Volteface published an alarming article on the Medicines and Healthcare Products Regulatory Agency (MHRA) sending warning letters to CBD producers and distributors in the UK.
The MHRA sent letters to cannabidiol (CBD) producers and distributors in the UK demanding they should stop selling, supplying, promoting, advertising, or processing orders for CBD products within the next 28 days.
The letters announced that CBD now satisfied the definition of a medicine, and leaves UK patients with no legal access to CBD products if their suppliers don’t have the proper licensing.
The letter states:
“We have come to the opinion that products containing cannabidiol (CBD) are a medicine. Products for therapeutic use must have a medicines’ license before they can be legally sold or supplied in the UK. Products will have to meet safety, quality and effectiveness standards to protect public health.”
Patients are further warned if they have questions they should speak to their GP, or other healthcare professionals. Products will have to have marketing authorization before they can be legally sold, supplied or advertised anywhere in the UK.
The letter ends by saying regulatory guidance can be given to any company wishing to apply for a license.
A selection of our products
Does this pertain to Epidiolex’s trial results?
The question on everyone’s mind is whehter the results released by GW Pharmaceuticals last month of the latest phase III clinical trial for Epidiolex, led to the action taken by the MHRA.
The product is still on trial, and not available to patients. The company hopes to achieve approval in Europe first. This liquid formulation of CBD is in development to treat rare pediatric epilepsy disorders including Dravet Syndrome and Lennox-Gastaut Syndrome.
Any unregulated market raises concern
The unregulated CBD market has raised many concerns in the past and Peter Carroll of a UK based medical cannabis patient advocacy group, End our Pain campaign, said they agree there is a need for more control in the CBD market. Regulation must make sure people get reputable products, and know what they are taking, but this sudden move will cause distress. This action will only force people to get CBD products on the black market. He said it is like using a sledgehammer to crack open a nut.
How costly and timely the license application will be for current CBD vendors, and if any application will in fact be successful, remains to be seen. Medical products are required to meet very stringent standards before marketing authorization is granted. The process could take many years, and it is unclear if the results of the Epidiolex trails can be seen as generic, and relevant to other CBD products, or if are they limited to only the unique formulation of GW Pharmaceuticals.
Medicinal use for cannabis oil
CBD has recently become very popular, and people purchase it in a variety of preparations to help them quit smoking, to relax, or as an alternative medicine for some serious ailments. CBD has potential as a treatment with strong anecdotal evidence of efficacy in treating many conditions, some of which there is no conventional treatment for.
Medicinal use for cannabis oil has received testimony of success in treating epilepsy, MS, anxiety and depression from people with these and many other conditions. Now, it seems, CBD in the UK will be “owned” by pharma, and the flow of CBD to those hoping to treat medical conditions will slow to a trickle or be cut off altogether. Just because there is medicinal use for cannabis oil, should it be illegal?