The Food and Drug Administration is on the cusp of deciding whether to ban a controversial bright cherry-red dye used in drinks and snacks but that has been linked to cancer in animals.

Food safety advocates for years have pressured the agency to ban the dye used in bubble gum, candy and fruit cocktails, contending it would be safer to use natural coloring derived from plants such as beets and red cabbage.

The FDA maintains the additive approved for permanent use more than 50 years ago is safe for humans to consume, but the regulatory agency’s decision nonetheless arrives at a pivotal time for the food industry. Robert F. Kennedy Jr., President-elect Donald Trump’s pick to lead the nation’s health department, along with social media influencers and lawmakers from both parties are increasingly scrutinizing the chemicals and ingredients found in food and drinks.

The decision on red dye No. 3 is more than three decades in the making.

In 1990, the FDA forbade the use of the color additive in cosmetics, like lipstick and blush, because studies showed high doses could cause cancer in rats. The agency at the time said it would “take steps” to eliminate the artificial dye in food and other products, while a top FDA official recently said there is no evidence that ingesting the coloring causes cancer in humans.

“There is a systems-level failure at the federal level that allows unsafe chemicals to linger in our food supply for, in this case, decades,” said Thomas Galligan, the principal scientist for food additives and supplements at the nonprofit Center for Science in the Public Interest, which led a 2022 petition asking the agency to formally remove the dye from the list of approved color additives in foods.

The International Association of Color Manufacturers, which represents the color additives industry, stands behind the dye. The group maintains red dye No. 3 is “safe for its intended uses” and argues pulling the dye from products would lead to higher costs for consumers, Sarah Codrea, the trade group’s executive director, said in a statement.

The FDA expects to make an announcement probably in the “next few weeks,” Jim Jones, the agency’s deputy commissioner for human foods, told senators earlier this month.

If the timing holds, it could set up a decision before a vote on Kennedy’s confirmation, which is expected early next year, and whom Trump has pledged to let “go wild on the food.” Kennedy has been fiercely critical of artificial food dyes, and scientists have long debated the safety of such additives.

A color conundrum

Opponents of red dye No. 3 — also known as erythrosine or FD&C Red No. 3 — argue it should be banned since it is only added to enhance the color of food and serves no nutritional purpose.

Some prominent consumer advocacy groups insist there is enough evidence to show food dyes may cause some harm to children, arguing that some studies have connected artificial dyes, including red dye No. 3, to negative behavioral problems. They point to a 2021 review performed by the California Office of Environmental Health Hazard Assessment, which concluded the consumption of some food dyes can result in hyperactivity and other neurobehavioral problems in some children though sensitivity varies.

But the FDA contends a definitive link has not been established.

“The totality of scientific evidence shows that these color additives in food — when used at approved levels — are safe for all consumers,” the FDA said in a statement to The Washington Post.

The agency approves the use of color additives, and in 1969, it permanently listed red dye No. 3 for use in food. But the color additive had only been allowed temporarily in cosmetics, which made it easier to pull the dye from cosmetics and topical creams in 1990.

At the time, federal officials made clear the decision was based less on scientific evidence but instead on a federal law called the Delaney Clause, which prohibits additives found to cause cancer in humans or animals at any dose. Louis W. Sullivan, who was serving as Health and Human Services secretary, “all but apologized for banning the dye from certain uses,” The Post reported.

The agency then declared its intent to ban the dye in food, but it never followed through.

When a substance is shown to cause cancer in animals, food safety advocates say it is presumed to cause cancer in humans. But red dye No. 3 has posed a conundrum for the FDA, with Jones saying the issue has “challenged” the agency for many years.

“You have a scenario where although there may be cancer evidence in animals, there is also evidence that it is not harmful to humans,” Jones said at a hearing before the Senate health committee earlier this month.

But food safety advocates argue the FDA has no choice.

“The law is very clear,” said Melanie Benesh, a vice president of the nonprofit Environmental Working Group, which signed on to the petition asking the FDA to revoke the dye’s approved uses. If there’s any evidence of cancer in animals or humans, “the FDA is required to ban it,” she said. “It’s just simply not allowed in food.”

‘Writing on the wall’

Absent federal action, at least one state has moved to ban the dye on its own. Last year, California passed a law prohibiting food from being sold in the state if it contains red dye No. 3, brominated vegetable oil and other additives. Companies have until 2027 to reformulate their food and drinks or stop selling the products.

Even before the California law goes into effect, some prominent manufacturers have started removing the dye from popular items, such as Peeps candy and PediaSure nutritional shakes made by Abbott.

“They can see the writing on the wall,” said Jensen Jose, who serves as regulatory counsel at the Center for Science in the Public Interest.

Other dyes have faced public pushback, such as red dye No. 40, a widely used dye found in some popular breakfast cereals that has a different chemical composition from red dye No. 3.

The FDA is facing pressure to crack down on red dye No. 3 from both Republican and Democratic lawmakers. Sen. Tommy Tuberville (R-Ala.) quizzed agency officials on the dye during the Senate health committee hearing. Rep. Frank Pallone Jr. (N.J.) — the top Democrat on the House Energy and Commerce Committee — said he was frightened the dye remains in food commonly found on store shelves.

“There is simply no reason for this chemical to be in our food except to entice and mislead consumers by changing the color of their food so it looks more appealing,” Pallone wrote this month in a letter to FDA Commissioner Robert M. Califf. “Reliable scientific evidence exists for FDA to ban this chemical.”

Food safety advocates have said it takes far too long for the FDA to reassess chemicals in food. In response to the criticism, agency officials say they recently finalized a massive reorganization creating a new Human Foods Program, which includes an office dedicated to reviewing chemicals found in food.

Testifying before Congress, Califf pleaded for more money for the agency he’ll oversee for one more month before the second Trump administration begins.

“We have repeatedly asked for better funding for chemical safety,” Califf told lawmakers this month. “Please look at our request for funding.”