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published on 11 November 2020 | Reading time approx. 6 minutes
by Florian Donath
Whether in drugstores, supermarkets or specialised “hemp shops”, the production and distribution of products containing cannabidiol (CBD) is flourishing. There is still a lively debate in society and politics as to whether marijuana should be legalised or whether it should be possible to purchase, possess or sell it in the future without an official licence. Nevertheless, the number of products which, according to manufacturers, contain hemp and yet can be sold freely and without proof of an explicit need is growing. From the often baffled faces of customers, it can be seen that general scepticism prevails as to whether the sale of these products is legal and completely without criminal relevance. As in the case of all new phenomena, the answer to this question is not easy. In any case, there is no conclusive case law on this (yet); therefore, searching for legal clues is necessary.
Cannabidiol (CBD) is a “non-psychoactive cannabinoid derived from female hemp (cannabis)” [1]. The substance is used both in medicine, e.g. in the treatment of multiple sclerosis, as well as in foodstuffs or other products such as oils. While CBD is said to have significant positive effects on stress, anxiety, pain, inflammation or obesity, critics see the substance as a pure “placebo” whose only “positive” effect is lining the pockets of its manufacturers and retailers. Undisputed proof of CBD’s effectiveness is not yet publicly available, so that products containing this substance are likely to continue to be the subject of vigorous debate.
The term “cannabis” is inevitably associated with the Narcotic Drugs Act (Betäubungsmittelgesetz, BtMG). Nevertheless, it is worth taking a closer look at CBD, because the classification is not that simple and straightforward after all:
First, however, it is essential to take a look at the Narcotic Drugs Act. CBD should be clearly distinguished from tetrahydrocannabinol (THC), which is the psychoactive substance from the genus of cannabis plants, the consumption of which produces an intoxicating effect [2].
In contrast to THC, CBD is not mentioned in the annexes to BtMG, so that at first glance it could be considered as a legal substance. A closer look, however, reveals that cannabis is defined in Annex I to BtMG as “marijuana, plants and plant parts of plants belonging to the genus cannabis”.
Thus, if cannabis plants or only parts of plants are contained in the product in processed or natural form, the Narcotic Drugs Act applies as a rule. In this context, plant parts mean non-viable parts of the plant, e.g. leaves, flowers, seeds [3]. Caution should therefore be exercised when making or buying hemp flower teas or smoking blends, as these products generally still contain parts of the cannabis plant.
Two exceptions are, however, provided for by law to the production or purchase of products containing plant parts, which is in principle punishable under BtMG:
According to Annex I to BtMG, cannabis seeds are excluded from drug regulations provided they are not intended for illicit cultivation. Conversely, this exception means that cannabis seeds may thus be contained in cereals, spices or other products if this is not intended for illicit cultivation of cannabis “through the back door”. Of course, no product manufacturer is able to completely rule out this scenario; however, it depends on the purpose of the product.
A further exemption applies to cannabis plants and preparations derived from them, which are grown in EU countries using certified seeds or whose THC content does not exceed 0.2 per cent and which are placed on the market for commercial or scientific purposes only.
Industrial hemp is used, example.g., in the manufacture of textiles or ropes. E.g,, Levi Strauss is said to have made his first jeans from hemp. The probability of this rumour cannot be completely dismissed, especially since Levi's is still advertising today to use so-called cottonized hemp (i.e. hemp chemically treated to match the texture of cotton) in its jeans for sustainability reasons.
In the case law of higher courts, it has sometimes been argued that the exclusively commercial or scientific purpose is applicable to both alternatives and must therefore always be given priority. E.g., if a product has lower content of the active ingredient but is not used exclusively for commercial purposes, the criteria for the exemption are not fulfilled. At first glance, the wording of the provision on the exemption does not allow contesting this view.
In addition, however, in some sources of the case law it is argued that the end user must use the ingredient for a purely commercial or scientific purpose [4]. This has not yet been confirmed in the highest court case law, nor does it necessarily arise from the law. However, as the view has already been taken by several higher courts, it must be expected that other courts (will) also follow this stance in case of doubt.
If a manufactured product can be classified as “safe” (e.g. ropes, textiles, etc.), it may be sold as a consumer good, since it can then no longer be misused for intoxication purposes [5].
Especially in the manufacture of food, it is problematic to identify when a product has reached the status of “safe”. Therefore, a grey area still exists. There are opinions that are based on the reference values published by the German Federal Institute for Risk Assessment (BfR) for the maximum THC content in foodstuffs. But, this view has not yet caught on, although it seems to be the most reasonable alternative. On the other hand, it would be too much to say that a product is safe only if none of the substances listed in Annexes I to III to BtMG can be detected, as otherwise the work of the BfR in this respect would have to be questioned.
