If you’ve been wondering why red dye 3 was recently banned after over 60 years of use, you may be surprised to learn what’s going on behind the headlines…
Recently, Ann and I hosted a Student Enrichment Experience (SEE) seminar for middle schoolers throughout Lancaster County. We combined cooking and nutrition into a 90-minute session, covering some basics (What are macronutrients? What is the most accurate way to measure ingredients?), engaging in conversations about current food trends, and demonstrating how to make Energy Bites, a reader favorite on the blog.
One student asked, “How do you know which chemicals in food are harmful?” It was a wonderfully relevant question, as it hit on many hot topics, including labeling and ingredient lists, nutrition research, and FDA oversight of food safety.
I answered the student’s question more broadly, but I had an inkling that he may have gotten inspiration from recent headlines concerning red dye 3. I didn’t have time to thoroughly go down that rabbit hole during the seminar, but the silver lining is that his question inspired me to do the deep dive on red dye 3 for our FAK readers!
Because there’s definitely more to this than what the headlines tell us..
A quick recap of what’s been going on with the red dye situation:
There are a few different types of red dye in food products. Specifically, red dye 3 (or erythrosine) is an additive that enhances the red color in foods like cereals, candies, cookies, frozen desserts, and more. It is derived from petroleum, which sounds super alarming, I know. As a frame of reference, for better or worse, there are thousands of common products made with petroleum, including water pipes, vitamin capsules, artificial limbs, and anesthetics.
In January 2025, the FDA revoked the authorization to use red dye 3 in food and beverages (with a reformulation mandatory start date of January 2027) and drugs (with a mandatory start date of January 2028). They stated that their decision was based on a matter of law, and as we will cover below, this is a very important distinction.
The decision comes on the heels of California taking matters into their own hands in 2023 by banning the manufacturing or sale of products with red dye 3. Other countries like Australia, Japan, and countries in the EU have also banned it.
And just this week (as this article was going live!), RFK Jr., appointed head of the Department of Health and Human Services, said he planned to phase out all artificial food dyes by the end of the year, pushing for an even earlier date than the one initially posted in January 2025.
Is this a major win?
In some ways, yes. It shows a willingness for change and perhaps gives the American people more confidence and trust in the FDA. And also peace of mind that there will be less chemical additives in our food supply.
Additionally, there’s little push back from consumers on this decision. Besides companies who may think the color is critical to the look of their product, people won’t miss it. Red dye 3 has no redeeming nutritional qualities, doesn’t enhance flavor, and is a completely unnecessary substance.
So maybe it’s more like an easy win?
Why did the FDA announce the ban, now, in 2025?
For decades the public has voiced concern that red dye 3 is carcinogenic in humans, but red dye 3 has remained authorized. So, something must have happened recently to change minds at the FDA. Right?
Well interestingly, it’s not because of any new or novel studies, but rather a research study done about 30 years ago showing very high doses of red dye 3 could cause cancer in male rats. Using these conclusions, a petition was submitted in 2022 claiming the FDA was violating the Delaney Clause by allowing red dye 3 in food and drugs.
What is the Delaney Clause?
Enacted in 1958, the Delaney Clause prohibits FDA authorization of an additive if it has been found to induce cancer in humans or animals. With this clause in mind, it makes sense that red dye 3 would be banned.
But does the timeline seem odd? If we’ve known since the 1990’s that red dye 3 causes cancer, why didn’t the FDA ban it sooner? Here’s a current statement, verbatim, from the FDA’s website:
The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.
Putting the pieces together…
Ah, OK, so this makes more sense. In one way, it’s understandable that if red dye 3 is not causing harm to humans, it could be considered safe in food and drugs.
On the other hand, the Delaney Clause clearly states if additives induce cancer in animals, the FDA should ban it for human consumption as well. This is why the FDA made sure to state that the reason this was going into effect was due to “a matter of law” as noted above.
And this is where it gets murky…
What does that 1990’s research study actually say?
While I do have university access to scientific research (including papers that most people cannot see in full) so that I can do adequate research for you, I couldn’t view more than the abstract, or intro, for this one.
