The FDA today has issued an order today that will ban Red No. 3 from food products and ingested drugs.
The dye, which was approved to use in 1907, has been banned in cosmetics and topical drugs since 1990 over evidence that it can cause cancer. Its use in food is already banned or restricted in Australia, Japan and countries in the EU.
Red No. 3. is commonly found in candy, gum, and cookies, including Brach’s candy corn, Betty Crocker sprinkles, and strawberry Ensure.
Food manufacturers will have until January 15, 2027 to remove it from all products, while makers of ingested drugs will have until January 18, 2028.
The new ban is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which was enacted in 1960. The Delaney Clause prohibits the FDA from authorizing any food or color additive that has been found to cause cancer.
“The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in human or animals,” said Jim Jones, the FDA’s deputy director for human foods, according to NBC. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.”
The move came in response to a petition from the Center for Science in the Public Interest and 23 other organizations, which included data showing male lab rats exposed to high levels of Red No. 3 got cancer.
However, the FDA noted that studies in humans and other animals did not show the same effect, saying that “available data does not raise safety concerns for humans.”
They also said that Red No. 3 is used in Canada and Europe but under the name erythrosine.
While Red No. 3 has been banned in cosmetics and topical drugs for nearly 35 years, it has remained in food and ingested drugs — but not for lack of concern.
In fact, the FDA previously announced that intended to ban it in food in 1992 but ultimately did not take action because of the resources that would be needed to remove its authorization.
The federal ban comes over a year after The California Food Safety Act, in which Red No. 3 and three other food additives were banned in the state. That law, too, will not be implemented until 2027.
Other states including New York, New Jersey, Pennsylvania, Maryland, West Virginia, Illinois and South Dakota have also introduced legislation.
What is Red No. 3 and what foods is it in?
Also called Red 3 or FD&C Red 3, it is a synthetic food coloring.
According to the Center for Science in the Public Interest, it can currently be found in MorningStar Farms Veggie Bacon Strips, Vigo Saffron Yellow Rice, some versions of Peeps, and fruit cocktail cherries.
