FDA Bans Red Dye No. 3 Decades After Research Linked to Cancer

"Now that Red Dye No. 3 is finally banned, the FDA should expand a ban to other dyes in the industry that affect our long-term health and immediate behavior in the kids that are most attracted to them." -Jorge I., CEO, Holistic Nutrition, B.S. Biology.
After being found to cause cancer in rats more than 30 years ago, the FDA banned its use in cosmetics, but only recently extended the ban to food and ingested drugs on January 15th, 2025. This long-overdue decision was made after a 2022 petition requested the FDA apply the Delaney Clause towards Red Dye No. 3 [1].
The Delaney Clause, enacted in 1960, prohibits FDA authorization of food or color additives found to induce cancer in humans or animals. Since Red Dye No. 3 was evaluated to induce cancer in rats in a 1988 study, this ban should have logically been extended to food products in 1990, when its use in cosmetics was prohibited. This delayed action reflects a troubling inconsistency in the enforcement of regulations designed to protect public health. This is not the first time the Delaney Clause has been invoked to revoke FDA authorizations. In 2018, the FDA banned six synthetic flavoring substances, including synthetically derived benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, and pyridine [2].
Red Dye No. 3, a synthetic food dye, has been widely used to give foods and drinks a vibrant red hue. Despite its popularity, its health risks have made it a focal point of consumer advocacy for decades. While Red Dye No. 40 is often marketed as a “safer alternative,” it has not escaped scrutiny. Though Red Dye No. 40 has not yet been definitively linked to cancer, experts argue that its safety, along with other synthetic dyes, warrants further evaluation. Other dyes that demand reevaluation include Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3. These dyes have been implicated in various health issues, ranging from allergic reactions to behavioral changes in children, such as hyperactivity [3].
Mechanisms of Action & Toxicology of Synthetic Dyes
Red Dye No. 3 exerts its effects through various mechanisms that raise health concerns. The following studies found:
-
Thyroid Disruption: A 2024 study found that Red Dye No. 3 disrupts thyroid hormone regulation, by inhibiting the thyroid gland’s ability to absorb iodine and blocking an enzyme essential in thyroid hormone regulation [4, 5].
-
Oxidative Stress: Red Dye No. 3 was seen to increase oxidative stress that damages tissues and impairs communication between neurons, the cells of the nervous system [6].
-
Inflammation: In a 2024 study, Red Dye No. 3 triggered inflammation that could lead to neuronal damage and dysfunction [7].
Similarly, Yellow No. 5 (tartrazine) and Yellow No. 6 (sunset yellow) have been associated negatively with:
-
Allergic Reactions: A 2023 review highlighted that Yellow No. 5 induces hypersensitivity reactions in 2-7% of the general population. These reactions were noted to occur more in individuals with asthma or aspirin sensitivity [8].
-
Migraines: A 2024 study found that 18% of participants reported migraine onset within 12 hours of consuming products with Yellow 5 [9].
Blue No. 1 (brilliant blue) and Blue No. 2 (indigotine) have raised concerns towards:
-
Allergic Reactions: Similar to the other listed dyes, the immune system may recognize the dye as a foreign substance, which triggers the release of histamines and other inflammatory mediators [9].
-
Genotoxicity: Blue No. 1 has been linked to chromosomal damage, which can lead to genetic mutations and increase the risk of cancer [10].
-
Behavior Effects: Studies have shown Blue No. 1 affects neurotransmitters in the brain, which may correlate to hyperactivity and behavioral problems in children [10].
Although the relevance of these findings to human health remains unclear, they underscore the need for rigorous evaluation of long-term safety.
Behavioral and Developmental Impacts
One of the most controversial aspects of synthetic dyes is their impact on behavior, particularly in children. Research has linked artificial food colorings to hyperactivity and attention deficits in susceptible children. A 2007 study published in The Lancet found that a mixture of food colorings, including Yellow No. 5 and Red No. 40, exacerbated hyperactive behavior in children from the general population [11]. Although the mechanisms are not fully understood, some researchers suggest that synthetic dyes may alter dopamine signaling in the brain, which could influence attention and activity levels.
In response to these findings, the European Union requires warning labels on foods containing synthetic dyes, stating that they “may hurt activity and attention in children.” This measure has encouraged many manufacturers to switch to natural colorings in the European market, while similar reforms have lagged in the United States.
Natural Alternatives: A Safer Future
The push to eliminate synthetic dyes has spurred interest in natural alternatives, such as beet juice, spirulina, turmeric, and paprika extracts. These natural colorants are generally recognized as safe (GRAS) by the FDA and have not been linked to the adverse effects associated with synthetic dyes. For example, anthocyanins—natural pigments found in blueberries, blackberries, and purple carrots—not only provide vibrant colors but also offer antioxidant benefits. Similarly, curcumin, derived from turmeric, has anti-inflammatory properties and has been explored for its potential to prevent chronic diseases.
