FDA Bans Red 3 Dye in Foods After Cancer Risk Concerns

The U.S. Food and Drug Administration (FDA) has officially banned the artificial dye known as Red 3 from use in food products, citing cancer risks associated with its consumption. This decision comes nearly 35 years after Red 3 was prohibited in cosmetics due to similar concerns.

The ban, announced on January 15, 2025, follows a petition filed in 2022 by health advocates who urged the FDA to review the safety of the dye, also known as erythrosine or FD&C Red No. 3. The agency emphasized that studies have shown Red 3 caused cancer in laboratory rats, which prompted the legal requirement to remove it under the Delaney Clause, a statute that mandates the ban of any additive found to cause cancer in humans or animals.

Food manufacturers have until January 2027 to eliminate Red 3 from their products, while those producing ingested drugs will have until January 2028 to comply. While some other countries still permit its use in specific applications, all imported foods must adhere to the new U.S. regulations concerning the dye.

Consumer advocates expressed approval of the FDA’s decision. Dr. Peter Lurie, director of the Center for Science in the Public Interest, noted that the prohibition was overdue, highlighting the inconsistency of allowing Red 3 in food products while banning it from cosmetics.

Despite the ban, it remains uncertain whether it will face legal challenges from food manufacturers. The FDA has previously stated that the way Red 3 may induce cancer in rats does not directly translate to effects in humans, leading to years of debate over its safety.

The international community has already moved to ban Red 3 for food use, with regulations in place in Europe, Australia, and New Zealand, while various U.S. states explore similar restrictions.