The Food and Drug Administration may finally take action to outlaw artificial red food coloring, which is present in candy, cereals, snacks, and beverages.
Jim Jones, the FDA’s deputy commissioner for human foods, stated during Thursday’s Senate Health, Education, Labor and Pensions Committee meeting that the safety of the artificial colorant Red No. 40 had not been reassessed in more than ten years. We have a petition to revoke the authorization board in front of us with Red 3, and we plan to take action on it within the next two weeks, he stated.
Frank Pallone Jr., D-N.J., a ranking member of the House Energy and Commerce Committee, also requested the FDA to outlaw Red No. 3, a petroleum-based dye that gives food and beverages a vibrant cherry hue.
Pallone stated in a letter to the EPA, “It is frightening that this chemical remains hidden in these foods that we and our children are eating, especially during the holiday season when sweet treats are abundant.” Food firms are only required to make sure that their products fulfill FDA requirements, even though they must also make sure that the food they promote is safe. This implies that hundreds of goods containing this chemical can continue to be sold.
President-elect Donald Trump’s choice for health secretary, Robert F. Kennedy Jr., has stated that food dyes cause cancer, but he has not stated what he would do if the Cabinet post was verified about artificial food dyes in American cuisine.
Kennedy told NBC News in November that some FDA divisions, including the nutrition department, need to be eliminated because they are failing to protect our children and are not performing their duties.
Over three-quarters of the food supply in the US is regulated by the FDA.
Before being used in food that is sold in the United States, all color additives must receive FDA approval. Nine of the 36 color additives that have FDA approval are synthetic dyes. Among them are the two red dyes under government investigation.
Pharmaceutical medications can contain some of the same dyes used in food, but each usage requires a different approval. Because Red No. 3, commonly referred to as erythrosine, was found to be carcinogenic at high levels in lab rat experiments, the FDA prohibited it from cosmetics and topical medications in 1990 under the Delaney Clause.
FDA’s Jones stated, “We don’t think there is a risk to humans.”
In other nations, certain food dyes that are permitted in the US are either prohibited or need to be labeled with a warning. Products containing three artificial food dyes that have been approved in the United States must bear a warning label, according to the European Union:
- 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 necessary label cautions that children’s activity and attention may be negatively impacted by the additive.
The precautionary principle is essentially the idea that it’s better to be safe than sorry, according to Jerold Mande, an adjunct professor of nutrition at the Harvard T.H. Chan School of Public Health and a former senior adviser to the FDA as well as the Agriculture Department’s deputy undersecretary for food safety. The fact that we don’t follow it is a badge of honor worn by the United States.
Even if there is inconclusive data on potential effects, other nations do not want to take a chance, he added.
According to Thomas Galligan, lead scientist for food additives and supplements at the Center for Science in the Public Interest, these food dyes have only one purpose in food: to make it look nice so you and I want to buy it.
What the science says about artificial food dyes
The FDA maintains that its authorized artificial food colors are safe when used in compliance with the agency’s recommendations, despite the claims of certain experts and consumer advocacy groups that there is sufficient evidence that some color additives may be harmful, especially to children, to justify a ban.
In 2011, an FDA advisory group reviewed the potential connection between artificial food colors and hyperactivity and concluded that there is no proof of a causal association between color additive exposure and hyperactivity in children in the general population. In 2019, the agency went over the matter again and stuck to its position. Regarding the findings of studies, scientists and regulatory bodies have come to differing views.
In reference to studies supported by the US government, Mande stated, “The most concerning is that we do so little science to understand the harms.”
Researchers found that while artificial food colorings are not the primary cause of ADHD, they may play a significant role in some cases and in others may push a child over the diagnostic threshold. This conclusion was reached in a 2012 review of studies on artificial food dyes and ADHD symptoms, which included the 2011 FDA-presented research.
The three seminal placebo-controlled studies carried out in children in the United Kingdom, which have been used as justification for restricting or outlawing the use of artificial dyes, were hardly enough, according to the researchers, to identify the statistically negligible but clinically significant effects observed.
