Ask the MHRA
Part 2 of The Hemp Hound Agency's 'Ask the...' series of FAQ's
On 06/11/2022 I submitted four separate Freedom of Information requests (FOI) to the Medicines and Healthcare products Regulatory Agency (MHRA).
On 06/12/2022 the MHRA replied to three, but did so in the email chain for the 4th FOI they didn't acknowledge.
The 3 FOI's they replied to were:
Any communications between the Home Office (HO) and the MHRA between 01/01/2016 and 01/01/2017 in regards to 'Cannabinoids' and/or 'Cannabidiol' (CBD) - this was asked to determine whether they had a continuing presence when influencing other government departments on behalf of GW from 2016 through to the current day.
Any communications between GW Pharmaceuticals and the MHRA between 01/01/2016 and 01/01/2017 in regards to 'Cannabinoids' and/or 'Cannabidiol' (CBD) - This was asked due to an attempt by the MHRA to define CBD as a purely medicinal compound in 2016, did GW alone ask them to do this?
Any emails between the MHRA, Home Office or Foods Standards Agency, between 16/06/2021 to 01/11/2022 in regards to the TIGRR (Taskforce on Innovation, Growth and Regulatory Reform) report, specifically in regards to 'Cannabis', 'Cannabinoids' or 'Cannabidiol' - this report highlights the intention to turn the UK into a powerhouse for medicinal CBD and cannabinoid based products, which will be regulated by the MHRA, but at what cost to the hemp and CBD food supplement industry?
The TIGRR report is below, the point to reference is P.81 Proposal 11.15: Regulation of medical cannabinoids and medicinal CBD from the Home Office to DHSC / MHRA to create a regulatory pathway for assessment and approval based on patient benefit
The FOI that the MHRA didn't reply to was:
How many CBD food supplement companies, between 31/03/21 and 01/11/22, have been enforced against due to making unproven medical claims - this was asked because I believe the MHRA have deliberately been quiet since the first companies were added to the FSA public list for CBD Novel Foods, for reasons I will go into later in the article.
The MHRA's reply can be found below.
So the three they have replied to are deemed as 'similar', which means I now have to break the FOI's down to explain the intent
Of course the questions could be viewed as related in that one person has asked all four, and all focus on CBD and cannabinoids in some way, but this is a 'back off' reply, and it almost feels like they were ready for me.
If I'm right in that assumption though, I have no-one but myself to blame. I do like to tell people what I'm doing after all, and quite publicly, so it's possible they saw the 'Ask the FSA' article that I published on 04/11/2022, and that I shared it stating that I would be approaching them next, and dug down into their defensive positions.
That being said, I'm glad they did, so let's go through their reply:
During initial review we logged these as separate requests, under the references FOI 22/1099, FOI 22/1100 and FOI 22/1101. We judge that these requests are sufficiently similar that we can combine and treat as one request as we are entitled to do under the Act; we are treating the combined request under the reference number FOI 22/1099.
The two FOI's that focus on 2016, maybe, however I'd like to think that I will justify why they are not similar further below. But of course, how are those two FOI's similar to that which requests data in regards to the MHRA's involvement in the TIGRR report which was published in 2021?
We can confirm that the MHRA does hold some of the information that you have requested. However, we have also determined that the information is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further. Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
And this kids, is why you should always keep your FOI requests short and sweet. If you ask for information that they don't want to give you, Section 12 of the Freedom of Information Act is usually the first port of call, which is then normally followed by the Public Interest Test (Section 17). Considering the awareness of cannabis as a whole though, I doubt they would willingly want to test Section 17 in a hurry.
So straight away we can see why they have combined the FOI's, so they can enact Section 12, and that's further reflected in the next part of their reply.
In attempting to locate the emails and electronic files in scope of your request, we asked our IT department to run searches across the MHRA IT estate. The search has returned 8,016 results. It appears that the searches our IT department conducted include in the results large quantities of metadata, and it has not been possible to separate out emails from the results. Whilst we do not believe that this number is representative of the total number of emails that are specifically in scope of your requests, in order to ensure that pertinent emails were extracted accurately a manual review of each item would be required, which would take in excess of the 24 hours allowed.
8,016 qualifying bits of information... so the MHRA have been busy!
To break that down though, that's the total number of results for the three FOI's that have been combined and rejected, but I suspect that a lot of those emails focus more on the TIGRR report.
The logic in that suspicion works like this: The HO and/or GW Pharmaceuticals (Now Jazz Pharmaceuticals but GW all the same) approached the MHRA in 2016 to 'request' that they define CBD as a purely medicinal compound, the MHRA said "why not!?!", but then got flummoxed by the public backlash, and quoted this as the reason why CBD supplemental products were able to remain on shelves within the UK beyond that point.
I don't think there would be many emails for this, but I think that what is there will be telling. I also think that there's much more scope say for the MHRA negotiating with the HO to allow for a licensing system for companies to apply to grow unlicensed cannabis for medicinal uses, or possibly emails between the MHRA and FSA on how to 'let' the CBD industry become medicinally focused, which would be one or two steps closer to the TIGRR reports stated intention.
