The scientist behind the study used to ban a cancer-linked ingredient from US food has spoken out about how his work influenced the change.
Dr Joseph Borzelleca, 94, studied the effect of Red Dye No.3 in 1987, looking at its effect on male rats.
His study found that male rats consuming very high doses of Red Dye No.3 had a significantly higher risk of developing polyps, or abnormal cell growths, in their thyroids. It did not show that the additive caused cancer.
It was the only paper cited by the FDA in its order banning Red Dye No. 3 from use in foods, however, with the order set to go into force in January 2027.
Shockingly, Dr Borzelleca thinks the risks have been overblown.
In fact, he said he had no problem with his kids or grandkids consuming the dye that is found in thousands of sweet treats throughout the US.
The professor emeritus of toxicology and pharmacology at Virginia Commonwealth University said: ‘If I thought there was a problem, I would have stated it in my paper.
‘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.’
It comes as new HHS Secretary Robert F. Kennedy Junior makes no secret of his mission to get artificial dyes out of products, telling food executives on March 10 to reformulate their foods or he would ban the additives.
Dr Joseph Borzelleca, behind the study used to suggest Red Dye No. 3 causes cancer, said that he was comfortable for his children and grandchildren to consume the dye. He is pictured above in 2001 receiving an award from Virginia Commonwealth University
Thousands of products sold in the US, from cereals to candies, beverages and cake toppings, use artificial food colorings.
The colorings are not strictly necessary for the foods, but they give them a bright color that makes them more appealing to consumers.
Speaking to KFF Health News, however, Dr Borzelleca — who has published dozens of studies on the toxicity of food dyes — said he was not concerned over Red Dye No. 3.
‘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,’ he said.
‘Our study did not find this was a carcinogen.’
The FDA says in its rule banning the additive that it can cause cancer, although it is not clear what research it is citing to make this claim.
Dr Borzelleca has published dozens of research papers on the toxicology of food additives, pesticides and water contaminants.
He is also a former president of the Society of Toxicology, and consulted for both the National Academy of Sciences and the World Health Organization.
In his 1987 research, Dr Borzelleca and two co-scientists administered doses of Red Dye No. 3 to 120 rats.
The rats were exposed to the dye in their foods for up to 30 months, and then examined afterward for any body changes.
Results showed male rats on the highest dose had significant increases in the weight of their thyroids compared to those that were not consuming the dye.
They were also found to have a higher risk of hyperplasia, an abnormal increase in the number of cells, and adenomas, non-cancerous tumors.
Many experts are concerned the dye might also have a similar effect in people.
Other countries including the European Union and UK have also banned Red Dye No.3, but in each case they have also cited studies suggesting the dye can cause hyperactivity in children.
Dr Borzelleca’s work was funded by the industry, and published in the scientific journal Food and Chemical Toxicology. In 1990, it was also cited by the FDA in its decision to ban the additive from make-up.
Red Dye No.3 was approved for use in the US in 1907, and has been incorporated into thousands of products since to give them a cherry red coloring.
