The true extent of control

An opinion piece from The Hemp Hound Agency

"There are bodies buried everywhere, you just have to know where to look." Chuck Palahniuk

I'm not looking for bodies, but I am looking for skeletons in various closets, mainly ones that tie back to Novel Foods, the TIGRR Report, the Home Office (HO), and GW/Jazz Pharmaceuticals (GW/Jazz if the action was after Jazz brought GW, or just GW if it was an action before that).

I believe I may have found what I'm looking for, and it indicates that the HO might just be responsible for Novel foods 2017, as well as 2019, because they didn't like how things turned out the first time around...

...or at least GW/Jazz didn't, so they might have got the HO to direct the Food Standards Agency (FSA) to approach the EU to reverse their own 2017 distinction, so that it wasn't just CBD isolate that was classed as a Novel Food.

What's more is that they did this without the UK having a head of Novel foods at the time, and now the UK, EU and US are all looking at GW/Jazz lab reports which are being used to establish a regulatory framework for hemp and CBD products in their respective areas.

What if the HO actually did do that, effectively award a global market to one company who they happen to have a 20+ year long strong working relationship with, and what if the suggestion for this comes from the head of Novel Foods by way of a response he provided in regards to potential interactions between the Medicines and Healthcare Regulatory Authority (MHRA) and the FSA, and their intentions in regards to the Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) report?

And if they did initiate or influence Novel Foods twice, are we talking Ultra Vires?

On 09/03/23 The Hemp Hound Agency received a reply from the FSA in regards to a press request submitted on 25/01/23. The request itself was sent in to an FSA contact I have talked to before, as well as the FSA helpline email address, but it was replied to by the head of Novel Foods Mr Paul Tossall.

The request focused on the MHRA, the TIGRR report, and cannabinoids as a food v a drug. It's worth mentioning that it was submitted before and replied to after Deloitte were identified as winning a contract to independently review Novel Food Regulations.

The questions and responses are below, as well as my breakdown of Mr Tossall's replies. They are designed to be partly in response to Mr Tossall, as well as to inform the reader of events and relevant information on the topics below.

PT: Apologies for the time taken to reply on this. I have been searching for more conclusive evidence to answer your question on attendance and this took longer than I would have liked. As I was not able to find conclusive evidence either way, I have made suitable notes below to aid your understanding of the situation.

It's not often that I include pleasantries from emails in any article I write, but there's two reasons why I have in this case.

• It's a nice reply, and seemingly sets the response up in a friendly context, which I like and feel is missing from some government agencies, even when the questions are genuinely asked due to industry confusions and not from someone like myself trying to find answers to questions that aren't forthcoming.

• It means that his part in my public interest disclosure complaint has been investigated, at least the part where he's the focus, and it's probable that the findings will come back suggesting that he's done a great job, has not misled companies with vague replies, has not ignored evidence to show that companies have had products validated despite them not existing on 13/02/20, has ignored evidence to show that some products are more drugs than food in the eyes of the law, and has not resided over the Novel Foods farce as I have described it.

I could be wrong, but you know, there are others within the FSA who could have answered that press request.

Then there's the fact that as a named individual in that complaint (that as of today has yet to be concluded), is it appropriate he should he be emailing me? True the FSA's handling of the Novel Food process was specified, but other than Mr Tossall, I named no other FSA worker.

There could be an argument from his side that he's the head of Novel Foods, I've raised concerns, and attended and asked him direct questions at a couple of recent webinars, but they were industry focused, and he was announced as a key speaker on both. I also didn't ask any questions in regards to the public interest disclosure complaint, and out side of that I have not in anyway made contact with him since the FSA accepted my complaint on 08/12/22 as it would be inappropriate to do so.

I don't know how I feel about this at the moment, I guess I'll ask myself the question again when I receive the final report to my complaint, presumably at the end of this month.

1. Has there been any discussions between FSA and MHRA that focused on CBD products and the TIGRR report?

• No. The FSA proposed work to review the novel foods legislation (not just CBD but all novel food work) as part of the wider work on climate change and potential foods such as cultivated meats, insects, etc. The current legislation is sufficient for the needs of processing the early applications from the CBD industry,. The decisions on moving industry to compliance pre-dated the TIGRR work.

First thoughts:

I like that 'No', but then I don't believe for a second that Mr Tossall is part of every conversation, and there's always a head of the heads, if you know what I mean.

The 'proposed work' is also something I'm curious about, considering global movement I wouldn't be surprised if it was more a proposal from the World Economic Forum who seem to be influencing that push rather than the FSA.

Points of interest:

"(not just CBD but all novel food work)" - Ok, but please do direct me to another entire industry that's caught up in Novel Food uncertainty, and by that I mean with more than 10 companies in it. Do that and I'll happily tone down my commentary to said uncertainties, equally if the FSA were to recognise in some way that the hemp and CBD industry has been impacted by frustrations with the Novel Foods process, I'll do the same.

