What does cannabis offer?
The cannabis plant has been around for centuries and was widely grown and valued for a range of purposes, including paper, textiles and rope from the stalks, protein from the seeds, as well as for oil and medicine. It grows well and quickly in many soil types, providing it has moisture and plenty of light, and requires few inputs so it is highly sustainable. However, the plant became a social and regulatory pariah in the UK and many other countries in the first half of the twentieth century because the plant can also be cultivated for recreational drug use.
Cannabis plants contain a variety of compounds, known as cannabinoids. The recreational drug is produced from one of these, tetrahydrocannabinol (THC), which is present in some varieties of the cannabis plant but not all of them. Recently, though, THC has also been recognised as having medicinal attributes, including for the treatment of epilepsy. The range of medicinal benefits is not yet well-understood but research is burgeoning.
Another of the key cannabinoids is cannabidiol (CBD). CBD is non-psychoactive, so you cannot get ‘high’ from it. It is widely credited with providing a range of health benefits, including improving sleep, reducing stress, managing muscle and joint discomfort as well as containing antioxidant properties. CBD is also now recognised as having medicinal attributes and these are also being investigated.
Although the medicinal and wellness properties of cannabis are only now being rediscovered, certain varieties of the plant with low levels of THC have been grown in the UK, on a small scale, as ‘industrial hemp’. The fibres from the stalks are used to produce products such as textiles, paper and fibreboard, whilst oil can be extracted for use in products such as varnish, fuel and detergents, as well as for food and health supplements.
A controlled substance
Cannabis is a Class B controlled drug in the UK in accordance with the Misuse of Drugs Act 1971 (MDA). It is unlawful to possess, supply, produce, import, export or cultivate it without a Home Office licence. Licences are granted for either research or ‘other special purposes’ .
There are two separate licensing regimes for the cultivation of cannabis plants, depending on whether the varieties contain high or low levels of THC .
Industrial hemp cultivation
Industrial hemp cultivation is deemed by government to constitute a ‘special purpose’ under the MDA. Anyone wishing to grow industrial hemp must first obtain a licence from the Home Office. The varieties which can be grown are limited to those which are permitted in the EU plant catalogue, and which contain THC levels of 0.2 per cent or below.
Home Office policy dictates that plants can only be cultivated for the fibre and seed, which contain the lowest levels of THC. The other parts of the plant, including the bud and flower, are deemed to be ‘controlled’ parts . They cannot be used and must be destroyed. Sales of buds and flowers are not legal.
The Home Office also grants licences to grow varieties of cannabis which contain THC levels of above 0.2 per cent, although the actual number granted is small. Licences are granted for three year periods. A government response to a written question in March 2019 stated that since 2016 the Home Office had granted 7 High THC cannabis cultivation licences for research and 30 High THC cannabis cultivation licences for the extraction of cannabinoids.
In 2018, following pressure from families who were facing significant challenges in trying to import cannabis products to treat severe epilepsy in children, cannabis-based products were authorised for medicinal use in the UK .
Specialist medical practitioners can now prescribe ‘cannabis-based products for medicinal use in humans’ without needing a licence or further permission to do so. There is no limit on the type of condition for which a practitioner may prescribe cannabis-based products. However, save for one specific product (a nasal spray for the treatment of MS sufferers), no cannabis-based medicines have yet been licenced in the UK.
Few prescriptions have as yet been written and there currently exists a considerable degree of uncertainty around the efficacy of prescribing cannabis-based products. NICE (the National Institute for Clinical Excellence) is currently developing guidance for practitioners and many hope that this will help to provide clarity. In the meantime, research into the medicinal benefits of cannabis is gaining traction and it seems likely that the UK will start to grant licences for cannabis-based medicines in the not too distant future. Earlier this month Sativa, a UK listed company, was granted a licence to grow cannabis with a high THC content to enable it to start a partnership with King's College London to research the impact of cannabis on inflammation and respiratory conditions.
Pure CBD is not classified as a cannabis-based medicinal product for the reasons set out below. However, any CBD products which do not meet the exempt product criteria and are supplied as medicinal products will ultimately require a licence to be marketed in the UK, although they can in the meantime be prescribed by specialist practitioners in line with the above.
