The US Food and Drug Administration has banned the use of red dye No. 3 in food, beverages and ingested drugs, more than 30 years after scientists discovered links to cancer in animals, the agency announced Wednesday, January 15.
A synthetic color additive made from petroleum and chemically known as erythrosine, red dye No. 3 is used to give foods and beverages a bright cherry-red color.
The move acts on a November 2022 petition submitted by multiple advocacy organizations and individuals, including the Center for Science in the Public Interest and the Environmental Working Group, which cited links to cancer. The decision by the federal agency also follows in the footsteps of California, whose government banned the additive in October 2023.
Manufacturers using red No. 3 in food and ingested drugs have until January 15, 2027, and January 18, 2028, respectively, to reformulate their products, according to the FDA. Foods imported to the United States also must comply with the requirements.
“Today’s action by FDA is long overdue, is a small step in the right direction, and hopefully signals a renewed effort by FDA to do its job despite the many barriers the food industry places in its way,” said Dr. Jerold Mande, adjunct professor of nutrition at the Harvard University T.H. Chan School of Public Health, via email.
Red dye No. 3 is found in at least dozens of candy, food and beverage products, but some of the most popular brands either never used, or have already stopped using, the additive.
Fewer than 10% of products made by the candy company Ferrara, which produces Brach’s candies, for example, contain the additive, as the company began phasing out the use of it in early 2023, a Ferrara spokesperson said via email.
Some companies instead utilize red dye No. 40, which has been considered a healthier alternative as it hasn’t been as extensively associated with cancer in animals.
Red dye No. 3 has been permissible for use in food despite the Delaney Clause of the FDA’s Federal Food, Drug, and Cosmetic Act. The clause, in part, “prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested,” according to the agency.
The U.S. FDA already banned the use of red dye No. 3 in cosmetics and topical drugs in 1990 under the Delaney Clause after research found the additive to be carcinogenic at high doses for rats in lab tests. The mechanism for the dye causing cancer in rats doesn’t occur in humans, so those studies didn’t raise safety concerns, and therefore the FDA didn’t revoke the authorization for red dye No. 3 in food, according to the agency.
The FDA has reevaluated the ingredient’s safety multiple times since its initial approval — based on trials conducted in animals, not humans — in 1969, according to the agency.
There don’t appear to be any studies establishing links between red dye No. 3 and cancer in humans, and “relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats,” the FDA said in its constituent update posted Wednesday.
“Claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.
But it doesn’t matter, because the FDA mandate under the Delaney Clause says that if it shows cancer in animals or humans, they’re supposed to keep it from the food supply,” said Dr. Jennifer Pomeranz, associate professor of public health policy and management at New York University’s School of Global Public Health.
