FDA Bans Red No. 3 Food Dye Due to Cancer Risk in Animals

FDA Bans Red No. 3 Food Dye Due to Cancer Risk in Animals

Edited by: TJVNews.com

The Food and Drug Administration (FDA) announced on Wednesday its decision to ban the use of Red No. 3, a synthetic dye widely used to create the vibrant cherry-red color in various food and drink products. This action, according to a report on NBC News, stems from concerns about the dye’s link to cancer in animal studies, which has prompted years of advocacy by food safety groups and lawmakers.

Red No. 3 is present in thousands of food items, including popular candies, cereals, fruit cocktail cherries, and strawberry-flavored milkshakes. The Center for Science in the Public Interest (CSPI), a leading food safety advocacy organization, reported that more than 9,200 food products contain the dye, citing data from the U.S. Department of Agriculture. Despite its widespread use, the FDA has deemed the additive unsafe due to evidence showing its carcinogenic potential in animals, as was indicated in the NBC News report.

The FDA’s decision marks a significant victory for consumer advocacy groups and lawmakers who have long campaigned against the dye. The report on NBC News explained that these groups have criticized the agency for maintaining a “regulatory paradox,” wherein Red No. 3 was banned in cosmetics under the 1990 Delaney Clause—federal legislation prohibiting additives linked to cancer—but remained legal in food products. Dr. Peter Lurie, president of CSPI, applauded the FDA’s move, stating to NBC News, “At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick but perfectly legal to feed to children in the form of candy.”

The risks associated with Red No. 3 have long been a point of contention. NBC News notes that the dye was linked to potential cancer risks following studies conducted decades ago. Additionally, concerns about artificial dyes affecting children’s behavior have persisted. The FDA reviewed the possible link between synthetic dyes and hyperactivity in children in 2011 but concluded that no causal relationship could be established. Despite this, calls to reevaluate synthetic dyes have intensified, leading to the current ban.

Food manufacturers now face a deadline of January 15, 2027, to reformulate their products without Red No. 3, while producers of ingested drugs and dietary supplements will have until 2028. This extended timeline reflects the challenges companies may face in adjusting their production processes.

Jim Jones, the FDA’s deputy director for human foods, explained to NBC News the rationale for the ban, stating, “The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals. Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.” The decision reflects the agency’s commitment to enforcing safety standards under the Delaney Clause.