No Distribution of CBD Products Allowed?

Food supplements containing cannabidiol (CBD) cannot be marketed without further action, according to recent decisions of the Administrative Courts (Verwaltungsgerichte, VG) of Berlin and Hamburg in Germany.

Currently no marketing authorization for CBD products

Issues at stake in the decision in Berlin were capsules and oils containing CBD. According to the Berlin Administrative Court, new kinds of food may only be placed on the market as such or used in foodstuffs / food supplements when authorized under the Novel Food Regulation and included in a list drawn up by the Union. Foods containing CBD are currently not authorized and are also "novel" within the meaning of the Novel Food Regulation because there is no evidence of the use of foods containing CBD for human consumption in the Union before the relevant date under the Novel Food Regulation.

The subsequent order to immediately prohibit the production and marketing of foodstuffs / food supplements containing CBD is legal despite economic disadvantages for the manufacturer / distributor of the capsules and oils containing CBD. Evidence of a concrete health risk was not required insofar. The only decisive aspect here was that a novel foodstuff, which had not previously been tested for health hazards, should not be placed on the market. The Hamburg Administrative Court had already ruled similarly in the case of hemp seed oils with added CBD hemp extract.

CJEU ruling and WHO recommendation

The Court of Justice of the European Union CJEU, on the other hand, ruled last year that the free movement of goods in the EU also applies to cannabis products. There is an exception for "narcotic substances", but CBD is not considered to be one of them. According to the CJEU, CBD, unlike THC, has "no psychotropic effects or harmful effects on human health".

The WHO recommends removing CBD preparations from the Single Convention on Narcotic Drugs as long as the THC content does not exceed 0.2 per cent. However, this was not (yet) adopted by the Commission on Narcotic Drugs (CND) of the United Nations (UN) in the 63rd session. In addition, the German Federal Institute for Risk Assessment (BfR) recently recommended a new (lower) THC limit for hemp preparations.

Read more here about the Berlin and Hamburg decisions: VG Hamburg, Beschluss vom 26.01.2021 - 7 E 4846/20 - and VG Berlin, Beschluss vom 04.03.2021- VG 14 L 37/21 -.

Conference Recommendations

Go back

GMP Conferences by Topics