The U.S. Food and Drug Administration (FDA) announced it will revoke the authorization of Red 3, a food coloring dye, for use in foods. The decision stems from concerns over its link to cancer in laboratory animals, despite the FDA previously stating that evidence did not suggest a cancer risk to humans.
Legal Mandate Behind the Decision
The FDA cited the Delaney Clause, which prohibits the agency from authorizing any food or color additive found to cause cancer in humans or animals. According to Jim Jones, the FDA’s deputy commissioner for human foods, “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red №3.”
While the FDA maintains that current scientific evidence does not support a significant human health risk from Red 3, the legal requirements compelled the agency to act.
Impact on Food Products
Red 3 has been widely used in various food products, including candies, snacks, fruit cups, and even some beverages. Popular products containing the dye include Jelly Belly’s Candy Corn, Tootsie’s Dubble Bubble gum, Del Monte cherry mixed fruit cups, and Nesquik’s strawberry low-fat milk. Food manufacturers have until January 2027 to phase out its use.
Advocacy and State-Level Action
The FDA’s decision follows a petition filed by the Center for Science in the Public Interest (CSPI) and other advocacy groups in 2022. CSPI has also supported state-level bans, such as California’s 2023 decision to outlaw the dye. Highlighting the aesthetic purpose of food dyes, Dr. Peter Lurie, CSPI president, stated, “When the function is purely aesthetic, why accept any cancer risk?”
Broader Health Concerns
In addition to the cancer concerns, Red 3 and other synthetic dyes, such as Red 40, have been scrutinized for their potential impact on children’s neurobehavior. A 2021 review by California’s Environmental Protection Agency found that synthetic dyes could contribute to hyperactivity in some children.
International Use
Globally, Red 3 — also known as erythrosine or E127 — is permitted in limited applications. In Europe, for instance, its use is restricted to cocktail cherries and candied cherries.
Industry Response
The candy industry and other food manufacturers have pledged to comply with the FDA’s updated regulations. Industry representatives emphasized the importance of a unified, science-based regulatory approach to food safety to avoid inconsistent state laws.
This regulatory move underscores growing concerns over the safety of artificial additives and their long-term impact on both public health and food industry practices.
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