Posts Tagged ‘Medicines and Healthcare Products Regulatory Agency’
The FSA’s Intervention in the CBD Market is a Farce. Here’s the Clear and Simple Solution.
I’m not sure whether to laugh or cry about the mess the Food Standards Agency (FSA) has got itself into in the cannabidiol (CBD) market. After imposing costs of millions of pounds on business for no good reason, its deadlines have been missed, it’s got very few products on its ‘approved’ list and the whole situation is chaos. It’s changed the staff involved (again) and there is no sign it is going to achieve anything except fritter away more taxpayers’ money and impose more unnecessary costs on more businesses.
It was always going to be a disaster because deeming CBD products ‘novel foods’ was false from the beginning. It was the European Commission (EC) that first imposed this nonsensical ruling, refusing to consider the comprehensive evidence submitted by the European Industrial Hemp Association (EIHA) that extracts of CBD (and other cannabinoids) have been widely used in foods since as long ago as the 12th Century. Then, in anticipation of Brexit, the FSA, with no good reason, chose to adopt the EC’s novel foods policy and so this sad and futile story began.
The CBD market does need better regulation but ‘novel foods’ doesn’t address any of the issues of concern at all. It is a completely misguided policy.
There is no evidence of anyone, anywhere in the world, ever coming to any harm from consuming CBD as a food supplement, so the whole basis of deeming it as a ‘novel food’, as well as being false, is predicated on nothing. The reason for ‘novel foods’ regulation is safety and there is no evidence that CBD is unsafe.
There are just two issues which need addressing in regulating a CBD product: what the product contains and how it is marketed.
The first can be solved, at a stroke, by requiring all products to have an independent laboratory test certificate. Not a certificate of analysis (COA) from a laboratory commissioned by the supplier but a certificate from an independent laboratory that has itself been certified by the regulator which, yes, should be the FSA. So this independent, ‘official’ COA will specify the cannabinoid content, certify that controlled cannabinoids are within the legal limit and that heavy metals and other contaminants are within prescribed safety limits.
The second can be solved, at a stroke, by properly funding the Medicines and Healthcare products Regulatory Agency (MHRA) to fulfil its function as regulator of the Human Medicines Regulations 2012, the law that prohibits claims of medical benefit being made for commercial gain about products which are not licensed as medicines. The MHRA has dismally failed to fulfil this function, which is ironic as it first brought CBD to regulatory attention in 2016 over the issue of these medical claims. It simply does not have the resources to do this job. Hundreds of reports have been submitted to the MHRA by the two trade associations, the CTA and CannaPro, but not acted upon. As a result the law is now widely ignored both by unethical suppliers and by all the national newspapers which regularly run unlawful advertisements and advertorials despite the fact that in theory, the maximum penalty for these offences is two years in jail.
These two steps, taken together, will completely solve the regulatory requirements for the CBD market.
Courage and Cannabidiol
The story of how brave British small-businesses created a £1.7 billion market and now face destruction at the hands of the overbearing Food Standards Agency and its big business sponsors.
Hundreds of people who set up small businesses selling CBD products face the looming deadline of 31st March 2021 that the Food Standards Agency (FSA) has imposed for its ‘novel foods’ regulations to come into force.
These people, the essence of the British entrepreneurial spirit, are being crushed by misguided over-regulation that is not based on any evidence and which will gift the market to big business while removing from shelves the products which millions of people have gained great benefit from.
The FSA has not consulted with the industry in any meaningful fashion and is imposing draconian new rules which even at this late stage remain unclear, confusing and require enormous, unnecessary and wasteful expenditure in pointless bureaucracy.
To be clear, if you are one of those millions who discovered that CBD could help with anxiety, pain, insomnia and or a host of other conditions, the products you rely on may not be available much longer. But there is a way through this. Read to the end of this article to find how you will still be able to access the ‘real CBD’ that you need.
The most important thing to understand is that there is no evidence anywhere in the world that anyone has ever come to any real harm from using CBD products. Despite this, the FSA is forcing businesses to put their products through an incredibly complex series of tests which cost a huge amount of money, in some instances hundreds of thousands of pounds.
Even the smallest companies are having to submit a dossiers on individual products which cost around £5000 each to produce. Imagine how many bottles of CBD oil a small shop or website has to sell to pay for just one of these. And they are completely pointless. There is no need for them at all. The FSA has just invented them and it’s nothing to do with public safety because there is no danger from any of the products concerned.
The Association for the Cannabinoid Industry
What this is really about is that big business missed out on the CBD boom. They turned their corporate noses up at it, didn’t want to get involved because of the stigma and prejudice associated with anything to do with cannabis. Then, within the space of a few years, they found that all their big customers, the multiples, were starting to stock CBD and it was selling very well indeed. So much so that the value of CBD sold in Britain is now more than the value of all vitamin C and vitamin D products combined. It’s a huge market with estimates of its size ranging from £300 million to £1.7 billion per year (New Frontier Data).
So big business is now calling the shots. A sinister organisation, the Association for the Cannabinoid Industry (ACI), run by a man, Steve Moore, with connections to the sleaziest end of the Conservative Party, is supporting the FSA in this scheme and his aim is simply to price small businesses out of the market and hijack it for his big business friends. Never has a bigger confidence trick been pulled on consumers. The small businesses that created the CBD market had established trade associations from within their own ranks which charged a few hundred pounds for membership and did an excellent job of representing the industry. The ACI demands membership fees of £25,000 per year, pricing out the small businesses and using its funding to bully and intimidate any business that doesn’t want to sign up.
Steve Moore of the Association for the Cannabinoid Industry
There are problems in the CBD market that need addressing. It does need better regulation. There are disreputable businesses selling products that are not what they claim. They don’t have the amount of CBD in them that is advertised and they are certainly not medicines which can treat cancer, diabetes, depression and serious illnesses. But these problems are already covered by existing laws. The problem is they are simply not being enforced. The regulators who should be acting against these rogue companies include the Medicines and Healthcare products Regulatory Agency (MHRA), the Advertising Standards Authority (ASA) and Trading Standards. Despite reputable CBD businesses delivering hundreds of reports about rogue suppliers, virtually nothing has been done. To be fair the MHRA and Trading Standards just don’t have the resources to carry out this work, so the idea of giving them even more work, with incredibly complex regulations to enforce, is just barmy. It makes no sense.
The Human Medicines Regulations 2012
Even our largest newspaper publishers have been allowed to get away with breaching the Human Medicines Regulations 2012 which prevent anyone from making a commercial gain out of claiming medicinal benefit for a product which is not a licensed medicine. This criminal offence can result in a two year prison sentence, yet the Daily Mail runs such ads every day. So do most of the tabloids and those newspapers that like to call themseleves ‘quality’, do something equally illegal. They run advertorials or sponsored reviews of products which if you click and buy pay the publishers commission.
These crimes have been reported to the MHRA and to the ASA but they have done nothing about it and the illegal advertising continues to this day. As for the confidence trickster companies making these illegal medicinal claims, nothing has been done about them either and they continue to scam people with cancer cures and miracle medicines. Now the ACI is using this conduct as part of the justification for their ‘novel foods’ scam. Of course the two issues are completely unrelated.
But all is not lost. Undoubtedly, the ‘real CBD’, the whole plant extract, containing all the goodness and nourishment extracted from low-THC cannabis plants, will be taken off the shelves of the multiples but there will be a flourishing ‘grey’ market, mainly online and there will be nothing that the FSA, ACI or their enforcers will be able to do about it.