I have a few friends who are doctors in town, and they also couldn’t access it, even through their hospital (and university hospital!) affiliations. I emailed the researcher himself (he’s 94, by the way) and am still awaiting a copy of the study. But if health professionals can’t even see the primary source, are we just relying on a handful of soundbites from various journalists to interpret the conclusions for us?
My point being, there is more to this than just the headlines, and it is nearly impossible for us, especially without access to the research, to formulate our own opinions here.
Should we be worried about red dye 3 in foods we eat from now until 2027?
I did find a recent quote from the researcher himself, Jospeh Borzelleca, professor emeritus of pharmacology and toxicology at Virginia Commonwealth University, which gives us a bit more insight.
He says, “If I thought there was a problem, I would have stated it in the paper…I have no problem with my family — my kids and grandkids — consuming Red 3. I stand by the conclusions in my paper that this is not a problem for humans.”
And let’s remember, red dye 3 has been used to enhance the color of certain foods as well as various pharmaceuticals since the 1960’s. So, to Michael Pollen’s dismay, not only could my grandmother pronounce “red dye 3,” she was also probably eating it.
I’m not insinuating that just because something has been around for a while, it can’t cause us damage (we all remember Johnson &Johnson baby powder). It’s just a reminder that dyes in food is not a new phenomenon or concept.
What does The Academy of Nutrition and Dietetics say?
This is the largest organization of nutrition professionals and the central resource for most nutrition practices, including those at doctor’s offices and hospitals around the country. They made a statement about the recent ban, which I find to be reasonable and a helpful way to look at things:
Making America’s food supply healthier is a great step toward improving public health, reducing chronic diseases, and fostering a stronger, more resilient society. However, it is important to note that no one ingredient or food increases cancer risk. It is the amounts and patterns of food consumed over time, along with other genetic and lifestyle factors, that influence health risk.
I think this hits on the overarching point. Foods with dyes are also typically the most ultraprocessed. These are foods we do not want to consume in excess. And because bright colors attract kids’ attention, it is our children who are often most vulnerable to this category of foods in general. And that’s perhaps why it concerns us the most.
But, if we remove an artificial food dye from an ultraprocessed food, is there a false sense of security that this food is now healthy for us? It doesn’t magically remove the risks of a diet heavy in ultraprocessed foods. Despite what is being said about dyes, I’m hard-pressed to understand how they could directly be linked to obesity, when in all likelihood excessive intake of the ultraprocessed food (regardless of artificial dyes) is likely the bigger culprit.
What about behavior changes, ADHD, and hyperactivity in children?
In related but different content, there are questions over whether red dyes (most specifically #40) cause hyperactivity or ADHD in children. This is a separate conversation based on different scientific studies. I can cover this one at another time!
For now, the American Academy of Pediatrics recommends children limit foods that often contain synthetic dyes, such as sugary drinks, juices, and candy, that may affect children’s behavior and attention.
Nothing new.
A note on FDA oversight
I’ve mentioned this before, but specifically in discussions about dietary supplements. The FDA seems to have more of a hands off or passive approach in general. As opposed to constantly testing or doing research to ensure food safety, they often rely on consumer or advocacy group complaints prior to doing investigations – like innocent until proven guilty. This is a hard one for me to swallow.
Also, because food dyes are listed in the ingredients but not the exact amount, we can’t know how much we’re consuming per serving. Throw us a bone FDA! This is why avoiding it all together makes sense to people. There’s no way to tell how much we’re taking in, and this can feel scary.
So, what’s the point? How do we apply this to real life?
We have to use common sense here. A diet consisting of daily bags of Swedish fish won’t do us any favors…but that may be the whole (and rather uninteresting) moral of the story!
Key Takeaways
- Red dye 3 is no longer authorized in foods or drugs starting in 2027 and 2028, respectively.
- It’s unclear what kind of health impact red dye 3 has on us, but it is unlikely to cause cancer in humans (who eat more than just red dye) based on the 1990 study at the forefront of the petition sent to the FDA in 2022.
- In general, avoid excessive intake of ultraprocessed foods, including foods with red dye 3. Focus more on consuming a wide variety of foods, so as not to put your eggs all in one basket, so to speak.
Please leave any questions or comments below regarding red dye 3. And, if you’re interested in personal nutrition counseling, read more about how you can connect with me one on one!
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