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.
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. In 1990, the EPA outlawed the cosmetic additive.
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 of FD&C Red No. 3.”
What is red dye No. 3?
Petroleum is the source of Red Dye No. 3, which was authorized for use in food in 1907.
Following a study in the 1980s that discovered tumors in male rats subjected to high doses of the chemical, the FDA first learned that the additive may 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.
In nations outside of the United States, such as Australia, Japan, and the European Union, Red No. 3 is already prohibited or highly 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.
According to CSPI, California and several other states have already taken steps to outlaw the food coloring.