In a landmark move, the US Food and Drug Administration (FDA) has banned the use of Red Dye No. 3 in food, beverages, and ingested medications. The synthetic colourant, also known as erythrosine, has been linked to cancer in animal studies, a connection that has prompted concern from public health advocates for over 30 years. The FDA’s decision follows increasing pressure from health organisations and a petition filed in November 2022 by multiple groups, including the Centre for Science in the Public Interest and the Environmental Working Group.
Advocacy groups, such as the Centre for Science in the Public Interest, have long called for a ban on Red Dye No. 3 in food products, citing the potential health risks. Their efforts, coupled with recent developments in California, where the dye was banned in 2023, have finally led to the FDA’s decision.
Ken Cook, cofounder and president of the Environmental Working Group, also praised the decision, describing it as a “monumental victory” for public 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.
Dr. Jennifer Pomeranz, associate professor of public health policy and management at New York University’s School of Global Public Health, explained the situation: “It doesn’t matter, because the FDA mandate under the Delaney Clause says that if it shows cancer in animals or humans, they’re supposed to keep it from the food supply.” This has led to criticism of the FDA for not acting sooner to protect consumers from a known health risk.
However, while Red Dye No. 40 remains in use, the new ban on Red Dye No. 3 is seen as a victory for public health advocates who have long called for stricter regulation of food additives.
While the FDA’s action is a step forward, experts argue that more needs to be done to ensure consumer safety. Dr. Galligan noted that the decision addresses the “regulatory paradox” of Red Dye No. 3 but that the FDA still has a long way to go in reforming the system that allowed such potentially harmful ingredients to remain in the food supply for decades.
Dr. Mande, from Harvard University, also expressed concerns over the broader food safety system in the US. “Americans are sick because of our food,” Mande said. “This is because food companies have lost sight of their primary mission, providing food we will thrive on, and focusing entirely on their profits instead.”
For medications, it is advised to check the “inactive ingredients” section of the label or search for dye-free versions of some drugs. As always, consult with a healthcare provider before making changes to medication.
The FDA's decision to ban Red Dye No. 3 marks a significant shift in the regulation of food and drug additives in the US. This long-awaited action is expected to improve public health by reducing exposure to a substance linked to cancer in animals. However, experts emphasise that further reforms are needed to address the broader issue of food safety and protect consumers from potentially harmful ingredients.
Budget with ET
Before budget, a few positives blink on Sitharaman's dashboard
Will Sitharaman make roti, kapada, makaan affordable again?
Rail Budget may see up to 20% hike, focus on station upgrades & modern trains
What is the Campaign Against Red Dye No. 3
The controversy surrounding Red Dye No. 3 began more than three decades ago when studies found links between the dye and cancer in laboratory animals. Despite these findings, the dye continued to be used in food products and medications, as there was no direct evidence linking it to cancer in humans. The FDA initially banned the additive in cosmetics and topical drugs in 1990 after animal studies showed high doses caused cancer in rats. However, it remained permitted for use in food, leading to a regulatory paradox.Advocacy groups, such as the Centre for Science in the Public Interest, have long called for a ban on Red Dye No. 3 in food products, citing the potential health risks. Their efforts, coupled with recent developments in California, where the dye was banned in 2023, have finally led to the FDA’s decision.
A Step Forward for Public Health
Experts have welcomed the FDA's action, calling it a significant step forward for consumer health. Dr. Jerold Mande, adjunct professor of nutrition at the Harvard University T.H. Chan School of Public Health, expressed support for the ban, 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 and president of the Environmental Working Group, also praised the decision, describing it as a “monumental victory” for public 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.
What impact will it have on manufacturers
Manufacturers who currently use Red Dye No. 3 in their food and drug products must reformulate their offerings by January 15, 2027, for food and by January 18, 2028, for ingested medications. Imported products will also be required to comply with the new regulations. Some major companies, such as Ferrara, the candy maker behind Brach's, have already begun phasing out the dye. According to a Ferrara spokesperson, fewer than 10% of their products still contain Red Dye No. 3, with the company starting to remove it in early 2023. Just Born, the maker of PEEPS, also plans to stop using the dye after Easter 2024.The Regulatory Paradox
The FDA's decision to ban Red Dye No. 3 highlights a longstanding issue in food safety regulations. The Delaney Clause of the FDA’s Federal Food, Drug, and Cosmetic Act prohibits the approval of food additives that cause cancer in animals or humans. Despite evidence showing that Red Dye No. 3 was carcinogenic in animals, the FDA had allowed its continued use in food, citing the lack of direct evidence linking it to cancer in humans.Dr. Jennifer Pomeranz, associate professor of public health policy and management at New York University’s School of Global Public Health, explained the situation: “It doesn’t matter, because the FDA mandate under the Delaney Clause says that if it shows cancer in animals or humans, they’re supposed to keep it from the food supply.” This has led to criticism of the FDA for not acting sooner to protect consumers from a known health risk.
Alternatives to Red Dye No. 3
In response to the ban, many companies have already switched to alternative dyes. Red Dye No. 40, a more widely used food colouring, has become a popular substitute, although it too has been the subject of some health concerns. California, for example, has banned Red Dye No. 40 in foods and drinks sold in public schools due to potential links to behavioural and attention issues in children. One study found that Red Dye No. 40 may contribute to tumour growth in mice and contains benzene, a known carcinogen.However, while Red Dye No. 40 remains in use, the new ban on Red Dye No. 3 is seen as a victory for public health advocates who have long called for stricter regulation of food additives.
A Global Comparison
The FDA’s decision aligns the US more closely with Europe, where Red Dye No. 3 has been banned in food since 1994, with the exception of maraschino cherries. The European approach reflects a precautionary stance, where food additives are banned if there is any potential health risk. Dr. Thomas Galligan, principal scientist for food additives and supplements at the Centre for Science in the Public Interest, remarked, “The ban also moves the food landscape slightly closer to that of the European Union.”While the FDA’s action is a step forward, experts argue that more needs to be done to ensure consumer safety. Dr. Galligan noted that the decision addresses the “regulatory paradox” of Red Dye No. 3 but that the FDA still has a long way to go in reforming the system that allowed such potentially harmful ingredients to remain in the food supply for decades.
Dr. Mande, from Harvard University, also expressed concerns over the broader food safety system in the US. “Americans are sick because of our food,” Mande said. “This is because food companies have lost sight of their primary mission, providing food we will thrive on, and focusing entirely on their profits instead.”
Consumer Guidance and Future Considerations
Consumers concerned about Red Dye No. 3 should carefully read food labels, as the dye is listed as “red 3,” “FD&C Red #3,” or “erythrosine.” The FDA requires manufacturers to disclose its presence in food products. Additionally, avoiding ultraprocessed foods can help reduce exposure to artificial food dyes. The Centre for Science in the Public Interest recommends that parents avoid all numbered dyes, including Yellow No. 5 and Red No. 40, as they may pose health risks to children.For medications, it is advised to check the “inactive ingredients” section of the label or search for dye-free versions of some drugs. As always, consult with a healthcare provider before making changes to medication.
The FDA's decision to ban Red Dye No. 3 marks a significant shift in the regulation of food and drug additives in the US. This long-awaited action is expected to improve public health by reducing exposure to a substance linked to cancer in animals. However, experts emphasise that further reforms are needed to address the broader issue of food safety and protect consumers from potentially harmful ingredients.
