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Robert F. Kennedy Jr., nominated to be the next Secretary of Health and Human Services (HHS), has been a vocal critic of artificial dyes, including Red Dye No. 3. He’s long argued they’re tied to concerns like hyperactivity in children and cancer. His commentary has added political momentum behind the public’s increasing skepticism of synthetic colorants.
The new rule covers Red Dye No. 3 (erythrosine), an iodinated derivative of fluorescein popular for its vivid, cherry-like color. While the FDA prohibited its use in cosmetics and topical drugs back in 1990, it remained in the food supply for decades. Under the fresh ban announced in January 2025, manufacturers must remove Red Dye No. 3 from foods by January 2027 and from ingested drugs by January 2028.
What’s being banned and why
Backstory on the FD&C Red No. 3 petition
In October 2022, the Center for Science in the Public Interest and other advocacy groups filed a petition (PDF link) urging the FDA to ban Red No. 3. The petition emphasized FDA’s own findings that the dye is unsafe, noting:
“FDA concluded in 1990 that ‘FD&C Red No. 3 is an animal carcinogen when administered in the diet’ and ‘[t]he studies showing FD&C Red No. 3 to be a carcinogen when ingested are relevant and appropriate.'”
The petition highlighted widespread exposure, particularly among children:
“According to FDA, FD&C Red No. 3 is in baby foods, breakfast cereal, cakes and cupcakes, chewing gum, cookies, decoration/chips for baking, dried fruit, frostings and icings, frozen breakfast foods, hard candy, ice cream/frozen yogurt/sherbet, ice cream cones, ice pops, meal replacement drinks and bars, soft candy/gummies, and toaster pastries.”
The petitioners argued that under the Delaney Clause, “if a color additive is found to induce cancer in humans or animals, even if the risk of cancer could be ‘exceedingly small,’ it is unsafe and cannot be approved for any use.”
The legal backdrop centers on the Delaney Clause, part of the Color Additives Amendment to the Federal Food, Drug, and Cosmetic Act. Enacted in 1960, it stipulates that any additive shown to induce cancer in humans or animals cannot be approved. Studies linking high doses of Red No. 3 to thyroid tumors in rats have been at the heart of calls to phase it out entirely.
Acknowledging the cancer risks observed in lab animals, the FDA explained its reasoning in a statement explained its move, which is a response to a petition arguing the Delaney Clause applies to Red No. 3 because of cancer studies in male rats. The agency simultaneously downplayed the risk to humans, pointing out that “the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans” and that real-world exposures are typically far lower. But the Delaney Clause’s zero-tolerance requirement for carcinogens, enacted in 1960, ultimately forced the FDA to ban the dye from food and ingested drugs.
The Clause states in part “no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal.”
Key concerns and brief historical context
Red dye No. 3’s history dates back to the dawn of synthetic colorants, when an accidental discovery of mauve dye in 1856 played a role in driving interest in chemistry. The industry exploded after Queen Victoria wore a mauve-dyed silk gown to the Royal Exhibition of 1862, making synthetic dyes fashionable overnight. By the 1870s, chemists had developed fluorescein, the precursor to what would become Red No. 3, or erythrosine. Though synthetic dyes transformed industries with their affordability and vibrancy, safety concerns emerged—including a 1980s study linking dye industry workers to elevated cancer risks. In 1990, the FDA restricted erythrosine in cosmetics after cancer studies in rodents, yet U.S> food products continued to feature the additive in a variety of foods
Renewed pressure mounted in 2022, when the Center for Science in the Public Interest and other advocacy groups petitioned the FDA to revisit Red No. 3’s approval. By January 2025, the FDA agreed, setting the stage for a comprehensive phase-out.
Food manufacturers face a two-year timeline to reformulate products without Red No. 3, while pharmaceutical companies have three years. In practice, many have already begun exploring alternatives such as beet juice, the insect-based dye carmine, or beet extract to achieve red hues.
