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December 11, 2024

FDA Moves Toward Ban on Red Dye No. 3: What You Need to Know

Medically Reviewed by
Updated On
December 11, 2024

The U.S. Food and Drug Administration (FDA) is considering a ban on Red Dye No. 3 (erythrosine), a synthetic food coloring commonly used in the U.S. food supply. This potential action reflects increasing concerns over the dye’s possible health risks, consumer advocacy efforts, and growing regulatory attention at both state and federal levels.

If finalized, the ban could represent a significant moment in food safety regulation, with potential implications for manufacturers and consumer choices. 

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What Is Red Dye No. 3?

Red Dye No. 3 is a synthetic food coloring derived from petroleum and used to create bright, cherry-red hues in various products. While other food dyes, like Red 40, are more prevalent, Red Dye No. 3 is often found in:

  • Candies: Examples include certain seasonal treats and confections.
  • Baked Goods: Frostings, fillings, and packaged pastries.
  • Snack Foods: Some cereals, gummies, and fruit-flavored snacks.
  • Medications: Select syrups, tablets, and lozenges.

Its vibrant color and cost-effectiveness have made it popular among food manufacturers for decades. However, these characteristics, along with the availability of alternative dyes, have placed it under increased scrutiny.

The History of Red Dye No. 3 and Regulation

The discussion around Red Dye No. 3 is not new. In 1990, the FDA restricted its use in cosmetics and topical medications due to studies suggesting a possible link to thyroid tumors in lab animals. However, it has remained approved for food and certain medications.

Key Concerns:

  • Animal Studies: Research from the 1980s suggested a potential association between high doses of Red Dye No. 3 and thyroid tumors in lab rats. Although these findings do not directly translate to humans, public health advocates argue for a cautious approach.
  • Behavioral Impacts: Some research, including a meta-analysis from the Journal of the American Academy of Child and Adolescent Psychiatry, has explored correlations between synthetic food dyes, including Red Dye No. 3, and behavioral challenges in sensitive populations, such as children. While not conclusive, these studies highlight areas warranting further investigation.

Why Ban Red Dye No. 3 Now?

Several factors are driving the FDA’s renewed focus on Red Dye No. 3:

  • State-Level Action: California’s 2023 California Food Safety Act banned Red Dye No. 3 and other additives starting in 2027. As a major market, California’s decisions often influence nationwide practices.
  • Global Context: Red Dye No. 3 is already prohibited in countries like Norway and across much of the European Union, where stricter precautionary measures guide food safety policies.
  • Consumer Advocacy: Groups like the Center for Science in the Public Interest (CSPI) have long urged action on synthetic food dyes, citing potential risks and public demand for natural ingredients.

Potential Health Risks Associated with Red Dye No. 3

The following concerns may be associated with Red Dye No. 3:

Cancer Concerns

One concern about Red Dye No. 3 is its potential association with carcinogenic effects. In studies, high doses of the dye were linked to thyroid tumors in male rats, prompting questions about its safety in the food supply.

Although the doses tested were significantly higher than typical human exposure, opinions among scientists vary on whether any level of risk is acceptable in food additives.

Neurodevelopmental Risks

Some research has explored the potential impact of synthetic food dyes, including Red Dye No. 3, on children’s behavior and cognitive function. A 2007 study published in The Lancet found a correlation between certain artificial dyes and hyperactivity in children.

While the findings remain contested, they prompted the European Union to require warning labels on foods containing synthetic dyes, signaling a more cautious approach.

Allergic Reactions

In rare cases, individuals may report sensitivities to Red Dye No. 3, such as skin irritation, headaches, or respiratory symptoms. Although these reactions are less common, they highlight the importance of awareness for sensitive populations.

