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The high court: the battle continues for the CBD industry in Ireland

Following a series of raids, product seizures and court battles, what exactly is going on with the Irish CBD market?

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Thailand: A collection of CBD oil in bottles and CBD flower

As several high-profile cases over THC content are set to take place in Ireland this year, we speak to three store owners about their experiences.

It’s been a difficult time for CBD stores in Ireland. While there have been issues with stock shortages, Brexit regulations and COVID restrictions, CBD sellers have had the added problem of raids by the Irish gardaí. 

Several stores across the country have reported gardaí entering their premises or homes to search for cannabis before seizing CBD products instead. The products are sent for testing and often not seen again. But as Ireland is in Europe, and these products are therefore under the European THC limits, so why is this happening? 

Cannabis Wealth speaks to three CBD stores across Ireland to ask, what’s going on. 

Little Collins: A photo of the front of the Galway store that sells CBD products in Ireland

Little Collins

Little Collins is one of the most well known CBD stores in Ireland. Originally located in Galway, the store can now be found in Dublin and Kilkenny too. The store sells a variety of CBD flower, balms, pet products and topicals. 

The store, owned by JP O’Brien and his wife, Ide Clancy was one of the first to draw attention to the raids in 2020 with a series of social media posts. They received a huge amount of support following the raids that saw several gardaí enter their premises in Kilkenny before seizing products. 

The Kilkenny store was then raided in 2021 by the Gardaí who seized over €10,000 of raw hemp, infused oils, butter and tea products. 

Speaking with Cannabis Wealth, Ferdia Mooney from Little Collins said: “It started about a year after we opened when we just had the Galway cafe and office. There was a lot of CBD flower coming in. Sometimes things aren’t packaged properly because the suppliers can be used to sending them to parts of Europe where this is fine. So the documentation will be in the box, customs will open it and pass it through. However, that doesn’t happen here.”

He added: “We have a problem where we really have to stress to suppliers that things need to be triple-wrapped and packaged properly. We had one supplier who didn’t wrap properly and it was caught by customs immediately. That triggered the first raid.”

Although the raids have slowed down, Ferdia highlighted that the effect of the raids has been problems with stock. 

“The last raid we had was around this year. The frequency came in waves where we had a few months of being okay then there would be a raid, seizures than the same at a different premise. The knock-on effect is that we don’t have the products to sell so business is tougher. Between that and the rising price of fuel, it’s having an effect on our business. It seems they want to disrupt us as much as possible. 

He explained: “We got lucky in the sense that we built up this strong infrastructure already. So once the raids hit, we were ready. If my shop is raided in one location then I can send stock to another ready for the next day. It’s been difficult, but they chose the wrong company as we are very stubborn.”

Social media support has been vital for lifting staff morale and also, highlighting the issues the store owners are facing. 

“Customers are still coming by and going to the cafes, especially after there has been a raid. Social media support has gone through the roof. I think most customers understand what’s happening. It’s just so unjust as big stores aren’t being raided. Customers understand that this will affect everybody as they will just keep doing it and we will be left with just pharmaceutical companies which no one wants.”

The uncertainty around selling CBD in Ireland makes it difficult to make long term business decisions. Especially as Little Collins is still waiting on a court case that has been delayed more than once. 

Ferdia said: “It’s like a black cloud lingering over everything. We are pretty confident we are going to win but even if we don’t then it goes to the EU then it will be there. It’s just a matter of time. However, in the meantime, it affects simple things like tax. Do we pay tax for a year if we are going to be shut down in February? Do we sort phone plans for the year? It makes working life really difficult.” 

Releaf cafe

Mark Jenkins is the owner of Releaf Cafe in Dungarvan and Clonmel in Tipperary. He moved into the CBD industry after studying business in college and identifying that CBD sales were on the increase in Ireland. He has experienced a high amount of raids on both his business and his home.

Mark said: “We’ve had about ten raids now all together between the shops and our house. I’ve been getting blocked in on the roads too just so a Garda can say hello. It’s more intimidation. To tell someone to get out of the car to be searched because you own a CBD shop, to me is wrong.”

He added: “I go over to the UK to pick up stock a lot. I got pulled in by Irish customs the last time where they searched my van. They had no problem with it being CBD but it’s the local gardaí who do. It’s because they can’t differentiate between the two different products. It’s not easy as we have over €100,000 worth of products taken from us.”

