The United States Food and Drug Administration (FDA) has announced a ban on erythrosine, commonly referred to as Red 3, due to research indicating its potential carcinogenic effects on male rats. This decision impacts the use of this dye in food products, beverages, and oral medications. The ruling follows a long-standing prohibition on Red 3 in topical drugs and cosmetics since 1990. Many countries, including the European Union, Australia, and New Zealand, have already restricted its application as a food additive, with limited exceptions. Manufacturers will have until January 2027 for food items and January 2028 for medications to adjust their formulations. This change also extends to imported goods. The move came after a petition by over 20 organizations in 2022, citing the Delaney Clause, which prohibits additives found to cause cancer in humans or animals.

Ban Details and Regulatory Context

In a significant development during the autumn season, the US FDA declared that Red 3, a widely used artificial coloring agent, would no longer be permissible in consumable products. Research findings revealed that this dye could induce cancer in male rats when exposed to high concentrations. Consequently, manufacturers now face deadlines to reformulate their products. For foods, the transition period ends in January 2027, while for oral medicines, it extends until January 2028. Importers must also adhere to these guidelines. This action aligns with existing bans in place since 1990, which prohibited Red 3 in external applications like cosmetics and topical drugs. Internationally, regions such as the EU, Australia, and New Zealand have largely phased out Red 3 as a food additive, except for specific uses like preserving cherries.

The ban was prompted by a petition from more than 20 advocacy groups in 2022, emphasizing the legal framework provided by the Delaney Clause within the Food, Drug, and Cosmetic Act. According to Jim Jones, the FDA’s deputy commissioner for human foods, the clause explicitly states that any additive shown to cause cancer in humans or animals cannot be authorized. However, he noted that the evidence of cancer risk is limited to male rats exposed to high doses, and the specific hormonal mechanism involved does not apply to humans. Despite this, the FDA acknowledges the legal basis for the ban, aiming for consistency and transparency in regulatory practices.

Peter Lurie, president of the Center for Science in the Public Interest (CSPI), welcomed the decision, highlighting the inconsistency in regulations where Red 3 was illegal in lipsticks but allowed in candies consumed by children. This move aims to resolve such discrepancies and enhance consumer protection.

From a journalistic perspective, this regulation underscores the importance of rigorous scientific scrutiny in ensuring public health and safety. It reflects a balanced approach where legal mandates and scientific evidence converge to drive policy changes. While the risk to humans remains debated, the ban sets a precedent for prioritizing precautionary measures in food safety regulations. This decision may prompt further reviews of other additives, fostering greater transparency and consistency in regulatory frameworks.