In a report submitted to the agency Jan. 19, CSPI calls on FDA to require warning labels on dyed foods and beverages that caution about the risk of food colorings impairing the behavior of children. It also directs the agency to update the information on its website to reflect the danger of such dyes and ultimately ban the use of synthetic dyes in foods and beverages unless companies can provide convincing evidence that the dye is safe based on sensitive studies.
The consumer advocacy group bases these recommendations on eight independent analyses, including two meta-analyses, that found excluding food dyes reduces the adverse behavior in some children and the “growing consensus” that food dyes are connected to attention deficit hyperactivity disorder and other behavior disorders, according to the report.
All of the research was published after FDA most recently reviewed the safety of dyes in 2011, at which time an advisory committee of experts reviewed evidence on the association of dyes and children’s behavior in response to a Citizen Petition filed by CSPI. The panel of experts voted 11 to three that there was insufficient evidence connecting the colors to hyperactivity in children.
Based on that review, and ongoing safety evaluations, FDA has stood by the safety of color additives, and specifically notes in a blog post that “results on studies about a link between color additives and ADHD have been inconclusive, inconsistent or difficult to interpret due to inadequacies in study design.”
New research strengthens association, CSPI claims
However, CSPI suggests FDA’s conclusion is based on flawed reasoning and potentially inconclusive analyses of newer research.
It points to a meta-analysis published in 2012 that was funded by the food industry and which found excluding dyes and certain other ingredients improved ADHD symptoms for about a third of children with the disorder. A separate analysis by the same authors concluded that synthetic colorings were associated with a slight statistically significant increase in ADHD symptoms, according to CSPI.
A second meta-analysis published in 2013 that looked only at children formally diagnosed with ADHD also found dietary changes, including eliminating artificial colors and adding free fatty acids, eased symptoms.
Other studies conducted since the 2011 review compared the magnitude of the effect of dyes on behavior to that of low doses of lead, CSPI says.
CSPI also complains in the report that earlier studies that tried to establish a causal connection between the dyes and behavior disorders woefully underestimated the amount of exposure to the average child.
It notes that many early studies examining the relationship tested dosages of 26-30 mg of dyes, but that FDA previously estimated 5- to 12-year-olds ingested as much as 150 mg of dyes per day.
Indeed, a single cup of Kool-Aid Burst Cherry contains 50 mg of dyes, and 16 ounces of Sunny D Strawberry Orange contains 40 mg of dyes, which is “more than the amount of dyes that triggered adverse reactions in some children,” CSPI argues.
In addition, it notes: “A study of food labels in one supermarket found that more than 90 percent of child-oriented candies, fruit-flavored snacks and drink mixes and powders are artificially colored,” and “a majority of child-oriented foods made by such companies as Kraft, PepsiCo and General Mills are dyed.”
A costly additive
CSPI appeals to FDA to make the change on economic grounds.
Based on one analysis that suggested 8% of children with ADHD have symptoms caused by dyes, CSPI says the annual cost to society from the dyes is between $2.9 billion and $4.2 billion, based on values in 2005. This jumps to $3.5 billion to more than $5 billion using 2015 currency values.
Many companies phasing out synthetic colors
Many food and beverage manufacturers are not waiting for FDA to weigh in on the debate again, and under pressure from consumers and advocacy groups have announced plans to phase out artificial colors.
General Mills, for example, announced in 2015 that it will phase out artificial colors in its fruit flavored snacks, following an announcement it would phase them out of its cereals. Nestle USA and Kraft also made promises to remove artificial colors and preservatives from some of their products, as did others.
Given some companies ostensible reticence to reformulate without direction from FDA, CSPI asks the agency at a minimum to “follow the lead of European authorities and encourage companies to reformulate foods without dyes and require dyed foods to bear a label warning consumers that dyes can trigger behavior problems in children.”