If anyone thought that the road to cannabis reform was going to be easy, a decision last week in Cologne, Germany has just confirmed the fact that this is going to be a prolonged battle, fought all the way with regressive skirmishes and undoubtedly, setbacks.
Here is the latest example. Shockingly, the Administrative Court in Cologne has just ruled that the legal classification of CBD drops (i.e. good old CBD extract) are medical products. As such, they must be approved by the Federal Institute for Drugs and Medical Devices (BfArM)—Germany’s version of the American Food and Drug Administration (or FDA).
The court’s logic on this ruling is that the nutritional value of CBD is still an unknown. Further as outlined in the legal decision, the plaintiff company could not prove that there were comparable products on the market or that CBD might be used as a part of a diet rather than medical regime. The plaintiff’s suggestion that hemp tea might serve as one example was dismissed as the court maintained that cannabis tea is subject to narcotics law—thanks to the indecisive ruling on this in 2021.
The timing of this case, not to mention the finding of the court is also telling. It could potentially throw the entire German CBD business back to the dark ages—even though this is just a state-level, not a federal ruling. Walk into every health food store, not to mention the growing number of CBD specialty shops in Germany, and it is possible to find CBD oil, of various concentrations, on the shelves.
According to Kai-Friedrich Niermann, a leading cannabis attorney in Germany, “The ruling of the Cologne Administrative Court poses a significant risk to the CBD market in Germany if further authorities and courts refer to BfArM and the ruling.”
The case, which was brought by a company with two different CBD oils on offer, was filed against the 2019 BfArM finding that such products “should be” medicinal products because CBD has a “pharmacological effect.”
This is of course, in contradiction to the 2020 ruling of the European Court of Justice that CBD is not a narcotic.
The company now must file an application to appeal the verdict.
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The Fight for Cannabis Reform in Germany’s Largest State
This case is a bellwether legal showdown. It clearly shows how schizophrenic the laws around both CBD and cannabis are in Germany right now, not to mention how political cannabis reform—even of the CBD variety—is. North Rhein-Westphalia, in which Cologne sits, is Germany’s most populous state. It is also the seat of the HQ of BfArM.
What this decision does, in effect, is uphold BfArM’s 2019 decision about CBD, which also occurred before the EU level decision at the Court of Justice. But it also does more than this. According to Niermann, “BfArM and the Cologne Administrative Court contradict the established case law of the European Court of Justice, which requires a significance threshold for the distinction between foodstuffs and medicinal products with regard to the pharmacological effect.”
Further, the case smacks of political interference at a time when the federal government is delaying full recreational reform. All the court has done is merely confirmed the opinion of BfArM.
However, there is a silver lining.
According to Niermann, “The decision is also 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 member states have a problem with the novelty of the ingredients, but not with the pharmacological effect. At minimum, the principle of free movement of goods should then once again ensure the marketability of CBD in Germany, at least for foreign EU products.”
The Backlash Against Legalization in Germany
While any patient will tell you that CBD can have medicinal effects, the problem now before the legal system in Germany (and unlikely to magically just disappear upon the advent of THC legalization), is what cannabinoids actually are. The fight over CBD of course is what will continue to prompt such cases—for now. Look for even more convoluted decisions after “federal legalization” that includes THC.
This is, of course, because cannabis of both the CBD and THC kind can be used both “medically”—namely via prescription of a doctor—and non-medically. In the case of CBD, this means that over the counter products will now fall under the rubric of the medicines agency until this new ruling is challenged.
It also seems to indicate that unless there is a federal decision about cannabis as a plant, as well as its best-known extracts, these issues will show up repeatedly, in court.
The unhappy producer is currently facing 100,000 euros in fines. However, they will undoubtedly appeal. If there was ever a legal “straw man” to be knocked down, the precedent set in this case is certainly one of them.
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