The U.S. Food and Drug Administration (FDA) has announced a ban on Red Dye No. 3, a synthetic food colouring widely used in candy, baked goods, and over-the-counter medications. The decision follows mounting evidence linking the dye to potential health risks, including its classification as a carcinogen in animal studies.
The FDA gave the decision granting a 2022 petition filed by several food safety and health advocates urging to ban the food dye used for its bright red hue. The agency said that some studies have found that the dye caused cancer in lab rats, and now it has been removed from the list of approved colour additives in foods, dietary supplements and oral medicines.
“Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No.3. Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans,” said Jim Jones, the FDA’s deputy commissioner for human foods.
Red Dye No. 3, also known as erythrosine, has been used in the food and pharmaceutical industries for decades, chosen for its vibrant hue. However, the dye has been under scrutiny since the 1990s, when the FDA prohibited its use in cosmetics after studies indicated a potential link to thyroid tumors in laboratory animals. Despite these findings, the dye remained approved for food and drug applications, sparking criticism from consumer advocacy groups and health experts.
The FDA’s latest decision comes after years of lobbying by health organizations and a growing body of research questioning the safety of artificial food dyes.
The FDA has set a six-month grace period for manufacturers to comply with the ban, though enforcement will begin immediately for new product approvals. Food manufacturers will have to remove the dye from their products by January 2027, while makers of oral medicines have until January 2028 to do the same.
The agency has also committed to reviewing the safety of other artificial food dyes still in use, including Yellow No. 5 and Blue No. 1, signaling a broader shift toward stricter regulation of food additives.
The FDA decision is expected to be challenged in court by food manufacturers, because so far there is no evidence that the dye causes cancer in humans.