The legal classification of CBD drops as medicinal products subject to authorization by the Federal Institute for Drugs and Medical Devices has been confirmed in a judgment by the Administrative Court of Cologne.
According to the court, even products with a low content of the anti-inflammatory and calming cannabinoid fall under this classification.
Hanf Magazine reports
A company that has two different oils on the market as dietary supplements previously complained about the BfArM’s finding from 2019 that the products should be medicinal products that are subject to approval. The claims that CBD must have a pharmacological effect because it is also contained in other medicines were the arguments of the Federal Institute, which have now been confirmed by a judgment by the court in Cologne.
Not a dietary supplement
The Cologne Administrative Court also considered it factually correct that CBD must also have a pharmacological effect in other products due to its use in approved medicinal products. Even if the cannabinoid were underdosed in the respective hemp goods, it could be assumed that it would have an effect. The pharmacological effect can build up step by step even below the effectiveness threshold of the active substance. It would therefore not start abruptly when a certain threshold was reached.
Also, the plaintiff company’s products are not mere food or dietary supplements, as it is not known that CBD can be used for nutrition. The lawsuit was dismissed because the foodstuffs cited by the plaintiff, such as hemp seeds or teas , either did not contain any CBD at all or would fall under the narcotics law due to their THC content. The BfArM has therefore rightly classified the products as medicinal products requiring approval.
