Chanelle McCoy is carving out a unique position in the CBD industry with her brand Pureis. She tells Arthur Walsh about the behind-the-scenes work that has led to a recent world-first safety assessment from the UK Food Standards Agency

Irish born, Berkshire-based entrepreneur Chanelle McCoy was first inspired to enter the CBD market in 2014 when she became familiar with the story of Cork mother Vera Twomey. Twomey’s daughter Ava suffered with Dravet syndrome, a severe form of epilepsy, and faced a long battle sourcing the medicinal cannabis that helped with her seizures – leading to a prescription written and filled in the Netherlands being seized when Twomey landed back at Dublin Airport in 2017.

“The only thing that was controlling and reducing those seizures was CBD,” says McCoy. “We just felt it was awful that people who needed access to CBD couldn’t get it – there was a level of ignorance on the Irish Government’s part.”

McCoy – who has appeared as a dragon on the Irish edition of Dragon’s Den – had lengthy experience launching medicines in global markets when she first got the idea to crack the CBD market. As the co-founder and head of Chanelle Medical – an offshoot of the veterinary medicines company set up by her father Michael Burke – she was responsible for getting 2,500 product licences for generic medicines and selling them into almost 100 markets around the world. “We registered fluoxetine all over the world before the patent expiry,” she says.

When she learned of the Twomey case, the seeds were sown for Pureis, the CBD range from her new company, Chanelle McCoy Health. Speaking with chief scientific officer and co-founder Caroline Coen, who worked with her at Chanelle Medical, McCoy says: “We thought, we’re pharmaceutical girls, we should be able to develop a product and make it accessible and price-competitive for those families so they don’t have to travel abroad for it. That’s really where the inspiration came from.”

The next step was to seek the views of global authorities on how to get a product registered. “We come from prescription and OTC medicines; the regulatory landscape would always be the first place we would look.”

Epidyolex, a CBD product licensed in the UK for severe epilepsy since 2020, is expected to remain on patent for another decade, says McCoy. It was therefore decided at an early stage to “progress as a food supplement initially and continue on a medicine journey in parallel,” in the first instance looking to appeal to consumer interest in CBD for conditions like pain and anxiety and engaging in efficacy studies to support a future move into the licensed medicine space.

This is a lengthy process that has seen McCoy and her team carry out extensive safety studies on the product, which is manufactured in the UK in an MHRA-approved facility: “Even though it’s a food supplement, we wanted the highest quality standards.”

The other crucial decision was to develop a synthetic CBD product rather than using the cannabis plant. “With our home territory being pharmaceuticals, we decided to go down the lab-made route because we wanted a product that could be given to kids without any traces of cannabis, or to professionals like pilots and air traffic controllers. They’re not going to fail a drug test if they take Pureis.

“Our data suggests that we reached our end points much quicker than what was reported in the literature on hemp-derived CBD,” says Glynn-Coen. “In the scientific literature, synthetic is getting much better efficacy at lower strengths. That’s ultimately what the body wants; you don’t want to have to be ingesting thousands of milligrams. It’s not good for the body to expel all that.”

Safety assessment

A major hurdle was recently cleared on the path to food supplement status. On 30 April, the UK Food Standards Agency (FSA) awarded a Positive Safety Assessment to Pureis and to extract-based product Cannaray, the first decision of its kind globally. “This is a monumental achievement and a complete game-changer for the CBD industry,” said McCoy in a statement at the time. “The first rule of a novel food is that this particular ingredient was not in the food chain commonly before 1997 – it’s about safety, whether a product is safe if you take it long term,” she explains.

It’s been nine years since they started on this journey, and three since they first submitted their dossier to the FSA. “For the UK to be the first mover globally and legislate CBD as a food supplement shows great pragmatism,” says McCoy. “Our product is fully deemed safe.”

The FSA decision “also allows us to offer our raw material and product to other companies to use as an own-label”, says McCoy. “The next part is that the FSA will hand our dossier over to the regulators, who will fine tune the licence. Then it essentially goes to the Government.”

Once a novel food licence is granted, the company plans to launch a suite of new products; since 2020 there has been an embargo on new products containing the novel ingredient. At the top of the R&D pipeline are combination products containing CBD as well as other products like glucosamine, lavender and magnesium.

“Despite anecdotal feedback from people taking our product, we are unable to make claims about what CBD does – but adding lavender, for example, means we are then able to talk about sleep. What it means for the consumer is that they can now start to navigate the CBD category more easily, as those ingredients are very familiar.”

McCoy is disappointed that European regulators have been slower and “less pragmatic” than the UK. “The devil is in the dose with CBD, but that’s like any other molecule,” she says. “There are ingredients in our food cupboards that would not pass the same toxicology tests we had to go through. The FSA understood that – unfortunately Europe didn’t. What it means is that consumers in the UK can buy a product knowing there is a clear legislative pathway behind it.

“We both come from the generic space and are used to doing studies; it wasn’t in our vocabulary to launch something without doing clinical trials; we just wouldn’t do it.”

