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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘Food Standards Agency

CannaPro Seizes the Initiative in the CBD and Novel Foods Debacle

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Cannabis Professionals (CannaPro), the trade association for the UK’s cannabis, CBD and hemp businesses, has instructed solicitors to take decisive action in the ongoing row between the Food Standards Agency (FSA) and the UK’s fastest-growing food supplement market for cannabidiol (CBD) products.

TLT Solicitors, acting on behalf of CannaPro, has sent a formal letter to the FSA warning it of the consequences of taking any enforcement action against CannaPro Certified Businesses.  An industry-wide claim for such compensation could amount to many hundreds of millions of pounds/euros.  A copy of the letter can be seen here. This offers some degree of protection to all businesses that are CannaPro Certified.

Acting in conjunction with its opposite numbers in several EU states, the FSA has sought to classify CBD products and all cannabis extracts as ‘novel’ by listing them in the EU Novel Food catalogue. This threatens to destroy a market that is now worth up to £100 million pa, employs hundreds of people and is meeting the healthcare and wellness needs of hundreds of thousands of UK citizens.

A ‘novel food’ is defined as a food or food ingredient that was not in widespread consumption in the EU area before 1997.  In reality, cannabis, in varieties known as hemp, has been consumed as food for at least 10,000 years and is listed in the Guinness Book of Records as the world’s oldest cultivated crop. The FSA’s action is irrational, defies history and reverses previous statements by the FSA that cannabis and hemp are not ‘novel’.

Peter Reynolds, president of CannaPro, said:

“The FSA has made a series of errors in the way it has handled this.  The whole process has been misguided and unlawful, not to say that the whole idea CBD products can be regarded as novel is nonsense. It has undertaken no proper consultation and although there have been vague discussions around the issue for a couple of years, the FSA has changed its position time and time again.  What’s really going on here is that big business and powerful vested interests have been caught on the hop while enterprising small businesses have established a market which is now worth an awful lot of money. Improper pressure has been brought on the regulator to find a way of clamping down.  It would suit these vested interests to see the market so strictly regulated that small businesses are unable to compete.  CannaPro is not going to stand by and let that happen.”

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Written by Peter Reynolds

March 26, 2019 at 6:00 pm

CBD Isolates Are NOT Becoming A Controlled Substance

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Mike Harlington’s CTA has put out an announcement that CBD isolates are becoming a controlled substance.  There is no truth in this at all, it is nothing but speculation and opinion.

Even if the speculation is correct that isolates will remain classified as a novel food, the terminology is wrong. ‘Controlled’ has a specific meaning in UK law and is applied to drugs classified and scheduled under the Misuse of Drugs Act 1971.  There is no prospect whatsoever of this applying to CBD in any form.

It is correct that the FSA initially classified isolates as novel in January 2018 and no reasonable person can have any objection to this.  Clearly, there cannot be any evidence of them having been consumed in the EU area prior to 1997.  It’s a separate point that this is bureaucratic overkill.  There’s no evidence that isolates are unsafe so there’s no reason to require them to go through an authorisation process except simply to comply with the letter of the law. It is bureaucracy for bureaucracy’s sake and a complete waste of the FSA’s time and taxpayers’ money.

Another, more pertinent point is that despite isolates being classified as novel for well over a year, the FSA has done absolutely nothing about enforcement.  This whole rigmarole is pointless and doing little else other than keeping civil servants in work, making up rules which they then do nothing about.

What remains a far more worrying prospect, which has been entirely overlooked, is that in June 2018, the FSA also indicated that selective extracts would be regarded as novel. The argument for this is equally as strong and logical as it is for isolates and this poses a much more worrying prospect for the CBD industry.

Selective extracts are extracts in which the proportions of the component moleclues have been adjusted, most commonly by the elimination of THC.  Making such adjustments, dialling up or down particular components is an inherent facility of supercritical CO2 extraction. But just as there can be no evidence of isolates having been consumed in the EU area prior to 1997, neither can there be any for selective extracts.  Extracts consumed in the past will have been made by less sophisticated processes that do not permit such adjustments.

So the deep irony in this is that in order to avoid any infringement of drugs laws by removing the THC, such products will be in breach of food law.

Where the FSA is going with this no one knows. It has made major errors in its bungling and incompetent attempt to outlaw CBD products and its top priority now seems to be saving face.  Similarly, having bragged about his mythical ‘close working relationship’ with the FSA, Harlington is also desperately trying to save face and make it look as if he is ahead of the game.  It’s just more of his characteristic bluster and bullshit.  Don’t be taken in.

Any predictions I will make about the future will also be speculation but I am quite confident that this time next year whole plant, low-THC cannabis extracts will still be on sale. In fact I am sure that the market will have continued to expand rapidly.

Written by Peter Reynolds

March 13, 2019 at 10:35 pm

Presentation at the Hemp CBD Expo, 2nd March 2019

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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.”

Another Attack by Bureaucrats on CBD and its Consumers

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Today’s article in the Daily Mail on CBD follows that publication’s usual pattern – there is a kernel of truth but on top of that is piled inaccuracy upon misleading comment upon nonsense.

So let’s deal with the truth and send the nonsense back to the Daily Mail where it belongs.

Within the last few days it has emerged that the UK Food Standards Agency (FSA), has been working surreptitiously with its opposite numbers in four other EU countries to add all products derived from cannabis except hempseeds to the EU Novel Food Catalogue. This step has been taken without any communication or consultation with the CBD industry or the millions of consumers benefiting from the products. It is important to understand that inclusion in this catalogue does not create law.  Suppliers of CBD are entitled to continue marketing their products if they consider they are not ‘novel’.

