban the dye in October 2023, signaling growing momentum for change. According to the FDA, manufacturers will have until January 15, 2027, to remove red dye No. 3 from food products, and until January 18, 2028, to comply for ingested drugs. Imported food products will also need to meet the new requirements.
Dr. Jerold Mande, an adjunct professor of nutrition at Harvard University, emphasized that this decision is “long overdue,” but noted that it represents a small step in the right direction. Ken Cook, president of the Environmental Working Group, hailed the ruling as a monumental victory for public health, crediting long-time advocates who fought for this ban over the years.
While some major companies, such as Ferrara and Just Born, have already phased out the use of red dye No. 3 in their products, many others still rely on the controversial colorant. Products such as candies, beverages, and even some medications often contain this artificial dye, although it is being gradually replaced with alternatives like red dye No. 40, which has not been as widely linked to cancer.
The FDA’s decision also addresses what experts have described as a regulatory paradox. Despite the Delaney Clause in the Federal Food, Drug, and Cosmetic Act, which prohibits substances shown to cause cancer in animals or humans from being approved for use in food, red dye No. 3 remained permissible. The FDA had banned its use in cosmetics and topical drugs in 1990 after studies found its carcinogenic effects in lab rats, but the agency did not extend that ban to food, citing the absence of direct evidence linking the dye to cancer in humans.
However, studies conducted in recent years have raised doubts about the safety of red dye No. 3, including a 2012 report linking the additive to cancer in animals. Further studies in California and elsewhere have also suggested potential behavioral impacts in children, such as increased attention difficulties, particularly with prolonged exposure to the dye.
Critics, including Dr. Jennifer Pomeranz of NYU’s School of Global Public Health, have questioned why the FDA did not act sooner. The agency has faced intense scrutiny for allowing harmful substances like red dye No. 3 to remain in the food supply for decades. In Europe, the dye was banned in food products as early as 1994.
As the U.S. moves closer to aligning its food safety regulations with those of the European Union, the decision to revoke the authorization for red dye No. 3 in food marks a significant shift in consumer protection policy. However, experts agree that this is just the beginning of much-needed reforms in the FDA’s approach to food additives.
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