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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘Cannabis Trades Association UK

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.

 

 

 

 

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Talking Cannabis With the MHRA

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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.

A Significant Day For Cannabis Law Reform In The UK.

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This Thursday past, 25th May 2017, was the inaugural general meeting of the Cannabis Trades Association UK (CTAUK).

While this may not excite your average cannabis consumer too much, it represents a very important, even momentous occasion in our progress towards a regulated cannabis market.  Anyone spotting our meeting room would have seen it as just another group of business people in a day long meeting with Powerpoint presentations, flipcharts and gallons of coffee and mineral water.  GSK were just down the corridor, an insurance company was next door, it all looked very corporate and pretty boring.

This is exactly the point.  We are bringing cannabis into the mainstream, overcoming the stigma, making it respectable.  The idea that the Holiday Inn at Gatwick would have signs pointing to a ‘cannabis’ meeting would have been unthinkable until very recently.

Of course, CTAUK is concerned only with the legal cannabis trade so, in the main, that means CBD products but membership has started to expand rapidly.  In the coming weeks we anticipate we will be joined by UK hemp growers and a very important new medical cannabis research consortium.  Within the next few months we expect almost every significant player in all aspects of the UK cannabis market to be part of the association.

So, although at first glance, this boring business meeting may not excite CLEAR members and followers, it heralds the dawn of a new age.  Cannabis is coming out of the shadows. Reform is just round the corner.

Twenty years ago similar meetings took place in California, fifteen years ago similar meetings were held in Canada, Israel, the Netherlands and other US states.  Just three or four years ago they were happening in Colorado, Washington, Oregon, etc.  The UK’s time has come. Not a joint was rolled, not a bong was lit, there wasn’t a vapouriser or a hash cookie to be seen.  No longer are we playing at this, it’s now become serious.

Written by Peter Reynolds

May 27, 2017 at 4:20 pm

How To Campaign For Cannabis Law Reform Under A Theresa May Government.

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  • Lobbying Parliament

  • If the Government Won’t Regulate Cannabis Then We’ll Do It For Them

  • The CBD Market

  • Medical Cannabis

  • Educating And Influencing Researchers

For cannabis and drugs policy reform, out of 650 MPs, there could not have been a worse person to seize power than Theresa May.  There are a few who come close on both Tory and Labour benches but no one who has such a long record of bigotry, denial of evidence and refusal even to consider the subject.

Senior Tory MPs For Cannabis Law Reform

To be fair, I am a member of the Conservative Party, which to many people involved in the cannabis campaign is a mortal sin but my advocacy is based on science and evidence, not tribalism or wider politics.  In any case, though many find this fact hard to accept, there has always been more support from Tory MPs than Labour. Highly influential and senior Tory MPs such as Crispin Blunt, Peter Lilley and Dr Dan Poulter are powerful advocates for reform. I firmly believe that the only sustainable route to legalisation is commercialisation and the left wing, nanny state, anti-business types are already pushing the ‘Big Cannabis’ scare stories.

So what can we do and what are we doing to advance our cause in these dark days?  Theresa May always has been secretive, inaccessible, unresponsive and entirely disinterested in any opinion except her own.  How can we possibly make any progress with a PM who has already shown she is prepared to cover up or falsify evidence and defines herself by her belief in a supernatural power?

There is more support for cannabis law reform in Parliament than ever before.  It is now official policy of both the Liberal Democrats and the Scottish National Party. The support from Scotland is far more valuable than that from the discredited LibDems.  With the added factors of Brexit and Scottish Independence, the SNP is in a powerful position to advance its policies.  Also, in Ireland, both north and south, public support for medical cannabis reform is exploding.  Michelle O’Neill, SinnFein’s new leader, has pledged medical cannabis reform if she is re-elected (though she has no power to do so!).  Her negotiating position is immensely strong now that the problems at Stormont, the rise of Sinn Fein and the Brexit factor all combine to make a united Ireland a real possibility.

