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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘industrial hemp

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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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

Report Of Meeting With MHRA On Regulation of Cannabidiol (CBD).

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Tom Whettem, Cannabidol; Anthony Cohen, Elixinol UK; Tom Rowland, CBD Oils UK; Karl Spratt, Hempire; Peter Reynolds, CLEAR Cannabis Law Reform; Mike Harlington, GroGlo Research & Development

Tom Whettem, Canabidol; Anthony Cohen, Elixinol UK; Tom Rowland, CBD Oils UK; Karl Spratt, Hempire; Peter Reynolds, CLEAR Cannabis Law Reform; Mike Harlington, GroGlo Research & Development

Yesterday, 3rd November 2016, six delegates from the UK Cannabis Trade Association (UKCTA) met with Medicines and Health Products Regulatory Agency (MHRA) representatives at the agency’s headquarters in Victoria.

We were courteously received. The meeting was cordial, productive and enabled both sides to clarify their positions and better understand each other’s perspective.

In summary, in my opinion, there is no immediate threat to to CBD consumers or businesses. The MHRA has now extended until 31 December 2016 the date by which businesses should voluntarily comply with its opinion, either by withdrawing existing products from the market, or by complying with necessary regulation. Thereafter, the next step would be to begin the process of statutory enforcement.  This would take a matter of some months and I believe, even were this to be started, we are looking at more than a year before any impact would be felt.  More importantly, based on the meeting, I think the outcome is likely to be that we can negotiate a form of regulation that will work for everyone.

The MHRA team was led by Gerald Heddell, Director of Inspection, Enforcement and Standards. Also present were regulatory advisors David Olszowska and Chris Groutides; Dr Chris Jones, Manager of the Medicines Borderline Section; Greg Markey, Senior Medical Assessor and Malcolm Evans, Head of Patient, Public and Stakeholder Engagement.  Mr Heddell opened the meeting by thanking us for bringing to the agency’s attention just how many people are using CBD, some for quite serious medical conditions.

The MHRA set out its reasons for its opinion that products containing CBD used for medical purposes are medicines.  Greg Markey explained the mechanisms of action and pharmacology that had been considered and Dr Jones explained that the Borderline Section existed to deal specifically with products where it was difficult to determine whether they should be regarded as medicines or food supplements.  The example was offered of vitamin C where if it was being used to treat scurvy then it was clearly a medicine, whereas if it was used to supplement a normal diet it could be regarded as a food supplement.  We were able to explain that all so-called CBD products on the market, with the exception of crystals, are actually whole plant extracts from low-THC cannabis, usually industrial hemp.  We pointed out that the growth in the CBD market had been driven by people seeking the therapeutic benefits of medicinal cannabis which until now had been denied by the British government.

The nub of the issue is really the nature of the condition for which CBD is used.  The MHRA has already issued orphan designations for CBD for Dravet Syndrome, graft versus host disease and perinatal asphyxia.  Orphan designations are granted where the benefit of a medicine can be recognised even though necessary regulatory processes have not yet been completed.  It is important to understand that this is what has guided the MHRA’s opinion, viewing CBD as a medicine for very serious conditions.

We discussed a range of options whereby, at the lowest level, CBD products could continue to be marketed as a food supplement.  For minor conditions, not requiring medical supervision, it may be possible to obtain a Traditional Herbal Registration (THR) at a cost of a few hundred pounds.  A third option is a ‘Specials’ exemption where a doctor or prescriber has specified and taken responsibility for an unlicensed medicine for a particular patient.  Finally, the highest level is a Marketing Authorisation (MA) where the costs including fees and clinical trials are probably a minimum of £250,000.

It is our view that CBD products should be regulated at all these different levels dependent on the purpose for which they are used and the concentration at which CBD is present.  We have agreed that we will write formally setting out these proposals and the MHRA will respond accordingly.

The UKCTA and a number of individual companies have now obtained legal advice including counsel’s opinion.  We have shared this with the MHRA and formal solicitors letters have already been served.  In essence, the advice is that the MHRA has failed to comply with its own guidelines and requirements in issuing its opinion to CBD suppliers and that any requirement to comply with regulations would have to be addressed on an individual, product by product basis.

So, all in all, we believe the meeting was a success.  We demonstrated that the new trade association is to be taken seriously and that we will work constructively with the agency.  There was visible surprise at the level of professionalism we presented, particularly with the legal advice we had obtained.  I believe we convinced the MHRA that we could establish a set of rules, guidelines and standards that would enable the industry to comply with its requirements.

The CBD market in the UK is presently worth several million pounds a year.  If it is to continue to grow, provide safe, effective products for consumers and patients and job security for its workers, then we need to establish UKCTA so that it effectively represents the whole industry.  We need to show that we are responsible, we care, we are professionals and we are ready to put our collective head above the parapet as a legal, ethical and regulated industry.

The LCA Leadership Election

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The ballot papers have been mailed to members today.  The candidates are Stuart Warwick and myself.  Voting closes a week today.  The result will be announced shortly afterwards.

