FDA Panel Digests Data Linking Food Coloring, Hyperactivity

March 31, 2011— -- SILVER SPRING, Md. -- Judging from the data and the discussion during the first day of an FDA panel meeting on food dyes, it appears likely that juices, candies, cereals, yogurts, and hundreds of other everyday foods will maintain their brighter-than-bright hues.

The FDA Food Advisory Committee is reviewing data on whether dyes used in food cause hyperactivity in kids, and will vote Thursday on whether the agency should take action on dyes, which could include banning them altogether.

FDA reviewers said there isn't enough evidence to show a link between chemical color additives and hyperactivity. However, 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, FDA reviewers said in a 2010 memorandum on the subject.

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The Food Advisory Committee -- a panel of outside experts in nutrition, toxicology, food science, immunology, and psychology -- is meeting 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.

The panel focused much of its attention Wednesday on a randomized, double-blind, placebo-controlled, crossover trial conducted in England that 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.

One of the authors of that study, Jim Stevenson, PhD, of the University of Southampton, told the FDA panel that 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.

Do Food Dyes Make Kids Hyper?

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.

Both studies have a number of shortcomings, however. For one thing, no studies teased out which specific dyes produce a given effect. The studies all administered a combination of dyes.

An expert on attention-deficit/hyperactivity disorder (ADHD) told the panel that Americans consume five times as much food dye as they did in the 1950s. He presented data that indicate there is a link between food dye and hyperactivity, although he said dye certainly won't make an otherwise normal child develop ADHD.

"Food dyes are not the main cause of ADHD; I think that's been well-demonstrated," said Dr. L. Eugene Arnold, a child psychiatry professor emeritus at Ohio State University. "But they may contribute to it in some cases. They [the dyes] maybe push these kids over the diagnostic threshold."

The International Food Information Council (IFIC) a group funded by the food industry, pointed to the lack of scientific evidence linking food colors to hyperactivity.

"Food colors add to our enjoyment of foods by maintaining or improving their appearance," said IFIC President and CEO David Schmidt, in a prepared statement. "Without sufficient scientific evidence that a causal link truly exists between food colors and hyperactivity in children, communications that suggest a link could have unintended consequences, including unnecessarily frightening consumers about safe ingredients that are consumed every day."

On Thursday, the panel will hear from the International Association of Color Manufacturers, a color additive trade group.

The panel will then vote what, if any, action the FDA should take on food coloring.

The debate over food coloring began in the 1970s with Dr. Benjamin Feingold and the popularization of the Feingold diet that promotes eliminating food additives such as dyes and preservatives as a way to treat hyperactive children. The diet is controversial among many in the mainstream medical community.