The FSA’s understanding of CBD and cannabis is virtually non-existent. The original CBD trade associations spent years trying to educate FSA’s people and urging them to co-operate on appropriate regulation but they didn’t want to know. Now the FSA has chosen to listen to its own and ACI’s ‘experts’ who are trained and indoctrinated in the prohibition mindset. Consequently its statements and rulings on its new regulations are so poorly drafted that they leave a gaping hole for the brave, pioneering businesses that created this market. A genuine, whole plant oil that preserves the natural proportions of the compounds in the hemp plants from which it is extracted is molecularly identical to those plants and hemp is specifically excluded from novel foods regulations.
So ‘whole plant’ is what you must look for if you want ‘real CBD’, the product that so many people benefit from. The ACI and FSA are pushing nasty, ineffective isolates and synthetics that are useless in comparison and require far higher doses to achieve the same results as a few drops of whole plant oil.
One More Problem as the Home Office Steps In on THC Levels
CBD originally took off because more and more people were becoming aware of the medicinal benefits of cannabis. CBD was seen as a way to enjoy some of these benefits legally and without getting ‘high’ from the THC in cannabis. But CBD was always a euphemism to avoid the stigma around cannabis and to reassure people they weren’t buying something illegal. In fact, whole plant CBD products are low-THC cannabis oil. Under a provision of the Misuse of Drugs Regulations, a trace amount of 1mg of THC per bottle of CBD oil has been allowed. It’s far too little to get anyone high. You’d have to drink about three bottles in one go before you felt anything.
But surprise, surprise, now the Home Office has started to get involved too. Again, without a shred of evidence of any harm, it is considering reducing this limit very substantially.
Why?
Undoubtedly this is co-ordinated with the FSA and the ACI. The aim is the same, to destroy the small businesses that created this market, to ramp up the costs of selling CBD so high that only big business can afford it and to prohibit the sale of the whole plant, low-THC cannabis oil that is so valuable for so many people. And there is no credible evidence to support any of it, except what the FSA has cooked up to support its pre-determined conclusion. There is no evidence that the trace amounts of THC in whole plant oil have or could cause anyone any harm and it is all part of the same scam.
So remember, if you want ‘real CBD’, you’re going to have to go online. Look for those courageous businesses that provide whole plant extracts and avoid isolate or synthetic products which are a waste of money.
Presentation at the Hemp CBD Expo, 2nd March 2019
I spoke at the Hemp CBD Expo at around 5.00pm on Saturday, 2nd March 2019. Below is my speech as originally composed. An audio file is available here. A video will be available shortly. My PowerPoint presentation file is here.
“Good afternoon ladies and gentlemen.
My name is Peter Reynolds and I am the president of CLEAR Cannabis Law Reform. We were founded in 1999 and we now have around three-quarters of a million followers on social media and we’re approaching a total of 5,000 paid up members. That makes us the longest-established cannabis group in the UK and our follower and membership base is several times that of all other UK drugs policy groups put together.
Last year we launched Cannabis Professionals or CannaPro, the trade association for the UK’s cannabis, CBD and hemp businesses. I am going to explain to you why, what we think we can contribute to this industry and how we are going to do it.
First of all though I have some BREAKING NEWS!
Downing Street has just confirmed that the mastermind behind the FSA’s decision to place CBD products in the EU Novel Food Catalogue is none other than Theresa May’s number one fixer, Chris Grayling!
Now that’s not really true, in fact it’s fake news but there is a kernel of truth in it and that is that just like everything else Grayling touches, this move is the height of incompetence and just as many are calling for Grayling’s blood, so too they will be calling for some accountability at the FSA.
First of all, these are CLEAR’s aims and objectives.
It’s a pleasure to be asked to speak to you today and I do think that this event represents a significant moment in the legal cannabis industry in the UK.
Of course we’ve had a legal cannabis industry for thousands of years. There was just a brief interlude between 1964 and 1993 when even the cultivation of industrial hemp was banned. So, although there have been severe restrictions on cannabis since 1928, it was actually only those 29 years when there was no legal industry at all.
The CBD business as we know it today started in about 2012 and at CLEAR we saw immediately what it was about. By then, largely due to uptake of the internet, knowledge of the medicinal benefits of cannabis was exploding. People were looking for a way that they could enjoy these benefits without breaking the law. The big leap came with the story of Charlotte Figi, when the almost miraculous effect of CBD on epilepsy became widely understood. It was really in 2013/14 when CBD websites started to appear in numbers. Back in those early days the leading brands were Plus CBD and, of course, Charlotte’s Web. In Europe, Endoca was leading the way.
And now look where we are! This show is the realisation of a market which no one has really quantified but is certainly worth at least £50 million a year and probably a whole lot more.
At CLEAR we realised very early on that the way this market developed was going to have a huge influence on wider cannabis law reform and that’s why we have been deeply involved with it from the very beginning. I genuinely believe that the medical reforms last year only happened because the booming CBD market has washed away a lot of the stigma around cannabis and shown hundreds of thousands of people that it does have real therapeutic benefits.
And here we come to one of the most difficult aspects of this business. CBD businesses are not allowed to claim or imply any medicinal benefits from their products yet you can be absolutely certain that is exactly the reason most people are buying them!
I cannot think of another market or a comparable situation where anything like this has happened before. It is one of the principle reasons why we are facing such opposition from the medical and big business establishment.
I have never been a supporter of the Big Pharma conspiracy theory that pervades the cannabis campaign. Particularly in the USA, the pharmaceutical industry is thought to be almost entirely responsible for continuing federal prohibition. In fact if you read Facebook comments from our American followers you’d think that Big Pharma was responsible for nearly every problem on our planet!
Now I don’t say there’s no truth in it at all but there’s precious little evidence aside from the isolated instance of Insys Therapeutics where the former directors are now looking at very long jail sentences for a variety of corruption offences. But there’s not much else to support the theory. In fact, if Big Pharma could harness the healing power of cannabis that some of the more extreme evangelists claim for it, they’d be all over it. And no, it’s not true that you can’t patent cannabis, there are hundreds of patents on extracts, applications and techniques.
It is a different world in America though, far more competitive about medicines because they don’t have an NHS. Unlike here, drug companies advertise direct to the public and branding is as big in medicine as it is in soft drinks or fast food.
However, I do think that the intervention in this industry from the MHRA back in 2016 and now the FSA has some sinister, vested interests behind it. I think major corporations see a potentially huge market here and it would suit them for it to be so heavily regulated that only the biggest businesses can make it work. I also think it’s a pathological obsession of bureaucrats to interfere when something big is happening which they haven’t got their claws into – and I think these regulators are being improperly influenced to interfere when there’s no real justification.
After all, the World Health Organisation has given CBD a clean bill of health, not in the equivocal way that most such decisions are made but absolutely. It says CBD is safe.
I’ve had a number of meetings with the FSA over the past 12 – 18 months. The most recent being on 1st February about the current novel foods debacle. One moment stands out from that which is instructive about the way that regulators operate. The Head of Novel Foods confirmed for me that the purpose of the legislation was to ensure safety of food and food ingredients. He also confirmed that the FSA has no evidence to suggest that CBD products are unsafe.
