It’s Official: Red Dye 3 Is Banned. Here’s What to Know

FDA Bans Red Dye No. 3: What You Need to Know About the Impact and Safety

In a significant move to ensure consumer safety, the U.S. Food & Drug Administration (FDA) has announced a ban on Red Dye No. 3, commonly used in a wide variety of food and drug products. The decision, which was officially made public on January 16, 2025, is the result of a 2022 petition calling for the removal of this synthetic color additive from the marketplace. This ban is particularly notable as it directly impacts several well-known products, including candy, baked goods, cereals, and even over-the-counter medications like Tylenol.

The FDA’s ruling on Red Dye No. 3 stems from concerns raised in two studies that suggested the dye could be linked to cancer in laboratory rats. Despite the lack of conclusive evidence connecting Red Dye No. 3 to cancer in humans, the agency’s decision aligns with the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the use of any food or color additive that could potentially cause cancer in either humans or animals.

Why Was Red Dye No. 3 Banned?

The primary reason for the FDA’s ban on Red Dye No. 3 is its potential risk based on animal studies, where it was shown to cause cancer in laboratory rats under heavy exposure. These studies, while important for consumer safety, have not provided evidence to suggest that Red Dye No. 3 is dangerous to humans or other animals. Still, as a precautionary measure, the FDA has decided to follow the established legal framework that prohibits any substances deemed potentially carcinogenic.

Under the Delaney Clause, if an ingredient or additive is found to cause cancer in any test animal, it must be removed from the market, regardless of whether it has similar effects in humans. Although the science on Red Dye No. 3 remains inconclusive for humans, the precautionary approach led to the FDA’s ruling.

It is important to note that Red Dye No. 3, also known as Erythrosine, has been used in a wide range of products for decades. Common items that have included Red Dye No. 3 are candies like Pez and Ring Pops, various grocery store baked goods (including cupcakes and sugar cookies), flavored beverages like Nesquik strawberry milk, and even medications such as Tylenol and some types of antacids. With the ban in place, manufacturers will have to reformulate these products by removing Red Dye No. 3 by 2027 for food products and 2028 for drugs.

Timeline for Implementation and Impact on Products

The FDA has given companies time to adjust their formulas and remove Red Dye No. 3 from their products. The timeline for full implementation is divided into two parts:

• Food products: Manufacturers will have until January 15, 2027, to ensure that Red Dye No. 3 is no longer used in food items.
• Drugs: For drugs, companies will need to remove Red Dye No. 3 by January 18, 2028.

While the ban does not take effect immediately, this extended period provides manufacturers ample time to explore alternative color additives and make necessary changes to their formulations.

Should You Be Concerned About Red Dye No. 3?

One of the most frequently asked questions following the FDA’s announcement is whether people should be concerned about consuming products that contain Red Dye No. 3 before the ban takes full effect. According to Jessica Ball, M.S., RD, a nutrition expert, there is limited scientific evidence suggesting that Red Dye No. 3 poses any immediate risk to human health. While the studies showing potential cancer links were conducted on rats and are not directly applicable to humans, it is understandable that some consumers might want to avoid the dye in light of the FDA’s decision.

Ball adds that, for most people, the presence of Red Dye No. 3 in food products should not be a major cause for concern. “If you want to avoid it for personal reasons prior to when it is fully off the market, feel free to do so,” she advises. However, she stresses that focusing on a well-rounded, nutritious diet—rich in fruits, vegetables, whole grains, healthy fats, and lean proteins—would be more beneficial for your overall health than focusing on individual ingredients to avoid.

For those who are still concerned, there are plenty of alternatives available. Many brands are already offering products that do not contain synthetic dyes, opting for natural coloring from ingredients like beet juice or turmeric. By choosing products made with natural ingredients or those that explicitly state they are free from artificial dyes, consumers can make informed decisions about their purchases.

What About Other Food Dyes?

Although Red Dye No. 3 is being banned, this ruling does not apply to other food colorings, such as Red Dye No. 40 (Allura Red). Red Dye No. 40 remains legal and continues to be widely used in the food and beverage industry. Some critics have raised concerns about the potential risks associated with other synthetic food dyes, including Red Dye No. 40, Yellow No. 5, and Blue No. 1. However, the FDA has approved these dyes for use and does not currently see a need for their removal.

If you are worried about artificial food colorings in general, it’s important to read product labels carefully. More and more consumers are demanding natural and organic alternatives to artificial dyes, which has led many manufacturers to reformulate their products. As consumer preferences continue to shift, it’s possible that other food dyes may come under scrutiny in the future.

What Does This Mean for the Future of Food Additives?

The FDA’s decision to ban Red Dye No. 3 may signal a shift in the way food additives are regulated in the United States. As more scientific research emerges and consumer concerns about food safety grow, there could be greater pressure on regulatory bodies to reassess the safety of other additives commonly used in food products.

In the coming years, we may see an increasing trend toward natural and plant-based colorants as the demand for clean-label products rises. Ingredients like beet juice, spinach powder, and turmeric are already being used as alternatives to artificial dyes in many foods. These natural alternatives not only provide consumers with safer options but also offer a healthier alternative for the food industry to consider.

Conclusion: The Road Ahead

The FDA’s decision to ban Red Dye No. 3 reflects a growing concern for consumer health and safety, even in the absence of definitive proof that the dye is harmful to humans. As the timeline for phasing out Red Dye No. 3 continues, both consumers and manufacturers will have to adapt to the changing landscape.

For most consumers, the decision to avoid Red Dye No. 3 in the short term should be a personal choice based on individual preferences and concerns. However, for the majority, there is no immediate health risk associated with the dye. It is essential to focus on an overall balanced and nutritious diet rather than worrying too much about individual ingredients.

As we move forward, it is important to remain informed about the additives in our food and take advantage of available resources to make healthier choices. Whether it’s opting for products free from artificial dyes or choosing those made with natural ingredients, consumers can make a significant impact on their health by staying informed and making thoughtful decisions.

In conclusion, while Red Dye No. 3 will gradually disappear from the market, its ban also serves as a reminder of the importance of continuous oversight in food safety and the need for ongoing research to ensure the well-being of the public.