However, transitioning to natural dyes poses challenges for manufacturers, as these colorants can be less stable under heat and light, and may interact with other ingredients. Despite these hurdles, consumer demand for clean-label products has driven innovation in this area. For instance, microencapsulation technology is being developed to improve the stability and vibrancy of natural colorants, making them more viable for large-scale production.
The Path Forward
The FDA’s recent ban on Red Dye No. 3 is a critical step toward reducing public exposure to harmful chemicals, but it is only the beginning. Regulatory agencies must prioritize the reassessment of all synthetic dyes to ensure their safety. Public health organizations, researchers, and policymakers should collaborate to strengthen the scientific foundation for regulatory decisions, ensuring that outdated approvals are revisited in light of new evidence.
For consumers, awareness is key. Reading ingredient labels, choosing products free of artificial dyes, and supporting brands that use natural alternatives can collectively drive the industry toward safer practices. Ultimately, protecting public health requires a comprehensive approach that combines stringent regulation, scientific innovation, and informed consumer choices.
Manufacturers who use Red No. 3 in food products have until January 15, 2027, to stop using it and those who make drugs have until January 18, 2028, to reformulate their products.
Holistic Nutrition's Pledge to Saftey
Other companies may put their profits over your health but Holistic Nutrition prioritizes safety above all else. We ensure that we never compromise the well-being of our customers and employees with rigorous testing and manufacturing of our supplements and holistic solutions to minimize any potential harm.
References:
1. FDA. (2025). Revoking Authorization for the Use of Red No. 3 in Food/Ingested Drugs. U.S. Food and Drug Administration. https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs
2. FDA. (2018). FDA Removes 7 Synthetic Flavoring Substances from Food Additives List. U.S. Food and Drug Administration. https://www.fda.gov/food/hfp-constituent-updates/fda-removes-7-synthetic-flavoring-substances-food-additives-list
3. Amchova, P., Siska, F., & Ruda-Kucerova, J. (2024). Food Safety and Health Concerns of Synthetic Food Colors: An Update. Toxics, 12(7), 466. https://doi.org/10.3390/toxics12070466
4. Paramasivam, A., Murugan, R., Jeraud, M., Dakkumadugula, A., Periyasamy, R., & Arjunan, S. (2024). Additives in Processed Foods as a Potential Source of Endocrine-Disrupting Chemicals: A Review. Journal of Xenobiotics, 14(4), 1697-1710. https://doi.org/10.3390/jox14040090
5. Evanthia Diamanti-Kandarakis, Jean-Pierre Bourguignon, Linda C. Giudice, Russ Hauser, Gail S. Prins, Ana M. Soto, R. Thomas Zoeller, Andrea C. Gore, Endocrine-Disrupting Chemicals: An Endocrine Society Scientific Statement, Endocrine Reviews, Volume 30, Issue 4, 1 June 2009, Pages 293–342, https://doi.org/10.1210/er.2009-0002
6. Singh, M. and Chadha, P. (2024), Erythrosine-Induced Neurotoxicity: Evaluating Enzymatic Dysfunction, Oxidative Damage, DNA Damage, and Histopathological Alterations in Wistar Rats. J Appl Toxicol. https://doi.org/10.1002/jat.4731
7. Kesavan Damotharan, Damotharan, K., et al. (2024). Biochemical processes mediating neurotoxicity induced by synthetic food dyes: A review of current evidence. Chemosphere, 364, 143295. https://doi.org/10.1016/j.chemosphere.2024.143295
8. Bhatia M. S. (2000). Allergy to tartrazine in psychotropic drugs. The Journal of clinical psychiatry, 61(7), 473–476. https://doi.org/10.4088/jcp.v61n0703
9. Pozo-Rosich P. (2025). Headache research in 2024: new data on migraine prevention. The Lancet. Neurology, 24(1), 11–13. https://doi.org/10.1016/S1474-4422(24)00485-X
10. Potera C. (2010). The artificial food dye blues. Environmental health perspectives, 118(10), A428. https://doi.org/10.1289/ehp.118-a428
11. McCann, D., Barrett, A., Cooper, A., Crumpler, D., Dalen, L., Grimshaw, K., Kitchin, E., Lok, K., Porteous, L., Prince, E., Sonuga-Barke, E., Warner, J. O., & Stevenson, J. (2007). Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial. Lancet (London, England), 370(9598), 1560–1567. https://doi.org/10.1016/S0140-6736(07)61306-3