Anxiofit-1 and reduction of subthreshold and mild anxiety: Evaluation of a health claim pursuant to article 14 of regulation (EC) No 1924/2006

Following an application from Anxiofit Ltd. pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Hungary, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked for an opinion on the scientific substantiation of a health claim related to Anxiofit-1 and reduction of subthreshold and mild anxiety. The food/constituent, Anxiofit-1, an Echinacea angustifolia root extract, standardised for the content of echinacoside (at least 3%) and the profile of alkamides, is sufficiently characterised. The Panel considers that reduction of subthreshold and mild anxiety, risk factors for anxiety and depressive disorders, is a beneficial physiological effect. Two short-term human intervention studies showed a selective effect of Anxiofit-1 (80 mg/day for 7 days) on state anxiety and no effect on trait anxiety in subjects with subthreshold and mild anxiety. A randomised controlled trial (RCT) lasting 6 weeks showed no effect of Anxiofit-1 at 40 or 80 mg/day on anxiety symptoms using a different psychometric tool. No evidence has been provided to establish that the short-term, selective effect of Anxiofit-1 on state anxiety observed in two RCTs can be sustained with continuous consumption of the food/constituent, or that a short-term reduction of subthreshold anxiety (or state anxiety alone) reduces the risk of anxiety and depressive disorders in individuals with subthreshold anxiety. No human intervention studies investigating the effect of Anxiofit-1 on the risk of anxiety and/or depressive disorders have been provided. The information submitted by the applicant does not provide evidence for a plausible mechanism by which Anxiofit-1 could exert the claimed effect in vivo in humans. The Panel concludes that the scientific evidence is insufficient to establish a cause-and-effect relationship between the consumption of Anxiofit-1 and the reduction of subthreshold and mild anxiety as risk factors for anxiety and depressive disorders.