Even California gets things right sometimes
“E for Additives” by Maurice Hanssen was first published in 1984. Thanks to Hanssen’s research and that of many others, many adults, throughout the world, know to steer clear of harmful chemicals in their food, as well as how to protect their children from the many additives that were, already in the 1980s, becoming known for their ability to cause hyperactivity and other disorders, especially in the young.
And yet, 40 years later, Medpage Today, a leading medical news website, featured an article titled, “Are food dyes bad for your health?”
Gasoline in your Skittles?
Medpage Today was prompted to address the issue by the news that California has become the first state in the nation to ban six artificial food dyes from meals served to children in public schools.
The dyes concerned are:
(A) Blue 1 (CAS 3844-45-9).
(B) Blue 2 (CAS 860-22-0).
(C) Green 3 (CAS 2353-45-9).
(D) Red 40 (CAS 25956-17-6).
(E) Yellow 5 (CAS 1934-21-0).
(F) Yellow 6 (CAS 2783-94-0).
These dyes were approved by the FDA in the 1930s and remain permitted by the FDA to this day, despite the fact that most developed countries have banned them over the past few decades. Yellow 5 was last reviewed by the FDA in 1969; Red 40 was last reviewed in 1971.
Blue 1 is derived from petroleum and is banned in the European Union (EU) as well as Norway. Blue 2 is derived from indigo and is banned in Norway. Green 3 is chemically very similar to Blue 1 and is banned in the EU. Red 40 is also banned in the EU; it is derived from petroleum, as are Yellow 5 and 6 which are also banned in the EU and Norway.
The FDA maintains that these dyes are safe to be ingested; consequently, they are to be found in thousands of food products including commonly eaten foods such as Cap’N Crunch, Skittles, Doritos, Pop Tarts, Gatorade, and Lucky Charms, as well as in drugs such as ibuprofen and Advil.
Yellow 5 and 6 contain benzidine which is a known carcinogen (in a dose-dependent manner). Yellow 5 has been shown to be linked to hyperactivity in children. In studies, Green 3 was tentatively linked to the development of tumors in rodents as was Blue 1. Despite these findings, these food dyes, along with many others, are defined by the FDA as "generally recognized as safe" (GRAS).
Three years to review a report?
California cannot be accused of being hasty in its decision, which was made based on a report published in 2021. The report was compiled by the state’s Office of Environmental Health Hazard Assessment (OEHHA) and it concluded that the evidence it examined was sufficient to associate food dye exposure with adverse behavioral outcomes in some children.
The researchers who compiled OEHHA’s report looked at 27 different clinical trials, with a focus on three high-quality trials conducted in the UK in 2004, 2007, and 2010 which were all double-blinded and placebo-controlled. These trials showed a statistically significant increase in hyperactivity in children when exposed to certain artificial food dyes. While the OEHHA researchers suggested that the children in the studies could have been “particularly susceptible ... based on genetic factors” they still recommended withdrawing the dyes from foods given to children.
Thomas Galligan, PhD, of the Center for Science in the Public Interest (CSPI), a nonprofit consumer advocacy organization based in Washington, D.C., called the OEHHA report the “best assessment we have had to date,” and pointed out that the trials OEHHA looked at confirmed previous findings in animal trials.
I don't think we need more research. I think the evidence is crystal clear that food dyes are causing behavioral problems in some kids ... [and I] urge pediatricians, and other healthcare providers, particularly those interacting with children and their families, to really be mindful of the potential impacts that dyes are having.
Is ADHD the worst that could happen?
Mark Miller, MD, MPM, of OEHHA, who co-authored the report, was more circumspect in his conclusions and expressed himself in favor of more research in order to identify the children for whom food dyes are harmful so that families and clinicians can determine a "safe" level of exposure. However, he also questioned the “ethics” of doing such research — how could scientists feed children substances known to be harmful to some children?
Can you actually do a study where you feed children something that is already proposed to have these effects?
Speaking to Medpage Today, Dr. L. Eugene Arnold, MD, of Ohio State University in Columbus, suggested that further research was desirable in order to investigate problems other than behavioral ones.
It might be that cognitive behavioral effects are kind of the tip of the iceberg. There may be other things going on underneath that are deleterious to health.
