Based on our review of the data from published literature, FDA concludes that a causal relationship between exposure to color additives and hyperactivity in children in the general population has not been established. For certain susceptible children with Attention Deficit/Hyperactivity Disorder and other problem behaviors, however, the data suggest that their condition may be exacerbated by exposure to a number of substances in food, including, but not limited to, synthetic color additives. 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