Synthetic food dyes are under fire for potential safety concerns — and amid rising consumer complaints and a petition from researchers and consumer groups, the Food and Drug Administration said this month it is likely "weeks" from a fresh verdict on the most problematic of the bunch: Red 3.
This comes on the heels of a full ban of Red 3 in California last year, along with a ban of six other major artificial food dyes at public schools across the state earlier this fall.
So, how concerned should we be about artificial food dyes, especially for children, and what can we do about it?
The Cool Down spoke to several independent, nonpartisan experts to dig into the science behind synthetic food dyes — and what you should know to protect yourself.
What are artificial food dyes?
Synthetic food dyes are used to give products a bright color, and they're used in candies like Skittles and M&Ms, fruit-flavored snacks, drink mixes and powders, and even pain medications and cough syrup.
Blue 1, Blue 2, Green 3, Red 3, Red 40, Yellow 5, and Yellow 6 — as well as the less frequently used Orange B and Citrus Red 2 — are "added to our food exclusively to increase their visual appeal, to make them look a certain way so that consumers want to buy them," said Thomas Galligan, the principal scientist for food additives at the nonprofit, nonpartisan Center for Science in the Public Interest (CSPI). Galligan has a Ph.D. in biomedical sciences with a focus on toxicology and endocrinology.
The most common of the nine approved artificial dyes used in the U.S. are Red 40, Yellow 5, and Yellow 6, making up 90% of food dye usage in the U.S. More than 36,000 food products contain Red 40, according to the Department of Agriculture, as reported by CSPI.
These artificial dyes are made from petroleum and do not provide any nutrients, preserve food, or otherwise provide any sort of essential function, Galligan explained. And products with food dyes are primarily marketed to children. One study showed that over 43% of products marketed to children contain synthetic food dyes.
"It's a money-making marketing tool for the food industry," Galligan told us.
What's the problem with food dyes?
"The interesting thing about food dyes is that they're fairly unique among food chemicals you'll find in food, because we have very clear evidence of harm in humans," Galligan said.
Galligan's concerns are part of a rising chorus of industry voices raising further alarm in recent years, culminating in a recent groundswell of support that has included a major public petition this fall from the independent consumer advocacy organization Consumer Reports.
"Studies have linked synthetic food dyes to inattentiveness, learning difficulties, and other adverse behavioral outcomes in children," Brian Ronholm, the organization's director of food policy, told TCD.
"A landmark study released in 2021 by the California Office of Environmental Health Hazard Assessment found that many food dyes are known to make some children vulnerable to behavioral difficulties and decreased attention."
The California study evaluated the seven most commonly used food dyes across 27 human clinical trials and concluded that "food dyes can have long-term impacts on children if kids are continually exposed to them," including causing hyperactivity, inattentiveness, and restlessness "that then impairs their ability to succeed in school or socially," he said.
"It's a very strong conclusion that's based on human, animal, and in-vitro evidence," Galligan added.
Red 3 is of particular concern because, in addition to the neurobehavioral effects shown in the California study, "it's been shown to cause [thyroid] cancer in rats," Galligan said. "The FDA itself determined that Red 3 is an animal carcinogen in 1990 and have been obligated to ban it ever since … and they have just failed to do so for approaching 35 years."
There are other reported health issues with artificial food dyes, too, most notably that some people are allergic to Yellow 5. But avoiding them isn't simple, as the dyes are ubiquitous in grocery stores nationwide.
And that ubiquity, Galligan says, is part of the problem even for those not actively trying to avoid them, because "ongoing exposure to the food dyes can be a serious problem."
"The FDA itself determined that Red 3 is an animal carcinogen in 1990 and have been obligated to ban it ever since … and they have just failed to do so for approaching 35 years."
– Thomas Galligan,
Center for Science in the Public Interest
Are synthetic food dyes safe in any quantity or for anyone?
While it appears that some children seem to be predisposed to be particularly sensitive to synthetic food dyes, "it's unclear what's the driver of that predisposition," Galligan said.
And though the FDA had set "safe" levels for acceptable daily intake, Galligan said: "Right now, the levels that they're used at do clearly present a risk to some kids." Furthermore, for kids sensitive to food dyes: "It's unclear exactly what the 'safe' dose might be for a kid that's sensitive to dyes."
Companies also don't have to disclose how much food dye is in a product, making it hard to calculate the amount consumed.
As stated in an op-ed by Consumer Reports CEO Marta L. Tellado: "Since there are no nutritional benefits to food dyes … why risk it, especially for children?"
Why hasn't the FDA banned artificial dyes?
The FDA says that "color additives are safe when they are used in accordance with FDA regulations," including provisions on "the types of foods in which it can be used," "any maximum amounts allowed to be used," and "how the color additive should be identified on the food label."
