Red #3's Swan Song: The Science Behind the FDA's Latest Decision

Understanding why the FDA must ban a food coloring it says is safe for humans

If you've been following the news (or just scrolling through your social media), you've probably seen about 1,000 scary headlines about the FDA banning Red Dye #3. Your group chats might be lit up with questions, and I've seen everything from "Finally! These toxic dyes are being exposed!" to "Is nothing safe anymore?" Let's dive into what's actually happening, look at the real evidence, and put this regulatory change in proper context.

First, let's address what might have you seeing red (see what we did there?): No, you haven't been poisoning yourself or your kids with Red Dye #3. The FDA's decision, announced on January 15, 2025, comes from a fascinating intersection of law, science, and public health policy - and understanding this context is critical.

Breaking Down the Decision

The FDA is revoking authorization for Red Dye #3 (also known as FD&C Red No. 3 or erythrosine) in food and ingested drugs. Manufacturers have until January 15, 2027, for food products and January 18, 2028, for drugs to reformulate. This decision wasn't triggered by new safety concerns or emerging evidence of harm - instead, it stems from a 2022 petition by the Center for Science in the Public Interest that invoked a specific legal requirement called the Delaney Clause.

Here’s the FDA’s IG post on the matter:

fdafoods

A post shared by @fdafoods

The Science: What We Actually Know

Let's talk about the research that led here. Studies showed that male rats exposed to very high levels of Red #3 developed thyroid tumors. Here's the crucial context: this occurred through a hormone mechanism specific to male rats that doesn't exist in humans. The FDA's own analysis shows a 210-fold safety margin between typical human exposure (0.25 mg/kg body weight per day) and levels causing effects in rats (35.8 mg/kg per day).

Even more telling: studies in other animals - including female rats, mice, gerbils, and dogs - showed no cancer effects. Human studies have consistently failed to show evidence of harm at normal exposure levels.

Why Use Food Dyes At All?

We explored this question in depth in a previous newsletter, but given how often this comes up, let's briefly address it. The instinctive response many have is: "If dyes add no nutritional value, why not just eliminate them all?"

While it's true that food dyes don't contribute to nutrition, their role in our food system is more complex than it might seem. Research shows that color profoundly influences not just our food choices, but our actual experience of food at a neurological level. Studies using functional MRI imaging demonstrate that color-appropriate foods activate different brain regions than foods presented in unexpected colors - even before tasting.

When foods lose their expected color during processing and storage:

• Consumers reject substantial amounts of safe, nutritious food

• People perceive flavors as less intense

• Overall product acceptance decreases

• Food waste can increase

This doesn't mean we must keep using synthetic dyes. However, any transition away from current colorants needs to consider:

• Food waste implications

• Production costs and accessibility

• Environmental impact of alternatives

• Consumer acceptance

• Technical feasibility at scale

Natural alternatives, while appealing, come with their own challenges - from increased water usage and agricultural demands to stability issues and new potential allergen concerns. For a deeper dive into this complex topic, including the environmental and practical implications of various alternatives, check out that previous newsletter here:

The key is making evidence-based decisions that balance legitimate concerns with practical realities - exactly what our regulatory system aims to do through continuous monitoring and updates to safety standards.

Food Dyes and Behavior: What Does the Science Say?

One of the most common questions I'm getting is about ADHD and behavioral effects. This is where understanding the specific chemistry and research matters. Red #3 (erythrosine) is chemically distinct from other food dyes, and the research presents a nuanced picture:

Early studies examining Red #3's behavioral effects showed mixed results:

• A 1983 developmental toxicity study by Vorhees et al. found no consistent dose-dependent behavioral effects in rats and concluded there was no evidence that dietary exposure to Red #3 was psychotoxic to developing rats

• While some early studies suggested potential effects on neurotransmitter systems, follow-up research by Mailman & Lewis (1981) found that many of these early biochemical findings were actually artifacts of the testing methods

The broader research linking food dyes to behavioral changes has primarily focused on different dyes, particularly Red 40 (Allura Red) and Yellow 5. According to Dr. Joel Nigg, director of the ADHD Research Program at Oregon Health and Science University, while food dyes may affect behavior in some sensitive children, these effects are typically small and vary significantly between individuals. His research shows that in the U.S., Red 40, Yellow 5, and Yellow 6 comprise over 90% of food dyes used - not Red #3.

This distinction is important because when people discuss food dyes and behavior, they're usually referring to studies on these other colorants - not Red #3. The European Union and United Kingdom have required warning labels on foods containing certain dyes since 2008, but these regulations were primarily focused on other food colorings, not Red #3 specifically.

Important note: The FDA documents note that their latest safety assessment specifically considered exposure to Red #3 in children, calculating that even the highest estimated exposure levels in young people (0.25 mg/kg body weight per day) remain 210 times lower than levels causing any effects in animal studies. While some parents understandably have concerns about food dyes and children's behavior, it's important to note that the comprehensive research linking food dyes to behavioral changes in children has focused primarily on other dyes - not Red #3.

For parents specifically concerned about food dyes and behavior, it's worth noting that Red #3 is actually one of the less commonly used food colorings in children's products. Most red-colored foods that appeal to children (like fruit drinks, candies, and cereals) typically use Red 40 instead…

What Products Actually Contain Red #3?

Interestingly, Red #3 is used far less frequently than many people assume. It's primarily found in:

• Maraschino cherries

• Some candies (especially red cinnamon candies)

• Select gummies and jello cups

• Certain ice creams

• Some baked goods

Most red-colored foods actually use Red 40 (Allura Red), which isn't affected by this ban.

