FDA Decision Promotes Safer Food and Medicine Choices with Ban of Popular Food Dye

January 19, 2025

The U.S. Food and Drug Administration (FDA) has announced a ban on the use of FD&C Red No. 3 in foods and ingested drugs, marking a significant step toward enhanced consumer safety. Studies linked the synthetic dye to cancer in male laboratory rats, prompting this proactive decision to protect public health.

Red No. 3, also known as erythrosine, has been commonly used to impart a bright, cherry-red color to various products, including candies, baked goods, and certain medications. The FDA’s decision requires food manufacturers to phase out the dye by January 15, 2027, with drug manufacturers following by January 18, 2028.

This move aligns with actions taken by other regulatory bodies worldwide and underscores the FDA’s commitment to enforcing the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits any food or color additive linked to cancer in humans or animals.

While studies found cancer development in male rats exposed to high levels of Red No. 3, the FDA notes that human exposure levels are significantly lower. However, the regulatory action ensures safer choices for families and businesses.

Manufacturers are now reformulating their products to meet the new guidelines. This change reflects a broader commitment to consumer well-being, offering greater confidence in food and medicine choices.