FDA's Ban of Red Dye No. 3 Goes Into Effect in Two Years
The FDA is banning the use of synthetic food dye FD&C Red No. 3, citing the Delaney Clause of the Federal Food, Drug, and Cosmetic Act as the impetus for the ban, according to a Jan. 15 constituent update. The ban is effective in stages, starting on Jan. 15, 2027.
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The Delaney Clause prohibits FDA authorization of a food additive or a color additive if it has been found to induce cancer in humans or animals. The FDA determined that while the dye causes cancer in male rats, the same outcome doesn't occur in humans.
Manufacturers who use Red No. 3 in food will have until Jan. 15, 2027, to reformulate their products, while manufacturers of ingested drugs will have a Jan. 18, 2028 deadline. Foods imported into the U.S. also must comply with U.S. requirements. Other countries still currently allow for certain uses of Red No. 3, which can also be called erythrosine.
Red No. 3, a synthetic food dye that gives foods and drinks a bright, cherry-red color, 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, according to the FDA. The FDA said it estimated that FD&C Red No. 3 is not as widely used in food and drugs when compared with 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.
The FDA's ban starting on Jan. 15, 2027, is just two weeks after California's ban of the same substance is set to take effect. California Gov. Gavin Newsom (D) signed a law in October 2023 banning the dye, effective Jan. 1, 2027. Other substances, including brominated vegetable oil, potassium bromate and propylparaben, were also named as banned substances in that law.
The FDA revoked the use of Red No. 3 in foods and ingested drugs after the Center for Science in the Public Interest petitioned the agency about the substance, according to an FDA notice to be published in the Federal Register.