On January 15, the FDA announced it is revoking the approval for FD&C Red No. 3 in food and ingested drugs, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. This decision follows a 2022 petition requesting the agency reconsider the dye’s use. The petition cited studies that showed cancer in male rats exposed to high levels of FD&C Red No. 3, but this risk is specific to rats and does not apply to humans. Human exposure to the dye is much lower than the levels that caused cancer in rats, and no similar effects were observed in other animals or humans. Therefore, the available scientific evidence does not support claims that the dye poses a risk to human health.

The Delaney Clause, enacted in 1960, prohibits any food or color additive found to cause cancer in humans or animals. FD&C Red No. 3 is a synthetic food dye used in products like candy, cakes, cookies, and some medicines. Manufacturers have until January 2027 for food products and January 2028 for drugs to remove the dye. While other countries still allow its use, imported foods to the U.S. must meet the new regulations.