
The Food and Drug Administration said on Wednesday that it is banning red dye No. 3 from food products.
Two studies have shown cancer in laboratory male rats exposed to high levels of red dye No. 3, the FDA said. And while the FDA said studies in other animals and in humans did not show these effects, the Delaney Clause—enacted in 1960 as part of the Color Additives Amendment to the Federal Food, Drug, and Cosmetic Act—prohibits FDA authorization of a food or color additive if it has been found to induce cancer in humans or animals.
This is not the first time the agency revoked an authorization based on the Delaney Clause. In 2018, the FDA revoked the authorization for certain synthetic flavors based on the Delaney Clause in response to a food additive petition
“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 Center for Science in the Public Interest (CSPI) President Dr. Peter G. Lurie.
The food and drug industries used more than 200,000 pounds of Red 3 in 2021, CSPI said in a statement on Wednesday.
Red dye No. 3 is a synthetic food dye made from petroleum that gives foods and drinks a bright, cherry-red color used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs.
“Food safety is the No. 1 priority for U.S. confectionery companies, and we will continue to follow and comply with FDA’s guidance and safety standards,” the National Confectioners Association said in a statement. “Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework. We have been saying for years that FDA is the rightful national regulatory decision maker and leader in food safety.”
Manufacturers who use red dye No. 3 will have until January 2027 to reformulate their products.
In 2023 California signed a bill to ban four chemicals used in candy and other food and drinks, including red dye No. 3, starting in 2027.
Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.