Controversial red dye found in candy and drinks could be banned

Decision on red dye no. 3 is more than three decades in the making.

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

“There is a system-wide failure at the federal level that has allowed unsafe chemicals to remain in our food supply for, in this case, decades,” said Thomas Galligan, chief 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 food.

The International Association of Color Manufacturers, which represents the color additive industry, stands behind the paint. The group claims that the red dye no. 3 is “safe for its uses” and argues that removing the dye from the products would result in higher costs for consumers, Sarah Codrea, the trade group’s executive director, said in a statement.

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

If time 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 “run wild with food.” Kennedy fiercely criticized artificial food dyes, and scientists have long debated the safety of such additives.

Opponents of red paint no. 3 – also known as erythrosin or FD&C Red No. 3 – argue that it should be banned because it is only added to enhance the color of food and serves no nutritional purpose.

Some prominent consumer advocacy groups insist that there is enough evidence to show that food dyes can cause some harm to children, arguing that some studies have linked artificial dyes, including red dye no. 3, with negative behavioral problems. They point to a 2021 review by the California Office of Health Risk Assessment, which concluded that eating some food dyes can lead to hyperactivity and other neurobehavioral problems in some children, although sensitivity varies.

But the FDA says no definitive link has been established.

“The totality of the scientific evidence shows that these food color additives — 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 was only temporarily allowed in cosmetics, which made it easier to extract the dye from cosmetics and topical creams in the 1990s.

At the time, federal officials said the decision was based less on scientific evidence than on a federal law called the Delaney Clause, which bans additives known to cause cancer in humans or animals at any dose. Louis W. Sullivan, who served as Secretary of Health and Human Services, “apologized for banning the dye from certain uses,” The Post reported.

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

When a substance is proven to cause cancer in animals, food safety advocates say it is presumed to cause cancer in humans. But the 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, while there may be evidence of cancer in animals, there’s also evidence that it’s not harmful to humans,” Jones said at a Senate health committee hearing earlier this month.

But food safety advocates say the FDA has no choice.

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

In the absence of federal action, at least one state has moved to ban the dye itself. Last year, California passed a law banning 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 went into effect, some major manufacturers began removing the dye from popular items such as Peeps candies 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 rejection, such as red dye no. 40, a widely used dye found in some popular breakfast cereals, which has a different chemical composition than red dye no. 3.

FDA faces pressure to crack down on red paint no. 3 from Republican and Democratic lawmakers. Sen. Tommy Tuberville (R-Alabama) questioned agency officials about the paint during a Senate health committee hearing. Rep. Frank Pallone Jr. (New Jersey) — the top Democrat on the House Energy and Commerce Committee — said he is alarmed by leftover food coloring in foods commonly found on store shelves.

“There is simply no reason for this chemical to be in our food other than to lure and mislead consumers by changing the color of the food to make it appear more appealing,” Pallone wrote this month in a letter to FDA Commissioner Robert M. Califf. “There is reliable scientific evidence for the FDA to ban this chemical.”

Food safety advocates said it is taking far too long for the FDA to reevaluate chemicals in food. In response to criticism, agency officials say they recently completed a massive reorganization by 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 will oversee for another month before the start of the second Trump administration.

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