The FSA (Not Mr Tossall in this account) recently replied to a different press request where it was stated that a mention to a review of Novel Food Regulations first appeared on a document titled: The Benefits of Brexit (01/01/22). This document seems to be referred to in the context of an announcement, however I would argue against that being the case.

The press request in question focused on Deloitte, who were recently named as the winner of a contract to independently review Novel Food regulations, however, basic background checks revealed that they could be viewed as far from independent, and have connections to GW Pharmaceuticals, Jazz Pharmaceuticals, the acquisition of GW by Jazz, and ties to British Associated Food who own British Sugar, and in turn grow hemp under contract for GW/Jazz. Everyone of those companies has an interest in redefining Novel Food Regulations to a point where it's harder to describe CBD and all other cannabinoids as a food.

The same response also included two links, both to certain points in the governments public contract tender site, and both are treated in a similar context as the 'Benefits of Brexit' document... it's 'expected' that you know of these things, and not so much that the regulatory authority in that area who has a duty of care to inform people of change, or contracts that could facilitate change, tell you of them.

If the Novel Food Regulations review wasn't about CBD in anyway, why be so secretive, why not turn around to the hemp and CBD industry and tell them? We know that Novel Food Regulations need an overhaul, but bringing about those changes through cloak and dagger manoeuvres???

The FSA did not help it's case in anyway by not announcing the contract when it was release (03/10/22), not announcing it when it was won (12/12/22), and saying nothing to the hemp and CBD industry (barely, if you can count a LinkedIn post as an announcement) until 15/02/23 despite the contract concluding on 28/02/23.

In fact it's not just the hemp and CBD industry, where has any industry under the care of the FSA been directly told of a review of Novel Food Regulations?

Eating bugs, fake meat, protecting the environment... we know that there's a push in those areas, but none of them separately came with the mention of reviewing Novel Food Regulations. Genetically modified organisms being used to create foods for example didn't require changing Novel Food Regulations, that just required an act of parliament, although I do believe that synthetic CBD products were riding off that legislation before it existed, and I also believe that this is why synthetic CBD is deemed as the same as isolated, plant derived CBD, even though it isn't.

The point of this question was to determine whether or not the FSA and MHRA had been talking about CBD products within the context of the TIGRR report, and was submitted before the discovery of Deloitte winning the contract to review Novel Food Regulations, and you've got to wonder if they were briefed on TIGRR before they started. If they were, there'd be little point in the MHRA and FSA talking about CBD products before any consideration of Deloitte's review.

The current legislation is sufficient for the needs of processing the early applications from the CBD industry - 'early applications'... 'early'... What's that all about?

The only 'early applications' I can think of are maybe those that had products validated before we had a sea of 'awaiting evidence', and in some cases, before the products even truly existed. They're also more than likely to be from companies who indicated to the FSA that there was no need for an extension to Novel Food deadlines, because the Covid lockdowns weren't hampering their progression in creating Novel Food applications by all accounts!

It's a very conspicuous word, 'early', and I would invite Mr Tossall to explain what he means by it.

Then we move to 'sufficient for the needs', and that seems to be a recent development, unless we're still talking about early applicants.

Mr Tossall spoke on two webinars in January this year, the first was for the Cannabis Industry Council (CIC), which was followed shortly after by the other for the Association for the Cannabinoid Industry (ACI). In the former he stated that there would be no more validated products until well into next year (2024), but then he heard Steve Moore of the ACI say during their webinar that there would be products validated 'this' year (2023) and didn't correct him, so something happened in that week that accelerated the validating process.

This was confirmed on 14/03/23 when the ACI released this statement.

So what do you reckon changed in that time? Everyone had their toxicology data in by then, looked at, and was on standby, so what clicked at FSA HQ to lop off a whole year and validate some products?

I say validate, the FSA are yet to update the public list for CBD products, and as of midday on 19/03/23 it still shows 131 validated products. I also said 'everyone had...', but I am aware of some products still not being listed by the FSA despite applications being submitted on time, or 'early' if it was more than a day before.

Regardless, this is movement, and I should feel happy, especially as one of these companies happens to be a member of The Hemp Hound Agency, but I'd feel a lot happier when others also have had their products validated. Two applications with under 30 products combined after all barely scratches the surface of the FSA public list, which contains 12,115 products in total.

I'd be very ecstatic if this signals an opening of the floodgates, but... and I feel that I have to say this... I would be most confused and frustrated if we see a couple of validated products from each consortium application, only to then be told that there's more missing data, and that the clock has to be stopped until late next year.