It’s bureaucracy for bureaucracy’s sake. In my opinion, a flagrant waste of taxpayers’ money, that’s our money, when there are so many more important things we could be spending it on. For me, as a Brexiteer, it’s more reinforcement of the reason I voted leave. We have more than enough busy body bureaucrats in the UK without more and more layers of it from the EU. It should be instructive to everybody of the way that civil servants’ minds work that this attack on our industry was made surreptitiously through the EU when we’re supposed to be freeing ourselves of those shackles.
As a wider point, if we’ve got civil servants kicking their heels, desperate to interfere in something new, why don’t they get on with regulating the entire cannabis market properly? The immense damage that the £6 billion criminal market causes in our society is something that really does need intervention.
So, going back to the MHRA’s intervention in the CBD market in 2016. There had been mutterings for some months but it was Dan Culbertson of Love CBD who tipped me off that something was actually happening.
I spoke to some of my key contacts, particularly Tom and Tony of Love Hemp and I approached the MHRA seeking a meeting. As in most cases like this, its first resort was to try and ignore us but eventually I had the Conservative MP, Crispin Blunt and the neurologist Professor Mike Barnes write to the chief executive. They were both members of the CLEAR board and that did lead to the MHRA agreeing to meet.
This was the creation of the Cannabis Trades Association. As well as Love Hemp I invited other key contacts to attend the first meeting and then offered the job of running the CTA to an individual who you all know, who at the time Tom, Tony and I were in partnership with as he was supposed to be running a licensed industrial hemp farm for the extraction of CBD oil.
The progress of the MHRA’s intervention followed a path which seems to be strangely repeated in what is now happening with the FSA. That is, it came in very heavy handed and aggressive to begin with, threatening action which it really didn’t have the authority to implement but then it backed off quite quickly when we stood up to its bullying and demonstrated a professional attitude. Based on the clinical trials that GW Pharma were conducting with Epidiolex, its cannabidiol medicine, I proposed a maximum daily adult dosage of 200mg as the most important element of an agreement that would enable CBD to continue to be sold as a food supplement.
Now, even to this day, the MHRA has still not confirmed its agreement to this (last they told me was that they are still ‘considerin’g it) but in practice it has accepted it. Again, this should be instructive to all of us about the way that bureaucrats work.
The other big issue, of course, was about not making medical claims and for the two years that I worked intensively as part of the CTA, we did a good job of bringing responsible businesses into compliance and, largely speaking, we had defeated the MHRA’s attempt to close the industry down.
As many of you will know, I, and indeed Love Hemp, resigned from the CTA in October last year. Anyone who wants to know why can very easily find out. Just look at my personal website. Suffice to say that we had very grave concerns about issues of dishonesty and unethical conduct.
I’m not going to say any more about that today but I am going to talk about how I believe a trade association should operate.
Now this is not a pitch for members because CannaPro doesn’t have members in the same way as other organisations. It makes no difference to me or to CannaPro if you choose to give large amounts of money to another trade body. We see no necessity to charge large monthly fees for providing a service which directly supports CLEAR’s aims and objectives. As I said at the beginning, we see the development of the legal cannabis market as one of the most important drivers of cannabis law reform. Only if we can demonstrate that we can run responsible and legally compliant businesses in CBD and exempt products will we be able to claim we can do the same with products that contain THC.
Also, we don’t believe it is desirable for a trade association to make money or turn into a bureaucracy itself. It’s the businesses that should be making a profit and building resources for themselves. A trade association should not be about empire building, its focus should be on the businesses it is supposed to support, not on itself.
So while I don’t rule out CannaPro ever charging membership fees, for now the only time we ask for money is when we carry out a review of a business’s products, website, marketing methods and trading standards. This then enables us to offer any necessary advice or guidance on compliance and if we are satisfied to certify the business, so that it can display a CannaPro Certified badge. We charge a £120 one-off application fee for this and there are no further ongoing charges.
We are already well advanced, working with leading media consultants on putting together a national advertising campaign delivering the same message that we are already doing on social media. Something like this…
Similarly, CannaPro will always publish all its advice and guidance openly. We can see no purpose in keeping it secret or operating behind closed doors when our intention is to support the industry as a whole.
We have communicated openly about our recent negotiations with the FSA and we will continue to do so. If you follow CannaPro we will keep you apprised of the latest developments as they happen and we will not insist you have to become a member and pay fees in order to share in this intelligence.
Another important principle is that CannaPro represents the industry to the authorities and not vice versa. We are not an extension of government, doing its enforcement work at our members’ expense. It is our job to stand up to meddling, interfering bureaucrats and to push back at them. We will defend this industry against attack without requiring it to fund a new bureaucracy in its trade association.
For instance, we entirely support the prohibition of medical claims for CBD products. This is not a new thing and clearly before anyone can claim medical benefits for anything it must be subject to testing and verification. The alternative is that we will have snake oil, nothing more than coloured water, offered as a cancer cure and to be fair, we have already had almost exactly that in the CBD market. If any of you have ever come across a joker trading as Sacred Kana, that is exactly what he is doing. Claiming to sell 10,000 mg of CBD for less than fifty quid which will cure you of stage 4 cancer. He’s an extreme case. There are others operating along the same lines and frankly I do think people like this need strong action against them. They should go to jail and be permanently restrained from ever running a business.
But the trouble is the MHRA is doing virtually nothing about enforcement. Similarly, the FSA, which declared CBD isolate a novel food over a year ago, is doing nothing about enforcing that.
Really medicines regulation in this country and across the first world is broken, unfit for purpose and entirely self-serving for the pharmaceutical industry. The process, administered by the MHRA, has been designed for the pharmaceutical industry by people who used to work in the pharmaceutical industry and it is incapable of regulating a plant based medicine. Everyone involved has a vested interest in prolonging the process and extending its complexity because the millions spent on clinical trials go into companies which are owned by the pharmaceutical industry.
There was a study published in the Journal of Molecular Neurobiology last year which identified CBD as an ideal candidate for a fast-acting, effective anti-depressant with few side effects. But the reality is that to obtain a marketing authorisation in the UK or the EU or an FDA licence would take many, many years, tens of millions in investment and would result in a much higher price than necessary. But as it stands that is the only way to develop a medicine that can be prescribed by a medical profession that is so risk averse it has forgotten how to care for patients. Just since the new regulations on medical cannabis last November I have lost count of the number of reports we have received where a consultant flatly refuses even to consider cannabis but will prescribe opioids in a prescription that can be repeated simply by asking for it. And the British Paediatric Neurology Association says that using CBD for epilepsy should be the last resort. Literally they say try brain surgery, slicing into a child’s brain, before trying CBD.
So we have these bureaucracies which are supposed to be acting in the public interest but they’re marking their own homework, ensuring their former and future colleagues benefit from the regulations they impose with fat fees and lucrative contracts and preventing anyone who isn’t part of their club from having any chance of getting a licence for a medicine. They overreach themselves, attempting to set rules and regulations often beyond their lawful authority (the Home Office is a particularly heinous examples of this) and then, when these regulations are breached, they’re not even enforcing the most serious infringements.
