FDA bans the use of Red No.3 in Food because of links to cancer. What’s the actual risk?
On Wednesday, January 15th, the FDA banned the use of a synthetic red dye, Red Dye No. 3, typically added to food and drinks in the US. Prior to and following the ban, many claims online about the health risks of this synthetic dye, linking it to cancer and ADHD in children, have been made. Dr. Mark Hyman is among those who claim that Red No.3 and other synthetic dyes “wreak havoc on our bodies.” However, the evidence for the impacts on human health is not strong. Here, we break down what you need to know.
There is no scientific consensus suggesting that Red Dye No. 3 causes cancer in humans, and the FDA acknowledges that the mechanisms causing cancer in rats do not apply to humans. The ban enforces a law that some experts argue is outdated. However, discussions around the ban on social media have amplified its significance, in a way that lacks scientific nuance or context.
The ban on Red Dye No. 3 raises questions about the application of outdated regulations in light of modern scientific evidence. It also highlights the potential for public misunderstanding of health risks, as alarmist narratives on social media can amplify unsupported claims, shifting attention away from pressing dietary and public health concerns.
Look at the quality of the evidence available and whether studies were done on humans or only on certain animals. If they were only on animals, it’s unlikely we can say anything certain about the health impacts on humans.
Context
Why did the FDA decide to ban the use of Red No. 3 dye in food and drugs?
The ban is in response to a 2022 petition from several groups, including the Centre for Science in the Public Interest, calling for the enforcement of the Delaney Clause.
The Delaney Clause is a law that prohibits the use of any chemical that causes cancer in humans or animals in food, at any dose. This is important because a ban under this clause does not necessarily mean that there is definite evidence of harm in humans.
The Delaney Clause was enacted in 1958, but some researchers contest its utility in today’s context, calling it a ‘regulatory relic’ in its current form. According to cancer research scientist John H. Weisburger, the Delaney Clause was entirely justified in the context of the 1950s, as we knew a lot less about what causes cancer in humans and the mechanisms of carcinogenesis. In his paper, published over thirty years ago, he argued for an update of the Delaney Clause in light of the then-current scientific knowledge; for example, advances in analytical chemistry have allowed scientists to accurately determine trace amounts of chemicals, which wasn’t possible in the 1950s.
Although the Delaney Clause, introduced in 1958, was intended to protect public health, it no longer reflects modern scientific understanding. Banning additives like Red No. 3 under this law misrepresents current science, fuels unnecessary fear, and diverts attention and resources away from more pressing public health issues, such as ensuring food equity. While consumer safety is crucial, relying on an outdated law that treats animal and human risks as equal is fundamentally flawed. It also undermines scientific consensus and contributes to the erosion of public trust in evidence-based nutrition guidance.
There is no evidence that red food dye causes cancer in humans
The FDA ban is based on evidence linking Red Dye No. 3 to cancer in male lab rats. However, online claims are now linking Red Dye No. 3 to cancer in animals and humans, which goes beyond the available evidence.
For example, the Environment Working Group (EWG), one of the groups lobbying for the ban, described Red Dye No. 3 as a “Chemical linked to cancer, memory problems in children,” while the Center for Science in the Public Interest (SCPI) said, “Red 3 has been banned from use in topical drugs and cosmetics since 1990, when the FDA itself determined that the dye causes cancer when eaten by animals.” These articles, and other online claims, fail to mention any evidence or context for human health. By not mentioning the dose or the fact that the link is based on one study, claims appear exaggerated.
The study, conducted in the 1980s, found that male rats who consumed high levels of Red Dye No. 3 developed thyroid tumours. Two key points mean we can’t use the data to know that it causes cancer in humans: the dose and the fact that humans are not rats.
As Dr Andrea Love explains in her post addressing this issue, cancer occurred when rats ate 4% of their body weight in Red Dye No.3. “That is equal to a person weighing 150 lbs eating 102 grams of red 3 every day for months,” said Dr Andrea Love. “The average person MIGHT eat 0.2 milligrams per day. That’s 7,500 TIMES LESS than what those rats were fed.”
The FDA “noted that studies had not found a link to cancer in other types of animals.” They also stated that the claims that humans are at risk because red dye is used in foods “are not supported by the available scientific information.” Jim Jones, the FDA’s deputy commissioner for human foods, also said in a statement, “Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans."
There’s no strong evidence that Red No. 3 increases cancer risk in humans. The decision to remove it from foods and drugs in the U.S. was primarily based on studies involving male rats that developed thyroid tumors after being exposed to extremely high doses of Red No. 3. These tumors were linked to a rat-specific hormonal mechanism that doesn’t occur in humans.
The evidence linking food dye to ADHD is weak
While the FDA ban on Red Dye No. 3 is solely linked to the study on cancer, claims have also been made about potential links between red dye and increased symptoms of behavioural conditions, such as ADHD, in children.
For example, the EWG claims “memory problems in children” and a Fox News article states “It has also been linked to behavioral issues in children, including ADHD,” but neither provides any further context or nuance about these findings.
Danielle Shine, registered dietician and PhD candidate researching nutrition misinformation on social media, says that “unfortunately, there’s a lot of misinformation about artificial food dyes causing hyperactivity or ADHD in children.” She adds that “currently, there’s no strong scientific evidence to support these claims. While some studies suggest a potential link between synthetic food dyes and hyperactivity in a small subset of more susceptible children, findings have been inconsistent, and the overall evidence remains inconclusive. Overall, while a small group of children may be more sensitive to synthetic dyes, the broader evidence does not support a causal link between food dyes and ADHD or hyperactivity.”
Over the last few decades, several studies have examined the associations between food dye consumption and increased symptoms of behavioural conditions, such as ADHD, in children.
