Update, Jan. 15, 2025: This story was edited and updated with new reporting that reflects changes to FDA policy. (This article was originally published Feb. 9, 2024.)
The Food and Drug Administration banned FD&C Red No. 3, the artificial color-enhancing chemical commonly known as Red Dye 3, from the US food supply on Wednesday, following yearslong pressure from advocates to remove it from popular products that include candy and beverages.
Food and beverage makers have until January 15, 2027 to remove the additive. Drug makers have until January 18, 2028.
The announcement cited a 2022 petition filed by the Center for Science in the Public Interest in collaboration with 20-plus other organizations and scientists. That petition invoked the Delaney Clause, legislation that requires the FDA to ban any food additive that is found to cause cancer in humans or animals. (More on this below.)
In a statement, CSPI president Peter G. Lurie, MD, MPH wrote, “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. 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?”
The National Confectioners Association also released a statement, writing, “Food safety is the number one priority for U.S. confectionery companies, and we will continue to follow and comply with FDA’s guidance and safety standards.”
More than three decades ago, the FDA banned the use of Red 3 in cosmetics, like lipsticks and blushes, because studies had found that high doses of the dye caused thyroid cancer in rats. But the ingredient has remained approved for use in food and medicines, and appears on thousands of product labels.
The dye has been on the market since 1907. In October 2022, California became the first US state to ban Red 3 in food products starting in 2027. And a slew of other states, including New York, Illinois, and Washington, have introduced bills to ban Red 3. (Red 3 has been prohibited for almost all food uses in the European Union since the early ’90s. It’s also banned in Japan, China, the UK, Australia, and New Zealand.)
Here’s what you need to know about Red Dye No. 3.
What is Red Dye 3?
Also known as Erythrosine, Red Dye No. 3 “is a coal tar dye, meaning that it’s a synthetic colorant made from petroleum,” says Homer Swei, PhD, the senior vice president of Healthy Living and Consumer Safety Science at the Environmental Working Group, a nonprofit research organization focused on public health and consumer safety. Since the early 1900s, the dye has skyrocketed in popularity in the food and drug industries due to its bright red hue, making it a go-to choice for adding colors to drinks, confectioneries, and more.
