FDA Considers Federal Ban on Artificial Red Dye 3 in Food and Drugs

The review follows health concerns linking the petroleum-based dye to cancer in animals and behavioral issues in children.

The FDA is reviewing a petition to ban Red Dye No. 3, a synthetic additive used in nearly 3,000 food products and medications in the U.S.
The dye, already banned in cosmetics and in the European Union, has been linked to cancer in lab animals and hyperactivity in children, though human studies remain inconclusive.
The Delaney Clause, which prohibits additives linked to cancer in animals, is central to the petition filed by 24 advocacy groups and scientists in 2022.
California has already passed legislation banning Red Dye No. 3 in foods starting in 2027, while other states are considering similar measures.
Some companies, such as Abbott, have begun voluntarily removing Red Dye No. 3 from their products in response to growing consumer and regulatory pressure.