United States: The US Food and Drug Administration (FDA) has announced a ban on the use of red dye 3, a synthetic food colouring commonly used to give products a bright, cherry-red hue. The decision comes after examinations linked the additive to cancer in male laboratory rats, triggering a compulsory ban under US law.
The dye, also known as Red No. 3 or erythrosine, has been widely utilised in candies, baked goods, frozen desserts, frosting, and certain medications. Manufacturers have until January 2027 to remove the dye from food products and until January 2028 for pharmaceuticals. The ban also extends to imported goods containing the additive.
The FDA’s decision follows a 2022 petition pointed by advocacy groups, including the Center for Science in the Public Interest (CSPI), which argued the dye posed significant health risks. The CSPI praised the ban, calling it “long overdue.” Dr. Peter Lurie, the group’s president, stated that, “At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but completely legal to feed to children in the form of candy.”
Today, the FDA is issuing an order to revoke the authorization for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition that requested the agency to review whether the Delaney Clause applied. https://t.co/Qd0NFOIUz8 pic.twitter.com/Bpr6XNC8OR
— U.S. FDA Human Foods Program (@FDAfood) January 15, 2025
This ban adds to previous restrictions. Red No. 3 has been banned in cosmetics since 1990, and California banned it in food products in October 2023. It is also restricted in Australia, New Zealand, and the European Union.
While studies indicate the risks from normal disclosure are much lower in humans than in laboratory animals, the law requires a ban if any carcinogenic link is found.
Red dye 3 has long been used in a variety of products, including coloured candies like Pez, maraschino cherries, toaster pastries, cough syrups, and gummy vitamins. However, some companies have already taken steps to eliminate the dye. In 2023, Dole removed Red No. 3 from its fruit bowls, and many manufacturers are switching to alternatives such as red dye 40.
While red dye 40 is considered a safer substitute, studies have raised concerns about its health effects. Research by the UK’s Food Standards Agency linked it to hyperactivity in children, leading to its prohibition in California schools in 2023. Another study associated the dye with bowel disorders in mice.
The FDA’s ban on Red No. 3 reflects growing scrutiny over synthetic additives and their impact on public health, especially in products consumed by children.
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