Red 3: Controversial Food Dye and Regulatory Challenges

Red 3's continued presence in U.S. food raises serious safety concerns despite its link to cancer in rats.

### The Controversy of Food Dyes: Red 3 and Its Implications
* 🎃 In 1950, Halloween brought a wave of sickness among children across the U.S. due to a **toxic FDA-approved dye** called Orange 1, leading to its **eventual ban**.
* 🍬 Today, Red 3, another synthetic dye linked to **cancer in rats** and **behavioral issues in children**, remains prevalent in nearly **3,000 food products** despite its risks.
* 📜 Red 3 is one of nine synthetic dyes approved by the FDA, with its safety assessments dating back to the late 1960s, but it has been **banned from use in cosmetics due to health concerns**.
* 🧪 The FDA's Food Additives Amendment of 1958 mandates that any food additive found to **induce cancer must be banned**, yet Red 3 has not been removed from food products even after evidence of its **risks emerged**.
* ⚖ A petition by the Center for Science in the Public Interest to remove Red 3 has been pending for two years, while California has taken action by passing a bill to **ban it by 2027**, highlighting **growing state-level frustration with federal inaction**.
* 📊 Studies show a **significant correlation** between synthetic dyes and behavioral issues in children, raising alarms among parents and lawmakers regarding the **outdated FDA approvals**.
* 🌍 With California's ban, which could lead to a **national shift similar to the removal of artificial trans fats**, the food industry may finally be compelled to **prioritize safer alternatives**.
* 🚫 Ultimately, food dyes like Red 3 serve **no nutritional purpose** and exist solely for marketing, making their continued use a **dangerous risk for children's health**.

Halloween night, 1950. Dozens of children in cities across the United States were sick. There was something in the candy. Okay, no one died, but this was obviously a problem. The issue was an FDA-approved ingredient called Orange 1, a color additive that was in all types of food at the time, from Halloween candy to hot dogs. The large amounts of it in candy gave it a festive orange hue, but also made it super toxic, giving kids rashes and severe diarrhea. So luckily, you will not find Orange 1 in our food anymore. After this Halloween incident, the FDA banned it along with several other color additives. But in recent years, another potentially harmful dye is making headlines. It's in candy and nearly 3000 other foods we eat. Red 3. It's been linked to cancer in rats and behavioral issues in kids. So why is it still in our food? Red 3 is just one of nine synthetic dyes.

approved for use in the US by the Food and Drug Administration. We've been using dyes like Red 3 as far back as 1907, before the FDA even existed. But this list has largely remained unchanged since the late 60s. Today, Orange B and Citrus Red 2 are only approved for limited use, but the other seven are approved for widespread use in food, drugs, and cosmetics. Well, except Red 3. The question I wrote here was, “What's the deal with Red 3?” That's very helpful. [Laughs] I'm happy to talk about it. I can address that question. Thomas Galligan is the principal scientist for food additives and supplements at the Center for Science in the Public Interest, a consumer advocacy group focused on improving the food system in the U.S. Red 3 is a - of the synthetic dyes - a bit of a unique case. Because even though Red 3 is in a ton of our food,

it's banned from use in topical drugs and cosmetics. Here's why. After the 1950s Halloween fiasco, the U.S. passed new legislation: the Food Additives Amendment of 1958 and the Color Additives Amendment of 1960. What that amendment did was require the FDA to assess the safety of any color additive before it is used in any FDA-regulated product. So, all the color additives that were in use prior to that had to be formally approved again. So, by 1969, Red 3 and several other additives were permanently approved for use in food based on the research that was available at the time. But then, two decades later... The cosmetics industry petitioned the FDA to permanently approve Red 3 for use in cosmetics and topical drugs. At this point, the latest research found that when fed to rats, Red 3 slightly increased their risk of developing thyroid cancer. So, in 1990, the FDA denied the petition for cosmetics and topical drugs and said that they would go back

and banned it in food for the same reason. In fact, they were legally required to. Within that Food Additives Amendment of 1958 is a provision called the Delaney clause, which says the FDA is required to ban food additives that are found to cause or induce cancer in humans or animals, as indicated by testing. So, on the basis of that evidence, and on the FDA's own conclusion, the agency was obligated to ban it across all of its products that it regulates, including drugs, cosmetics, and foods. Then what happened was 34 years have elapsed, and Red 3 is still on the market, and the FDA still hasn't acted. They just never got around to it. I did reach out to the FDA for comment, and they didn't have time for an interview, but their press officer did direct me to their website. Today, on the FDA's website, you'll find a statement saying that the research on thyroid cancer in rats has limited relevance to humans. I don't entirely understand why the FDA has dug in

