Advertisements

Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘MHRA

Presentation at the Hemp CBD Expo, 2nd March 2019

with one comment

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.”

Advertisements

Cannabis and CBD. UK and EU Bureaucrats -v- The People and Parliament.

with 3 comments

For decades, public opinion and knowledge on cannabis has been way ahead of those in Parliament and civil servants in the Home Office and the Department of Health.

In other countries, governments have been more ready to update themselves on scientific knowledge and they are more speedily held to account through more effective democracies. At last, the UK Parliament has acted on access to cannabis for medical use as it should have 20 years ago.  Both Canada and the Netherlands introduced legal access in 2001 and California even five years before that.

But the will of Parliament is being stifled and subverted by bureaucracts in the NHS and the Department of Health.  As MPs are never shy to remind us, under our constitution, Parliament is supreme.  That makes the conduct of these civil servants unlawful.  They are being obstructive about the prescribing of cannabis.  They need to be compliant with the law or they become guilty of maladminstration.  We should have no more patience with this wilful misconduct.  Their responsibility is to facilitate implementation of the law, not find ways to delay it because of their personal opinions.

The same goes for the Home Office which has done absolutely nothing to revise its cannabis licensing policy in accordance with the new regulations.  Well-qualified, experienced, international corporations, willing to make multimillion pound investments in Britain to produce the cannabis-based products (CBPMs) which we need are being refused licences for no good reason. If the products are not available, how will they ever reach the patients who Parliament has decreed are entitled to access them?

For 50 years, the Home Office has run a systematic campaign of disinformation because it is institutionally opposed to cannabis. Until Sajid Javid, civil servants have thwarted the efforts of all minsters that have tried to introduce any drugs policy reform.  Now he has to stand up against the subversive forces within his own department or someone has to fund judical review of the Home Office’s maladminstration of cannabis licensing. Just as in the Windrush Scandal, the Home Office maintains a ‘hostile environment’ based on senior civil servants’ personal prejudices rather than the best interests of Britain and now, the law.

CBD. Big Pharma Protectionism, Bureaucrat Box-Ticking or Both?

Many people are not yet aware of the meddling that is going on with CBD products.  There is a real threat that they could be removed from sale within the next few months.  This depsite their soaring popularity with the public and that hundreds, if not thousands of people are now employed in our burgeoning CBD industry.

CBD products are, in fact, whole plant extracts from low-THC cannabis which meet the criteria under drugs law to be exempt.  They have become very popular because people were seeking a legal way of accessing the medicinal benefits of cannabis which have become widely understood, mainly as the internet has provided knowledge previously suppressed by government and media scaremongering.

Two years ago, the meddling began as civil servants from the MHRA, the medicines regulator, stepped in with heavy-handed threats to close the market down because of unlawful medicinal claims.  To be fair, there was good justification for this.  Medicines regulation is an essential function of government, otherwise we will have snake oil confidence tricksters selling coloured water as a cancer cure.  So CLEAR acted and organised a response to the MHRA from the leading CBD companies.  Now, the responsible and ethical companies have regulated themselves, stopped making medicinal claims and market their products as food supplements, just like vitamins and minerals than can help to maintain health and boost wellness.

So CBD companies have successfully negotiated their way through both drugs and medicines law but now the food police have stepped in with yet more problems.  This time the civil servants objections are entirely unnecessary and unjustifiable but they are the most serious threat that CBD companies and consumers have faced.

The Food Standards Agency (FSA) from the UK and its opposite numbers in other EU countries have placed cannabis extracts in the EU Novel Foods Catalogue, which is for products that have not been consumed to a significant degree in the EU before 1997. This means that without going through a lengthy and very expensive authorisation process, all CBD products could become unlawful to sell.

Why?  When I met with the FSA and its novel foods team just over a week ago, it acknowledged that the purpose of the novel foods regulations was to ensure that food products and supplements are safe.  It also confirmed that it had no evidence that cannabis extracts or CBD products are unsafe. So, on the face of it, this seems to be simply a matter of bureaucrats who want their boxes ticked, for no other reason than that is what bureaucrats do.

But the widely-held opinion from those in the know, is that what is really behind this are the vested interests of painkiller companies who are seeing a big impact on sales of their products. Even the World Health Organization has recently given CBD an unequivocal endorsement as safe and effective, whereas the toxicity of paracetamol, ibuprofen, other NSAIDs and opioids is now well understood.

