Bio Pharma Vertriebs wins German probiotic bacteria lawsuit

03/05/06 Lactobact omni FOS is lawfully marketed as a food supplement in Germany. This has just been decided by the Higher Administrative Court (Oberverwaltungsgericht) in Münster, Germany (OVG NRW 13 A 1977/02). Legal action had been taken by HLH Bio Pharma Vertriebs GmbH together with their Dutch supplier Winclove Bio Industries BV.

The German authorities had initially claimed to classify the product containing probiotic bacterial strains as a medicinal product. In The Netherlands however, it has been marketed as a food supplement in supermarkets for more than 10 years. The bacteria strains are used in a powdered form for the promotion of the digestive function. A health-promoting activity is ascribed to them.

With the classification of Lactobact omni FOS as a food supplement the Higher Administrative Court (Oberverwaltungsgericht, OVG) of Münster has come to the same result as The Netherlands had before. According to a judgement issued by the European Court of Justice which the OVG had requested for a preliminary ruling relating to this question (ECJ, C-211/03), the courts of the Member States of the European Union will nevertheless be obliged to come to a new decision in each case in the future in which a probiotic, mineral or vitamin product is to be classified as medicinal product of food supplement in their territories – irrespective of the question if and how many other European States have already decided on this issue.

“The judgement of the Higher Administrative Court has clarified that the bacterial cultures used in Lactobact omni FOS can freely be marketable as food. However, the argumentation produced by the court cannot automatically be transferred to all other probiotic bacterial cultures and all other imaginable strains without further considerations. It must be examined in every single case which bacterial cultures in which dosage are used”, says Dr. Thomas Büttner from the Lawyer Co-partnership Forstmann Kleist Büttner Krüger who has won the lawsuit for Lactobact omni FOS and HLH Bio Pharma Vertriebs GmbH at the OVG.

With view to the existing diverging rules Professor Frans M. Rombouts from the Food Microbiology Group at the University of Wageningen (NL) claims an obligatory guideline for the whole European territory: “In the sector of probiotics there is an urgent need for harmonisation – especially with view to the free movement of goods.“ He argues for the inclusion of bacterial strains in the European Food Supplements Directive (2002/46/EC): Probiotics should generally be classified as food supplements in order to create legal certainty for all parties.

Lactobact omni FOS has been available on the German market since 1997. It contains the bacteria cultures Lactobacillus acidophilus, Lactococcus lactis, Enterococcus faecium, Bifidobacterium bifidum, Lactobacillus casei and Lactobacillus salivarius in a concentration of 1 000 000 000 organisms per gram of powder. It is dissolved in water or used for the preparation of probiotic yoghurt. The purpose is to contribute to a well-balanced intestinal flora and to support the functions of the natural intestinal flora.