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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘CTA

Mischievous ‘Centre for Medicinal Cannabis’ Report Smears UK CBD Industry With Misleading Data

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A new report from the Centre for Medicinal Cannabis (CMC) paints an appalling picture of the CBD market in the UK and has led to headlines and alarm everywhere that consumers are being ripped off and the whole industry is not to be trusted.

Cannabis has great medical potential. But don’t fall for the CBD scam – The Guardian

Calling on the UK CBD sector to have better regulation and reform – Health Europa

Centre for Medicinal Cannabis survey finds six million adults used CBD in UK – NHS Executive

CBD oil brands contain little to no CBD, test by Sativa’s UK lab reveals – Proactive Investors

It is true that there are some rogue businesses and fake products but the impression given by this report is false, misleading and wildly inaccurate.  For nearly three years the leading CBD businesses in the UK have been engaged in serious, responsible self-regulation and consumers can be confident if they buy from members of the two trade associations Cannabis Professionals (CannaPro) or Cannabis Trades Association (CTA) they will be getting a quality product which is lab tested and contains exactly what is claimed.

The report is nothing but a market manipulation exercise by the authors. To understand why, it’s necessary to understand who is behind the ‘Centre for Medicinal Cannabis’ and examine their record.

The CMC is the latest front for Paul Birch, a multimillionaire, who since 2015 has been funding a series of ventures in the cannabis campaign. Mr Birch has brought one extremely valuable commodity to the campaign which it had been sorely lacking – money.  He has hired a lot of people with the right connections, impressive letters after their name and has thrown a great deal of his cash into expensive PR which, to be fair, has proved very effective. In fact, as with this CBD report, it is characterised by just how much media coverage it has obtained.  This, of course, has earned Birch’s cannabis ventures a reputation as leaders in their field. In fact, they are very much followers.  The content of their work is either directly copied from others’ work or is just a repeat of what has been done before.

The most high profile success achieved with Birch’s money and PR was the campaign around Billy Caldwell and Alfie Dingley, two children with severe epilepsy, whose stories touched the heart of the nation and under enormous moral pressure forced the UK government into long-overdue reform of its blanket ban on cannabis as medicine.  Birch’s money certainly made all the difference. Exactly the same stories and messages had been delivered to the media many times before but it is a fact of life that you only get on to the breakfast and daytime TV shows and in all the tabloids with a very expensive PR operation.

So Birch is at it again with the CMC. It describes itself as the UK’s first and only industry membership body for businesses and investors operating in cannabis based medicinal products (CBMPs) and cannabidiol (CBD) wellness markets.“, which is as wholly false a claim as has ever been published about anything, anywhere.

The existing trade associations, CannaPro and the CTA, were formed years before the CMC and between them represent nearly 1,000 businesses operating in the legal cannabis sector.  Neither of them were consulted before or since the CMC’s report and the fact of their existence and the work they do in regulating the industry has been excluded from the report.

Of course, the CMC won’t name the products which its report showed to be so deficient because this would show that they are not from members of CannaPro or CTA and are therefore not at all representative of what consumers are actually buying. The irony is that PhytoVista, the lab used by the CMC, is itself a member of the CTA and provides testing services to many CannaPro and CTA members.

So take the results of the CMC CBD report with a very large pinch of salt, or perhaps with a tablespoon of hempseed oil containing only a trace of CBD.  It doesn’t tell the truth. It paints a false picture of an industry that is actually a model of self-regulation.

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Written by Peter Reynolds

July 9, 2019 at 3:38 pm

CBD Isolates Are NOT Becoming A Controlled Substance

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Mike Harlington’s CTA has put out an announcement that CBD isolates are becoming a controlled substance.  There is no truth in this at all, it is nothing but speculation and opinion.

Even if the speculation is correct that isolates will remain classified as a novel food, the terminology is wrong. ‘Controlled’ has a specific meaning in UK law and is applied to drugs classified and scheduled under the Misuse of Drugs Act 1971.  There is no prospect whatsoever of this applying to CBD in any form.

It is correct that the FSA initially classified isolates as novel in January 2018 and no reasonable person can have any objection to this.  Clearly, there cannot be any evidence of them having been consumed in the EU area prior to 1997.  It’s a separate point that this is bureaucratic overkill.  There’s no evidence that isolates are unsafe so there’s no reason to require them to go through an authorisation process except simply to comply with the letter of the law. It is bureaucracy for bureaucracy’s sake and a complete waste of the FSA’s time and taxpayers’ money.

Another, more pertinent point is that despite isolates being classified as novel for well over a year, the FSA has done absolutely nothing about enforcement.  This whole rigmarole is pointless and doing little else other than keeping civil servants in work, making up rules which they then do nothing about.

What remains a far more worrying prospect, which has been entirely overlooked, is that in June 2018, the FSA also indicated that selective extracts would be regarded as novel. The argument for this is equally as strong and logical as it is for isolates and this poses a much more worrying prospect for the CBD industry.

