The Food and Drug Administration announced Wednesday that it is banning Red No. 3, a synthetic dye responsible for the vibrant red cherry color in many foods and beverages. The dye has been associated with cancer in animal studies.
Despite this, Red No. 3 is still widely used in thousands of food products, including candy, cereals, cherries in fruit cocktails, and strawberry-flavored milkshakes. According to the Center for Science in the Public Interest (CSPI), a food safety advocacy group that petitioned for the ban in 2022, over 9,200 food items contain the dye, including products from major food manufacturers, citing data from the Agriculture Department.
The FDA’s ban does not extend to other artificial dyes, such as Red No. 40, which has been linked to behavioral issues in children.
.jpg)
The FDA’s decision marks a significant win for consumer advocacy groups and U.S. lawmakers who have long pushed for the revocation of Red No. 3’s approval. They have cited extensive evidence linking the dye’s use in beverages, dietary supplements, cereals, and candies to cancer risks and potential impacts on children’s behavior.
“At long last, the FDA is addressing the regulatory inconsistency of Red No. 3 being banned in lipstick but still allowed in candy consumed by children,” said Dr. Peter Lurie, president of the Center for Science in the Public Interest (CSPI). The agency prohibited the additive in cosmetics back in 1990 under the Delaney Clause, a federal law requiring the FDA to ban food additives shown to cause cancer in humans or animals.
Food manufacturers will have until January 15, 2027, to reformulate their products, while companies producing ingestible drugs, such as dietary supplements, will have an additional year to comply.
“The FDA cannot approve a food or color additive that has been found to cause cancer in humans or animals,” said Jim Jones, the FDA's deputy director for human foods, in a statement. “Evidence demonstrates that male laboratory rats exposed to high levels of FD&C Red No. 3 developed cancer.”
What is Red No. 3?
Red No. 3, first approved for food use in 1907, is a synthetic dye derived from petroleum. The FDA has long considered banning it, spurred by evidence from a 1980s study showing high doses caused tumors in male rats.
“It removes an unnecessary hazard from the American food supply, and we welcome that action, even though it should have occurred more than three decades ago,” said Dr. Peter Lurie, president of the Center for Science in the Public Interest (CSPI).
Melanie Benesh, vice president for government affairs at the Environmental Working Group, called the ban a long-overdue win for consumers. “This is a big win for consumers, that this cancer-causing chemical is finally going to be out of the food supply,” she said. Benesh also expressed hope that federal regulators would scrutinize other artificial dyes.
“The FDA is feeling pressure from consumers who are worried about what is in their food,” Benesh added. “This is certainly an important positive step forward.”
The Consumer Brands Association, representing food companies, emphasized its commitment to safety. “Revoking the authorized use of Red No. 3 is an example of the FDA using its risk and science-based authority to review product safety,” said Sarah Gallo, senior vice president of product policy and federal affairs.
Broader Impact and Reactions
California, alongside ten other states, had already moved to ban Red No. 3, with additional restrictions in regions such as Australia, Japan, and the European Union. Some U.S. manufacturers have proactively removed Red No. 3 and other artificial dyes from their products.
In 2023, California became the first state to enact a broader ban on Red No. 3 and several other food additives linked to health concerns. Democratic Assemblymember Jesse Gabriel, who introduced the legislation, praised the FDA’s decision, viewing it as a result of sustained state-level advocacy.
“To me, this is a clear indication that our strategy of putting pressure on Washington to take its regulatory responsibilities seriously is working,” Gabriel said.
Gabriel noted bipartisan enthusiasm for addressing harmful additives and described the FDA’s decision as the beginning of a larger movement. “This is an important moment, but I think it’s just the beginning of a lot more to come,” he said.
Artificial Dye Safety and Review
The FDA oversees 36 approved color additives, including nine synthetic dyes, all of which must be deemed safe before use. However, artificial dyes have faced criticism for potential behavioral effects on children. A 2011 FDA review found no conclusive evidence linking artificial dyes to hyperactivity, though concerns persist.
The FDA’s move to ban Red No. 3 follows a petition from advocacy groups, including the CSPI, urging action based on the dye’s cancer risks.
A spokesperson for the National Confectioners Association affirmed the industry’s commitment to compliance and food safety. “We have been saying for years that FDA is the rightful national regulatory decision maker and leader in food safety,” the group stated.
With manufacturers required to reformulate affected products by January 15, 2027, the FDA’s decision signals a renewed focus on protecting consumers and ensuring safer food options nationwide.
0 Comments