Lets just come back to the MHRA's claim that the three FOI's they replied to are similar
This is both intriguing and unsettling at the same time, are they saying that the TIGRR report in some guise existed 5 years before it was officially unveiled?
Well the intent was the same back in 2016, but if a move such as this 'was' to have played out back then, surely there would have been one sole winner in that equation, and that's GW. Sure, they're still the head honcho with medicinal cannabinoid based products, but there are other players in that marketspace now as well, and the MHRA will have to listen to all of their concerns.
But a couple of questions arise from this, has GW had an input over time into either the creation of the TIGRR report, or the implementation of it? Another question is, how long has there been an intention to make Britain a powerhouse for medicinal CBD and cannabinoid based products?
All of a sudden, the rejected petitions for legalisation, the unified responses from politicians of "Skunk is bad", the 'recreational vs medicinal' debate, and every other deflection from talking about the public interest in cannabis kind of makes sense.
Well, if there was some kind of intended roadmap before the actual roadmap was announced that is, it'll also explain why the politicians are getting antsy with the judiciary and police, who the press claim have effectively decriminalised cannabis.
Why though, why would 99% of all politicians be so uninterested in having an open conversation about cannabis, unless of course there are interests to protect? They can see how the world is changing, how many uses the plant has outside of a medicine, or something you can smoke to relax, and they can definitely see the tax money that the countries that have legalised or decriminalised cannabis use have been pulling in. The approval rating combined for such a move in the UK has been in excess of 50% ever since the legalisation medicinal cannabis in 2018, so it's suspicious that very few politicians are prepared to bring up a topic that the public thinks should be discussed, let alone the fact that a blind eye is being turned from something that could not only bring in another source of revenue into His Majesty's coffers, but also give the police more freedom to focus more pressing concerns.
Maybe, maybe not - it just happens to be an opinion that fits the facts, although if that 'is' the case, what does it say about every political party when they all repeat familiar lines?
But I'm digressing here, so lets get back to that FOI response from the MHRA, which tails off with the standard ending to an FOI reply: you can refine your request, please note that substantially familiar requests made in 60 days will still fall under section 12, you can query the reply, you can request an internal review if you're not happy, and you can go to the ICO if still unsatisfied...
Now lets go through the questions, and why I asked them
Well the saying goes 'let sleeping dogs lie', but this is The Hemp Hound Agency... so WOOF!!!
Cannabis is a food before a medicine, but that's not appropriately recognised in the UK, so we only get access to that food when the body is starved effectively to a point where that food becomes a medicine... outside of the hemp and CBD industry of course, but then that's still restricted, and if GW get their way, there will be further restrictions to come.
There is space enough for a food supplemental industry and a medicinal CBD industry to co-exist, without one interfering in the other, but unfortunately, there is the small issue of 148 patents, a road map for medicinal CBD and cannabinoid based products that may or may not have existed 5 years before it was published (TIGRR), 16 lab GW reports to clamp down on a competitor industry that a public backlash only just saved in 2016, and an unanswered FOI that I suspect will show that the MHRA have not carried out any enforcement on any companies making unsolicited claims about their wares since the first validated products were announced in the Novel Foods process, because they are priming themselves for the mother of all clampdowns, which they warned in 2018 would happen as soon as the consumer viewed CBD supplements as medicinal, because it then allows the MHRA to secure a medicinal CBD and cannabinoid industry... and I'd say that this is not only just about to happen, but also that it was allowed to get to this point.
So in regards to the FOI for files and emails in between GW and the MHRA from 01/01/2016 to 01/01/2017 that mention 'cannabinoids' and 'cannabidiol'
First off, I've reduced the time window to between 01/04/2016 and 01/10/2016 in my reply to the MHRA which you can find at the end of this article, although I still think there won't be much activity other than:
GW : Wassup, fancy helping out a buddy?
MHRA : Of course, what's up?
GW : That CBD food supplement industry, they're stepping on our toes. Can you like... step on theirs... and award CBD to us? If there are some shareholders there, we'll drop a tenner in the the drinks fund for your next Christmas party!
MHRA : Sure thing, leave it with us!
GW : Awesome, cheers buddy!
MHRA : Erm... the public, they seem to know a little more about cannabis and CBD than we thought. Your mates at the HO are slacking a bit, aren't they? Can't they demonise that Skunk you grow a bit more to scare people into thinking that cannabis and THC should only be used as a medicine, we'll get it sorted then!
GW : Nope, hang fire! You do nothing for a bit, we'll just have a chat with the FSA and HO, then you can pick up where you've left off. By the way, what are we paying you for again?
Joking aside though, how much of this conversation do you think could be close to the mark? Well GW do pay the MHRA as their accounts for 2019-20 below will show.
I also want to highlight that it has been reported and confirmed that those who work in the MHRA do tend to have shares and interests in the companies who also pay licensing fees, as recently released lists of interests associated with the MHRA's Board of Directors will show.
What exactly do these companies pay the MHRA for though? that's the question, especially when there are three entities bearing the GW initials, all of which are intertwined, and all have made payments totalling £80,147 in 2019.
How much is for product licensing, and how much is for protecting GW's interests? Because that's exactly what the MHRA are there for, as their funding seems solely from pharmaceutical companies on the basis that the licensing monies accrued goes towards the day to day running of the MHRA.