Selective extracts are extracts in which the proportions of the component moleclues have been adjusted, most commonly by the elimination of THC.  Making such adjustments, dialling up or down particular components is an inherent facility of supercritical CO2 extraction. But just as there can be no evidence of isolates having been consumed in the EU area prior to 1997, neither can there be any for selective extracts.  Extracts consumed in the past will have been made by less sophisticated processes that do not permit such adjustments.

So the deep irony in this is that in order to avoid any infringement of drugs laws by removing the THC, such products will be in breach of food law.

Where the FSA is going with this no one knows. It has made major errors in its bungling and incompetent attempt to outlaw CBD products and its top priority now seems to be saving face.  Similarly, having bragged about his mythical ‘close working relationship’ with the FSA, Harlington is also desperately trying to save face and make it look as if he is ahead of the game.  It’s just more of his characteristic bluster and bullshit.  Don’t be taken in.

Any predictions I will make about the future will also be speculation but I am quite confident that this time next year whole plant, low-THC cannabis extracts will still be on sale. In fact I am sure that the market will have continued to expand rapidly.

Written by Peter Reynolds

March 13, 2019 at 10:35 pm

The MHRA On CBD/Hemp Products And Its Relationship With Trade Associations

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This is an email from the MHRA to a CBD/Hemp supplier which name is redacted.  It clearly sets out the MHRA’s position regarding the Cannabis Trades Association, its ‘Cannabis Products Directive’ proposal and how anyone is able to obtain advice from the MHRA without having to join any trade association.  It also explains how medical claims may only be made about a CBD product if it has the required licence known as a marketing authorisation.

This is authoritative guidance from the medicines regulator which is an agency of the Department of Health and Social Care.  If you have received alternative guidance or suggestions that you must join a trade association to sell CBD products, this is incorrect.

 

From: xxxx.xxxx@mhra.gov.uk
Date: October 2018
Subject: CTA and CBD
To: Redacted

Dear xxxx,

Thank you for your email of 22ndSeptember 2018 to the Agency. Please note that we can only comment with regards to our position and advise you to contact appropriate Government Departments with regards to obtaining their views.

The CTA represent a number of companies in the UK who market CBD and they have proposed a framework, which they have termed the ‘Cannabis Products Directive’, that effectively sets out quality requirements for their members.

The Medicines Borderline Section of the MHRA has been clear from the outset that we will work with companies and trade bodies to ensure compliance in respect of CBD products. This is in line with our approach across the borderline and we do not require a company has membership of a trade body to enter into dialogue with us. There are a number of trade bodies, covering a range of product types who are well versed in borderline matters and they are able to advise companies but, if a company does not want to become a member, we can provide them with advice regarding their products. On occasions we may work with trade bodies; as they are able to communicate information on our behalf to their members and we may assist them if they want to come up with guidance on a specific aspect etc. However, ultimately MHRA is responsible the licensing of medicines and for the classification of borderline medicinal products and this cannot be passed to third parties.

We list a large number of trade bodies etc who have an interest in borderline matters in a ‘Useful addresses’ Appendix in our Guidance Note 8 (GN8).

Our current position with regards to CBD is as follows:

MHRA has offered an opinion on the regulatory status of CBD and advised that we are currently evaluating the evidence of pharmacological effect. At present we are providing the following general guidance to enquirers until we determine the status of CBD.

MHRA is of the opinion that products containing CBD, when used for a medical purpose, should be regulated as medicinal products. The MHRA’s opinion has been issued at this stage with the intention of seeking voluntary compliance by companies supplying CBD for medical purposes. This does not preclude MHRA from seeking to use Part 9 of the Human Medicines Regulations to classify any particular product.

A “medicinal product” is defined in Article 1 of Council Directive 2001/83/EEC and included as Regulation 2 of the Human Medicines Regulations. The definition is as follows:

(1) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(2) Any substance or combination of substances which may be used by or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis”

In respect of the first limb of the definition, were you to market any product that makes a medicinal claim, this would mean that the product falls within the definition of a medical product. For the avoidance of doubt, you should also be aware that this includes any testimonies, studies, links to articles, historical uses etc that you may wish to include on your website or any other promotional material. Further guidance in relation to medicinal claims can be found in our Guidance Note 8

Insofar as the second limb of the definition of a medical product applies to your products, it is a matter of fact that there have been a number of clinical trials which demonstrate that CBD has a therapeutic effect, particularly in the treatment of severe epilepsy. MHRA’s clinical assessors have reviewed relevant scientific and clinical evidence to support the mode of action of CBD in the treatment of a range of medical conditions. It should also be noted that the European Medicines Agency has given CBD products an orphan designation on four occasions, for three different clinical conditions; graft versus host disease, perinatal asphyxia and Dravet syndrome.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2014/11/human_orphan_001425.jsp&mid=WC0b01ac058001d12b

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2016/10/human_orphan_001832.jsp&mid=WC0b01ac058001d12b

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2015/08/human_orphan_001612.jsp&mid=WC0b01ac058001d12b

The MHRA is now working with trade bodies in relation to making sure products containing CBD, used for a medical purpose, which can be classified as medicines, satisfy the legal requirements of the Human Medicines Directive as transposed into UK law by the Human Medicines Regulations 2012. This work is ongoing. Given the ongoing evaluation, MHRA can give no assurance that any particular product, including products under development, will not subsequently be classified as a medicinal product.