On this particular issue, when it's incredibly clear that Red 3 is in violation of the Delaney clause. CSPI, the organization Doctor Galligan works for, filed a petition with the FDA asking them to formally remove Red 3 from our food. It's been two years now, and it's still being reviewed. And in the meantime, here it is still in our food. But there is another way the US might get rid of Red 3... without the FDA. In 2023, California signed a bill banning Red 3 from food in their state by 2027. The bill is partially in response to the fact that Red 3 might cause more problems than just the rat cancer risk, specifically problems in kids. A recent compilation of 25 studies showed that over half the research found a correlation linking synthetic dyes to behavioral issues in children. The studies that FDA based its original approvals on for these synthetic colors were not designed for or able to detect neurobehavioral problems in children.

And so, FDA's approvals and the science on which those approvals are based are outdated. This isn't as clear-cut as a bunch of kids getting sick on Halloween. But it does raise concerns for parents and ultimately, state lawmakers. So aside from California, a handful of other states have also introduced bills that would ban certain food additives or take other action to sort of right the wrongs in the FDA regulatory system. This flurry of state action that we have seen in recent years is brought about because of frustration with FDA inaction. Many of these dyes, including Red 3, are already banned or require warning labels in other countries, including all of the European Union. In the US, California being the first state to ban Red 3 is a really big deal because this state is listed as the world's fifth-largest economy. The industry already has the alternative. They already know what to do. They're simply choosing to sell safer food in Europe and less safe food here, rather than remove their products entirely.

We'll likely see them adjust in the US as well. We're actually already seeing it. The ban in California will de facto usher in a national ban on Red 3. This has happened before. In the 1990s, research emerged linking artificial trans fats to heart disease and strokes. While the FDA was going through the process of finding the evidence and honestly taking too long, California stepped up and then banned it in the interim. This ultimately led to a change in the industry. Food manufacturers started removing artificial trans fats from their food as early as 2009. Long before the FDA issued a nationwide ban. This conversation has drawn attention to some major flaws in the way we regulate food in the United States. The current system allows unsafe food chemicals to remain in our food system long after we know that they are unsafe. California is already taking steps to ban other synthetic dyes starting in school lunches. I think it's really important to remember in this whole conversation that these food dyes are not necessary, right?

They exist purely as a marketing tool for the food industry. They don't change the way food tastes. They don't change the nutrition. They don't preserve the food. They offer no benefit beyond the aesthetics of how it looks. And that is not a good reason to put kids at risk. On Halloween or any other day.

Why Red 3 is still in your candy

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In 1950, Halloween candy containing the FDA-approved dye Orange 1 caused widespread illness in children, leading to its ban.

Red 3, another synthetic dye linked to cancer and behavioral issues, is still approved for use in the US, despite its potential harm.

The list of approved synthetic dyes has remained largely unchanged since the late 60s, with Red 3 being a unique case due to its widespread presence in food.

Red 3 was banned from use in topical drugs and cosmetics due to its association with an increased risk of thyroid cancer in rats.

The FDA's Food Additives Amendment of 1958 and the Color Additives Amendment of 1960 required formal approval of color additives, leading to Red 3's initial approval for food use.

Despite the evidence linking it to cancer, the FDA has not yet banned Red 3 across all regulated products, citing the limited relevance of the research to humans.

Red 3 is in violation of the Delaney clause, and despite a petition from CSPI to the FDA for its removal, the dye is still present in food after two years.

California has signed a bill to ban Red 3 from food by 2027, in response to concerns about its potential impact on children's behavior.

Frustration with the FDA's inaction has led to a flurry of similar bills in other states, while the dye is already banned or requires warning labels in other countries.

California's ban on Red 3 is expected to lead to a national ban, similar to the previous impact of the state's action on artificial trans fats.

The current food regulation system in the US has flaws, allowing unsafe chemicals to remain in the food supply for too long.

The use of synthetic dyes in food is primarily for marketing purposes and offers no real benefit, raising concerns about their impact on children's health.