And that means compliance, and probably in this case, financing the Borderline Medicines Department
Let's just get one thing straight, because if this was written by someone else and I was the reader, I would be wondering what exactly the author was trying to imply...
The fact of the matter is that I don't think paying a government agency licensing fees, and said agency using those fees to protect the interests of the licensee is wrong per say, but there is a line, and that is when a company influences a government agency to target a competitor industry which to a point, is outside of the remit of said government agency.
That's the reason for this FOI, to ensure that the MHRA were not acting on behalf of GW to redefine CBD as a purely medicinal compound back in 2016. If they were, there would be questions in regards to competitions, as well as a possible monopoly market issue to look into.
Patents in the pharmaceutical world mean nothing in the food world, which is why I believe there was a move to redefine a food to a medicine. That's why I feel the MHRA should answer this FOI, but if they want to play the Section 12 card, this is why I believe the second FOI is not directly related, and by extension, not similar.
All files and emails in between HO and the MHRA from 01/01/2016 to 01/01/2017
Ok, topic matter and time scales yes, but from there the intent of the FOI's is different. There are certain things that I can understand in this world, like for example the MHRA and HO liaising between each other 'to a point' when it comes to medicinally focused cannabis companies. That being said, we're talking about the HO now, and forgive me for saying it but 'to a point' might be a meaningless phrase.
They themselves are known to have approached the FSA in 2017 to request that all cannabinoids were deemed as Novel Foods, and the FOI below shows the HO guiding the VMD towards outlawing all CBD pet products in 2018.
It's worth mentioning that if there was a plan in 2016 to push the UK towards being a world leader for medicinal CBD and cannabinoid based products, the HO would have known about it from the start, and if that's the case, we're talking about links to historic and as yet to be resolved conflicts.
Let's start with Victoria Atkins (VA), and the position she was awarded as Minister for Drugs in 2017 despite it (allegedly) being disclosed to the HO that her husband, Paul Kenward, was made MD of British Sugar (BS) a year before her appointment after he switched their tomato greenhouses over to growing hemp, and on the basis of supplying GW for all their CBD needs.
One side note on this is that BS are mentioned as growing a strain of cannabis called M250, which is defined as high in CBD, but also as marijuana despite there being suggestions that the THC level is negligible. I can only find references to it in a single paper called: A Review of Medical Cannabis Studies Relating to Chemical Compositions and Dosages for Qualifying Medical Conditions, so one would assume that their license requirements will be a little bit tighter than that for hemp farmers who also grow under glass.
The Motley Fool - www.fool.co.uk/investing-basics/market-sectors/investing-in-cannabis-stocks-in-the-uk
2017... was VA the Minister for Drugs at this time? Because that type of information would be essential for her husband's licensing, and one wonders if that information would have made it to her desk.
Maybe there wasn't even a need for that, because as it goes, she was the one who announced to the House of Commons in 2016 that BS had acquired a licence to grow medicinal cannabis whilst sitting as a back bench MP.
But fun facts and interesting thoughts aside, you've got to see the conflict, right?
Think of it this way - in the UK, politicians will talk about 'cannabis and drugs', to a point where cannabis is over focused on, and the others aren't worth mentioning other than in a collective sense. In some kind of absurd way, it's almost like rolling a blunt is less acceptable than sticking a needle full of heroin in your arm.
As the Minister for Drugs, you could argue that VA's focus was 70% cannabis vs 30% 'drugs', yet it wasn't until a few weeks before the legalisation of medicinal cannabis in the UK that VA 'recused' herself from questions on cannabis due to her husbands position, and a perceived conflict due to that and her position as Minister for Drugs.
That was on 23/10/2018, medicinal cannabis was legalised on 01/11/2018, and BS would have substantially gained from that move. But they would have also substantially gained if in 2017 the FSA decided that all cannabinoids were novel as the HO requested, as they would have if the MHRA successfully defined CBD as a purely medicinal compound in 2016, which I believe is the year BS were awarded their license to grow a strain of hemp for GW whose existence is barely confirmed by whispers within a couple of news reports and one (found) medical study.
And the crowning jewel in all of that is...
VA would have been holding the reins of the "Skunk is bad" movement, and we know that GW owns and grow the genetics for Skunk #1, so all of a sudden, it looks like her job focus was in fact 70% protecting the interests of GW and her husband/BS vs 30% 'drugs'.
The intriguing part of this is that according to the HO, they were aware of VA's potential conflicts when she was appointed as the Minister for Drugs, but if that's the case, why did she feel the need to recuse herself from questions in regards to cannabis?
More to the point, if she had disclosed those interests, why was she then placed in a position where she couldn't talk about more than half of her workload?
It's not just me who thought this was off, there was in fact calls of 'hypocrite' from the press 5 months before she 'publicly' recused herself
Whilst the HO claim that VA "voluntarily excused herself from policy or decisions relating to cannabis, including licensing" in November 2017, you have to ask that if it was the case, why did she get that job?