In 2008, the European Food Safety Authority likewise came to the conclusion that the results lacked consistency.
The California Office of Environmental Health Hazard Assessment, a 2021 evaluation of all the existing research that examined whether artificial food dyes may have an impact on human health, was finished by regulators more than 10 years later. Conclusion: Children differ in their susceptibility to synthetic food colors, and some may have hyperactivity and other neurobehavioral issues as a result of consuming them.
According to Galligan, the research now clearly indicates that certain children who consume these will have nervous system side effects that resemble ADHD. These dyes do, in fact, negatively affect children’s behavior, according to 27 human clinical research.
How the U.S. differs from Europe
Red No. 40 received approval in 1971, whereas Yellow No. 5 and Red No. 3 received approval in 1969. Animals, not humans, were used in the safety tests at the time. Since then, scientists have examined safety in a variety of animal studies as well as a few child placebo-controlled trials. These things are a bit ambiguous because we don’t have the science we should, but there is a proven link between these dyes and behavioral problems, according to Harvard’s Mande.
According to Mande, once synthetic food additives are legalized, the government invests very little money in their development.Research on nutrition-related topics receives less than 5% of the National Institutes of Health’s research funding.
According to Mande, the FDA is well aware of acute problems like poisoning, but we don’t research long-term repercussions or subtle factors like behavior.
According to Jennifer Pomeranz, an associate professor of public health policy and management at the New York University School of Global Public Health, the FDA does not have a formal procedure for reviewing substances that are already in the food supply, known as a post-market review. This could allow harmful additives to remain in the food system even as new research becomes available.
According to her, removing something that could be dangerous from the food system can take decades, even with vast amounts of data. Because these additives have been in the food system for so long without undergoing a post-market review, it is obvious that the FDA needs additional funding for post-market research.
Jones stated during Thursday’s committee meeting that the U.S. differs from Europe in this lack of follow-up.
According to him, the main difference between the United States and Europe is that the former has been doing post-market reviews of substances for more than 20 years. Despite having the authority to conduct post-market review, the FDA is not required by law to do so.
That might not be the case.
The FDA hosted a public hearing in September to discuss recommended improvements to the re-evaluation of chemicals, such as color additives, that have been approved for use in food. The public comment period was also extended by the agency to the end of January 2025.
In an email, a representative for the FDA stated that the World Health Organization Expert Committee on Food Additives and the Joint Food and Agriculture Organization of the United Nations examine the food dyes that the FDA has approved.
As part of our post-market efforts to guarantee the safety of compounds added to food, the FDA supports and takes part in worldwide risk assessments carried out under JECFA in addition to its own studies and reviews, the spokeswoman stated. The JECFA recently evaluated the safety of each of the mentioned colors in food and determined that they are all safe to use in food under the present conditions of use.
States already banning the artificial food dyes
Manufacturers are already under pressure from states to stop using artificial hues in food and drink. Three states have introduced or enacted laws prohibiting specific color additives in the past 12 months.
The California School Food Safety Act was passed by lawmakers in October of 2023. By 2027, six of the nine FDA-approved artificial food dyes—Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3—will be prohibited from being used in public school meals and beverages.
Legislators in Illinois adopted legislation in April that will outlaw Red No. 3 in the state by 2028.
In February, lawmakers in New York filed a bill that would outlaw Red No. 3 in the state’s food and beverages starting in 2026.
According to Mande, the actions, especially in California, may pressure food producers to stop using the colors in their products across the country.
Many nations currently prohibit the use of certain food colors. Producing diverse cuisines for various nations is one thing, but doing it for various states is impossible, he argued.
Artificial colors have already been eliminated from several food manufacturers’ goods.
In 2015, Kraft voluntarily eliminated synthetic dyes from its macaroni and cheese in response to years of public criticism, substituting natural coloring for Yellow No. 5 and Yellow No. 6. In the same year, Nestl eliminated Yellow No. 5 and Red No. 40 from more than 250 items, 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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