The FDA announced today it will revoke authorization for FD&C Red No. 3, a synthetic cherry-red food coloring currently found in more than 3000 food products, based on evidence of carcinogenicity observed in laboratory rats.

The decision, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, comes in response to a 2022 petition that presented evidence of carcinogenicity in male rats exposed to high levels of the dye.

The FDA emphasized that while the studies showed cancer development in male rats, "The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans." The agency further noted that "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."

The color additive is widely used in pediatric products, including PediaSure nutritional beverages, various candies, and popular snack foods. It is also present in numerous pharmaceutical formulations.

Manufacturers have been given a transition period, with food producers having until January 15, 2027, and pharmaceutical companies until January 18, 2028, to reformulate their products. The dye, known as erythrosine in other countries, remains authorized for use in some international markets, though imported products must comply with US requirements.

The synthetic dye has primarily been used to color candies, cakes, cupcakes, cookies, frozen desserts, and frostings, along with certain oral medications. According to FDA data, FD&C Red No. 3 is less commonly used than other certified color additives.

This marks the FDA's second major color additive revocation under the Delaney Clause, which prohibits the authorization of food additives found to induce cancer in humans or animals. The agency previously revoked authorization for certain synthetic flavors in 2018 based on similar grounds.

Today's announcement follows the agency's ongoing commitment to food safety regulation under the Color Additives Amendment of 1960, continuing its mandate to review and assess the safety of food additives in the American food supply.

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