US food regulator bans 'Red No. 3' after animal tests show it causes cancer
The U.S. Food and Drug Administration (FDA) has announced that it will ban the use of the synthetic food coloring '
FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs | FDA
https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs
FDA bans red dye No. 3 in food | Live Science
https://www.livescience.com/health/food-diet/fda-bans-red-dye-no-3-in-food
Red dye No. 3: FDA bans ingredient from food | CNN
https://edition.cnn.com/2025/01/15/health/red-dye-no-3-ban-fda-wellness/index.html
The FDA announced that it was 'revoked as a matter of law the authorization for use of Red No. 3 under the Delaney Provision of the Federal Food, Drug, and Cosmetic Act.'
The Delaney Clause is a law that prohibits the use of any additive that is known to cause cancer in humans or animals, no matter how small the amount.
According to the FDA, in two studies in which Red No. 3 was administered to rats, the male rats developed cancer due to a hormonal mechanism specific to rats. In one study, 70 male rats were given a high dose of Red No. 3, equivalent to 4% of the normal lifetime intake. As a result, 15 rats developed thyroid tumors, most of which were not cancerous. Male rats given a lower dose had no problems, and female rats did not develop tumors regardless of the dose.
Furthermore, in studies using mice rather than rats, no tumors were observed in either sex of the mice.
Because the mechanism by which Red No. 3 causes cancer is specific to rats and does not occur in humans, the FDA said, 'any claims that the use of Red No. 3 in food or medicines poses a risk to people are not supported by available scientific information.'
However, the Delaney Clause applies to 'humans and animals,' and while Red No. 3 did not cause any problems in humans, it caused tumors in rats when ingested in large quantities. As a result, the FDA took steps to ban it as a 'legal matter' rather than through a scientific review process, as mentioned above.
'It doesn't matter whether there is scientific information about human health risks, because the FDA's Delaney Clause mandate says that if there are signs of cancer in animals or humans, they must be removed from the food supply,' said Jennifer Pomerantz, an associate professor of public health policy and management at the School of Global Public Health at New York University.
Reportedly, the FDA's decision to revoke the approval of Red No. 3 is due to a petition submitted in November 2022 by several lobbying groups and individuals concerned about the carcinogenicity of the coloring agent. Prior to the FDA, California had banned the use of Red No. 3 in 2023.
Red No. 3, also known as erythrosine, is a petroleum-derived additive that gives foods a bright cherry-red color. According to the FDA, Red No. 3 is used primarily in candy, cakes, cookies, frozen desserts, frostings and icings, but is less widely used than other color additives.
The ban on Red No. 3 has a grace period, meaning that U.S. food manufacturers that use Red No. 3 in food products must reformulate their products by January 15, 2027, and drug manufacturers must reformulate their products by January 18, 2028. Although its use is not banned in other countries, food products imported into the U.S. must comply with this decision.
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