The safety of dyes in cosmetics and food has been a topic of debate for decades. According to the U.S. Food and Drug Administration (FDA), FD&C Red No. 3 — also known as Red Dye No. 3, Red Dye 3, and erythrosine — is a petroleum-based colour additive used to give products a bright red hue. This dye appears in a variety of consumables, including cookies, candy, frozen desserts, and frostings, across numerous popular food categories in the U.S.
Manufacturers have used this dye for decades, but the FDA has now ruled that FD&C Red No. 3 will no longer be permitted in food or ingested drugs. The FDA has issued an order revoking all previous authorizations for its use in these products. Manufacturers must comply by January 15, 2027, for food products and by January 18, 2028, for medications.
Why the change, and what does it mean for consumers? Let’s explore the history of Red Dye 3 and the impact of the FDA ban. At Think Dirty, we recognize the importance of understanding potential risks in everyday products, and we strive to keep you informed about what’s really inside the items you use.
The 1990 FDA Ban of Red Dye 3 in Cosmetics
To understand the significance of the latest ban, it’s essential to look at the history of Red Dye 3 in cosmetics. A colour additive is any dye, pigment, or substance used solely to add colour to a product, whether in food, drugs, or cosmetics. These additives can enhance product appeal or help distinguish specific items, such as medication dosages.
Colour additives are classified into three categories: straight colours, lakes, and mixtures. Straight colours, like FD&C Red No.3, have not been mixed or chemically altered. Lakes, on the other hand, result from a chemical reaction between straight colours and other substances, while mixtures combine multiple colour additives.
Red Dye 3 was first approved for use in 1927, and within four years, 15 straight colours received approval. However, concerns over the safety of dyes in cosmetics soon emerged. The Food and Drugs Act of 1906 laid the groundwork for regulation, but it lacked the necessary oversight. Some previously approved products were later found to be misbranded or even toxic. One notorious case involved an eyelash dye that blinded women, prompting further regulatory action.
In 1960, the Color Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C) empowered the FDA to prohibit colour additives that were found to cause cancer in humans or animals. This was a crucial shift, allowing the FDA to protect consumers from known carcinogens.
The FDA worked to remove unsafe colour additives, either by permanently listing safe ones or terminating approval for harmful ones. Red Dye 3 became a major concern when studies showed that high doses caused cancer in male lab rats due to a hormonal mechanism. However, subsequent research did not find the same effects in other animals or humans. The FDA maintains that there is no evidence that FD&C Red No.3 causes cancer in people.
The 2025 Ban of Red Dye 3 in Food and Medication
On January 15, 2025, the FDA announced that FD&C Red No. 3 would no longer be allowed in food and ingested drugs. This means that manufacturers must reformulate their products to eliminate this additive.
Major food and beverage brands are already making adjustments. Yoo-hoo’s strawberry drink is being reformulated to remove the dye, and companies like Pop-Tarts, MorningStar Farms, Toll House, Nesquik, and Marie Callender’s are taking similar action. Some brands, such as McCormick, had already begun phasing out the dye before the FDA’s announcement.
The ban ensures that no food or drug manufacturer in the U.S. will continue using FD&C Red No. 3. It sets a deadline for compliance, pushing the industry toward safer ingredient choices.
Why the FDA Banned Red Dye 3
The FDA’s decision to ban Red Dye 3 was driven by growing evidence of potential health risks. Following the announcement, House Energy and Commerce ranking member Frank Pallone Jr. (D-N.J.) emphasized that Red Dye 3 is known to be an animal carcinogen and that children are particularly vulnerable to its effects. He also pointed out that its use in cosmetics had been discontinued long ago.
The 2025 ban was largely influenced by advocacy from the Center for Science in the Public Interest, which petitioned the FDA to prohibit the dye and pushed for stricter regulations on synthetic additives in food and drugs. As scientific understanding has evolved, there has been increasing pressure to eliminate harmful ingredients, and rightfully so!
Global Perspectives: EU and Health Canada Regulations
The U.S. is not the only country taking action against Red Dye 3. In the European Union, the dye is banned as a food additive except for use in cocktail cherries. Australia and New Zealand have also prohibited its use.
In Canada, Red Dye 3 is still permitted as a food colouring, provided it meets Health Canada’s food-grade specifications. A 2018 review by Health Canada found no significant health risks to the general population. However, different countries apply varying levels of caution when regulating dyes in food and cosmetics.
Red Dye 3 vs. HC Red Dye 3: What’s the Difference?
There is some confusion between Red Dye 3 and HC Red Dye 3. While FD&C Red No.3 is banned in cosmetics, food, and medication, HC Red Dye 3 is a distinct substance used specifically in hair colouring products.
HC Red No. 3, also known as Hair Colorant Red No. 3, is found in semi-permanent hair dyes and tints. The Cosmetic Ingredient Review Expert Panel has evaluated this dye and deemed it safe for use in hair products, provided it is not combined with certain chemicals.
If you’re concerned about synthetic dyes in hair products, there are natural alternatives available. Look for plant-based hair dyes made with botanical extracts for a safer option.
How to Stay Informed: The Think Dirty App
Want to stay on top of ingredient safety? The Think Dirty App helps you identify potentially harmful ingredients in your favourite products. With our search feature, you can check whether a product contains Red Dye 3 or other concerning additives before making a purchase.
At Think Dirty, we’re committed to empowering consumers with knowledge about product safety. Download the Think Dirty App today and take control of what goes on your skin and into your body!
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FDA Bans Red Dye 3: What It Means for Your Food and Cosmetics was originally published in Think Dirty on Medium, where people are continuing the conversation by highlighting and responding to this story.