In a ruling dated 25 October 2024 (Case No.: 26 K 2072/23), the Administrative Court of Düsseldorf dealt with the question of the legal classification of CBD oral care sprays as foodstuffs, cosmetics or medicinal products.
By administrative order dated 1 July 2020, the city of Düsseldorf had issued a general ruling prohibiting the marketing of foodstuffs containing cannabidiol (hereinafter referred to as "CBD") in the city area. By decree of February 2023, the city threatened the plaintiff, a company based in the city area that produced and distributed products containing CBD in the form of food, cosmetics and pharmaceutical applications, with a penalty payment the event of non-compliance or incomplete compliance with the general ruling, which the plaintiff opposed in court.
While the defendant City of Düsseldorf considered the products in dispute to be foodstuffs and therefore considered the scope of application of its general ruling to be open, the plaintiff was of the opinion that, based on their recommended use ("Spray into the mouth as desired up to a maximum of 3 sprays per day. Spit out after 30 seconds and do not swallow."), its products were not foodstuffs but cosmetics, that were not subject to the general ruling.
The Düsseldorf Administrative Court then ruled that the plaintiff's products in dispute, which are declared as "cosmetic oral care spray with cannabis leaf extract" and are available with a CBD content of 5 or 10 per cent, were subject to the general ruling of the City of Düsseldorf. In the opinion of the court, these products –despite the plaintiff's subjective purpose to the contrary – are foodstuffs within the meaning of Article 2 sentence 1 of Regulation (EC) No 178/2002 due to their objective presentation and the established consumer expectation, so that the threat of a penalty payment issued to the plaintiff was also permissible.
The legal definition of Art. 2 sentence 1 of Regulation (EC) No. 178/2002 must be taken into account for the question of the categorisation of a product as a foodstuff. According to this, "food is any substance or product which is intended to be or may reasonably be expected to be ingested by humans in a processed, partially processed or unprocessed state.”
According to case law, the term "expectability" is always relevant when the subjective intended purpose of the manufacturer must be objectively corrected. Thus, a product may not be excluded from the applicability of food law by virtue of its subjective intended purpose if it can reasonably be expected that the product will be consumed by humans. The question of what can reasonably be expected is in turn based on the average informed, attentive and reasonable consumer.
In the opinion of the court, such a correction had to be made in the present case. According to the subjective intended purpose of the product at issue, which is evident in particular from the instructions for use and the labelling of the product as a "cosmetic oral care spray", the court was of the opinion that it could not be assumed that the product was a foodstuff, as this would require administration via the mouth/nose with subsequent passage through the gastrointestinal tract. In the court's opinion, however, this contradicted the objective perception of the product. Thus, there is an established expectation on the part of an average informed, attentive and reasonable consumer that CBD oils are intended as "lifestyle" products for oral administration, from which consumers hope for positive health effects. To determine this objective perception, the court relied in particular on the presentation of the products, their description in the webshop, their proximity to CBD products that are intended for consumption according to their subjective purpose and the fact that the products at issue were not flavoured to prevent ingestion. Furthermore, the court referred to the results of a study according to which consumers almost exclusively attribute properties to CBD products that have no relation to a cosmetic use, but are achieved solely through consumption.
Moreover, in the opinion of the VG Düsseldorf, the products in dispute also did not qualify as medicinal products within the meaning of Art. 1 No. 2 of Directive 2001/83/EC. In order to qualify as a functional medicinal product, the necessary scientific evidence of a significant pharmacological effect was lacking - at least at the low dosage in dispute. Classification as a presentation medicinal product was to be rejected for the simple reason that the products in dispute did not present themselves to consumers as medicinal products due to their packaging and the accompanying product information
Conclusion: The judgement of the VG Düsseldorf makes it clear that manufacturers cannot remove their products from the scope of application of food law through their subjective intended purpose if this is not in line with the objective expectation of an "average consumer". In this case, the subjective purpose must be objectively corrected.
Co-Author: Farina Simon
