FDA bans red dye used in medicines over cancer risk
The FDA has banned the use of a synthetic red dye used in oral medicines, as well as foods and dietary supplements, more than 30 years after it was linked to cancer, after a citizen's petition was filed by consumer advocacy and patient groups.
Pharma manufacturers will no longer be able to use Red Dye No. 3 – sometimes called erythrosine – in newly registered ingested products, said the regulator. However, those that currently do so will not have to pull them from the market straight away, as there will be a grace period extending out to 18th January, 2028, to reformulate them.
The ban will also apply to medicines and food products imported into the US from other countries, according to the FDA.
The decision follows a petition filed in 2022 by a number of groups, including the Center for Science in the Public Interest (CSPI), which argued that the dye should come under the Delaney Clause, a section of the US Federal Food, Drug, and Cosmetic Act that requires the FDA to ban food additives found to cause or induce cancer in humans or animals.
The groups argued that studies as far back as 1990 had established that Red Dye No. 3 induced cancer when fed to laboratory male rats, and highlighted their concern about the widespread exposure to the additive by US consumers, particularly children, who could consume it in candy as well as commonly-used medicines like cough syrups.
The dye was banned for cosmetic use in the US 35 years ago and is also restricted overseas, including in the EU, leading consumer groups to question why the FDA had taken so long to implement its own ban.
"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 the CSPI's president, Dr Peter Lurie, in a statement that called the delay a "decades-long regulatory failure."
"The primary purpose of food dyes is to make candy, drinks, and other processed foods more attractive," added Lurie. "When the function is purely aesthetic, why accept any cancer risk?"
In its statement on the decision, the FDA said that the two studies that showed a link to cancer in rats used high levels of Red No. 3 and were due to a rat-specific hormonal mechanism that does not occur in humans.
"Studies in other animals and in humans did not show these effects," added the regulator. "Claims that the use of […] Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information."