An example in point is the question of hemp teas. Now if these are made from leaf and flower, they are cannabis and they are an illegal, class B drug which theoretically could get any of you selling them 14 years in jail. But this has never been enforced and CannaPro will certify businesses that sell hemp teas. We will not certify businesses that sell CBD flowers or buds because these are cannabis and their THC content is irrelevant to their legal status. Yet there’s no enforcement of this going on. There are shops in virtually every town in this country openly selling low-THC cannabis flowers and nothing is being done about it. Now this is wrong. These businesses are stealing your business when you are doing your best to operate within the law and they should be stopped. Even when cannabis is fully legalised, there will still be regulations that need to be enforced.
Believe it or not, I was contacted by the drugs lead at West Midlands Police just last wek asking for my advice on hemp flowers, so I told him. I confirmed they are illegal and I explained to him why and how they cannot be classified as exempt in the same way as CBD oil. And what I said to him was the same as I would say to anyone else. If you’re going to break the ridiculous law which prohibits adults accessing cannabis, then my advice is have some THC in your buds. It makes no difference under the law whether your flowers have 0.2% THC or 20% but I know which I prefer.
So it’s about balance. It’s about being sensible. The MHRA says a link to a study about CBD for anxiety is an implied claim of medicinal benefit. Strictly speaking it probably is but provided it’s not part of a concerted attempt to present products as medicines then it would not stop that business being certified by CannaPro.
CannaPro is on the side of the entire industry whether you’re certified by us or not because this industry’s future is the future of cannabis. We are not exclusive of anyone. We are inclusive. You can have our advice and guidance without charge.
And we are in the vanguard of developing CBD medicines. All the work I do for CLEAR and CannaPro is voluntary. I get paid nothing for it. I make my living as a writer and marketing consultant but more and more as an advisor on cannabis product development and licensing. I am working with clients on the development of products which can be marketed under the new regulations as Cannabis-based Products for Medicinal use – CBPMs. Also on products for which we will apply for a Traditional Herbal Registration – THR and for veterinary CBD products which require a marketing authorisation from the VMD.
As I published when I first created the CTA, the intention was to establish a trade association that would represent to government the interests of those engaged in legitimate production and sale of cannabis products. Those are the values and the purpose which we carry forward in CannaPro and I look forward to working with a many of you as possible in that cause towards ending forever the prohibition of cannabis.
My real, long term objective is to close down CLEAR. I look to the day when complete reform of our cannabis laws has been achieved. There will still be regulations as there are in all legal markets but as long as adults have legal access to cannabis in all its forms for both therapeutic use and as an alternative to alcohol as a recreational drug – and the right to grow it, even within limits – then and only then, our work will be done.”
The MHRA On CBD/Hemp Products And Its Relationship With Trade Associations
This is an email from the MHRA to a CBD/Hemp supplier which name is redacted. It clearly sets out the MHRA’s position regarding the Cannabis Trades Association, its ‘Cannabis Products Directive’ proposal and how anyone is able to obtain advice from the MHRA without having to join any trade association. It also explains how medical claims may only be made about a CBD product if it has the required licence known as a marketing authorisation.
This is authoritative guidance from the medicines regulator which is an agency of the Department of Health and Social Care. If you have received alternative guidance or suggestions that you must join a trade association to sell CBD products, this is incorrect.
From: xxxx.xxxx@mhra.gov.uk
Date: October 2018
Subject: CTA and CBD
To: Redacted
Dear xxxx,
Thank you for your email of 22ndSeptember 2018 to the Agency. Please note that we can only comment with regards to our position and advise you to contact appropriate Government Departments with regards to obtaining their views.
The CTA represent a number of companies in the UK who market CBD and they have proposed a framework, which they have termed the ‘Cannabis Products Directive’, that effectively sets out quality requirements for their members.
The Medicines Borderline Section of the MHRA has been clear from the outset that we will work with companies and trade bodies to ensure compliance in respect of CBD products. This is in line with our approach across the borderline and we do not require a company has membership of a trade body to enter into dialogue with us. There are a number of trade bodies, covering a range of product types who are well versed in borderline matters and they are able to advise companies but, if a company does not want to become a member, we can provide them with advice regarding their products. On occasions we may work with trade bodies; as they are able to communicate information on our behalf to their members and we may assist them if they want to come up with guidance on a specific aspect etc. However, ultimately MHRA is responsible the licensing of medicines and for the classification of borderline medicinal products and this cannot be passed to third parties.
We list a large number of trade bodies etc who have an interest in borderline matters in a ‘Useful addresses’ Appendix in our Guidance Note 8 (GN8).
Our current position with regards to CBD is as follows:
MHRA has offered an opinion on the regulatory status of CBD and advised that we are currently evaluating the evidence of pharmacological effect. At present we are providing the following general guidance to enquirers until we determine the status of CBD.
MHRA is of the opinion that products containing CBD, when used for a medical purpose, should be regulated as medicinal products. The MHRA’s opinion has been issued at this stage with the intention of seeking voluntary compliance by companies supplying CBD for medical purposes. This does not preclude MHRA from seeking to use Part 9 of the Human Medicines Regulations to classify any particular product.
A “medicinal product” is defined in Article 1 of Council Directive 2001/83/EEC and included as Regulation 2 of the Human Medicines Regulations. The definition is as follows:
(1) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(2) Any substance or combination of substances which may be used by or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis”
In respect of the first limb of the definition, were you to market any product that makes a medicinal claim, this would mean that the product falls within the definition of a medical product. For the avoidance of doubt, you should also be aware that this includes any testimonies, studies, links to articles, historical uses etc that you may wish to include on your website or any other promotional material. Further guidance in relation to medicinal claims can be found in our Guidance Note 8
Insofar as the second limb of the definition of a medical product applies to your products, it is a matter of fact that there have been a number of clinical trials which demonstrate that CBD has a therapeutic effect, particularly in the treatment of severe epilepsy. MHRA’s clinical assessors have reviewed relevant scientific and clinical evidence to support the mode of action of CBD in the treatment of a range of medical conditions. It should also be noted that the European Medicines Agency has given CBD products an orphan designation on four occasions, for three different clinical conditions; graft versus host disease, perinatal asphyxia and Dravet syndrome.
The MHRA is now working with trade bodies in relation to making sure products containing CBD, used for a medical purpose, which can be classified as medicines, satisfy the legal requirements of the Human Medicines Directive as transposed into UK law by the Human Medicines Regulations 2012. This work is ongoing. Given the ongoing evaluation, MHRA can give no assurance that any particular product, including products under development, will not subsequently be classified as a medicinal product.
‘The advice contained within this email relates to the MHRA’s opinion regarding the status of CBD. The Home Office can advise on psychoactive substances and the Misuse of Drugs Act and any products which are subject to these regulations. Your products must comply with the relevant regulations at all times. It is possible that your products may contain residual levels of THC, and/or other controlled substances. We therefore advise that you contact the Home Office first who can advise in respect of psychoactive substances and the Misuse of Drugs Act. The Home Office can also advise with regards to what licences will be required to grow/import/export such products/substances from/into the UK. Please note that we are only providing general information above and this is in no-way, shape or form an approval of any product. We have not seen any information relating to the products in question and therefore, we cannot comment on its acceptability. If you wish to license your products as medicines in the UK then the attached links provide more information about how to obtain a marketing authorisation (MA) in the UK which we hope you will find helpful. Home Office has also published a Factsheet in respect of CBD and you are advised to review this first: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/674713/Factsheet-_Cannabis__CBD_and_Cannabinoids-_January_2018.pdf
The Agency reserves the right to change its view in the event of any information or evidence which has a bearing on the status of the products, including the way in which they are presented and promoted. This also includes any information, which we have not assessed. You should seek independent advice or consult a suitable trade association or the appropriate regulatory authority about the acceptability of any product you are considering selling, supplying or advertising.
