Where is Red Dye No 3 Banned? A Global and US Guide

December 23, 2025 •

5 min read

As of early 2025, the U.S. Food and Drug Administration (FDA) has announced a ban on the use of Red Dye No. 3 in food, beverages, and ingested drugs, bringing the country in line with many other nations that have long restricted its use. This decision follows years of regulatory delays and consumer advocacy, stemming from evidence linking the additive to cancer in lab rats.

Quick Summary

The synthetic food dye Red Dye No. 3 is now banned in the U.S. for use in food, drinks, and ingested medications, with manufacturers given until early 2027 to comply. Similar bans or heavy restrictions have been in place for years in Europe, Australia, and New Zealand. The action was prompted by animal studies showing a link to cancer, despite industry claims and inconclusive human data. California also implemented its own statewide ban.

Key Points

Federal Ban in the US: The FDA officially banned Red Dye No. 3 from food, drinks, and ingested drugs in January 2025, with compliance deadlines in 2027 and 2028.
International Restrictions: Red Dye No. 3 is also banned for most food uses in the European Union, Australia, New Zealand, Japan, and China.
Cosmetics Banned Earlier: The US banned Red Dye No. 3 in cosmetics and topical drugs in 1990 after animal studies showed a link to cancer.
California's Role: California's 2023 ban on Red Dye No. 3 for foods, effective in 2027, helped spur the nationwide federal action.
Reason for the Ban: The decision was based on the Delaney Clause, which prohibits food additives that cause cancer in animals, though no conclusive link was found in humans at typical consumption levels.
Prevalence in Products: Before the ban, the dye was common in candies, frostings, maraschino cherries, fruit cocktails, and some medications.

A Landmark Decision: The US Ban on Red Dye No. 3

The FDA's announcement in January 2025 to ban FD&C Red No. 3 (also known as erythrosine or E127) from food and ingested drugs marks a significant moment in consumer food safety in the United States. This ruling was the culmination of decades of advocacy and came nearly 35 years after the same substance was banned in cosmetics due to evidence linking it to cancer in laboratory rats. The decision was ultimately guided by the Delaney Clause, a federal law prohibiting the use of any additive found to cause cancer in either humans or animals. The ban is set to be fully implemented over the next few years, giving manufacturers a transition period to reformulate their products.

The delayed federal action, however, was preceded by important state-level initiatives. In 2023, California passed the California Food Safety Act, making it the first US state to ban Red Dye No. 3 and three other additives, effective in January 2027. This was a major catalyst for federal regulators and put pressure on national manufacturers to move toward safer alternatives to sell their products in the large Californian market. Other states have since considered or introduced similar legislation, indicating a broader shift in food safety consciousness across the country.

Global Regulations: How the US Compares

While the U.S. ban is a recent development, many other nations have been ahead of the curve for years, enforcing bans or strict restrictions on Red Dye No. 3. The varying international stances on this additive highlight the differences in regulatory approaches and safety standards around the world.

European Union (EU): Red Dye No. 3 has been largely restricted for food use in the EU since 1994, with one narrow exception for candied and cocktail cherries, where very low levels of the dye are permitted. This long-standing precautionary approach reflects a more cautious stance on food additives linked to potential health risks.
Australia and New Zealand: These countries also have a comprehensive ban on the use of Red Dye No. 3 (E127) in most food products, with an exception for cocktail cherries, similar to the EU. This aligns with their stringent food safety standards.
Japan and China: Both nations have also banned the use of this food coloring, reflecting a widespread international consensus regarding its potential risks.

Products That Contained Red Dye No. 3

Prior to the ban, Red Dye No. 3 was used extensively in the American food supply, often in brightly colored and processed items aimed at children. The dye gave products a vivid cherry-red or pink hue, making them visually appealing. Consumers can still find products containing this dye on shelves until manufacturers complete their reformulation, so it's important to check ingredient labels.

Common Products Containing Red Dye No. 3 (before the ban):

Candies: Many seasonal candies, including candy corn, conversation hearts, and gum.
Baked Goods: Icing, frostings, and certain snack cakes.
Beverages: Some fruit-flavored drinks, strawberry milk, and protein shakes.
Cherries: Maraschino cherries were a significant user of the dye, though many brands have now switched to alternatives.
Medications: Some oral drugs, like cough syrups and gummy vitamins.

Why Was Red Dye No. 3 Banned?

