The Food and Drug Administration (FDA) announced on Wednesday that it is banning the use of Red No. 3, a synthetic dye that provides food and drinks with their bright red cherry color. The dye has been linked to cancer in animals. Red No. 3 is still used in thousands of products, including candy, cereals, cherries in fruit cocktails, and strawberry-flavored milkshakes. The Center for Science in the Public Interest, a food safety advocacy group, had petitioned the FDA in 2022 to end its use.
The FDA’s decision to ban the use of Red No. 3 is seen as a victory for consumer advocacy groups and some U.S. lawmakers who have long called for the revocation of the additive’s approval. They cited substantial evidence that its use in foods, beverages, dietary supplements, cereals, and candies could cause cancer and impact children’s behavior.
Food manufacturers will have until January 15, 2027, to reformulate their products, while companies that produce ingestible drugs, such as dietary supplements, will be given an additional year to comply.
“The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals,” said Jim Jones, the FDA’s deputy director for human foods. “Evidence shows cancer in laboratory male 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 foods in 1907, is made from petroleum.
The FDA first became aware of Red No. 3’s potential carcinogenic effects following a study in the 1980s that found tumors in male rats exposed to the dye in high doses. As a result, the agency banned its use in cosmetics in 1990.
Dr. Peter Lurie, president of the Center for Science in the Public Interest, a leading food industry watchdog group, welcomed the FDA’s action, stating, “It removes an unnecessary hazard from the American food supply, and we welcome that action, even though it should have occurred more than three decades ago.”
Red No. 3 is already banned or severely restricted in other countries, including Australia, Japan, and members of the European Union. Some U.S. food manufacturers have proactively removed artificial dyes, including Red No. 3, from their products.
All color additives must be approved by the FDA before they are used in food sold in the U.S. There are 36 FDA-approved color additives, nine of which are synthetic dyes.
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