FDA Bans Red Dye No. 3 in Food and Drugs amid Health Concerns

The U.S. Food and Drug Administration (FDA) has announced a nationwide ban on the use of Red Dye No. 3 in food and oral medications, citing long-standing scientific evidence linking the synthetic additive to cancer in laboratory animals.

The ban, which takes effect in stages, will require food manufacturers to eliminate Red No. 3 from their products by January 2027 and drug manufacturers by January 2028.

Red candy | Source: Pexels

Red Dye No. 3, known on labels as “FD&C Red No. 3,” “FD&C Red 3,” or “Red 3,” is currently used in more than 9,000 food products in the United States, including candies, baked goods, frostings, beverages, and even medications such as acetaminophen and fluoxetine.

The decision comes after decades of concern. The dye was already banned for use in cosmetics and topical drugs in 1990, following studies in the 1980s that showed high doses of Red No. 3 caused thyroid tumors in male rats. A 2022 additive petition presented further evidence, prompting renewed FDA action.

“It’s definitive that Red No. 3 causes inflammation, causes cancer, causes major thyroid activity in rats and pigs. We’ve known this for 35 years,” said Dr. Frederic Bertley, President of the Center of Science & Industry.

Red sweets | Source: Pexels

Although the FDA notes a lack of direct evidence of cancer risk in humans, experts stress caution. “There hasn’t been a ton of data yet in humans… but there’s a preponderance of evidence that this stuff is not good,” Bertley said.

Health advocates recommend checking labels and avoiding products that contain the dye. Safer alternatives include naturally derived colorants like beetroot powder and vegetable juices, said registered dietitian Casey Parker.