International Context and Safety Standards

Here's where things get really interesting from a public health perspective. Different countries have taken varying approaches to Red #3:

• The European Union requires warning labels rather than bans

• Canada continues to permit its use

• Japan and other Asian markets allow it under the name erythrosine

• Australia and New Zealand have specific usage limits

The Delaney Clause: Understanding the Legal Trigger

This is where we need to talk about how U.S. food safety law works. The Delaney Clause, enacted in 1960, requires the FDA to ban any color additive that causes cancer in animals OR humans, regardless of:

• The relevance to human health

• The extremely high doses required

• The specific biological mechanism

• The actual risk level

• Whether the effect has been seen in humans

This is why the FDA can simultaneously acknowledge the minimal human risk while still being legally required to act.

The Color Additive "Triple Standard"

Here's something fascinating that many people don't realize: The Delaney Clause isn't unique to color additives. It actually appears in THREE different places in U.S. food safety law:

1. Color Additives (Section 721)

2. Food Additives (Section 409)

3. Animal Drug Residues (Section 512)

But here's where it gets interesting: The version applying to color additives is notably stricter. While food additives can get approval even if they contain trace amounts of carcinogenic constituents (based on a 1984 court decision in Scott v. FDA that interpreted the Delaney Clause to apply only to additives that cause cancer as a whole), no such flexibility exists for colors.

Why this extra stringency for colors? The court case Public Citizen v. Young (831 F.2d 1108) determined that Congress's stricter standard for colors was intentional based on several factors:

1. Colors are considered purely cosmetic - they don't provide any nutritional or functional benefit to food

2. There was heightened concern about synthetic colors in the 1960s due to several safety incidents

3. The law was written during a period of particular public suspicion about synthetic color additives

So while it might seem odd at first glance, this stricter standard for colors actually reflects specific historical concerns and the view that since colors are purely decorative, they warrant extra caution.

This historical and legal context helps explain why Red #3 must be banned despite minimal human risk, while other food additives might be evaluated differently under seemingly similar circumstances.

The Real Public Health Context

As a public health scientist, I actually find this case fascinating because it demonstrates both the strengths and complexities of our food safety system. The FDA's risk assessment shows:

• No evidence of human harm at typical exposure levels

• A massive safety margin between human exposure and animal effects

• Clear understanding of the rat-specific mechanism

• Continuous monitoring and review of safety data

A Notable Departure from Standard FDA Approach

Here's something fascinating from a regulatory science perspective: This decision represents an unusual departure from how the FDA typically evaluates food safety.

The FDA generally uses a "risk-based" approach to regulation, meaning they evaluate both the potential for harm AND the likelihood of that harm occurring under real-world conditions. This differs from a "hazard-based" approach (used by some other countries) that looks only at whether something could potentially cause harm, regardless of exposure levels or real-world context.

Yet with the Delaney Clause, the FDA is legally required to switch to a hazard-based framework. The legal language is explicit and inflexible. Section 721(b)(5)(B) of the FD&C Act states that a color additive "shall be deemed unsafe for any use which will or may result in ingestion of all or part of such additive, if the additive is found by the Secretary to induce cancer when ingested by man or animal."

The FDA's own response to public comments illuminates this tension. As they note in the January 2025 order: "The Delaney Clause prevents FDA from finding a food additive to be safe if it has been found to induce cancer when ingested by humans or animals, regardless of the probability, or risk, of cancer associated with exposure to the additive or of the extent to which the experimental conditions of the animal study or the carcinogenic mode of action provide insight into the health effects of human consumption."

Courts have reinforced this strict interpretation. In Public Citizen v. Young (831 F.2d 1108, 1122), the court held that Congress intended for the Delaney Clause to be "extraordinarily rigid," rejecting the FDA's attempt to make exceptions even for de minimis cancer risks.

This creates a situation where, despite the FDA's own scientific assessment concluding "FD&C Red No. 3-induced thyroid tumors in male rats are of limited relevance to humans," they must act based solely on the presence of the hazard - one of the few instances where U.S. food safety law requires a hazard-based rather than risk-based approach.

The Timing and Political Context

We’ve received dozens of questions about this decision's timing coinciding with changes in administration. (And, well, it does seem a bit…coincidental.) But the documented timeline shows this regulatory process began well before recent political shifts:

1. 2022: CSPI files the formal petition

2. February 2023: FDA publishes notice in Federal Register

3. May 2023: Public comment period ends

4. January 2025: Final decision announced

5. 2027/2028: Implementation deadlines

While some have speculated about potential political motivations, particularly given the incoming administration's "Make America Healthy Again" (MAHA) movement's focus on food additives, the timing aligns with standard regulatory procedures and timelines that began years earlier. The petition process, scientific review, public comment period, and implementation timeline follow typical FDA protocols.

Moreover, it's worth noting that the FDA's scientific assessment hasn't changed - they continue to maintain that human risk is minimal and the rat findings have limited relevance to human health. The action is triggered by the Delaney Clause's legal requirements rather than new safety concerns or political pressure.

This type of science-based regulatory action, following established procedures and timelines regardless of political transitions, actually demonstrates the resilience of our food safety system to operate independently of political cycles.

What This Means for You

If you're concerned about Red #3, remember:

1. Products made before the ban takes effect can still be sold

2. Most red-colored foods already use other dyes

3. Manufacturers have time to reformulate

4. The ban is based on a legal requirement, not new safety concerns

For those worried about other food dyes: while it's perfectly fine to choose dye-free products, the evidence doesn't support widespread alarm. Our regulatory system continuously monitors and evaluates safety, taking action when required - even when that action is based on legal requirements rather than immediate safety concerns.

Stay Curious,

Unbiased Science