Introduction

Despite increased market awareness of medical cannabis and cannabidiol (CBD) products, the UK remains restrictive in its approach to their regulation. UK legislators and regulators have been slower than their international counterparts to accept the legitimacy of medical cannabis and CBD products.

That said, progress has been made in recent years in relation to the licensing of medical cannabis. That trend is set to continue, particularly as overseas investors look to the underdeveloped medical cannabis market in the UK for new opportunities.

The state of CBD product regulation has remained murky in recent years. Having initially determined that the UK would adopt the EU’s novel foods approach to CBD, the Food Standards Agency introduced a regulatory amnesty to protect existing retailers of CBD products from criminal enforcement. However, the amnesty has been the subject of much controversy and legal argument, with its precise scope remaining somewhat unclear. The Food Standards Agency has also struggled with the mammoth task of processing applications for CBD products under the novel foods regime (the first such exercise undertaken by the Agency since Brexit).

The lack of clarity surrounding the CBD amnesty has been made worse by similar ambiguities in the maximum permitted concentrations of THC in CBD products. The definition of “exempt product” under the Misuse of Drugs Regulations 2001 (the “MDR 2001”) has received much attention and has led to extended correspondence between the Home Office and the Advisory Council on the Misuse of Drugs. In turn, this has delayed the Food Standards Agency in progressing CBD novel foods applications to full authorisation, as the Agency waits for legislative amendments to be made to the 2001 Regulations.

This is a sector that remains in a state of regulatory uncertainty. However, there are positive signs that the government is aware of this issue and is taking meaningful steps to develop a more robust system of regulation with clear rules and guidance for business. Whilst this process will take time, the mere fact that the government has acknowledged the need for better regulation is significant; this acknowledgment serves as a signal to business and regulators that the CBD market is legitimate and worthy of specific regulation.

Cannabis in the UK

By way of brief overview, cannabis remains a Class B controlled drug under Part II, Schedule 2, of the Misuse of Drugs Act 1971. As a result, it is generally a criminal offence to possess, supply, produce, import or export cannabis without a licence from the Home Office. Similarly, it is an offence to cultivate cannabis plants without a licence from the Home Office.

The penalties for breach of these restrictions remain severe. The maximum penalty for supply and production of unlicensed cannabis is up to 14 years’ imprisonment and an unlimited fine (with the risk of any fine being calculated as a percentage of the supplying business’s worldwide turnover). In addition to any fine imposed, a business engaged in these activities faces the prospect of confiscation proceedings under the Proceeds of Crime Act 2002, which would result in forfeiture of any profit made by the business through its unlawful trade.

The commentary below must be seen in the context of this stark starting point. From a commercial and regulatory perspective, it is essential that businesses ensure that they possess the relevant licence, fall within an applicable exemption, or benefit from an amnesty from enforcement. Without such certainty, it is difficult to secure long-term investment for CBD businesses.

It is unsurprising that – given the current lack of legal clarity (particularly in relation to CBD products) – business and investment in the sector in the UK has lagged behind international markets. However, there are a number of reasons to be optimistic. Legislators and regulators have taken steps in recent years towards providing better regulation and greater certainty for businesses. These efforts are to be welcomed and bode well for the future.

Cannabis for Medicinal Use

In November 2018, amendments were made to Regulation 2 of the MDR 2001 to introduce a new category of product known as a “cannabis-based product for medicinal use in humans” (or CBPM). Under these new provisions, a specialist doctor may prescribe a CBPM without the need for any licence from the Home Office (although businesses supplying CBPMs still require such a licence).

Whilst these changes were initially welcomed by industry, time has proven them to be less revolutionary than anticipated. This is due to a number of factors, but may be attributed largely to the lack of available medical evidence to support the use of many CBPMs in a clinical context. In addition, the National Health Service has not supported doctors in prescribing CBPMs to patients in the UK.

That said, from a regulatory perspective (and in contrast to the position in relation to CBD products), the path is clear for this sector to grow in the future.

CBD Products

The current state of CBD regulation in the UK can be broken into two sections: (i) novel foods regulation and (ii) THC content regulation.

