The Center for Science in the Public Interest (CSPI) petitioned the agency in 2008 to ban Yellow 5, Red 40, and other commonly used synthetic food colorings, saying that they “have long been shown in numerous clinical studies to impair children’s behavior”. The group also called for mandatory warning labels for products that contain artificial food colorings until a ban takes effect.
On Wednesday and Thursday this week the FDA intends to ask a panel to review the evidence as a result of the CSPI petition, and to decide what, if any, action is necessary to ensure public safety. The agency has also released background information for the Food Advisory Committee meeting, available here.
Director of the Nutrition Clinic at Rose F. Kennedy Children’s Evaluation and Rehabilitation Center at Albert Einstein College of Medicine, Dr. Keith Ayoob, said: “There is considerable misinterpretation of recent research linking food colors and hyperactivity. At first glance, a study may appear to show an association, but when you consider other important factors that could be responsible for the results, such as gender, maternal education level, pretrial diet, and other factors, it becomes impossible to affirm that the change in behavior was due to food colors.”
Controversy over the use of artificial food dyes gained momentum with publication of the notorious Southampton study in September 2007. The research, published in British medical journal The Lancet, looked at the effects of mixes of additives on 297 children aged three to nine, and concluded that synthetic food colors and additives had a “mild but significant” link to hyperactive behavior in children at least up to middle childhood.
The study has been the subject of criticism, however, largely because the children who took part in the trial were given cocktails of additives, making it impossible to ascertain which were responsible for the perceived hyperactivity effect.
The FDA said its review of published data has led it to conclude that a “causal link” between food color additives and hyperactivity “has not been established”.
It added: “Findings from relevant clinical trials indicate that the effects on their behavior appear to be due to a unique intolerance to these substances and not to any inherent neurotoxic properties.”
Calls in the US for warning labels on artificial food colorings have also been amplified following the European Parliament’s vote for a mandatory statement on food and beverage products containing certain colors, reading “may have an effect on activity and attention in children”, which industry observers have said amounts to a de facto ban. In 2009, a review by European authorities concluded all data available at the time did not support a link between food colorings and hyperactivity.