During a recent press conference, Dr. Marty Makary, head of the FDA, and HHS Secretary Robert F. Kennedy Jr. outlined six steps the FDA is taking to phase out the dyes, which have been linked to neurobehavioral issues in children.
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The U.S. Department of Health and Human Services (HHS) today said it will phase out all petroleum-based synthetic dyes from U.S. foods and medications.
In a press conference late this afternoon, Dr. Marty Makary, head of the U.S. Food and Drug Administration (FDA), and HHS Secretary Robert F. Kennedy Jr. outlined six steps the FDA is taking to phase out the dyes:
- Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
- Initiating the process to revoke authorization for two synthetic food colorings — Citrus Red No. 2 and Orange B — within the coming months.
- Working with industry to eliminate six remaining synthetic dyes — FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2 — from the food supply by the end of next year.
- Authorizing four new natural color additives in the coming weeks, while also accelerating the review and approval of others.
- Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
- Requesting food companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required.
“Today, the FDA is asking food companies to substitute petrochemical dyes with natural ingredients for American children as they already do in Europe and Canada,” Makary said in a press release.
At today’s event, Makary pointed out that numerous studies, including one published in The Lancet, have shown that artificial colors in children’s diet caused an increase in hyperactivity.
“Moms and dads have also tried to raise the issue,” Makary said. “Some parents have observed that these chemicals cause hyperactivity — and even aggressive behavior — and that it subsides when the chemicals are removed from the diet of the child and sometimes even reoccurs when those petroleum-based chemical dyes are reintroduced.”
Makary said his practice as a doctor taught him to “always listen to the mom.”
Other studies have shown that artificial dyes “mess with the child’s developing brain” by making ultraprocessed foods look attractive, “even when the child already feels full,” Makary said.
Getting petroleum-based dyes out of foods isn’t a “silver bullet” for solving U.S. children’s health issues, but it’s an “important step,” he added.
Kennedy agreed, saying that roughly only 3% of U.S. children had chronic disease during his uncle, John F. Kennedy’s, era. “Today it’s around 60%.”
‘Why gamble with the health of our children?’
Today’s announcement came as no surprise. Last month, Kennedy called on top executives from major food companies, including General Mills Inc. and Kraft Heinz Co., to remove artificial dyes before the end of his term.
Kennedy today commended the food companies for working with him on the issue.
Within the next four years, products containing petroleum-based synthetic dyes will either be off U.S. shelves or labeled as containing the substances, so that consumers are informed, Kennedy said.
Petroleum-based dyes are used in hundreds of thousands of U.S. food products, according to The New York Times.
But in Europe, where a warning label is required for some synthetic dyes, companies have already shifted to using natural color substitutes, the Times said.
Additionally, in Canada, Kellogg’s uses natural watermelon and carrot juice to color Froot Loops cereal, according to the BBC.
Currently, the FDA allows nine artificial dyes in U.S. foods.
Until now, the FDA has claimed that “color additives are safe when they are used in accordance with with FDA regulations,” while noting that “some evidence suggests that certain children may be sensitive to them.”
“My feeling is, why gamble with the health of our children? … We have some data points. We have some observational studies. We believe that these artificial food chemicals are implicated. My feeling is, Why not err on the side of safety? Why say, ‘Let’s just take the risk because the vibrance of the colors is so appealing, it’s worth it.’”
Research links dyes to neurobehavioral issues in kids
For years, research has piled up showing that common food dyes may harm human health.
For example, a 2021 report by the California Office of Environmental Health Hazard Assessment (OEHHA) found that synthetic food and drink dyes negatively affect attention and activity in children.
California’s report reviewed results of 27 clinical trials in children performed on four continents and animal studies on the neurobehavioral and neurological effects of seven dyes: Blue No. 1, Blue No. 2, Green No. 3, Red No. 3, Red No. 40, Yellow No. 5 and Yellow No. 6.
The dyes appeared in breakfast cereals, candy, soft drinks, juice, frozen dairy desserts and icings. “Evidence shows that synthetic food dyes are associated with adverse neurobehavioral outcomes in some children,” said OEHHA Director Lauren Zeise in a press release.
On Jan. 15, the FDA banned Red No. 3, citing evidence linking the synthetic dye to cancer in animals. The move came after safe food advocacy groups for years had petitioned the agency to ban it.
But Red No. 3 isn’t the only synthetic dye that groups want the FDA to ban.
For instance, the Environmental Defense Fund, the Center for Food Safety (CFS), the Center for Science in the Public Interest (CSPI) and the Environmental Working Group (EWG) in March 2023 asked the FDA to remove titanium dioxide, a colorant used in Kraft Cheddar Fat Free Shredded Cheese and Little Debbie Fudge Rounds, according to CSPI.
The groups cited evidence that the titanium dioxide’s nanoparticles may accumulate in the body and cause health issues, including cancer. “Europe has banned it and last week the state of Arizona banned it,” CFS Policy Director Jaydee Hanson told The Defender.
Food dyes’ sole purpose is ‘to make food companies money’
Safe food advocates welcomed the FDA’s plan to phase out synthetic dyes.
Dr. Peter Lurie, president of the CSPI, said in a statement, “The most important thing to know about food dyes is that their only purpose is to make food companies money.”
The dyes have no nutritional value and only “help make ultra-processed foods more attractive, especially to children,” Lurie said. “We don’t need synthetic dyes in the food supply, and no one will be harmed by their absence.”
Jerold Mande, an adjunct professor of nutrition at the Harvard T.H. Chan School of Public Health, told NBC in an email that food dyes contribute to over-eating and obesity by making ultraprocessed foods look more appealing.
Overweightness is “the primary food cause of cancer,” according to Mande, who formerly served as an FDA senior adviser and the U.S. Department of Agriculture’s deputy undersecretary.
Mande wrote:
“Thus, we must regulate the use of both synthetic and natural colors as well as flavors that allow food companies to transform powders and sludges into calorically dense, hyperpalatable ultra processed ‘foods’ that are making us and our children sick.”
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Many states move to ban dyes
Some states weren’t willing to wait for the FDA to take action on food dyes. Last month, investigative journalist Carey Gillam reported that at least a dozen states were pushing laws to ban food dyes.
On March 5, West Virginia passed a sweeping ban on certain yellow, blue, green and red dyes commonly used in drinks, snacks, candies and other foods.
In 2024, California banned six food dyes from foods served in children’s school lunches. Other states recently pushing legislation against synthetic dyes include New York, Virginia and Oklahoma.
“We’re pleased the administration is following the lead of states like California and West Virginia by finally announcing their intent to ban dyes,” said Melanie Benesh, EWG vice president for Government Affairs, in a statement. “We’re grateful that states like California and West Virginia have forced the FDA to make food safety a bigger priority.”
When asked for comment on the legislative activity, the National Confectioners Association told Gillam that the measures “will make food significantly more expensive for, and significantly less accessible to, people in the states that pass them.”
However, Makary pushed back against the claim. “To be clear,” he said, “the transition from petroleum-based food dyes to natural ingredient food dyes will not increase food prices. We know that from other countries that have already made the transition.”
The National Confectioners Association did not immediately respond to The Defender’s request for comment on the FDA’s plan to phase out petroleum-based synthetic dyes.
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