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.
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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