The FDA Just Banned Red Dye No. 3: The Future of Processed Foods

UPDATE 1/15/25:

The Food and Drug Administration (FDA) just announced in a press release that a ban on red dye No 3. would be in effect, and all U.S.-based food manufacturers have until January 27, 2027 to reformulate their products to meet the new standard. The dye—found in everything from soft drinks to candy coatings—is being removed based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act of 1938 which states that any study published that can link a food additive to cancer in animals can allow the FDA to enact a ban. The study referenced is one that was only done in rats, which caused some male rats under observation to develop cancer based on a hormonal function that’s specific to rats. However, it’s worth it to note that while the cherry-red No. 3 is officially banned across the country, red No. 40 (a darker red colorant) is still allowed in use.

PREVIOUS 11/25/24:

With social media influencers calling for the boycott of Froot Loops, health misinformation around food dyes is at an all-time high. It doesn’t help that Robert F. Kennedy Jr.—the founder of the “Make America Healthy Again” (MAHA) movement, and recent Department of Health & Human Services (HHS) secretary nominee—has vowed to “end corruption” in the U.S. Food and Drug Administration (FDA), which includes banning artificial food dyes in products.

In an interview with NBC News earlier this month, Kennedy made false, inflammatory claims, stating, “We have 1,000 ingredients in our food that are illegal in Europe that are illegal in other countries and they’re making our kids sick.” Kennedy later said, “Why do we have Froot Loops in this country that have 18 or 19 ingredients, and you go to Canada and it’s got two or three?”

However, these claims are unfounded. Froot Loops sold in the U.S. and Canada both contain 27 ingredients. Plus, many food dyes approved by the FDA are also approved in Europe—they are just labeled differently. While we know Allura Red AC (chemical name) as Red 40, in the European Union (EU), additives go by “E names,” so their common names are dissimilar. In Europe, Red 40 is E 129.

Andrea Love, PhD, immunologist, microbiologist, and author of the Immunologic newsletter, explains that all colorings used in the foods we eat are assessed by food safety and toxicology experts at the amounts that we would, on average, consume them in whatever product they come in. From there, each food has “an acceptable daily intake level assigned to them, which is the amount you could consume, every day, for your entire life, with no concerns about health impact,” Love says.

According to Love, other governments, including those in Europe, Canada, Australia, and Japan, follow the same approach to assessing additives in food, and they allow the very same food dyes the U.S. approves of. Food dyes are labeled differently because, in the U.S., the FDA approves and defines them under the Federal Food, Drug, and Cosmetic Act (FD&C). Hence, the FD&C in the name (for example, FD&C Red No. 40 or Red 40). In Europe, the European Food Safety Authority (EFSA) uses a different system, Love explains, which is where they get the “E names.”

Although research linking health risks to artificial food dyes is inconclusive, food dyes have become a hot-button issue for voters. In September, California passed legislation that prevents schools from serving foods with blue, green, red, and yellow additives, such as Froot Loops cereal and Flamin’ Hot Cheetos, for this very reason. The ban includes Blue 1, Blue 2, Green 3, Red 40, Yellow 5, and Yellow 6 (which are six of the nine FDA-approved color additives found in food and beverages). Now, nine other states—including New York, New Jersey, Pennsylvania, and Rhode Island—have introduced bills that would ban certain food dyes or other additives.

So, why does there seem to be a mass calling for food dye bans now? Read up on what the current research on food dyes says, and which foods and beverages would be affected should these bans become more widespread.

Why are bans on artificial food dyes happening?

This isn’t the first time politicians have talked about banning food dyes. In October 2023, Governor Gavin Newsom signed the California Food Safety Act, which prohibits food products containing Red 3 (used in purple and pink Peeps), brominated vegetable oil, potassium bromate, and propylparaben. The original act also included titanium dioxide, which is how Skittles makes that little ‘S’ label, and why media referred to it as “The Skittles Ban.” The ban later went forward without including the additive. Backers of the bill say these chemical additives have an array of health risks, including cancer.

These claims continue to be disproven by food scientists. “Red dye 3 has been evaluated by animal testing to be carcinogenic (cancer-causing substance) at high concentrations, but limited studies have demonstrated that there are potential health issues with this colorant in humans,” says Bryan Quoc Le, PhD, a food scientist and food industry consultant. After reviewing these animal studies, the FDA determined that the link between Red 3 and cancer in rats doesn’t occur in humans, so they didn’t revoke the authorized use of Red 3 in foods.

With Kennedy expected to head the HHS, followers of the MAHA movement, a coalition of voters and activists who are looking to “clean up” government agencies that they claim have been taken over by “Big Pharma” and “Big Food,” are lobbying for him to overhaul the systems that regulate food additives.

The research on food dyes

Kennedy has said that artificial food dyes are linked to cancer and hyperactivity in children with attention-deficit/hyperactivity disorder (ADHD), a neurodevelopmental condition that causes inattention, hyperactivity, and impulsivity. And because children, in particular, are a large target audience for foods with dyes—such as candies, packaged snacks, juices, and sodas—they are more vulnerable to these health risks. However, current research on artificial food dyes and ADHD doesn’t show any direct links.

