FDA moves to eliminate carcinogenic Red 3 from foods

More than 30 years after the Food and Drug Administration determined that the synthetic food dye Red 3 causes cancer, the agency is finally moving to eliminate the dye from the food, supplement, and drug supply. The move comes in response to a 2022 color additive petition filed by the Center for Science in the Public Interest and 23 other organizations and prominent scientists calling on the FDA to fully ban Red 3.

In 1990, based on evidence from the 1980s that Red 3 caused cancer in laboratory animals, the FDA prohibited the dye from use in cosmetics and topical drugs, and said it would "take steps" to ban it from foods and ingested drugs. But it failed to fulfill that commitment, until today.

"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," said CSPI president 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?"

CSPI petitioned the FDA in 2022 to ban Red 3 from food, dietary supplements, and drugs based on long-established evidence that the dye causes thyroid cancer when consumed by animals. The petition highlighted how FDA had previously rejected arguments by the food industry that Red 3 was only dangerous after it exceeded a certain threshold, an assertion which has never been backed up with evidence.

"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 US food supply."

In 1958, Congress made clear that it wanted no cancer-causing dyes in the food supply - not even in small amounts. It is that authority - the Delaney Clause - that FDA finally acknowledged as it banned Red 3 today.

The food and drug industries used more than 200,000 pounds of Red 3 in 2021. CSPI's advice to parents is to avoid not only Red 3, but all numbered dyes, such as Yellow 5 and Red 40. Aside from the risk of cancer posed by Red 3, concerns have mounted about the adverse impacts of these synthetic dyes on children's behavior.

"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," Lurie said.

The fact that Red 3 and the other synthetic dyes have remained authorized long after evidence of harm emerged is a symptom of a broader problem at FDA, according to CSPI. The agency has failed to effectively monitor the safety of chemicals after they come to market, which is why, after years of prompting by CSPI and its partners, FDA announced plans in 2024 to develop an enhanced framework for conducting post-market assessments of food chemical safety.

Even as FDA works to develop that plan, consumers continue to be exposed to unsafe food chemicals including not just dyes but also the artificial sweetener aspartame, the white pigment titanium dioxide, the preservative propylparaben, and the phthalate food packaging chemicals, according to CSPI.

CSPI says the Trump Administration could take steps to protect consumers from each of these chemicals and support FDA's broader post-market assessment efforts. It could ensure that FDA sets health-protective limits on heavy metals, like lead, arsenic, and cadmium, in foods consumed by children. And it could work with Congress to close the loopholes by which companies themselves, without the FDA's involvement, self-certify that the chemicals they use in food are safe, according to the group.

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Tags

• Food Dyes
• Additives
• Red 3

Topics

• Food Additives
• Government Accountability
• Industry Accountability

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