“I’m actually suing the state to say what you are doing is illegal. I have experts coming from Sweden and the UK for the case where we have to prove that we are not guilty. We’ve done everything we can as a vendor but the court has to decide otherwise we are going to Europe. We know we are 100 per cent legal but is the Irish law that’s the problem.”

Mark highlighted that this could have a huge effect on the country in terms of upgrading facilities.

“We were in the district court trying to get our case held. They wouldn’t put the order in place so we are waiting for the high court. If the order had been put in place then a lot of cannabis cases in Ireland would have to be put on hold until mine is done as it shows the testing is inadequate. It could cost the state millions because they have to change the whole testing facilities.”

The effects of the raids are not just on stock or on time spent preparing for court cases. There has been a mental health cost.

Mark explained: “They came into the house then the last time, they took me down to the garda station just to hold me in a cell. They weren’t even doing any questions that night but it was just to rattle me another bit.”

Ireland CBD: The front of Denise Lynch's store in Cavan

D’Hemp Shop

D’Hemp shop in Cavan is also challenging the high court in Ireland about the raids. Denise Lynch was raided in September 2021 where several products were seized. As with Little Collins and ReLeaf, all products were legally sourced. Her home and car were also searched.

Denise decided to open her store after she experienced the benefits of CBD for her arthritis pain. Although she had heard about the controversy in Ireland surrounding the 0.2 per cent THC levels and the seizures, she didn’t expect to be raided. She was surprised to be handed a notice to say the premises was being searched under the misuse of drugs act 1977.

Denise said: “They raided my home and my car on the street. They were here for five hours and this is a small business. They were in my home for a long time while my husband was working, my kids were at school and I was here. So there was no one home at the time.”

“It was frustrating because we weren’t doing anything wrong yet we were treated like criminals. It was upsetting for that reason. It’s a small town so people are thinking, well if the gardaí are there then she must be doing something illegal. It brought a bad atmosphere to the place and that’s one of the main reasons I am fighting this. I want to clear my name because we are doing nothing illegal.”

Since news of her legal battle broke, Denise has received an overwhelming level of support from customers and other CBD sellers. She hadn’t properly realised the scale and potential of the case until she was contacted by so many people.

“I’ve been getting so many emails, messages and phone calls from people I don’t even know. They have been so supportive and want me to do well. Other stores have given me a message of support through social media. Some of the other companies have their own battles going on and they are really good people who genuinely want to help others. It’s been really tough on everyone including the farmers.”

When it comes to change, Denise highlighted that what is needed, is clarity.

“It was said to me that I could be prosecuted over this as the products were sent for analysis with under 0.2 per cent THC. I raised it to the garda that in the EU, I am allowed to sell that amount. His reply was that, well, you’re in Ireland.”

She added: “We are part of the EU. This needs to be sorted and we need to realise we have rights as EU citizens. What we need is clarity from the government. We need to know that they are going to stop coming into companies using the misuse of drugs act.”

Features

Oli White: from YouTube star to CBD entrepreneur

In his decade-long career in YouTube, Oli White has racked up half a billion views and more than 4 million subscribers.

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Oli White Unique CBD
Home » News » The high court: the battle continues for the CBD industry in Ireland

Cannabis Wealth caught up with the YouTuber-turned-entrepreneur to hear about his journey and how the anxiety that came with fame led him to discover CBD.  

Oli White found his fame as one of YouTube’s first major stars. Since he started uploading videos as a teenager he’s racked up over half a billion views and more than 4 million subscribers across his three channels.

Now, the 27-year-old vlogger has branched out from his career in entertainment to launch his own CBD company, Unique CBD, along with his partner and fellow influencer Evie Marcer.

A decade-long career in YouTube 

“I was a pretty nerdy, geeky kid,” Oli said over Zoom. “I loved editing, filming on cameras, special effects. One day, I just started making videos and got the courage to put my face on camera.”

This was 2012. YouTube was still in its infancy and the platform’s very first vloggers were only just beginning to gain significant recognition.

“This was a period when YouTube was so new,” Oli said. “People weren’t spending a million pounds on a challenge; you’d just sit there and talk about a subject or work on a little skit. To get a million views or even 100,000 views back then was the biggest amount of views the platform had seen.

“You couldn’t earn money off of YouTube either. Brands wouldn’t advertise with YouTube and there were no brand deals or anything like that.”

After a couple of years, Oli’s channel started to explode. He soon found himself part of a community of fellow YouTubers, namely Caspar Lee and Joe Sugg, who would become huge stars in their own right.

Before he knew it, Oli was jetting from continent to continent, meeting fans from across the world. In the space of just three years, he went from a creative teenager making videos in his bedroom to an international star with over a million subscribers.

