Is Erythrosine a Risk? Examining the Red Dye Controversy

January 7, 2026 •

3 min read

In January 2025, the U.S. Food and Drug Administration (FDA) officially revoked authorization for erythrosine (FD&C Red No. 3) in foods and ingested drugs, citing safety concerns. This decision has reignited public debate about whether erythrosine is a risk, highlighting the complex science and regulatory history of this common food dye.

Quick Summary

This article examines the health risks associated with erythrosine, also known as Red Dye 3. It details the controversial studies, particularly those linking high doses to thyroid tumors in rats, behavioral issues in children, and allergic reactions in some individuals. Recent regulatory actions, including the FDA's ban, are explored, alongside the nuances of scientific interpretation and the availability of safer alternatives.

Key Points

FDA Ban: The U.S. FDA banned erythrosine in foods and ingested drugs in January 2025, with compliance deadlines in 2027 and 2028, respectively.
Legal vs. Scientific Rationale: The FDA ban was primarily driven by the Delaney Clause, a U.S. law mandating the removal of any additive found to cause cancer in animals, not by a change in the dye's risk assessment for humans.
Thyroid Tumor Concerns: High-dose animal studies linked erythrosine to benign thyroid tumors in male rats, but this mechanism is not considered relevant to human physiology.
Behavioral Effects: Some studies suggest a link between synthetic food dyes, including erythrosine, and hyperactivity in sensitive children, though a definitive causal link has not been established for the general population.
Allergic Reactions: Like many synthetic additives, erythrosine can cause allergic or hypersensitivity reactions in susceptible individuals.
Global Differences: Regulatory stances on erythrosine vary globally; for example, the EU heavily restricts its use but allows it in certain cherries, concluding that minimal exposure poses no safety concern.
Natural Alternatives: Consumers can opt for natural coloring alternatives like beetroot extract, anthocyanins, and paprika oleoresin to avoid synthetic dyes.
Consumer Empowerment: Understanding the controversy allows consumers to make informed choices about minimizing synthetic additive intake, especially for children or sensitive individuals.

Erythrosine: The Controversy Behind the Cherry-Red Hue

Erythrosine, also known as FD&C Red No. 3, is a synthetic dye used for its vibrant red or pink color in various products. While it enhances appearance in candies, baked goods, and syrups, its safety has been questioned, leading to significant regulatory changes.

The Thyroid Tumor Findings in Rats

Concerns about erythrosine primarily stem from 1980s animal studies where high-dose, long-term exposure caused an increase in benign thyroid tumors in male rats. This effect was due to a hormonally mediated disruption in the thyroid-pituitary feedback loop, resulting in excessive thyroid-stimulating hormone (TSH).

The relevance of these rat findings to humans has been debated due to physiological differences in thyroid function, suggesting humans are less susceptible to this tumor formation mechanism. However, the U.S. FDA's 2025 ban on erythrosine in foods and ingested drugs was largely driven by the Delaney Clause, a legal mandate requiring the banning of food additives found to cause cancer in animals, irrespective of dose or mechanism, rather than new scientific evidence.

Potential Behavioral Effects and Allergic Reactions

Other potential health concerns include possible links to behavioral issues in children, such as hyperactivity and ADHD symptoms. However, research results are inconsistent, and a clear causal link for the general population remains unestablished. Some sensitive individuals may see behavioral improvements by avoiding artificial colors.

Erythrosine can also cause hypersensitivity or allergic reactions in some individuals, ranging from skin rashes to severe cases like anaphylaxis.

Global Regulations and Regulatory Divergence

Regulations for erythrosine vary globally. The U.S. FDA banned the dye in food and ingested drugs in 2025 based on a legal interpretation. Other regions have different stances:

United States: Erythrosine (Red Dye No. 3) is banned in foods and ingested drugs as of January 2025, with compliance deadlines in 2027 and 2028.
European Union: Erythrosine (E127) has been restricted since 1994, mainly used in processed cherries. The European Food Safety Authority (EFSA) considers it safe at these low exposure levels.
Canada and Australia/New Zealand: These countries have various restrictions or acknowledge low exposure levels. Health Canada stated in 2025 it doesn't pose a health risk at regulated levels.

