Peter Reynolds

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MHRA Confirms Meeting With CBD Industry Representatives.

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Today, the Medicines and Healthcare products Regulatory Agency (MHRA), has arranged a meeting with representatives from the UK Cannabis Trade Association (UKCTA) to discuss its designation of cannabidiol (CBD) as a medicine.

mhra-logoA request for a meeting was was first made in writing on 20th September 2016, when the possibility of the MHRA’s action was still little more than a rumour.  Nearly six weeks later, after repeated requests, complaints and lobbying from many companies, individuals and MPs, the meeting has been fixed for 3rd November 2016.

The main aim of the meeting will be to discuss interim arrangements for people currently using CBD as a food supplement.  Clearly, we will also address concerns over the impact of this decision on many small businesses and the people they employ.

Written by Peter Reynolds

October 19, 2016 at 5:08 pm

The Man From The MHRA. Endangering Public Health With Precipitate Action On CBD.

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Dr Ian Hudson, Chief Executive, MHRA

Dr Ian Hudson, Chief Executive, MHRA

The Medicines and Healthcare Products Regulatory Agency (MHRA) apparent decision to designate cannabidiol (CBD) as a medicine is an unholy mess and has been handled about as badly as it is possible for a government agency to deal with a matter of public safety.

The desk of Dr Ian Hudson, the Chief Executive, will shortly be groaning under the weight of correspondence from MPs asking him to explain exactly what is going on.  We know that the MHRA call centre has been swamped with calls from people desperate for information and in fear that they will be cut off from supplies of the food supplement that is so important for their health.  Many are now being told that no final decision has been taken and everyone is in limbo waiting for some coherent response.  We say “apparent decision” because nothing is clear, no public statement has been issued and anything you have seen in the press is from responses to individuals.

Crispin Blunt, the Conservative MP and a member of the CLEAR advisory board has written to Dr Hudson urging him to meet with CLEAR, Professor Mike Barnes and the newly-formed UK Cannabis Trade Association to discuss what interim arrangements can be put in place.  Tens of thousands of people’s health has been placed in jeopardy and not for trivial matters.  People suffering from serious conditions such as epilepsy, chronic pain, anxiety and Crohn’s Disease have come to rely on CBD products to maintain their health. There are also hundreds of jobs in danger at suppliers providing CBD to the UK market.

We know that many CLEAR members have asked their MP to write to the MHRA seeking clarification.  In Crispin Blunt’s letter he goes further.

“The decision to designate CBD as a medicine is directly contradicted by the Home Office’s position that cannabis has no medicinal value.  It is vital that we do not let this anomaly in government policy cause harm to people’s health. I should be grateful, therefore, if you could explain how the MHRA reached its decision, the consultations it undertook, which specific regulatory regime it proposes for these products and whether the continued supply of these products, regulated as food supplements, can be ensured until such time medicinal marketing authorisations can be obtained.”

CLEAR has received a holding response from the MHRA indicating that a meeting will be arranged and that we will hear by the end of this week. Responsible action from a government agency that is supposed to protect, not endanger public health is urgently needed.


Professor Mike Barnes Speaks Out On the CBD Ban.

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Professor Mike Barnes, Scientific and Medical Advisor to CLEAR

Professor Mike Barnes, neurologist, scientific and medical advisor to CLEAR Cannabis Law Reform, has issued the following statement.

“It is encouraging that the MRHA is recognising that CBD has medicinal value but it is concerning that many people benefitting from CBD now will suffer in the short term as good quality manufacturers have to stop production pending MRHA approval” 

A redacted copy of the letter now being sent to all CBD suppliers can be seen here.

For some weeks, rumours and half stories have been swirling around about the MHRA taking action on CBD.

Initially a number of suppliers were warned about making medicinal claims, even testimonials from satisfied customers were ruled as unlawful.  Anything which suggested that CBD was a medicine or provided therapeutic effects was ruled out under UK medicines legislation.

