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The US Food and Drug Administration (FDA) has banned the use of the synthetic colourant Red Dye 3 in food, beverages and ingested drugs.

The decision, announced on 15 January 2025, follows two studies that linked the dye to cancer in male laboratory rats.

It responds to a 2022 petition filed by multiple organisations including the Center for Science in the Public Interest, Breast Cancer Prevention Partners and the Center for Food Safety. The petition urged the FDA to review whether the Delaney Clause – which prohibits authorisation of a food additive or colour additive if it has been found to induce cancer in human or animals – applies to Red Dye 3, citing the two studies among other data.

Red Dye 3 is a synthetic colourant made from petroleum. It is used to give a vibrant, cherry-red hue to a wide range of food products including confectionery, cakes, cookies and frozen desserts. It is currently used in many popular food products across the US including Pez assorted fruit candies and Nesquik strawberry low-fat milk.

In a statement, the FDA noted that relevant exposure levels to Red 3 for humans are ‘typically much lower than those that cause the effects shown in male rats,’ adding that the cancer found in the laboratory rats exposed to the dye was due to a ‘rat-specific hormonal mechanism’.

However, it acknowledges that the Delaney Clause, which was enacted in 1960 as part of the Color Additives Amendment to the Food, Drug & Cosmetic Act (FD&C), requires the FDA to prohibit the additive’s use in food products and ingested drugs (such as cough syrups and medicinal gummies) as a matter of law.

Food manufacturers in the US that have used Red Dye 3 will be required to reformulate their products by 15 January 2027. Manufacturers of ingested drugs, including dietary supplements, will be given until 15 January 2028.

While some countries still allow certain uses of the colourant, foods imported to the US must comply with the new US requirements. The use of Red Dye 3 is limited in Australia, New Zealand, and the UK and EU, where it is known as ‘erythrosine’ or ‘E127’ and is authorised only for use in cocktail cherries and candied cherries.

This is not the first time the FDA has revoked an additive’s authorisation based on the Delaney Clause in response to petition. In 2018, the FDA banned the use of six artificial flavourings due to studies showing the substances caused cancer in laboratory animals.

Commenting on the ban, the National Confectioners Association – the trade organisation for the confectionery industry in the US – said: "Food safety is the number one priority for US confectionery companies, and we will continue to follow and comply with FDA’s guidance and safety standards".

"Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework. We have been saying for years that FDA is the rightful national regulatory decision maker and leader in food safety."

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