“It was one of the most surreal things in my life,” Oli said. “I remember going to the Philippines and at the airport, we had hundreds and hundreds of people there, including TV crews and paparazzi. We did a stage show with thousands of people in the audience. It was crazy.

“I’m so grateful for the travelling I’ve been able to do, the people I’ve been able to meet and the brands I’ve been able to work for. I’ve worked with some of the biggest brands in the world and that’s all because of these little videos in my room.”

Youtube isn’t what it used to be. The platform has grown exponentially over the past decade. According to analytics company Socialblade, there are now more than 51 million active channels. Around 22,000 of these have over a million subscribers.

The oversaturated nature of the market has led Oli to different outlets, notably TikTok which he says offers a more rewarding way to promote and discover content.

@oliwhite

I started a Buisness in lockdown and this is what happened. #fyp #business #UniqueCBD

♬ original sound – Oli White

Discovering CBD

Several years into Oli’s YouTube career, the impact of his astronomical rise to fame started to catch up with him.

“When I was 18 and we were doing events and there were loads of people there, I was fine. I still felt like a kid,” he said. “But as I was getting into my 20s, I started developing a lot of anxiety around meeting people and going to events where there were loads of people.

“It then just stopped me from doing things. I would say to myself, ‘I don’t really like doing that’, but it was actually my anxiety saying, ‘no, you can’t do that’.

“I think it just grew on me,” he continued. “I’d go to a red carpet [event] and I’d worry about no one knowing me and ‘what if this happens’ or ‘what if that happens’. I just ended up in with my thoughts. I knew that I was dealing with a lot of anxiety but I just pushed it to the side.”

It was Oli’s Mum who recommended he try CBD. Years earlier she had been diagnosed with cancer which she later overcame. CBD helped her manage the crippling anxiety she experienced going through treatments.

At the time, the UK’s CBD industry was young and underdeveloped, so Oli and his partner Evie headed to the US to sample a few products. “We tried some CBD and it was just amazing,” Oli said. “My anxiety was completely relaxed and I  just thought ‘wow, this is incredible’.”

On his return to the UK, Oli ordered himself and Evie a pack of what he thought were CDB capsules but the feeling of calm he experienced in the US never materialised. After a couple of weeks of research, he realised he had in fact been sold hemp seed oil which contains zero CBD.

“As we researched the industry more, we realised that there was such a lack of information, transparency and professionalism,” Oli said. “It has definitely got better with companies publishing third-party lab results but that’s something that I’ve only seen a lot more of in the last year.

“Having lab reports is like a selling factor for CBD, but it should be absolute general practice. It just shows how new the industry is. I can’t wait until there’s more clarity within the space. I think that’s what we need to really move forwards.”

The beginning of Unique CBD

Unique CBD Day Drops

Unique CBD launched its first product in 2020.

Over the past several years, Oli has increasingly turned his attention to the world of CBD, teaming up with his partner Evie – who is also an influencer – to form a business wholly separate from his media personality.

At first, Oli and Evie simply wanted to create a product they could trust for their own personal use. The couple started educating themselves on the CBD space before connecting with a neuroscientist who they collaborated with to create a high-quality product that achieved the same results they experienced in the US.

“For a year, if not longer, we started intensively educating ourselves on the space and the different companies on the market,” Oli said. “We collaborated with a neuroscientist and worked with him on an oil and we started trialling it.

“We then ordered a bit more and started giving it to friends and family.”

The pair soon realised that others could benefit from the products they had spent the past year developing, so in August 2020, they launched their own company, Unique CBD.

“Our mission always was, and still is, is to create premium, trustworthy and transparent products”, he added. “We created and have some incredible products that I’m just so proud of.”

Growing the business

Unique CBD grew organically over the next two years. The couple started by launching day drops before developing higher strength night drops. They later branched out into skincare following the introduction of Novel Food applications which prevented them from releasing other ingestible products.

While the UK CBD industry continues to experience teething problems, the young company’s focus is on building an “amazing foundation”, honing its products and brand before potentially seeking out funding later down the line.

All of Unique CBD’s products are made from isolate extract and produced independently. Rather than working with a manufacturer, each product is made in-house and owned by the company.

“We don’t work with a manufacturer that creates the same oils for multiple other companies. Every single product that we create is completely customised to us,” Oli said. “Everything is carefully considered and created by us which is something that a lot of CBD brands don’t tend to do because it costs a lot of money.

