The pharmaceuticalisation of CBD Products?
Today news swept across the internet and social media that Cannabidiol (CBD), the non-psychoactive cannabinoid, is going to be scheduled as a medicine.
A number of CBD companies have received letters from the Medicines and Healthcare products Regulatory Agency (MHRA) notifying them that they will have to cease selling CBD Products on November 1st 2016.
Many patients across the UK have now been struck with worry that the only legal access to cannabis products, and their only source of relief from a variety of ailments, is going to be taken away from them. They wonder, will this make them a criminal if they continue to buy these products off-licence?
Craig Swiftson, a Social Media Marketing Consultant said “This is terrible. I need to know if it is going to be legal to access. It is currently the only thing keeping my mother off of Amyltryptaline for her Fibromyalgia” a condition that affects around 30,000 people in the UK. Amyltriptaline has a number of unpleasant and unwanted side effects that CBD just doesn’t have.
Another CBD user, Linda Ferguson, is equally concerned by this news, telling us, “Me and my friend are treating her dog (who has neuro problems and fits) with CBD. This dog is a new dog since being treated with CBD oil bought from Holland & Barrett mixed with coconut and hemp oil. The Vet is too expensive.”
Because we all know dogs just want to get high…on non-psychoactive CBD. Bloody hypochondriacs.
Taken by shock, there has been a real wonder among patients and activists as to what has instigated this turn of events in what seemed to be a thriving and ever-growing CBD industry in the UK. Could all of this suddenly come to an end? Are the lives of patients about to become more stressful, restricted, and tougher all round? CBD is non-psychoactive and has no recorded negative health effects, so why is it being removed from the market place, when study after study shows its efficacy?
Well, you have to look at the bigger international picture to gather a wider understanding.
In 2012 Realm of Caring’s “Charlottes Webb“, a strain of cannabis with virtually no THC and mainly CBD was being touted as the most effective treatment for childhood seizures. These were more patients who could not be accused of faking getting better, and a perfect test case to prove that CBD works.
In fact it showed such promise that Dr Sanjay Gupta, associate chief of neurosurgery at Grady Memorial Hospital in Atlanta, Georgia, assistant professor of neurosurgery at the Emory University School of Medicine, and CNN’s chief medical correspondent, released a TV series investigating the medical benefits of cannabis, in which he covered CBD in some depth. This ultimately initiated some US proceedings for those with their fingers already firmly in the pharmaceutical cannabis pie.
GW Pharmaceuticals have a new product in the pipeline called Epidiolex, a mainly CBD preparation produced for paediatric patients with severe Epilepsy conditions and seizure disorders,. It has received a special status in the US from the FDA as an Orphan Drug Designation – a system designed to speed up the approval process for drugs that look to meet the requirements to treat conditions where a limited number of patients (under 200,000) are affected, and where there is no other drug available to treat their condition, in a safe and effective way.
In June 2016 it was announced that Epidiolex is in the process of being approved after it showed positive results in its stage 3 trials in both the UK this March for Dravets Syndrome and the US in June for Lennox-Gastaut Syndrome.
Many will be familiar with GW’s Sativex, an approved cannabis mouth spray for MS patients and some cancer pain sufferers, that has equal parts of THC whole plant extract and CBD whole plant extract. Epidiolex just has the CBD whole plant extract in a tincture – but whole plant extract means it contains traces of other cannabinoids, terpenes and flavonoids. In its standardised form, GW Pharmaceuticals (who grow the cannabis and bottle it up) were able to carry out clinical trials that have proven that CBD does have a medical benefit.
You also have to look at the growing number of Medical Marijuana legal States in the US that are CBD-only. There are a whopping 13 States where you can only get medical cannabis if you are an epileptic child having 100 seizures a day or more, and only through a University. They regulate this product so tightly that it is kept in a safe where only one person has access to it and only 2 or 3 patients in the whole state are being treated. They are bills sponsored by corporate cannabis who are able to provide a standardised, CBD-only product.
What does this mean?
So, while patients have been claiming “CBD is my medicine” and “I want CBD on prescription” they might have just got what they wished for…they just didn’t realise it might come at a cost. CBD could become more expensive to order overseas, and, if CBD does become a prescription drug, it might not be available for their condition. For that, clinical trials may need to be carried out which could take years.
It might not be that bad though…it might be as simple as sellers having to abide by rules about the claims they make about the CBD products they sell. They might just have to have all products tested.
Until the MHRA make a clear statement, patients – as well legal distributors – are left in the dark.
For two years running the FDA have published the test results of products claiming to sell CBD across a number of States, only to show that the claims made about the CBD content were not what the label and marketing stated. This highlights some of the issues that consumers, who are mostly vulnerable due to their health condition, are exposed to when buying medical products on the open market. The law as it stands has almost given a free reign to cannabis oil scammers to sell through reputable sites like Amazon.
