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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘FSA

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.

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.

A Conspiracy Of Shabby, Venal Thieves

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It is truly pathetic isn’t it to see these pathetic, small men grubbing around in the gutter to try and save themselves?crosby

“Sir” James Crosby runs HBOS into the ground then bails out at the last minute to become vice-chairman of the FSA.  You really couldn’t make these things up unless you were writing a Mafia or organised crime novel.

He becomes one of the Prime Minister’s cronies and overpaid advisors but then is caught out by the whistleblower who he sacked.

They are tumbling like nine pins now but who is still getting away with it?  Who has been in post for longer than any of these bank robbers?  Who was responsible for settiong up the regulatory system that has proved to be corrupt and incompetent?  Gordon Brown, the worst, most corrupt, most incompetent, most myopic, most venal of them all.

There is no more time.  This tyrant must be overthrown now.  All these knighthoods must be withdrawn.  Criminal investigations and personal bankruptcies must follow.

Written by Peter Reynolds

February 11, 2009 at 12:16 pm

Now Is The Time For Recrimination – Before They Get Away!

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I am delighted to see that The Times and now, this morning, Andrew Marr, are joining me in calling for bankers to be brought to account.  The “Thunderer” even said that “heads must roll”.  Roll they must, many of them, until the baskets are full and the streets of the City are running with blood.  The executions should take place in public so that the greedy thieves and scoundrels who have pillaged our economy can be subject to public humiliation and villification as they meet their doom.

I will carry the metaphor no further but the dread and fear that should now be ruining the weekends of the chief executives and chairmen of the banks should be little different from that of the French aristocrats awaiting the guillotine.

We must insist that those individuals who have taken multi million pound bonuses from banks, funds and all forms of financial institutions that are now insolvent must be able to justify the payments in the same way that a director of a small business that had gone bust might have to explain his drawings to a liquidator.  In many instances money will have to be recovered.

Whether guilty of personal wrongdoing or not, the chairmen, chief executives and non-executive directors who have presided over this catastrophe must take responsibility and go!  The same sanction must fall on the heads of the regulators.

Lord Adair Turner, Chairman, and Jon Pain, Managing Director Retail Markets, who both accepted poisoned chalices at the FSA only last month may have some excuse but the rest of the board should be summarily dismissed, not even allowed to resign.

Gordon Brown and Alistair Darling have been extraordinarily unequivocal in many of their statements this week.  We want to know much, much more detail about the “mechanisms” that will put in place to restrain the banks in future.   If the taxpayer has saved your business then in future you will not be gambling on ludicrously complex financial products that only you understand and for which you set the rules.  We prefer that you lend £100,000 to a small business rather than £10 million to a virtual roulette wheel.

“There a million stories in the Naked City”.  Now is the time for “le dénouement”.