Regulatory Update
FDA Bans Use of Red No. 3 Food Dye
Image by Alexander Schimmeck via Unsplash.
The U.S. Food and Drug Administration is revoking the authorization for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive position.
The petition requested the agency review whether the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act) applied and cited, among other data and information, two studies that showed cancer in male laboratory rats exposed to high levels of Red No. 3 due to a rat specific hormonal mechanism. The FDA says the way that Red No. 3 causes cancer in male rats does not occur in humans.
The FDA adds relevant exposure levels to Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects. The agency says claims that the use of Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.
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. 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 No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. The FDA estimates that Red No. 3 is not as widely used in food and drugs when compared to other certified colors based on information available in third-party food product labeling databases, food manufacturers’ websites and other public information, and the FDA’s certification data. Red No. 3 has been primarily used in food products such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs.
Manufacturers who use Red No. 3 in food and ingested drugs will have until Jan. 15, 2027 or Jan. 18, 2028, respectively, to reformulate their products. Other countries still currently allow for certain uses of Red No. 3 (called erythrosine in other countries). However, foods imported to the U.S. must comply with U.S. requirements.
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