Headshops across the UK thought that CBD products were going to be one of their new flagship products; a wonderful refreshing change after the Psychoactive Substances Act forced their hand to stop them selling “legal highs.” Already worried that they were going to see Cannabidiol lumped in with all these weird chemicals in the Psychoactive Substances Act, they just didn’t see this one coming.
If there is concern that products are not tested and could be labelled incorrectly, then providing a system to allow products to be 3rd party tested before they are sold would be a sensible option – rather than removing all products from the shelves in 28 days. Where does that leave the many in need of the medicine that works for them? Opening a cannabis testing facility in the UK would even provide legal cannabis jobs…
Could Cannabidiol’s recent press coverage have given it too much positive attention? Nate Diaz takes a CBD vape blast after his UFC match.
What about those producing CBD?
By all accounts GW Pharmaceuticals, who ship their British-grown CBD products all over the world, will be unaffected by the news. We doubt very much that they received a letter.
It turns out after many discussions throughout the day that *some* CBD retailers were informed of this impending change up to a year ago, and continued to sell the products without making any other CBD sellers aware. This has resulted in the bulk of remaining sellers learning their 28 day fate with all but no time to establish any well planned opposition or chance to gather awareness and support from the industry, consumers, and supporters of the movement.
There are over 30 UK based CBD companies. Some employ up to 20 staff. These people could potentially be out of work within a month.
Chris MacKenzie, who runs CBD Tardis in Glasgow, has contacted his local police and asked if he will be arrested for selling CBD Products after the 28 days is up, to which they replied he would not, and that Scotland does not have an influence on the UK drug policy which is based in England and Wales.
He is now waiting to see if he receives the same letter as other CBD distributors. If he does he has said he will be holding a protest outside his CBD Tardis, and will continue to sell CBD products. “Will they arrest me and make me the first #CBDCriminal?” he said. We will have to wait and see.
A protest is needed in any case, we cannot let these tragic decisions be made without repercussions for the thoughtlessness that they have been executed with.
CBD Brothers, a brand consistently receiving high praise for their products in our CBD Product Review group on Facebook, were contacted by MHRA a couple of months ago asking them to remove claims of any medical properties of cannabis and the history of its medical use. At this time however, numerous companies had already been informed of a cease of sale date, namely November 1st 2016. On Tuesday they received official confirmation from MHRA along with a number of other companies, hammering the final nail into the coffin before some even knew the lid was coming down.
“This means it [cannabis] is considered to have medicinal value and as such will be given the same status as other mainstream medicines, it will also mean there is more regulation within the industry, something we know the UK Cannabis industry is in desperate need of plus the recognition of cannabis as having medicinal properties is a big step in the right direction.”
“We are well into the process of applying for the license and as soon as the MHRA have worked out the final details of the reclassification we will be ready to go.” – CBD Brothers
Roo & Co seem only minorly phased by the hurdle that has popped up seeing it as potentially only an expensive licensing issue. It could cost anything between £6,000 and £103,000. If it turns out that there is already an existing available licence in place that CBD could fall into, such as Traditional Herbal Registration where hemp can be claimed to have been used therapeutically for minor conditions for over 30 years then it will be cheaper. Or if not, it might require full marketing authorisation with clinical trials…expensive stuff!
Love CBD said, “If you’re unhappy about this I’d suggest contacting your local paper and MP about it.”
What should people do?
The UK Cannabis Social Clubs do not think this decision has been made in malice, to screw over patients or sellers of CBD. We believe this is a natural progression of getting cannabis regulated, lead by those who got there first with protected corporate interest. It is fundamentally down to us as individuals and as a united community (consumers and business owners) to come together to oppose drastic measures to the change in sale of CBD products, and to offer practical solutions to help further the conversation rather than shutting all doors.
We have been in contact with 38 Degrees who have given us advice on how best we can move forward with the aim of getting their membership on side with our campaign. The UKCSC will be posting up links to a community petition that we hope everyone can get behind and gain the support of one of the largest campaigning organisation in Europe. Even if we cannot stop the pharmaceutical giants, we must do all we can to raise awareness and use any movement in cannabis reform as leverage to get our side of the story heard.
It would be wise, at this point, to connect with your roots. I don’t mean put on some Bob Marley and chill out…NO! Go and find a copy of Dallas Buyers Club to watch. It’s the story of a man that contracts HIV/AIDS and discovers that the only things that keep his health from declining so rapidly were not approved by the FDA. Many of them were non toxic supplements but because they had not been tested for the claims that were made about them they were ordered to be removed from sale. This is not the only similarity that we need to draw on with CBD. We must look at how patients across the US took to starting up their own Buyers Clubs, where patients paid a monthly subscription fee to get their medicine. It is going to take this kind of action to make sure the most vulnerable in our community are able to access the good quality medicine that they need. UKCSC have already been in touch with several CBD producers to prepare for these measures. If it comes to it – we are prepared to do it. If they want to bust a CBD Co-Op then they can take all 30-100 patients to court and prosecute them for doing everything they can to stay as healthy and pain free as they can.
For further updates and to find out how to sign the petition when it comes live, please sign up to the UKCSC newsletter.