06 Dec The Facts About CBD In The UK. December 2016.

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On 3rd October 2016 the Medicines and Healthcare products Regulatory Agency (MHRA)  issued notices to a number of CBD suppliers stating that cannabidiol (CBD) was being designated as a medicine and that sale of all CBD products must stop within 28 days, ostensibly by the 1st November.

A lot has happened since.  Most importantly, the Cannabis Trades Association UK (CTAUK) has been established to represent the industry and protect the interests of CBD consumers but there remains great confusion as to the legal status of CBD and whether these products will still be available.  This article sets out the facts and explains how the market is likely to develop. The most important point is that there is no need for panic.  There will be some changes but no one will lose access to CBD for the foreseeable future.

Background

Through the summer of 2016, rumours and half stories had been swirling around about the MHRA taking action on CBD. When the news broke it caused real panic, both for the thousands of people using CBD products and for those working in CBD businesses.  It looked like a real disaster for everyone. On the one hand the government, through the MHRA, was finally recognising the truth that CBD and cannabis are medicine.  On the other, it seemed that the whole industry was going to be shut down, businesses would close, people would lose their jobs and, most importantly, those who rely on CBD products for maintaining their health were going to suffer real harm.  If CBD was going to be regulated as a medicine it would require the investment of hundreds of thousands of pounds to obtain the necessary authorisation to put any products on the market.

It quickly became clear that the MHRA was unprepared for the reaction it received. Its switchboard was swamped by worried callers.  Social media exploded with the inevitable Big Pharma conspiracy theories and even the national press covered the story demonstrating that medicinal cannabis is now an issue of mainstream interest.

ctauk-logoCLEAR took action to rally our friends and colleagues in the legitimate cannabis business and this led to the creation of CTAUK.  The same day the news broke we wrote to the MHRA notifying it of the formation of the trade association and seeking a meeting.

On 13th October, the MHRA issued a statement on its website explaining its actions.

CLEAR’s advisory board members, Professor Mike Barnes issued a statement to the media and Crispin Blunt MP wrote to Dr Ian Hudson, the chief executive of the MHRA.  Even the British Medical Journal covered the story.

On 19th October the MHRA finally confirmed a meeting with the CTAUK to take place on 3rd November.  On 21st October, Dr Ian Hudson replied to Crispin Blunt’s letter.  CTAUK appointed solicitors who in turn obtained counsel’s opinion and on 28th October a solicitor’s letter was sent to the MHRA formally objecting to its action. On 1st November the MHRA updated its statement on its website softening its position by claiming that its notices to CBD suppliers were merely its “opinion” that it should be designated as a medicine.

The meeting took place at MHRA headquarters on 3rd November.  It was cordial and constructive and on 16th November CTAUK wrote to the MHRA formally proposing a system for the regulation of CBD.  Essentially this suggests that CBD products with daily adult dosage of up to 200mg should continue to be marketed as a food supplement.  Products with a daily adult dosage of up to 600mg would require a Traditional Herbal Registration and higher dosage products would require a full Marketing Authorisation.  We await the MHRA’s response.

The MHRA has since written to CBD suppliers requiring them within seven days to provide samples of their products along with various information about them.  However, CTAUK has been able to negotiate that our members have until the end of January to comply.  This is excellent news and demonstrates recognition of the association by the MHRA.

Is CBD Legal In The UK?

Yes, CBD is not a controlled drug under the Misuse of Drugs Act 1971, neither is it covered by the Psychoactive Substances Act 2016.  As long as it is marketed as a food supplement without any medicinal claims it is perfectly legal to sell and to buy.

Is The MHRA Going To Ban CBD?

No, the MHRA will have to assess each product on its own merits, particularly taking into account how it is marketed and whether any claims of medicinal benefit have been made.

What Will Happen In the Future?

We hope that the MHRA will accept our proposals for a system of regulation, meaning that only the highest dose products, such as GW Pharma’s soon-to-be- released ‘Epidiolex’ will require a full Marketing Authorisation.  However, even if the MHRA tries to take formal action about any other products, this is going to take many months and probably a much as a year before anything changes.  We remain confident that we will come to an agreement that will enable everyone to continue to access CBD products.

  • Rob Atkinson

    The Headline inferes that these are the “The Facts”…. When in actual fact it appers to be no more than an article or the opinions of Peter Reynolds…… According to the UK Governments website…. “The Facts” do not concur as they clearly state – Update 1 November 2016,
    An MHRA spokesperson said: ” While MHRA has given its opinion that products containing cannabidiol (CBD) used for medical purposes are medicines, we have also carefully considered the needs of individuals using CBD products to treat or manage the symptoms of medical conditions.
    Our primary concern is patient safety. In order to ensure that products remain available until individuals have the opportunity to discuss
    their treatment with their doctor, companies now have until 31 December 2016 to voluntarily operate within the law, by withdrawing their
    existing products from the market, or working with MHRA to satisfy the legal requirements of the Human Medicines Regulations 2012.
    We have today written to the manufacturers of CBD to make them aware of the timeline for engagement “.
    So in conlusion, as far as I can tell, The MHRA may well have received the proposals put forward by CTAUK, but until there is a further update the deadline of 31 December 2016 is still in force.

