The United States Food and Drug Administration (FDA) has issued a directive prohibiting the use of red dye No. 3 in consumable products, including food, beverages, and oral medications. This decision was announced on January 15th and is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which mandates that any additive shown to cause cancer in animals or humans must be banned from the market.

Research findings played a crucial role in this decision. Several studies have indicated that male laboratory rats developed thyroid tumors when exposed to high doses of red dye No. 3 over extended periods. Although these effects were not observed in other species or in human subjects, the FDA adhered strictly to the Delaney Clause, leading to the ban. Previously, in 1990, the agency had already restricted the dye's use in cosmetics and topical drugs due to similar concerns. The new ruling extends this prohibition to all ingestible products.

Moving forward, manufacturers will need to adapt to the changes. Companies producing foods or drugs containing red dye No. 3 have until January 2027 and January 2028, respectively, to reformulate their products. Despite the lack of direct evidence linking the dye to human health risks, the FDA's action underscores its commitment to public safety and preventive measures. This move reflects the regulatory body's dedication to ensuring that only safe additives enter the food supply chain, reinforcing the importance of stringent oversight in safeguarding consumer health.