The FDA has revoked authorization for the use of FD&C Red Dye No. 3 in food and ingested drugs, based on the Delaney Clause. That clause prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals. The FDA revoked the authorization for some synthetic flavors based on this Clause in 2018.
Two studies showed that cancer in laboratory male rats that were exposed to high levels of FD&C Red No. 3 occurred due to a rat-specific hormonal mechanism. This mechanism does not exist in humans. Relevant exposure to this color for humans is typically much lower than the exposures that caused the cancer in rats. Claims that the use of FD&C Red No. 3 in food puts people at risk are not supported by available scientific information.
FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. The FDA estimates that FD&C Red No. 3 is not as widely used in food and drugs when compared to other 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. 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.
Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028, respectively, to reformulate their products. And while other countries that export food to the U.S. still use this dye, those foods must comply with U.S. requirements.
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