The licensing process is by no means easy, especially with little regulatory knowledge. We have included links below which will direct you to the relevant pages on the MHRA website. As an indication of the Legal Basis, you should focus on an 8(3) Full Application, submitted under the complex fee. A National procedure is for authorisation in the UK only.
In order to market the product in the UK, a Marketing Authorisation is required. As there are no step by step guidelines, please see the below links for the submission of new marketing authorisation applications (MAA).
https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk
(Guidance regarding how to apply for a market authorisation in the UK)
http://ec.europa.eu/health/documents/eudralex/vol-3/index_en.htm
(EU scientific guidelines for medicinal products)
(Licence application forms)
https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk#fees
(Fees)
(MHRA fees definitions)
Furthermore, to obtain marketing authorisations in the UK you must have a registered office or representative either in the UK or another EU member state. GMP (Good Manufacturing Practice) inspections will take place after marketing authorisation applications have been submitted if the site has not been inspected by an EU authority in the last 3 years and does not hold a valid GMP certificate.
Please see the below link with regards to the requirements for having Manufacturers and Wholesale Dealers licences: Importers Licence queries.
https://www.gov.uk/apply-for-manufacturer-or-wholesaler-of-medicines-licences
CLEAR Advises Department of Health and MHRA on Definition of Cannabis-Derived Medicinal Products.
Last week, CLEAR was invited to participate in a teleconference with representatives of the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA). This followed our written submissions made over the last few weeks.
The teleconference included two representatives from each party. The DHSC was represented by the Medicines Pharmacy and Industry section. The MHRA was represented by the Licensing Division.
CLEAR has now submitted a summary of all the advice offered which is reproduced below.
1. The definition of cannabis-derived medicinal products (CDMP) is for products that will be re-scheduled in the Misuse of Drugs Regulations out of schedule 1 and ostensibly into schedule 2. These products will be available for prescription by doctors.
2. With the exception of Sativex, a whole plant cannabis extract with a THC:CBD ratio of 1:1, there are no cannabis-derived medicinal products available in the UK which have been licensed by the granting of a marketing authorisation (MA) or a Traditional Herbal Registration (THR). THR licensing is for minor ailments only that do not require the supervision of a doctor. MA licensing would be required for any CDMP aiming to treat most of the conditions for which cannabis is currently being used illicitly unless such CDMPs are prescribed as an unlicensed medicine.
3. In every other jurisdiction in the world where CDMPs are legally available, governments have recognised that licensing regimes designed to regulate single molecule pharmaceutical medicines synthesised in a lab are not suitable for regulating CDMPs. All such governments have either established entirely new cannabis regulators or created a specialist division within the existing medicines regulator. If there is a genuine intent to enable legal access to CDMPs by the estimated one million people currently using illicit cannabis as medicine, this is the only practical route forwards. The cost and length of time involved in obtaining an MA makes them prohibitive for a plant-based medicine. Given the experience of using cannabis as medicine over many millennia, its non-toxic nature and very low risk profile, the rigorous approach of an MA is unnecessary.
Recommendation 1. A CDMP regulator should be established encompassing genuine expertise in the use of cannabis as medicine. The Cannabis Trades Association UK (CTA) is already in the process of developing the Cannabis Products Directive (CPD) in co-operation with the MHRA and FSA.
4. There is no justification or evidence that can support cannabis being in such a restrictive schedule as schedule 2 alongside opioids and cocaine. The potential for causing social harm, which is the criterion used to determine the correct schedule, is several orders of magnitude greater with all existing schedule 2 drugs. They are all demonstrated to produce far higher levels of problematic dependence and long-term health harms than cannabis.
Recommendation 2. CDMPs should be re-scheduled into schedule 4 alongside Sativex.
5. The primary objective of the definition should be to ensure that the products are safe. Cannabis is non-toxic with no practical lethal dose and any harmful health or social effects are only likely with sustained and abusive use. In normal, moderate and especially medical use the potential for any harm is extremely low, certainly no higher than with common over-the-counter medicines. The main safety considerations are therefore the risk of contamination during cultivation and in subsequent processes such as extraction and refinement of oils, arising from the use of pesticides, herbicides, nutrients and solvents.
6. The definition should be wide enough to encompass all cannabis products that are produced to specified quality standards. It should not be so narrow as to prohibit high THC and/or low CBD products that may well be appropriate in individual circumstances. Prescribing guidelines should be issued to enable doctors to make appropriate clinical judgements on appropriate THC:CBD ratios for different conditions. These guidelines must be compiled by experts in the use of cannabis as medicine, not by the ‘non-experts’ who have been appointed to the expert panel on cannabis-derived medicine. FOI Requests have revealed that none of the members of the panel have any knowledge, experience or expertise in the use of cannabis as medicine.
7. The definition should be wide enough to provide for a future in which doctors can vary THC:CBD ratios and terpene content in accordance with evidence for therapeutic effect. For example, in paediatric epilepsy, CBD has been shown to be the most important compound but some children require a small percentage of THC for it to become effective. Doctors should be free to vary dosage in the same way as they do with many licensed medicines in accordance with the way the patient responds.
8. Regulators/authorities will properly require some independent assessment of the safety of products as defined above. The only such assessments currently available are Good Manufacturing Practice (GMP) and certification by the Cannabis Trades Association UK (CTA). By definition, these certifications are only available for products that are legally available and CTA only operates within the UK where only exempt, low-THC products (known as CBD products) are legally available. GMP certification is available on some cannabis products legally available outside the UK.
9. Cannabis consists of around 500 molecules including approx. 110 cannabinoids, 120 terpenes and 20 flavonoids which provide the important therapeutic effects, most effectively, when working together in what is known as ‘the entourage effect’. The most significant cannabinoids are believed to be THC and CBD. THC has long been demonised as the principal psychoactive component but it has very important therapeutic effects, notably as an analgesic, an anti-spasmodic and an appetite stimulant. CBD works as an analgesic, anti-inflammatory, anxiolytic and anti-psychotic. It is beyond doubt that they work best together as they enhance each other’s positive effects and ameliorate any side effects. It is vital that cannabis for medical use contains a balance of both. In some conditions, THC is more important than CBD and in others the reverse will be the case. We recommend that for medical use the ratio of THC:CBD should ideally not be less than 10:1. This will protect against any negative effects of THC which a very small proportion of patients may be vulnerable to. In most instances, for medical use, the ideal THC:CBD ratio will be 1:1. Doctors should however be free to prescribe outside these parameters including high THC and high CBD products, subject to prescribing guidelines.
Recommendation 3. The definition of CDMPs should be primarily concerned with safety in the production process. CDMPs should have either a. GMP certification b. CTA certification c. an existing MA d. an existing THR. The composition and cannabinoid ratios of CDMPs should be a matter for determination by doctors in accordance with prescribing guidelines.
Recommendation 4. Prescribing guidelines for CDMPs should be developed by experts in the use of cannabis as medicine, not by the ‘non-experts’ who have been appointed to the expert panel on cannabis-derived medicine.
