Spotlight on cancer-causing food additive as advocates demand FDA ban Red Dye 3

In the waning days of the Biden administration, a long-fought battle over a cancer-causing food additive is again in the spotlight as consumer advocacy groups and lawmakers demand federal regulators ban Red Dye No. 3, a chemical used to give popular candies, foods and drinks their cherry-red colors.

The issue took center stage Thursday at a US Senate hearing where lawmakers grilled Jim Jones, Food and Drug Administration (FDA) deputy commissioner for human foods, over the issue.

“Red 3 has been known to cause cancer in cosmetics but we still allow it to be put in our food. I don’t understand that,” Sen. Tommy Tuberville said in the hearing.  “If we know something is deadly for anybody that ingests it how do we continue to just study that and not say hey, enough is enough?”

Industry studies linked Red Dye 3 to cancer in rodents more than 30 years ago, and public health groups have spent years lobbying food companies and regulators to get the chemical out of foods.

Two years ago, two dozen organizations and scientists submitted a petition to the FDA demanding a ban, citing a 1990 FDA conclusion that the chemical causes cancer when fed to rats.

Last month, 23 members of Congress sent a letter to the FDA also calling for a ban, saying the FDA “should act quickly to protect the nation’s youth from this harmful dye.” The letter noted Red Dye 3 has been banned or mostly banned in Europe, Australia and New Zealand and California has a ban on the dye in food taking effect in 2027.

“Thirty-four years of inaction is far too long,” the letter states.

In Thursday’s hearing, Jones said the agency was “hopeful” it would “be acting on that petition” in the “next few weeks.”

It is “long past time,” for the FDA to ban the dye, US Rep. Frank Pallone said in a Dec. 5 letter to the FDA. “With the holiday season in full swing where sweet treats are abundant, it is frightening that this chemical remains hidden in these foods that we and our children are eating.”

An “easy action”

The agency’s inaction, which persists despite a clause in the Federal Food, Drug and Cosmetic Act that requires the agency to ban cancer-causing food additives, has long frustrated public health advocates.

“In Europe where these dyes are banned – or at least they have to have warning labels on them – they use the precautionary principle which says if there is any question about the safety they don’t go into the food supply,” Marion Nestle said on CNN on Friday. “We do it the opposite way. We put them in the food supply and then wait to see if people get sick.”

The FDA’s inaction on Red Dye 3 embodies a broader agency problem, with the FDA taking “a very lax approach” to regulating food additives, said Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest (CSPI), one of the groups that petitioned the FDA in 2022.

“Basically, once chemicals are in the food system, they can stay there for as long as [companies] want because the FDA is not taking action when new evidence of harm emerges,” said Galligan.

While the petition currently sits with the White House Office of Management and Budget, the FDA can grant the petition on its own, without the office’s approval, said Melanie Benesh, Vice President of Government Affairs for the Environmental Working Group (EWG), one of the groups backing the 2022 petition.

“This would be an easy action for the Biden Administration to take to get a cancer-causing chemical out of food,” said Benesh.

Industry pushback

Red Dye 3 is found in staple holiday candies such as Halloween candy corn and Valentine’s Day conversation hearts as well as over 2,800 other food products in EWG’s Food Scores database, ranging from childhood favorites like Fruit by the Foot and Dubble Bubble chewing Gum, as well as certain brands of mashed potatoes, yellow rice and some medications.

In 2021, food and drug manufacturers used about 200,000 pounds of Red Dye 3 in their products.

In 1990, the FDA banned Red Dye 3 from use in cosmetics such as lipsticks as well as externally applied drugs, citing industry research from the 1980s that found consuming the additive caused thyroid cancer in male rats.

The FDA did not take action on the dye in food, however, stating on its website that industry studies “did not raise safety concerns” because “the way that [Red Dye 3] causes cancer in animals, specifically rats, does not occur in humans so these animal results have limited relevance to humans.”

Industry groups insist that is the case. In public comments filed with the FDA last year, a letter signed by the American Bakers Association; Consumer Brands Association; National Confectioners Association states that the findings in rats are species-specific and that “authoritative scientific bodies and many world-renowned toxicologists over many decades” have concluded that “the findings of thyroid carcinogenesis in male rats is not relevant to humans.”

The groups requested that the FDA conduct a scientific review of research to determine the safety of Red Dye 3 “and decide to maintain Red No 3 in the permanent list of color additives.”

Mounting pressure

In 2021, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment released a report that concluded synthetic food dyes such as Red Dye 3 have been linked to inattentiveness, hyperactivity and restlessness in some children, with federal consumption levels for these chemicals failing to account for recent research. The report also found that children are often exposed to levels of Red Dye 3 that exceed the FDA’s Acceptable Daily Intake Level.

Following the report, state lawmakers passed the California Food Safety Act or so-called “Skittles Bill,” which will ban the manufacture and sale of Red Dye 3 as well as three other food additives statewide beginning Jan. 1, 2027. In August, the state passed the California School Food Safety Act, which will ban six food dyes linked to childhood learning problems from meals served at California public schools beginning Dec. 21, 2027.

Following California’s lead, nine other states are currently working on legislation that would ban Red Dye 3, with Pennsylvania proposing a ban on five other food additives as well.

And a spokesperson for Abbott Laboratories, the company that makes the children’s nutrition shake PediaSure, said it removed Red Dye 3 from the drink in 2024 and will remove the additive from other products next year.

But while actions by California and other states are good news for consumers, “it shouldn’t have to come to basically voluntary action and state action to get this type of chemical out of our food,” said Galligan. “By making [Red Dye 3] federally illegal, it takes it out of the hands of industry,” he added. “It’s the ultimate goal because then all American consumers are guaranteed that protection.”

The RFK factor

If the petition to ban Red Dye 3 does fail to pass under the Biden administration, it should still be acted upon by the Trump administration, said Jensen Jose, regulatory council for CSPI.

The potential for budget cuts to the already budget-strapped FDA looms, however, under an administration already touting plans for $500 billion cuts in government spending, Jose said.

“Unfortunately, when cuts are made, some of the first things to go are the budgets to the food programs,” Jose. “If this is not on their radar and they’re just making massive cuts then, yeah, this will be a problem.”

While the Trump platform is heavily on deregulation, Trump’s nominee to head the US Department of Health and Human Services (HHS), which oversees the FDA, is Robert F. Kennedy Jr., and Kennedy has spent years advocating against food additives he says are “literally poisoning our children.”

Kennedy, commonly referred to as RFK, has built a career railing against corporate influence, and calling for tighter regulations, particularly for food, pharmaceutical and chemical industries.

While some of his views are considered controversial, many environmental and public health advocates are hopeful he will make the changes they want to see.

“The question here for RFK, if he does become nominated, is, is he going to do more than just go after a few chemicals here and there?” said Jose. “Is he going to listen to the science, is he going to listen to us and actually try to fix the FDA? That will remain to be seen.”

(Featured image by Mockup Graphics on Unsplash.)