According to the MP's register of interest, VA was happy to register the interests of her brother, and that BS had donated £1,120 for 4 nights stay at a hotel with her husband whilst attending the 2017 Conservative Party Conference. There is no mention that her husband was in fact the MD for BS during her tenure as the Minister for Drugs within the Register of Interests, strangely however, she was required to disclose that spousal conflict in May of 2022 whilst Minister of State under Boris Johnson (BoJo) whilst he was the Prime Minister (PM) of the UK.
So why wasn't her conflict recorded and accessible to the public when she was the Minister for Drugs before said public found out about her potential conflicts approximately 1 year after she had been appointed, and 5 seconds away from a point where legalised medicinal cannabis in the UK would put her husband in a very 'nice' position?
That being said, it wouldn't have been the HO who appointed her to her 2017 position as the Minister for Drugs, that would've been BoJo's predecessor Theresa May (TM), who herself had question marks placed over her name in regards to conflicts of a similar nature just before the legalisation of medicinal cannabis. A curious question would be 'did VA declare her interests to TM?'
TM was the Home Secretary (HS) from 2010 until 2016, the year that BS was awarded a licence to grow cannabis for GW, where on the 11th of July, she was elected as the leader of the Conservative Party, and by extension PM of the UK.
On the eve of the legalisation of medicinal cannabis, her husband Philip May (Phil, can't call him PM for obvious reasons) was also pointed out by the press as someone who stood to gain financially from the legalisation of medicinal cannabis, but to be fair that's not quite true. Nope, when you look into the facts a bit, there's more the potential for him being a man on the inside, rather than a man who was due a big payday as the result of a law that his wife as PM ultimately signed off.
On the left is Billy and Charlotte Caldwell, both fought with others and won the fight for access to legalised medicinal cannabis in the UK. On the right are Mr and Mrs May, who both would have worked with GW Pharmaceuticals in some fashion between 2005 through to 2021 when they were brought by Jazz Pharmaceuticals.
Phil is a Relations Manager for Capital group, who themselves felt it necessary to point out via a press release when TM became PM, and further stated that he was without a financial or property based portfolio. Capital Group at the time had a 22% stake of GW, who themselves would have had some window of connection to TM when she was still the HS. So if the HO did approach the MHRA with GW back in 2016 to get CBD defined as a purely medicinal compound, odds are that as HS, TM would have known what was going on.
Now I need you to consider this carefully - from 2010 to 2016 TM would have been very aware of GW, in fact GW would have been liaising with the HO before TM was appointed HS. Phil became Capital Groups Relations Manager in 2005, whose job is to pop and see clients to make sure they have what they need. All of a sudden, GW had exactly what they needed, an extra avenue to the HO through the wife of the relations manager being appointed HS in 2010. For all we know, Phil could have had some serious conversations with TM in regards to stumbling blocks, and how GW's shareholders would benefit should they be overcome.
And then TM became PM in 2016, and Capital Group and GW must have thought that Christmas came early.
Did she pass a baton in 2017 to VA?
Well let's put it this way - both couples would have no doubt been able to discuss key topics over the dinner table, and due to that spousal conflict, what's to say that the information and/or head's up on progress and plans either by represented companies or political intent was not discussed?
Another way to put it is that any conversation that led to the legalisation of medicinal cannabis in 2018 ultimately benefitted GW, whether that was between TM and her husband, or VA with hers.
Now you might think I'm losing track here, but on the contrary
The two FOI's are to determine the intentions of GW and the HO back in 2016, and whether one or the other, or both for that matter, approached the MHRA with a request to define CBD as a purely medicinal compound.
I really don't expect much in this area though, in fact I suspect that GW and the HO won't be in all of the emails and files regarding cannabinoids and cannabidiol between 01/01/2016 and 01/01/2017. But in an attempt to accommodate the FOI requirements, I have narrowed the time frame for both requests to 01/04/2016 to 01/10/2016, whilst trying to explain to the MHRA why I don't think it's a good idea to define these FOI's as related. See one is to determine whether a company has been trying to protect their interests by influencing a government agency to redefine a food, whilst the other is to determine whether the HO, possibly by enabling certain people with known conflicts, have acted through all of the key dates mentioned in this article to influence departments and industries for the interests of one company.
The problem with FOI's is that...
When you come across guidance for submitting FOI requests you are normally informed that you shouldn't, or don't need to explain why you want the information you're requesting. That's a bit of an escape clause if you think about it, because it gives an agency a chance to hold you off whilst they find a way out of your request, or try to at least.
That being said, I'm a bit bored of playing the political game of back and forth every 30 to 60 days dependent of the complexity and number of the FOI's submitted. On top of that I promised you an FAQ's from the MHRA, and their non-reply says more than I could have hoped for, which leads to the third FOI that was combined with the other two.
Emails between the MHRA, Home Office or Foods Standards Agency, between 16/06/2021 to 01/11/2022 in regards to the TIGRR (Taskforce on Innovation, Growth and Regulatory Reform) report, specifically in regards to 'Cannabis', 'Cannabinoids' or 'Cannabidiol'.
If I was being absolutely uncritical of the response from the MHRA, the connection on the three replied to FOI's are the words 'cannabinoids' and 'cannabidiol'. Is that truly enough to lump them all together though?
