Why the FDA Banned Red Dye No. 3 and What Medical Professionals Should Know

FDA Bans Red Dye No. 3: What Medical Professionals Should Know

On January 15, 2025, the U.S. Food and Drug Administration (FDA) made a pivotal decision to ban red dye No. 3 (also known as erythrosine) from food, drinks, and ingested drugs. This move has garnered attention due to its significance in the ongoing discussion around food additives, consumer safety, and public health. While this dye has been used for decades to give products a vibrant red hue, its association with cancer in laboratory animals—specifically male rats—has led to this regulatory shift. Let’s explore the science behind red dye No. 3, its historical use, the FDA's reasoning behind the ban, and the potential impact on both public health and the food industry.

What Is Red Dye No. 3?

Red dye No. 3, or erythrosine, is a synthetic food coloring that imparts a bright, cherry-red color to a wide range of products, from candies to cosmetics. It has been a staple in the food industry for over a century. This dye is particularly notable for its use in products like candies, cakes, cookies, frozen desserts, and even some beverages. However, despite its widespread use, concerns have been raised over the years about its potential effects on human health, particularly its link to cancer.

Erythrosine is part of a family of FD&C color additives, which are approved by the FDA for use in food, drugs, and cosmetics. The dye is classified under FD&C Red No. 3, and its bright red color has made it a go-to ingredient in products aimed at appealing to children, with the dye appearing in popular treats such as fruit cocktails, lollipop rings, and beef sticks. It is also used to enhance the appearance of certain pharmaceutical products, including cough syrup.

The Science Behind the Ban: Red Dye No. 3 and Cancer Risk

The main catalyst for the FDA's decision to remove red dye No. 3 from the market is the findings from several laboratory studies. These studies, which have been ongoing for decades, suggest that the dye could cause cancer in male rats under specific conditions.

The Key Study
One of the critical studies that led to the FDA's ban was conducted in the 1980s, where 70 male rats were fed a diet consisting of 4% red dye No. 3 for their entire lifespan. The results showed that 15 of the rats developed thyroid tumors, a type of cancer that affects the glands in the throat. However, it's crucial to note that most of these tumors were not cancerous, and females and mice in similar tests did not show the same results. Tumors were specifically noted in the male rats, and the research suggested that the tumors were caused by a specific hormonal response triggered by the dye, which was not relevant to humans.

The Delaney Clause and Its Implications
The Delaney Clause of the Federal Food, Drug, and Cosmetic Act is the cornerstone of the FDA's decision. This clause mandates that any food or color additive found to cause cancer in humans or animals must be banned from the food supply. Importantly, this applies regardless of whether the cancer-causing effects are observed in humans or animals, and whether or not the risk is considered low in humans.

Despite the fact that subsequent studies have shown that red dye No. 3 does not cause cancer in humans at typical exposure levels, the Delaney Clause leaves little room for interpretation. According to Jennifer Pomeranz, an expert in public health policy at New York University, “It doesn’t matter if the risk is relevant to humans or not; the law mandates that the FDA ban it if it’s linked to cancer in animals."

How Does Red Dye No. 3 Affect Human Health?

While red dye No. 3 has been definitively linked to cancer in rats, the evidence for its cancer-causing effects in humans is far less clear. The FDA has emphasized that human exposure to red dye No. 3 is typically much lower than the levels that caused cancer in lab rats. Therefore, it is unlikely that typical consumption of products containing the dye would pose a significant cancer risk to humans.

However, the potential risk to humans is not the primary reason for the ban. Instead, the Delaney Clause requires that any additive with a link to cancer in animals must be removed from the food and drug supply, even if the effects do not extend to humans. The fact that red dye No. 3 could potentially cause tumors in rats has led the FDA to apply this precautionary principle, erring on the side of consumer safety.

FDA’s Action and Timeline: What It Means for the Food Industry

The FDA’s ban on red dye No. 3 applies not only to food products but also to ingested drugs, such as cough syrup and other medications. This is significant because many pharmaceutical products use red dye No. 3 for color. However, the FDA has provided a transition period for manufacturers to comply with the new regulations.

• Food manufacturers will have until January 2027 to reformulate their products and remove red dye No. 3.
• Drug manufacturers will have until January 2028 to phase out the use of red dye No. 3 from their products.
• Imported food and drug products containing the dye will also need to comply with this new restriction.

This timeline provides manufacturers with enough time to find suitable alternatives for erythrosine, which may include other food colorings that are deemed safer by regulatory bodies.

The Role of Advocacy Groups in the Ban

Consumer advocacy groups like the Environmental Working Group (EWG) played a pivotal role in raising awareness about the potential dangers of red dye No. 3. In 2022, the EWG and several other organizations petitioned the FDA to reevaluate the safety of red dye No. 3, urging the agency to consider the Delaney Clause in its review. The EWG has been a vocal critic of synthetic food colorants, advocating for stricter regulation and greater transparency in food labeling.

While some critics argue that the EWG may overstate the risks of various chemicals in food, their role in the red dye No. 3 ban cannot be overlooked. Their pressure on the FDA and their continued advocacy for consumer safety highlight the growing concerns around food additives and the need for comprehensive safety evaluations.

Impact on Consumers and Public Health

The ban on red dye No. 3 will have several immediate and long-term effects on the food and pharmaceutical industries, as well as on consumers. Here are some key points to consider:

1. Consumer Safety
From a public health perspective, the FDA's decision is a victory for consumers who are increasingly concerned about the ingredients in their food and medications. By removing potentially harmful additives like red dye No. 3, the FDA is prioritizing safety and taking a cautious approach to potential health risks. However, consumers will still need to be vigilant, as other food colorants and additives may also pose health risks that have yet to be fully investigated.

2. Food and Drug Reformulation
Manufacturers will face a logistical challenge in reformulating their products to remove red dye No. 3. The reformulation process may lead to changes in the appearance and taste of some products. This could result in an adjustment period where consumers may notice differences in the products they consume, particularly in brightly-colored foods like candies and desserts.

3. Alternatives to Red Dye No. 3
The market for alternative food colorings is likely to expand, with companies turning to more natural options, such as beet juice powder, spirulina, and other plant-based colorants. However, these alternatives often come with different aesthetic properties, so manufacturers will need to balance safety with consumer expectations for color and appearance.

Conclusion: Moving Forward with Caution

The FDA's decision to ban red dye No. 3 reflects a broader trend toward increasing transparency and consumer safety in the food and drug industries. While the evidence linking red dye No. 3 to cancer in humans is minimal, the regulatory requirements outlined in the Delaney Clause leave no room for ambiguity. As food and drug manufacturers work to comply with the new regulations, consumers can take comfort in knowing that the FDA is erring on the side of caution.

As the industry moves away from red dye No. 3, it's a reminder of the ongoing challenges that regulators face in balancing the interests of public health with the needs of a dynamic and fast-paced food market.