The fight for CBD oil continues in Germany

If anyone thought the road to cannabis reform was going to be easy, a decision last week in Cologne, Germany just confirmed the fact that this will be a protracted battle, fought to the end with regressive skirmishes and no doubt setbacks.

Here is the latest example. Shockingly, the Cologne Administrative Court has just decided that the legal classification of CBD drops (i.e. the good old CBD extract) is a medical device. As such, they must be approved by the Federal Institute for Drugs and Medical Devices (BfArM) – the German version of the American Food and Drug Administration (or FDA).

The logic of the court in this ruling is that the nutritional value of CBD is still unknown. Additionally, as set forth in the court decision, the plaintiff company failed to show that there are comparable products on the market or that CBD could be used as part of a diet rather than a medicinal regime. The plaintiff’s suggestion that hemp tea could serve as an example was dismissed as the court contended that cannabis tea was subject to the Narcotics Act – thanks to the deadlock on it in 2021.

The timing of this case, not to mention the court’s finding, is also telling. It could potentially throw the entire German CBD business back into the dark ages — even if this is just a state-level decision, not a federal decision. If you step into any health food store, not to mention the growing number of CBD specialty shops in Germany, you will find CBD oil in different concentrations on the shelves.

According to Kai-Friedrich Niermann, a leading cannabis lawyer in Germany, “The ruling by the Administrative Court of Cologne poses a significant risk for the CBD market in Germany if further authorities and courts refer to the BfArM and the ruling.”

The lawsuit, brought by a company offering two different CBD oils, challenged the BfArM’s 2019 finding that such products “should” be medicinal products because CBD has a “pharmacological effect”. .

This, of course, contradicts the 2020 European Court of Justice ruling that CBD is not a narcotic.

The company must now appeal the verdict.

The fight for cannabis reform in Germany’s largest federal state

This case is a landmark legal showdown. It clearly shows how schizophrenic the laws surrounding CBD and cannabis are in Germany at the moment, not to mention how political the cannabis reform – including the CBD variant – is. North Rhine-Westphalia, where Cologne is located, is Germany’s most populous federal state. It is also the headquarters of the BfArM.

This decision effectively confirms the 2019 BfArM decision on CBD, which also preceded the EU-level decision before the Court of Justice. But it also does more than that. “According to Niermann, the BfArM and the Cologne Administrative Court contradict the established case law of the European Court of Justice, which requires a significance threshold for the differentiation of food and medicinal products with regard to the pharmacological effect.”

Additionally, the case reeks of political interference at a time when the federal government is delaying full leisure reform. The court only confirmed the opinion of the BfArM.

However, there is a silver lining.

Niermann: “The decision is likely to be difficult to reconcile with other European law. The ongoing applications to the European Commission for approval of various CBD ingredients as novel foods show that the Commission and the member states have a problem with the novelty of the ingredients, but not with the pharmacological effect. At least for foreign EU products, the principle of the free movement of goods should then at least ensure the marketability of CBD in Germany.”

The backlash against legalization in Germany

While any patient will tell you that CBD can have medicinal effects, the problem now facing the legal system in Germany (and unlikely to just magically go away with the advent of THC legalization) is what cannabinoids actually are. The fight over CBD will, of course, continue to spark cases like this — for now. Look for even more complicated decisions after “federal legalization” that includes THC.

This is, of course, because cannabis of both the CBD and THC varieties can be used both “medicinally” – namely with a doctor’s prescription – and non-medicinally. In the case of CBD, this means that over-the-counter products will now fall under the Drug Administration’s rubric until this new decision is challenged.

It also seems to indicate that unless there is a federal decision on cannabis as a plant, as well as its most well-known extracts, these issues will repeatedly crop up in court.

The unfortunate producer is currently threatened with a fine of 100,000 euros. However, they will no doubt appeal. If ever there was a legal “straw man” who needed to be taken down, the precedent set in this case is surely one of them.

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