During the coalition government from 2010 to 2015, few doors were closed to us.  Over that period, CLEAR conducted more meetings with ministers and senior politicians than the entire UK campaign had achieved in 50 years.  Because we had support from the LibDems, and introductions from the Deputy Prime Minister, even Tory ministers were ready to see us, even if they were merely paying lip service.  That all stopped with the election of a majority Conservative government and after Cameron stepped down the doors were slammed in our faces, bolted and double-locked.  The campaign has been in the doldrums ever since. Or has it?

The last major achievement of the last few year’s campaigning was the release of the APPG report on medical cannabis in September 2016.  Alongside it, Professor Mike Barnes, CLEAR advisory board member, published his review ‘Cannabis: The Evidence for Medical Use‘.  To all impartial and reasonable observers, these documents should have initiated positive government action towards reform, even if it was only very limited in scope.  But no, Theresa May didn’t leave it to Amber Rudd, her successor as home secretary, she stepped straight in herself on the day of publication, before she could even have read it and dismissed the report out of hand.  This echoes the apocryphal story of James Callaghan, then PM, throwing the 1969 Wooton Report in the bin without even opening it.  Such is the inertia and prejudice that has not softened at all amongst the bigots despite 45 years of science and research proving that there are better, safer, more beneficial options available on cannabis.

Lobbying Parliament

For now, individual lobbying of MPs is our only route to power. Over the years we have refined our approach to this and we know what works.  Getting into ping pong correspondence with an MP is a waste of time.  An initial letter or email needs to be followed up with a face-to-face meeting and a determined focus on getting a tangible result. What sort of result you should look for depends on your circumstances but getting your MP to arrange a meeting with a government minister should be your goal.

If you’re a medical user then you’ll want to meet a health minister, preferably the Secretary of State, if not a junior minister or perhaps an advisor to the Department of Health.  Work with your MP to achieve the best result you can.  Your MP doesn’t necessarily have to agree with you about cannabis but they should facilitate your communication with government, that’s their job. If you’re more interested in the economic or social benefits to be gained from reform, you could ask for an introduction to the Chancellor, a treasury or business minister, or someone at the Cabinet Office who is involved in policy development.  CLEAR can usually provide someone to accompany you on meetings but this must be arranged in advance and agreed with your MP or whoever your appointment is with.  Alternatively, we can provide advice over the telephone on how to approach the meeting, what to ask for and what evidence or supporting material to take with you.

If the Government Won’t Regulate Cannabis Then We’ll Do It For Them

With an intransigent government that does it all it can to evade engagement on this issue, there is more that CLEAR is already doing.  If the government won’t take responsibility and regulate cannabis, then step by step we are going to do it for them.  Someone has to, there is far too much harm and suffering caused by present policy.

The CBD Market

Through 2016 the CBD market in the UK really began to take off.  These are products derived from industrial hemp, grown legally under licence that offer many of the therapeutic benefits of cannabis.  They should, in fact, be more accurately termed low-THC cannabis as apart from crystals and a few, rare examples of isolated CBD, they are whole plant extracts and contain all the cannabinoids, terpenes, flavonoids and other compounds found in the plants from which they are made.  Therefore they offer many of the ‘entourage effect’ benefits but with very low levels of THC.  It was obvious though that this market was heading for problems.  More and more dubious suppliers were starting up, many making brazen claims for the medical effects and benefits of their products and many without any product testing, quality assurance or honest customer service.  The law was then and always has been crystal clear, you cannot make medical claims for a product without it being properly licensed or regulated.  Inevitably, in June 2016 the MHRA stepped in and sent threatening letters to a number of CBD suppliers.

