The Food and Drug Administration issued an order to ban the popular food additive Red No. 3 from food and drugs sold in the U.S.
The FDA's decision comes after a 2022 petition to revoke the additive's authorization based on the Delaney Clause. The Delaney Clause requires the FDA to ban additives that are found to cause or induce cancer in humans or animals as indicated by testing.
The FDA said that studies of Red No. 3 in male rats show it raises the risk of cancer. The FDA added that the way in which Red No. 3 causes cancer in male rats does not occur in humans.
"Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats," the FDA said. "Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and ingested drugs puts people at risk are not supported by the available scientific information."
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Food producers will have two years to reformulate their products, while drugmakers will have until 2028 to reformulate their products.
The dye is used to give foods and drinks a bright, cherry-red color. It is commonly used in candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings. The World Health Organization analyzed a number of studies on erythrosine, which is red dye No. 3, and concluded that “dietary exposures to erythrosine for all age groups do not present a health concern.”
It noted that high doses and not normal consumption pose a risk.
Advocates, however, say red dye No. 3 and similar chemicals should be banned from food. California had already approved a law banning the additive from food starting in 2027. Some food makers had already needed to make adjustments to comply with the California law.
According to the Environmental Working Group, red dye No. 3 is found in 3,023 food products. The items range from mixed fruit to ice cream, yogurt, protein drinks, and candy. By comparison, red dye No. 40 is found in over 11,600 products.
