By Cindy Orser | Chief Science Officer
A significant event occurred in the UK last week for the cannabis world as we currently know it. The UK’s equivalent to our FDA, the Medicine and Healthcare Products Regulatory Agency (MJRA), sent out letters to cannabidiol (CBD) producers and distributors ordering them to stop selling, promoting, advertising, and processing orders within 28 days’ time. This was a predictable event given several facts starting with the 2007 IND (Investigational New Drug) filing for CBD in the US by GW Pharma, its’ successfully launched clinical trial undertakings around the world including in the US for its CBD-dominant product called Epidolex for the treatment of a number of conditions including rare pediatric epilepsy disorders like Dravet Syndrome and Lennox-Gastaut Syndrome; and, our own FDA’s issuance of a limited and less foreboding warning letter exercise earlier this year to CBD producers and distributors in the US. The upshot being that CBD falls within the definition of a medicinal product requiring licensure and with its rapidly impending approval as Epidolex around the world has destined all CBD to prescription drug status.
The foreboding nature surrounding these events signals an end to easily accessible CBD products at your local medical marijuana and/or retail marijuana dispensary for self-administration, not to mention the open interstate CBD commerce that has exploded over the past 3 years. On the brighter side, the idealistic interpretation is that now CBD products will have to meet quality guidelines and standards set for other pharmaceutically formulated drugs and suppliers wishing to continue marketing CBD based products will need to essentially apply for a license that will require proof of efficacy and safety that requires implementation of quality management systems and in-process validation to enable creation of needed clinical trial data and mandatory total cessation of sales during said licensure period. All of this is upsetting due to the unknown length of time that would be required to satisfy the layers of bureaucracy to achieve prescription drug status in either the UK or US or whether or not any other company could use the Epidiolex trial data to qualify their own products as a biosimilar.
It could be that a Natural Products route may still exist for small producers of CBD-based products sold and marketed without any health claims but that is a route yet to be fully tested under the newly heightened