The United States has banned a synthetic dye commonly used to give foods a vibrant cherry-red color. The U.S. Food and Drug Administration (FDA) announced on Wednesday that manufacturers will no longer be allowed to use the dye, known as Red No. 3 or Red Dye 3, after studies linked it to cancer in male laboratory rats.
Although the amount of the dye humans are normally exposed to is much lower than the exposure of the laboratory rats in the study, U.S. law requires that if any link to cancer is found, its use must be banned. According to the agency, the dye is primarily used in candies, cakes, cookies, frozen desserts, and icings, as well as in some medications.
The ban is the result of a petition filed in 2022 by several groups, including the Center for Science in the Public Interest. They argued that the dye should be banned given its link to cancer and its widespread use among U.S. consumers, particularly children. Red Dye 3 was already banned for use in cosmetics by the FDA 35 years ago. California also banned the additive in food in October 2023. Countries outside the U.S., such as Australia, New Zealand, and the European Union, have also restricted it.
The Center for Science in the Public Interest said the FDA ban was "long overdue." The organization, a U.S.-based non-profit consumer advocacy group, has long pushed for the ban. "Finally, the FDA is ending the regulatory paradox of Red Dye 3 being illegal in lipstick but perfectly legal to feed to children in candy," said the group's president, Dr. Peter Lurie, in a statement on Wednesday.
Food manufacturers using Red Dye 3 will have until January 2027 to reformulate their products, while drug manufacturers will have an extra year, until January 2028, to make the adjustment. The FDA said that food imported into the U.S. must also comply with the new ban. Red Dye 3, also known as erythrosine or Red Dye No. 3, has been used in a variety of candies, baked goods, fruit products, and beverages.
Colored candies, such as Pez, use the additive as an ingredient. It is also used in toaster pastries, maraschino cherries, and some sodas and fruit-flavored drinks. The additive was once used in cough syrups and gummy vitamins to give them their vibrant red color. Some manufacturers have already phased out the dye in their products, such as Dole, which removed the dye from its fruit bowls in 2023. Some companies have begun using Red Dye 40 as a substitute for Red Dye 3, which is considered a healthier alternative, although one study linked it to an increase in intestinal diseases in mice. Another study by the UK Food Standards Agency linked Red Dye 40 to an increase in hyperactivity in children. The additive was banned in California schools last year.