
Announced earlier today, the FDA is "revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act)."
The topic has been discussed extensively in recent years, especially after a 2022 "color additive petition," in regards to "two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3." The FDA note does state "the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans." The new authorization will apply to food and ingested drugs; the dye had already been banned in cosmetics years ago.