CLEAR took the initiative.  We wrote to the MHRA requesting a meeting.  We engaged with the leading CBD suppliers and our advisory board members Professor Mike Barnes and Crispin Blunt MP were quickly on the case.  The story has already been extensively reported but now, nearly a year on, our efforts are coming to fruition. We led the approach to the MHRA and in the process created what is now the Cannabis Trades Association UK (CTAUK).  It is now recognised by the MHRA, it has established a code of conduct and it is now the gold standard of quality, ethics and legality that can give anyone buying CBD products real peace of mind.  There are still cowboys out there, making false claims, selling products that offer no real benefit and even endangering their customers with products that are illegal under the Misuse of Drugs Act 1971 or the Psychoactive Substances Act 2016.  Now though, customers can go to the CTAUK website and choose a supplier that is operating legally, ethically and within the regulations that the industry itself has established.  We expect the MHRA very shortly formally to endorse CTAUK members as legitimate suppliers of CBD products as food supplements.

Medical Cannabis

Professor Nigel Mathers, Honorary Secretary, Royal College of GPs

Neither can we accept the government’s irresponsible and cruel policy towards people who need cannabis as medicine. So CLEAR has taken a further initiative. After Theresa May’s dismissal of the APPG report, we approached the Royal Colleges of medicine.  We pointed out that whatever the government might say, around one million people are using cannabis as medicine.  Doctors have a duty and an ethical responsibility to educate themselves on the subject and be able to provide properly informed care to their patients.  Our efforts have borne fruit.  Professor Mike Barnes and I have worked with Professor Nigel Mathers of the Royal College of GPs (RCGP).  We will be producing a draft set of guidelines on medicinal cannabis for GPs which will go the next meeting of the RCGP Council and is planned for publication in June 2017.  If the government won’t do it, we will and the medical profession agrees with us.  This will be the greatest practical advance ever made in medical cannabis in the UK.

Educating And Influencing Researchers

Dr Musa Sami, Peter Reynolds

The UK is the most prolific source of research into the harms of cannabis, particularly the tenuous links between cannabis and psychosis.  Despite dozens of studies, mainly from the Institute of Psychiatry at King’s College Hospital, this has never been shown to be any more than statistical correlation.  Most of these studies are confounded by tobacco use but the latest work from Professor Sir Robin Murray and his team shows an even stronger correlation between tobacco and psychosis than cannabis.

Across the world, UK scientists have become notorious for this scaremongering which seems little different from the ‘reefer madness’ hysteria.  To be fair, much of this is down to the UK media which has barely advanced since the 1930s in its reporting.  It provides the environment in which researchers are able to gain funding for research into cannabis harms but hardly ever for cannabis benefits.

CLEAR is now working with the Institute of Psychiatry to develop a new and more balanced way of surveying the effects of cannabis.  Dr Musa Sami has asked us to advise on the construction of a questionnaire on which the Institute will base its future work.

WARNING. So-Called ‘Indica’ CBD Products Are Illegal.

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Any CBD products marketed in the UK as derived from ‘indica’ cannabis are illegal and you could be prosecuted for possession, importation or supply as with any other form of prohibited cannabis.

The situation which started last October with the MHRA trying to shut down marketing of CBD products arose because of irresponsible, cowboy companies making medicinal claims about their products.  It was well understood by all professional CBD companies that this would cause problems and indeed it has. Only the intervention of CLEAR and the formation of the Cannabis Trades Association UK has saved the market from collapse.

We are deeply concerned to see that at least one company is now advertising some CBD products as derived from indica cannabis grown in the Netherlands. This is unlawful.  The only cannabis strains that may be grown as industrial hemp and therefore used to produce exempt products are on the EU approved list. There are no indica strains.

You have been warned.  Please do not endanger yourself.

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Written by Peter Reynolds

January 8, 2017 at 5:54 pm

The Facts About CBD In The UK. December 2016.

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On 3rd October 2016 the Medicines and Healthcare products Regulatory Agency (MHRA)  issued notices to a number of CBD suppliers stating that cannabidiol (CBD) was being designated as a medicine and that sale of all CBD products must stop within 28 days, ostensibly by the 1st November.

