The great CBD oil conundrum
Consumer interest in cannabidiol or CBD oil is growing fast, but should pharmacists embrace the market as a new opportunity or run for the hills?
A recent report in The Times revealed that more than half of CBD oils on sale do not contain the level of CBD specified on the label. Nearly two-thirds of 29 tested products contained less than 90 per cent of the declared CBD content, while one product contained no CBD at all.
The non-psychoactive compound is found in cannabis plants and typically extracted from strains such as industrial hemp, which contain high concentrations of CBD and low concentrations of the illegal psychoactive ingredient tetrahydrocannabinol (THC). Half the products in The Times investigation contained THC, albeit in small traces.
The National Pharmacy Association (NPA) advises pharmacists to check the legal status of CBD products before selling them or risk breaching their indemnity insurance.
Pharmacists considering whether to stock non-medicinal CBD products need to ensure they are “acting legally and putting the needs of patients first”, says Jasmine Shah, head of advice and support services at the NPA.
“In the case of non-medicinal CBD products, pharmacists should take account of current Home Office guidance. Currently the evidence about the long-term effects of these products is limited and the regulations are complex,” she admits.
The NPA “would welcome more research and authoritative guidance that makes it easier for manufacturers, healthcare professionals, retailers and consumers to make informed choices, keeping everyone on the right side of the law and safe from harm”.
In order to protect customers and pharmacists against the sale of illegal substances, “testing of all CBD products should be undertaken to ascertain their safety profiles and that the content mirrors that stated on the label”, says Mark Tucker, chief executive of TTS Pharma, a supplier of cannabinoid products. “However, this should not be the responsibility of pharmacists and should be the concern of manufacturers.”
The company has commissioned an independent analysis of its own CBD oil by a Government-certified laboratory and sees providing this assurance as its responsibility. All CBD manufacturers should do the same, Tucker believes.
In August, the UK’s Centre for Medicinal Cannabis (CMC), which tested the products in The Times report, announced a new cannabinoid industry quality charter to help foster a legally compliant and innovative CBD industry in the UK. To help guarantee standards and to give consumers trust in the available products in what is a £300m – and fast growing – market, CBD manufacturers are attempting to introduce a quality ‘kitemark’.
“Any supplier of CBD should be able to explain in detail the processes behind its production, quality control and testing protocols,” says Satipharm’s chief executive officer Jonathan Hartshorn.
“The proposed industry quality charter should only be issued to products that adhere to stringent international requirements such as good manufacturing practice. Other measures of quality include products that provide reliable dosage and proven bioavailability.”
As for the professional and legal obligations for pharmacists selling CBD products, “they need to use reputable brands that are of proven potency and purity and passed by Government regulators”, advises Paul Mavor, a pharmacist at Medical Choices UK, a charity educating about legal medicinal cannabis.
Due to Home Office concerns on the lack of labelling transparency, a detailed certificate of analysis and certificate of origin should be obtained from the manufacturer before the product can be sold, says the NPA. Product specific liability cover is recommended, as well as full supply chain traceability, advises Mark Tucker.
Crucially, pharmacists should know where the CBD product comes from as “most suppliers buy third party, whereas we control the whole process from ‘seed to shelf’,” says Hannah Skingle, chief operating officer, Dragonfly Biosciences. Pharmacists should ensure they are selling CBD as a food supplement and be clear about what exactly they are selling, just as they would be if selling vitamin C, she says.
Testing of all CBD products should be undertaken to ascertain their safety profiles
Food supplements or medicines?
CBD-containing products are widely marketed in the UK as food supplements – and manufacturers are keen to keep things this way. If the MHRA determined that CBD products should be classed as medicines, this would increase manufacturers’ costs significantly. Selling products that have efficacy proven by clinical trials would effectively cause the MHRA to view them as medicines, requiring licences.
Paul Mavor says that while there are proven medical benefits in some conditions, the current UK prohibition-style access scheme for medicinal cannabis needs to change.
“Given that CBD is not psychoactive, low on the addiction scale and not subject to abuse, its OTC status should be maintained, as should the current rule that no medical claims can be made about a CBD product.” In a perfect world “CBD should be pharmacy-only”, he believes.
Hannah Skingle points out that CBD companies “don’t have hundreds of millions of pounds” to do clinical trials and says the focus instead should be on ensuring “safety, dosage and potency” for consumers.
- Only CBD lines marketed as non-medicinal products or food supplements with no medical claims can be legally sold OTC
- Pharmacists should stock only CBD products with proven purity and provenance
Home Office view
The Home Office has taken the view that any amount of controlled substance, namely THC, whether or not inadvertently included in a CBD product, renders it illegal for sale. If a product contains THC, it is “highly likely” to be classed as a controlled drug, the Royal Pharmaceutical Society advises.
While it is “extremely difficult to extract pure CBD without trace amounts of other cannabinoids being present, there is as yet no legal definition of the levels of precision required to prove that CBD products are THC-free”, Mark Tucker says.
As CBD and THC “are very difficult to separate”, pharmacists should be “very careful” when it comes to the CBD products they sell, Terry Maguire, a community pharmacist in Belfast, cautions.
Paul Mavor says the recent Times report on CBD products, “certainly indicates a wide variety ranging from artisan products of questionable integrity to gold standard pharmaceutical grade CBD of known purity and potency.
“The public and retailers definitely need a better system [of quality control], but I think this should be led by regulators. They have obviously fallen asleep at the wheel and it has taken a private study to highlight the discrepancies,” he says.
Suppliers “must be clear on the provenance and quality of any CBD product and ensure it meets the required EU and UK regulations”, says Mark Tucker. They must obtain the relevant import and processing Home Office licenses and hold appropriate certificates of origin and purchase orders to verify the provenance of imported CBD or hemp.
