The law and regulation in the UK of medical cannabis and the sale of cannabidiol (CBD) is complex, often contradictory and regularly developing. There are also different regulatory regimes applying to medical cannabis and CBD products sold to consumers. Given recent developments in the CBD space, now is a useful time to reflect on the regulatory landscape.
In the UK, cannabis is currently categorised as a Class B Drug under the Misuse of Drugs Act 1971 and Misuse of Drugs Regulations 2001. It is therefore a criminal offence to possess, supply, grow, import or export cannabis or any cannabis derived product if it contains even a trace of THC except under a Home Office licence.
THC is the principal psychoactive compound of the cannabis plant. The UK regulatory landscape differentiates between so called "low-THC" (industrial hemp), being THC content not exceeding 0.2%, and "high-THC" cannabis, being THC content exceeding 0.2%. All strains of cannabis contain some THC, and so require licensing.
Where CBD is used for medicinal purposes, the product will constitute a "medicine" and will therefore need to be subject to a Medicines and Healthcare products Regulatory Agency (the MHRA) licence, unless subject to a possible exemption.
The new regime for medical cannabis became law on 1 November 2018. Under the regime (implemented as an amendment to the Misuse of Drugs Act), where a CBD medicinal product is not subject to a marketing authorisation granted by the MHRA, it can only be prescribed by a specialist doctor on the General Medical Council's Specialist Register. General practitioners are unable to prescribe it. Additionally, medical cannabis can only be prescribed when there is an "exceptional clinical need".
This regime has proved so restrictive that, in the period from I November 2018 to February 2020, it was reported that there were no known instances of NHS prescriptions for medical cannabis.
In January 2019, the European Commission (the Commission) categorised CBD extracts as a “novel food” in the Novel Foods Catalogue, under Regulation (EU) 2015/2283. The UK's Food Standards Agency (the FSA) subsequently accepted the Commission's position and set a deadline of 31 March 2021 for businesses looking to sell CBD ingestibles in the UK to submit a valid novel food application to the European Commission and European Food Safety Authority (the EFSA). After this deadline, only CBD products, where a valid application has been submitted, will be allowed to remain on the market.
Until 31 March 2021, businesses will be permitted to sell their existing CBD ingestibles, without novel food approval, provided that they are not incorrectly labelled, are not unsafe to eat and do not contain any substances which fall under drug legislation. Local Trading Standard Authorities and Local Authorities can monitor these CBD products and remove them from sale if they fail to meet these requirements.
If a novel food is liable to have an effect on human health, the Commission will request the EFSA to carry out a risk assessment as part of assessing the novel food application. We anticipate that this will be the case for CBD, given the reported issues surrounded the health effects of CBD. This means that a large body of information, including safety assessments, is required to make a novel food application. Given the amount of evidence required, collaboration between businesses looking to sell CBD products in the UK could be critical to achieving a valid novel food authorisation application and submitting high quality scientific evidence in the timeframe.
More recently, the Commission has reportedly paused over 50 Novel Food applications concerning non-synthetic CBD products, as it decides whether to classify extracts from hemp flowers as narcotic or psychotropic. It is therefore clear that CBD's regulatory framework is not yet finalised and further developments are to be expected.