The Food and Drug Administration announced last week that it will revoke authorization for FD&C Red No. 3 in food and ingested drugs under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. Red No. 3, a synthetic food dye, gives products like candies, frosting and frozen desserts their bright, cherry-red color.
The decision follows a 2022 petition and studies showing cancer in male rats exposed to high levels of the dye. While the cancer-causing mechanism is specific to rats and does not occur in humans, the Delaney Clause prohibits the FDA from approving additives shown to cause cancer in humans or animals, regardless of exposure levels.