“We don’t want to be ‘that influencer’s CBD brand’”

While Oli has by no means left his career in entertainment behind, his priority now is Unique CBD. “For the most part, we’re solely focusing on the company because this industry is ready to grow fast and we want to really make sure that we’re there at the forefront and we’ve got the company prepared when things take off,” he said.

It would have been easy for Oli to capitalise on his massive personal following to push the brand, but instead, he initially chose to stay quiet about his new venture due to fears that attaching himself to the brand could taint its reputation.

“In the first year and a half of us launching, we didn’t really talk about the brand at all,” he said. “We didn’t want it to be ‘that influencer’s CBD brand’. Sometimes those kinds of reputations can be quite damaging so in the early stages of the company we very much stepped to the side.”

@uniquecbd

Introducing this CBD infused BODY CREAM #skintok #skincaretips #cbd #cbdskin #cbdskincare #uniquecbd #cbdskincareproducts

♬ original sound – UNIQUE CBD

While they have avoided attaching their faces to the brand, the pair have drawn from their careers as influencers to shape their marketing strategy. As Instagram and Facebook continue to prevent CBD companies from advertising through the platforms, Unique CBD has focused their efforts on TikTok and YouTube.

“With my background, we produce all of the content, from the imagery of our products to content on TikTok and YouTube,” Oli continued. “For me personally, education is a really important thing in this space. With our TikTok videos, we’re creating educational pieces of content surrounding CBD, but we also try and add a bit of a health and wellness factor to that as well.”

Unique CBD continues to develop new products, with two new face serums in the pipeline.

“There are so many products that we want to work on,” Oli added. “It’s expensive and it takes a long time to develop them right but there’s so much more we want to do.”

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Broughton expands experience from nicotine into cannabinoids

Broughton CEO Chris Allen spoke to Cannabis Wealth about the company’s ambitions to support safe and effective cannabinoid delivery.

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Broughton expands experience from nicotine into cannabinoids
Home » News » The high court: the battle continues for the CBD industry in Ireland

UK-based Broughton Group is leveraging its extensive experience in nicotine replacement therapies and analytical testing to support the development of cannabinoid delivery devices. 

Established in 2006, contract research organisation Broughton is working to develop its position as a full-service solutions provider to the global life sciences sector. With extensive experience in next-generation nicotine delivery products, the company succeeded in developing one of the first devices approved for nicotine replacement therapy.

Broughton’s services cover product development, scientific and regulatory consultancy and laboratory services across the pharmaceutical, nicotine and cannabinoid industries.

Read more: Broughton expands into North America for next phase of growth

Its nicotine product experience covers electronic nicotine delivery systems, modern oral nicotine pouches, heated tobacco products (HTPs), nicotine replacement therapy and synthetic nicotine. The company has been applying its knowledge to the cannabis device market, which is expected to reach US$26.52bn (~£22.41bn) by 2031, according to Transparency Market Research.

Broughton CEO, Chris Allen, who has been working in the medical device industry for 25 years, shared the company’s journey from its inception to its move into cannabinoids, where it will apply its knowledge of regulations to develop safe and effective devices. 

The journey into cannabinoids

Chemistry graduate Allen has been heavily involved in analytical and regulatory science throughout his career. Early on, he worked in respiratory medicines at Melbourne Scientific, now part of Intertek, where he began working on drug registration programmes through inhalation.

After moving location, Allen began working at a company that focused on animal feed testing, where he met Broughton co-founder Paul Moran. The pair succeeded in obtaining GMP accreditation for the company’s testing facility and within two years, doubled the turnover of the business. 

Read more: Structure change to drive the growth of Broughton

In 2006, Allen and Moran decided to establish Broughton together, beginning the business by focusing on animal health products. By 2011 Broughton moved into nicotine replacement therapies and supported the securement of the first licensed medicinal product for electronic cigarettes.

This move led Broughton into different regulations for tobacco harm reduction products, where the company saw the most significant growth. 

Allen commented: “Broughton has the ability to be able to interpret different regulations from around the world and bring that sound science and pragmatic view to adhering to those regulations.

“The heartbeat of the businesses is analytical testing, but being able to complement that with the consultancy business. So, bringing in project managers, toxicologists, scientific consultants, clinical experience and behavioural experience – to be able to provide that full package – it was always more than just data for us.

“It’s about what that data actually means – what are you trying to prove, and therefore, how do we design the study? When you get the data – what should you be doing next? 

“It’s about the ability to start looking at how we can apply those services, those learnings, into other markets, and that has now brought into the cannabis industry.”

