Distribution ban for food supplements?

The distribution and promotion of novel foods and food ingredients requires appropriate authorisations and/or notifications pursuant to the Novel Food Regulation. The Federal Court of Justice (BGH) was called upon to decide whether a food supplement more than 2500 years old made from extracts of the kudzu root is novel and therefore falls under this EU regulation.

A pharmaceutical wholesaler promoted and distributed a food supplement without the authorisations or notifications required under the Novel Food Regulation. The food supplement in question consists of kudzu capsules, which is a plant that grows in India and has been used for more than 2500 years to support human health. The wholesaler was therefore of the opinion that its food supplement did not fall under the Novel Food Regulation.

The Association for Fair Competition (Verband Sozialer Wettbewerb e.V.) was of the opinion that the defendant's product is a novel food which, due to the lack of approval or notification under the Novel Food Regulation, must not be distributed or promoted in the EU, and it brought an action for an injunction based on pharmaceutical advertising law.

The lower courts ruled in favour of the Association for Fair Competition (Verband Sozialer Wettbewerb e.V.) and granted the association's action for an injunction.

Court's Decision

The Federal Court of Justice (BGH) ruled on 16.4.2015 – Az. I ZR 27/14 – in favour of the Association for Fair Competition (Verband Sozialer Wettbewerb e.V.) and thereby confirmed the legal opinion of the lower courts.

When examining whether a food supplement consisting of the dry extract of a plant root constitutes a novel food or novel food ingredient within the meaning of the Novel Food Regulation, the decisive factor is whether corresponding food supplements were used in significant quantities for human consumption prior to the entry into force of this EU regulation. However, the pharmaceutical wholesaler failed to provide evidence of this in the course of the proceedings.

Conclusion

The promotion and distribution of novel foods and food ingredients requires appropriate authorisations and/or notifications pursuant to the Novel Food Regulation. Violations of these provisions constitute breaches of pharmaceutical advertising law and can be subject to cease-and-desist notices from competitors.