The United States Food and Drug Administration (FDA) has banned the use of red dye No. 3 in food, beverages, and ingested drugs, decades after studies linked the synthetic additive to cancer in animals.
Red dye No. 3, chemically known as erythrosine, is a petroleum-based additive used to impart a bright cherry-red hue to various products.
The FDA’s decision which was announced on Wednesday follows a November 2022 petition from advocacy groups such as the Center for Science in the Public Interest and the Environmental Working Group, which highlighted the dye’s carcinogenic properties. The ban aligns with California’s October 2023 prohibition of the additive.
Manufacturers have been given deadlines to reformulate their products: by January 15, 2027, for food, and by January 18, 2028, for ingested drugs. Imported goods must also meet the new regulatory requirements.
“Today’s action by FDA is long overdue, is a small step in the right direction, and hopefully signals a renewed effort by FDA to do its job despite the many barriers the food industry places in its way,” said Dr. Jerold Mande, an adjunct professor of nutrition at Harvard’s T.H. Chan School of Public Health.
Advocates hailed the ban as a landmark moment for consumer health. “We wouldn’t be celebrating this historic decision today without the relentless leadership of public health champions like Michael Jacobson and others who took up this fight decades ago on behalf of consumers,” said Ken Cook, co-founder and president of the Environmental Working Group.
Red dye No. 3 is present in numerous candies, foods, and beverages. However, major brands have already begun eliminating the additive. Ferrara, the maker of Brach’s candies, reported that fewer than 10% of its products contain red dye No. 3 after the company started phasing it out in early 2023. Just Born, the producer of PEEPS, discontinued the additive after Easter 2024.
Some companies have turned to alternatives like red dye No. 40, which is considered less harmful due to fewer associations with cancer in animals.
However, California banned red dye No. 40 in public schools in September 2024, citing its potential links to behavioural and attention issues in children, as well as its benzene content, a known carcinogen.
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