Traditionally pharmacies have sold a range of vitamins, healthcare products and food supplements. CBD products are no different
Should pharmacies sell CBD?
Given the sensitivities surrounding CBD sales in pharmacy, there are some who question whether the sector should be selling the products at all. While views may differ on the professional ethics of selling CBD, what isn’t in doubt is that this is a rapidly growing category and there is growing clinical and anecdotal evidence that CBD oil may help in conditions like arthritic pain, anxiety and sleep disorders.
This, in the eyes of some, makes the issue more a case of which CBD products pharmacists should sell in order to provide a valued service to customers. After all, pharmacy is uniquely placed to offer assurance and professional advice on sales of CBD lines, as opposed to websites and health food or vape stores.
Dragonfly is “passionate about CBD in pharmacy in order to legitimise the category”, says Hannah Skingle. While recognising it is a “very early stage category”, pharmacists are “great educators” to promote CBD to interested customers. Most consumers are currently purchasing CBD products online.
Pharmacies are “a more responsible source to purchase CBD products from” agrees Mark Tucker. “Pharmacists are well trained to understand the customer needs and help them understand what they are purchasing and any potential risks, especially when other medical conditions may need to be taken into account.”
As consumer demand is high and the range of products available in the high street and online is so vast, a simple starting point should be that pharmacists select only products with proven purity and provenance. The alternative would be to not offer any CBD products at all, but this is unlikely to remove the demand and may result in consumers using less trustworthy or even illegal products. This would clearly be detrimental to safety.
For Paul Mavor, the answer to the question of whether pharmacy should sell CBD products is a resounding yes. “Traditionally, pharmacies have sold a range of vitamins, healthcare products and food supplements. This is no different.”
But not all pharmacists are in favour of CBD. Terry Maguire, for instance, describes it as “the new homeopathy”. There is a commercial return to be made but we must remember our professional responsibility, he says.
Pharmacist Lila Thakerar says she stocked CBD products for a few months and, while they proved popular with customers, she recently took them off the shelves after the NPA’s advice.
With a potential market worth hundreds of millions of pounds, CBD could rise to the top tier of OTC categories. However, with audits in the US and UK indicating examples of misleading labelling and inclusion of THC and other contaminants in CBD products that compromise safety, not to mention examples of unauthorised health claims, pharmacy could have a key role to play in providing consumer protection.
“Pharmacists are uniquely positioned to provide reliable information and product recommendations for those interested in purchasing and using legal CBD products safely,” says Mark Tucker. “The information available on the internet can be confusing and, in many cases, conflicting, so it is important for consumers to have access to a trustworthy source of information. Pharmacists can fulfil this role as well as ensuring that only products of the highest quality and safety are on offer.”
Jonathan Hartshorn agrees pharmacy can play a key role in providing consumer protection. “They can apply quality standards, and understand bioavailability and quality certification. They are the best people to advise patients on which products to take.”
What is the research telling us?
It is important to be aware of the health conditions for which advocates of cannabidiol (CBD)-containing and cannabis-based products for medical use (CBPM) say there is evidence supporting their use. While the evidence base is far from complete, it is “certainly compelling enough to warrant use” of products in certain circumstances, says Paul Mavor.
In January 2017, he says, the US-based National Academies of Sciences, Engineering and Medicine released a report that found evidence to support use of medical cannabis in chronic neuropathic pain, MS and nausea in cancer chemotherapy.
Four months later, he says, the New England Medical Journal published “a gold standard clinical trial” that showed medical cannabis may be of benefit in rare, severe, drug resistant epilepsy. Other conditions, such as PTSD, dementia and anxiety, are the focus of a number of current research projects, he says.
Mark Tucker says there is increasing evidence to suggest that CBD-containing and cannabis-based medical products may have clinical benefits. Investigations are underway looking at a range of conditions including anxiety, schizophrenia and Parkinson’s disease, he says.
“Most patients seeking CBD are trying to get help rather than get high,” says Paul Mavor, adding that CBD-based treatments “could be life changing”.
Jonathan Hartshorn says there is now “a large body of evidence” on the benefits of CBD and CBPM.
Pharmacy can enhance its role by providing a reliable source of CBD products backed by informed advice, says Hannah Skingle. “Pharmacists are fantastic at digesting technological and scientific data and providing information to customers that is easily understandable,” she adds.
But could pharmacy risk ‘losing’ the category and the opportunity, as with e-cigarettes? “Had pharmacies been involved in selling these devices [for smoking cessation], the public might now be more certain about the safety and quality of different products,” says Mark Tucker.
Change on the way?
CBD-containing products are widely marketed in the UK as a food supplement but the EU has recently reclassified CBD as a novel food for the purposes of the EU Novel Food Catalogue, says legal firm Charles Russell. Whilst this does not have direct legal effect in the UK, the regulatory body responsible for food standards (the Food Standards Agency, or FSA) must have regard to the catalogue as part of its regulatory functions.
In light of the EU reclassification of CBD oil, in March 2019 the FSA issued the following statement: “The FSA accepts the clarification from the EU that CBD extracts are considered novel foods.” Businesses should have their CBD products authorised as novel foods before putting them on the market.
“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 market place in a proportionate manner,” says the agency.
The FSA plans to issue advice on bringing unregulated CBD products on the market in line with the novel food regulations.
(Updated September 27)
It is estimated that 6 million adults have used CBD oil in the UK and the market is growing rapidly. However, there remains confusion around its legal status and even the legal threshold for the presence of THC.
It is extremely important that pharmacists are up to date with the evidence, and source and recommend safe, high quality products that are legal and as described.
Work through this new-style module to increase your confidence in reassuring parents of children with allergies, and know what advice and products to recommend