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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘FSA

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

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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.

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Written by Peter Reynolds

February 10, 2019 at 2:19 pm

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

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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

Statement Concerning The Cannabis Trades Association UK

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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

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

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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.

Hoodwinked By The Banker Robbers

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That’s you and me.  We’re the one’s who’ve been conned and cheated.  Gordon, Alistair, the FSA – they’re all either criminally negligent incompetents or co-conspirators.

Absolutely nothing has changed in the world of banking.  Is any more proof needed that the people running banks are liars, cheats and thieves?  Aside from the systematic extortion of the taxpayer, none of the promises about lending to the real ecomony or reining in their depraved “culture” have been kept.

Spineless assurances will not do anymore.  The government must radically overhaul the terms of the licences under which banks operate.   Real leadership and responsibility is needed now to ensure that this happens  before the end of the year – not after months or years of consultation and behind the scenes corruption.

Businesses that want to enjoy the huge privilege of serving UK consumers as bankers must be held to a strict and rigidly enforced rulebook.   No participation in casino banking, minimum levels of lending, maximum levels of interest rates and charges, a “right to borrow” for those businesses and consumers who meet straightforward criteria.

These steps are essential to re-establish the operation of an effective market economy.  In a world which has become entirely monetised we can no longer be subject to the rapacious and avaricious behaviour of those who run the money business.