BLURRING BOUNDARIES: THE EVOLUTION OF CBD
In recent years, cannabidiol (commonly known as CBD) products have soared in popularity in the UK and across Europe, spurred on by claims made about their medical benefits.
While CBD is being touted as a potential treatment for a spectrum of different conditions, manufacturers are utilising the compound as an add-on to a whole range of fast-moving consumer goods (FMCG) products - blurring the line between medical, wellness and recreational.
CBD, in its pharmaceutical form, has been approved for medical use. Epidiolex, for example, is prescribed as a treatment for severe epilepsy (Dravet and Lennox-Gastaut syndrome) and there is promising research for its use as an antipsychotic drug for treating schizophrenia. CBD is also an anti-inflammatory, and anecdotal evidence shows that it offers a potential treatment for conditions such as arthritis, anxiety, pain, addiction and autoimmune conditions, although research has so far been inconclusive.
As well as its strictly medical usage, CBD oils are being sold in the UK as a health supplement, in well-known chains like Holland & Barrett and Boots. The compound is also found in products such as CBD-infused food and drinks sold in supermarket chains like Planet Organic and Sainsbury’s. Amid the hype about its health benefits, the CBD industry has been flourishing across Europe, and the UK is no exception.
However, many over-the-counter CBD products are being marketed and promoted as healthcare products without thorough regulation and standardisation. In 2016, the Medicines and Healthcare Products Regulatory Agency (MHRA) said that CBD products, if advertised for medical purposes, need to be licensed. However, no licences have been issued and products can continue to be sold as long as claims are not made about their medical benefits, leaving the UK market mostly grey and unregulated.
Dr Ethan Russo is the Director of Research and Development at the International Cannabis and Cannabinoids Institute (ICCI). Asked about the longevity of the market, he said: “I believe that CBD, despite its meteoric rise in public attention, retains the broad safety and applicability to remain an essential ingredient in pharmaceutical products, supplements and artisanal preparations in the long-term.”
However, the need for standardisation and regulation in the industry is paramount. Dr Russo continued: “Standards are necessary for cannabidiol in whatever form it may take. While one pharmaceutical preparation, Epidiolex, is already available in the USA, it is clear that consumers worldwide have an increasing demand for its benefits in various other forms.”
Meanwhile, the EU has introduced new rules that could change the face of the CBD market. The EU’s Novel Food Regulations ((EU) 2015/2283) state that any food considered to be ‘novel’ requires authorisation from the European Commission before it can be sold as a foodstuff in the EU. A food is considered ‘novel’ if it was not consumed in the EU to any significant degree before May 1997.
Recent updates to the Novel Foods Catalogue mean that CBD and other cannabinoids are now considered ‘novel’. A novel foodstuff will only be authorised if it can be demonstrated that the product is safe, does not mislead the consumer, and is not nutritionally disadvantageous.
A novel food application for CBD is currently under consideration with the European Food Safety Agency (ESFA), to authorise the use of CBD isolate in food supplements for adults with a daily intake of up to 130mg. If the application is successful, the European Commission must draft an implementing act authorising the use of the product within seven months.
While the EFSA’s guidance is non-binding and down to member states to enforce, the UK Food Standards Agency said in January that it would seek to have CBD food products removed from the shelves, and that it is looking to achieve compliance in a 'proportionate' manner. This places many of the CBD products being sold in a grey area. While there has been some enforcement of the guidance in Italy, Spain and Austria, major UK retailers in the UK are still stocking CBD food products, and new brands are popping up every day.
ICCI’s Director of Government Affairs, Thomas Sadilek, explained: “The expected impact and purpose of novel food regulation is to ensure the safety of products that are/will be on the EU market, including labelling. Companies operating in this area now have to undergo a registration process where the main part is focused on the safety of the products. It is clear that products without registration of their product will be sooner or later withdrawn from the market.”
ICCI’s Director of Innovations, Steph Sherer, will be speaking at Cannabis Europa London, which will explore how the standardisation of processes and practices, and the education of healthcare professionals will be key to ensuring the development of a sustainable medical cannabis framework across Europe.
Ms Sherer is also the founder and Executive Director of Americans for Safe Access and a founding member of International Medical Cannabis Patients Coalition (IMCPC). She has become the foremost international leader and expert on medical cannabis patient advocacy and, alongside the American Herbal Products Association (AHPA) has created the first industry standards in the areas of distribution, cultivation, analytics, manufacturing, packing, and labelling.
Early Bird Tickets for Cannabis Europa London can be bought here. Book now to avoid disappointment.