Chris Allen, CEO, Broughton

Safe and effective cannabinoid delivery

Broughton has spent the last two years unpicking the right markets to work in from a global perspective. With a growing customer base in North America, the business is establishing a US Subsidiary with the aim of building its presence in the region. 

Allen commented: “Going into the US is very state by state at the moment if you’re not in recreational. So, our real focus now is inhalation because we have a lot of the consultants here, myself included, and a lot of the analytical facilities focused on inhalation products. 

“That’s been through the electronic cigarettes but also inhaled pharmaceuticals. Looking at cannabinoids, the historical way of consuming those has been through inhalation. 

“We always look for the safest way to deliver drugs – the most effective way – but the safest possible way as well. And that’s always avoiding combustion. So, as we look to inhalation products.

“We look at how we can work with companies to design the right products, demonstrate the right level of safety from an efficacy perspective, but also from a perception and behavioural.”

In this regard, Allen notes that a lot of nicotine replacement therapies do not work because they do not mimic the action of smoking and this same principle applies to the consumption of cannabinoids.

Broughton has also been looking heavily at the UK’s Novel Foods process which has raised a lot of confusion in the industry. Allen says, the company has seen many businesses making mistakes with Novel Foods. Allen highlights that the cannabis industry is fragmented from a regulatory perspective, which is no different from the nicotine industry that has very localised regulations.

“We have been looking at those regulations – what’s right about them, what’s wrong, how to apply them, and how to go and support companies through that process,” said Allen.

Allen emphasises that the cannabinoid industry can learn a lot from the nicotine industry, which, in the early days of nicotine vaporisers saw many products focused on flavours and branding, fuelling a negative perception of the products.

“Don’t make ridiculous claims about cannabinoids – you have to be able to back those up,” said Allen. “If companies start to work from day one responsibly, it’s only going to help the industry. Self-regulate as much as possible.”

Broughton is launching its cannabinoids services, where it is looking to help those companies that have been let down by providers.

“It is about bringing a degree of pragmatism, sound science, good consultancy, and applying the right studies to support those companies that are looking to take products through the Novel Foods process,” said Allen.

“We’re hearing some horrendous stories coming out of poorly thought out studies and poor quality testing that’s been conducted.

“It is about bringing our experience into this industry to try and bring control, and also to try and change public perception as well. The commonality of a lot of the products that we’re starting to look at is actives that potentially have been around for a very long time, but the perception isn’t right. 

“They have a lot of therapeutic benefits, but they also have a stigma attached to them. It’s a passion point of the company to see what new products can we help bring to market and change that public and healthcare perception of some of these drugs.”

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Growing pains: fresh challenges for the UK’s CBD industry

The regulatory hurdles are many, but the potential UK market – thought to be the largest untapped market in Europe – is significant.

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UK CBD industry

David Hardstaff and John Binns of BCL Solicitors LLP discuss the regulatory landscape in the UK following the EFSA’s decision to pause all novel foods evaluations for CBD products.

The European Food Safety Authority (EFSA) has dealt a blow to the European and UK CBD industries, identifying several hazards related to CBD intake and pointing out deficiencies in both the experimental animal and human research data.

The EFSA’s ‘Statement on safety of cannabidiol as a novel food: data gaps and uncertainties’ is intended to ensure the ‘harmonised scientific assessment’ of novel foods in the EU.

However, its findings primarily highlight a lack of sufficient evidence needed to fully assess the safety of CBD as a food. Whilst the findings are not binding on UK regulators, the beleaguered UK CBD industry must now brace itself for its inevitable fallout.

An industry under fire

Although no longer a member of the EU, the UK continues to align with its Novel Food Regulation; and so, whilst not determinative, the findings of the EFSA are likely to concern UK regulators grappling with the CBD issue.

UK-based CBD companies had already been feeling bruised prior to the release of the EFSA’s statement. From operating within a light-touch regulatory regime, founded on the belief that CBD products were no different to any other readily available food supplement, the closing drawbridge that was the Food Standards Agency’s (FSA) novel food application process has been a shock to the industry’s system.

The process, which required non-medicinal CBD products to be the subject of an application for authorisation, has caused a stir within UK CBD businesses and exposed brands’ reliance on white label goods. This has left many querying the real value behind some of the celebrity-endorsed brands vying for a piece of the UK’s CBD landscape.

The longer-term consequences are unclear.

