Dietary supplements and herbal medicinal products: For a clear differentiation. Statement of the Society for Phytotherapy (GPT) to the „Article 13 health claim list“ of the EFSA

Abstract

Herbal medicinal products are trusted by the public. Their therapeutic indications are validated in established authorization procedures by regulatory authorities. Regulation (EC) 1924/2006, in effect since 19 January 2007, is dedicated to meet the expectations of the consumers in correctness and scientific validity of health claims for dietary supplements, as claims will have to be authorized by the European Food Safety Authority EFSA in the future. The EC „Consolidated List of Article 13 Health Claims“ [1] published by the EFSA in January 2009 seems to contradict these expectations. In this list the claim proposals of manufacturers of dietary supplements from all over Europe are presented. This list contains, besides many other substances, almost all herbal drugs in „well-established use“ or „traditional use“ as herbal medicinal products with therapeutic indications authorized by European drug regulatory agencies, as e.g. the German drug regulatory authority BfArM. This fact has raised doubts, whether it will be possible also in the future to distinguish dietary supplements with scientifically unfounded claims from herbal medicinal products authorized for the treatment of patients and therefore meeting high quality standards.