Introduction
As an oncology dietitian, my job is to sift through the noise and focus on the science. Recently, the FDA’s ban on Red Dye No. 3 has raised concerns about cancer risks. Understanding the reasoning behind the ban helps to determine if Red Dye No. 3 poses a significant health threat. This is particularly vital for cancer survivors who already navigate a complex world of health decisions.
The Science Behind Red Dye No. 3: The Rat Studies
The ban on Red Dye No. 3 was mostly based on studies done in rats. These showed an association between the dye and cancerous tumors. However, these studies were conducted with extremely high doses that do not represent real-world human consumption. The levels of Red Dye No. 3 used in these studies were hundreds of times higher than what humans typically consume in their diets.
Moreover, the cancer-causing mechanism observed in these rats involved hormonal changes that simply don’t occur in humans. The FDA has acknowledged that the rat-specific hormonal mechanism is not relevant to human biology, making these studies of limited value when considering the potential effects on humans.
Why You Don’t Need to Worry About Red Dye No. 3
Despite the rat studies, multiple scientific agencies, including the FDA, the World Health Organization (WHO), and other global regulators, have concluded that Red Dye No. 3 poses a minimal risk to human health. When used in food, the exposure levels are far too low to trigger any concerns. In fact, human consumption of Red Dye No. 3 is typically so low that it’s hundreds of times lower than the levels linked to adverse effects in animal studies.
As cancer survivors, it’s important to recognize that the real risk factors for cancer are far more complex than food additives. Dietary habits, exercise, and lifestyle choices are much more significant in terms of your health and cancer prevention.
What About Red Dye and the Effect on Children’s Attention
You may have heard that Red Dye No. 3 (or all dyes) cause attention problems in kids. A few studies suggest that certain kids, especially those with ADHD, might react to food dyes by becoming more hyperactive, but this doesn’t happen to all kids. It’s also hard to blame just Red Dye No. 3. Most studies look at all food dyes together, not just this one, so we don’t know if it causes problems by itself.
If you notice your child acting differently after eating foods with dyes, you can try cutting them out to see if it helps. But for most people, eating a little Red Dye No. 3 now and then isn’t harmful. We also must consider that oftentimes, foods with dye are high in sugar and calories but low in beneficial nutrients, so a parent may not want their child to consume excess amounts of these foods anyway.
The Role of Public Perception in Food Safety
While the FDA’s decision may seem alarming, it’s also influenced by public concern about food additives, even when the scientific evidence does not support a direct link to human health risks. In this case, the Delaney Clause has forced the FDA to act on animal data, even though the evidence for cancer or other health risk in humans is not compelling.
We must understand that public sentiment often influences food safety regulations. This means that public pressure can sometimes lead to restrictions on substances that have minimal risk. The decision to ban Red Dye No. 3 is an example of this dynamic, and while it might make headlines, it’s based more on legal requirements than on evidence of harm to humans.
Read Part 1 about Red Dye No. 3 and Cancer Risk HERE
Citations:
- Borzelleca JF, Capen CC, Hallagan JB. Lifetime toxicity/carcinogenicity study of FD & C Red No. 3 (erythrosine) in rats. Food Chem Toxicol. 1987;25(10):723-733. doi:10.1016/0278-6915(87)90226-2
- Stevens LJ, Kuczek T, Burgess JR, Stochelski MA, Arnold LE, Galland L. Mechanisms of behavioral, atopic, and other reactions to artificial food colors in children. Nutr Rev. 2013;71(5):268-281. doi:10.1111/nure.12023
- U.S. Food and Drug Administration (FDA). (2025). FDA revokes authorization of Red No. 3 in food and ingested drugs. Retrieved from FDA.gov
- Nigg JT, Lewis K, Edinger T, Falkowski V. Meta-analysis of attention-deficit/hyperactivity disorder or attention-deficit/hyperactivity disorder symptoms, restriction diet, and synthetic food color additives. J Am Acad Child Adolesc Psychiatry. 2012;51(1):86-97. doi:10.1016/j.jaac.2011.10.015
This blog is not intended as medical nutrition therapy, medical advice, or diagnosis and should in no way replace consultation or recommendation from your medical professional.
