05 Oct Fast Developing News On CBD And Medicinal Cannabis.

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.

  • rockstar

    Cheers for clearling some of that up. Id like to think something positive will come of this but worry about any delays that could cause untold harm to people who rely on this medicine.

  • Claire Wheeler

    So bad news for current distributors but it may work out positive once the beurocracy is dealt with and the powers that be have been paid off then. Is that the gist of it?

    • Diana Linaker

      the problem being it will take years as bureaucrats drag their heels on the whole “cannabis” thing and in the meantime loads of patients will suffer…….

  • richYK

    The MHRA would make a statement prior to sending letters, they don’t just out of the blue just start sending letters, they make official announcements,
    this whole thing sounds strange.

    • You are incorrect. I have seen one of the letters and we will be publishing it shortly.

  • John Dobie

    I called them just now (MHRA) , they have no info on what we do in the mean time, i said thousand will probably be wondering so here’s the details to contact them. i need to know if we can still get from europe

    Email – [email protected]

    Telephone

    020 3080 6000.

  • Paz

    They cannot stop us pushing products just because other companies products fail the measurements. That is clearly illegal against trade

  • discerner

    Could Big Pharma be behind this as a result of lobbying? Yes it is seemingly classed as a medicine now, however due to this ‘new’ classification it will not be sold through the normal legitimate channels. Thus a competitor is eliminated from the market for a period of time. Furthermore it could be driven underground with unsrupulous suppliers ‘cashing in’. One option maybe to source from oversees suppliers depending how genuine you think the product is.

    • A far fetched conspiracy theory in my view.

      • Paz

        Conspiracy theory? Of course it’s Pharma led, far fetched to think anything differently

  • rusty

    Another stitch up by our government,

  • Paz

    a blanket letter? how on earth can they do that? they have no idea who all the producers are do they if most of it is imported. certainly nothing came through my Spanish door 🙂 Prob good for us cos we can be even more in demand and we have government approval this end. Since Brexit UK needs Pharma more than ever Im afraid.

    • Diana Linaker

      totally agree with you xx

  • Diana Linaker

    how about petitioning the government?

    • Guaranteed to achieve nothing. Petitions are a ruse by government to divert campaigners into thinking they are doing something effective. They are a waste of time. Go and meet your MP face to face. This will achieve far more and if thousands of people did so it would change things. Sadly, most people are too lazy.

      • Diana Linaker

        that may well be but we have to try, just signed a petition with 38 degrees and will be harassing my local MP. I am not ill but take it for the onset of old age, bone mass and rheumatism mostly.

  • Well it’s good and bad news depending on who you are. Good news for the corporations as they now can take control of the market. Bad news for companies already selling cbd that have put much time and expense into creating a market and are now being royally shafted.
    Bad news for the people as we’re going to end up with gw pharma inferior medication that costs several hundred pounds a week to the NHS instead of maybe £20 a week at its current market prices which is affordable to many patients.

    After speaking to five sativex users through the years and learning that in all instances the spray ultimately causes throat bleeds.

    So now sale of cbd is illegal and at the same time last year most police forces set a guideline to leave small and medical growers free to grow their own medicine.

    All these legal contradictions are just going to make the lawyers a lot of cash over the coming years that’s one thing we can bank on

  • Thecatsloose

    the head of hmra dr ian hudson used yo work for gw pharmaceuticals.

    what a coincidence

    • Peter Reynolds

      No he didn’t! Another conspiracy theory too far! He worked for GSK.

  • Manda

    With regards to the traditional registration, would the numerous medical texts dating from before the Roman era & onwards count as proof?

  • Chris X

    Thank you for this (unwelcome) news. Some points:

    – You say that “most CBD products are in fact low-THC, whole plant extracts derived from industrial hemp, legally grown under licence.” I suspect that most, or at least a high proportion of product currently available for retail sale in the UK either online or in shops is imported, so grown outside UK and therefore subject to different rules. Also, the Home Office will not issue a licence for growing hemp for CBD extraction, or so they told me.

    – Every day more imported product is advertised, even in the face of the MHRAs diktat. Yet to manufacture the product legally in the UK, impossibly high barriers are set by the MHRA. The fees will not deter serious potential manufacturers, but the EU directive demanding clinical trials probably will.

    – Not only does the MHRA’s action unfairly play into the hands of large established pharmaceutical companies, it precludes the development of a “CBD cottage industry” which would be a nightmare for the MHRA to inspect. So we all know where they are coming from. But the poor old punter who is getting relief from pain and the other symptoms of disease (or even perhaps curing their own disease without being poisoned with chemo and cut up like a piece of meat) is going to be left high and dry. Well, dry, anyway.

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  • cbdbro

    Check out CanaXen – one of the oldest CBD companies in the UK and full member of the CTAUK CBD Oil

  • James Wardle

    Tories have an mp who stated last week cannabis has no medical value while in the meantime her rich husband harvests his cannabis plantantasion true story . So it’s like this you can’t have it but they can. End of. About it being better being regulated rubbish better leaving it to Me. Science is a shill. Not noticing bitter herbs are healthy for you there just vile scum Amen

  • James Wardle

    And it no worries I have vast knowledge of how to navigate what nature provides. Cbd is just a bandwagon there are many others .

  • Rachel Attwood

    Very grateful to Clear and the CTA for helping turn this scenario to a very different one in 2018. fortheageless.com (CTA member)