Red 3 dye banned in US food and drugs

The US Food and Drug Administration (FDA) has banned the commonly used food dye erythrosine, also known as Red 3, from food, drinks and oral medicines, citing research showing it causes cancer in male rats.

In the US, the colouring has been banned from use in topical drugs and cosmetics since 1990. It is largely already banned as a food additive elsewhere, including the EU, Australia and New Zealand (with limited permitted uses, including in preserved cherries).

Under the FDA’s new rule, manufacturers that use Red 3 in food or ingested medications will have until January 2027 and January 2028 to reformulate their products, respectively. The ban will also apply to imported products.

The FDA action came in response to a petition filed in 2022 by over 20 organisations, including the Center for Science in the Public Interest (CSPI). The FDA has now concluded that the dye’s use violates a provision within the Food Drug and Cosmetic Act called the Delaney Clause.

‘The Delaney Clause is clear; the FDA cannot authorise a food additive or colour additive if it has been found to cause cancer in humans or animals,’ stated Jim Jones, the FDA’s deputy commissioner for human foods. Nevertheless, he pointed out that the evidence shows cancer only in male rats exposed to high levels of erythrosine, and the specific hormonal mechanism implicated in rats does not occur in humans.

While acknowledging the legal basis for the ban, the FDA maintains that the available evidence does not support claims that erythrosine poses a cancer risk to humans at typical exposure levels. But CSPI president, Peter Lurie, said the move aids consistency and transparency in regulation. ‘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,’ Lurie stated.