A lot has happened since.  Most importantly, the Cannabis Trades Association UK (CTAUK) has been established to represent the industry and protect the interests of CBD consumers but there remains great confusion as to the legal status of CBD and whether these products will still be available.  This article sets out the facts and explains how the market is likely to develop. The most important point is that there is no need for panic.  There will be some changes but no one will lose access to CBD for the foreseeable future.

Background

Through the summer of 2016, rumours and half stories had been swirling around about the MHRA taking action on CBD. When the news broke it caused real panic, both for the thousands of people using CBD products and for those working in CBD businesses.  It looked like a real disaster for everyone. On the one hand the government, through the MHRA, was finally recognising the truth that CBD and cannabis are medicine.  On the other, it seemed that the whole industry was going to be shut down, businesses would close, people would lose their jobs and, most importantly, those who rely on CBD products for maintaining their health were going to suffer real harm.  If CBD was going to be regulated as a medicine it would require the investment of hundreds of thousands of pounds to obtain the necessary authorisation to put any products on the market.

It quickly became clear that the MHRA was unprepared for the reaction it received. Its switchboard was swamped by worried callers.  Social media exploded with the inevitable Big Pharma conspiracy theories and even the national press covered the story demonstrating that medicinal cannabis is now an issue of mainstream interest.

ctauk-logoCLEAR took action to rally our friends and colleagues in the legitimate cannabis business and this led to the creation of CTAUK.  The same day the news broke we wrote to the MHRA notifying it of the formation of the trade association and seeking a meeting.

On 13th October, the MHRA issued a statement on its website explaining its actions.

CLEAR’s advisory board members, Professor Mike Barnes issued a statement to the media and Crispin Blunt MP wrote to Dr Ian Hudson, the chief executive of the MHRA.  Even the British Medical Journal covered the story.

On 19th October the MHRA finally confirmed a meeting with the CTAUK to take place on 3rd November.  On 21st October, Dr Ian Hudson replied to Crispin Blunt’s letter.  CTAUK appointed solicitors who in turn obtained counsel’s opinion and on 28th October a solicitor’s letter was sent to the MHRA formally objecting to its action. On 1st November the MHRA updated its statement on its website softening its position by claiming that its notices to CBD suppliers were merely its “opinion” that it should be designated as a medicine.

The meeting took place at MHRA headquarters on 3rd November.  It was cordial and constructive and on 16th November CTAUK wrote to the MHRA formally proposing a system for the regulation of CBD.  Essentially this suggests that CBD products with daily adult dosage of up to 200mg should continue to be marketed as a food supplement.  Products with a daily adult dosage of up to 600mg would require a Traditional Herbal Registration and higher dosage products would require a full Marketing Authorisation.  We await the MHRA’s response.

The MHRA has since written to CBD suppliers requiring them within seven days to provide samples of their products along with various information about them.  However, CTAUK has been able to negotiate that our members have until the end of January to comply.  This is excellent news and demonstrates recognition of the association by the MHRA.

Is CBD Legal In The UK?

Yes, CBD is not a controlled drug under the Misuse of Drugs Act 1971, neither is it covered by the Psychoactive Substances Act 2016.  As long as it is marketed as a food supplement without any medicinal claims it is perfectly legal to sell and to buy.

Is The MHRA Going To Ban CBD?

No, the MHRA will have to assess each product on its own merits, particularly taking into account how it is marketed and whether any claims of medicinal benefit have been made.

What Will Happen In the Future?

We hope that the MHRA will accept our proposals for a system of regulation, meaning that only the highest dose products, such as GW Pharma’s soon-to-be- released ‘Epidiolex’ will require a full Marketing Authorisation.  However, even if the MHRA tries to take formal action about any other products, this is going to take many months and probably a much as a year before anything changes.  We remain confident that we will come to an agreement that will enable everyone to continue to access CBD products.