FDA debates link between food dyes, hyperactivity

The FDA Food Advisory Committee will vote today on whether the agency should take action on food dyes after hearing data suggesting the dyes could be linked to hyperactivity in children.

The panel, which features experts in nutrition, toxicology, food science, immunology and psychology, is meeting in response to a 2008 petition from the Center for Science in the Public Interest (CSPI) requesting that the agency ban eight of the nine FDA-approved food dyes, including Yellow No. 5, Red 40 and Blue No. 1.

“It is medically and unethically unwise to burden hyperactive children and their parents with concerns about foods with synthetic dyes,” CSPI members wrote in the petition.

“Eliminating dyes from the food supply should yield a direct benefit without any health risk, and companies that wish to voluntarily stop using dyes would benefit from the ‘even playing field' that regulation would provide,” they added.

In the past, FDA review committees have deemed the evidence inadequate to establish a causal relationship between artificial food coloring and hyperactivity, but noted that dyes may exacerbate the condition in “certain susceptible children,” including those with an existing ADHD diagnoses or other behavioral problem behaviors.

The agency noted that an intolerance to the color additives and other food components may be to blame, and does not believe the “problem behaviors” are “due to an inherent neurotoxic property of the food or food components,” according to a 2010 memorandum.

The purpose of this week's meeting is to determine if new data is available to overturn the FDA's earlier conclusions, and also to determine whether the National Institute of Health's 1982 recommendation against elimination diets to treat children with hyperactivity is still valid.

Yesterday, Jim Stevenson, PhD, of the University of Southampton in the United Kingdom, presented data from a randomized double-blind placebo controlled trial that involved 153 3-year-olds and 144 8- and 9- year olds recruited from nurseries, preschools and schools in the Southampton School District.

Study results indicated that children experienced increased levels of hyperactivity after drinking fruit juice that contained food dye and sodium benzoate compared with when they drank a placebo juice that did not contain the additives.

David Schab, MD, an assistant clinical professor in the department of psychiatry at Columbia University presented data from a separate meta-analysis. Findings from that study indicated that children that were already hyperactive became even more hyper after consuming food with artificial coloring.


Both studies, however, involved a combination of dyes administered to children, and critics have noted that it is impossible to determine which dyes produced what effect.

Today's decision could have a range of potential outcomes, from no change at all, to modifying food labels, to banning dyes outright.

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