You see, however CBD products are sold, it is an indisputable fact that they are purchased for their medicinal benefit – and that they work.  This is a big threat to pharmaceutical company profits and so they are wielding their big stick.  They tried through the MHRA to close down CBD and now they are trying through the FSA.

Exactly the same thing is happening in the USA.  The recent passage of the Farm Bill has removed CBD from the Controlled Substances Act but now the FDA (which combines the functions of our MHRA and FSA) has stepped in and said it is illegal to sell as a food supplement because it is the active ingredient in a licensed medicine.

We Will Overcome

So a battle royal is starting.  What the outcome will be is uncertain.  It is complex and multi-threaded.  Different strategies are being developed and varying ideas are being put forward as to how to deal with this threat.  Many people now rely on CBD for their health and the imminent threat of it not being available is a danger to individuals and so to our entire society.

Whatever happens, I am certain that commonsense and the people will prevail.  For a century, the use of cannabis as medicine has continued despite every effort from governments and vested interests to stamp it out.  The same will happen with CBD.  Even it it disappears from the high street, it will continue to be available online and if it can’t be sold as a food supplement, it will move into a new category.

Once again, it will take politicians far too long to wake up and out-of-control civil servants will try to pursue their own agenda which, I am quite sure, is under the corrupt and improper influence of big business.  It will be challenging and very difficult but the people have dealt with these dark forces before and we will continue to do so.

Written by Peter Reynolds

February 10, 2019 at 2:19 pm

Daily Mail Profits From Illegal Advertising For Cannabis

with one comment

On the same day that the Mail publishes yet another inaccurate and misleading article on cannabis and CBD in particular, it is carrying a full page advertisement for CBD which breaches medicines, food and advertising law.

The ad, from Woods Supplements at https://www.woodshealth.com/, claims medicinal benefits for its product for joint pain, migraine, psoriasis, acne, depression, pain and inflammation.

While there is probably a substantial amount of truth in these claims, it is unlawful to make them without the product having a licence or marketing authorisation (MA) from the MHRA.

Why does this matter? I advocate for the medicinal use of cannabis in all its forms, so why would I object to any company making these claims?

Medicines regulation is essential, otherwise we will have people selling bottles of coloured water as a cancer cure.  Most CBD companies are responsible and understand it is unlawful to make medicinal claims, so irresponsible companies like Woods Supplements need to be stopped.  They are stealing business from responsible companies. So Woods Supplements is NOT a reputable company as it claims in its ad.

But despite the MHRA regularly flexing its muscles and talking tough, it does nothing.  There is simply no enforcement going on. Remember in 2016, it threatened to shut the entire CBD industry down over medicinal claims?  Most companies work extremely hard at considerable cost to stay compliant but the MHRA does nothing to support them.

As for the Daily Mail, scourge of truth about cannabis, profiting by illegal advertising, what should be done?  Well as these offences can result in a two year jail term and the publisher and editor of the Daily Mail are clearly complicit in them, when we can expect to see them marched from their desks in handcuffs?

Presumably the directors of Woods Supplements will be waiting at HMP Brixton to welcome them.

Written by Peter Reynolds

January 30, 2019 at 4:53 pm

Another Attack by Bureaucrats on CBD and its Consumers

with one comment

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.

********

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 Professionals. The Trade Association for the UK’s Cannabis, CBD and Hemp Businesses

with one comment

Cannabis Professionals (CannaPro) is the trade association for the UK’s cannabis, CBD and hemp businesses.

CannaPro will represent this fast-growing sector to the authorities, standing up to the Home Office, MHRA, FSA and Trading Standards, advocating for members’ interests, not acting as a government enforcer but as our members’ champion and to promote the development of the legal cannabis sector.

CannaPro will offer guidance and support to all businesses, helping them to navigate through law and regulations on drugs, medicines, food and cosmetics.

CannaPro will also launch a social media campaign, aiming to inform and educate the public about the benefits of CBD and the pitfalls.  The market is full of scammers, fake claims and snake oil salesmen.  Because of the historic stigma and fear around cannabis, government authorities are doing nothing, many people are misinformed and misunderstand.  CannaPro will explain the facts clearly and direct consumers to certified businesses which they can rely on.

Membership of CannaPro is without charge. All guidance will be published openly for everyone to benefit from. Free-of-charge support and answers to individual questions will be available online.

