The Food and Drug Administration may finally move to ban artificial red food dye, the coloring found in beverages, snacks, cereals and candies.
At the Senate Health, Education, Labor and Pensions Committee meeting Thursday, Jim Jones, the FDA’s deputy commissioner for human foods, said it’s been over a decade since the safety of the synthetic color additive Red No. 40 has been re-evaluated. “With Red 3, we have a petition in front of us to revoke the authorization board, and we’re hopeful that in the next few weeks we’ll be acting on that petition,” he said.
House Energy and Commerce Committee ranking member Frank Pallone Jr., D-N.J., also urged the FDA to ban Red No. 3, which is made from petroleum and gives food and drinks a bright cherry color.
“With the holiday season in full swing where sweet treats are abundant, it is frightening that this chemical remains hidden in these foods that we and our children are eating,” Pallone wrote in a letter to the agency. “While food companies must ensure that the food they market is safe, they are also only required to ensure that their products meet FDA’s standards. This means that thousands of products that contain this chemical can remain on the market.”
Robert F. Kennedy Jr., President-elect Donald Trump’s pick for health secretary, has claimed food dyes cause cancer, but has not said what he would do if confirmed to the Cabinet post — if anything — about artificial food dyes in American food.
“There are some departments such as the nutrition departments in the FDA that have to go, that are not doing their job, they are not protecting our kids,” Kennedy told NBC News in November.
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The FDA regulates more than three-quarters of the United States’ food supply.
Health
All color additives must be approved by the FDA before they are used in food sold in the U.S. There are 36 FDA-approved color additives, nine of which are synthetic dyes. This includes the two red dyes facing federal scrutiny.
Some of the same dyes that are used in food are also used in pharmaceutical drugs, but the dyes are approved separately for each use. In 1990, the FDA banned Red No. 3, also known as erythrosine, from cosmetics and topical drugs under the Delaney Clause, because the chemical was shown to be carcinogenic at high doses in tests on lab rats.
“We don’t believe there is a risk to humans,” FDA’s Jones said.
Some of the dyes allowed in food in the United States are either banned or require a warning label in other countries. The European Union requires a warning label on products that contain three artificial food dyes approved in the U.S.:
- Yellow No. 5, also known as tartrazine.
- Red No. 40, also called E129 or Allura Red AC.
- Yellow No. 6, called sunset yellow or E110.
The required label warns that the additive “may have an adverse effect on activity and attention in children.”
“There is something called the precautionary principle, which is basically the thought that it’s better to be safe than sorry," said Jerold Mande, an adjunct professor of nutrition at the Harvard T.H. Chan School of Public Health, who is also a former FDA senior adviser and former deputy undersecretary for food safety at the Agriculture Department. “The U.S. wears it as a badge of honor that we don’t adhere to it.”
Other countries do not want to take a risk, even if data on potential harms is not conclusive, he said.
“These food dyes only serve one function in food, to make them look pretty so you and I want to buy it, it’s a marketing tool,” said Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest.
What the science says about artificial food dyes
Some experts and consumer advocacy groups argue there is enough evidence showing some color additives may cause harm, particularly in children, to warrant a ban, but the FDA maintains that its approved artificial food dyes are safe when used in accordance with the agency’s recommendations.
An FDA advisory committee conducted a review of the possible link between artificial food dyes and hyperactivity in 2011 and determined that “a causal relationship between exposure to color additives and hyperactivity in children in the general population has not been established.” The agency revisited the issue in 2019 and maintained its stance. Regulatory agencies and scientists alike have reached conflicting conclusions about what research has found.
“The most concerning is that we do so little science to understand the harms,” Mande said, referring to research funded by the U.S. government.
In a 2012 review of studies on artificial food dyes and ADHD symptoms, which included the research presented to the FDA in 2011, researchers concluded that artificial food colorings “are not a main cause of ADHD, but they may contribute significantly to some cases, and in some cases may additively push a youngster over the diagnostic threshold.”
The researchers also said that three landmark placebo-controlled studies conducted in children in the U.K., which have been cited as reason for banning or restricting the use of artificial dyes, “were barely sufficient to detect the statistically small but clinically important effects noted.”
The European Food Safety Authority also concluded in 2008 that the findings showed “a lack of consistency.”
