Written by Olivia Farrow, RD, MHSc
Reviewed by Krista Kolodziejzyk, RD, MPH, MBA and Maria Dellanina, RDN
Summary Snapshot
The U.S. FDA is banning Red Dye No. 3 because of evidence that it caused cancer in rats at very high doses. The ban is required by law under the Delaney Clause, which mandates that any substance linked to cancer in animals be banned in food and drugs, regardless of human health risk. Typical human exposure to Red 3 is much lower than the doses that caused cancer in rats and the cancer-causing mechanism observed in rats does not occur in humans. Other food dyes, including the more commonly used Red Dye No. 40 (Allura Red) will still be allowed in foods.
What’s In the News
The FDA has announced a ban on the use of synthetic Red Dye No. 3 in foods and ingested drugs by 2027 due to its cancer-causing effects in male rats. This decision was driven by the Delaney Clause, which mandates bans on additives linked to cancer in animals or humans, regardless of relevance to human health. Manufacturers have until 2027 (for food) and 2028 (for drugs) to reformulate products.
Red Dye No. 3, also known as erythrosine, is primarily used in candies, baked goods, frozen desserts, and frostings but is less common than Red Dye No. 40, which many manufacturers already use as an alternative.
Countries like the EU, Australia, and New Zealand have restricted Red 3. Other countries, including Canada, continue to permit Red Dye No. 3 in food.
What the Evidence Says
Red 3 (erythrosine) has been linked to cancer in animal studies including male rats at high doses (2). The cancer-causing mechanism observed in rats does not occur in humans, and typical human exposure levels are much lower than the doses used in the studies (1). Typical human exposure levels are much lower than the doses used in studies.
Red 40 (Allura Red) is a different synthetic dye used widely in foods, often replacing Red 3 in some products. It, and other food dyes, have been associated with behavioral issues in children and potential gut inflammation and DNA damage in animal studies (3-16). Though, again, at doses much higher than typical human consumption and the research is not conclusive at this time. Read more about synthetic food dyes in this blog article.
Synthetic dyes are primarily found in ultra-processed foods, which themselves may be associated with chronic disease risks in some contexts, such as excessive consumption replacing other nutritive foods.
Why This Matters to Dietitians
Being informed about the Red Dye No. 3 ban helps dietitians provide accurate, evidence-based advice to clients who may have concerns about food additives.
As Red 3 is phased out, clients may encounter product reformulations or marketing shifts, including the use of natural dyes or other synthetic dyes. Some products may start using messaging around being “Red Dye No. 3-free,” though this doesn’t imply any nutritional benefit.
Our role is to focus on guiding clients to make choices that align with their nutritional needs and health concerns, always emphasizing whole foods where possible.
Questions Clients Might Ask
“Why is Red Dye No. 3 being banned in the U.S.?”
“The FDA is banning Red Dye No. 3 because of studies that showed it caused cancer in rats when they were exposed to very high amounts. However, the amount people eat is much lower than the levels used in those studies. This decision is based on a law that requires the FDA to ban anything linked to cancer in animals.”
“Is Red 3 worse than Red 40?”
“They are different types of dyes. Red 3 has been linked to cancer in rats, which led to its ban, while Red 40 has been studied for some negative effects, there isn’t any data proving that they have negative effects on humans. Red 40 still permitted for use because it has not shown to be cancer causing in animals due to the Delaney Clause.”
“Should I avoid foods with Red 40 now?”
“That’s up to you. Red 40 is still allowed in foods, but if you’re concerned, choosing natural alternatives or foods without dyes is possible. Is this something you would like to explore?”
“Why are dyes still allowed in some countries?”
“Regulations differ between countries based on their assessment of risk and available evidence. The U.S. uses the Delaney Clause, which bans additives linked to cancer in animals, while other countries may focus on human studies.”
Open-Ended Questions Dietitians Could Ask
To better understand a client’s concerns about food dyes, you might ask:
- “Are there specific foods or drinks you’re worried about for yourself or your family?”
- “How do you decide what’s most important when it comes to your food choices?”
- “What do you think might change in your eating habits if you avoided synthetic dyes?”
Key Takeaways
- Synthetic food dyes, such as Red 3 and Red 40, are commonly added to foods, especially those marketed to children, to enhance their appearance.
- Red 3 is being phased out in the U.S. due to links to cancer in rats, although typical human exposure is much lower than the levels shown to cause harm.
