By Phil Galewitz, KFF Health News

When the FDA announced in January, before President Joe Biden’s term ended, that it would ban a dye called red dye No. 3 in food and ingested drugs, the federal agency cited just one 1987 study on rats to support its action.

The industry-funded study, based on data from two prior studies, was led by a Virginia toxicologist who said then — and still believes today, decades after concerns first arose that the chemical could be carcinogenic — that his research found the petroleum-derived food coloring doesn’t cause cancer in humans.

“If I thought there was a problem, I would have stated it in the paper,” Joseph Borzelleca, 94, a professor emeritus of pharmacology and toxicology at Virginia Commonwealth University, told KFF Health News after the FDA’s announcement. “I have no problem with my family — my kids and grandkids — consuming Red 3. I stand by the conclusions in my paper that this is not a problem for humans.”

Soon after Borzelleca’s paper was published in a scientific journal, Food and Chemical Toxicology, the FDA examined the data his team had collected and reached its own conclusion: that the dye caused cancer in male lab rats. In 1990, the FDA cited the study in banning Red 3 in cosmetics.

In 1992, the FDA said it wanted to revoke approval of Red 3 in food and drugs. But the agency didn’t act at the time, citing a lack of resources.

More than 30 years later, after a renewed push by consumer advocates, the Biden administration announced the ban in its last days in power. The move came just weeks before the Senate confirmed Robert F. Kennedy Jr., President Donald Trump’s nominee to head the Department of Health and Human Services, which oversees the FDA.

Kennedy has been a vocal critic of food additives, including Red 3. On March 10 he met with top food industry executives and told them if they don’t eliminate artificial food dyes from their products, the federal government will force them to do so, Food Fix reported.

Consumer advocacy groups cheered the Red 3 ban, even as the FDA said there is no evidence that the dye is dangerous to people. “Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans,” Jim Jones, FDA deputy commissioner for human foods, said in a statement.

Jones resigned from FDA in February, criticizing Trump administration cuts that he said hobbled his office.

The FDA did not respond to a request for comment, but Marty Makary, Trump’s nominee to lead the agency, said at his Senate confirmation hearing on March 6 that he is concerned about whether food additives such as Red 3 harm children.

“It did not make sense that red dye No. 3 was banned in cosmetics but allowed in the food supply,” Makary told Sen. Tommy Tuberville, who questioned why the FDA ban doesn’t take effect until 2027.

“We want to kill people for two more years?” the Alabama Republican said. “I would hope that you would, if you’re confirmed, you’d go in and look at it very quickly and say, ‘Why do we want to put our people in harm’s way?’”

The International Association of Color Manufacturers says Red 3 is safe in the tiny levels typically consumed by humans. The dye was approved for use in foods in the U.S. in 1907, and today it’s an ingredient in thousands of products including cereals, candy, beverages, and cake toppings.

Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest, which petitioned the FDA for a ban, said that a federal regulation known as the Delaney Clause prohibits any ingredient that causes cancer in animals from being included in foods. (The publisher of KFF Health News, David Rousseau, is on the CSPI board.)

“At the end of the day, this is an unnecessary additive,” he said. “It’s a marketing tool for the industry to make foods look more appealing so consumers will buy them. But federal law is clear: No amount of cancer risk is acceptable in foods.”

Galligan said he was not surprised Borzelleca’s opinion on Red 3 had not changed or that the food dye industry has played down the risk.

In October 2023, California became the first state to ban Red 3 in food starting in 2027, superseding the FDA’s earlier rule allowing small amounts in foods as a color additive. The state legislature acted after a state analysis concluded the dye could cause hyperactivity in children.

The European Union, Australia, and Japan are among the locations that already ban the chemical in foods. The EU’s ban also cites hyperactivity in children. The EU requires food makers to include a warning that food dyes that are still allowed may “have an adverse effect on activity and attention in children.”

The IACM points to research by scientific committees operated by the World Health Organization, including a 2018 review that affirmed the safety of Red 3 in food.

Some food manufacturers have already reformulated products to remove Red 3. In its place they use beet juice; carmine, a dye made from insects; or pigments from foods such as purple sweet potato, radish, and red cabbage.

It isn’t clear how the FDA determined that Red 3 can cause cancer in male rats. Borzelleca’s paper said some rats that were fed Red 3 developed polyps in their thyroid gland but doesn’t mention cancer.

Borzelleca, whose study was funded by the IACM, then known as the Certified Color Manufacturers Association, said he was stunned the FDA banned the dye and used his research to back the move.

“I am surprised all this time has gone by and it’s been safe for human use, and now it’s being pulled from the market due to concerns not supported by the data,” Borzelleca said. “Our study did not find this was a carcinogen.”

His study was a response to the FDA’s requirement in the 1980s for additional long-term feeding studies in rats and mice as a condition for the continued provisional approval of several color additives, including Red 3.

Over decades, Borzelleca published dozens of research papers on the toxicology of food additives, pesticides, and water contaminants. He also served on advisory boards for the tobacco industry and represented cigarette maker R.J. Reynolds in negotiations with the Department of Health and Human Services about cigarette additives, according to a 1984 corporate memo. Borzelleca is a former president of the Society of Toxicology and consulted for the National Academy of Sciences and the World Health Organization.

The commonwealth of Virginia gave him a lifetime achievement award in 2001 for his work helping assess dangers in foods, drugs, and pesticides.

Phil Galewitz: pgalewitz@kff.org, @philgalewitz