The Food and Drug Administration banned the use of red dye No. 3 in food and ingested drugs on Wednesday, more than 30 years after the additive was found to cause cancer in rats.
Advocates have been calling on the FDA to ban the additive for years. In 2022, they filed a petition asking the agency to remove it from its list of color additives that are “generally recognized as safe.” Jim Jones, top food regulator at the FDA, said at a congressional hearing in December that the agency was hoping to make a decision in the next few weeks.
“Today’s action by the FDA marks a monumental victory for consumer health and safety,” Ken Cook, president of the Environmental Working Group, which was among the groups that had petitioned for the ban, said in a press release. “This ban sends a strong message that protecting the health of Americans — especially vulnerable children — must always take priority over the narrow interests of the food industry.”
Peter Lurie, president of Center for Science in the Public Interest, another group that petitioned for the ban, said, “It’s extraordinary that it has taken as long as it has, particularly when the agency conceded the underlying science over three decades ago and, in conceding the science, removed red 3 from cosmetics and topical drugs.”
Robert F. Kennedy Jr., Donald Trump’s pick for secretary of Health and Human Services, has blasted the FDA for failing to take swift action against potentially harmful additives. He’s not alone in that criticism; public health experts have been baffled by the agency’s slow pace. The FDA’s ban comes right before Donald Trump takes office, when he and Kennedy could take action and fulfill their campaign promise to crack down on additives.
Companies use additives to enhance the color, texture, and durability of food. Petitioners pointed to the Delaney Clause in the Food, Drug and Cosmetic Act, which prohibits FDA authorization of an additive if it has been found to cause cancer in humans or animals. The FDA ultimately agreed that red dye No. 3 falls into this category, though Jones clarified that “the way Red No. 3 causes cancer in male rats does not occur in humans.”
“The Delaney Clause is clear; the FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals,” Jones said.
Food manufacturers will have until January 2027 to remove red dye No. 3, and drug makers will have until January 2028.
Statements from industry trade groups suggested they’re not planning to resist the rule. “Food safety is the number one priority for U.S. confectionery companies, and we will continue to follow and comply with FDA’s guidance and safety standards,” the National Confectioners Association said in a statement.
Sarah Gallo, a senior vice president for the industry trade group Consumer Brands Association, said: “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.”
The responses are noteworthy given that “concerted industry pressure” was largely responsible for the decades-long delay in banning the dye from most foods, according to CSPI’s Lurie. The maraschino cherry industry was particularly vocal in opposing a ban, arguing that “somehow consumers will never consume them unless they have this bright red element to them,” he said. In Europe, which banned red dye No. 3 in 1994, there’s an exception for maraschino cherries.
Red dye no. 3 is also present in candies like Pez Candy and Brach’s Candy Corn, as well as various kinds of juices, meat products, and more, according to an Environmental Working Group database. More than 3,000 products currently contain the dye, the database shows.
A study in the early 1980s showed that after 70 male rats were fed doses of red dye No. 3 equaling 4% of their diets over their lifetime, 15 developed thyroid tumors. Most were benign. The agency in 1990 banned its use in ice cream, baked goods, and cosmetics. But it permitted red dye No. 3 in most foods. Officials weren’t convinced by the scientific evidence, but admitted that the Delaney Clause may force their hand. Thirty five years later, it did.
California took matters into its own hands last year, banning red dye and three other additives. The state found that synthetic food dyes could increase hyperactivity in children. Activists have continued to encourage states to enact their own laws on additives. This has amped up pressure on the FDA to act, as food companies complained about the prospect of patchwork food safety laws.
In September, the FDA outlined a plan to more comprehensively and proactively evaluate the safety of chemicals added to food. Congress, however, denied its request for $19 million to stand up the program. Without a boost in resources, Jones warned that progress could be slow.
“Simply put, prioritization and drive can only take us so far,” Jones said. “Our current budget constraints will limit the number and speed of assessments. But you have to start somewhere.”
STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.