Red dye 3 banned from food, drinks and ingested drugs by FDA

The US Food and Drug Administration (FDA) announced on Wednesday that it has banned the use of red dye No. 3 in food, beverages, and ingested drugs, following over 30 years of scientific evidence linking the dye to cancer in animals.

Red dye No. 3, a synthetic additive made from petroleum and chemically known as erythrosine, is commonly used to colour food and beverages with a bright cherry-red hue. The move follows a petition submitted by advocacy groups, including the Centre for Science in the Public Interest and the Environmental Working Group, which cited research connecting the dye to cancer risks.

This decision also comes after California banned the dye in October, 2023. Manufacturers using red No. 3 in food and drugs will have until January 15, 2027, and January 18, 2028, respectively, to reformulate their products to comply with the new regulations. Imported foods must also meet the new standards.

Dr Jerold Mande, adjunct professor of nutrition at Harvard University, welcomed the decision as a long-overdue step, stating, "Today's action by FDA is long overdue, is a small step in the right direction, and hopefully signals a renewed effort by FDA to do its job despite the many barriers the food industry places in its way."

Ken Cook, cofounder of the Environmental Working Group, called the ban a "monumental victory" for consumer health. "We wouldn’t be celebrating this historic decision today without the relentless leadership of public health champions like Michael Jacobson and others who took up this fight decades ago on behalf of consumers," Cook said.

Red dye No. 3 is found in numerous products, including candies, food, and beverages. However, some major brands, such as Ferrara, the maker of Brach’s candies, have already begun phasing out the use of the dye. Fewer than 10% of Ferrara’s products still contain the additive, according to the company.

The dye has been linked to various health concerns, including cancer in animals. In 1990, the FDA banned its use in cosmetics and topical drugs due to carcinogenic findings in lab rats, but it remained authorised for use in food.

Despite numerous reevaluations, the FDA maintained that studies did not show direct risks to human health from the dye in food, though experts argue that the Delaney Clause of the Federal Food, Drug, and Cosmetic Act requires a ban if a substance causes cancer in animals or humans.

The decision marks a shift towards greater consumer safety, bringing US regulations closer to the European Union, which banned red dye No. 3 in 1994. Some states, including California, have also moved to ban other food dyes due to concerns about behavioural effects on children.

Dr Thomas Galligan, principal scientist at the Centre for Science in the Public Interest, called the ban a crucial step. However, he stressed that the FDA must address broader issues in the food safety regulatory system to prevent similar delays in the future.

As the FDA's ban takes effect, manufacturers will need to explore alternative colouring agents, such as red dye No. 40, which is considered less harmful, though concerns about it persist. The ongoing debate reflects broader concerns over food additives and their potential health impacts.

For consumers concerned about avoiding red dye No. 3, checking ingredient labels for "red 3" or "FD&C Red #3" is advised. The FDA has already required manufacturers to list the dye on labels, giving consumers a means to avoid its use until the ban is fully enforced.

The ban represents a victory for consumer health advocates, but it also highlights ongoing tensions between public health concerns and the food industry's practices.