
FDA Bans Red No. 3 Artificial Dye in Food, Ingested Drugs
Key Takeaways
- The FDA revoked FD&C Red No. 3 in food and drugs due to cancer risks in male rats, despite no human risk evidence.
- The Delaney Clause mandates banning additives causing cancer in humans or animals, influencing the FDA's decision.
The FDA cites cancer risk and the Delaney Clause in its decision to revoke food and drug uses of the dye.
Today, the FDA announced the revocation of FD&C Red No. 3 for use in food and ingested drugs, citing the
FD&C Red No. 3, a synthetic dye that imparts a bright cherry-red color, has primarily been used in food products such as candy, cakes, cupcakes, cookies, frozen desserts, and frostings and icings, as well as some ingested drugs. Manufacturers must now reformulate affected products by early 2027 or 2028 to comply with the new regulations.
“At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy,” said Peter Lurie, MD, MPH, president of the Center for Science in the Public Interest,
This announcement aligns with
The Delaney Clause, incorporated into the Federal Food, Drug, and Cosmetic Act by the Food Additives Amendment of 1958, requires the FDA to ban food additives that are found to cause or induce cancer in humans or animals as indicated by testing.4 The petition requested the FDA review whether the Delaney Clause applied, noting 2 studies that showed cancer in laboratory male rats exposed to high levels of the dye due to a rat-specific hormonal mechanism.1
“In cases where data demonstrates that a color additive intended for ingestion can induce cancer in human or animal based on appropriate tests, the Delaney Clause directs the FDA to find such uses of the color additive unsafe,” the FDA stated.5
However, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans, with relevant exposure levels to FD&C Red No. 3 being typically much lower in humans than those that cause the effects shown in the rats.1 Furthermore, studies in other animals and humans did not show these effects, meaning claims that the use of FD&C Red No. 3 in food and ingested drugs puts people at risk of cancer is not supported by the available scientific findings.
“We’re not surprised the FDA has asserted that the risk is small, since it’s a chemical they failed to ban for years, and they want to reassure the public that the agency hasn’t been placing them at risk for decades,” said Lurie.2 “But the truth is Congress made plain decades ago that this was exactly the type of chemical—one that causes cancer in animals—it was trying to keep out of the US food supply.”
References
1. FDA to revoke authorization for the use of Red No. 3 in food and ingested drugs. FDA. News release. January 15, 2025. Accessed January 15, 2025.
2. FDA moves to eliminate carcinogenic Red 3 from foods. Center for Science in the Public Interest. News release. January 15, 2025. Accessed January 15, 2025.
3. Edney A. Seeing red: What RFK Jr and US food regulators have in common. Bloomberg. November 14, 2024. Accessed January 15, 2025.
4. Regulation of cancer-causing food additives—Time for a change. Government Accountability Office. December 11, 1981. Accessed January 15, 2025.
5. FD&C Red No. 3. FDA. News release. January 15, 2025. Accessed January 15, 2025.
Newsletter
Stay ahead of policy, cost, and value—subscribe to AJMC for expert insights at the intersection of clinical care and health economics.