FDA Bans Red Dye No. 3 in Food Products

According to the FDA, Red No. 3 is most commonly used in baked goods and candies.

Red Dye No. 3 – which has been the topic of controversy for decades – has been banned by the U.S. Food and Drug Administration (FDA). The agency announced that the dye cannot be used in food products due to its link to health conditions including cancer, and cited the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

According to the FDA, manufacturers who use that synthetic food dye in food have until Jan. 18, 2027 to reformulate their products. The agency noted that Red Dye No. 3 has been mainly used in candy, cakes and cupcakes, cookies, frozen desserts and frostings and icings.

There had been a groundswell of efforts to motivate FDA to officially enact the ban in foods, as it had for cosmetics and topical drugs back in 1990. The Center for Science in the Public Interest (CSPI) is one advocacy group that long pushed for the move. “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 Dr. Peter G. Lurie, CSPI president. “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?”

Julie Chapon, co-founder of the Yuka project that includes an app enabling consumers to determine the added chemicals an additives by scanning items at the grocery store, also commented on the FDA’s action. "It's about time,” she declared, noting that Red Dye No. 3 has long been banned in Australia and restricted to candied cherries in Europe. “The FDA's decision is a step forward, but we must continue to push for stronger regulations – dozens of risky additives are still allowed in the U.S."

In its Jan. 15 statement on revoking the use of Red Dye No. 3 in food, FDA did point out that the exposure levels of Red Dye No. 3 for humans are typically much lower than those that cause the effects shown in male laboratory rats.