10. Cannabis has traditionally been smoked and millions of people have gained great benefit from it over many centuries. The principal benefits of smoking, which are extremely important, without any of the negative effects, can now be achieved through vaporising. The benefits are rapid onset of therapeutic effect and accurate self-titration of dose. When ingested, either through the GI system or absorbed through the mucus membranes, onset is much slower, the effect is prolonged and accurate titration is very difficult to achieve. Vaporisers are already in widespread use and a variety of different types are available. The Storz and Bickel ‘Volcano’ has a CE mark and is a licensed medical device in Canada and Israel. The Teva Pharma ‘Syqe’ has completed three clinical trials with positive outcomes for safety and efficacy.
11. Vaporised, pharmaceutical-quality, standardised herbal cannabis with consistent cannabinoid and terpene levels is the gold standard in the use of cannabis as medicine. Presently the only way to achieve this in Europe is with GMP-certified cannabis produced by Bedrocan BV, the Netherlands government officially contracted producer. Some Canadian producers are also GMP certified.
Recommendation 5. Vaporisers should be made available on loan, for subsidised purchase or free-of-charge in accordance with existing provision for those in receipt of benefits.
12. The DHSC should prevail on GW Pharmaceuticals to reconsider its pricing strategy on Sativex which is presently under a ‘do not prescribe’ edict from NICE on the grounds that it is not cost-effective. The price of Sativex is extraordinarily high and products which, for all practical considerations of safety and efficacy, are identical are available over-the-counter for one-tenth of the price in US cannabis dispensaries. There is no justification for the price of Sativex except for the recovery of the cost of clinical trials which GW Pharma was required to engage in in order to obtain a marketing authorisation. GW Pharmaceuticals should also be encouraged to make herbal cannabis products available as an alternative to Bedrocan, something it should be able to achieve within a few months with little difficulty.
13. Cannabis extracts and oils will be required for some patients, particularly children, and those that cannot or do not wish to use inhalation via a vaporiser. Prescribing guidelines must recognise that the pharmacology of cannabis is totally different when ingested through the GI system or absorbed through the mucus membranes. Absorption of oil through suppositories has also been found to a valuable method of ingestion.
14. While CLEAR fully supports decriminalisation of domestic cultivation of cannabis for personal use, homegrown cannabis should never be considered part of a therapeutic programme under the supervision of medical professionals. The potential for contamination and poor quality is far too high.
Recommendation 6. In the short term, aside from low-THC exempt products known as CBD products, the only CDMPs readily available are from GW Pharmaceuticals, Bedrocan BV or Canadian producers, notably Tilray. Standardised herbal cannabis for vaporising or oils for other methods of ingestion should be available from these producers immediately.
15. Originally Nick Hurd MP, the Home Office minister, wrote in The Times, 29th June 2018, that cannabis would be rescheduled and could be prescribed by GPs whenever a benefit could be identified. Without any explanation that now appears to have morphed into ‘specialist’ or ‘senior’ clinicians and only in cases of ‘exceptional clinical need’. As well as a broken promise which is causing widespread consternation, this is irrational, as are suggestions that cannabis should be regarded as a medicine of last resort. The safety profile of cannabis is such that any rational, evidence-based policy would suggest cannabis as a medicine well before many analgesics, anxiolytics and anti-depressants which are widely, readily and regularly prescribed by doctors without any concern.
16. A workable definition of CDMPs together with well-informed prescribing guidelines that enable prescription by GPs for any condition where a benefit is identified is essential. Unless this is satisfactorily achieved, the one million people in the UK currently using cannabis as medicine will continue to do outside the law, outside any form of medicines regulation and without any medical supervision. The likelihood is that this cohort of patients will continue to expand rapidly as knowledge of the therapeutic benefits of cannabis and its use in other countries becomes more widespread. The implications of failing to establish a proper regime are very significant for health, patient-doctor relationships, the criminal market in cannabis, the police and the criminal justice system. This is a nettle that must be grasped.
Recommendation 7. CDMPs should be available in accordance with the Home Office’s initial commitment, that is on prescription by GPs for any condition where a benefit can be identified
Cannabis Trades Association Receives Official Endorsement From the MHRA.
For nearly two years the Cannabis Trades Association (CTA) has been working with the Medicines and Healthcare products Regulatory Agency (MHRA), the Food Standards Agency (FSA), the Home Office, Trading Standards and other UK authorities to bring order and professional standards to the growing market in legal cannabis and CBD products.
The MHRA has now officially recognised CTA by inclusion in its Guidance Note 8 ‘A guide to what is a medicinal product’.
This is long overdue recognition for the CTA’s work which includes regular liaison with the authorities, providing guidance to businesses operating within the market on the law, regulations, professional and quality standards. The CTA with the MHRA and FSA is also in the process of developing the Cannabis Products Directive (CPD), a framework for regulation and licensing of all cannabis and cannabinoid products. CPD has been translated and submitted to all 28 member states of the EU by the European Food Safety Agency (EFSA). It is anticipated that CPD will become UK law within the next two years and will relieve the Home Office of the burden of the cannabis regulation and licensing process, placing it in expert hands.
The CTA was initially conceived at a meeting in Manchester Airport in September 2016. In November 2016, with the assistance of Crispin Blunt MP, then a member of the CLEAR Advisory Board, it was invited to an initial meeting with the MHRA to represent the emerging CBD industry. The market for legal, low-THC cannabis products derived from industrial hemp had grown rapidly within just a few months but was becoming out of control with a multitude of new companies making unlawful medical claims for their products, which themselves were totally unregulated and of inconsistent quality and unknown provenance.
Through negotiation and a growing relationship with the authorities, CTA was instrumental in bringing the market back from the brink of a serious clampdown. Now, with over 300 full members and more than 1200 registered sellers, CTA encompasses not just CBD suppliers but also licensed growers and producers of cannabis and businesses involved in the long term development of cannabis products.
CTA is closely involved in the rapidly developing reform of the laws around medical use of cannabis and will be working with the authorities to manage development of the products and systems required for what is expected to be a huge new market.
The Facts About CBD In The UK. April 2018.
This article is an update to ‘The Facts About CBD In The UK. December 2016.‘
The past three years have seen a true phenomenon develop around the cannabis law reform movement which has quickly crossed into mainstream society, commerce and general awareness. It’s the explosion of the CBD market, a trade that has grown from zero to £50 million per annum in the UK in this very short period.
There has been a great deal of nonsense published about the market, the products and their legality both under drugs laws, food and medicines regulation. The facts that are set out in this article are established from close involvement with the developing market on a daily basis as well as consultation with a number of lawyers of all types and levels of experience as well as direct contact with the Home Office, the Medicines and Healthcare products Regulatory Agency (MHRA), the Food Standards Agency (FSA) and other authorities.
The market has been driven initially because of growing interest in the medical benefits of cannabis and the recognition that, within certain constraints, products derived from low-THC cannabis, legally grown under licence as industrial hemp, are a legal alternative. An important factor has been that CBD is most often consumed by placing a few drops of oil under the tongue. This has avoided the stigma of smoking a joint and is more in line with the way people perceive a medicine or health food.
The CBD market has also exposed the contradictions, inconsistencies and errors in the Misuse of Drugs legislation and particularly in the confused and inconsistent way in which the Home Office attempts to administer it. For instance, currently there are CBD products produced legally in other EU countries and the USA which can legally be sold in the UK but which the Home Office will not permit UK companies to produce.
