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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘CBD Oils UK

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.

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UK Cannabis Trade Association Meeting With MHRA This Week.

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MHRA Headquarters

MHRA Headquarters

After all the speculation, many misleading and false reports and a plethora of attempts to interpret the MHRA’s actions concerning cannabidiol (CBD), this week the chips are down.

On Thursday 3rd November, at MHRA headquarters in Victoria, six representatives of the UK Cannabis Trade Association (UKCTA) will sit down with those responsible for the agency’s statements on CBD.  We will be armed with counsel’s opinion on the legality of the MHRA’s action but most importantly we hope to secure clarification for those who rely on CBD as a food supplement.  We will publish details of the outcome of the meeting as soon as we can.

Those attending as UKCTA representatives are:

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

Fast Developing News On CBD And Medicinal Cannabis.

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cbd-molecule-spoon-oil

We learned today that the Medicines and Healthcare products Regulatory Agency (MHRA) has started issuing letters to CBD suppliers advising them that CBD is being designated as a medicine and that sale of CBD products must stop within 28 days.

This will be alarming news to many people.  However, it is a complex situation which has some positive aspects to it.  In the short term, if you are already using CBD products, you would be well advised to stock up as much as you can afford.

CLEAR has been aware of this possibility for several weeks and consequently we have been working with leading CBD suppliers and licensed producers of both low and high THC cannabis on establishing the UK Cannabis Trade Association (UKCTA).  We are already in correspondence with the MHRA seeking to represent all stakeholders, to establish a consultation process on regulating CBD products and to protect the interests of producers, suppliers and consumers.

lovehemp-oilWhat these MHRA letters mean is that for CBD to be sold in future, suppliers will have to obtain either a ‘marketing authorisation’ or a ‘traditional herbal registration’ from the MHRA.

A marketing authorisation can be fantastically expensive, requiring an initial application fee of £103,000 and full scale clinical trials demonstrating safety and efficacy.

A traditional herbal registration is not as expensive, around £6,000 but relies on the product having been “traditionally used to treat the stated condition for a minimum of 30 years, 15 years of which must have been in the European Union (EU).”  It also requires “scientific evidence relating to the safety, quality and traditional use of the herbal product”. It is far from certain that CBD will qualify for this scheme and in any event registration is only granted if the medicine is used for minor health conditions where medical supervision is not required.

CBD is not a ‘controlled drug’ and is not prohibited but most CBD products are in fact low-THC, whole plant extracts derived from industrial hemp, legally grown under licence.  So yes, they are a legal form of cannabis and, of course, according to the Misuse of Drugs Act 1971, cannabis has ‘no medicinal value’.  So, you may well ask, how can the MHRA classify it as a medicine?

MHRA Headquarters

MHRA Headquarters

This is just the first of many complications for the MHRA, the Home Office and the government. Potentially, it could be very positive as it could make the government acknowledge the medicinal value of cannabis and, in effect, force the beginning of cannabis regulation.

It has been certain for some time that many of the CBD products presently on the market are unlawful because they contain levels of THC and CBN which exceed the limits stated in the Misuse of Drugs Regulations 2001. Some CBD suppliers have taken a head in the sand attitude to this, even in some cases foolishly promoting the THC levels in their products. This led to CLEAR removing its  endorsement of one supplier earlier this year and recommending CBD Oils UK instead.

epidiolexThe path ahead is uncertain. The UKCTA is pressing for an urgent meeting with the MHRA. Apart from the advice to consumers to stock up, these will be very worrying times for CBD suppliers and their employees. Another factor is that GW Pharmaceuticals is very close to applying for FDA approval in the USA and an MHRA marketing authorisation for its CBD epilepsy medicine, Epidiolex.

CLEAR, the UKCTA and leading CBD companies are working together to clarify and progress this situation.  We will keep you closely informed of developments.

Facebook Says Calling A Black Man A Baboon “Doesn’t Violate Our Community Standards”.

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On the other hand Facebook says that recommending a responsible, reputable supplier of verified, lab-tested, legal CBD food supplements does violate its standards.

lovehemp-40-cbd

LoveHemp 40% CBD Oil

At a guess (because you can’t get a straight answer from Facebook about anything), the issue is “We prohibit any attempts by unauthorised dealers to purchase, sell or trade prescription drugs, marijuana, firearms or ammunition.”

Now CBD food supplements are fully legal products.  They are not prescription drugs.  True, CBD is present in cannabis but it is also found in many other plants.  So it’s difficult to understand what the problem is – but not as difficult as getting a coherent answer from Mr Zuckerberg and his disciples.

For the ‘offence’ of recommending a CBD supplier your page gets a seriously heavy warning to all page admins, a threat of permanent deletion and I, as the author of the post sharing a link to CBD Oils UK, was banned from Facebook for 30 days.  Such is the reality of living under the diktat of the unaccountable, overbearing, bureaucratic monolith that Facebook has become.

However, when some vile American Trumpoid leaves a comment on the CLEAR page calling a black man a baboon, that’s just fine and dandy.

baboon-comment

It is time that Facebook was placed under serious regulation for its unfair and oppressive trading practices.  It has become so ubiquitous that it now has a responsibility that goes beyond any independent business.  It is virtually impossible for individuals and small businesses to operate without a Facebook account.  It should be subject to strict standards and forced to comply with fair practices.

I’m all for free enterprise but it’s time to slam Facebook hard for its tax dodging, its failure to take responsibility for publishing abuse and its unfair treatment of users and advertisers.