Novel foods regulation

On 1 January 2018, Regulation (EU) 2015/2283 (“the Novel Food Regulation”) came into effect. The Novel Food Regulation defined “novel foods” and set out a process requiring authorisation before a novel food could be marketed within the EU. This approval process was managed by the European Food Safety Authority (EFSA). Where products were granted authorisation they were placed on the “Union List”. The European Commission also established the Novel Food Catalogue (the “Catalogue”). Whilst the Catalogue does not have any true legal basis – it is, in essence, a policy statement – it remains highly influential in the determination of whether a food product is a “novel food”. As such, the Catalogue serves as guidance for member states in determining whether a particular product requires novel food authorisation in the first place.

Up until mid-January 2019, the Catalogue provided that most CBD products were not considered novel foods. In broad terms, novel foods authorisation was only required to market CBD if the levels of CBD were significantly boosted beyond their natural levels. However, in 2019, and despite concentrated lobbying by the CBD industry, the European Commission decided to change its stance and amend the Catalogue so that all CBD would be considered “novel foods”.

From a UK perspective, this change in policy stance was rendered all the more complex by the UK’s imminent withdrawal from the EU. For some time, it remained unclear whether the Food Standards Agency would adopt the same approach taken by the European Commission or whether this was an area that would see regulatory divergence from the EU. Some in the CBD industry saw this as an opportunity to develop a lighter-touch approach to CBD regulation in contrast to the EU stance.

However, in February 2020, the Food Standards Agency announced that it would adopt the European Commission’s stance on CBD products and that it would be implementing a similar novel foods process as had previously been undertaken by EFSA.

Since no manufacturer or supplier of CBD products held novel food authorisation at the time of this announcement (and since the announcement required no underpinning legislation, as it was simply a reinterpretation of the existing novel foods regime), the consequence was to effectively criminalise the entire CBD industry overnight. Recognising that this would be capricious, the Food Standards Agency announced a regulatory amnesty from prosecution for existing CBD retailers. This gave “grandfather rights” to businesses which already had CBD products on the market whilst preventing new CBD products from being introduced.

The response from industry was unsurprisingly negative. Legal challenge was made by way of judicial review, but this ultimately failed due to the time taken before issuing legal proceedings.

To make matters worse, the Food Standards Agency suffered from significant delays in processing applications for authorisation. A register was established to record the details of products which had “validated” applications (ie, valid applications in process), but much time passed before any applications were added to the register. The process of adding applications to the register has remained extremely slow, with businesses facing the risk of criminal enforcement if their products do not appear on the register (regardless of whether a valid application has been submitted).

Despite announcing this process in February 2020, as of April 2025 no CBD product has received full authorisation. The Food Standards Agency has previously indicated that it is waiting to progress any applications to full authorisation until legislative amendments have been made to the Misuse of Drugs Regulations 2001 to stipulate the permitted maximum concentration of THC in CBD products (discussed below). However, that process has suffered from significant unexplained delays, which have been further complicated by the election of a new government in July 2024.

Nonetheless, the industry has reason to be hopeful. As discussed further below, in November 2024 the Food Standards Agency released a roadmap for future regulation of CBD products. There is good reason to think that, once the regulatory structure has been finalised (and expectations are communicated to manufacturers), authorisations for CBD products will follow quickly. This would be a very welcome development for the UK CBD sector.

THC content regulation

In its purest form, CBD does not contain THC. In reality, however, many production methods will result in small trace amounts of THC being contained in CBD products. From a business certainty perspective, it is essential that manufacturers and suppliers have clear rules about the maximum permitted concentration of trace THC in CBD products. Unfortunately, however, this is not the case. It is a topic which has garnered significant government interest and discussion but as yet remains unresolved.

The most often cited legislation in this context is Regulation 2(1) of the MDR 2001, which provides the definition for an “exempt product”. Whether this exemption applies to CBD products has been the topic of much debate between the government and industry in recent years. In particular, part of the definition requires that “no one component part of the product or preparation [may contain] more than one milligram of the controlled drug”.

The natural question which this definition raises is: what is a “component part”? Does it depend on the way in which the product is packaged? If so, would a blister pack of ten tablets be counted as a single component part or ten component parts? By defining a total weight of controlled drug rather than a maximum concentration or ratio, the law remains highly unclear on this point.