What an FDA Ban Would Mean for the Food Industry

If the FDA bans Red Dye No. 3, food manufacturers may need to reformulate numerous products. This could involve:

  1. Using Natural Alternatives: Options like beet juice or paprika extract are potential substitutes, though they can be more expensive and may affect taste or shelf life.
  2. Higher Production Costs: Reformulating recipes, updating packaging, and ensuring supply chain adjustments could increase operational expenses.
  3. Regulatory Challenges: Manufacturers might face penalties or legal action if they do not meet updated compliance standards within the required timelines.

How Can Consumers Protect Themselves?

While regulatory decisions are still pending, consumers can take steps to reduce their exposure to synthetic dyes:

  1. Check Labels: Look for products that mention "no artificial colors" or include plant-based alternatives.
  2. Choose Clean-Label Brands: Opt for brands that emphasize transparency and minimal processing.
  3. Support Advocacy: Participate in campaigns and petitions that encourage manufacturers and regulators to prioritize food safety.

Parents may find that reducing children’s intake of artificially colored snacks, candies, and beverages can contribute to a more balanced and healthier diet.

A Shift Toward Transparency in Food Additives

The discussion about Red Dye No. 3 reflects a broader shift toward greater transparency and safety in food production. Increasing consumer demand for minimally processed, cleaner foods is encouraging companies to rethink ingredient sourcing and labeling.

If the FDA enacts a ban, it would underscore the importance of prioritizing public health and safety, signaling a step toward more rigorous food safety standards.

Conclusion: A Step Forward in Food Safety?

The FDA’s potential reconsideration of Red Dye No. 3 highlights the value of reevaluating food additives in light of emerging scientific evidence. While synthetic dyes may not disappear entirely, this move could reflect a shift toward greater regulatory oversight and consumer protection.
As public awareness increases, the push for safer, cleaner food options may continue to influence the food industry for years to come.

The information in this article is designed for educational purposes only and is not intended to be a substitute for informed medical advice or care. This information should not be used to diagnose or treat any health problems or illnesses without consulting a doctor. Consult with a health care practitioner before relying on any information in this article or on this website.

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  • Bailey, M. M. (2024, April 15). Synthetic food dyes: A rainbow of risks. Center for Science in the Public Interest. https://www.cspinet.org/cspi-news/synthetic-food-dyes-rainbow-risks
  • California Legislative Information. (2023, October 9). Bill text - AB-418 the California food safety act. Leginfo.legislature.ca.gov. https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=202320240AB418
  • Center for science in the public interest. (n.d.). Center for Science in the Public Interest. https://www.cspinet.org/
  • European Food Safety Authority. (2009). Food colours. European Food Safety Authority. https://www.efsa.europa.eu/en/topics/topic/food-colours
  • FDA. (2024). US food and drug administration. Fda.gov. https://www.fda.gov/
  • Hiasa, Y., Ohshima, M., Kitahori, Y., Konishi, N., Shimoyama, T., Sakaguchi, Y., Hashimoto, H., Minami, S., & Kato, Y. (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. Japanese Journal of Cancer Research, 79(3), 314–319. https://doi.org/10.1111/j.1349-7006.1988.tb01593.x
  • 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. The Lancet, 370(9598), 1560–1567. https://doi.org/10.1016/s0140-6736(07)61306-3
  • Nigg, J. T., Lewis, K., Edinger, T., & Falk, M. (2012). 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 & Adolescent Psychiatry, 51(1), 86-97.e8. https://doi.org/10.1016/j.jaac.2011.10.015
  • Nutrition, C. for F. S. and A. (2023). FD&C Red No. 3. FDA. https://www.fda.gov/industry/color-additives/fdc-red-no-3
  • PubChem. (2024). FD+C red no. 3. Nih.gov; PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/FD%26C%20Red%20No.%203
  • Weisbrod, D. B., Caruana, D. L., Li, D., Wan, L., & Szema, A. M. (2023). A case report of allergic hypersensitivity to color additives in Slurpee® beverages. Yale Journal of Biology and Medicine, 96(1), 79–82. https://doi.org/10.59249/kgft1011
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