The US has banned the use of a synthetic dye usually added to foods and drinks to give them a bright, cherry-red hue.

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 lab rats, the U.S. Food and Drug Administration (FDA) announced Wednesday.

While normal exposure to the dye in humans in the studies is much lower than in rats, U.S. law requires a ban if a link to cancer is found.

The dye is used primarily in candy, cakes, cookies, frozen desserts and frosting, as well as some medications, the agency said.

The ban is the 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 banned because of its link to cancer and its widespread use by U.S. consumers, particularly children.

Red No 3 was banned in cosmetics by the FDA 35 years ago. California also banned the additive in food in October 2023.

Use is restricted in countries outside the United States such as Australia, New Zealand and the European Union.

The FDA’s ban has been “long-delayed,” said the Center for Science in the Public Interest, a U.S.-based nonprofit consumer advocacy group that has long advocated for the ban.

“The FDA is finally ending the regulatory paradox that using Red 3 in lipsticks is illegal but feeding it to children in the form of candy is completely legal,” said the group’s president, Dr. Peter Lurie, in a statement on Wednesday.

Food manufacturers using the red number 3 have until January 2027 to reformulate their products, while drugmakers have an additional year – until January 2028 – to adapt.

Food imported into the U.S. must also comply with the new ban, the FDA said.

Red No. 3, also called erythrosine or red dye 3, is used in numerous candies, baked goods, fruit products and beverages.

Colored candies – like Pez – contain the additive as an ingredient. It has also been used in toaster pastries, maraschino cherries, and some fruit-flavored sodas and drinks.

The additive was used in cough syrups and gummy vitamins to give them a bright red color.

Some manufacturers have already stopped using the dye in their products, such as Dole, which banned it from its fruit bowls in 2023.

Instead of red dye 3, some companies have started using red dye 40, which is considered a healthier alternative even though it has been linked to an increase in intestinal disease in mice in one study.

Another study by the UK Food Standards Agency linked red pigment 40 to increased hyperactivity in children. The additive had been banned in California schools since last year.