The Food and Drug Administration announced on Wednesday that it is prohibiting the use of Red No. 3, a synthetic dye responsible for the bright red color in food and beverages, which has been associated with cancer in animals.
Red No. 3 is currently present in numerous food items, such as candy, cereals, fruit cocktails with cherries, and strawberry-flavored milkshakes. The Center for Science in the Public Interest, a food safety advocacy group, requested the FDA to discontinue its use in 2022.
This decision by the FDA is a triumph for consumer advocacy organizations and certain U.S. legislators who have persistently urged the FDA to withdraw approval for the additive due to substantial evidence indicating its potential to cause cancer and impact children’s behavior when used in beverages, dietary supplements, cereals, and candies.
Food manufacturers are given until January 15, 2027, to reformulate their products, while companies producing ingested drugs like dietary supplements have an additional year for compliance.
Jim Jones, the FDA’s deputy director for human foods, stated, “The FDA cannot approve a food or color additive if it is found to induce cancer in humans or animals.” He highlighted evidence of cancer in male rats exposed to high levels of FD&C Red No. 3.
Initially approved for food use in 1907, Red Dye No. 3 is derived from petroleum. The FDA became aware of its potential carcinogenic properties in the 1980s after a study revealed tumors in male rats exposed to high doses, leading to its ban in cosmetics in 1990.
Dr. Peter Lurie, president of the Center for Science in the Public Interest, praised the removal of this unnecessary hazard from the American food supply, emphasizing that the action should have been taken over three decades ago.
Red No. 3 is already prohibited or significantly restricted in various countries outside the U.S., including Australia, Japan, and European Union nations. Some U.S. food manufacturers have already eliminated artificial dyes, including Red No. 3, from their products.
All color additives must receive FDA approval before being used in food sold in the U.S., with 36 FDA-approved color additives, including nine synthetic dyes. The FDA has been actively reassessing the approval of Red No. 3 following a petition from a coalition of organizations, including the CSPI, expressing concerns about its cancer risks.
While the FDA is now revoking its approval, discontinuing its use nationwide, several states had already taken steps in this direction. California and ten other states had initiated actions to ban the food dye, as reported by CSPI.
