Two red dyes have been banned by the FDA: Red Dye No. 2, removed from the food supply in 1976, and Red Dye No. 3, which the FDA revoked on January 15, 2025. Red No. 3 is the one making headlines right now, and manufacturers have until 2027 to reformulate their food products and until 2028 for ingested drugs.
Red Dye No. 3: The 2025 Ban
Red Dye No. 3, also called erythrosine, is a synthetic dye that gives foods a bright cherry-red color. It has been used primarily in candy, cakes, cupcakes, cookies, frozen desserts, frostings, and certain medications you swallow. On January 15, 2025, the FDA issued an order revoking its authorization for use in food and ingested drugs.
The timeline for removal is staggered. Food manufacturers have until January 15, 2027, to reformulate. Drugmakers have a bit longer, until January 18, 2028. So products containing Red No. 3 may still appear on shelves for a while as companies transition. The FDA notes that Red No. 3 is already less widely used than other certified color additives, so the shift affects a relatively narrow slice of the market.
What makes this ban unusual is how long it took. The FDA actually banned Red No. 3 from cosmetics and topical drugs back in 1990 after animal studies linked it to cancer. But it remained legal in food for another 35 years. The reason for that gap comes down to a legal technicality: in 1990, the cosmetics ban was triggered when a manufacturer petitioned for permanent approval and had to submit safety data. The existing cancer data made approval impossible under the Delaney Clause, a provision in federal law that prohibits any additive shown to cause cancer in humans or animals, regardless of dose. Food use, which was already authorized under a separate process, wasn’t revisited until decades later.
Why Red No. 3 Was Removed
The core concern is thyroid tumors in rats. In animal studies, Red No. 3 promoted the development of thyroid tumors in rats that had undergone partial thyroid removal and were exposed to a cancer-initiating chemical. In one study, 91% of rats in that group developed thyroid tumors when also given Red No. 3, compared to 64% in the control group that received the cancer initiator but no dye. The dye elevated levels of thyroid-stimulating hormone, which appeared to drive tumor growth.
The Delaney Clause doesn’t require proof that a substance causes cancer in humans. If it causes cancer in animals at any dose, it cannot be approved. That strict, bright-line rule is what ultimately forced the FDA’s hand, both in 1990 for cosmetics and in 2025 for food.
Red Dye No. 2: The Original Ban
Red Dye No. 2, known as amaranth, was the first red food dye banned in the United States. The FDA pulled it in 1976 after years of mounting concern. Trouble started in 1960, when amendments to the Federal Food, Drug, and Cosmetic Act added the Delaney Clause. Then in 1969, scientists at the Moscow Institute of Nutrition found increased tumors among rats fed the dye. American researchers spent years trying to replicate or refute those findings, and the results were inconclusive. The FDA ultimately concluded that while Red No. 2 couldn’t be proven harmful, it also couldn’t be certified as safe, which was enough to pull it from the market.
Red No. 2 is no longer used in the U.S. food supply and hasn’t been for nearly 50 years. If you see a red-colored food product today, it contains a different dye.
Red 40 Is Still Legal, With Caveats
Red 40, also called Allura Red, is the most widely used red food dye in the United States and remains fully legal. It’s the red you see in most sodas, snack foods, cereals, and sauces. However, it faces tighter restrictions in other countries. The European Union requires any food containing Red 40 and certain other synthetic dyes to carry a warning label stating the product “may have an adverse effect on activity and attention in children.”
That warning is rooted in research linking synthetic food dyes as a group to hyperactivity in some children. A meta-analysis published in the Journal of the American Academy of Child and Adolescent Psychiatry found a small but statistically significant effect of food color additives on attention and hyperactivity symptoms, with an estimated 8% of children with ADHD potentially having symptoms related to synthetic food colors. High-quality studies confined to color additives found that roughly 24% of children tested showed measurable behavioral responses. The effect sizes are modest, but for affected children, removing dyes from their diet can make a noticeable difference.
The U.S. does not currently require behavioral warning labels on foods containing Red 40 or other synthetic dyes.
How to Spot Red Dyes on Labels
On U.S. food labels, synthetic dyes must be listed by their FD&C name. The ones to look for are:
- FD&C Red No. 3 (erythrosine): the dye being phased out by 2027
- FD&C Red No. 40 (Allura Red): still legal and widely used
These names appear in the ingredients list, typically near the end. Some products list both the FD&C number and the chemical name in parentheses. If you’re trying to avoid synthetic red dyes entirely, scan for any ingredient starting with “FD&C Red” or “Red” followed by a number.
What Manufacturers Are Using Instead
Companies reformulating away from Red No. 3 have several natural alternatives. The most promising are anthocyanins, pigments found in blackberries, red cabbage, and grapes that produce rich, stable shades of red, orange, and yellow. Research at Ohio State University has driven much of the commercial adoption of anthocyanin-based colorants, which are already being used in beverages, baked goods, and other products. Beet juice concentrate and carmine (derived from cochineal insects) are other common replacements, though carmine must be labeled as an allergen for some sensitive individuals.
These natural alternatives generally cost more than synthetic dyes and can behave differently during processing, changing shade with pH or heat. But as demand has grown, the technology for stabilizing plant-based colors has improved significantly, and many major brands had already voluntarily switched away from Red No. 3 before the ban was announced.