‘The advice contained within this email relates to the MHRA’s opinion regarding the status of CBD. The Home Office can advise on psychoactive substances and the Misuse of Drugs Act and any products which are subject to these regulations. Your products must comply with the relevant regulations at all times. It is possible that your products may contain residual levels of THC, and/or other controlled substances. We therefore advise that you contact the Home Office first who can advise in respect of psychoactive substances and the Misuse of Drugs Act. The Home Office can also advise with regards to what licences will be required to grow/import/export such products/substances from/into the UK. Please note that we are only providing general information above and this is in no-way, shape or form an approval of any product. We have not seen any information relating to the products in question and therefore, we cannot comment on its acceptability. If you wish to license your products as medicines in the UK then the attached links provide more information about how to obtain a marketing authorisation (MA) in the UK which we hope you will find helpful. Home Office has also published a Factsheet in respect of CBD and you are advised to review this first: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/674713/Factsheet-_Cannabis__CBD_and_Cannabinoids-_January_2018.pdf

The Agency reserves the right to change its view in the event of any information or evidence which has a bearing on the status of the products, including the way in which they are presented and promoted. This also includes any information, which we have not assessed. You should seek independent advice or consult a suitable trade association or the appropriate regulatory authority about the acceptability of any product you are considering selling, supplying or advertising.

The licensing process is by no means easy, especially with little regulatory knowledge.  We have included links below which will direct you to the relevant pages on the MHRA website.  As an indication of the Legal Basis, you should focus on an 8(3) Full Application, submitted under the complex fee.  A National procedure is for authorisation in the UK only.

In order to market the product in the UK, a Marketing Authorisation is required.  As there are no step by step guidelines, please see the below links for the submission of new marketing authorisation applications (MAA).

https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk

(Guidance regarding how to apply for a market authorisation in the UK)

http://ec.europa.eu/health/documents/eudralex/vol-3/index_en.htm

(EU scientific guidelines for medicinal products)

https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk#application-process-all-procedures

(Licence application forms)

https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk#fees

(Fees)

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/313624/MHRA_fees_definitions.pdf

(MHRA fees definitions)

Furthermore,  to obtain marketing authorisations in the UK you must have a registered office or representative either in the UK or another EU member state. GMP (Good Manufacturing Practice) inspections will take place after marketing authorisation applications have been submitted if the site has not been inspected by an EU authority in the last 3 years and does not hold a valid GMP certificate.

Please see the below link with regards to the requirements for having Manufacturers and Wholesale Dealers licences: Importers Licence queries.

https://www.gov.uk/apply-for-manufacturer-or-wholesaler-of-medicines-licences

 

Written by Peter Reynolds

October 18, 2018 at 12:41 pm

Cannabis Trades Association Receives Official Endorsement From the MHRA.

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For nearly two years the Cannabis Trades Association (CTA) has been working with the Medicines and Healthcare products Regulatory Agency (MHRA), the Food Standards Agency (FSA), the Home Office, Trading Standards and other UK authorities to bring order and professional standards to the growing market in legal cannabis and CBD products.

The MHRA has now officially recognised CTA by inclusion in its Guidance Note 8 ‘A guide to what is a medicinal product’.

This is long overdue recognition for the CTA’s work which includes regular liaison with the authorities, providing guidance to businesses operating within the market on the law, regulations, professional and quality standards.  The CTA with the MHRA and FSA is also in the process of developing the Cannabis Products Directive (CPD), a framework for regulation and licensing of all cannabis and cannabinoid products. CPD has been translated and submitted to all 28 member states of the EU by the European Food Safety Agency (EFSA). It is anticipated that CPD will become UK law within the next two years and will relieve the Home Office of the burden of the cannabis regulation and licensing process, placing it in expert hands.

The CTA was initially conceived at a meeting in Manchester Airport in September 2016. In November 2016, with the assistance of Crispin Blunt MP, then a member of the CLEAR Advisory Board, it was invited to an initial meeting with the MHRA to represent the emerging CBD industry.  The market for legal, low-THC cannabis products derived from industrial hemp had grown rapidly within just a few months but was becoming out of control with a multitude of new companies making unlawful medical claims for their products, which themselves were totally unregulated and of inconsistent quality and unknown provenance.

Through negotiation and a growing relationship with the authorities, CTA was instrumental in bringing the market back from the brink of a serious clampdown.  Now, with over 300 full members and more than 1200 registered sellers, CTA encompasses not just CBD suppliers but also licensed growers and producers of cannabis and businesses involved in the long term development of cannabis products.

CTA is closely involved in the rapidly developing reform of the laws around medical use of cannabis and will be working with the authorities to manage development of the products and systems required for what is expected to be a huge new market.