The U.S. Food and Drug Administration (FDA) has officially banned Red Dye No. 3 from use in food, beverages, and ingested medications more than 30 years after scientists discovered links to cancer.
This decision comes decades after concerns about its health risks first surfaced. Scientists and public health advocates who have pushed for stricter regulations on artificial food dyes see the move as long overdue.
What Is Red Dye No. 3?
Red Dye No. 3, erythrosine, is a synthetic colour additive derived from petroleum. It has been used for decades to give food and drinks a bright, cherry-red hue. Commonly found in candies, baked goods, and even cough syrups, this additive was a go-to choice for manufacturers aiming to make their products visually appealing.
However, controversy has surrounded Red Dye No. 3 since the 1980s, when research linked it to cancer in laboratory animals. While the FDA banned its use in cosmetics in 1990, it has remained permissible in food and other ingestible products.
Why Did the FDA Ban It?
The FDA’s decision to ban Red Dye 3 in food and beverages follows mounting pressure from advocacy groups, scientists, and public health experts. Research showed that high doses of the dye caused cancer in rodents, raising alarms about its long-term safety. Although studies haven’t confirmed similar effects in humans, U.S. law mandates that any additive causing animal cancer cannot remain in the food supply.
This regulatory change also aligns the U.S. more closely with Europe, where Red Dye No. 3 has been restricted since 1994, except for limited uses like in some preserved cherries. Many argue the U.S. has lagged behind other nations in taking precautions against potentially harmful food additives.
What Happens Next for Manufacturers?
Companies using Red Dye 3 must comply with the ban by reformulating their products. The FDA has set a phased timeline: food manufacturers have until January 2027, while pharmaceutical companies must comply by January 2028. Imported foods must also meet these new standards to enter the U.S. market.
Some brands are already ahead of the curve. For example, Ferrara, the maker of Brach’s candies, began phasing it out in 2023, and PEEPS discontinued the dye in 2024. However, many manufacturers may shift to Red Dye No. 40, which hasn’t been as heavily scrutinized for health risks.
Health Concerns and Scientific Debate
The debate over Red Dye 3 highlights broader concerns about the safety of artificial food colourings. While the FDA maintains that the dye poses minimal risks at human consumption levels, critics argue the science isn’t conclusive. They also point out that the dye offers no nutritional value, questioning why it was allowed for so long.
In addition, some studies have raised questions about its impact on children’s health. Research from California’s Office of Environmental Health Hazard Assessment found links between synthetic food dyes and behavioural issues in children, including attention and focus problems. Parents are often advised to avoid artificial dyes altogether as a precaution.
How Consumers Can Avoid Red Dye 3
Checking product labels is key for those looking to avoid Red Dye No. 3 until the ban fully takes effect. The dye often appears as “FD&C Red #3” or “Red 3” on ingredient lists. It’s commonly found in ultra-processed foods like bright-coloured candies, gelatin, and sodas.
Another way to avoid artificial dyes is to choose whole, minimally processed foods. Fresh fruits, vegetables, and homemade meals are free from chemical additives. Parents and caregivers can consult online resources or advocacy groups that maintain updated lists of products containing Red Dye No. 3 if in doubt.
The Bigger Picture: Food Safety in the U.S.
The FDA’s ban on Red Dye No. 3 signals progress in addressing outdated regulations, but many feel it’s just the tip of the iceberg. Public health experts argue the U.S. food safety system needs a significant overhaul to prioritize consumer well-being over industry profit. The delay in banning Red Dye No. 3 is often cited as an example of the regulatory challenges of industry lobbying and limited resources.
California has already taken stronger steps, banning Red Dye No. 40 and other additives in public schools due to potential health risks. Advocates hope the FDA will follow suit by reviewing and restricting other synthetic food dyes with questionable safety profiles.
Red Dye 3 in Canada
According to the nation’s health agency, Canada has allowed red dye No. 3 as a food colouring for “many years. ”
An agency spokesperson told CTV News that according to Health Canada’s Food and Drug Regulations, the dye must fulfil food-grade standards.
The spokesperson said a legal provision “requires the FDA to ban food additives found to cause cancer in humans or animals.”
“The available scientific evidence does not support claims that the use of this color in food puts people’s health at risk, and studies in humans and other animals did not show these effects.”
Following a UN committee’s assessment of the dye as a food additive in 2018, Health Canada declared that FD&C Red No. 3 exposure through the diet “does not pose a health risk to the general Canadian population at the levels set out in the List of Permitted Food Colours.”
Even though the dye is legal in Canada, “Health Canada will take action to mitigate that risk, including, if necessary, no longer permitting it to be used as a coloring agent in food and drugs” if fresh scientific evidence indicates that the dye poses a risk to human health.
