FDA revokes authorization to use Red No. 3 as a color additive in food or drugs

The U.S. Food and Drug Administration has announced in a constituent update today that the Agency is revoking authorization for the use of FD&C Red No. 3, a synthetic food dye that creates a bright cherry-red color in foods and beverages. The decision is in response to a 2022 color additive petition. According to the constituent update, that petition cited two studies showing cancer in rats exposed to high levels of FD&C Red No. 3.

While the FDA says that the mechanisms by which the rats developed cancer from exposure to FD&C Red No. 3 is rat specific and does not occur in humans, the Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the Food Drug & Cosmetic Act (FD&C Act), prohibits FDA from authorizing food or color additives that have been found to induce cancer in humans or animals.

Food manufacturers that use FD&C Red No. 3 have until January 15, 2027 to comply while ingested drug manufacturers have until January 18, 2028 to comply and reformulate their products. Additionally, foods imported to the U.S. must also comply with the new U.S. requirements.