Medpage’s author, Jennifer Henderson, adds, “including potential carcinogenicity.” Apparently she is not aware of research showing carcinogenicity in many of these newly-banned dyes conducted decades ago.
1 in 3 kids 'with ADHD' may just be reacting to food dyes
There have in fact been a number of studies conducted on food dyes over the years, several published in reputable medical journals, which have confirmed an association between artificial food coloring (AFC) and ADHD. One meta-study, published in the Journal of the American Academy of Child and Adolescent Psychiatry in 2012, concluded that “a restriction diet benefits some children with ADHD.”
We began by examining whether a restriction diet improves ADHD symptoms, concluding that it does so, with perhaps 30% of children with ADHD being responsive.
The researchers scanned the medical literature for studies of food additives and found that despite the small number of high-quality studies to examine, the association between food coloring and ADHD was still clear:
The result for studies restricted only to food colors was, due to the small number of studies and small aggregate sample, vulnerable to single study effects. Even so, the overall pooled result is sufficiently robust that it would not be easily overturned even if several unpublished, negative results exist.
The effect they found on children was high — up to 33 percent of that of ADHD benefit from a change in their diet:
It also seems that food additives can influence ADHD symptoms across different outcome measures, with effects that are in the range of one-sixth to one-third the size of a medication effect, depending on the outcome measure and challenge type. Although these average effect sizes are small in clinical terms, they could be quite substantial from the perspective of population-wide prevention efforts...
In conclusion, approximately 33% of children with ADHD may respond to a dietary intervention. Although as many as 8% may have symptoms related to food colors, the source of most of this dietary response remains unclear. We thus conclude that dietary effects on and treatments of ADHD, including food additives and colors, deserve renewed investigation.
The researchers also expressed their surprise that the United States appears to be lagging behind Europe in this area, and called for more research to be conducted:
Indeed, it is striking that despite several recent studies in Europe, in the past 20 years there have been no studies restricted only to FDA-approved food colors and almost no studies of unselected samples. These gaps reflect a complete absence of modern studies of this topic in the United States since the early 1990s.
4x more food dyes used in the last 50 years
Another study, published in Neurotherapeutics in the same year (2012), drew a number of conclusions.
Interim Working Conclusions:
AFCs [artificial food colors] 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...
By affecting nutrients and other metabolism in the periphery, AFCs could affect the brain without crossing the blood-brain barrier...
The deleterious effect does not appear to be confined to ADHD (a general effect has been replicated). Therefore AFCs may be more a general public health problem than an ADHD problem...
The magnitude of reported effect is reminiscent of subclinical lead poisoning ... which led to the eventual removal of lead from gasoline...
Per capita daily consumption of AFCs quadrupled in the last 50 yrs...
There may conceivably be a possible deleterious effect on classroom climate from most children deteriorating slightly, thus additively or even synergistically impairing the learning atmosphere.
What's more important: 'Ensuring public confidence' or the health of the public?
Commenting on California’s new measures, Sean Taylor, an organic and biological chemist with the International Association of Color Manufacturers in Washington, D.C., told Medpage Today that he felt that “consistency” across the country was vitally important, apparently feeling that this consideration outweighed an abundance of caution with regard to children’s health:
Consistency in food regulations across states and federal agencies is critical for ensuring public confidence.
He stressed that the FDA has also reviewed the very same studies that OEHHA examined and “concluded there was no causal link between children consuming synthetic dyes and unwanted behaviors.” Californian health authorities have in fact not claimed a causal link as this would be extremely challenging to prove. However, they apparently feel that it is wiser to err on the side of caution.
FDA: Only 'certain' children affected, and so...
Medpage Today also quoted Kathleen Holton, PhD, MPH, of American University, who pointed out that “Americans have greater exposure to food additives than any other country in the world,” and that food dyes provide no benefit to the consumer other than making food look more attractive — a task that can also be accomplished using natural dyes.
Meanwhile, the FDA shows no sign of being influenced by the California legislation, even as nine other states (Illinois, Maryland, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Dakota, Washington, and West Virginia) seem poised to enact laws of their own restricting a number of food dyes from public consumption (not only in school meals).
"Reassessing the safety of chemicals in food as new, relevant data become available is a priority for the FDA," the FDA said in a statement in August.
The FDA has reviewed the research on the effects of color additives on children's behavior including the literature review cited by the Bill. 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.