The short and long answers are surely 'no!', at least I believe so anyway, and certainly most of all with this one FOI as it's requesting information from 5 years past 2016, and focuses on a document that mentions the MHRA 35 times.
I have however taken direction from the FOI response and refined the request, whilst asking that the MHRA reconsider what it says about the direction of cannabis in the UK by stating that this FOI, as well as the two that focus on events in 2016, are related.
Did the TIGRR report exist in all but name in 2016?
I have asked them in a round about way to confirm whether that is the case, but I've removed the HO from that request, because at the end of the day they are already in an active process to hand a level of responsibility of cannabis to the MHRA with the intention of them governing the UK's move towards a medicinal CBD and cannabinoid world, and you have to wonder where hemp and CBD food supplements come into that equation.
So the focus is now purely between the MHRA and the FSA, which is more convenient. The FSA themselves have admitted that they are over stretched at the moment, to the point where they have suspended projects and certain operations due to the lack of funding. That's interesting, as I've believed for a long time that the intention was to hand CBD products to the MHRA, who themselves suggested in 2018 that the plan was to wait until the consumer views CBD products as medicinal in nature before reintroducing themselves properly to companies with interests in the industry.
All of the hallmarks are there for the transfer of power, with the suggestion that a situation has been manipulated to a point where companies would be allowed for some time to make claims, possibly to the point where the FSA questions whether CBD products are more advertised as having medicinal impact rather than being a food, and then it's bye bye to a fair chunk of the FSA's public list.
And guess what percentage of the list has products down as awaiting evidence?
98.02%, but then there's equally as high a percentage of validated products that seem to be made by companies who have strong ties with the MHRA, and obviously with the FSA going on the basis that they ignored several complaints about validated products that didn't qualify for CBD Novel Foods, and that in itself led to a public interest disclosure complaint of the FSA's handling of the Novel foods process, which can be found below.
If it was decided that CBD products are medicines, it's highly likely that the public list will drop from thousands, to hundreds, and the ones who do survive that will be further squeezed out on the basis of whether they fit in with the 'inner circle'.
And that leads us to the unanswered FOI, which was basically to find out how many companies have been at the receiving end of enforcement action for making unlicensed medicinal claims on their CBD food supplement products
It's bizarre don't you think? receive 4 FOI's and reply to 3 on the 4th un-replied to FOI? I respect that anyone can have a bad day in the office, but if your job was in some part to deal with FOI's, you'd think you would notice that you're looking to reply through an unread email... that contains another FOI!
If they do reply to this one, I suspect that the number will be negligible at best, and if that is the case, I believe it would have been a deliberate un-enforcement of the MHRA guidelines that has led to the industry getting too comfortable with overstating the medicinal properties to that which is marketed as a food. The threat from 2018 may not have been a threat, in fact it may have been a warning of what was to come.
Take a look at your peers, look at their sites, and tell me who is suggesting that their products do more than help regulate core bodily functions. Now have a look at the MHRA's A guide to what is a medicinal product document, and tell me if you're even allowed to say that!
"We're just waiting for the consumer to view your products as medicinal, then we'll jump in!"
Dr Chris Jones, then head of Borderline Medicines department of the MHRA, 2018, Cannabis Trades Association AGM, Warwick (Source: C. Jones, live sound engineer for the event)
Now all things considered, I feel that if the MHRA did state that CBD products are viewed as medicinal by consumers in the UK, there will be a backlash, but they have just released guidance for companies who are looking to grow unlicensed cannabis for medicinal purposes, and that's a complication at best.
It says 'unlicensed', but you need licenses to grow it. To get them, you have to go through a merry dance between the HO and MHRA, but on the whole it doesn't look like a problem for companies who have time, money, resources, and the infrastructure to get the ball rolling.
If you've got all of that in place, and you get granted the relevant licenses, then what? Well as mentioned the MHRA is funded by licensing fees from companies, and those fees in part will be used to protect the interests of the licensees.
Considering that cannabis products both high and low in THC are now easily obtainable through clinics, and that the list of conditions that cannabis is helpful with is almost unexhaustive, the only way you can protect those interests is either redefining CBD and cannabinoids as medicinal compounds, or by launching a serious clampdown on all companies who make unlicensed medical claims on their food supplemental products.
It's appropriate to mention that this clampdown extends to the criminal world, where the HO recently announces a three strike system that could lead to passports and driving licenses being removed from individuals. The madness is that the government will tell you that it's all about Skunk and THC, but there's 11 other controlled cannabinoids in the UK, most of which are owned by GW in some fashion, and the HO are trying to protect GW by stopping you having access to those 12 controlled cannabinoids, all of which are present in cannabis in varying degrees dependent on the strain grown, and curing methods employed.
Government Chemist Guidance Analytical Limits for Controlled Cannabinoids in Specified Products Containing Cannabidiol (CBD), Pub. Jan 2021
But back on track, and I feel that there is a clear danger, and I feel that Novel Foods may have been used to whittle out some undesirables, whilst the rest are all distracted from the true intent, and that is to complete a mission that was started back in 2016
What's more, there's excuses to perform such an action, and further to that it's not just about the interests of GW any more, although their 16 lab reports and 148 patents rightly or not put them firmly in the driving seat for medicinal cannabinoids in a journey that for them, started in 2001 when their first patent was filed.
