The Food and Drug Administration (FDA) has banned the use of synthetic food dye Red No. 3 for being linked to cancer in test animals, health officials said Wednesday.
The ban comes nearly 35 years after Red No. 3 was prohibited from cosmetic products for its potential connection to cancer, Newsweek reported.
FDA officials said the agency is “revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
The announcement cited two studies that showed “cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat specific hormonal mechanism,” though tests on other animals and humans “did not show these effects.”
Originally approved for use in foods in 1907, Red No. 3, — made from petroleum, according to the FDA — was the subject of a decades-long banning effort by the agency after it first became aware of lab rats growing tumors when exposed to it in high doses, NBC News reported.
The dye, which has already been banned in Australia, Japan, and European Union countries, is common in American candy — including Pez, Dubble Bubble gum, and Jelly Belly jellybeans — as well as baked goods like muffins, toaster pastries, and cookies with red icing or decorations, according to Newsweek.
It is also easily found in several sodas, strawberry-flavored milks, and maraschino cherries.
Some medications and supplements, including cough syrups, gummy vitamins, and PediaSure Grow & Gain Kids’ Ready-to-Drink Strawberry Shake also contain the dye.
According to the food safety advocacy group Center for Science in the Public Interest (CSPI), which petitioned the FDA to ban the product in 2022, over 9,200 food products contain the synthetic dye.
Food manufacturers will have until January 15, 2027, to remove the dye from their products, and companies that produce ingested drugs like supplements will have until 2028.
“The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in human or animals,” FDA deputy director for human foods Jim Jones said in a statement obtained by NBC. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.”
“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,” CSPI president Dr. Peter G. Lurie said in a statement. “The primary purpose of food dyes is to make candy, drinks, and other processed foods more attractive. When the function is purely aesthetic, why accept any cancer risk?”
