title: A research model for investigating the effects of artificial food colorings on children with ADHD.
abstract: The United Kingdom and European Union recently restricted the use of artificial food colorings (AFCs) to improve the health of children. These decisions provide an interesting case study of the role of scientific evidence in the assessment of food additives and risk to children's health and formulation of food policy. Although there continues to be uncertainty concerning the link between AFCs and attention-deficit/hyperactivity disorder (ADHD), policy decisions have been made that have far-reaching implications. In addition, publicity surrounding the policy changes may shape public perceptions concerning effective management of ADHD. We believe that the balance of existing evidence neither refutes nor supports the link between AFCs and ADHD, which highlights the need for carefully designed studies to further investigate the link between AFCs and ADHD. In this article we describe a model for such studies. In developing our model, we drew from current investigative standards in ADHD research, such as those used in the landmark Multimodal Treatment Study of Children With ADHD. These standards encompass methodologic considerations including sample selection, outcome assessment, and data analyses. It is our hope that this model research methodology may prove valuable in addressing design considerations in future studies of AFCs and ADHD with the goal of producing reliable data that will enable policy-makers to better formulate effective, evidence-based food-policy decisions.
authors.affiliation: Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA. rkleinman@partners.org
authors.forename: Ronald E
authors.initials: RE
authors.lastname: Kleinman
authors.forename: Ronald T
authors.initials: RT
authors.lastname: Brown
authors.forename: Gary R
authors.initials: GR
authors.lastname: Cutter
authors.forename: George J
authors.initials: GJ
authors.lastname: Dupaul
authors.forename: Fergus M
authors.initials: FM
authors.lastname: Clydesdale
mesh_terms: D001289:Attention Deficit Disorder with Hyperactivity / Q000178:diet therapy*; D035843:Biomedical Research / Q000379:methods*; D002648:Child; D005505:Food Coloring Agents / Q000009:adverse effects*; D059022:Food Safety / Q000379:methods*; D006801:Humans
chemical_list: D005505:Food Coloring Agents