When announcing the publication of its list of products which have submitted a valid novel food application, the FSA confirmed the role of enforcement authorities and that it had recommended to local authorities that any products not on the list should be withdrawn from the market. Such products would be deemed ‘unsuitable for progressing to authorisation’, or in other words, unsellable.

This was prior to the EFSA’s statement, which will clearly not aid the industry’s plight. The FSA will publish its full list of pending novel food applications this month.

The position of the EFSA

Although the EFSA has not commissioned its own research, its statement points to existing animal and human studies which have been conducted to identify safety concerns linked to CBD. In considering the safety of food products, the same cost-benefit analysis used when assessing the safety versus efficacy of medicines doesn’t apply. Put simply, adverse effects from food consumption are not tolerated, regardless of other perceived benefits. The bar to find grounds for caution in the regulation of CBD as a foodstuff is therefore a low one.

The EFSA statement refers to its finding ‘clear evidence’ for liver toxicity of CBD, demonstrated by liver hypertrophy in laboratory animals and increases in liver enzymes in experimental animal and human studies. Data gaps are identified in relation to other areas of concern, including on gastrointestinal tract, endocrine system, nervous system and on psychological function.

The statement recognises that most of the existing human data emanates from studies into the efficacy of the CBD-based medicine Epidyolex at therapeutic doses. The limitations of such studies in the context of assessing CBD as a food are clear.

As one door closes, another opens?

Although bad news for CBD products marketed as foodstuffs, the EFSA’s statement and novel food considerations shouldn’t impact on the availability of CBD products as medicines, which are separately regulated.

Outside of pharmaceuticals, one of the largest and arguably sustainable CBD customer bases have been consumers with some sort of health or therapeutic need, for which they are unable to access medicinal cannabis.

One potential consequence of the drive to rein in the UK’s CBD industry is reduced access to the previously available wide range of products. In recent times, it has been difficult to find a high street or retail centre between John o’ Groats and Land’s End without CBD products for sale. That position could dramatically change, shifting some products into, and prompting changes to, the medicinal CBD space.

Cannabis-based products for medicinal use, or CBPMs, have been available for prescription in the UK since 2018; however, access is strictly limited through existing and bespoke regulatory controls. In addition to the regulatory barriers to access, funding has long been cited as a problem, with limited patient access through the UK’s National Health Service (NHS). On drilling down into the issue, a lack of UK-based research as to the efficacy of CBPMs is the starting point.

Several laudable initiatives have sought to plug the research gap, including Project Twenty21, the UK’s largest observational medicinal cannabis study. However, observational studies have their limitations, which is why most have recently welcomed with open arms the UK Health Research Authority-approved trial, Canpain.

Canpain is planned to run for three years and aims to conduct clinical trials involving up to 5,000 patients suffering from chronic pain. The trial will be the first of its kind in the UK and could be significant in opening access to CBPMs for the UK’s estimated 1.4 million patients currently accessing cannabis through the illicit market.

As highlighted by the EFSA statement, reliable data on the number of CBD consumers with some sort of therapeutic need is patchy, but as access to CBD products becomes more limited through enforcement of the novel food regime, access to CBD-based medicines could provide an important lifeline.

This could also present opportunities for the CBD industry, which until now has seen a benefit in its separation from the medicinal market. The industry must ask itself whether it is now time to explore the jump from consumer products to medicines.

Can a more agile CBD industry flourish and better serve patients?

No one would suggest that the development and marketing of a new medicinal product is a straightforward task. Although CBD is not a controlled drug in the UK, the position of the UK Home Office remains that it is difficult to produce CBD without any trace element of THC, which is controlled.

Consequently, it is usually necessary to begin the process of developing a CBD-based medicine with an application to the Home Office for a Schedule 1 controlled drug licence for research purposes. Further licences are likely to be necessary throughout the development process, including a Schedule 2 controlled drug licence for operating with CBPMs, as well as Manufacturers (Specials) and Distributors licences from the Medicines and Healthcare products Regulatory Agency (MHRA).

The regulatory hurdles are many, but the potential UK market – thought to be the largest untapped market in Europe – is significant.

Turning to the development of CBD-based medicines could represent a lucrative opportunity for some of the brands which have until now limited their reach to what might be described as the lifestyle market. That may not explain or justify the EFSA and FSA’s stance, and nor does it remove the urgent need to liberalise access to CBPMs in the UK.

But for consumers with a therapeutic need, a more agile CBD industry, equipped to cross the barrier between the medicinal and non-medicinal worlds, would unquestionably be a good thing.

Authored by Senior Associate David Hardstaff and Partner John Binns of BCL Solicitors LLP

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