The Medicines and Healthcare Products Regulatory Agency (MHRA) may be softening its hardline position on the removal from sale of CBD oil products, as a well-coordinated effort by specialist manufacturers and campaigners gathers pace.
In early October the MHRA issued an opinion that all products containing cannabidiol (CBD) used for medical purposes are now considered a medicine in the UK. This applies regardless of whether products make medicinal claims, so it affects low dose products presented as food supplements.
The MHRA simultaneously wrote to manufacturers and suppliers in terms that some have called “threatening”. Suppliers were told: “You must cease to sell, supply, promote, advertise or process orders for the above products until appropriate authorisation has been granted for them. You must confirm this in writing within 28 days from the date of this letter that you have taken the above steps.”
CBD is one of 60 compounds found in the cannabis plant, and one of the most useful therapeutically. It is non-toxic and, unlike THC, is non-psychoactive. As an extract, usually of industrial hemp, CBD is used to treat a range of conditions from MS, Parkinson’s and dementia, to fibromyalgia, Chron’s disease and chronic pain.
The MHRA’s decision was immediately criticized by brand-owners, campaigners and politicians, and a 38 degrees petition was launched (it currently has over 10,000 signatures). Crispin Blunt MP, a supporter of the cannabis reform group CLEAR, wrote to the MHRA saying that its decision to designate CBD as a medicine was directly contradicted by the Home Office’s position that cannabis has no medicinal value. “It is vital that we do not let this anomaly in government policy cause harm to people’s health,” he wrote. He also asked for details of how the decision was reached and what consultations undertaken.
In addition, solicitors representing the recently formed trade association, the UK Cannabis Trade Association (UKCTA), have served legal letters on the MHRA, warning the Agency that it may be in breach of its own guidelines, which require it to consider each product on a case-by-case basis. A blanket ban on products containing CBD could be unlawful, they say.
Now, as the campaign to stop the ban of CBD products gathers momentum, there are signs that MHRA is rethinking its hardline approach. On 1 November, the Agency announced that having “considered the needs of individuals using CBD products to treat or manage the symptoms of medical conditions” it would be extending the deadline for the removal of products until 31 December 2016.
The MHRA also agreed to hold a meeting on 3 November with representatives of UKCTA, who pressed their case for the continuing availability of lower dose products as food supplements, and affordable costs for THR licences. Achieving these objectives is seen as crucial to ensure that smaller manufacturers are not pushed out of the market.
Peter Reynolds, president of CLEAR, commented: “All in all, we believe the meeting was a success. We demonstrated that the new trade association is to be taken seriously and that we will work constructively with the agency. There was visible surprise at the level of professionalism we presented, particularly with the legal advice we had obtained. We need to show that we are responsible, we care, we are professionals and we are ready to put our collective head above the parapet as a legal, ethical and regulated industry.”
“I think should be challenging this opinion from the MHRA, otherwise our sector risks death by a thousand cuts as products are lost one by one”
Concerns however are likely to persist in the health food trade. Avril McCracken at the National Association of Health Food (NAHS) Retailers told NPN: “This feels like further erosion of the safe and effective products we sell. This all seemed to start with a company who wanted to secure a licence, who lobbied and lobbied the MHRA to re-classify it as a medicine. The likelihood is that this will knock out smaller suppliers.”
One brand owner told NPN: “These products are true food supplements, the best of them are very high quality products, and they don’t make claims. I think we should be robustly challenging this opinion from the MHRA, otherwise our sector risks death by a thousand cuts as products are lost one by one.”