FDA Panel Says No Support for Linking Food Dyes, Hyper Kids

SILVER SPRING, Md. -- The FDA's Food Advisory Committee has voted 11-3 that there is not enough evidence to conclude that artificial dyes used to color foods contribute to hyperactivity in children.
But the panel -- which included outside experts in nutrition, environmental health, toxicology, food science, immunology, and psychology -- didn't rule out that food coloring might have a negative behavioral effect on kids. The committee agreed that more studies need to be done, and split over whether thousands of food products that contain dyes should have to carry labels warning there may be some risk of consuming the chemical coloring.
The FDA does not have to follow the advice of its advisory committees, but it often does.
But the committee's negative assessment of the studies linking dye to hyperactivity in kids means that juices, candies, cereals, yogurts, and hundreds of other everyday foods will likely maintain their brighter-than-bright hues.
Thursday's votes came at the end of the panel's two-day meeting, which was held at the request of the Center for Science in the Public Interest (CSPI), which petitioned the FDA in 2008 to ban eight of the nine FDA-approved food dyes, including Yellow No. 5, Red 40, and Blue No. 1. The one coloring that the CSPI is not petitioning to ban is Citrus Red No. 3, which is used only to make the skins of oranges a more vibrant color.
There are over 50 studies on the effects of dyes, but the FDA selected about 30 studies it wanted the panel to focus on. Of those, the panel spent most of the meeting discussing two studies.
The first trial, a randomized, double-blind, placebo-controlled, crossover trial conducted in England, enrolled 153 3-year-olds, recruited from nurseries, preschool groups, and playgroups, and 144 8- and 9-year-olds, recruited from the Southampton school system.
For the study, the children drank two different mixes of fruit juice spiked with food dye and sodium benzoate and later consumed a placebo fruit juice drink without artificial dye or sodium benzoate.
The study concluded that artificial colors (together with the sodium benzoate) increased the average level of hyperactivity in 3-year-olds and in 8- and 9-year-olds.
Another study, which was a meta-analysis of double-blind, placebo-controlled trials, showed that when children who are already hyperactive eat food that is artificially colored, they become even more hyper.
But the FDA had major concerns with both studies, and so did the panelists. Committee members said there isn't enough evidence to show a link between chemical color additives and hyperactivity.
"We're left with science that can't support a causal claim," said Xavier Castellanos, MD, a child psychiatrist and director of research at New York University Child Study Center. However, he added, "these data [also] don't give us any confidence that we can say there's nothing to worry about here."
The FDA reviewers even said that for "certain susceptible children," such as those with ADHD and other behavioral problems, their condition might be exacerbated by a number of substances in food, including artificial food dyes.
A handful moms testified Thursday that their children had major behavioral issues until they discovered the "Feingold Elimination Diet," popularized in the 1970s by Benjamin Feingold, MD. The diet promotes eliminating food additives such as dyes and preservatives as a way to treat hyperactive children.
One mom said she noticed a marked increase in hyperactivity when her child ate jelly beans, or other candies with artificial coloring. All said their children's behavioral problems essentially disappeared after cutting out dye.
The women all urged the FDA to ban artificial food coloring from foods and medicines.
Panelist Lisa Lefferts, an environmental health expert, said she is convinced that "there is something going on with dye causing hyperactivity."
"I feel very convinced that there is something going on here," she said. "There are a lot of unknowns, but the picture is starting to fill out in ways that make sense. This is hard to measure, but are we going to wait for another 50 studies to be done before we reach any conclusions?"
The panel voted 14-1 that more studies testing dye's link to hyperactivity are needed.

Several committee members asked the question through the two-day hearing, "What's the point of adding dye, if it adds no nutritional value?"
But Sean Taylor, PhD, scientific director for the International Association of Color Manufacturers (IACM), a group funded by the food industry, explained that in the packaged food industry, coloring food is important.
"Consumers expect foods to look a certain way," he said. "They play a critical role in how we taste and enjoy food, how we think about food being palatable."
A food science expert on the panel, Christopher Waldrop, of the Consumer Federation of America, took issue with Taylor's characterization.
"You said consumers won't buy foods different than the norm, but in some cases the norm has been shifted," he said. "The norm may be brown cereal, but that's been shifted in terms of kids being attracted to colored cereal."
As an example of how ingrained dyes are in the diets of Americans, consider margarine, which is naturally white. Almost since the advent of margarine in the late 19th century, the butter industry was successful in getting the government to ban margarine manufacturers from adding yellow dye to their product. During World War II, housewives who wanted yellow margarine had to buy a yellow dye to mix in with their uncolored margarine to make it look more like butter.