The United States Food and Drug Administration (FDA) has declared a ban on the use of Red No. 3 artificial food coloring in food products and ingested medications, effective within the next few years. This decision comes after decades of scrutiny from health advocates and research linking the dye to thyroid cancer in animal studies. The ban applies to both domestically produced and imported goods, reflecting growing concerns about the safety of this petroleum-derived additive.

Red No. 3, also known as erythrosine, has been under scrutiny for its potential health risks. Despite being banned in cosmetics and external drugs since 1990, it remained permissible in food and ingestible medicines until now. The FDA's recent announcement follows years of pressure from parents, health organizations, and legislative actions at both state and federal levels. California led the charge by prohibiting the sale of foods containing Red No. 3, while several other states introduced similar legislation.

The FDA's decision is not without controversy. While acknowledging the carcinogenic effects observed in animal studies, the agency maintains that these findings may not be directly applicable to humans. Exposure levels for humans are typically much lower than those used in laboratory tests, and there is no definitive evidence linking Red No. 3 to cancer in people. Nonetheless, the FDA has conceded to the mounting pressure from public health advocates and scientific petitions.

Internationally, Red No. 3 faces stricter regulations. In the European Union, its use is limited to specific food items, while countries like Korea prohibit synthetic colors in products primarily consumed by children and teenagers. The FDA's move aligns with global trends toward tighter control over potentially harmful additives.

Manufacturers have been given until January 2027 or 2028 to reformulate their products, depending on whether they produce food or medications. Common sources of Red No. 3 include candies, fruit juices, and snack foods, with over 2,800 items currently containing the dye. Medications such as Tylenol PM and Vyvanse also list Red No. 3 as an ingredient. Despite limited human studies, some researchers express concern over the additive's potential impact on behavior, particularly in children.

The FDA's decision marks a significant shift in food safety policy, reflecting a balance between scientific evidence and public health concerns. As manufacturers adapt to the new regulations, consumers can expect changes in product formulations and labeling. The move underscores the ongoing debate over the safety of artificial food additives and highlights the importance of continuous evaluation of substances used in everyday products.