- Food dyes add no nutritional value, and clients can choose many nutritious options that don’t contain artificial colors. Support clients in focusing on minimally processed foods to reduce their intake of synthetic dyes, keeping in mind their unique health and dietary needs.
- It’s important to approach clients’ concerns about food dyes with respect and empathy, offering practical advice without fear-mongering or dismissing their concerns. Encouraging label-reading and helping clients make informed choices are key strategies.
Meet all of your professional development needs and access to 300+ client handouts with a Dietitian Success Center membership. Get started for free! Access your DSC starter kit and join a supportive community of dietitians today.
References
- U.S. Food and Drug Administration. FDA to revoke authorization for the use of Red No. 3 in food and ingested drugs. Constituent Update. January 15, 2025. Available from: https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs
- Borzelleca JF, Capen CC, Hallagan JB. Lifetime toxicity/carcinogenicity study of FD & C Red No. 3 (erythrosine) in rats. Food Chem Toxicol. 1987 Oct;25(10):723-33. doi: 10.1016/0278-6915(87)90226-2. PMID: 2824305.
- Boris, M, and F S Mandel. “Foods and additives are common causes of the attention deficit hyperactive disorder in children.” Annals of allergy vol. 72,5 (1994): 462-8.
- Bateman, B et al. “The effects of a double blind, placebo controlled, artificial food colourings and benzoate preservative challenge on hyperactivity in a general population sample of preschool children.” Archives of disease in childhood vol. 89,6 (2004): 506-11. doi:10.1136/adc.2003.031435
- McCann, Donna et al. “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) vol. 370,9598 (2007): 1560-7. doi:10.1016/S0140-6736(07)61306-3
- Connolly, A et al. “Pattern of intake of food additives associated with hyperactivity in Irish children and teenagers.” Food additives & contaminants. Part A, Chemistry, analysis, control, exposure & risk assessment vol. 27,4 (2010): 447-56. doi:10.1080/19440040903470718
- Martyn, Danika M et al. “Food additives and preschool children.” The Proceedings of the Nutrition Society vol. 72,1 (2013): 109-16. doi:10.1017/S0029665112002935.
- Nigg, Joel T et al. “Meta-analysis of attention-deficit/hyperactivity disorder or attention-deficit/hyperactivity disorder symptoms, restriction diet, and synthetic food color additives.” Journal of the American Academy of Child and Adolescent Psychiatry vol. 51,1 (2012): 86-97.e8. doi:10.1016/j.jaac.2011.10.015
- Schab, David W, and Nhi-Ha T Trinh. “Do artificial food colors promote hyperactivity in children with hyperactive syndromes? A meta-analysis of double-blind placebo-controlled trials.” Journal of developmental and behavioral pediatrics : JDBP vol. 25,6 (2004): 423-34. doi:10.1097/00004703-200412000-00007
- Miller, Mark D et al. “Potential impacts of synthetic food dyes on activity and attention in children: a review of the human and animal evidence.” Environmental health : a global access science source vol. 21,1 45. 29 Apr. 2022, doi:10.1186/s12940-022-00849-9
- Stenius, B S, and M Lemola. “Hypersensitivity to acetylsalicylic acid (ASA) and tartrazine in patients with asthma.” Clinical allergy vol. 6,2 (1976): 119-29. doi:10.1111/j.1365-2222.1976.tb01889.x
- Dipalma, J R. “Tartrazine sensitivity.” American family physician vol. 42,5 (1990): 1347-50.
- Neuman, I et al. “The danger of “yellow dyes” (tartrazine) to allergic subjects.” Clinical allergy vol. 8,1 (1978): 65-8. doi:10.1111/j.1365-2222.1978.tb00449.x
- Center for Science In the Public Interest. “Food Dyes: A Rainbow of Risks”. (2010). Available from https://www.cspinet.org/sites/default/files/attachment/food-dyes-rainbow-of-risks.pdf
- Owczarek, Danuta et al. “Diet and nutritional factors in inflammatory bowel diseases.” World journal of gastroenterology vol. 22,3 (2016): 895-905. doi:10.3748/wjg.v22.i3.895
- Kwon, Yun Han et al. “Chronic exposure to synthetic food colorant Allura Red AC promotes susceptibility to experimental colitis via intestinal serotonin in mice.” Nature communications vol. 13,1 7617. 20 Dec. 2022, doi:10.1038/s41467-022-35309-y