But then it's also the 148 patents that means they should not be in the driving seat of Novel Foods, and the 16 lab reports from them and no one else to define requirements for CBD products within Novel Foods, as well as their undeclared interests within the Centre for Toxicity meetings that led to those 16 lab reports being used as the yard stick, raises questions of competitions and monopolies.
Do those patents have jurisdiction within the world of food?
No, which is why I believe it was at GW's behest that the MHRA tried to do what they did in 2016. If CBD is a medicine, GW's shareholders get better dividends.
And just who are the shareholders of GW? Who knows outright, but they themselves do claim to have a 20+ year strong working relationship with the HO, which may have had an influence in 2016, did have an influence in 2017 with Novel Foods Mk. 1, did have an influence in 2018 when the VMD were guided towards outlawing supplemental CBD products for pets, and did have an influence with the 16 lab reports and (allegedly) holding the FSA's hand in regards to MoDR and the application of the 1mg rule. They're also the ones who launched a consultation on controlled cannabinoids after the deadline for submitting Novel Foods applications on 31/03/21, after the then Police Minister Kit Malthouse called into question whether there was the potential to harvest or abuse any controlled cannabinoids within CBD products.
That's right, the Police Minister, who in turn reported back to the HO
GW/Jazz Pharmaceuticals submission to the Home Affairs Committee Enquiry on Drugs, March 2022.
This submission include mentions of a 20+ year working relationship with the HO, and more!
Further to the 20+ year strong relationship, GW stated that controlled cannabinoids were dangerous. In fact they are the ones who specifically say that from what I can see, everyone else is either 'cannabis', or 'THC', but GW are more specific. They have to be though, because they have those patents, with over 30 of them listing THC, and a fair few beyond that which include nearly all the other controlled cannabinoids in the UK.
I say the only ones, there are also the Association for Cannabinoid Industries (ACI), who were launched by the Centre for Medicinal Cannabis (CMC), and who I believe are funded by GW. They too called for tighter controls on controlled cannabinoids, and seem very active in promoting the UK as a potential powerhouse for medicinal CBD and cannabinoid products.
Their name suggests that they are a trade association, however they have recently admitted to being a members club, which means that when they say they are entirely funded by their members but don't give those members a vote, or publish their own financial records, they're not a trade association.
GW in sheep's clothing maybe? Well they did make their opinion known about testing methods and controlled cannabinoid levels for products, inconveniently after key deadline dates where such opinions could only cause further stress and uncertainty to companies who followed the rules, only to see a 'trade association' suggest tighter measures.
Earlier, I asked the question of whether GW has had any hand in the creation of the TIGRR report
Well if you scroll through the report, page 129 names The Centre for Medicinal Cannabis on the engagement list, who as mentioned launched the ACI.
You can take that as you like, but when I see joint reports from the ACI and CMC both promoting GW to a point that suggests collaboration, and further reports in political media from a co-founder of the CMC and ACI that reinforces that, all I would need is for said co-founder, whose neither got a presence of social media or on companies house, to mention at an industry event that he is a paid consultant for GW... which allegedly has happened, and indicates that there's a wolf in the flock, whose ulterior motive is to claim to be there for the industry, whilst actually working towards protecting GW's intellectual property. That being controlled cannabinoids, and promoting effective testing measures to ensure no one goes over new but as yet unannounced controlled cannabinoid levels 20 times lower than the current 1mg rule.
And if you want to see every antagonistic industry event that ties back to the ACI, and where they themselves suggest direct connections to GW, click here
There's further visible connections as well, in fact all you have to do is look into who has been championing the 'recreational vs medicinal' debate to the canna-community, and after some background checks, you'll find a few familiar faces tie back to GW. This will in fact be the basis of an article coming very soon!
But that's why I believe there will be a push to redefine CBD to a medicinal product, and all of those who do survive that will be 'compelled' to sell products that are made with isolates, and as far away from wholeplant as possible... because there's no money unless you starve people of cannabinoids, to the point where they go from a food to a medicine.
Which is why if GW maintain the level of influence that they have, there will probably never be a legalised or decriminalised recreational cannabis industry in the UK, because even by smoking it, cannabis can be that one apple a day that keeps the doctor away!
And of course, they'll get their way of getting more political direction on CBD products, which considering what I've outlined above is hard to imagine, unless of course that then opens the window for the full implementation of the intentions behind the TIGRR report.
And if you're still not convinced that TIGRR is the way forward
On 11/10/22 Open Access Government released an article called 'A blueprint for the UK Cannabis Industry', which was supposed to promote a document from the All Party Parliamentary Group (APPG) for Cannabidiol (CBD, although it turned into 'everything about cannabis', hence why labelled as a blueprint for...), but if you click on the link for 'UK cannabis industry' which is supposed to go to that document, it goes to a different article about the TIGRR report, which strangely was released AFTER the APPG's article in regards to their blueprint was released...
Think about that for a little
I contacted the Secretariat of the APPG to highlight this, which I was thanked for and assured that it was a mistake that will be rectified, yet 3 months later, their document is still replaced with that article that points towards the UK becoming a powerhouse for medicinal CBD and cannabinoid based products, the TIGRR report.
