Red No. 3, a synthetic dye that gives food and beverages their vibrant red cherry color but has been connected to animal cancer, will no longer be used, the Food and Drug Administration announced Wednesday.
The Center for Science in the Public Interest, a food safety advocacy group, petitioned the EPA in 2022 to stop using the dye, claiming that it is still present in hundreds of goods, including as sweets, cereals, cherries in fruit cocktails, and milkshakes with strawberry flavors. Citing data from the Agriculture Department, CSPI stated that the dye is present in over 9,200 food items, including hundreds of products produced by major food corporations.
Consumer advocacy organizations and certain U.S. lawmakers have long encouraged the FDA to revoke the additive’s approval, claiming substantial evidence that its use in beverages, nutritional supplements, cereals, and sweets may cause cancer and influence children’s behavior. The FDA’s decision represents a triumph for these groups.
According to Dr. Peter Lurie, president of the CSPI, the FDA is finally resolving the regulatory conundrum of Red 3 being prohibited for use in lipstick yet entirely permissible for children to consume as candy. Under the Delaney Clause, a federal rule that mandates the FDA to prohibit food additives that are shown to cause or induce cancer in humans or animals, the agency outlawed the chemical in cosmetics in 1990.
The deadline for food makers to reformulate their products is January 15, 2027. Businesses that produce consumed medications, such dietary supplements, will receive an extra year.
Jim Jones, the FDA’s deputy director for human foods, stated in a statement that “the FDA cannot authorize a food additive or color additive if it has been found to cause cancer in human or animals.” “Evidence shows cancer in laboratory male rats exposed to high levels ofFD&C Red No. 3.”
What is red dye No. 3?
Petroleum is the source of Red No. 3, which was authorized for use in food in 1907.
The FDA has been considering banning the color for many years. After a study in the 1980s that discovered tumors in male rats subjected to high doses of the chemical, the agency first learned that the additive might be carcinogenic.
“We applaud that action, even though it should have happened more than thirty years ago, because it eliminates an unnecessary hazard from the American food supply,” Lurie said.
The removal of this carcinogenic ingredient from the food supply is a huge victory for consumers. Melanie Benesh, vice president for government affairs at the Environmental Working Group, a health advocacy and research group that signed the petition to ban Red No. 3, stated that it is long overdue. That the FDA has finally succeeded in getting it across the finish line makes us very happy.
“I hope federal regulators will look more closely at other artificial dyes that advocacy groups have long expressed concern about,” Benesh continued.
“I believe the FDA is experiencing pressure from consumers who are concerned about the ingredients in their food,” she said. This is undoubtedly a significant improvement.
A trade group called the Consumer Brands Association stated that corporations would abide by the FDA’s restriction and that food safety is their top priority.
In a written statement, senior vice president of product policy and federal relations Sarah Gallo stated that the FDA’s decision to revoke the approved use of Red No. 3 is an example of how it uses its risk and science-based authority to assess the safety of products in the marketplace. To guarantee that consumers have safe and accessible options, food and beverage firms will continue to adhere to all food safety rules and the most recent scientific findings.
Prior to the Senate confirmation hearings for President-elect Donald Trump’s choice for health and human secretary, Robert F. Kennedy Jr., the Biden administration took this action. Kennedy has stated that the administration would prioritize eliminating artificial coloring from the food supply.
According to CSPI, California and several other states have already taken steps to outlaw the food coloring. In nations outside of the United States, such as Australia, Japan, and the European Union, it is also prohibited or severely limited.
Red No. 3 and other artificial colors have already been eliminated from several American food producers’ goods.
A representative for the National Confectioners Association, a trade association that advocates for chocolate, candies, gum, and mints, said in a statement that the company will continue to adhere to and obey the FDA’s recommendations.
“Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework,” a spokeswoman stated. “We have been saying for years that FDA is the rightful national regulatory decision maker and leader in food safety.”
Before being used in food that is sold in the United States, all color additives must receive FDA approval. Nine of the 36 color additives that have FDA approval are synthetic dyes.
After a coalition of groups, including the CSPI, petitioned the FDA to remove Red No. 3’s approval in foods due to possible cancer risks, the FDA stated that it has been actively investigating the additive’s approval.
Concerns have also been raised regarding the potential behavioral effects of artificial food coloring. In 2011, the FDA examined the potential connection between children’s hyperactivity and artificial dyes. However, it concluded that there was no way to prove a causal association.
Other states had already acted, but now the FDA is rescinding its approval, halting its usage statewide.
Democratic Assemblymember Jesse Gabriel expressed his satisfaction with the FDA’s ruling in California, which in 2023 became the first state to outlaw Red No. 3 and a number of other food additives connected to possible health issues.
Gabriel, who introduced California’s bill to ban Red No. 3 statewide and the California School Food Safety Act, which forbids the use of six other synthetic dyes in food served in public schools, said, “To me, this is a clear indication that our strategy of putting pressure on Washington and putting pressure on the FDA to look at these issues more closely, to step up to the plate and take their regulatory responsibilities seriously.”
Both Republicans and Democrats have expressed excitement about the FDA’s restriction, Gabriel added.
“We have observed a growing national movement around this. He declared, “It is a bipartisan movement.” “This is an important moment, but I think it s just the beginning of a lot more to come.”