The Court of Justice of the European Union has ruled that a medicinal herbal tea classified as a traditional herbal medicinal product cannot, in principle, be marketed with the organic logo
Summary
On 26 June 2025, the Court of Justice of the European Union (CJEU) handed down an important judgment (Judgment C-618/23, SALUS Haus Dr. med. Otto Greither Nachf. GmbH & Co. KG v Astrid Twardy GmbH) concerning the labelling of traditional herbal medicinal products, in particular medicinal herbal teas. The central question was whether organic farming references could be included on the packaging of these products. The Court ruled that traditional herbal medicinal products covered by Directive 2001/83/EC cannot simultaneously be classified as “traditional herbal preparations” within the meaning of Regulation (EU) 2018/848 on organic products. Consequently, indications such as “organic” or organic logos are not permitted on their packaging, as they are not considered “useful information for the patient” and could be promotional in nature
Facts
The case involved two German companies, SALUS Haus and Astrid Twardy GmbH. SALUS marketed herbal medicinal teas, presented as traditional medicines, and labelled their packaging with indications such as “Agriculture UE/non-UE”, the European organic logo, or terms such as “from organic farming”. Twardy contested this labelling, arguing that it violated drug regulations.
The dispute concerned the interpretation of two European texts. Firstly, Directive 2001/83/EC on the Community code relating to medicinal products for human use and secondly, Regulation (EU) 2018/848 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007. The question was whether medicinal herbal teas could fall within the scope of both regulations and whether organic indications were permitted on their packaging.
Questions referred
The German court submitted three questions to the CJEU:
- Can medicinal herbal teas, qualified as “traditional herbal medicinal products” within the meaning of Directive 2001/83, also be considered as “traditional herbal preparations” falling within the scope of Regulation 2018/848?
- If so, do the labelling rules of regulation 2018/848 (such as organic logos) take precedence over those of directive 2001/83?
- If not, can these organic indications be considered as “useful for the patient” information authorized by directive 2001/83?
The Court’s answers
On the first question, the Court ruled that a product cannot fall under both sets of regulations simultaneously. Traditional herbal medicinal products, subject to Directive 2001/83, are excluded from the scope of Regulation 2018/848. The Court emphasized that the regulation of medicinal products is exclusive and aims above all to protect public health. It recalled that, in case of doubt, it is the qualification of “medicinal product” that prevails, in accordance with Article 2(2) of Directive 2001/83.
On the third question, the Court held that information relating to organic production could not be considered “useful for the patient” within the meaning of Article 62 of Directive 2001/83. It explained that the labelling of medicinal products must be limited to the information strictly necessary for their correct use and must avoid any overload or confusion. Organic logos or indications, which have no direct health value, could influence purchasing and be promotional in nature, which is prohibited.
The second question was not answered, as the first answer rendered it irrelevant.
Practical implications
This ruling has important implications for companies in the herbal medicines sector. On the one hand, it confirms that traditional herbal medicinal products cannot benefit from the organic indications provided for in Regulation 2018/848. Secondly, that the strict rules of Directive 2001/83 on the Community code relating to medicinal products for human use take precedence, aimed at avoiding any superfluous or promotional information. And finally, that national authorities must ensure that the packaging of these medicinal products contains only the information essential for their proper use.
In conclusion, the CJEU reinforces patient protection by strictly limiting the labelling of traditional herbal medicinal products, excluding any mention likely to be perceived as promotional or irrelevant to their use.