More than a decade later, officials completed the California Office of Environmental Health Hazard Assessment, a 2021 review of all the available research that studied whether artificial food dyes may have an effect on human health. The conclusion: “Consumption of synthetic food dyes can result in hyperactivity and other neurobehavioral problems in some children, and that children vary in their sensitivity to synthetic food dyes.”
“The evidence now shows pretty conclusively that when some kids eat these, they will experience nervous system effects that look like ADHD,” Galligan said. “There are 27 human clinical trials that show these dyes do in fact harm children’s behavior.”
How the U.S. differs from Europe
Red No. 40 was approved in 1971 and Red No. 3 and Yellow No. 5 were approved in 1969. At the time, the safety trials were conducted in animals, not people. Researchers have since tested safety in a mix of animal studies and a few placebo-controlled trials in children. “We really don’t have the science we should have so these things are a little unclear, but these dyes and behavioral issues, there is an established connection,” Harvard’s Mande said.
The government spends very little money researching synthetic food additives once they are approved, Mande said. Less than 5% of the National Institutes of Health’s research budget goes to studying issues related to nutrition.
Acute harms, such as poisoning, are well understood among FDA-approved products, Mande said, “but the effort to understand the effects in the long term or subtle things like behavior, we don’t study that.”
The FDA lacks a formal way to review substances that are already in the food supply — known as a post-market review — which could allow unsafe additives to linger in the food system even as new research becomes available, said Jennifer Pomeranz, an associate professor of public health policy and management at the New York University School of Global Public Health.
“Even when there is an enormous amount of data, it can take decades to remove something that might be harmful from the food system,” she said. “The FDA clearly needs more resources for post-market research because of these additives that have been in the food system for so long without any post-market review.”
This lack of follow-up sets the U.S. apart from Europe, Jones said at Thursday’s committee meeting.
“The biggest distinction between the U.S. and Europe is that they have been doing post-market review of chemicals for over 20 years,” he said. “The FDA, although we have authorization to do post-market review, there’s no statutory mandate.”
That may change.
In September, the FDA held a public meeting about proposed enhancements to re-evaluating chemicals that have been approved for use in food, including color additives. The agency also extended the public comment period to late January 2025.
An FDA spokesperson said in an email that the food dyes it has approved are reviewed by the Joint Food and Agriculture Organization of the United Nations and World Health Organization Expert Committee on Food Additives.
“In addition to evaluations and review by the FDA, the FDA supports and participates in the international risk assessments conducted under JECFA as a part of our post-market activities to ensure safety of substances added to food,” the spokesperson said. “All the colors listed have recently undergone assessments for safety in food by the JECFA and were found to be safe for use in food under current use conditions.”
States already banning the artificial food dyes
States are already putting pressure on manufacturers to remove artificial dyes from food and beverages. In the last year, three states have introduced or passed legislation banning certain color additives.
In October 2023, legislators passed the California School Food Safety Act. The law will ban six of the nine FDA-approved artificial food dyes –– Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2 and Green No. 3 –– in public school food and drinks by 2027.
In April, Illinois lawmakers advanced legislation that would ban Red No. 3 in the state by 2028.
New York legislators introduced a bill in February that would ban Red No. 3 in food and drinks in the state beginning in 2026.
The moves, particularly in California, could push food manufacturers to remove the dyes from food nationwide, Mande said.
“These food dyes are things that a lot of countries already don’t allow. It’s one thing to produce different foods for different countries, but to do it for different states is a nonstarter,” he said.
Some food manufacturers have already removed artificial dyes from their products.
After years of pressure from the public, Kraft voluntarily removed synthetic dyes from its macaroni and cheese in 2015, replacing Yellow No. 5 and Yellow No. 6 with natural coloring. That same year, Nestlé removed Red No. 40 and Yellow No. 5 from over 250 products, including candy bars.
A ban on the federal level would be relatively simple, Center for Science in the Public Interest’s Galligan said: “They just have to make the decision that it no longer meets the safety standard and issue a decision that it is no longer allowed in food.”
An FDA spokesperson told NBC News that it has reviewed the studies cited by California lawmakers in the California School Food Safety Act.
“The totality of scientific evidence shows that most children have no adverse effects when consuming foods containing color additives, but some evidence suggests that certain children may be sensitive to them,” the spokesperson said in an email.
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