FDA Bans Cancer-Linking Red Dye in Candy, Drinks, and Snacks!

The United States Food and Drug Administration (FDA) has officially banned the use of a bright red dye, Red No 3, commonly found in a variety of food and drink products, including candies, snacks, cakes, and drinks. The dye, also known as erythrosine, has long been controversial due to its potential links to cancer in laboratory animals. This ban, which took effect on January 15, 2025, follows years of consumer and health advocacy pressure and a deep examination of the risks posed by this artificial food coloring.

The Rise of Red No 3: A Historical Overview

Red No 3, once a staple of vibrant food coloring in the United States, has had a troubled history. Originally approved by the FDA in the 1970s, it became a go-to solution for food manufacturers wanting to achieve an appealing, bright cherry-red hue in their products. Over time, however, studies began to emerge linking the dye to thyroid cancer in laboratory rats. In 1990, following these findings, the FDA banned the use of Red No 3 in cosmetics due to its cancer risk. However, the dye remained in food products and ingested drugs, sparking controversy and debate about its safety in the human diet.

The Cancer Link: Red No 3’s Role in Animal Studies

Research studies have long indicated a potential link between high doses of Red No 3 and cancer in lab rats, specifically thyroid cancer. These studies, conducted in the 1980s, demonstrated that male rats exposed to high amounts of the dye developed thyroid tumors, leading to widespread concerns about the safety of the additive. Despite these findings, the FDA has repeatedly stated that the cancerous effects observed in rats do not directly correlate to human health, citing significant biological differences between the two species.

Nevertheless, as public awareness of potential health risks grew, so too did calls for a comprehensive review of the dye’s use. A petition filed by more than 20 advocacy groups, including Consumer Reports, Public Citizen, and the Environmental Working Group, eventually led to the FDA revisiting the issue, culminating in the 2025 ban. The groups argued that the dye posed an unacceptable health risk, particularly given the availability of safer alternatives widely used in Europe and other countries.

The FDA’s Decision: Legal and Scientific Grounds

The FDA’s decision to ban Red No 3 is rooted in a federal law known as the Delaney Clause, which prohibits the use of any food or color additives that are found to cause cancer in humans or animals. According to Jim Jones, the FDA’s deputy commissioner for human foods, the Delaney Clause is clear: if a substance causes cancer, it cannot be allowed in food products. Although the FDA acknowledged that the mechanism by which Red No 3 induces cancer in male rats does not occur in humans, the agency emphasized that it could not overlook the risks presented by the dye.

This ban extends to not only food products but also ingestible drugs that contain the additive, requiring drugmakers to reformulate their products by 2028. The FDA has given manufacturers a grace period to comply with the ban, but the ultimate goal is to eliminate the presence of this harmful ingredient from consumer products entirely.

Consumer Reactions to the Ban

The FDA’s decision has been met with both approval and skepticism. Consumer groups and health advocates have strongly supported the ban, seeing it as a necessary step to protect public health. Brian Ronholm, the director of food policy at Consumer Reports, stated that Red No 3 posed an unacceptable risk to health and welcomed the FDA’s decision to eliminate it from the food supply. Health experts such as Linda Birnbaum, former director of the National Institute of Environmental Health Sciences, also argued that there was no need for bright red dye in food products, emphasizing that food manufacturers should use safer alternatives already available.

On the other hand, some food industry groups have expressed concern about the logistical implications of the ban. The Consumer Brands Association and the National Confectioners Association both indicated that they would comply with the ban but also highlighted the need for a consistent, science-based national regulatory framework that supports both consumer health and the food industry.

What is Red No 3 and Where is It Found?

Red No 3 is an artificial food coloring that has been widely used in processed foods for decades. It is commonly found in candies, fruit juices, cakes, frozen desserts, and even some medicines. Popular products like Fruit by the Foot, Dubble Bubble chewing gum, Pez hard candies, Brach’s candy corn, and Tylenol PM have all used Red No 3 as an ingredient. In fact, 26% of baking decorations and dessert toppings were found to contain this dye, as per an analysis by the GoCoCo app.

While Red No 3 has been predominantly used in foods that are consumed infrequently, it has raised concerns due to its widespread use in products marketed to children, such as candy, gum, and beverages. Its presence in common medications, like gabapentin and doxycycline, has further drawn attention to its potential risks.

The Risks of Artificial Food Dyes

The safety of artificial food dyes has been a point of contention for years. While the FDA and the European Food Safety Authority (EFSA) have concluded that most food dyes, including Red No 3, do not pose significant health risks under regulated amounts, there is growing concern about the potential long-term effects of consuming these additives. Studies have suggested that while food dyes may not directly cause cancer in humans, they can be linked to behavioral health issues in children, such as Attention Deficit Hyperactivity Disorder (ADHD).

Research has shown that consumption of food dyes, particularly those in brightly colored snacks and beverages, can contribute to increased hyperactivity in children. Some experts argue that these additives may affect certain children more than others, leading to behavior and cognitive issues. As a result, there has been a growing movement to eliminate or reduce the use of artificial food coloring in children’s food, and the ban on Red No 3 is seen as a critical step in that direction.

What Does the Ban Mean for Food and Drug Products?

The ban on Red No 3 is expected to have far-reaching implications for both the food and pharmaceutical industries. For food manufacturers, the ban means a shift towards using safer, more natural colorants. Many companies have already begun to phase out Red No 3 and replace it with alternatives such as beet juice and paprika extract, which offer vibrant colors without the associated cancer risks.

For the pharmaceutical industry, the FDA’s ban presents a significant challenge, as many drugs have used Red No 3 in their capsules and coatings. Drugmakers will now need to reformulate their products to ensure they comply with the new regulations. Although the 2028 deadline gives companies time to adjust, the transition is expected to be costly and logistically complex.

Safer Alternatives and Future of Food Dyes

As the ban on Red No 3 takes effect, the focus will shift to finding and implementing safer alternatives for artificial food coloring. Natural dyes, such as beet juice powder or turmeric extract, offer a safer option without the associated health risks. These alternatives are already widely used in many countries, including those in Europe, where regulations on food additives are often stricter than those in the United States.

The long-term effect of the ban on Red No 3 could usher in a broader shift in the food industry towards healthier, more sustainable practices. As consumer demand for safer, cleaner products grows, manufacturers may increasingly turn to plant-based colorants and other natural alternatives.

The FDA’s decision to ban Red No 3 marks a significant milestone in the ongoing effort to improve food safety and protect public health. While the ban has sparked debate, it also highlights the growing concern over the risks of artificial food coloring, particularly in children’s products. As the regulatory landscape evolves, it is clear that consumer health, especially the health of vulnerable populations like children, will remain at the forefront of future decisions. The move away from harmful additives like Red No 3 signals a positive step toward a healthier food supply, encouraging the use of safer alternatives and setting a precedent for other nations to follow suit.