As noted above, this has not gone unnoticed by the government. In January 2021, Kit Malthouse (the Minister of State for Crime and Policing) wrote an open letter to the Advisory Council on the Misuse of Drugs (ACMD). The letter indicated that the government was considering amending the MDR 2001 to clarify the legal position and asked the ACMD to recommend a THC limit by weight.

In December 2021, the ACMD reported back and recommended a maximum weight of 0.05mg of THC per “unit of consumption”. This has been interpreted as meaning 0.05mg per “dose” or “single serving” in consumer products.

Initially, this suggestion was welcomed by many in industry as providing much needed clarity to this area of law. Unfortunately, however, almost two years passed without any indication from the government as to whether the ACMD’s recommendations would be accepted.

Finally, in October 2023, the government responded and accepted the ACMD’s recommendations. It stated: “The Government accepts this recommendation and intends to bring forward legislation to implement it, subject to Parliamentary approval. The specificity of the terms of legislative provisions setting the Unit of Consumption (or serving) for the permitted dose, which will differ between different products, will require further careful consideration.”

The open correspondence between the ACMD and the government indicated that the definition of “exempt product” would be further tightened to exclude products which were intended for administration to humans. However, the ACMD separately recommended that the “50 microgram per unit of consumption” threshold be applied to consumer CBD products.

When the government accepted this recommendation, two things appeared likely. First, the definition of “exempt product” in Regulation 2 of the MDR 2001 would be amended so as to exclude consumer CBD products. Second, a specific 50 microgram limit for THC would be placed on consumer CBD products (which it was assumed must be by way of separate legislation).

However, the election of a new Labour government in July 2024 introduced uncertainty, as it was unclear whether the commitments made by the precious Conservative government would be adopted. Whilst no formal statement has been made by the new government, in October 2024 the Home Office updated its drug licensing factsheet regarding CBD. The amended guidance makes no reference to amending legislation and refers only to the existing wording of Regulation 2(1) of the MDR 2001 but suggests that CBD products will benefit from the exemption. In particular, the guidance states: “It is the Home Office view that the applicable unit of measure (i.e. the component part of the product or preparation) for the 1mg ‘threshold’ referred to in Limb (c) is that of the container (such as a bottle of oil) and not (for example) the supposed typical dose (of any product).” It remains unclear whether the new government intends to introduce any amending legislation to give effect to this interpretation, or whether it hopes that the courts will simply apply the government’s interpretation of the existing legislation by applying the gloss in the Home Office guidance. As matters stand, the latter seems likely.

Shortly thereafter, in November 2024 the Food Standards Agency announced that it would be making recommendations regarding CBD to the government in spring/summer 2025. In December 2024, it was reported that the Food Standards Agency board had discussed the future of CBD regulation. There appeared to be some disagreement among board members as to the framing of maximum THC content in CBD products. In particular, whilst the board accepted the Home Office’s amended guidance regarding the Regulation 2 MDR 2001 exemption, some members suggested that the Food Standards Agency should push manufacturers to achieve zero detectable THC. If this proposal is adopted, it could lead to a distinction being drawn between the regulation of CBD as a controlled drug and its regulation as a novel food. In other words, it is possible that a CBD product containing trace amounts of THC might benefit from the controlled drug exemption in the MDR 2001 but nevertheless fall foul of novel foods law (for example, if the Food Standards Agency imposed a condition that novel foods applications for CBD products would only be approved where the product contained zero detectable THC).

As such, the CBD industry once again faces regulatory uncertainty. Bespoke legislation, as envisaged by the previous government, would have been welcomed by industry and regulators alike. It can only be hoped that the government will make the legal position clear after the Food Standards Agency’s recommendations are published in spring/summer 2025.

Conclusion

Whilst there remains much work to be done to rationalise the law, the outlook is good for the UK medical cannabis and CBD sector. From a regulatory perspective, the path is clear for the medical cannabis market to grow in the future. As for CBD, it appears that the government is willing to take meaningful steps towards legitimising consumer CBD products and providing much-needed legal certainty in relation to regulation. This cannot come soon enough for the UK CBD industry.