The US Food and Drug Administration (FDA) has announced that it has banned the use of synthetic food dye Red No.3 in food, drink, and ingested medicine products, after studies in rats linked it to cancer.
What is Red No. 3 – and what’s happening to it?
Red No. 3, also known as erythrosine, is a synthetic dye or color additive that is used in products such as candy, frosting, and some medicines to give it a bright, cherry-red color. It had previously been banned from cosmetic products back in 1990, but now the FDA is banning its use in food, beverages, and ingested drugs too.
Manufacturers that currently use Red No. 3 in these products will have until January 15, 2027 (for food) or January 18, 2028 (for ingested drugs) to remove it, and foods imported to the US will also be required to comply.
Why is it being banned?
The ban of Red No. 3 comes following a petition submitted to the FDA in 2022, supported by numerous organizations including the Center for Science in the Public Interest (CSPI) and the former director of the National Institute for Environmental Health Sciences, Linda S. Birnbaum.
Those involved with the petition called for the dye to be banned, citing research that demonstrated it was able to induce cancer in male lab rats. It’s important to note, however, that this doesn’t necessarily mean that Red No. 3 is also carcinogenic in humans.
“The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats,” said the FDA in a statement announcing the ban.
“Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.”
That’s not to say that future research might not demonstrate otherwise, but in this particular circumstance, the decision to ban the synthetic dye is actually just a case of following the law.
In 1958, the Delaney Clause was added to the Federal Food, Drug and Cosmetic Act, stipulating that the FDA is required to “ban food additives which are found to cause or induce cancer in humans or animals as indicated by testing.”
After evaluating the data submitted with the petition, and other available data, the FDA concluded that the Delaney Clause had to be applied.
Nonetheless, the announcement of the ban has been welcomed by those who’ve long advocated for it.
“At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy,” said CSPI President Dr Peter G. Lurie in a statement. “The primary purpose of food dyes is to make candy, drinks, and other processed foods more attractive. When the function is purely aesthetic, why accept any cancer risk?”
Others have called the ban only one step in solving a wider problem of regulatory holdups.
“Animal studies dating back to the 1980s demonstrated that high doses of this synthetic dye increased tumor risks,” said Dr Melinda Ring, director of the Osher Center for Integrative Health at Northwestern University Feinberg School of Medicine, in a statement.
“The decades-long delay underscores the need for more responsive regulatory processes when credible evidence of harm emerges. Continuing to prioritize science-based decisions will help build a healthier, more transparent food system.”
