What is the cancer-linked red dye found in candy, drinks banned by US FDA?

The United States Food and Drug Administration (FDA) has banned a bright red dye, used in candy, drinks and snacks, that has been linked to cancer in animals. American health officials have barred the use of artificial food colouring Red No 3, decades after the dye was removed from cosmetics.

The FDA’s decision comes two years after consumer and patient advocacy groups pressed the regulatory agency to disallow the dye.

Let’s take a closer look.

What has FDA said?

Red dye No 3 will no longer be used in food or ingested drugs in the US. The ban came into effect on Wednesday (January 15), the agency announced.

The FDA has directed drugmakers who use the colouring to reformulate their products by January 18, 2028.

The US agency said its decision was based on the federal law called the Delaney Clause, which prohibits the use of any additive that causes
cancer in humans or animals in food.

“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,” Jim Jones, the FDA’s deputy commissioner for human foods, said in a statement, as per The Washington Post.

“Importantly, the way that … Red No 3 causes cancer in male rats does not occur in humans,” the statement added.

Today, the FDA is issuing an order to revoke the authorization for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition that requested the agency to review whether the Delaney Clause applied. https://t.co/Qd0NFOIUz8 pic.twitter.com/Bpr6XNC8OR

— U.S. FDA Human Foods Program (@FDAfood) January 15, 2025

The FDA’s move comes amid criticism by Robert F Kennedy Jr, US President-elect Donald Trump’s pick for health secretary, of some food dyes. He has vowed a crackdown on some chemicals and ingredients found in food and drinks if he is confirmed claiming the dyes cause cancer and ADHD in children, as per reports.

Red dye No 3 linked to cancer

Studies have shown that high doses of red dye No 3, also known as erythrosine, could cause cancer in lab rats, specifically thyroid cancer.

However, the FDA has pointed out that those studies “have limited relevance to humans” because cancer is not caused in the same way in both species.

“The petitioners provided data demonstrating that this additive induces cancer in male rats,” the FDA wrote in its notice Wednesday.

In 1990, the US agency banned the cherry-red additive in cosmetics after studies linked it to cancer in rats.

Reactions to the ban

Proponents of the ban have welcomed the FDA’s move.

“Red Dye 3 poses an unacceptable risk to our health, especially when safer alternatives are readily available,” Brian Ronholm, director of food policy at Consumer Reports, told Bloomberg. “By banning Red Dye 3, the FDA will protect the public by encouraging manufacturers to switch to safer ingredients already used in products sold in Europe and numerous other countries.”

Linda Birnbaum, former director of the National Institute of Environmental Health Sciences, reportedly said last month, “If you can’t put it on your skin why would you eat it? Bright red dye is completely unessential. We don’t need bright red candies.”

As per Bloomberg, Birnbaum along with 20 advocacy groups including Consumer Reports, Public Citizen and the Environmental Working Group signed a petition in 2022 to ban Red No 3 in the US.

California banned this dye in foods in 2023.

The Consumer Brands Association, a food industry group, and the National Confectioners Association, a candy-focused trade organisation, have said both companies will comply with the ban.

“Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework. FDA is the rightful national regulatory decision maker and leader in food safety,” the candy group said in a statement.

What is Red Dye No 3?

Red No 3 is a colour additive found in hundreds of processed foods, as per the Environmental Working Group.

The now-banned artificial food colouring is used in candy, fruit juice, cakes and frozen desserts.

An analysis of October data performed by healthy food app GoCoCo found 26 per cent of baking decorations and dessert toppings have Red No 3. It is also present in 16 per cent of chewing gum and mints, 13 per cent of candy, and 11 per cent of cookies and biscuits, reported Bloomberg.

As per the Environmental Working Group and the Center for Science in the Public Interest, some types of Fruit by the Foot, Dubble Bubble chewing gum, Entenmann’s Little Bites, Hostess’ Ding Dongs, Nestle strawberry milk, Jordan Almonds, Pez hard candies, Brach’s candy corn and some flavours of Ringpop have listed red 3 as an ingredient.

Betty Crocker’s loaded mashed potatoes, Vigo saffron yellow rice, Don Pancho green and blue tortilla chips also use the colouring in their products, as per a Forbes report.

Medicines like Tylenol PM, gabapentin and doxycycline also contain Red No 3. The dye is also an inactive ingredient in the capsule shell of the popular ADHD drug Vyvanse.

How harmful are food dyes?

Artificial food dyes have long been controversial due to their safety. However, the US FDA and the European Food Safety Authority (EFSA) have concluded that the additives do not pose significant health risks, as per Healthline.

That being said, consuming high levels of food dye that has contaminants could adversely impact health.

So far, studies have not found that Red No 3 causes thyroid cancer in humans. Research has, however, linked the dye to behavioural health issues, like attention deficit hyperactivity disorder, in children.

Over the years, clinical trials have shown that children who drank juices containing food dyes saw a small but significant increase in hyperactivity.

“There’s a reasonable suspicion that food dyes may be harmful, at least for some kids,” Joel Nigg, a professor of psychiatry at Oregon Health and Science University, told The New York Times. “So why expose them to it?”

With inputs from agencies