Ironically, the most significant development has been that responsible CBD suppliers have moved away from claiming the sort of medical benefits that are, in fact, the reason for the market’s existence. Although everyone knows this is why people are buying CBD, if you’re in the business of supplying the products you can’t say a thing, not even indirectly, about the medical benefits it offers.
18 months ago, all the leading and responsible suppliers of CBD products in the UK joined together to create their own trade association. The Cannabis Trades Association UK (CTA UK) now represents 80% by turnover of all the CBD suppliers in the UK. It is governed by its members who have established a set of standards on products, labelling and marketing which all abide by. These standards are designed to protect and inform consumers and to ensure that all CTA UK members are compliant with the law.
The formation of CTA UK was prompted by the MHRA issuing warnings to some suppliers about making medical claims for their products. To remain within the law, CBD products must be sold as food supplements and the most that can be said about them is that they help to improve and maintain health and wellbeing. Before any product can be marketed with medicinal claims it must have a marketing authorisation from the MHRA. Food supplements must also comply with certain laws and regulations administered by the FSA.
CTA UK is now engaged in a continuous dialogue with both the MHRA and FSA. Regular meetings are held to consider new suppliers and products entering the market to ensure they comply with the law, regulations and CTA UK standards.
When supplied by a CTA UK member, consumers can be certain that the product they are buying is 100% legal and is accurately labelled and described. CBD is not a ’controlled drug’. It does not appear in any of the classifications or schedules to the Misuse of Drugs Act 1971.
There is widespread misunderstanding about the 0.2% THC limit in industrial hemp. This is the limit in the growing plant and is not relevant to CBD products. Clearly what may be under 0.2% in the growing plant would be far higher in an extract which is, by definition, concentrated. The Misuse of Drugs Regulations 2001 make it clear that any product derived from low-THC cannabis grown legally under licence as industrial hemp is “exempt” provided it contains “not more than one milligram” of THC or CBN. This is the limit that matters. See The Misuse of Drugs Regulations 2001 ‘Interpretation’ 2-(1) (a)(b)(c)
Contrary to suggestions that the market is “in chaos”, “half-legal”, “a bit of a mess” and other spurious claims, in fact, it is a model of self-regulation where the industry itself has put aside its competitive instincts to co-operate for the benefit of consumers and in its own long term self-interest.
No suppliers will be admitted to membership of CTAUK unless they cease making medicinal claims, stop selling illegal products (for instance with high levels of THC, described as ‘indica’ or intended for pets or veterinary purposes). Indeed, any suppliers that continue such conduct are likely to be subject to enforcement action by the MHRA and Trading Standards.
There are further changes or clarifications in the law relating to some CBD products which have emerged in the last few weeks. These arise out of regulations from the FSA. Isolates or pure CBD are now no longer permitted as they have been classified as ‘novel foods’. This could mean a prison sentence of up to two years for anyone selling them.
It’s a myth, although regularly reported in the press, that there has been any change in the law or that CBD has been made legal or classified as a medicine. CBD products can already be prescribed by doctors without any restriction, just as any other food supplement. When the inevitable cannabis law reform takes place it will still be unlawful to make medicinal claims about any CBD or cannabis product without a marketing authorisation from the MHRA.
Within the next few months, the first CBD medicine will receive a marketing authorisation from the MHRA. Epidiolex, a whole plant extract, refined to deliver 98% CBD, is GW Pharmaceuticals’ second cannabis-derived prescription medicine which is intended for severe forms of paediatric epilepsy. It is not derived from industrial hemp but from high CBD strains of cannabis grown specifically for the purpose. It should be noted that this is to be administered in massive doses of up to 20 mg per day per kg of body weight, CBD as a food supplement for adults has a maximum recommended dose of 200mg per day.
The CBD food supplement market will continue to grow. Other medicines may be authorised in the near future, most likely under the MHRA’s Traditional Herbal Registration scheme, which will permit them to be described as medicines for minor ailments not requiring the supervision of a doctor.
Clearly, it remains urgent that our government gets to grips with the reality of the need and benefits of cannabis for medical use in the wider sense. However, even as we begin to make progress the CBD market in its present form will continue to fulfil an important need for many years to come.
Talking Cannabis With the MHRA
MHRA Headquarters
In November 2016 I organised a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) and a number of key players in the CBD market. It was in response to the MHRA seeking to clamp down on sales of CBD oil and related products. That meeting led directly to the formation of the Cannabis Trades Association UK (CTAUK) which now represents more than 80% by turnover of all CBD suppliers in the UK.
Since that first meeting my friend and colleague Mike Harlington has taken on the leadership role at CTAUK and I give him great credit for what has been achieved. We expect formal recognition by the MHRA is only a few weeks away and that is a tremendous coup. For the first time ever, in the face of total intransigence by government, we have established to a significant degree a legally regulated cannabis market. Clearly, it doesn’t yet go anywhere near far enough but this is the most concrete move ever towards long overdue cannabis law reform.
The first 18 months of CTAUK have not been easy. Other than the MHRA, the other branches of government concerned are the Food Standards Agency (FSA) and the Home Office. The FSA has also become a close working partner but, unsurprisingly, the Home Office remains difficult and our efforts to engage constructively with it have been characterised by responses that are inconsistent, irrational, contradictory and a realisation that it’s losing its grip on cannabis policy. It is impossible to deal with. In fact, I almost sympathise with the unfortunate civil servants charged with administering a policy that is itself irrational and contradictory and driven only by outdated prohibitionist values. Maladministration of the Misuse of Drugs Act is now a persistent reality and several legal challenges to the Home Office’s conduct are imminent. Soon the High Court will become involved in UK cannabis policy and then, in theory, facts and evidence should prevail rather than propaganda and government disinformation.
Dr Chris Jones
The CTAUK has been engaged in regular meetings with the MHRA and I was invited along for the most recent occasion. The CTAUK team was Mike Harlington, Tom Whettem of Canabidol and myself. The MHRA team was Dr Chris Jones, head of the Borderline Medicines section and Raj Gor. We discussed many administrative matters and gave a great deal of time again to discussing medicinal claims and how members could avoid mistakes. It seems obvious that no claims of medicinal benefit can be made but there are many instances where it’s not clear cut. A particular case we looked at was the use of ‘night’ and ‘day’ CBD products. Eventually it was agreed that this description is acceptable but only just. This is an excellent example of how CTAUK works to represent its members’ interests and with goodwill on both sides how positive agreement can be reached.
On a continuing, day-to-day basis CTAUK and MHRA are in constant touch, ironing out problems, asking for and taking advice from each other. I am impressed with the way the relationship has evolved and jointly we bring great benefit to the industry and consumers.
Misleading Parliament Again. Victoria Atkins, The Drugs Minister With A Family Cannabis Farm.
She’s back! Victoria Atkins MP is again engaged in answering parliamentary questions on cannabis for the UK government. Clearly this is wholly improper when she directly benefits from commercial production of cannabis.
Ms Atkins disappeared from public view for a few weeks after CLEAR revealed that her husband is growing 45 acres of cannabis under government licence while she argues against drugs regulation in Parliament. It was particularly notable that she was absent from the House of Commons during the recent urgent question debate on a medical cannabis licence for Alfie Dingley. Instead, her colleague Nick Hurd MP, ostensibly the Police Minister, was required to answer a question on drugs. Similarly, she was nowhere to be seen as Paul Flynn MP’s bill came up for debate, which sadly, as CLEAR had predicted, never took place.