What does ‘novel’ mean?  The EU novel foods legislation states that any food or ingredient used in foods that was not in widespread use prior to 1997 will be subject to an authorisation process that must demonstrate either evidence of widespread use prior to 1997 and/or that it is safe.

To be clear, the Daily Mail’s claim that this means “experts probe whether it has any real health benefits” is nonsense. It has nothing to do with that at all.

Love Hemp, CBD market leaders

Anyone who has any knowledge at all about cannabis will understand how ludicrous it is to suggest that it is ‘novel’ in any form.  It is even described as the oldest cultivated plant in the Guinness Book of Records. It is widely recognised to have been cultivated for at least 12,000 years.

So this move by the FSA and its equivalents in France, Germany, Italy and the Netherlands is, demonstrably, bureaucracy for bureaucracy’s sake. Cannabis is the oldest crop cultivated and used by mankind. Asking for evidence of its widespread use before 1997 is no different and as absurd as asking for the same evidence for wheat or barley.

The CBD industry and consumers faced a similar atack from the Medicines and Healthcare products Regulatory Agency (MHRA) in 2016.  Then, as now, it was CLEAR that stepped in and organised the response.  The MHRA quickly backed off, accepted that it had no power to carry out a wholesale shutdown of the industry and the leading CBD companies began a process of self-regulation which has led to the development of a very successful marketplace.  Millions of consumers now gain great benefit from CBD products which help to maintain health and improve wellbeing.

Whichever side of the Brexit debate you are on, it is precisely this sort of overbearing, oppressive bureaucracy at an EU level that led many people to vote leave. There can be no sensible suggestion that CBD is harmful.  In 2017, the World Health Organisation (WHO) published an unequivocal conclusion that CBD “does not cause harm”. It is, therefore, safe and is demonstrated to be so by thousands of years of use.  So why is the EU and the FSA, its agent in the UK, engaged in this spurious and wholly unnecessary attack?  Can it be for any other reason than simply to sustain the bureaucracy and create work for the bureaucrats keeping them in their comfortable jobs?

It remains to be seen whether the FSA will try to explain its actions.  CLEAR’s trade association for CBD businesses, Cannabis Professionals (CannaPro), has been dealing with the FSA for some time and trying, unsuccessfully, to obtain straight answers. We participated in a conference which included the Head of Novel Foods in December 2018 and only yesterday we wrote to him complaining that, if anything, the situation was becoming more confused.  Now, unconfirmed statements from the FSA suggest that it is requesting Trading Standards to work with it on ‘enforcement’ and to remove CBD products from shelves. In our view the FSA and Trading Standards would be exceeding their lawful authority if they took this action as inclusion in the EU Novel Food Catalogue does not represent law.

It’s also important to understand the context in which the FSA bureaucrats are flexing their muscles and trying to talk tough.  For some time, CBD isolate has been in the EU Novel Food Catalogue and it has been genrally accepted by the industry that it is genuinely novel.  All responsible businesses have stopped selling isolate but there are a host of disreputable companies still selling isolate and neither the FSA nor Trading Standards have taken any enforcement action whatsoever.

Similarly, when the MHRA tried to get tough in 2016, it had a legitimate complaint that unlawful claims of medicinal benefit were being made.  All responsible businesses have ceased to make such claims but the marketplace is still full of confidence tricksters and the MHRA has taken no enforcement action whatsoever.  There are full page advertisements appearing in newpapers (including the Daily Mail) making the most outrageous medicinal claims but the MHRA does nothing. And this lack of enforcement severely damages responsible businesses that are working hard to remain compliant.

So, the truth is that even when justified and necessary, no enforcement is taking place.  In austerity Britain, even if you report a burglary or a car theft, the police will do nothing about enforcement.  The FSA’s action may well cause some of the major retailers to step back from the market.  It will certainly cause unnecessary confusion and damage to this burgeoning market but there is zero chance that it will stop people buying and selling CBD products.  Thousands of jobs now depend on the British CBD industry and millions of people find the products helpful and beneficial.

Key Points of Advice and Guidance

Don’t panic.  If you’re using CBD it will continue to be available. You might find it easier to buy it online in future.

Don’t panic.  If you’re a CBD business, the future remains bright, you should be used to a few obstacles in your path!

Don’t panic.  If you are visted by Trading Standards, stay calm and explain that your products contain nothing ‘novel’ and have been in widespread use for hundreds of years.

Don’t panic.  All CannaPro Certified businesses will have support in compiling evidence that your products are not ‘novel’. You are entitled to be given time to submit this.

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A final point that needs to be made on this subject.  When CLEAR organised the successful response to the MHRA’s intervention in 2016, it led directly to the establishment of the Cannabis Trades Assocation UK (CTA).  For reasons concened mainly with the ethical conduct and antecedents of Mike Harlington, who we appointed to run the CTA, we, along with many CBD businesses have disassociated themselves. This is turn led to the formation of Cannabis Professionals.

One of the main concerns about Harlington were his false claims of a ‘special relationship’ with the MHRA and FSA. These events should put the final nail in the coffin of those lies.  He and the CTA have had more than two years to establish a successful working relationship with these authorities but this has clearly been an absolute failure.  More than ever, the UK’s legal cannabis, CBD and hemp businesses need proper and effective representation.  Clearly, the CTA is unable to provide that.

Cannabis Trades Association Receives Official Endorsement From the MHRA.

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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.

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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

with 4 comments

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.