Red 3 (also called FD&C Red No. 3 or erythrosine) is banned because it causes cancer in laboratory animals, and a decades-old federal law prohibits the FDA from approving any food additive shown to cause cancer at any dose. In January 2025, the FDA formally moved to revoke authorization for Red 3 in food and ingested drugs, ending a regulatory saga that stretched back more than 30 years.
The Law That Made the Ban Inevitable
The legal basis for the ban is the Delaney Clause, a provision added to the Federal Food, Drug, and Cosmetic Act in 1958. It’s unusually strict: the FDA cannot approve any food additive that has been found to induce cancer in humans or animals, at any dose. There’s no room for risk assessment or safety thresholds. If an additive causes tumors in lab animals, it fails the Delaney Clause, period.
Studies conducted in the 1980s found that high doses of Red 3 caused thyroid tumors in male rats. Specifically, the dye triggered abnormal growth in thyroid follicular cells, leading to tumors. That finding put Red 3 squarely in conflict with the Delaney Clause and set the stage for its eventual removal from the food supply.
Why It Took Over 30 Years
The FDA actually recognized the cancer risk decades ago. In 1990, a company petitioned the agency to permanently authorize Red 3 for use in cosmetics and topical drugs. Because the petitioner couldn’t overcome the animal cancer data, the FDA denied that petition under the Delaney Clause. Red 3 has been banned from cosmetics and externally applied drugs ever since.
The obvious question: why wasn’t it pulled from food at the same time? In 1992, the FDA announced its intention to revoke Red 3’s authorization in food and ingested drugs for the same reason. Then the agency simply decided not to follow through, citing the resources required to complete the process. For more than three decades, Red 3 remained legal in food despite the FDA’s own conclusion that it triggered the Delaney Clause.
The final push came from a 2022 petition filed by consumer advocacy groups, along with growing state-level pressure. California passed the California Food Safety Act in 2023, which will prohibit the sale of food products containing Red 3 (along with several other additives, including brominated vegetable oil) starting January 1, 2027. The FDA’s federal revocation gives food manufacturers until January 15, 2027, to reformulate, and drug manufacturers until January 18, 2028.
What Red 3 Does in the Body
Red 3 is an iodine-containing synthetic dye. At high doses in rats, it disrupts normal thyroid function. The thyroid gland responds to the disruption by overproducing cells, and that sustained overgrowth eventually leads to follicular cell tumors. Whether this same mechanism poses a meaningful cancer risk to humans at typical dietary exposure levels has been debated for years, but the Delaney Clause doesn’t require proof of human harm. Animal evidence alone is enough.
Beyond cancer, there are concerns about neurological effects in children. A report from California’s Office of Environmental Health Hazard Assessment found that synthetic food dyes, including Red 3, are associated with adverse neurobehavioral outcomes in children, particularly hyperactivity. Animal studies showed that synthetic dyes can affect activity levels, memory, and learning, and cause changes in brain neurotransmitters. The report also noted that typical childhood exposure to Red 3 from just a few common foods may exceed the existing acceptable daily intake level.
Where Red 3 Has Been Hiding
Red 3 gives foods a bright cherry-red or pink color. It has been used primarily in candy, cakes, cupcakes, cookies, frozen desserts, frostings, and icings. It also appears in certain ingested medications, particularly those with colored coatings or liquid formulations. The FDA notes that Red 3 is not as widely used as other certified color additives, but it still shows up in enough products that reformulation will be a significant undertaking for parts of the food and pharmaceutical industries.
If you want to check whether a product contains it, look for “FD&C Red No. 3,” “Red 3,” or “erythrosine” on the ingredient label. It’s distinct from Red 40, which is a different synthetic dye and remains legal.
How Other Countries Handle Red 3
The European Union hasn’t banned Red 3 outright, but it has restricted it far more tightly than the U.S. did for most of the past three decades. Under EU regulations, erythrosine (labeled E 127) is only authorized for a handful of very specific uses: cocktail cherries, candied cherries, and cherries in syrup and cocktails, with strict concentration limits of 150 to 200 milligrams per kilogram depending on the product. You won’t find it in European candy, baked goods, or frozen desserts the way it appeared in American products.
What Replaces Red 3
Reformulating without Red 3 is doable but not always simple. Natural red and pink pigments exist, most notably anthocyanins, the compounds that give blackberries, red cabbage, and grapes their color. The challenge is that traditional natural colorants tend to degrade when exposed to heat, light, or common food ingredients like vitamin C. Researchers at Ohio State University have developed modified versions of these pigments, called pyranoanthocyanins, that hold their color under harsher conditions. Beet juice and other plant-based alternatives are also widely used already in products marketed as “naturally colored.”
For manufacturers, the transition involves testing new colorants for stability across shelf life, adjusting for slightly different shades, and navigating consumer expectations. Many large brands had already started phasing out Red 3 before the formal ban, anticipating regulatory action and responding to consumer demand for cleaner ingredient lists. Smaller manufacturers and generic drug makers face a tighter timeline to make the switch.