WASHINGTON, USA — After decades of debate and advocacy, the US Food and Drug Administration (FDA) has banned the use of red dye No. 3 in food, beverages, and ingested drugs.
The synthetic additive, linked to cancer in animal studies over 30 years ago, will be phased out of use by January 15, 2027, for foods and January 18, 2028, for drugs, the agency announced Wednesday.
Red dye No. 3, chemically known as erythrosine, has been used to give products a bright cherry-red colour.
Despite mounting concerns, the dye remained permissible in foods for decades, creating what experts called a “regulatory paradox.”
Decades of Delays
The Delaney Clause of the FDA’s Federal Food, Drug, and Cosmetic Act prohibits the approval of colour additives shown to cause cancer in humans or animals.
While the FDA banned red dye No. 3 in cosmetics and topical drugs in 1990 after animal studies revealed carcinogenic effects, it allowed the dye to persist in food products.
“Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats,” the FDA explained in its update.
However, legal requirements under the Delaney Clause ultimately necessitated the ban.
“This decision ends the regulatory paradox of Red 3,” said Dr. Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest.
“But the FDA still has a long way to go to reform the broken system that allowed Red 3 to remain in foods for decades.”
A Victory for Advocacy
The ban follows a November 2022 petition spearheaded by advocacy organisations like the Center for Science in the Public Interest and the Environmental Working Group, as well as growing legislative momentum.
California led the charge, banning red dye No. 3 in October 2023.
Ken Cook, co-founder and president of the Environmental Working Group, called the FDA’s decision a “monumental victory” for public health.
“This historic decision wouldn’t have been possible without the relentless leadership of public health champions like Michael Jacobson and others who fought for consumers decades ago,” Cook said.
Industry Adaptations
Many companies have already begun phasing out red dye No. 3.
Ferrara, the maker of Brach’s candies, reported that fewer than 10% of its products still contain the additive.
Just Born, the company behind PEEPS, stopped using the dye entirely after Easter 2024.
Some manufacturers have replaced red dye No. 3 with alternatives like red dye No. 40, which is not as closely associated with cancer risks but has been linked to behavioural issues in children.
California banned red dye No. 40 in public schools in September 2024, citing concerns about attention and behavioural difficulties.
Broader Implications
The FDA’s decision aligns the United States more closely with the European Union, which banned red dye No. 3 in 1994, except in certain maraschino cherry products. Critics, however, argue the ban is long overdue.
“There is no rational reason the FDA didn’t ban red dye No. 3 in the 1990s,” said Dr. Jennifer Pomeranz, associate professor at NYU’s School of Global Public Health.
“This highlights how long it can take to remove harmful ingredients due to industry influence and regulatory inertia.”
Pomeranz also noted that artificial food colourings are predominantly found in ultra-processed foods and beverages, urging consumers to avoid these products as a precaution.
Public Health Concerns
Studies over the years have reinforced concerns about red dye No. 3 and similar additives.
A 2012 report found links between the dye and cancer in animals, while a 2021 California study identified behavioural issues in children exposed to artificial colourings.
“Our food industry has lost sight of its mission to provide nourishing products and prioritised profits instead,” said Dr. Jerold Mande, adjunct professor of nutrition at Harvard University.
Mande criticised the lack of federal funding for research on food safety, attributing it to lobbying by the food industry.
Practical Tips for Consumers
Consumers concerned about red dye No. 3 can check ingredient labels, where the dye may appear as “red 3” or “FD&C Red #3.”
For medications, it is advisable to consult a doctor before switching to dye-free alternatives.
The FDA’s ban marks a significant step in addressing food safety, but advocates stress that it is only the beginning of needed reforms.
As Galligan noted, “This decision is a win, but the fight for a healthier food system is far from over.”