In 2012, results from a meta-analysis suggested a small association between food colour additives and exacerbated ADHD symptoms. However, the result “was not reliable in studies confined to Food and Drug Administration-approved food colors.” Additionally, the authors noted that the results were derived from small sample sizes, and not generalisable to a wider population.
A later meta-analysis, released in 2021 by the California Office of Environmental Health Hazard Assessment (OEHHA), combined all relevant studies and conducted its own research to examine the association between food dyes and adverse neurobehavioral outcomes. They found an association between food dye consumption and adverse neurobehavioral outcomes in children, including ADHD.
However, the studies included in these meta-analyses, which are the basis for many of the claims made online, have major limitations. Many of the studies were conducted 30-40 years ago, with very small sample sizes, and cannot isolate one dye such as Red Dye No. 3 from other dyes and preservatives. However, on the basis of these and other meta-analyses, researchers are calling for more work to be done in this area.
Despite the suggested associations, there is still no evidence showing that food dyes such as Red Dye No. 3 are directly causing exacerbated symptoms of behavioural conditions such as ADHD.
Broader Implications
While advice to avoid synthetic dyes might seem harmless or prudent, the FDA’s recent ban on Red No. 3 has broader implications that extend beyond the dye's use.
Because of the quantities humans would have to consume for adverse health outcomes, the ban is unlikely to protect human health. However, it could negatively impact the perception and dissemination of evidence-based health information online.
Balanced nutrition and health advice doesn’t always suit social media algorithms, which tend to amplify the loudest voices. Unsubstantiated claims about the dangers of consuming products containing synthetic dyes have been circulating on social media for years. Health influencers like Mark Hyman are applauding the recent ban, which could give more validity to other widely shared and alarming claims about varying food products. The timing of the ban is being credited to Robert F. Kennedy Jr. 's influence, which could also fuel support in some other inaccurate health claims he’s made, which include topics such as vaccine safety, Covid, or fluoride in drinking water.
While most people would agree that the food industry needs to be reformed in order to prioritise people’s health, the sharing of alarming, unsubstantiated claims about synthetic dyes does not achieve this goal.
Repeated exposure to alarming claims, regardless of their scientific validity, can distort public understanding of actual health risks. What is at stake here is risk perceptions, which are influenced by how often a threat gets repeated through media exposure.
This dynamic not only erodes trust in the scientific process but also empowers health influencers who thrive on misinformation, drowning out the voice of experts and shifting focus from real dietary concerns to sensationalised ones.
As a result, people might overly fixate on avoiding ingredients which do not pose a proven risk, losing sight of the big picture of addressing broader dietary patterns. In other words, the popularity of toxic food thinking on social media platforms gets people to focus on the wrong issues. In reaction to the FDA’s announcement of its recent ban, Dr. Andrea Love states that “anti-science rhetoric based on chemophobia is a distraction from REAL food-related issues that impact health,” among which we find “food deserts, low fiber consumption by 90% of Americans, lack of affordable healthcare, overall dietary composition, reducing cost of fresh and frozen produce, encouraging conventional and modern farming methods-that ARE safe and nutritious, overall lifestyle & exercise habits.”
In extreme cases, this misinformation can escalate, as seen with individuals forgoing proven medical treatments illustrating the potential for real harm when misplaced health narratives dominate the conversation.
We have contacted Dr Mark Hyman and are awaiting a response.
For children with hyperactivity or ADHD, reducing foods containing artificial dyes may be worth exploring. However, it’s important to understand that hyperactivity stems from multiple factors, including genetics and environmental influences. Artificial food dyes are likely just one small piece of the puzzle and eliminating them may not always lead to noticeable changes in behavior. The most important focus should be on improving overall diet quality.
Parents are encouraged to follow evidence-based guidelines for a balanced, nutrient-dense diet that includes a variety of whole foods from all major food groups. This approach naturally reduces the intake of artificial dyes and also limits other ingredients like added sugars, saturated fats, and excess salt, all of which support overall health and wellbeing.
Sources
U.S. Food & Drug Administration (2025). “FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs.” https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs
Krishan, M. et al. (2021). ”A regulatory relic: After 60 years of research on cancer risk, the Delaney Clause continues to keep us in the past.” https://pubmed.ncbi.nlm.nih.gov/34737146/
Weisburger, J.H. (1994). “Does the Delaney Clause of the U.S. Food and Drug Laws Prevent Human Cancers?” https://academic.oup.com/toxsci/article-abstract/22/4/483/1667913
Hiasa, Y. et al. (1988). “The Promoting Effects of Food Dyes, Erythrosine (Red 3) and Rose Bengal B (Red 105), on Thyroid Tumors in Partially Thyroidectomized N‐Bis(2‐hydroxypropyl)‐ nitrosamine‐treated Rats.” https://pmc.ncbi.nlm.nih.gov/articles/PMC5917475/
Dr. Andrea Love’s Instagram Post: https://www.instagram.com/p/DE4qGOwpL58/?igsh=cjZlcnM5enU5NGhz&img_index=1
Nigg, J.T. et al. (2012). “Meta-analysis of attention-deficit/hyperactivity disorder or attention-deficit/hyperactivity disorder symptoms, restriction diet, and synthetic food color additives.” https://pubmed.ncbi.nlm.nih.gov/22176942/
OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT (2021). “Potential Neurobehavioral Effects of Synthetic Food Dyes in Children.” https://oehha.ca.gov/media/downloads/risk-assessment/report/healthefftsassess041621.pdf
BBC Verify Team (2024). “Fact-checking RFK Jr's views on health policy.” https://www.bbc.co.uk/news/articles/c0mzk2y41zvo
Ferrer, R. & Klein, W.M. (2015). “Risk perceptions and health behavior.” https://pmc.ncbi.nlm.nih.gov/articles/PMC4525709
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