It is simply extraordinary that the so-called Drugs Minister should duck and dive out of view when such issues of massive public interest hit the headlines. She has a massive conflict of interest and it is completely unacceptable for her to continue in her present role.
Yesterday, 7th March 2018, she answered a written question from Roger Godsiff, the Labour MP for Birmingham Hall Green.
“To ask the Secretary of State for the Home Department, if she will assess the health and economic benefits of legalising cannabis for medical use.”
Ms Atkins answered:
“The World Health Organization’s Expert Committee on Drug Dependence has committed to reviewing the scheduling of cannabis under the United Nation’s 1961 Convention. This is due to consider the therapeutic use, as well as dependence and the potential to abuse constituent parts of cannabis. This is due in 2019 and we will await the outcome of this report before considering the next steps.”
This answer is at best disingenuous and misleading. Once the full facts are understood it is clear that it is deceptive and mendacious.
British Sugar’s giant greenhouse in Wissington, Norfolk where Victoria Atkins husband, Paul Kenward, grows cannabis
Ms Atkins husband, Paul Kenward, managing director of British Sugar, grows cannabis under contract to GW Pharmaceuticals for the production of medicine. Ms Atkins deceit is predicated on another deception promoted by the UK government that is some way or another, Sativex, GW’s cannabis medicine is not cannabis. GW is perfectly straightforward about this. Sativex is a whole plant cannabis extract adjusted by simple blending of two different strains to deliver 1:1 ratio of THC:CBD. It contains all the other cannabinoids, terpenes, flavonoids and other compounds present in the plants from which it is made. The government deception is to justify the issue of a marketing authorisation (MA) for Sativex by the Medicines and Healthcare products Regulatory Agency (MHRA) which is itself a deception. The MA was issued on the basis that Sativex is THC and CBD alone. The MHRA conveniently overlooks the hundreds of other ingredients and calls them “unspecified impurities”. The consequence of this is that, ludicrously, Sativex is a schedule 4 drug whilst any other form of cannabis remains schedule 1 and may not be prescribed
But the plot thickens. The deceit goes even deeper. It has been widely reported and British Sugar confirms that its grow is not for Sativex but for production of Epidiolex, the 98% cannabidiol (CBD) medicine that has not yet received an MA. If, as appears certain, this is the case then the British Sugar grow is unlawful under the declared policy of the government. Cannabis production licences (other than low-THC industrial hemp) can only be issued for “research or other special purposes“. They most certainly cannot be issued for the production of a medicine that is not yet authorised. Even if the British Sugar cannabis is low-THC, it is definitely not an approved EU industrial hemp strain and the purpose of its production is presently unlawful.
Ms Atkins through her husband is therefore engaged in the unlawful production of cannabis and is directly engaged in misleading Parliament as to government policy, the law and the medical value of cannabis. The World Health Organization story is a trick, a distraction, an excuse to divert Parliament from understanding the truth.
Ms Atkins conduct cannot be described in any other way except as corrupt. She is a disgrace as a minister of the Crown, to Parliament, to her profession as a barrister, to the Conservative Party, to her constituents in Louth and Horncastle and to the United Kingdom as a whole and all of its citizens. She is manifestly unfit for any public office.
The Facts About CBD In The UK. December 2016.
On 3rd October 2016 the Medicines and Healthcare products Regulatory Agency (MHRA) issued notices to a number of CBD suppliers stating that cannabidiol (CBD) was being designated as a medicine and that sale of all CBD products must stop within 28 days, ostensibly by the 1st November.
A lot has happened since. Most importantly, the Cannabis Trades Association UK (CTAUK) has been established to represent the industry and protect the interests of CBD consumers but there remains great confusion as to the legal status of CBD and whether these products will still be available. This article sets out the facts and explains how the market is likely to develop. The most important point is that there is no need for panic. There will be some changes but no one will lose access to CBD for the foreseeable future.
Background
Through the summer of 2016, rumours and half stories had been swirling around about the MHRA taking action on CBD. When the news broke it caused real panic, both for the thousands of people using CBD products and for those working in CBD businesses. It looked like a real disaster for everyone. On the one hand the government, through the MHRA, was finally recognising the truth that CBD and cannabis are medicine. On the other, it seemed that the whole industry was going to be shut down, businesses would close, people would lose their jobs and, most importantly, those who rely on CBD products for maintaining their health were going to suffer real harm. If CBD was going to be regulated as a medicine it would require the investment of hundreds of thousands of pounds to obtain the necessary authorisation to put any products on the market.
It quickly became clear that the MHRA was unprepared for the reaction it received. Its switchboard was swamped by worried callers. Social media exploded with the inevitable Big Pharma conspiracy theories and even the national press covered the story demonstrating that medicinal cannabis is now an issue of mainstream interest.
CLEAR took action to rally our friends and colleagues in the legitimate cannabis business and this led to the creation of CTAUK. The same day the news broke we wrote to the MHRA notifying it of the formation of the trade association and seeking a meeting.
On 13th October, the MHRA issued a statement on its website explaining its actions.
CLEAR’s advisory board members, Professor Mike Barnes issued a statement to the media and Crispin Blunt MP wrote to Dr Ian Hudson, the chief executive of the MHRA. Even the British Medical Journal covered the story.
On 19th October the MHRA finally confirmed a meeting with the CTAUK to take place on 3rd November. On 21st October, Dr Ian Hudson replied to Crispin Blunt’s letter. CTAUK appointed solicitors who in turn obtained counsel’s opinion and on 28th October a solicitor’s letter was sent to the MHRA formally objecting to its action. On 1st November the MHRA updated its statement on its website softening its position by claiming that its notices to CBD suppliers were merely its “opinion” that it should be designated as a medicine.
The meeting took place at MHRA headquarters on 3rd November. It was cordial and constructive and on 16th November CTAUK wrote to the MHRA formally proposing a system for the regulation of CBD. Essentially this suggests that CBD products with daily adult dosage of up to 200mg should continue to be marketed as a food supplement. Products with a daily adult dosage of up to 600mg would require a Traditional Herbal Registration and higher dosage products would require a full Marketing Authorisation. We await the MHRA’s response.
The MHRA has since written to CBD suppliers requiring them within seven days to provide samples of their products along with various information about them. However, CTAUK has been able to negotiate that our members have until the end of January to comply. This is excellent news and demonstrates recognition of the association by the MHRA.
Is CBD Legal In The UK?
Yes, CBD is not a controlled drug under the Misuse of Drugs Act 1971, neither is it covered by the Psychoactive Substances Act 2016. As long as it is marketed as a food supplement without any medicinal claims it is perfectly legal to sell and to buy.
Is The MHRA Going To Ban CBD?
No, the MHRA will have to assess each product on its own merits, particularly taking into account how it is marketed and whether any claims of medicinal benefit have been made.
What Will Happen In the Future?
We hope that the MHRA will accept our proposals for a system of regulation, meaning that only the highest dose products, such as GW Pharma’s soon-to-be- released ‘Epidiolex’ will require a full Marketing Authorisation. However, even if the MHRA tries to take formal action about any other products, this is going to take many months and probably a much as a year before anything changes. We remain confident that we will come to an agreement that will enable everyone to continue to access CBD products.