Businesses wishing to be certified by CannaPro will be reviewed for their products, trading standards, marketing and conduct. Certified companies will be entitled to display the CannaPro badge as a mark of quality, ethics and reliability.

Backed by CLEAR, the UK’s longest-established cannabis group with a network exceeding all other UK drugs policy groups combined, CannaPro members will benefit from CLEAR’s wide reach and influence with UK consumers.

Website: https://cannapro-uk.org

Facebook Group: https://www.facebook.com/groups/cannapro/

Written by Peter Reynolds

November 20, 2018 at 4:52 pm

The MHRA On CBD/Hemp Products And Its Relationship With Trade Associations

leave a comment »

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.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2014/11/human_orphan_001425.jsp&mid=WC0b01ac058001d12b

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2016/10/human_orphan_001832.jsp&mid=WC0b01ac058001d12b

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2015/08/human_orphan_001612.jsp&mid=WC0b01ac058001d12b

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)

https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk#application-process-all-procedures

(Licence application forms)

https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk#fees

(Fees)

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/313624/MHRA_fees_definitions.pdf

(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

 

Written by Peter Reynolds

October 18, 2018 at 12:41 pm

Statement Concerning The Cannabis Trades Association UK

with 3 comments

With regret, I have withdrawn my endorsement of and support for the Hemp Trade Association Ltd (HTA) trading as Cannabis Trades Association UK (CTA).

I created and founded CTA in September 2016. Since November 2016, HTA has traded under the CTA name with my permission and I was appointed to its advisory board.  That permission has been withdrawn from 18th October 2018 and I have resigned from the advisory board with immediate effect.

The reasons behind this are complex and great effort has been made to resolve differences and agree a way forward but this has proved impossible to achieve.  The reasons include but are not limited to:

Systematic Dishonesty

Over the two years of HTA’s existence many false claims have been made, in particular about HTA’s relationship with the MHRA and FSA, alleged exclusive stakeholder arrangements and HTA’s ‘authority’ to regulate the CBD market.  Further claims have been made by the chairman about his links with the security services, other Home Office staff, ‘inside information’ and unlawful use of government computer systems to run DBS and criminal record checks on prospective members. HTA’s reputation and that of its members was severely damaged by the chairman’s recent conduct in relation to the States of Guernsey, which resulted in official government repudiation of his claims, and his personal feud with a major CBD supplier which is not a member.

Misuse of Members’ Funds

Members pay membership fees primarily in order to have their interests effectively represented to government and the authorities. In practice, very little if any of this takes place and instead membership fees are used to finance the chairman’s ambitions to establish the Cannabis Products Directive (CPD) across Europe. While some members are supportive of the CPD initiative, it is not HTA’s purpose, nor is extending HTA’s operations outside UK.

Failure to Represent Members’ Interests

Instead of representing members’ concerns and interests to the authorities, HTA acts as an enforcer for the authorities. The chairman has confirmed in writing that HTA will “never go against” and will always “work with the authorities”. Members who have complained about lack of action against non-compliant CBD suppliers have been told to “stop bitching”.  Non-compliant CBD suppliers is the issue of principal concern to members but HTA has failed to take this up effectively. As a result, it is a positive disadvantage to be a member of HTA as members are subject to stricter enforcement and additional costs than non-members.

Maladminstration of HTA, a Company Limited By Guarantee

HTA was fomed as company limited by guarantee deliberately to place control in the hands of its members rather than its directors. Members have not been properly included in decisions.  They have been subjected to autocratic rule, prevented from obtaining proxy votes and resolutions at general meetings have been railroaded through without time for proper discussion. Protests by members at such treatment have resulted in them being ejected from discussion groups.

Bullying, Threats and Intimidation

A large number of reports have been received from former and current members detailing instances of such behaviour as coercion to join HTA or to comply with HTA policies.

Chairman’s Antecedents

Evidence has come to light which reveals that the chairman has a string of 28 dissolved companies behind him and a large number of oustanding county court judgements relating to those companies. He is also indebted to the company of another director of HTA in a substantial five figure sum for a period in excess of two years with no effort made to commence repayment. As a result that director has now resigned.

Unlawful Restrictions on Members

Legal advice has been received which confirms that HTA has been exercising unlawful restrictions on members preventing them from trading freely.  This supports allegations that have been published accusing HTA of running a ‘protection racket’.

 

 

 

Written by Peter Reynolds

October 16, 2018 at 2:48 pm