So come on folks, what are we going to do to protect CBD as a food?
Because whether you like it or not, something is on the horizon, and it doesn't look good.
And what also doesn't look good is the shyness of the big three trade associations, or two and a half on the basis of the ACI's status, in tackling these issues, or any other for that fact!
I mean, Novel Foods is something that they should have challenged, especially with the amount of validated products that weren't on the market on 13/02/2020, but there's not even a whisper, and I doubt there will be for anything else other than 'how to get through the Novel foods process'... I'm sorry, but none of them are working towards a better industry, they are thinking about their own means and agendas!
Right now I'm hearing of companies being questioned if their products are tested above 50 micrograms of THC by Trading Standards, that's despite the HO insisting for a few years that we as an industry were working by MoDR.
They did suggest to the CTA in 2021, just before (if memory serves) the Novel Food application deadline of 31/03/2021, that the 1mg rule doesn't apply whilst knowing full well, as they were 'holding the FSA's hand' on the 1mg rule and controlled cannabinoids, that many companies had submitted applications for full spectrum products with that 1mg rule in mind.
50 micrograms - Unfortunately for the HO that's not in law, so if Trading Standards do ever quote that figure, please do consider legal action against them should their threats lead to loss of sales! Until either MoDR or MoDA is adjusted to accommodate CBD products, their opinion is exactly that, an opinion!
This is all designed to tire, frustrate, and break you. They want you to hang your gloves up, so that when the MHRA steps in, there shouldn't be 12,118 products and associated companies to go through.
And you, the big companies, do you think you're immune from all of this?
You'd be stupid if you do, which is probably why I've heard from a few of them now saying that they're riding the wave, and prepping to supply the medicinal cannabis market, in the hope that a recreational market will arise where they could rake in more money.
But the recreational market won't come as it's a threat to GW, and the food supplemental industry will be clamped down on until it's a members only club, and if you don't think the licensing for unlicensed cannabis for medicinal use won't be a members only club as well, let me just say that it's interesting to see Tilray have stepped into the fruit and veg sector, and of course, their reasons for doing so.
That's why we need to come together, as an industry, and in one unified voice to say enough is enough!
Foods have a right to some level of medicinal and preventative claims, which is accepted in other countries, and the MHRA, FSA and GW cannot on the basis of sound science deny that cannabis is a food.
In fact, I would like to invite the MHRA, FSA, GW and of course the HO to a respectful debate on cannabis the food vs cannabis the medicine, and the right to restrict access from one until the need reaches another.
I am happy to fight this fight, but I really do need people behind me on this. It's one thing catching the FSA on the hop, and another questioning the intentions of the MHRA on the basis of 2016 and the TIGRR report, but going against the HO and GW... I need some numbers behind me for that journey, and certainly from those who believe that GW's influence within the hemp and CBD industry is neither wanted, or appreciated.
Stick to your own industry, and stop interfering in ours!
And I feel the same should be said in regards to their influence on restricting any emerging debates on legalisation or decriminalisation of recreational cannabis, so if you're one of those who saw the con of the 'recreational vs medicinal' debate, your support will be welcome too!
At the end of the day, and as far as I'm concerned, any politician who mentions Skunk is either being paid off, being fed information from someone who is paid off, or is just too scared to acknowledge that the public know more about cannabis than politicians would like.
Ok, there could be one or two that haven't seen the tax dollars pour in stateside since there canna-boom kicked in, and some might not have seen CBD products, or that the police are getting more lenient on those who are caught growing more plants than the HO view as within the parameters of 'personal use'. Some might not have heard of the Endo-Cannabinoid System, or hempcrete, or the potential for cannabis to help clean up soil and sequester large amounts of CO2 from the atmosphere. Some might be completely blind to the potential of cannabis, and scream 'reefer madness' whilst not knowing that compounds in cannabis can be used to treat those with psychosis... but I promise you, that number will be low.
Do you love what you do, the customers that you talk to, the power of the plant, that it has the potential to help, heal, and bring people together?
Yep, me to, so maybe we should all have a chat! I do mean everyone of course, even those who should be making the noises I am, companies in the canna-space who don't like what's going on, and the rizla warriors who think GW and the HO should back off.
We need each other in this fight to secure the hemp and CBD food industry, because cannabis as a food helps everyone in the grand scheme of things, and we need to stand together to define the parameters of what is and is not acceptable.
That includes when it is appropriate for one single pharmaceutical company to have the power they have over an industry where their patents mean nothing, what are acceptable claims that can be made on hemp and CBD based products, and maybe a referendum of the legalisation or decriminalisation of recreational cannabis in the UK... because whether you follow religious scripture, or evolution theory, we have a very long history with that plant, and no 'one company' should have the influence over a plant that GW does with cannabis!
Maybe we should also ask why there's still been no investigation into the potential conflicts that surrounded Mrs May, and especially Mrs Atkins, because the HO may say that she did declare her interests in her job interview, but really that should have been publicly available information through the list of interests for all MPs as soon as she was announced in her position, and not something that 'just happened' after the public became aware of that conflict!
