Today, the U.S. Food and Drug Administration is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs.
Drug manufacturers who use FD&C Red No. 3 in ingested drugs will have until January 18, 2028, to reformulate their products.
FDA intends to issue guidance to provide drug manufacturers with recommendations regarding replacing color additives used in approved and marketed drugs, including recommendations for reformulation when a color additive regulation is revoked.
The FDA is revoking the authorization for the use of FD&C Red No. 3 based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals.
The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats. Studies in other animals or in humans did not show the same effect and there is no evidence showing FD&C Red No. 3 causes cancer in humans.