The U.S. Food and Drug Administration (FDA) issued a ban on Wednesday on Red Dye No. 3, a food coloring, nearly 35 years after prohibiting its use in cosmetics due to potential cancer risks.
The FDA approved a 2022 petition from various food safety and health advocates who sought the removal of the dye, which is used to color candies, snack cakes, and maraschino cherries a vibrant red.
The agency stated the ban is a legal imperative, citing studies indicating the dye caused cancer in lab rats. The FDA referenced the Delaney Clause, which mandates the banning of any additive shown to cause cancer in humans or animals.
Erythrosine, also known as FD&C Red No. 3 or Red 3, is being removed from the list of approved color additives in food, dietary supplements, and oral medications. Over three decades ago, the FDA rejected Red 3 for cosmetics and external drugs due to a study revealing cancer in rats that consumed it.
“The FDA is taking action to remove the authorization for using FD&C Red No. 3 in food and ingested drugs,” said 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 No. 3. Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.”
Food manufacturers have until January 2027 to eliminate the dye from their products; drug manufacturers have until January 2028. Imported foods must comply with the new U.S. regulation, although other countries may still permit certain uses.
Consumer advocates applauded the decision.
“This is a welcome, but long overdue, action from the FDA: removing the unsustainable double standard in which Red 3 was banned from lipstick but permitted in candy,” said Dr. Peter Lurie, director of the Center for Science in the Public Interest (CSPI), which spearheaded the petition.
Potential legal challenges from food manufacturers remain a possibility, given the absence of conclusive evidence demonstrating human cancer risk from consuming the dye. FDA Commissioner Dr. Robert Califf acknowledged this risk in a December hearing.
“When we do ban something, it will go to court,” he told members of Congress on Dec. 5. “And if we don’t have the scientific evidence, we will lose in court.”
When the FDA disallowed Red 3 in cosmetics and topical drugs in 1990, its use in food and ingested drugs was already authorized. Because research indicated that the mechanism of cancer causation in rats was not applicable to humans, “the FDA did not take action to revoke the authorization of Red No. 3 in food,” the agency stated.
Health advocates have repeatedly urged the FDA to reconsider this, including via the 2022 CSPI petition. In November, numerous members of Congress wrote a letter demanding the FDA ban Red 3.
Lawmakers cited the Delaney Clause, emphasizing the need to protect children, who consume proportionally more of the dye than adults.
“The FDA should act quickly to protect the nation’s youth from this harmful dye, used simply to give food and drinks a bright red color,” the letter stated. “No aesthetic reason could justify the use of a carcinogen in our food supply.”
Red 3 is banned for food use in Europe, Australia, and New Zealand, except in certain cherry types. California will ban it starting in January 2027.
The International Association of Color Manufacturers defends the dye’s safety at typical consumption levels, citing research from the United Nations and World Health Organization, including a 2018 review affirming Red 3’s safety in food.
Some food manufacturers have already switched to alternatives, including beet juice, carmine (insect-derived dye), and pigments from purple sweet potato, radish, and red cabbage, according to Sensient Food Colors.
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