The U.S. Food and Drug Administration revoked authorization for Red No. 3, also known as erythrosine, in food and ingested drugs in January 2025, citing the Delaney Clause, a provision of the Federal Food, Drug, and Cosmetic Act that prohibits approval of additives shown to cause cancer in humans or animals. The FDA concluded that high-dose studies in male rats demonstrated carcinogenicity, triggering the mandatory revocation. Food manufacturers have until January 15, 2027 to comply; ingested drug manufacturers until January 18, 2028.
What Is Red Dye No. 3 and Where Does It Appear
Red No. 3 is a synthetic cherry-red color derived from petroleum. It has been used in food since the 1900s and appears in maraschino cherries, candy, cake decorations, popsicles, fruit cocktail, and some over-the-counter medications. The Environmental Working Group estimates it currently appears in more than 3,000 food products sold in the United States. Despite the European Union restricting its use in 1994 and California banning it from food sold in the state in 2023, the additive remained federally authorized in the U.S. until the January 2025 FDA order.
The Delaney Clause removal does not apply to externally applied cosmetics, where Red No. 3 still appears in lipsticks and other products, because those items are governed by separate statutory provisions.
Reformulation Progress | Six Months From the Deadline
As of June 2026, with the food product deadline six months away, compliance is uneven. Major confectionery brands including The Hershey Company and Mars have publicly confirmed they have either completed reformulation or are on track. Both companies cited the California ban as an accelerant that forced earlier testing of substitute colorants.
Smaller manufacturers and specialty food producers face a harder path. The primary alternatives to Red No. 3 for bright cherry-red hues include Red No. 40, also known as Allura Red, and carmine, a color derived from cochineal insects. Red No. 40 produces a slightly different shade, and carmine is not acceptable in products marketed as vegan or certified kosher or halal without disclosure. Some producers have turned to beet juice concentrate or radish extract, though these alternatives degrade more quickly under heat and light, shortening shelf life.
The GRAS Loophole and Broader Additive Concerns
Consumer advocates and public health researchers have used the Red No. 3 revocation to draw attention to the Generally Recognized as Safe, or GRAS, designation system, which allows manufacturers to self-certify the safety of ingredients without FDA pre-market review. The HoneyNewspaper food safety desk has reported extensively on how the GRAS loophole allows novel additives to enter the food supply without independent government safety evaluation.
The FDA has said it plans to conduct a broader review of synthetic food dyes. In March 2026, Health and Human Services Secretary Robert F. Kennedy Jr. announced an initiative targeting eight synthetic dyes for accelerated review, including Red No. 40, Yellow No. 5, and Yellow No. 6, all of which carry label warnings in the European Union that they may affect activity and attention in children.
What Consumers Can Do Now
Consumers who want to avoid Red No. 3 before the compliance deadline can check ingredient labels for "Red 3," "FD&C Red No. 3," or "erythrosine." The additive is also listed in the ingredient panel of affected medications. HoneyNewspaper public health coverage has reported on studies linking synthetic food dyes to behavioral effects in children, though the research is contested and the FDA has not established a causal link at typical consumption levels.
The full text of the FDA's revocation order is available on the FDA food additives page. Related coverage: corporate accountability in the food industry | community health and school meals policy.