    • These are the facts Rob. If you don’t want to accept what I write that is your problem. I note you have a record of previously demonstrating a combative attitude which is something that is far too prevalent in the cannabis campaign and I am thoroughly bored of it. Indeed I have no more time for people who conduct themselves so.

      If you don’t want to be kept informed then please don’t follow CLEAR. Any further negative and destructive pontification from you will be dealt with accordingly.

      • Rob Atkinson

        The Fact is – The MHRA announced on their “latest” update that companies have to voluntarily operate within the law, by WITHDRAWING their
        existing products from the market – or working with MHRA to satisfy the
        legal requirements of the Human Medicines Regulations 2012.
        I have read throught the legal requirements of the Human Medicines Regulations 2012 and it is an absolute minefield and I suspect that satifying the legal requirements will be at best an uphill struggle even with the assistance of the MHRA.

        • @disqus_wHj3aWl3y0:disqus The article is provided to help inform people. You haven’t been involved in meeting or corresponding with the MHRA so why you think you know better than those who have, I don’t understand.

          For the sake of clarity, what is your involvement in the CBD market?

          • Rob Atkinson

            Hi Peter, despite your original derogitory remarks which you posted yesterday and then later amended.
            I have at no point been inflamatory or disrespectful, I have merely attempted to seperate the wheat from the chaff by establishing “The Facts”.
            As the MHRA have not found it neccessary to write to me, (I assume because I have complied with their guidelines) I have had to seek the advice of my solicitor to establish my legal position.
            My solicitor advises to abide by the letter of the law – as posted by The MHRA via the Governments website.
            My Business is Kana-Vape.com, the True first seller of Independently certified Cbd vaping oil in the UK.

          • Hello Peter,

            I’ve read the MHRA Letter and from what I understand it seems to only be concerned with retailers marketing CBD as a medicine or with Medicinal Benefits.

            If we sell CBD products without highlighting the Medicinal benefits or maybe even with a disclaimer saying that the products are sold with no implications of medicinal benefits I think the MHRA may leave us alone.

            This obviously is not ideal but at least would allow retailers to still sell CBD products.

            I have recently been looking at adding CBD oil, oil drops, E-Liquids and the isolate to our website but I am a little concerned by this news.

            Maybe now I’ll just add the drops and e-liquid but with some kind of disclaimer saying they are not for medicinal use.

            What is your professional opinion?

            Is this the way forward?

    • Mike Harlington

      This article has been put together with the help of the CTA UK which I presently run along with 8 founding members, it is not an opinion.

      The 31st of December is under review and may or may not be shifted, however, it is a voluntary compliance date, at which point the MHRA have an option to look at taking action against those who wish not voluntarily comply. The MHRA themselves have stated that this does not mean sellers have to stop selling, or shelves to be stripped. It simply means that if a seller wishes to not go through the regulatory procedures, then they can and should cease and desist by the 31st of December.

      • Rob Atkinson

        Hi Mike, at the risk of having my hand slapped again! I can only comply with the written word.
        The Fact is, ignorance or even self interpretation of regulations (Law) is no defence.
        The .Gov website has clearly given the date of 31/12/16 as a renewed cut off point for companies to voluntarily operate within the law, by withdrawing their existing products from the market, or working with MHRA to satisfy the legal
        requirements of the Human Medicines Regulations 2012.
        They have already extended the date from 31/10/16 In order to ensure that products remain available until individuals have the opportunity to discuss their treatment with their doctor.
        There has been no further update to date and until then it must be assumed that companies must withdraw their existing products from the market or satisfy the legal requirements of the Human Medicines Regulations 2012.

  • Andrew

    Recent experience with MHRA when we consult with them selling of a CBD products. Products containing CBD are medicinal products that require marketing authorization (licence). If it´s true what is written down here, MHRA obviously doesn´t respect that. What should CBD sellers do with that now?

  • So as long as you market the product with no medicinal benefits on the label the MHRA will not be interested so long as the dosage is below 200mg CBD?

  • From what it seems is so long as your product is not marked as a medicine you should be fine.

    I’m thinking it could still be traded in the grey area loop hole to which seeds are traded.

    You can list al the potential benefits and uses but a simple disclaimer to say seeds are sold as souvenirs makes them legal.

    If you list CBD with all the benefits an medicinal properties but have a disclaimer stating that we sell this product simply as a dietary supliment not for medical purposes this could maybe work on the same principle?

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  • Paul Penno

    I’m considering selling CBD. In this article it says as long as I do not make medicinal claims on the label everything will be legal. Now what constitutes as a medicinal claim? Obviously claiming it cures cancer will be illegal but if i put something like “Considered by many to reduce symptoms of chronic pain and anxiety” how legal would that be? And is there a way i could word that for it to be considered legal?