The question of whether CBD products fall under pharmaceutical law depends to a large extent on whether the product can be classified as a medicinal product at all. The answer to this question is often quite difficult and must be based on the definitions in Article 2 of the German Medicinal Products Act (Arzneimittelgesetz, AMG).
As mentioned above, there is currently no study available that fully demonstrates the effectiveness of CBD in medical treatment. Therefore, no reliable scientific evidence exists yet. If, however, a CBD product is advertised in package inserts, packaging, advertising material, etc. as a remedy for curing, alleviating or preventing diseases or disease symptoms, it can probably be assumed that it is a (presentation ) medicinal product which is also subject to prescription requirements. This is because, according to Article 48(1) sentence 1 no. 1 of the German Medicinal Products Act (AMG), all substances or substance preparations or medicinal products listed in Annex I to the Medicinal Product Prescription Ordinance (AMVV) which contain the substances or substance preparations listed therein are subject to prescription requirements. CBD is mentioned in this list.
It should be noted in this respect that distributors and also manufacturers of these medicinal products are liable to prosecution under Articles 95(1) No. 4, 43(1) sentence 2 AMG if they engage in unauthorised trade in prescription drugs or dispense them to consumers. According to the prevailing view, “trading” should be understood within the meaning of the term used in BtMG, which should be interpreted very broadly in accordance with the case-law of the Federal Court of Justice (Bundesgerichtshof). E.g., the trading process is deemed to be complete when serious negotiations with a seller have been entered into for an intended purchase[6]. Offenders could be pharmacists, doctors, veterinarians, pharmaceutical companies and wholesalers.
Finally, CBD products should be analysed in more detail, also in terms of food law. CBD products could involve criminal law liability on the grounds of the penal provisions of the German Food and Feed Code (LFGB), Articles 58 et seq. LFGB. In addition, there are a number of other legal sources that should be considered in this context. In addition to the Food Supplements Regulation (NemV), the regulations on novel foods (ingredients) are also extremely relevant. Of central importance here is the criminal liability for placing on the market novel foods or the use of novel foods on or in other foods, Article 59 (3) No. 2(a) of the German Food and Feed Code (LFGB) in conjunction with Article 1a (1) of the Novel Food and Food Ingredients Ordinance (NLV) and Article 6 (2) of the Novel Food Ordinance.
All manufacturers and distributors of the affected CBD products can be considered offenders; however, the law does not provide for criminal liability for the purchase and/or possession of these foodstuffs. The prerequisite is, of course, that the food must be a novel food.
According to Article 2 of the Basic Food Ordinance, food is defined as any substance or product which is intended to be, or may reasonably be expected to be ingested by humans in a processed, partially processed or unprocessed form. This also includes, among other things, substances that are intentionally added to the food during its manufacture, processing or treatment. If a product classifies both as a food but also as a medicinal product, the main objective purpose of the product should be taken into account[7]. If this cannot be determined with certainty, the provision of Article 2(3a) of the German Medicinal Products Act (AMG) applies.
However, the currently popular lifestyle products, such as “hemp chewing gum”, “hemp ice tea”, “hemp cola”, “hemp muesli” etc., should generally be clearly qualified as foodstuffs, so the question that remains is whether these products are to be regarded as novel within the meaning of the Novel Food and Food Ingredients Ordinance (NLV). In numerous decisions, administrative courts defined conditions under which products containing CBD can also be classified as novel. As a result, it can be stated that all of these products, which were assessed as novel, contained CBD, which was obtained by extraction [8]. In these cases, it can therefore be assumed that these products are novel within the meaning of the Novel Food and Food Ingredients Ordinance (NLV).
It should therefore be carefully examined in each individual case whether a food product is novel, because if the answer to this question is yes, it should undergo an authorisation procedure or, if it is substantially similar to an already known or authorised product, it should undergo a notification procedure in order to exclude criminal liability arising from placing the food on the market.
The sale and distribution of “hemp products” containing CBD is currently hip. At the same time, however, it is beginning to fall into a grey area, which entails considerable risks for manufacturers and distributors of these products. As long as the postulate “Make hemp legal” [9] made by Hans-Christian Ströbele in an interview of 15 March 2003 in “grow” hemp magazine is not implemented by the German legislator, CBD products will continue to be exposed to the risk of criminal liability. In view of the planned law on sanctions for associations, it is even more important to curb these liability risks, since then not only company managers would be affected by criminal liability, but also the company itself. In view of the possible sanctions for the company contained in the government's draft of the law on sanctions for associations, it is important to ensure that the company also ensures compliance in this respect. Sometimes it is more hip not to engage in risky deals than to follow the hype and get into deep water.
Ulrike Grube
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