Responsible CBD suppliers have known this for some time and were scrupulous in ensuring no such claims were made, even including disclaimers explicitly stating that their products were not for medical use. But as CLEAR has reported many times before, the CBD market is full of cowboys, get-rich-quick scam artists that tell bare faced lies about their products as well as making outlandish claims for the medicinal benefits.  The crackdown from the MHRA was inevitable when these fools put their short term gain ahead of developing a responsible and self-regulating market in which CBD could continue to be sold as a food supplement.

We have seen every sort of bad practice it is possible to imagine.  Some suppliers have attacked all of their competitors, stating that they are the only ‘ethical’ supplier and everyone else is telling lies.  MediPen put all its resources and efforts into marketing and PR without providing proper information to customers about what its product contained.  It achieved great coverage in tabloids like the Metro and the Mirror and even managed to spin a wholly misleading story that the NHS was “trialling” its product (In fact it was at last using an NHS accredited laboratory to test its product contents, that is all).  Another supplier called Sacred Kana was rebranding cheap and nasty Romanian hemp extract and selling a bottle for just over £50, claiming it contained 10,000 mg of CBD.  Testing showed that it actually contained less than 200 mg. Wrapped up in a warm, cuddly hippy-style marketing campaign, they were trying to pass themselves off as the Rick Simpson of CBD when all they are is conmen.

Responsible suppliers did include CBD information on their websites and often linked to scientific studies and research.  Clearly, even this has become too much for the MHRA and now the market is being closed down.  You can thank the greedy idiots, the conmen and the barrow boy salesmen trying to pretend they were scientists.

Of course the truth is that CBD is medicine, so the MHRA isn’t wrong.  Most CBD products are, in fact, low-THC, whole plant extracts, so they were, effectively, a legal form of cannabis.  The therapeutic benefits they offered were not just from CBD but from the ‘entourage effect’, recognised by science as the synergy between all the different components of cannabis.  Unfortunately, we even had some companies promoting the fact that their so-called ‘CBD oil’ actually contained significant proportions of THC and CBN, both ‘controlled drugs’ under the Misuse of Drugs Act 1971.

The crackdown was inevitable but it may leave tens of thousands of people with real health problems as they are no longer able to obtain what they were legitimately using as a food supplement.

Crispin Blunt MP, Political Advisor to CLEAR

Crispin Blunt MP, Political Advisor to CLEAR

Of course, designating CBD as a medicine is inconsistent with the UK government’s position that cannabis has “no medicinal value” but it’s been common knowledge that this is untrue for many years.  The only good news coming out of this debacle is that this could be the beginning of proper, honest regulation of cannabis as medicine. But if we’re looking at clinical trials before CBD can be marketed again, it could be many years away and that’s after someone or some company decides to invest the £250,000 or more that could cost.

CBD products will still be available offshore and you probably will be able to order online and have them delivered by post.  The price is bound to go up and you will be committing a criminal offence by importing an unlicensed medicine but no doubt may will choose to take this risk.

CLEAR is working with the UK Cannabis Trade Association and our Advisory Board members Professor Mike Barnes and Crispin Blunt MP, to try and persuade the MHRA to enter a consultation process and allow CBD to remain available as a food supplement in the short term.

In the longer term, as we know far too well, the only solution is for a proper system of regulation for cannabis. including its use as medicine.

Fast Developing News On CBD And Medicinal Cannabis.

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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 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.


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.

Home Secretary Invites CLEAR To ‘Enter A Dialogue’ On Cannabis Law Reform.

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Rt. Hon. Amber Rudd MP, Secretary of State for the Home Department

Rt. Hon. Amber Rudd MP, Secretary of State for the Home Department

In a letter dated 15th August 2016, Amber Rudd, the new Home Secretary, has invited CLEAR to raise “any queries and concerns” about present UK policy on cannabis. This is the first time since 2006, with Charles Clarke, that the UK cannabis campaign has had any direct contact with a serving Home Secretary.  It reflects the reality, now recognised in government, that changes in cannabis policy are imminent.

