The U.S. Food and Drug Administration (FDA) is revoking the authorization for the use of FD&C Red No. 3 in food and ingested drugs, citing the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action follows a 2022 color additive petition requesting a review of whether the Delaney Clause applied to FD&C Red No. 3. The FDA has amended its color additive regulations to reflect this decision.
The petition referenced two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat-specific hormonal mechanism. However, the mechanism causing cancer in male rats does not occur in humans, and the exposure levels for humans are significantly lower than those in the studies. Other animal studies and human research have not demonstrated these effects, and the FDA states that claims of significant risk to humans from FD&C Red No. 3 are not supported by current scientific evidence.
Enacted in 1960, the Delaney Clause prohibits the FDA from authorizing a food or color additive if it has been shown to induce cancer in humans or animals. The FDA previously revoked authorizations under this clause, including in 2018 when certain synthetic flavors were banned.
FD&C Red No. 3 is a synthetic dye known for imparting a bright, cherry-red color to foods and drinks. Its use has primarily been in products such as candies, cakes, cookies, frostings, frozen desserts, and some ingested drugs. According to the FDA’s certification data and third-party sources, FD&C Red No. 3 is less widely used compared to other certified colors.
Manufacturers will need to reformulate products containing FD&C Red No. 3 by January 15, 2027, for food products and January 18, 2028, for ingested drugs. While other countries still allow certain uses of FD&C Red No. 3 (also known as erythrosine), imported products must meet U.S. regulatory standards.
This decision underscores the FDA’s ongoing commitment to ensuring the safety of food and drug additives in the U.S. market.