This difference highlights the distinction between hazard-based (U.S.) and risk-based (Europe, JECFA) food safety approaches. {Link: More details on regulatory approaches can be found here https://gforss.org/2025/01/15/frsupdate_erythrosine/}.

Alternatives to Erythrosine

Natural and artificial alternatives are available for red coloring.

Natural Alternatives: Beetroot Extract provides pink to red hues, Anthocyanins offer a range of reds, and Paprika Oleoresin gives a reddish-orange color.
Artificial Alternatives: Allura Red (Red Dye No. 40) is a common red azo dye often used as a replacement.

Comparison Table: Erythrosine vs. Natural Alternatives


Feature	Erythrosine (FD&C Red No. 3)	Beetroot Extract	Anthocyanins (from Black Carrot, etc.)
Source	Synthetic (petroleum-based)	Natural (beetroot)	Natural (fruits and vegetables)
Health Concerns	Potential for thyroid tumors (in rats), hyperactivity, allergies	Generally considered safe	Potential for allergies in sensitive individuals
Regulatory Status (U.S.)	Banned in food and ingested drugs (effective 2027/2028)	Permitted (Generally Recognized as Safe)	Permitted (Generally Recognized as Safe)
Color Stability	Good stability, but sensitive to light	Stable under moderate heat and light	pH-sensitive; changes color in different pH levels
Cost	Typically low	Variable, often higher than synthetic dyes	Variable, can be higher than synthetic dyes
Flavor Profile	None	Mildly earthy taste in high concentrations	None or mild, depending on source

The Takeaway: Weighing Risk and Benefit

The question of whether erythrosine poses a significant risk has a nuanced answer. While animal studies showed thyroid tumors, these are not directly applicable to humans. The U.S. FDA ban was a legal requirement under U.S. law, not a change in the risk assessment. Concerns about behavioral issues in sensitive children and allergic reactions also warrant caution. Minimizing intake of synthetic dyes, especially for children, and choosing products with natural colorants is a practical approach. {Link: More on the FDA's rationale for the ban can be found here https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs}.

Conclusion

The debate surrounding whether erythrosine is a risk reflects the evolving nature of food safety science and regulation. Consumers can make informed choices by checking ingredient labels and considering natural alternatives.

Frequently Asked Questions

The FDA banned erythrosine (Red Dye No. 3) in foods and ingested drugs primarily due to the Delaney Clause, a U.S. law requiring the banning of any food additive found to cause cancer in animals. A high-dose rat study from the 1980s led to this legal obligation, despite scientific arguments that the cancer-causing mechanism in rats is not relevant to humans.

While high-dose studies showed thyroid tumors in male rats, the mechanism behind this effect is not considered relevant to human physiology. The FDA has acknowledged that there is no evidence suggesting erythrosine causes cancer in humans.

Some studies have suggested a link between synthetic food dyes, including erythrosine, and behavioral issues like hyperactivity in sensitive children. However, the evidence is not conclusive for all children, and individual sensitivity varies widely.

Yes, but its use is heavily restricted. The European Food Safety Authority (EFSA) limits erythrosine (E127) use mainly to cocktail and candied cherries. Based on this minimal exposure, EFSA has concluded there are no safety concerns.

Natural alternatives to erythrosine include beetroot extract, anthocyanins (derived from fruits like carrots and berries), and paprika oleoresin. These provide red and pink hues without synthetic additives.

Before the FDA ban, erythrosine was commonly found in a variety of products, including candies, baked goods, processed cherries (like maraschino cherries), and certain syrups and decorating gels.

Individuals with known sensitivities, allergies, or concerns about behavioral effects, particularly in children, may choose to avoid erythrosine. Reading ingredient labels and choosing products with natural colorants are effective strategies.