FDA Prohibits Red Dye 3 in Food, Candy, and Medicine

The United States Food and Drug Administration (FDA) has officially banned the use of Red No 3, also known as erythrosine, in food, candy, and medicine due to its association with cancer in male laboratory rats. Announced on Wednesday, the ban marks a significant regulatory shift concerning food safety and consumer protection. The additive was already prohibited in California schools as of last year, reflecting growing concerns over its safety.

The decision comes after sustained advocacy from health organizations, notably the Center for Science in the Public Interest (CSPI), which filed a petition in 2022 highlighting the dye's potential health risks. The CSPI's campaign emphasized the dye's widespread usage among American consumers, particularly children. Dr. Peter Lurie, president of CSPI, remarked on the decision:

"At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy." – Dr. Peter Lurie, president of the Center for Science in the Public Interest.

Red No 3 has been a common ingredient in various candies, baked goods, fruit products, and beverages. Despite its prevalence, some manufacturers have already begun phasing out its use. For instance, Dole eliminated erythrosine from its fruit bowls in 2023. The FDA's announcement mandates that food manufacturers reformulate their products by January 2027, while drug manufacturers have until January 2028 to comply. Additionally, food imported into the United States will also be subject to these new regulations.

This ban is considered "long-delayed" by CSPI and highlights historical inconsistencies in regulatory practices. Notably, Red No 3 was banned from cosmetics by the FDA 35 years ago. The current prohibition reinforces the need for comprehensive evaluations of food additives' safety.

In an interesting development, Red dye 40, considered a healthier alternative to Red No 3, has also been scrutinized. A study by the UK's Food Standards Agency linked Red dye 40 to increased hyperactivity in children. Furthermore, another study suggested an association between Red dye 40 and bowel disorders in mice, indicating ongoing concerns about artificial colorants.