“The studies being cited as evidence of harm are based on parent self-reporting of ADHD symptoms and there is no causal relationship identified,” Love says. “There is zero evidence these things cause cancer at exposures we would have, but RFK Jr. and others who claim this frequently cite animal studies where animals are given mega doses of these substances, which would cause harm no matter what the substance was.” Love also says these “mega doses” are upwards of 10 percent of an animal’s body weight. Body weight is important to consider for dosages, as the size of a body affects the concentration of the substance. So, in the case of animal studies, chemicals at 10 percent of a mouse’s body weight would mean a large concentration in their small bodies. For humans, if a person weighs 150 pounds, that would mean consuming fifteen pounds of something.

A 2022 review of studies published in Cureus looked at synthetic blue food coloring and its possible role in causing ADHD symptoms in children. Researchers found that restricting foods with artificial food dyes may help improve symptoms in some children with ADHD, but they weren’t able to pinpoint the exact source of these changes. In addition, a 2015 meta-analysis found that limiting artificial food dyes benefited only a small number of children with ADHD, which suggests that the benefits of dietary intervention as a treatment for the condition are unclear.

Le points out there is limited research on the effects of individual food dyes on humans. According to the same review above, mice studies have shown that Blue 1 has been found to affect neurodevelopment and cause hyperactive behavior when given in mega doses. But again, human studies are needed to determine how these individual food dyes may affect people, not mice. Therefore, there isn’t enough research to draw conclusions from the results of these studies.

Moreover, a 2022 review in Environmental Health shows that acceptable daily intakes (ADIs) for synthetic food dyes weren’t designed to assess the types of behavioral effects observed in children, so more research is needed on ADIs for food dyes to evaluate their neurobehavioral effects.

Kennedy has also been vocal about the cancer-causing effects of Yellow 5 (aka tartrazine), but a 2015 study shows that most DNA damage can be repaired. The damage that remained high was a result of long-term exposure. This suggests that prolonged and excessive use of tartrazine could trigger carcinogenesis (formation of cancer), but not at exposure levels people typically have.

Studies on foods containing Red 40 have shown it can also cause DNA damage, but they have only been done in vitro (in a lab dish or test tube) and in vivo (in animal studies, such as mice), and you can’t apply these results to humans. Therefore, additional research is needed.

Which foods are affected?

If a federal ban on these artificial food dyes goes into effect, breakfast cereals and candies won’t be the only foods affected. As the FDA notes, these color additives are also in beverages, frozen dairy desserts, cake frostings and icings, yogurt and other dairy products, puddings, condiments, and sauces.

“Dietary supplements also use colorings often, especially vitamins and gummy supplements,” Love says. “It would also impact medications like capsule coatings and liquid medicines, as well as cosmetic products, dental products, and even things like Play-Doh, markers, candles, decorations, and pet food/treats.”

What could happen if we ban these food dyes?

Food manufacturers would have to adjust their products to remove these artificial food colorings and reformulate them with other dyes that get approval, Le says. Kennedy and MAHA activists say they would like to replace artificial food dyes with dyes derived from natural ingredients, such as turmeric, spirulina, and berries. However, experts believe it will come at a huge environmental cost.

“There is likely to be an increase in food waste as natural dyes are used because they’re much less stable than their artificial dye counterparts, Le says. “Most food companies do not want to lose market share because of inferior coloring, as appearance is a significant factor in consumer purchasing decisions.”

Love also notes that the amount of food coloring currently used in food products is minuscule and replacing them with natural dyes is a distraction from addressing real health and nutrition issues. She calls this the ‘appeal to nature fallacy’. “Whether something is a natural chemical or an entirely synthetic chemical has no bearing on the safety of the chemical,” she states. “There are plenty of natural chemicals that can be incredibly harmful at low exposures and plenty of synthetic chemicals that are incredibly safe even at high exposures.”

Because natural food dyes are expensive, the cost of producing cereals and other foods and/or medications and supplements with them will also increase, and consumers are going to have to pay for these costs, Le says.

And, because food manufacturers will need to resubmit their products for regulatory review and approval, it would cause disruption and delays and impact global trade. Ultimately, consumers will have to deal with the fallback.

Love also notes that people of lower socioeconomic status and those who live in areas that have limited access to nutritious, affordable foods are going to be more negatively affected as these shelf-stable foods with dyes may be a larger part of their overall diet.

“What we should be focusing on is making fruits and vegetables more affordable and accessible for everyone, which includes alleviating misinformation about pesticide risks on conventionally grown produce” Love says. “which RFK Jr. has spread for decades and scares people away from eating fruits and veggies.”

What comes next?

For now, only California has signed bills into effect, while other states may follow suit in the next few months. The California ban won’t take effect until late 2027, so the general public is unlikely to see major product shifts for a few years. As part of a balanced diet, including some of these processed foods shouldn’t negatively impact your overall well-being, says Love. “Whether a cereal has a singular ingredient in it at minuscule levels has no bearing on health.”