Authorization for Red No. 3, a food dye that is found in thousands of products, is currently under review by the U.S. Food and Drug Administration. Here’s what to know about the potentially dangerous color additive.
Red No. 3, also known as FD&C Red No. 3 and erythrosine, is a food additive made from petroleum that gives foods a bright, cherry-red color, said the FDA. It has been authorized for use since at least 1931. Though changes to authorization for food coloring have come in the subsequent decades, Red No. 3 has remained authorized.
Citing the Environmental Working Group’s food database, there are over 2,900 food products that contain it, said Consumer Reports. Confections, beverages, cereals, ice cream cones, frozen dairy desserts, popsicles, frostings and icings are some of the items that contain Red No. 3, per the FDA.
Specific products that have contained Red No. 3, according to the Center for Science in the Public Interest, include varieties of candy corn, Nerds, Peeps, Pez and SweeTarts. Consumer Reports also said that Red No. 3 is an inactive ingredient in Vyvanse, a medication often prescribed for attention deficit and hyperactivity disorder.
“The FDA has evaluated the safety of FD&C Red No. 3 multiple times since its approval in 1969,” per the administration. “Currently, the FDA has two authorizing color additive regulations for FD&C Red No 3, one for food (CFR – Code of Federal Regulations Title 21 (fda.gov)) and one for ingested drugs (CFR – Code of Federal Regulations Title 21 (fda.gov)).”
While the additive is authorized for use in food, the Center for Science in the Public Interest noted in an article from October 2022 that it is illegal to use Red No. 3 in cosmetics such as lipstick and blush. It referred to the food dye as a “carcinogenic color additive.”
“More than 30 years ago the Food and Drug Administration told the cosmetics industry that it could no longer use an artificial color called FD&C Red No. 3, also known as Red Dye No. 3 and Red Dye 3. That’s because high doses of it had been found to cause cancer in animals,” Consumer Reports said.
Evidence that Red No. 3 caused cancer in lab animals was considered convincing by the National Toxicology Program, said the Center for Science in the Public Interest. That’s why it became banned for externally applied drugs.
“In 1990, FDA also said it would ‘take steps’ to ban its use in foods, ingested drugs, and supplements. But those steps were never taken,” the center added.
Consumer Reports said the International Association of Color Manufacturers industry group, “maintains that Red Dye No. 3 is safe at the levels that people typically consume and that human studies are more relevant than lab-rat studies (like the ones that led the FDA to ban it in cosmetics).” However, the outlet also said “considerable research suggests otherwise,” and that children may be the most affected.
In November 2022, the center and others filed a petition requesting for the revocation of the color additive listing for the use of Red No. 3 in food and drugs. By April 2023, the petition had garnered more than 35,000 comments and it led to the FDA review of the additive.
“The petition states that the Delaney Clause obligates the FDA to repeal the color additive regulations that permit the use of in foods (including dietary supplements) and in ingested drugs,” the FDA said. “The Delaney Clause, enacted in 1960, prevents FDA from finding a color additive to be safe if it has been found to induce cancer in humans or animals at any dose.”
Last year, California became the first state in the U.S. to officially ban the use of Red No. 3. At the time, Emily Broad Lieb, director of Harvard's Food Law and Policy Clinic, joined Audacy station KCBS Radio to discuss the move.
“I think that and many of these other substances that are permitted for use in food, there’s not really a system in place to look at them all over time within food,” she said. “So from time to time, when FDA is petitioned or put on notice about something, they look into it. And for whatever reason they were aware of. This issue... red dye number three... [it] just chose not to remove it from food and hasen’t really been pushed on it that much since.”
She said that one of the challenges to banning the additive is pushback from the industry about not being able to find a substitute. In California, businesses have until 2027 to comply with the ban and find other ways to color food.
“I think over time, ultimately, most people probably would rather their food look a little different than continue to be harmful,” said Lieb.