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But part of the problem, as Consumer Reports and the CSPI see it, is that these safety determinations are not regularly reassessed — and instead, there is a much bigger burden of proof to change the status quo than to keep it.
"In many cases, the FDA has either never had an opportunity to review food additives — or the last time they did was 40-60 years ago," Ronholm said.
In 2022, the CSPI, Consumer Reports, and over 20 scientists and organizations took extra measures to petition the FDA to ban Red No. 3, requiring the FDA to reevaluate the safety of food additives.
Since 2010, the European Union has had a requirement that foods that contain certain synthetic food dyes, including Red 40, Yellow 5, and Yellow 6, have a warning label on the product to indicate that they may impact children's behavior. This action, similar to requiring warnings on cigarette packages, had a massive effect on swaying companies to shift gears.
After all, if the color has no value to the taste or nutrition of the food and is only added to help it sell, big labels pointing out potentially unwanted ingredients would surely do the opposite.
"Some companies who sell products in the U.S. and the EU changed their formulas for the European market and got rid of those dyes entirely to avoid having to put that warning label on their product," Galligan explained. "So, you have companies that are selling the exact same product, like Skittles or M&M's, in the EU with different, safer color additives while continuing to sell the more harmful products in the U.S."
His conclusion: "It's a choice that the food industry is making, which is quite shameful, in my opinion."
Why do companies continue to use them? The FDA's website says they are used widely "because they impart an intense, uniform color, are less expensive, and blend more easily to create a variety of hues."
"It's a choice that the food industry is making, which is quite shameful, in my opinion."
– Thomas Galligan,
Center for Science in the Public Interest
"There's a clear value-add for the food industry to use these chemicals, otherwise they wouldn't use them," Galligan suggested. "It must be the most cost-effective way to achieve their goal, which is to sell food."
As the CSPI's website says, the FDA delisted Red 3 in cosmetics and topical drugs way back in 1990 after studies linked it with cancer. According to the CSPI, the FDA said it intended to do the same for food products soon after, but the maraschino cherry industry began fighting this effort in 1989, and the consensus is that the issue has been stuck on the back burner ever since.
What should consumers do?
"There should be concern, but consumers shouldn't panic," Ronholm said. "It's unfair that the current regulatory system creates an unfair burden on consumers, but it will require work from consumers to get educated on food additives and identify which ones to avoid."
One resource to educate consumers is the CSPI's "Chemical Cuisine" database, which independently ranks food additives by reviewing available scientific evidence and labeling them as "safe," "cut back," "certain people should avoid," "caution," or "avoid."
Customers can then look at product labels to avoid harmful additives, or they can use food-scanning apps such as Yuka, which recently added a feature to allow shoppers to email companies directly to provide feedback on ingredient choices.
"For all the food dyes, we do recommend that all consumers avoid them given the risks that they pose — and that's easier said than done," Ronholm said.
Avoiding ultra-processed foods, many of which contain additives that increase the long-term risk of health problems, "would be a positive step," Ronholm says, as well as looking for vegetable- and fruit-based food dyes such as turmeric and beet juice. "There are natural alternatives available — especially for dyes — that are less toxic and even just as cost-effective."
"Part of the problem with FDA's failure to act is that it does fall on consumers to have to protect themselves," Galligan said. "It's a big burden to ask consumers to review the ingredient list of every food product they ever consider buying, and certainly it's made even harder by the fact that when you're out dining at a restaurant you may not have access to an ingredient list."
"There should be concern, but consumers shouldn't panic."
– Brian Ronholm,
Consumer Reports
If the FDA decides to ban Red 3, it will take some time to become a reality. When the FDA decided to ban a chemical called BVO (brominated vegetable oil) in 2024, it gave companies a year to comply. As Ronholm said, companies already have a head start on replacing Red 3 either way since they have to in order to sell a product in California by 2027.
But Galligan said: "Red 3 is a symptom of a broader problem. … The FDA makes their approval decades ago and then never meaningfully reassesses the safety of these chemicals, even as evidence mounts that they are harmful, and so these chemicals linger in our food supply long after evidence of harm emerges. And that's really unacceptable."
The FDA recently announced it'll take a more proactive stance in assessing the safety of chemicals in our food, which Galligan says "is another good step forward."
Even with action on food dyes, many steps will remain. Estimates show that there are over 10,000 chemicals added to food packaging, for instance, so as Galligan pointed out: "That's a lot of chemicals to stay on top of."
That will also require more funding from Congress to provide the FDA with adequate resources.
"Our goal is to reform the whole broken system, and going chemical by chemical is one way to make progress, but it's one chemical at a time versus a systems-level reform. So we're hoping for Congress and the FDA to really step up and reform the whole system and take care of these chemicals in more of a one-fell-swoop kind of approach."
"It's a big burden," Galligan said, "but it's their obligation to American consumers."
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