Classification of CBD
Pure CBD is not classified as a controlled substance, providing it complies with all three limbs of the ‘exempt product’ criteria in the legislation. Essentially, these are that i) it is not designed for the administration of the psychoactive elements of cannabis (ie. THC); ii) any psychoactive element of the product is packaged in such a way that it cannot be recovered by readily applicable means, or at a level which would constitute a risk to health; and iii) it contains very small amounts of the psychoactive elements of cannabis (no more than one milligram per component part of the product).
Consequently, pure CBD is not considered a medicinal product and possession and supply of it does not fall foul of the MDA. However, it is very difficult to ensure that a CBD product is ‘pure’ and does not contain any controlled cannabinoids. Home Office policy states that 'the presumption has to be one of caution – that is, that a CBD containing product would be controlled under the MDA…'
It goes on to say:
'It is the Home Office view that, to establish [whether a CBD product meets the exempt criteria], testing eg. a full spectrum analysis to the appropriate threshold by an independent and licensed UK company, and provision of comprehensive and independently verifiable information and research of an appropriately rigorous nature will likely be required.'
CBD products are, however, readily available on any UK high street, and online, and it is questionable how many products go through such a rigorous testing process. Despite this, sales of CBD appear to go largely unchallenged.
CBD as food and supplements
The market place is seeing increasing numbers of foods and ‘health’ supplements which contain CBD. Assuming it can be demonstrated that the CBD is ‘pure’ and therefore falls within the exempt products criteria, the sale of these products does not constitute a breach of the MDA. However, food and health supplements are also required to comply with a range of other regulations and their presence on the market may well constitute a breach of those.
Save for a very few exceptions, products which are intended for human consumption, and which aren’t medicines, will fall within the EU food regulatory regime. CBD products which claim to have health benefits and which are not being made available as medicinal products are therefore regulated by the EU as ‘food supplements’. These state that any claims made asserting the health benefits of consuming a food, drink or food supplement must be one which appears on the EU register of authorised health claims . There are currently no authorised health claims in relation to CBD or cannabinoids. Consequently, CBD supplements or foods containing CBD should not be marketed or labelled as providing health benefits arising from their CBD content.
Even if direct health claims aren’t being made, however, it is likely that food and food supplements containing CBD are currently being placed on the market in breach of EU regulations. This is because in 2018 the EU declared CBD and other cannabinoids to be a ‘novel food’. The novel food regime is a system which assesses whether a food was used ‘for human consumption to a significant degree within the Union before 15 May 1997’ . If the EU decides that a food was not so consumed then authorisation from the EU is required before that novel food can be put onto the market. As yet, no authorisations have been granted in relation to CBD, or any other cannabinoids, and so anyone placing CBD supplements or food and drink containing CBD onto the market in the UK, or the wider EU, is likely to be deemed to be in breach of the novel foods regulations.
The Food Standards Agency (FSA), which regulates food businesses in the UK, issued a statement in May 2018 stating:
'The FSA accepts the clarification from the EU that CBD extracts are considered novel foods. We are committed to finding a proportionate way forward by working with local authorities, businesses and consumers to clarify how to achieve compliance in the marketplace in a proportionate manner.'
In practice, however, it appears that the FSA, along with Trading Standards who are tasked with enforcing the regulations at a local level, appear to be taking an extremely light touch approach to enforcement. It may be that either they don’t have the resources or that they are anticipating regulatory changes in the near future. In the meantime, it is clear that there are a number of businesses who are either unaware that they are potentially exposed to enforcement action or who are taking a calculated gamble on the regulator turning a blind eye.
As to the prospects of the EU approving CBD products for sale via the novel foods catalogue or otherwise taking a more wholesale change of approach, the messaging is unclear. The EU website lists one ongoing application for authorisation of a food supplement by a company based in the Czech Republic but there is no real clarity on its current status. In the meantime, the UK based Cannabis Trades Association (a membership body for a number of cannabis businesses) has recently announced a change of tack. It originally declared an intention to obtain novel food registration for CBD (whilst maintaining its position that cannabis extracts should never have been classified as a novel food in the first place) but in September 2019 announced that it would not be seeking novel food registration as this would prevent its members from selling their products whilst the application was pending. Instead, it intends to take a different approach by seeking a determination on the issue to provide ‘clarity’.
Whether you are a grower, a manufacturer, a retailer or a food service business, the mood music is such that there appear to be opportunities across the board in the cannabis and CBD sector. And depending on the outcome of Brexit, there may also be scope for regulatory changes to come to the UK more quickly than would otherwise be the case.
In the meantime, however, the regulatory regime remains confused and clarity in the sector would be welcomed by many.