In recent months, there has been a manifest and significant change in attitudes within the Home Office.  We have seen this through the process of obtaining a low THC cultivation licence for our partnership with GroGlo Research and Development.  The response from the drugs licensing department has been enthusiastic.  There has been no difficulty with our declared purpose of producing CBD oil for sale as a food supplement and we are now in detailed discussions on our application for a high THC licence, looking towards clinical trials for a medical product for chronic pain.

As soon as Theresa May announced that Amber Rudd would be heading up the Home Office, I contacted my MP, now Sir Oliver Letwin, thanks to Cameron’s resignation honours list.  Although he will not openly support our campaign, in the past year or so he has been very helpful indeed, meeting with me on roughly a monthly basis and helping me navigate through the Conservative government.  He has now put me in direct contact with Ms Rudd and I will be preparing a written submission as a preliminary to a face-to-face meeting.

In accordance with CLEAR policy, our first concern is how we can enable UK residents to gain access to medicinal cannabis on a doctor’s prescription.  In practice that means Bedrocan products as there is presently no other source of prescribable, consistent, high-quality, herbal cannabis.  I would expect that to change very soon though. Both Canada and Israel look like potential near-future sources.  GW Pharmaceuticals is undoubtedly considering entering the market and our venture with GroGlo could shift gear depending on how quickly UK policy changes.

We will also be addressing the need for wider reform and a legally regulated market for adult consumers.  Although medicinal access remains the top priority, there is no doubt that more overall harm is caused by prohibition of the recreational market.  It is this that creates the £6 billon per annum criminal market which is the cause of all the social harms around cannabis.  This will need to be handled much more carefully as, due to nearly a century of misinformation and  media scaremongering, many people still retain great fear as to what legal cannabis will mean.

The one thing that has been very lacking in the cannabis campaign is pragmatism. Most campaigners for recreational use continue to be lost in a swirl of ‘free the weed’, teenage angst, outrage, revolution and delight in being a rebellious outlaw. That was until 2011 when CLEAR introduced a new approach which has led to more engagement with government than ever before.  The emergence of the United Patients Alliance and now the End Our Pain campaign has helped this but these campaigns are focused only on medicinal use

The fact is that we need to work with Theresa May’s government and the anti-Tory tribalism that many still adopt is nothing but an obstacle to reform.

In addressing Ms Rudd, our overall strategy for wider reform will be:

1. A final separation from the ridiculous ‘free the weed’ movement and ‘stoner’ groups which are incapable of understanding how they are seen and despised by wider society.

2. Differentiation between medicinal use and the more controversial legalisation for adult, recreational use.

3. Shift public attention onto scientific and medical evidence rather than the very poor standard of media reporting.

4. End the fake policy that says ‘cannabis is dangerous therefore it must be regulated’.  Educate that nearly all the harms around cannabis are caused by its prohibition, not by cannabis itself.

5. Emphasise the importance of harm reduction information, education about excessive use and essential investment in treatment for those who do suffer health harms.

6. Clarify that decriminalisation is no solution and is a dangerous option that would probably increase harm.  The product needs to be sold within a properly regulated environment, careful that over-regulation would support a continuing criminal market.

BBC. The Truth About Healthy Eating.

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shopping whole foodsFor all you food fad fashionistas, vegans and vegetablists, with your gluten-free, organic, quinoa, tofu, dairy-free and right-on, overpriced naaaturaaal, whole and holy foods, this is the day you got found out!

Only the BBC could do a great programme like this which exposes, gently but unmercifully, the giant confidence trick that is the health food, supplement and superfood business.

It’s all a load of codswallop. You’re being cheated into spending tens of pounds on rip-off products when you can eat healthily for pennies.

Watch it and weep for those have been taken in by the goji berries and coconut oil scam.  A pack of butter and an apple is a far better buy.

Available on the BBC iPlayer here.

Written by Peter Reynolds

June 3, 2016 at 7:58 am