That's nearly a wrap...
But before you go, I just want to tie in the Battleplans for 2023 from The Hemp Hound Agency.
The intentions are to pursue and Article 4 from the FSA, for cold pressed cannabis sativa L oil, and fight any move to change the definition of, or the requirements needed to get products validated as not novel. There is the potential for this, especially as there is a revue of the Novel Foods process underway.
It won't just be for a cold pressed oil though, it will be with the right to advertise the naturally occurring cannabinoid content on the basis of it being nutritional data, and for the sake of consumer knowledge and safety due to us all working with cannabis, SHOULD be advertised.
Then comes the part that the MHRA, or their customers at least, won't like
This is me, once again, stating my intention, and that I will be chasing those intentions like a rabid dog... only politely, and with enough first class evidence to back up the points I am making.
There's a lot of people who pay the MHRA for 'this and that', a fair few of them on the basis of maintaining the 1941 Pharmacy and Medicines act which allows them to rip up nature and patent compounds from herbs that grow naturally, and some of them have interests in cannabis... or cannabinoids because you can't promote the source material for that which you isolate or synthesise from!
Nearly 100% of those companies recognise cannabis as a traditional herbal medicine within research documents that conveniently are available online, which then raises the question of whether or not a low THC cannabis sativa oil, cold pressed, would qualify for a traditional herbal registration.
It's suggested that 'medicinal cannabis' was reintroduced to the UK in the 1840's, but that suggests that it was known before this in that capacity, and the good news is that I've found quite a lot of information to back that up.
I'll be looking for more of course
But what's of interest is that there's multiple points that suggest cannabis has been mis-identified, by genus, overtime within the UK, and that everything points to low THC cannabis as being used as a medicinal herb. That's not 'high THC', 'indica', or with any suggestions of reefer madness as high THC cannabis didn't seem to exist in the UK before the 1800's.
lets look at the term though - it's arguably more suited for the fibre aspect of the plant, as historical records portrait hemp as being low in THC but THC wasn't isolated until after 'hemp' was defined.
Hemp has been mis-labelled, it's not 'low THC cannabis sativa L', it's a plant that has been bred for it's fibre content, but that comes from a cannabis plant, and I'll bet you 20p that before the 1800's it wasn't below 0.2% THC, which is how people define hemp in the here and now.
3 to 7%, and there's more of an argument that ruderalis was grown in the UK (satisfying the 3% quote) rather than a sativa plants that had been bred to restrict its expression of THC. There's also suggestions that despite the THC content the plant was still consumed, and that oils from bud and seed were processed.
Hemp for fibre, cannabis for everything else! Have you hemmed trousers? Do you live near a 'hempstead', or other places with hemp in the name that had a history of growing for fibre, which in turn was used for rope and 'can'vas? Did you know that the latter was quoted as a big reason why Britain ruled the waves? Did you know there first Levi Jeans were made from hemp? Did you know that the US declaration of independence was drafted initially on hemp paper, and that up until 1914 money in the US was not just used for creating paper money, but the $10 bill from that time had scenes of hemp farming on there as well?
And let's be honest, that knowledge should be imparted because of the way the government has portrayed cannabis over the years, and how it still does today.
Case and point, at least for the public, who probably don't see too much of the other battle with the same players trying to make CBD and cannabinoids medicinal, or at the very least, restrict controlled cannabinoid levels to the point where access comes from medicinal products, GW's products, and not through a food supplemental industry, or through recreational consumption.
But we can all see the absurdity with Skunk, certainly when you can't go anywhere in the UK without falling over someone who's trying to flog you some Star Dawg.
If the politician's argument had evolved with acknowledgement of other more stronger strains of cannabis that have emerged in the near 25 years since Skunk last had a noticeable presence in the UK, they might have be able to suggest (to some) that they were in touch with the electorate, but instead, they fed a continuous and tiring line that gets people like me asking questions, and in the case of others, finding absolute proof of GW's strain of choice.
Well the FSA and EFSA both recognise cannabis sativa L and certain extracts as a food, an old food, and not a Novel Foods such as CBD or selective cannabinoid extracts are. That being said, if the MHRA does manage to define CBD as a medicinal compound, what would that mean for Novel Foods as a whole?
So is 'this' fair?
What, government agencies working together for the interests of one company by interfering with an entire industry??? Because that's what's been happening: 2016, two Novel Foods, restricted pet products, 1mg rule before Novel Foods but now it's secretly less than 50 micrograms (Enforcement has already started I hear, even though no laws are set to support such actions), question marks over lab testing requirements to ensure low controlled cannabinoid levels, and of course what I believe, the MHRA turning a blind eye to compliance to allow companies the chance to overstate their products to the point that the consumer views CBD products as medicinal, takes over from the FSA, and mops up...
As I said above, it's about time we all come together, agree on what needs to be discussed, and then talk to the relevant agencies about fairness, and how there's space for everyone!
Below is a screen shot of the reply from The Hemp Hound Agency to the MHRA in regards to the four submitted FOI, this article as well will be sent to them, as well as the FSA, HO and GW/Jazz Pharmaceuticals for comment.
For more information in regards to The Hemp Hound Agency, email firstname.lastname@example.org