Red No. 3 is prohibited by the FDA as an artificial coloring for use in drinks, candies, and other foods.

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 on 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 it is still present in hundreds of goods, including as sweets, cereals, cherries in fruit cocktails, and milkshakes with strawberry flavors. Citing statistics from the Agriculture Department, CSPI stated that the dye is present in over 9,200 food items, including hundreds of goods produced by major food corporations. Other artificial colors, such as Red No. 40, which has been connected to behavioral problems in kids, are not prohibited by the FDA.

Consumer advocacy organizations and certain U.S. senators have long encouraged the FDA to revoke Red No. 3’s clearance, claiming substantial evidence that its usage in drinks, nutritional supplements, cereals, and sweets may cause cancer and influence children’s behavior. The FDA’s decision represents a triumph for these groups.

Dr. Peter Lurie, president of the CSPI, stated, “The FDA is finally resolving the regulatory conundrum of Red 3 being prohibited for use in lipstick but entirely permissible for feeding to children in the form of 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 people or animals, the agency outlawed the chemical in cosmetics in 1990.

The deadline for food makers to reformulate their goods 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.”

Red No. 3: What is it?
Petroleum is the source of Red No. 3, which was authorized for use in food in 1907.

For decades, the FDA has been working to outlaw the dye. After a research in the 1980s that discovered tumors in male rats subjected to high doses of the chemical, the agency 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 stated.

The fact that this carcinogen will soon be removed from the food supply is a huge victory for consumers. Melanie Benesh, vice president for government relations at the Environmental Working Group, a health advocacy and research group that signed on to the petition to ban Red No. 3, said, “It is long overdue.” “That the FDA has finally been able to get it over 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 that consumers who are concerned about the ingredients in their food are exerting pressure on the FDA,” she stated. “This is undoubtedly a significant advancement in the right direction.”

Food safety is “the number one priority” for businesses, according to the Consumer Brands Association, a trade association, and they will abide by the FDA’s prohibition.

In a written statement, senior vice president of product policy and federal relations Sarah Gallo stated, “Revoking the authorized use of Red No. 3 is an example of the FDA using its risk and science-based authority to review the safety of products in the marketplace.” “To guarantee that consumers have safe and accessible options, food and beverage companies will continue to adhere to all food safety regulations and the most recent scientific findings.”

Prior to the Senate confirmation hearings for President-elect Donald Trump’s choice for secretary of health and human services, Robert F. Kennedy Jr., the Biden administration took this action. Kennedy has stated that the government will 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 likewise 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 get 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 artificial dyes and children’s hyperactivity. However, it concluded that there was no way to prove a causal association.

Other states have previously 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 that would ban Red No. 3 statewide and the California School Food Safety Act that would ban six other synthetic dyes from 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 over 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.”