Is it safe to use erythrosine? Understanding the Red Dye Ban

October 8, 2025 •

3 min read

The United States FDA announced a ban on the use of erythrosine (Red Dye 3) in all foods and ingested drugs, with enforcement beginning in January 2025. This decision, rooted in decades of debate and animal studies linking the dye to cancer, marks a significant shift in food safety regulations.

Quick Summary

An in-depth look at erythrosine (Red Dye 3), a synthetic dye facing increased regulatory scrutiny due to potential health risks. Covers its historical use, animal study concerns regarding thyroid function and tumors, contrasting international regulations, and recent U.S. restrictions.

Key Points

FDA Ban: The U.S. Food and Drug Administration has banned erythrosine (Red Dye 3) for use in all food and ingested drugs, with enforcement beginning in 2027 and 2028 due to cancer risks found in animal studies.
Health Concerns: Long-term, high-dose animal studies have linked erythrosine to thyroid tumors, oxidative stress, and DNA damage.
Global Discrepancies: Regulatory bodies worldwide hold different views on erythrosine's safety. While the EU has restricted it for decades, Canada still permits its use at approved levels.
Mechanisms of Toxicity: The carcinogenic effect in rats is thought to be an indirect hormonal effect on the thyroid, not direct DNA damage, although more recent studies suggest genotoxic effects at high concentrations.
Poor Absorption in Humans: Human studies show that erythrosine is poorly absorbed by the body, which was previously cited as a reason for its safety, but concerns over potential long-term effects persist.
Shift to Natural Alternatives: Following the ban and rising consumer demand, many food manufacturers are replacing erythrosine with natural colorings like beet juice or carmine.

What is Erythrosine (Red Dye 3)?

Erythrosine, also known as Red Dye 3 or E127, is a synthetic red food coloring used for decades to impart a bright cherry-pink color to various products. Synthesized from petroleum, it's a disodium salt of tetraiodofluorescein. Its uses extend beyond food to cosmetics, pharmaceuticals, and dental products. It was commonly found in candies, cereals, baked goods, and maraschino cherries.

The Controversy: Why is Erythrosine Under Scrutiny?

The safety of erythrosine has been debated for many years, primarily due to findings from laboratory animal studies. These studies, particularly those involving high doses in rats, revealed potential health concerns.

Animal Studies and Health Concerns

Thyroid Function and Tumors: Long-term studies in rats exposed to very high doses of erythrosine showed an increased incidence of thyroid tumors. This is thought to be a non-genotoxic mechanism that disrupts the thyroid's hormonal balance by inhibiting the conversion of T4 to T3 in the liver, leading to increased TSH production and thyroid gland overstimulation.
Behavioral Effects: Some research has suggested a link between synthetic food dyes, including erythrosine, and hyperactivity in children, though evidence is mixed.
Oxidative Stress and DNA Damage: Recent studies have explored erythrosine's potential to cause gastrointestinal toxicity, oxidative stress, and DNA damage in rats, even below the Acceptable Daily Intake (ADI).

Shifting Regulatory Status

The regulatory status of erythrosine varies globally. The recent U.S. FDA ban marks a significant change.

United States: The FDA banned erythrosine in cosmetics and external drugs in 1990 due to animal studies linking it to cancer, applying the Delaney Clause. It remained in food and ingested drugs until the FDA revoked its authorization effective January 2025, with a transition period. California had already banned it at the state level in 2023.
European Union: Since 1994, the EFSA has severely restricted E127, primarily allowing it in specific products like processed cherries and certain pet foods and toothpastes.
Canada: Health Canada reaffirmed the dye's safety in 2025, stating it poses no health risk at permitted levels.
Australia and New Zealand: These countries have also restricted erythrosine's use to certain products.

A Global Comparison: Erythrosine Regulations


Regulatory Body	Status for Food/Ingested Drugs	Rationale	Notes
U.S. FDA	Banned (Effective 2027/2028)	Application of the Delaney Clause based on rat studies showing thyroid tumors	Allowed prior to 2025 announcement, but now in phase-out.
European Union (EFSA)	Severely Restricted	Precautionary principle and potential toxicity concerns	Only permitted for limited uses like cocktail cherries and pet foods.
Canada (Health Canada)	Permitted	Reaffirmed safety at set levels based on current data	Takes a different view on the available scientific evidence than the FDA.
Australia/New Zealand (FSANZ)	Restricted	Based on safety re-evaluation, aligns with JECFA ADI	Restrictions similar to the EU, allowing only limited use in some cherries and other items.

The Evolving Science of Erythrosine Safety

While high-dose animal studies showed links to thyroid tumors in rats, the relevance to humans at low dietary exposure levels was long debated. Regulatory bodies previously acknowledged potential hormonal effects in rats but maintained human exposure levels were typically below the ADI. The poor absorption of erythrosine in humans was also a factor. However, the recent U.S. ban reflects a more cautious approach, partly due to new research into potential genotoxic and oxidative stress effects at low doses, despite some conflicting results. Growing concerns over artificial food colorings have also led many companies to use natural alternatives.

Conclusion: Navigating the Changing Landscape of Food Colorings

The safety of erythrosine is now significantly impacted by recent regulations. For U.S. consumers, it will soon not be allowed in food and ingested drugs, as the FDA determined there is no longer a “reasonable certainty of no harm”. While other countries have different stances, the U.S. ban signifies a serious re-evaluation. As the industry moves away from Red Dye 3, natural alternatives are becoming more common. The ban highlights the dynamic nature of food safety regulations and the need for ongoing scientific review.

Visit the FDA's website for official statements on food color additive regulations.

Frequently Asked Questions

The FDA banned Red Dye 3 primarily due to the Delaney Clause, a U.S. law requiring the ban of any additive found to cause cancer in animals. Animal studies, particularly in rats, showed a link between high doses of the dye and thyroid tumors.

No, erythrosine is not banned globally. Regulations vary by region. The European Union has heavily restricted its use since 1994, while Canada continues to permit it at specific levels based on its own safety assessments.

The main health concern is the potential for high doses to promote thyroid tumor formation in rats through hormonal disruption. This happens when the dye interferes with thyroid hormone metabolism, leading to a compensatory overstimulation of the thyroid gland.

There is no conclusive evidence that erythrosine causes cancer in humans. The link was established in animal studies using very high doses. However, the FDA's application of the Delaney Clause, which does not require proof of human harm, led to the U.S. ban.

In the U.S., manufacturers are phasing out erythrosine. Enforcement of the ban begins in 2027 and 2028, but many companies have already reformulated their products. You can check the ingredient list for 'Red Dye 3' or 'erythrosine'.

Many food manufacturers are transitioning to natural alternatives to achieve a red color. These include beet juice concentrate (E162), carmine (E120), and pigments from fruits and vegetables like purple sweet potato, radish, and red cabbage.

Some studies and reports have suggested links between erythrosine and allergic reactions or hyperactivity, particularly in sensitive individuals or children. However, the evidence is mixed and not as robust as the animal studies concerning thyroid health.