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.
The change states the Delaney Clause, which "prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals." FD&C Red No. 3 is primarily used to give a bright, vibrant red color to various foods, drinks and drugs, ranging in everything from "candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs," as per the note.
Any manufacturer who still uses FD&C Red No. 3 will have until either two or three years from today (depending on if the product is food or medication) to "reformulate their products." The FDA note also states that while some other countries may allow for FD&C Red No. 3 in their products, all "foods imported to the U.S. must comply with U.S. requirements."
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