After decades of controversy, the U.S. Food and Drug Administration (FDA) has officially banned the use of Red Dye No. 3 in food, beverages, and ingested drugs. This decision comes more than 30 years after scientists discovered links between the dye and cancer in animal studies.
What is Red Dye No. 3?
Also known as erythrosine, Red Dye No. 3 is a synthetic color additive derived from petroleum. It is widely used to give food, drinks, and medications a vibrant cherry-red hue. Despite its visual appeal, the additive has been under scrutiny due to potential health risks.
A Long-Awaited Ban
The FDA's decision follows a November 2022 petition submitted by advocacy groups, including the Center for Science in the Public Interest and the Environmental Working Group, which cited evidence of the dye's carcinogenic properties. California set a precedent by banning the additive in October 2023, pushing the federal agency to take action.
Manufacturers have been given deadlines of January 15, 2027, for food products and January 18, 2028, for ingested drugs to comply with the new regulations. These rules will also apply to imported products containing the dye.
Consumer Advocacy and Public Health
Advocates are celebrating the ban as a significant victory for public health. Ken Cook, president of the Environmental Working Group, described it as a "monumental victory" for consumer safety. Meanwhile, Dr. Jerold Mande, a nutrition expert from Harvard University, expressed hope that this decision signals a renewed focus by the FDA on protecting public health despite industry resistance.
Current Use and Industry Changes
Red Dye No. 3 is still present in numerous candies, beverages, and other processed foods. However, some companies have already phased it out. Ferrara, the maker of Brach’s candies, began removing the dye in early 2023, and Just Born, the company behind PEEPS, stopped using it after Easter 2024.
Many manufacturers have switched to alternatives like Red Dye No. 40, which is considered less harmful but has its own set of controversies, including links to behavioral issues in children.
The Controversial History of Red Dye No. 3
The FDA banned Red Dye No. 3 in cosmetics and topical drugs in 1990 after research linked it to cancer in lab animals. However, the additive remained approved for food and drugs ingested orally due to the lack of conclusive evidence in humans.
Critics argue that the FDA’s delayed action contradicts the Delaney Clause, a federal law prohibiting carcinogenic additives in food. Dr. Jennifer Pomeranz from New York University emphasized that the clause mandates the FDA to ban substances shown to cause cancer in animals or humans, regardless of exposure levels.
International and State-Level Comparisons
The U.S. decision aligns its food safety regulations slightly closer to those of the European Union, which banned Red Dye No. 3 in 1994, except in certain maraschino cherry products. California and other states are also leading the charge, with 10 additional states proposing legislation to restrict the dye.
Tips for Avoiding Artificial Dyes
Consumers concerned about Red Dye No. 3 can take proactive steps:
- Check ingredient labels for terms like “Red 3” or “FD&C Red #3.”
- Avoid highly processed foods, which are the primary source of artificial dyes.
- Opt for dye-free or naturally colored alternatives in both food and medications.
The Bigger Picture
Advocates stress the need for broader reform in the U.S. food system. Dr. Thomas Galligan of the Center for Science in the Public Interest called the ban a positive step but highlighted the FDA’s slow response to known health risks.
With public health and food safety increasingly in the spotlight, the FDA's action may inspire further scrutiny of other artificial additives, ensuring that consumer safety remains a top priority.
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