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Nutrition Diet: Is Erythrosine Color Safe for Consumption?

5 min read

In January 2025, the U.S. Food and Drug Administration (FDA) finalized a ban on the food colorant erythrosine, also known as Red Dye No. 3, for use in food and ingested drugs. This landmark decision followed decades of debate over the safety of this common artificial ingredient, raising critical questions for consumers who prioritize a clean and healthy nutrition diet.

Quick Summary

An in-depth look at erythrosine (Red Dye No. 3), covering health concerns, regulatory actions, and the shift towards safer, natural alternatives. The article explains the reasons behind the recent FDA ban, its impact on the food industry, and how informed consumers can identify and choose healthier options for a modern nutrition diet.

Key Points

  • FDA Ban: In January 2025, the U.S. FDA banned erythrosine (Red Dye No. 3) in food and ingested drugs, effective 2027 and 2028, respectively.

  • Animal Carcinogen: High-dose animal studies linked erythrosine to thyroid tumors in male rats, leading to the ban under the U.S. Delaney Clause.

  • Thyroid Disruption: The dye disrupts thyroid hormone regulation, leading to increased TSH and potential thyroid issues, a mechanism observed in both animals and humans at varying levels.

  • Potential Hyperactivity: Erythrosine is among the synthetic food dyes linked to hyperactivity and other neurobehavioral issues in some children.

  • Global Regulation: Erythrosine's use has long been heavily restricted in the EU and other countries, often requiring warning labels.

  • Natural Alternatives: Safer natural alternatives like beetroot extract, anthocyanins, and carmine are widely available for coloring foods.

  • Poor Human Absorption: Erythrosine is poorly absorbed by the human body and largely excreted unchanged, but cumulative and high-level exposure remains a concern.

In This Article

What is Erythrosine (Red Dye No. 3)?

Erythrosine, often labeled as FD&C Red No. 3 in the U.S. or E127 in Europe, is a synthetic, petroleum-derived red-pink color additive used to enhance the visual appeal of food and drug products. It has been a mainstay in the food industry for over a century, providing a bright, cherry-red hue to a vast range of items, including candies, pastries, fruit cocktails, and even some medications. Chemically, it is a derivative of fluorescein that contains iodine, which accounts for some of the health concerns linked to its consumption.

The Health Concerns Linked to Erythrosine

Despite its widespread use, erythrosine has been a subject of controversy and scientific scrutiny for decades due to several potential health risks identified in various studies. While conclusive evidence of harm in humans is debated, regulatory bodies have acted on the precautionary principle, particularly regarding potential links to cancer and behavioral issues.

Thyroid Tumors in Animal Studies

One of the most significant concerns surrounding erythrosine stems from animal studies conducted in the 1980s. These studies showed that high doses of the dye caused thyroid tumors in male rats. The mechanism for this appears to be non-genotoxic and hormoned-mediated. In male rats, erythrosine can inhibit an enzyme responsible for converting thyroid hormones (T4 to T3), leading to decreased active thyroid hormone levels. This triggers a compensatory, long-term overproduction of thyroid-stimulating hormone (TSH), which, in turn, can cause the thyroid gland to become enlarged and develop tumors over time. Due to notable physiological differences, particularly concerning thyroid function, between male rats and humans, the relevance of these specific tumor findings to human cancer risk has been a point of contention for years, though the FDA ultimately acted on the animal data as required by law.

Potential for Hyperactivity in Children

Erythrosine, along with other synthetic food colorings, has been implicated in causing neurobehavioral effects in children, including hyperactivity and other behavioral problems. A 2007 study published in The Lancet highlighted this link, suggesting that some children may be particularly sensitive to these additives. Organizations like the California Office of Environmental Health Hazard Assessment (OEHHA) have also supported these findings, emphasizing that while effects may not be universal, they pose a potential risk to children's well-being.

Regulatory Landscape and the 2025 FDA Ban

The regulatory status of erythrosine has varied significantly across the globe, reflecting different approaches to risk assessment. In the U.S., the FDA banned erythrosine in cosmetics and externally applied drugs in 1990 but, for bureaucratic reasons, failed to extend the ban to food and ingested drugs for decades. This regulatory paradox was finally resolved in January 2025, when a court-ordered FDA ban took effect based on the 1958 Delaney Clause, which prohibits cancer-causing additives in food regardless of perceived risk level. The ban requires manufacturers to remove Red Dye No. 3 from food by January 2027 and from ingested drugs by January 2028.

