The FDA is revoking the authorization for the use of FD&C Red No. 3 and amending its color additive regulations to no longer allow its use in food and ingested drugs in response to a 2022 color additive petition.
The Petition
The petition requested that the FDA review whether the Delaney Clause applied and cited two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3. The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Studies in other animals and in humans did not show these effects; it claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.
Delaney Clause
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 found to induce cancer in humans or animals. This is not the first time the agency revoked an authorization based on the Delaney Clause. For example, in 2018, the FDA revoked the authorization for certain synthetic flavors based on the Delaney Clause in response to a food additive petition.
Red Dye
FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. FD&C Red No. 3 has been primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs.
Manufacturing
Manufacturers who use this dye in food and ingested drugs will have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products. While other countries still currently allow for certain uses of FD&C Red No. 3 (called erythrosine in other countries), foods imported to the U.S. must comply with U.S. requirements.
