Germany: BGH: Bacterial cultures are not foods for diet management

A decision by the Federal Court of Justice on 13 July 2023 (Ref: I ZR 68/21) deals with the prohibition of the marketing and advertising of capsules containing intestinal bacteria with the claim "for diet management".

The plaintiff is an association. The defendant is a manufacturer of products "for diet management" for various diseases, e.g. irritable bowel syndrome. These products are packaged in capsules and contain bacteria cultures capable of reproduction that occur naturally in the human intestine and which were advertised on the internet. The plaintiff issued a warning to the defendant for the distribution and advertising. The plaintiff was of the opinion that the defendant was marketing the products without authorisation as foods for special medical purposes within the meaning of Regulation (EU) No. 609/2013 on foods for infants and young children, foods for special medical purposes and daily rations for weight control diets. The decision of the lower court (Munich Higher Regional Court) was in favour of the defendant.

In its decision, the Federal Court of Justice came to the conclusion that the marketing and sale of the products "for diet management" violated Section 5 para. 1 UWG, as the targeted public was led to believe that the products were foods for special medical purposes. However, the products marketed by the defendant are not such foods within the meaning of Article 2 para. 2 lit. g of Regulation (EU) No 609/2013. According to regulation, "foods for special medical purposes" are foods to be used under medical supervision for the dietary management of patients, including infants, which are specially processed or formulated; those foods are intended for the exclusive or partial nutrition of patients with reduced, impaired or disturbed ability to ingest, digest, absorb, metabolise or excrete ordinary foods or certain nutrients or metabolites contained therein or of patients with other medically related nutritional requirements for whose dietary management the modification of the normal diet alone is not sufficient. According to the case law of the Court of Justice of the European Union, a product is a "food for special medical purposes" if there is an increased or specific nutrient requirement due to illness that is to be covered by the food. For such a categorisation, it is not sufficient for the patient to derive a benefit from the consumption of the food because the substances it contains counteract the disorder or alleviate its symptoms. If the product has no nutritional function, it cannot be categorised as a food for special medical purposes. This also follows from the definition in Article 2 para. 2 lit. g of Regulation (EU) No 609/2013. The nutritional function is also linked to the fact that a product must consist of nutrients. The products marketed by the defendant do not consist of nutrients within the meaning of Regulation (EU) No 609/2013 in conjunction with Article 2 para. 2 lit. s of the Food Information Regulation. The products contain bacteria that occur naturally in the human intestine. However, bacteria are not nutrients within the meaning of Article 2 para. 2 lit. s of the Food Information Regulation. The claim "for diet management" is therefore misleading, as it gives the impression to the relevant public that it is a food for special medical purposes within the meaning of Regulation (EU) No. 609/2013. The essential characteristics of a product within the meaning of Section 5 para. 1 and para. 2 No. 1 UWG also include its nature and thus its belonging to a product category that differs from other categories according to the public perception.

This is important | To Do: If a product cannot be classified as a food for special medical purposes within the meaning of Regulation (EU) No. 609/2013, it must also be ensured that it is not advertised with claims such as "for diet management".