The U.S. Food and Drug Administration (FDA) is revoking the authorization for Red Dye No. 3, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Delaney Clause, which was enacted in 1960, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals.

The revocation came in response to a 2022 color additive petition jointly filed by several organizations, which cited among other data and information two studies that showed cancer in male rats exposed to high levels of Red No. 3 due to a rat-specific hormonal mechanism. The way that the color additive causes cancer in rats, however, doesn’t occur in humans, FDA stated, and relevant human exposure levels to Red No. 3 are typically much lower than those that caused effects on male rats in the studies, the agency added. Further, studies in other animals and in humans didn’t provide evidence of a carcinogenic effect, the agency reported.

This isn’t the first time the agency revoked a food additive or color additive if found to induce cancer in animals. In 2018, FDA revoked authorization for certain synthetic flavors due to the Delancey Clause in response to a food additive petition.

FD&C Red No. 3 is a synthetic food dye that gives foods a bright cherry-red color. It’s not as widely used in food and drugs compared to other certified colors, FDA estimates, based on information available in third-party food product labeling databases, food manufacturer’s websites, and other public information, along with FDA certification data. It’s primarily used in certain food products like confectionery, as well as certain ingested drugs.

Manufacturers using Red No. 3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028 to remove Red No. 3 from food and drugs respectively. Imported foods must also comply with these requirements.

Advocacy Groups React

Advocacy organizations specializing in toxic chemicals described the move as a major victory.

Center for Science in the Public Interest (CSPI), which spearheaded the petition, noted that FDA removed Red No. 3 from cosmetics and topical drugs due to the Delancey clause, claiming that it would “take steps” to ban it from foods and ingested drugs.

“At long last, FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed children in the form of candy,” said Dr. Peter G. Lurie. “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?”

According to CSPI, FDA’s assertion that Red No. 3 only presents a danger when it exceeds a certain threshold isn’t supported by direct evidence. And the fact that synthetic dyes have remained authorized long after evidence of harm is part of a broader problem at the agency, CSPI said.

“We’re not surprised FDA has asserted that the risk is small, since it’s a chemical they failed to ban for years, and they want to reassure the public that the agency hasn’t been placing them at risk for decades,” Lurie said. “But the truth is Congress made plain decades ago that this was exactly the type of chemical, one that causes cancer in animals, it was trying to keep out of the food supply … If the incoming administration wants to protect children’s health, it should require companies to warn parents of the risks that all synthetic dyes pose to their children, right on the label of the package.”

“We wouldn’t be celebrating this historic decision today without the relentless leadership of public health champions like Michael Jacobson who took up this fight decades ago on behalf of consumers,” said Ken Cook, president and co-founder of the Environmental Working Group, a co-petitioning organization. Jacobson co-founded CSPI in 1971, and served as its executive director until 2017.  

“We all owe a debt of gratitude to Michael and the other early leaders who pushed the FDA to remove toxic chemical ingredients from the nation’s food supply,” Cook continued. “This ban sends a strong message that protecting the health of Americans, especially vulnerable children, must always take priority over the narrow interests of the food industry.”

The Environmental Working Group noted that other research presents troubling evidence of potential harms of Red Dye No. 3. For instance, a 2021 study led by California’s Office of Environmental Health Hazard Assessment found that synthetic dyes including Red No. 3 are associated with greater risk of behavioral difficulties in children, including decreased attention span and memory problems.