In contrast, the European Union (EU) has long taken a more restrictive approach. Since 1994, the EU has severely limited erythrosine's use (E127) to only a few products, such as processed cherries, and requires warning labels on any items containing it to note potential effects on children's activity and attention. Other countries, such as Australia, Canada, and Japan, have also significantly restricted or banned its use.

How to Find Erythrosine in Food Products

Consumers can identify products containing this dye by checking the ingredient list. Look for any of the following names:

  • FD&C Red No. 3
  • Red Dye No. 3
  • E127
  • Erythrosine

Common products where it was previously used include:

  • Maraschino cherries
  • Some candies and frosting
  • Fruit cocktails
  • Snacks and cereals
  • Certain medications and vitamins

The Rise of Natural Alternatives

With the shift away from synthetic dyes, manufacturers and consumers are increasingly turning to natural colorants. These alternatives offer a safer and often cleaner-label option for achieving vibrant colors in food and beverages. Below is a comparison of erythrosine with some popular natural alternatives.

Feature Erythrosine (Red Dye No. 3) Natural Alternatives (Beetroot, Anthocyanins)
Source Petroleum-based synthetic dye Plant-based (beetroot extract, fruits like purple sweet potato, etc.)
Health Concerns Linked to thyroid tumors in rats; potential for hyperactivity in children Generally considered safe for consumption
Regulatory Status Banned in U.S. food & ingested drugs (effective 2027/2028); restricted in EU Widely approved for food use globally
Color Profile Bright, cherry-red, consistent Variable shades of red, pink, and purple; may be less vibrant
Stability Generally stable to heat and light Varies; some may degrade with intense heat or light exposure
Consumer Perception Negative; concerns about synthetic additives Positive; seen as cleaner and healthier

Embracing a Colorful and Healthier Diet

Moving towards a more natural diet is not just about avoiding single controversial ingredients like erythrosine but embracing whole, minimally processed foods. For home cooks and those looking to ensure their food is free from artificial colorants, natural alternatives are easily accessible.

Examples of natural colorants:

  • Beetroot extract: Provides pink and red hues, ideal for icing, cakes, and dry mixes.
  • Anthocyanins: Sourced from berries, purple sweet potatoes, and red cabbage, they offer a range of reds, pinks, and purples, often shifting color with pH changes.
  • Paprika oleoresin: Adds a rich orange-red color derived from peppers.
  • Carmine: A red pigment derived from insects, offering a stable and vibrant color.

Conclusion

The recent ban on erythrosine marks a significant step toward greater food safety and transparency in the U.S. It brings regulatory standards closer to those long upheld in other parts of the world and signals a broader industry trend toward natural ingredients. While debates about the direct human risk from low-level consumption continue, the removal of this controversial dye offers consumers peace of mind and encourages healthier choices. By reading labels and exploring the wealth of natural alternatives, individuals can better manage their nutrition diet and avoid additives linked to health concerns. Making the shift away from synthetic colorants like erythrosine allows for a more vibrant, healthy, and conscious approach to eating.

Read more on food additives and nutrition

Center for Science in the Public Interest (CSPI) on the Red 3 Ban

Frequently Asked Questions

The FDA's ban was a result of the 1958 Delaney Clause, which prohibits food additives found to cause cancer in animals, regardless of the dose or relevance to humans. Animal studies showing thyroid tumors in male rats, even at high doses, triggered this legal requirement.

These are all different names for erythrosine. Red Dye 3 is a common name, FD&C Red No. 3 is the U.S. designation, and E127 is the code used in Europe.

Erythrosine was commonly used in products that required a cherry-red or pink color, such as maraschino cherries, some candies, cake decorating gels, frostings, cereals, fruit cocktails, and certain oral medications.

No. While the U.S. has banned its use in food and ingested drugs (effective 2027/2028) and the EU heavily restricts it, some countries may still permit its use in certain applications. Always check product labels, especially for imported goods.

Effective natural alternatives include beetroot extract, anthocyanins from sources like purple sweet potato and red cabbage, carmine (from cochineal insects), and paprika oleoresin.

To avoid erythrosine, check the ingredient list on packaged foods, supplements, and medications for 'FD&C Red No. 3' or 'E127.' Opt for products that use natural colorants or are explicitly labeled as 'dye-free'.

The FDA ban has enforcement dates in 2027 and 2028. After these dates, any food or pharmaceutical product containing erythrosine will be considered 'adulterated' and cannot be sold in the U.S. market, leading to recalls and removal from store shelves.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.