Following an application from Anxiofit Ltd. and ExtractumPharma Co Ltd., submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Hungary, the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Anxiofit-1 and reduction of subthreshold and mild anxiety.
The scope of the application was proposed to fall under a health claim referring to disease risk reduction.
The general approach of the NDA Panel for the evaluation of health claim applications is outlined in the EFSA general guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims.
The food that is the subject of the health claim is Anxiofit-1, Echinacea angustifolia root extract, standardised for the content of echinacoside (at least 3%) and the alkamide profile. The Panel considers that Anxiofit-1 is sufficiently characterised.
The claimed effect proposed by the applicant is ‘amelioration of subthreshold and mild anxiety which are risk factors in the development of anxiety disorders and depression’. The target population proposed by the applicant is ‘people having subthreshold and mild anxiety symptoms who are not eligible for anxiolytic medication’. The Panel considers that reduction of subthreshold and mild anxiety is a beneficial physiological effect. Subthreshold and mild anxiety is a risk factor for anxiety and depressive disorders.
The applicant provided three human intervention studies as being pertinent to the health claim.
In weighing the evidence, the Panel took into account that one human intervention study with a small number of participants showed a decrease of anxiety scores under the conditions of use proposed by the applicant. Another small study, performed by the same research group with patients with diagnosed generalised anxiety disorder, also showed a decrease of anxiety in this population. However, the Panel also took into account that the results have not been replicated in other studies. The information supplied by the applicant did not provide evidence for a plausible mechanism by which Anxiofit-1 could exert the claimed effect.
On the basis of data presented, the Panel concludes that the scientific evidence is insufficient to establish a cause and effect relationship between the consumption of Anxiofit-1 and reduction of subthreshold and mild anxiety.