14 September 2022
The German Federal Institute for Drugs and Medical Devices (BfArM) and companies from the life sciences sector repeatedly clash when it comes to the legal qualification of substances. In particular, the demarcation between medicinal products and foodstuffs or food supplements harbors a great deal of potential for dispute. One reason for this is the lack of a legal definition of the term "pharmacological effect" in Section 2 (1) No. 2 lit. a German Pharmaceutical Act (AMG).
A recent judgement of the Administrative Court of Cologne dated 22 March 2022 (Ref.: 7 K 954/20) concerns the active ingredient cannabidiol (CBD) which is extracted from the plant Cannabis sativa (hemp). The active ingredient has become increasingly popular in recent years and is used for many products. It is not known whether the judgement is now legally binding or whether an appeal has been filed.
A pharmaceutical entrepreneur marketed two different CBD drops as food supplements. In 2019, the BfArM issued two notices stating that the CBD drops were medicinal products requiring marketing authorization, arguing that CBD had various pharmacological effects and was already contained in medicinal products. The plaintiff resisted the determination. In support of its claim, it argued that the dosage was so low that pharmacological effects were not proven. Comparable amounts of CBD could also be ingested via the diet.
The Administrative Court of Cologne ruled on 22 March 2022 (Ref.: 7 K 954/20) that the BfArM had rightly classified the CBD drops as medicinal products subject to authorization. There is a presumption that if a drug with the same active ingredient has been approved in the EU, the same substance - CBD - will have the same pharmacological effect in another product. The presumption applies even if the dosage is lower since the effect builds up gradually and thus an effect is also given below the efficacy threshold. The main component of the ruling is the differentiation of medicinal products from foodstuffs and food supplements, where it is apparent from the modalities of use, the extent of distribution, and the awareness among consumers that CBD is identified exclusively as a medicinal product. According to the Administrative Court of Cologne, the substance lacked any nutritional purpose. The dietary supplements mentioned by the plaintiff would either not contain CBD at all (such as hemp seeds) or would fall under narcotics law due to their THC content (such as teas made from cannabis flowers). Due to the regulation in § 2 para. 3a AMG, a legal qualification as a foodstuff was no longer possible in the case of a classification as a functional medicinal product.
Authors: Dr. Daniel Tietjen, Katharina Hölle