The FDA has banned the use of Red Dye No. 3 in food and ingested drugs, citing studies that showed cancer in lab rats. The ban, effective for food manufacturers by January 2027 and drug makers by January 2028, comes after years of pressure from health advocates who argued that the dye poses a risk to human health. While the FDA stated the ban is based on the Delaney Clause, which prohibits additives causing cancer in humans or animals, it acknowledged that the way Red 3 causes cancer in rats doesn't apply to humans. The agency received a petition from two dozen food safety and health advocates in 2022.
While some studies have found red dye No. 3 causes cancer in laboratory rats, officials say the cancer risk has not been documented in people.FILE - Pez candy, which contains red dye no. 3 , is on display at a store in Lafayette, Calif., March 24, 2023.9:50 AM CST January 15, 2025, nearly 35 years after it was barred from cosmetics because of potential cancer risk.
The dye is known as erythrosine, FD&C Red No. 3 or Red 3. The ban removes it from the list of approved color additives in foods, dietary supplements and oral medicines, such as cough syrups. More than three decades ago, the FDA declined to authorize use of Red 3 in cosmetics and externally applied drugs because a study showed it caused cancer when eaten by rats.
It's not clear whether the ban will face legal challenges from food manufacturers because evidence hasn’t determined that the dye causes cancer when consumed by humans. At a hearing in December, FDA Commissioner Dr. Robert Califf suggested that's a risk. Lawmakers cited the Delaney Clause and said the action was especially important to protect children, who consume more of the dye on a bodyweight basis than adults, the lawmakers said.
FOOD DYE CANCER RISK FDA RED DYE NO. 3 HEALTH ADVOCATES
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