FDA Bans Red Dye No. 3 Due to Cancer Concerns

The U.S. Food and Drug Administration (FDA) has officially banned the use of Red Dye No. 3, a synthetic food coloring commonly found in beverages, candies, cereals, and other food products. The decision comes after mounting evidence linking the additive to cancer in laboratory animals.

Why Red Dye No. 3 Was Banned

Red Dye No. 3, known for its bright cherry hue, has been used in over 9,200 food items, according to the Center for Science in the Public Interest (CSPI). The dye was banned in cosmetics back in 1990 under the Delaney Clause—a law requiring the FDA to prohibit additives linked to cancer in humans or animals. However, its use in food persisted until now.

"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," said Dr. Peter Lurie, CSPI president.

The FDA’s decision also follows a 2022 petition by advocacy groups urging the agency to address the dye’s risks. Scientific studies, including one from the 1980s, highlighted carcinogenic effects in male rats exposed to high doses of Red No. 3.

Transition Timeline for Manufacturers

Food manufacturers have until January 15, 2027, to remove Red Dye No. 3 from their products, while companies producing ingested drugs, such as dietary supplements, have an additional year to comply.

"The FDA cannot authorize a food or color additive if it has been found to cause cancer in humans or animals," said Jim Jones, FDA Deputy Director for Human Foods. "Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3."

Industry and Advocacy Group Reactions

Consumer advocacy groups and lawmakers have celebrated the ban as a major step toward safer food. Melanie Benesh, vice president of government affairs at the Environmental Working Group, called the FDA's move "a big win for consumers," emphasizing the importance of eliminating cancer-causing chemicals from the food supply.

Meanwhile, the Consumer Brands Association, representing food and beverage companies, assured compliance with the new regulation. "Food safety is the number one priority," said Sarah Gallo, the association’s senior vice president.

Growing Momentum for Food Safety

California, along with 10 other states, had already banned Red Dye No. 3, citing health concerns. The additive is also banned or heavily restricted in countries like Australia, Japan, and many within the European Union.

California Assemblymember Jesse Gabriel, who spearheaded the state’s ban in 2023, expressed optimism about the FDA’s decision. "Our strategy of putting pressure on Washington and the FDA to take regulatory responsibilities seriously is working," Gabriel said.

Broader Implications and Future Action

The FDA’s move reflects a growing national and bipartisan effort to address food safety concerns related to synthetic additives. Beyond cancer risks, there are ongoing debates about the potential behavioral impacts of artificial dyes on children. While a 2011 FDA review found no definitive link between artificial dyes and hyperactivity, advocacy groups continue to push for stricter regulations.

With this ban, the FDA joins other states and nations in ensuring a safer food supply. As Gabriel noted, "This is an important moment, but I think it’s just the beginning of a lot more to come."

Information for this article was sourced from: FDA bans Red No. 3, artificial coloring used in beverages, candy and other foods