The United States Food and Drug Administration, FDA, officially banned Red Dye 3, a popular food additive found in food, beverages, and medications, after the dye was said to cause cancer in rats. The decision follows a petition submitted by consumer groups to the FDA in 2022 for the agency to ban the red dye, which had been outlawed from use in cosmetics for 35 years.

In a statement, the FDA said that the ban was a legal necessity, as it was mandated by the Delaney Clause, which prohibits any additive that is found to cause cancer in humans or animals. The law requires a ban if there is any evidence of cancer in animals, even though research has shown that the way Red Dye 3 causes cancer in rats doesn't apply to humans.

What is Red Dye 3?

Red Dye 3, also known as erythrosine or FD&C Red No. 3, is a bright red, petroleum-based color additive. It’s often used to give sweets and some medicines a cherry-red color. While the dye has been banned in cosmetics and non-oral medications since 1990 due to cancer concerns, it remained in use in certain foods and drinks until now.

Following the ban, manufacturers must reformulate their products to remove Red Dye 3. Food products have until January 15, 2027, and drugs until January 18, 2028, to comply with the new regulation.

How did the food industry react?

The U.S. National Confectioners Association, which represents the confectionery industry, reported that it is committed to adhering to the FDA's guidance. It guaranteed a consistent, science-based framework for food safety.

Meanwhile, the Center for Science in the Public Interest, one of the leading advocates for the ban, said it was a long-overdue correction of a regulatory lapse.

The International Association of Color Manufacturers countered that the cancer-causing effects observed in rats were due to very high doses of the dye, which don't necessarily translate to human risk.

With Robert F. Kennedy Jr. poised to lead the Department of Health and Human Services, more food additives could be under scrutiny. Kennedy has already criticized the use of artificial colors in cereals and voiced concerns about seed oils like canola and soybean oil. While his stance on seed oils has faced backlash from nutritionists, it suggests that future regulatory actions might target additional food ingredients.