FDA bans red no. 3, artificial color used in beverages, candy and other foods

This is stated by the Food and Drug Administration on Wednesday it prohibits the use of Red No. 3, a synthetic dye that gives foods and drinks their bright red cherry color but has been linked to cancer in animals.

The dye is still used in thousands of foods, including candies, cereals, cherries in fruit cocktails and strawberry-flavored milkshakes, according to Center for Science in the Public Interesta food safety advocacy group that petitioned the agency in 2022 to end its use.

The FDA’s decision marks a victory for consumer groups and some US lawmakers, who have long urged the FDA to revoke the additive’s approval, citing ample evidence that its use in beverages, dietary supplements, cereals and candy can cause cancer as well as affect children’s behavior.

“For the longest time, the FDA is putting an end to the regulatory paradox that Red 3 is illegal for use in lipstick, but perfectly legal to give to children in the form of candy,” said Dr. Peter Lurie, chairman of CSPI. The agency banned the additive in cosmetics in 1990.

Food manufacturers have until 15 January 2027 to reformulate their products. Companies that make ingested drugs, such as dietary supplements, get an extra year.

“FDA cannot approve a food additive or color additive if it has been shown to cause cancer in humans or animals,” Jim Jones, the FDA’s deputy director for human foods, said in a statement. “Evidence Shows Cancer in Male Laboratory Rats Exposed to High Levels of FD&C Red No. 3.”

What is red dye no. 3?

Red dye no. 3, approved for use in food in 1907, is made from petroleum.

The FDA’s move to ban the dye has been decades in the making. The agency first became aware that the additive was possibly carcinogenic after a study in the 1980s found tumors in male rats exposed to it in high doses.

“It removes an unnecessary hazard from the American food supply, and we welcome that action, even though it should have happened more than three decades ago,” Lurie said.

Red no. 3 is already banned or severely restricted in places outside the US, including Australia, Japan and countries in the European Union.

Some American food manufacturers have already removed artificial colors, including Red No. 3, from their products.

In a statement, a spokesman for the National Confectioners Association, a trade group that promotes chocolate, candy, gum and mints, said it will continue to follow and comply with the FDA’s guidance.

“Our consumers and everyone in the food industry want and expect a strong FDA and a consistent, science-based national regulatory framework,” the spokesperson said. “We’ve said for years that the FDA is the rightful national decision maker and leader in food safety.”

All color additives must be approved by the FDA before being used in foods sold in the United States. There are 36 FDA-approved color additives, nine of which are synthetic dyes.

The FDA has said it is actively reviewing Red No. 3’s approval follows a petition filed by a coalition of organizations, including CSPI, asking the FDA to revoke the food additive’s approval, noting its potential cancer risks.

There are also concerns about whether artificial food dyes can affect children’s behaviour. FDA in 2011 reviewed the possible connection between artificial dyes and hyperactivity in children. However, it ruled that no causal link could be established.

Although the FDA is now revoking its approval and ending use nationwide, other states had already taken action.

California, as well as 10 other states, have already taken steps to ban the food dye, according to CSPI.