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Red 3: FDA finally bans cancer-causing food dye [1]

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Date: 2025-01

The US Food and Drug Administration is finally banning the food dye Red 3 from use in foods, beverages, oral drugs, and dietary supplements, addressing a decades-long regulatory failure. Red 3 has been banned from use in topical drugs and cosmetics since 1990, when the FDA itself determined that the dye causes cancer when eaten by animals. Because the FDA failed to uphold its legal obligation to fully ban cancer-causing additives, Red 3 remained permitted in foods, supplements, and oral drugs more than 34 years later. That changed on Jan. 16, 2025, thanks to a color additive petition filed by CSPI in 2022. Here's what to know about the harmful additive, including where you might find it, and why the FDA's long-delayed ban is a win for public health.

In 1990, the Food and Drug Administration banned Red 3 from use in cosmetics, like lipstick and skincare products, as well as topical drugs, like pain-relief ointments. That’s because the FDA learned in the 1980s that Red 3 is a carcinogen in rats. Federal law requires that the FDA prohibit the use of any cancer-causing color additives in foods, drugs, and cosmetics. In 1990, the agency banned Red 3 for topical uses, but the FDA decided (and promised) to take separate regulatory action to ban Red 3 from the food supply and other oral products.

More than three decades elapsed, and the FDA never took those critical next steps, failing to keep its promise and, more importantly, failing to protect consumers from this clearly unsafe additive. Red 3 can still be found in thousands of candies, snacks, and fruit products.

In 2022, CSPI and 23 other organizations and prominent scientists petitioned the FDA to finally keep its promise and ban all remaining uses of Red 3.

Acting on that petition today, more than two years later, the FDA has done just that. Today's ban gives manufacturers until Jan. 16, 2027, to remove Red 3 from their products.

Red 3 and cancer

Animal studies completed in the 1980s revealed that Red 3 causes thyroid cancer in rats. When studies reveal that an additive causes cancer in humans or animals, the Delaney Clause—a provision of the Federal Food, Drug, and Cosmetic Act—obligates the FDA to deem it unsafe and prohibit it from use in food, drugs, and cosmetics.

FDA relied on the Delaney Clause to ban Red 3 from topical products in the US in 1990, and it did so again today in banning the dye from food products.

CSPI's petition to ban Red 3

With the FDA’s inaction on Red 3 after 1990, CSPI, along with 23 other organizations and scientists, petitioned the FDA to eliminate the carcinogenic dye from the food and drug supply in October of 2022.

In the two years since, California introduced, passed, and signed into law the California Food Safety Act, banning Red 3 and three other unsafe additives statewide, and other states subsequently introduced similar legislation—leaving the federal government to play catch-up.

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[1] Url: https://www.cspinet.org/cspi-news/red-3-fda-finally-bans-cancer-causing-food-dye

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