Omega-3 brain health claim rejected in EU
The claim, submitted by Belgian omega-3 supplements manufacturer, Minami Nutrition Health, suggested attention deficit-hyperactivity disorder (ADHD) could be reduced by improving the ratio between arachidonic acid (AA) and EPA (eicosapentaenoic acid) in the body.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) disagreed, saying the evidence was insufficient and that, anyway, the submitted claim was a treatment of disease claim, and therefore outside the scope of the EU nutrition and health claims regulation (NHCR).
Minami was not available for comment at the time of publication.
During the assessment process, the NDA panel made a ‘stop-the-clock’ contact with Minami to clarify the disease status of the claim as the regulation only accounts for the reduction of risk factors for disease under article 14 of the NHCR.
Minami said the disease risk reduction factor was an elevated AA/EPA ratio among children diagnosed with ADHD.
To that the NDA replied: “No evidence was provided by the applicant to substantiate that the AA/EPA ratio plays a role in the development of ADHD, that the AA/EPA ratio can predict the incidence of ADHD, or that lowering the AA/EPA ratio can lower the risk of ADHD.”
Minami initially proposed the claim: “EPA has been shown to reduce the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of
attention difficulties in children with ADHD-like symptoms. These children are also characterised by less hyperactivity and/or coexisting oppositional behaviour.”
It said 500mg of EPA per day with meals could achieve the effect among children aged 5-13 with ADHD-like symptoms and low blood
levels of omega-3 fatty acids.
The only approved EU health claim for EPA is an article 13, general function health claim for, “Maintenance of normal cardiac function”.
The latest NDA opinion can be found here.
