FDA Bans Red No. 3: Synthetic Dye Linked to Cancer Removed from Food Supply

The FDA's move to ban the red dye made from petroleum has been in the works for decades

The Food and Drug Administration (FDA) announced Wednesday its decision to ban Red No. 3, an artificial dye widely used to give food and beverages a vibrant cherry-red hue. The synthetic additive, long linked to cancer in laboratory animals, has faced growing criticism from consumer advocacy groups and lawmakers.

Background on Red No. 3
Approved in 1907, Red No. 3 is a petroleum-based dye found in thousands of products, including candies, cereals, fruit cocktail cherries, and strawberry-flavored milkshakes. Despite its widespread use, studies dating back to the 1980s raised concerns about its safety after male rats exposed to high doses developed tumors.

In 1990, the FDA banned Red No. 3 in cosmetics due to these findings but allowed its continued use in foods and beverages—a decision many advocacy groups criticized as contradictory.

A Long-Awaited Ban
The FDA’s decision marks a significant victory for food safety advocates, including the Center for Science in the Public Interest (CSPI), which petitioned the agency in 2022 to revoke the additive’s approval.

“At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick but legal in candy consumed by children,” said Dr. Peter Lurie, president of CSPI.

Melanie Benesh, vice president for government affairs at the Environmental Working Group, called the decision “long overdue,” adding, “This is a big win for consumers, removing a cancer-causing chemical from the food supply.”

Implementation Timeline
Food manufacturers have until January 15, 2027, to reformulate their products. Producers of ingestible drugs, including dietary supplements, will have an additional year to comply.

According to Jim Jones, the FDA's deputy director for human foods, “The FDA cannot authorize a food additive if it has been found to cause cancer in humans or animals. Evidence shows cancer in laboratory rats exposed to high levels of FD&C Red No. 3.”

Industry and Consumer Responses
The Consumer Brands Association stated that food companies prioritize safety and will comply with the FDA's ban. Meanwhile, some U.S. food manufacturers have already removed artificial dyes, including Red No. 3, from their products.

Sarah Gallo, senior vice president of product policy and federal affairs at the Consumer Brands Association, emphasized, “Revoking Red No. 3 demonstrates the FDA’s commitment to science-based reviews of product safety.”

Global and State Actions
Red No. 3 is already banned or heavily restricted in countries like Australia, Japan, and across the European Union. In the U.S., several states, including California, had previously moved to prohibit its use.

Concerns Beyond Cancer
Advocacy groups have also raised questions about the potential impact of artificial dyes on children’s behavior. While a 2011 FDA review found insufficient evidence to establish a causal link between artificial dyes and hyperactivity, the topic remains under scrutiny.

Looking Ahead
Consumer advocacy groups hope this ban signals a shift in federal regulators’ approach to other artificial dyes. “This is a positive step forward,” Benesh said. “Consumers are increasingly concerned about what’s in their food, and the FDA appears to be listening.”

For now, the FDA’s decision ensures Red No. 3 will join the growing list of food additives phased out of the U.S. market for safety concerns.