Peter Reynolds

Dear LCA member,

I am seeking election as leader of the Legalise Cannabis Alliance.

I have been campaigning for an end to the prohibition of cannabis for more than 30 years.

If elected, I can promise you radical change in the way that LCA goes about its business. We will launch a new campaign based around the theme: REFORM, REGULATE and REALISE.

That is REFORM the law to end prohibition, REGULATE production and supply based on facts and evidence and REALISE the huge benefits of the plant both as medicine and as a £10 billion net contribution to the economy.

This will be a tightly focused campaign aiming for the urgent availability of cannabis for those who need it as medicine and a properly regulated supply chain for the millions of British citizens who use it recreationally. That means we will take the business out of the hands of criminals, allow commercial growers to produce the plant under properly regulated conditions and permit small scale personal cultivation of up to six plants.

We will advocate sales of cannabis through licensed outlets such as tobacconists and/or coffee shops to adults only. It would remain a criminal offence to supply cannabis to under 18s. We accept that cannabis should be taxed, partly to cover the costs of the regulatory system and a health advisory service but also so that the entire country will benefit from bringing this huge market out of the black economy. Based on research by the Independent Drug Monitoring Unit and the Transform Drug Policy Foundation we estimate that with reductions in law enforcement costs and new tax revenue, there will be a net contribution of approx £10 billion to the UK exchequer.

We will not be diverted by peripheral issues such as the many uses for industrial hemp, although we will be glad to see progress in that area. We will run a campaign focused on achieving practical change, not promoting a philosophy. That means that our main concern will be to educate and influence MPs and get our message across in the media. MPs are the only people who can change the law and it is through the media that we can influence voter opinion so we will deal with them on their terms, in Westminster, in newspapers and television studios. We will bring a new professionalism to this issue and demand the attention and respect that our proposals deserve.

The prohibition of cannabis is unjust, undemocratic and immoral. Most cannabis users are reasonable, responsible and respectable people and I will demand our right to be heard and treated fairly.

I shall stand for parliament in every by-election and in the next general election on this single issue. Being realistic, we do not expect to win a seat but we will put cannabis back on the political agenda and we will be taken seriously. No longer will we allow the Daily Mail or other media to publish lies and propaganda uinchallenged. No longer will we allow prohibitionists like Debra Bell and Peter Hitchens to misinform and promote scare stories without any balance.

I want to transform the LCA into a professional, effective campaign that will achieve results. I believe that I am the right man for this job. Please vote for me. Vote to REFORM, REGULATE and REALISE.

My website at http://www.peter-reynolds.co.uk contains a wealth of information about cannabis and many articles that I have written on the subject. If you want more detailed information about me and what I stand for, that is the place to look.

Thank you for taking the time to read this.

Peter Reynolds

Stuart Warwick

Dear Member,

As one of the candidates seeking election for leadership of the LCA, I’ve been asked to write a short letter outlining my plans for the direction and actions I’d like to see the LCA take.

As Leader I would not seek to limit our campaign to the medical and recreational issues only (although I believe this should be our focus) but use the plethora of other applications that cannabis has in industry to gain support from as wide a demographic as possible.

I intend to campaign for legalisation, regulation & taxation.

Legalisation, done properly would remove the cannabis market from the hands of criminals and terrorists and open it up to legitimate businesses & entrepreneurs, giving the substantial profit back to society.

Regulation will help prevent dangerous contamination, ensure good quality and be more effective at keeping it out of the hands of children.

Taxation to put some of the profit back into the country – everyone benefits.

I think licensed outlets and growers is what we should be aiming to achieve. Licensing should cover not only the supply of cannabis but should also cover growing set-ups to ensure electrical and fire safety as this is a known hazard with some badly fitted installations. This would allow local growers to provide more variety in outlets, allowing users to clearly identify the strain that suits their needs the best.

Licenses should be available to cover a wide range of grow sizes to encourage both local and national business opportunities.

I think fact-based policy is a must, with genuinely unbiased research. To base policy purely on knee jerk emotional and moral arguments while ignoring scientific research is unjust and unproductive.

We know there are people in power who understand this but are forced to repeat the same prohibition mantra.

We need to let people know that if they decide to make a stand against prohibition we will be there to back them up. They will not want to make a move unless they know that when they do, they are not left hanging, We just have to give them the nod and be ready when they do.

By standing for elections, I hope to challenge not only my local MP’s and the other candidates but also policy on a national level. As leader of the LCA I hope to unite all of the voices in our community to achieve just that.

I have 2 sites that I have used to promote my ideas so far. Feel free to visit them, although there are some very early attempts on there, so quality isn’t always great, sorry.

http://www.youtube.com/user/NovictimNocrime08

http://www.facebook.com/pages/Hunar-for-Prime-Minister/238421977309

Thanks for your time – , this wasn’t as easy to write as I thought it would be!

Regards

Stuart Warwick.