As of January 16, 2025, the authorization for the use of FD&C Red No. 3 has been revoked by the Food and Drug Administration (FDA) using the Delaney Clause (section 721(b)(5)(B)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The color additive regulations will be amended to no longer allow for the use of this dye in food (including dietary supplements) and ingested drugs.
The Delaney Clause was enacted in 1960 as part of the Color Additives Amendment to the FD&C Act and authorizes FDA to ban a food additive or color additive if it has been shown to cause cancer in humans or animals. FD&C Red No. 3 is a synthetic food dye used to impart a bright, cherry-red color and 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.
Data provided in a 2022 color additive petition submitted to the FDA included two chronic feeding studies showing that male rats exposed to high levels of FD&C Red No. 3 developed cancerous tumors via a rat-specific hormonal mechanism. The current FDA evaluations for this dye state that, although it is known to cause cancer in male rats, the mechanism for this effect is not present in humans and, therefore, the carcinogenicity is not relevant to humans. In addition, the relevant exposure levels for humans are typically much lower than those causing the effects in male rats. No other data in from animal or human studies show these effects which indicate that the use of FD&C Red No. 3 in food and in ingested drugs as a causation of harm is not supported by the available scientific information. However, since cancer is a known effect in male rats upon ingestion of the dye, application of the Delaney Clause requires that the authorization for FD&C Red No. 3 be revoked.
To allow for reformulation of affected products, the final dates for authorized use of FD&C Red No. 3 in food is January 15, 2027, and January 18, 2028, for ingested drugs. It should be noted that, while this dye may be allowed for use in other countries, all foods imported to the U.S. must comply with U.S. requirements. Therefore, use of FD&C Red No. 3 after its authorization ceases will result in such food or ingested drugs being labelled as adulterated and not for sale or use with the responsible party subject to the relevant enforcement activities.
A summary from the FDA can be found at: FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs | FDA. The full Federal Register notice can be found at: Federal Register :: Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs
Published January 16, 2025
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