FDA Bans Use of Red No. 3 Dye in Foods and Drugs

The U.S. Food and Drug Administration (FDA) has announced a ban on Red No. 3, a synthetic dye commonly used to impart a bright, cherry-red color to various consumable products. This decision, unveiled on January 15, 2025, stems from concerns over the dye’s potential health risks, including links to cancer observed in animal studies.

Affected Products

Red No. 3, also known as erythrosine, has been a prevalent additive in numerous food items and beverages. According to the Environmental Working Group, more than 2,000 products sold in the U.S. contain this dye. Notable examples include:

– Candies: Brach’s candy corn, Valentine’s Day candies such as Brach’s conversation hearts, Pez, and Ring Pops.

– Desserts: Certain ice cream flavors like Safeway’s Select peppermint and Kroger’s Neapolitan, Nerds Bomb Pops, frostings on cupcakes and cakes, and cookies with red sprinkles, including Walmart’s Freshness Guaranteed heart sugar cookies and frosted circus animal cookies.

– Snacks and Other Foods: Nesquik strawberry-flavored low-fat milk, imitation bacon bits found in Betty Crocker pasta salads, Jack Link’s beef and cheddar sticks, Vigo yellow rice, and canned fruits in fruit juice, such as mixed fruit from Publix.

Implementation Timeline

The FDA has provided manufacturers with a timeline to reformulate their products. Food producers have until January 15, 2027, to eliminate Red No. 3 from their offerings, while pharmaceutical companies have until January 18, 2028, to remove the dye from ingested drugs. This phased approach aims to facilitate a smooth transition for both manufacturers and consumers.

Health Concerns and Regulatory Background

The ban follows a 2022 petition from advocacy groups citing studies where high doses of Red No. 3 led to cancer in male laboratory rats. While the FDA acknowledges that the carcinogenic effects observed in rats do not directly translate to humans, the decision aligns with the Delaney Clause, which prohibits additives found to cause cancer in humans or animals.

Notably, the FDA had already banned Red No. 3 from cosmetics in 1990 due to similar health concerns. However, its use in food and oral medications persisted until this recent ruling. Internationally, the dye has been prohibited in countries such as Japan, China, the United Kingdom, Australia, and New Zealand.