FDA Bans Red Dye No. 3 from U.S. Foods and Medicines Due to Cancer Risk
The U.S. Food and Drug Administration (FDA) has made a significant move by banning the use of Red Dye No. 3 in food products, candies, and certain medicines. This synthetic dye, often used to give products a bright cherry-red appearance, has now been deemed unsafe due to its links to cancer in animal studies. The decision comes after years of mounting pressure from health and food safety advocates.
The dye, known as erythrosine or FD&C Red No. 3, has been a staple in many popular items such as candies, maraschino cherries, baked goods, and some medicines, like cough syrups and gummy vitamins. The ban follows studies showing that high doses of the dye caused cancer in male lab rats. While these effects were not directly linked to humans in the same studies, the FDA is bound by a law known as the Delaney Clause, which requires the removal of any substance found to cause cancer in either humans or animals.
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The ban, announced in January 2025, comes after years of advocacy from groups like the Center for Science in the Public Interest (CSPI). In 2022, the CSPI, along with other health organizations, filed a petition urging the FDA to revoke the approval for Red Dye No. 3 in foods, citing concerns over its widespread use and its potential danger, particularly to children. Children consume more food coloring by weight than adults, making the issue especially important when considering public health.
Interestingly, Red Dye No. 3 has been banned in cosmetics for nearly 35 years due to similar cancer concerns, but it has remained legal for use in food products until now. Critics have pointed out the inconsistency in regulations, especially since the dye was deemed too dangerous for lipstick but remained legal in products commonly consumed by children, like candies and frosting. Dr. Peter Lurie of CSPI called the move a "long-delayed" victory, highlighting the absurdity of allowing a carcinogen in food while banning it in cosmetics.
This new ruling is set to impact food manufacturers, who will have until January 2027 to reformulate products without the dye. Companies that make ingested medicines will have until January 2028 to comply. Imported food products will also have to adhere to these new standards.
Countries such as Australia, New Zealand, and members of the European Union have already banned or heavily restricted Red Dye No. 3, and California has followed suit with a state-level ban set to take effect by 2027.
This FDA decision reflects growing concerns over food additives and their safety, especially as more research links food dyes to potential health risks. As more manufacturers move away from harmful additives, some have already started replacing Red Dye No. 3 with alternatives like beet juice or other natural coloring agents. However, as the FDA's decision takes full effect, it’s clear that this marks a significant shift in how food safety is managed in the U.S. and could pave the way for similar actions in other regions.
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