The ban is a result of a petition filed in 2022 by a number of groups, including the Center for Science in the Public Interest. They argued the dye should be barred due its links to cancer and its widespread use by US consumers, specifically children.
Red No 3 was banned in cosmetics 35 years ago by the FDA. California also banned the additive in food products in October 2023.
It’s restricted in countries outside the US, like Australia, New Zealand and the European Union.
The FDA’s ban is “long-delayed”, said the Center for Science in the Public Interest, a US-based a non-profit consumer advocacy group that has long pushed for the ban.
“At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy,” said the group’s president, Dr Peter Lurie, in a statement on Wednesday.
Food manufacturers using red No 3 will have until January 2027 to reformulate their products, while drug manufacturers will have an extra year – until January 2028 – to adjust.
Food imported into the US also will have to comply with the new ban, the FDA said.
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