The FDA could finally take action to outlaw artificial red food coloring, which is included in drinks, snacks, cereals, and sweets.
Red No. 40, a synthetic color additive, has had its safety reexamined for more than ten years, according to Jim Jones, the FDA’s deputy commissioner for human foods, who spoke at the Senate Health, Education, Labor and Pensions Committee hearing Thursday. “With Red 3, we have a petition to revoke the authorization board before us, and we hope to be taking action on that petition in the coming weeks,” he stated.
Frank Pallone Jr., a Democrat from New Jersey and ranking member of the House Energy and Commerce Committee, also called on the FDA to outlaw Red No. 3, a petroleum-based dye that gives food and beverages their vivid cherry hue.
In a letter to the FDA, Pallone stated, “It is alarming that this chemical is still present in the foods that we and our kids are consuming during the holiday season, when sweet treats are plentiful.” Food firms just need to make sure that their goods adhere to FDA regulations, even though they must guarantee the safety of the food they sell. This implies that the market can continue to carry thousands of items that contain this chemical.
The health secretary nominee for President-elect Donald Trump, Robert F. Kennedy Jr., has stated that food dyes cause cancer, but he has not stated what he would do if the Cabinet position was approved regarding artificial food colors in American cuisine.
“Some departments, like the FDA’s nutrition departments, need to be eliminated because they are not performing their duties and are not safeguarding our children,” Kennedy stated to NBC News in November.
More than three-quarters of the food supply in the US is governed by FDA regulations. Before any color additive is used in food that is sold in the United States, the FDA must approve it. Nine of the 36 FDA-approved color additives are synthetic dyes. This contains the two red dyes that are under government investigation.
Although they are allowed for each purpose independently, several of the same colors used in food are also used in pharmaceutical medications. Under the Delaney Clause, the FDA prohibited Red No. 3, sometimes referred to as erythrosine, from being used in cosmetics and topical medications in 1990 after lab rats found the chemical to be carcinogenic at high concentrations.
According to FDA’s Jones, “We don’t believe there is a risk to humans.” In other nations, certain food colors that are permitted in the US are either prohibited or need to be labeled with a warning. Products containing three artificial food colors that have been authorized in the United States must include a warning label, according to the European Union:
- Another name for Yellow No. 5 is tartrazine.
- Red No. 40, sometimes known as Allura Red AC or E129.
- Yellow No. 6, also known as E110 or sunset yellow.
The addition “may have an adverse effect on activity and attention in children,” according to the mandatory label.
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 possible effects, other nations do not want to take a chance, he added.
Thomas Galligan, chief scientist for food additives and supplements at the Center for Science in the Public Interest, stated that the sole purpose of these food colors is to make food seem appealing so that you and I want to purchase it.
What science has to say about synthetic food coloring
The FDA insists that its authorized artificial food colors are safe when used in compliance with the agency’s guidelines, but other experts and consumer advocacy groups contend there is enough evidence that some color additives may be harmful, especially to youngsters, to justify a ban.
“A causal relationship between exposure to color additives and hyperactivity in children in the general population has not been established,” according to a 2011 FDA advisory committee examination of the potential connection between artificial food colors and hyperactivity. In 2019, the agency went over the matter again and stuck to its position. Regarding the findings of studies, experts 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.”
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,” according to a 2012 review of studies on the subject that included the 2011 FDA-presented research.
The three seminal placebo-controlled trials carried out in children in the United Kingdom, which have been used as justification for reducing or outlawing the use of artificial colors, “were barely sufficient to detect the statistically small but clinically important effects noted,” the researchers added.
In 2008, the European Food Safety Authority likewise came to the conclusion that there was “a lack of consistency” in the results.
The California Office of Environmental Health Hazard Assessment, a 2021 evaluation of all the existing research that examined the potential health effects of artificial food colors, was finished by regulators more than ten years later. The conclusion states that “children vary in their sensitivity to synthetic food dyes and that consumption of synthetic food dyes can result in hyperactivity and other neurobehavioral problems in some children.”
“There is now pretty clear evidence that some children who eat these will have nervous system effects that resemble ADHD,” Galligan said. “The behavior of children is actually harmed by these dyes, according to 27 human clinical trials.”
How Europe and the United States are different
Red No. 3 and Yellow No. 5 were certified in 1969, while Red No. 40 was approved in 1971. 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 little unclear because we really don’t have the science we should have, but there is an established connection between these dyes and behavioral issues,” Mande of Harvard said.
According to Mande, when synthetic food additives are legalized, the government invests relatively little in their research. Nutrition-related research receives less than 5% of the National Institutes of Health’s research funding.
According to Mande, “the effort to understand the effects in the long term or subtle things like behavior, we don’t study that.” However, acute risks, including poisoning, are well documented among FDA-approved drugs.
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 might be harmful from the food system can take decades, even when there is an enormous amount of data.” “Given that these additives have been in the food system for so long without any post-market review, it is obvious that the FDA needs more resources for post-market research.”
At the committee hearing on Thursday, Jones stated that the U.S. differs from Europe in this lack of follow-up.
“They have been conducting post-market reviews of chemicals for more than 20 years, which is the biggest difference between the U.S. and Europe,” he stated. “The FDA has the authority to conduct post-market review, but there is no legal requirement to do so.”That might not be the case.
The FDA convened a public hearing in September to discuss potential improvements to the re-evaluation of chemicals, including color additives, that have been authorized 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 authorized.
“As part of our post-market activities to ensure safety of substances added to food, the FDA supports and participates in the international risk assessments conducted under JECFA in addition to evaluations and reviews by the FDA,” the spokesman stated. “The JECFA recently conducted assessments for food safety and determined that all of the listed colors are safe to use in food under current use conditions.”
States have already outlawed artificial food coloring.
Manufacturers are already under pressure from states to stop using artificial hues in food and drink. Three states have introduced or enacted laws prohibiting certain color additives in the past 12 months.
The California School Food Safety Act was enacted by lawmakers in October of 2023. By 2027, the legislation will ban the use of six of the nine FDA-approved artificial food colors in public school meals and beverages: Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3.
Legislation to outlaw Red No. 3 in Illinois by 2028 was advanced by lawmakers in April.
In February, lawmakers in New York proposed 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 distinct cuisines for various nations is one thing, but doing so for various states isn’t feasible,” he stated.
Artificial colors have already been eliminated from several food producers’ goods.
In 2015, Kraft voluntarily eliminated artificial coloring from their macaroni and cheese after years of public criticism, substituting natural coloring for Yellow No. 5 and Yellow No. 6. Nestlé eliminated Red No. 40 and Yellow No. 5 from more than 250 goods, including candy bars, in the same year.
The Center for Science in the Public Interest’s Galligan stated that a federal ban would be rather easy: “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.”
The FDA has examined the research referenced by California lawmakers in the California School Food Safety Act, a representative for the FDA told NBC News.
According to the spokesperson’s email, “the majority of children do not experience any negative effects from eating foods that contain color additives, but some evidence suggests that certain children may be sensitive to them.”