McCoy feels this gives them an advantage over their competitors, a lot of whom are “ex-finance guys” who don’t know the ropes: “They’re still fighting and claiming CBD is not a novel food because hemp goes back to the biblical days. Meanwhile, we have just got on with it.” Many have exited the market after failing to “make a quick buck”, she adds.

It’s not been cheap. “We have spent a number of millions on this, but we wanted to prove that the product was safe. We understood that this was a relatively new molecule and needed to be demystified, as exemplified by the approach taken by the Irish authorities: they didn’t understand the molecule, so they were blocking it. CBD is scientifically proven to be non-addictive and there’s never been one overdose fatality”.

Two-pronged approach

“We are embarking on phase II and phase III clinical efficacy studies,” says McCoy. The company wants to be able to make claims as a food supplement under the current 10mg dosage, and then as an OTC medicine at higher doses. “The holy grail is to come out with efficacy studies that show this is not just anecdotal and there is proven fact behind CBD.”

A Dragon’s Den question: where does McCoy see the business in five years’ time? “We’re very clear on our strategy going forward,” she says. “It’s the strategy we’ve had since the start –travelling down the medicine route and the food supplement route.

“We will continue to pursue the food supplement licences across the 40 countries where we have pending registrations, and there are markets like Europe where we need to provide further clinical data and will do so. “In the meantime, we will start efficacy studies to get CBD registered as an OTC medicine at a higher dose. When we complete that journey, we will be very happy.”

There are no plans to pursue a POM route at present, but there are plans for a line of topical products: “Some of our consumers over the last five years have been using it topically on their hands for psoriasis, eczema and cracked skin.”

A balm product will be launched in September, McCoy says: “We know from our research that people in the UK and Europe like to treat pain topically first before using oral treatments.

“We have an exciting R&D pipeline. The topical product we can launch now; that’s not subject to novel food approval because it’s not consumed.”

Bringing the pharmacist on board

Seeing themselves as the “grown-ups” in the CBD space, McCoy believes it is vitally important to reach out to healthcare professionals, particularly pharmacists.

But what is her pitch to the profession when it comes to handling a molecule she acknowledges has not been without controversy? She responds: “We empathise with the concerns raised by pharmacists over the last few years. This is the first time they’re actually dealing with a product that has been deemed safe by the Government.

Pureis is currently stocked in Boots and “we are ready to really branch out to a lot more pharmacies” on the back of the FSA decision, says McCoy.

Is it important for Chanelle McCoy Health to engage with community pharmacists? “Absolutely – we want to launch a targeted education programme for teams.

“This is something we’ve learned that we didn’t realise when we launched. We know about 60 per cent of people taking our product are on other medications. Even people who aren’t will want to ask questions before they embark on a CBD journey. It’s very difficult for the consumer to get that information on a supermarket aisle, which is why many will go to the pharmacy to buy CBD.

“We very much see the pharmacist as the gatekeeper to the CBD industry. Consumers will ask: Will CBD interact with my current medication? Is it addictive? Will I get a high? Can I drive?

“This is where the pharmacists hold the power to the market, and it’s why we are focused on educating the pharmacists even before we educate the consumer. If the pharmacist turns around and says, I don’t know much about CBD and can’t advise on it, that’s a lost opportunity for us.”

McCoy acknowledges the challenges that pharmacists may face in handling conversations without making a health claim, but argues the forthcoming combination product launches “will help pharmacists to navigate the range and make recommendations”. They commissioned a survey from CIG Research: “We wanted to put ourselves in the shoes of the pharmacist and find out how much they know about CBD – how it works on the endocannabinoid system, the difference between plant versus synthetic and so on.”

The research found that pharmacists are still hesitant to recommend CBD for some conditions, although an overwhelming majority (78 per cent) believe the pharmacy is an appropriate place for patients to access CBD products and almost 70 per cent expressed an interest in receiving training on the category.

She hopes her company’s clinical efficacy studies will change perceptions, and refers to “thousands” of ongoing clinical trials into CBD: “I think over half of them are in Parkinson’s. Then you’ve got anxiety, alcohol dependency and sleep – you won’t find any other molecule with so many clinical trials around the world across such an array of indications.”

“Ever since we launched, we’ve been reaching out to customers to get feedback. Sleep, stress and pain – they are the big things.”

“Our market is people who just want CBD with no other components such as THC. When you’re trying to extract one molecule out of 500, it’s impossible to get pure CBD. You’ll always be left with traces of the other components in the plant. With a synthetic formulation, every single batch is the same. It totally de-risks the pharmacy. They’re not going to get the customer coming back in, saying they had a funny effect and didn’t feel able to drive.”

The manufacturing process is more environmentally friendly, she adds, requiring far less land and water.

It’s an exciting time for a nascent industry, McCoy concludes. “It’s very rare that you get a new molecule like this. It’s not like launching a bottle of wine in the existing ‘wine’ category – this is about launching a whole new category.”