The ban on Red Dye No. 3 was not a snap decision but the result of scientific evidence accumulated over decades. Studies in the 1980s and 1990s, particularly involving male laboratory rats, showed that high doses of the dye could cause thyroid cancer. While the FDA acknowledges that the mechanism causing cancer in rats may not apply to humans, the Delaney Clause leaves no room for interpretation—if a substance causes cancer in animals, it cannot be approved for use in food.

Beyond the carcinogenic link, other health concerns contributed to the push for a ban. Some studies have suggested a link between certain synthetic food dyes, including Red 3, and neurobehavioral problems, such as hyperactivity and inattentiveness in children. These concerns, coupled with the fact that the dye provides no nutritional value, led consumer groups and health advocates to petition the FDA to act. The successful petition in 2022 ultimately led to the long-awaited federal ban.

Natural Alternatives to Red Dye No. 3

In response to mounting consumer pressure and new regulations, many manufacturers have already begun replacing synthetic food dyes like Red Dye No. 3 with natural alternatives. These plant-based colorants provide the same visual appeal without the associated health concerns. Some common alternatives include:

Beetroot: Provides a vibrant red and pink color, often used in ice creams, frostings, and candies.
Anthocyanins: Pigments found in fruits and vegetables like red cabbage, radishes, and purple sweet potatoes, which can produce a range of red, purple, and blue hues.
Carmine: A dye derived from cochineal insects, used to create red and pink colors. Dole, for instance, switched to carmine for its cherries.

Comparison of Red Dye No. 3 and Natural Alternatives


Feature	Red Dye No. 3 (E127)	Natural Alternatives (Beetroot, Anthocyanins)
Source	Petroleum-based synthetic chemical	Plant-based (beets, berries, vegetables)
Carcinogenic Risk	Linked to thyroid tumors in lab rats	No known carcinogenic risk
Behavioral Effects	Some studies suggest links to hyperactivity in children	Not associated with neurobehavioral issues
Nutritional Value	None	Some alternatives, like beetroot, offer minor nutrients
Labeling	Listed as “FD&C Red No. 3” or “E127”	Listed by their source (e.g., “beet juice concentrate” or “carmine”)
Regulatory Status	Banned in many countries; federal ban in US effective 2027-2028	Generally regarded as safe (GRAS)

Conclusion: A Shift Towards Safer Food

The long-delayed but finally enacted federal ban on Red Dye No. 3, following years of global restrictions and domestic state-level action, marks a significant turning point in food safety. For decades, a regulatory paradox existed where the dye was prohibited in cosmetics but allowed in food, even with known health risks. This change reflects a growing consumer and regulatory preference for fewer synthetic additives and more transparency in food production. As manufacturers transition to safer, natural alternatives, consumers have the power to influence the market by reading labels and choosing products that prioritize healthier ingredients. The ban on Red Dye No. 3 serves as a potent reminder of the importance of ongoing scrutiny and advocacy regarding the ingredients in our food supply. For more information on food dye safety, the Center for Science in the Public Interest (CSPI) is an excellent resource.

Frequently Asked Questions

Yes, as of January 2025, the FDA has banned Red Dye No. 3 for use in all food, beverages, and ingested medications in the United States. Manufacturers have until January 2027 to comply with the food and beverage ban and until January 2028 for oral drugs.

The European Union, Australia, New Zealand, Japan, and China have all banned or heavily restricted the use of Red Dye No. 3 in most food products for many years.

The ban was enacted based on the Delaney Clause, a federal law that prohibits food additives found to cause cancer in either animals or humans. Studies in the 1980s linked high doses of the dye to thyroid cancer in male lab rats.

Red Dye No. 3 is also known as FD&C Red No. 3 or erythrosine. In Europe, it is sometimes labeled as E127.

Before the ban, the dye was found in many brightly colored products, including candy corn, conversation hearts, fruit cocktails, maraschino cherries, strawberry milk, and certain oral medications like cough syrups and vitamins.

Natural alternatives used by food manufacturers include beetroot extract for red and pink colors, and anthocyanins, which are pigments derived from vegetables like red cabbage and radishes.

The use of Red Dye No. 3 has been banned in cosmetics and externally applied drugs in the U.S. since 1990, a decision also based on its link to cancer in animal studies.

Yes, once the ban is fully implemented, imported foods and ingested medications sold in the U.S. must also comply with the new regulation and be free of Red Dye No. 3.