It has to be noted that the ACI recently laid off a lot of staff, presumably due to cashflow issues, even though it's suspected that they're paid opposition within the hemp and CBD industry. Certainly their previous actions suggest this to be the case, and there's more than one or two links to GW/Jazz. So what if... hypothetically of course... a members club masquerading as a trade association (because that's what they are) turned around to the FSA and said "Validate some products, or we're gone!"?

There is reasonable justification for this thought, just as Paul Tossall was placed in his job on the start of Novel Foods in January 2019, the Centre for Medicinal Cannabis (CMC) created the ACI at the end of that year, not long before Novel Food Deadlines were announced, and strangely they had the ear of the FSA from the point of inception. The ACI have been controlled opposition to the industry from the get go, the 'industry voice' that provides legitimacy for the push for where ever Novel Foods is taking the hemp and CBD industry. If they folded, things would be different. The balance of power would shift, and the FSA would have to engage with the wider industry that it's been neglecting throughout the Novel foods timeline, and they wouldn't want that... hypothetically speaking of course.

So in essence, there is a chance that these validated applications are to help the ACI maintain a level of relevance. There's only one way to dispel that concern though, and that is by validating products from applications not associated with the ACI, and that by extension we now see that list moving steadily from a sea of 'awaiting evidence', into an ocean of 'validated' products.

Back to TIGRR though and I've still no doubt in my mind that it spells 'regulation' to your average humble dyslexic person like myself, and I don't even need to squint to see it. Mr Tossall is right that regulation came before the TIGRR report, however I believe that this is a formality. I believe that TIGRR in essence existed before 'regulation' in the sense of Novel Foods, the intent to give the MHRA control over CBD and cannabinoids in a medicinal context was shown in 2016 barely months after the conclusion of a trial by GW. Novel Foods 2017 and 2019 I believe only happened because the MHRA were unsuccessful in defining CBD as a purely medicinal compound in 2016, and when you read question 2 you'll see how Novel Foods on both accounts was seemingly 'encouraged' by the HO.

2. In 2017 the Home Office approached the FSA to ask that all cannabinoids were deemed as Novel Foods, the then head (I believe) Ruth Willis informed the Cannabis Trades Association of this, which they relayed to their members at that years AGM. Can you confirm whether or not GW was part of that conversation?

• It is not for the Home Office to deem a food novel or not, or to ask a food to be defined as such. This did not happen. The FSA owns the legislation that sets out the definitions of a novel food. The definitions in the legislation set out what constitutes a novel food; the first time a CBD product was placed on the market it became a novel food. It is my understanding (not having been involved with CBD or novel foods at this time) that the Home Office did seek clarification on whether they were novel foods. I am informed this is because to grant a licence to handle controlled substances the Home Office need to have a legal route for putting the resulting product on the market. These questions combined with discussions with some CBD businesses also asking if CBD was novel led to discussions with the EC that resulted in the clarification at the EU Working Group in January 2019.

• I am unaware of who was in the meeting you asked about. I tried to find any records of who was at the meeting but could not so; it is from others’ recollections that it is my understanding that GW was not a member at that time and not present at this meeting.

First thoughts:

Lets not even touch on whether GW was in that meeting or not, and only focus on the HO.

They did approach the FSA for distinction, but not to pressure them into defining all cannabinoids as Novel. But that as well as a few companies asking about the novel status of CBD/cannabinoids then led to the FSA approaching the EU to not just reverse their own 2017 distinction, but also plunge the whole EU into Novel Foods chaos... is that what you're reading as well?

Point's of interest:

"It is not for the Home Office to deem a food novel or not, or to ask a food to be defined as such. This did not happen." - That's confusing, especially as I have a direct quote from Guy Coxall who was the compliance director for the Cannabis Trades Association (CTA) at that time, and was one of those who was invited to talk to Mrs Willis about Novel Food for CBD products in 2017.

"In 2017, Mike Harlington (then Chair of the CTA) and myself (then Compliance Director of the CTA) attended a meeting at the FSA with Ruth Willis (then head of Novel foods) to discuss the Novel Food status of CBD products. Although at the time only CBD isolate was considered Novel due to the extraction process 'beyond a full botanical extract', she expressed concern that the Home Office had been placing pressure on the FSA to consider placing all cannabinoids as Novel." Guy Coxall, ex-compliance director for the CTA

Expressed concern...

"It is my understanding (not having been involved with CBD or novel foods at this time) that the Home Office did seek clarification on whether they were novel foods." - So contact was made, but lets just consider further what's been said by Mr Tossall.

He was effectively Mrs Willis' replacement, although there is a rather interesting gap between September 2018 when Mrs Willis was moved on from being head of Novel Foods, to January 2019 when Mr Tossall assumed the role.

I remember this time very well, and recall thinking that 'something' was about to happen. Lo and behold, Mr Tossall was appointed as head of Novel Food right off the bat of Novel Food 2.0. This article here shows Mr Tossall on 12/01/2019 being quoted in his then capacity as the head of the Allergy and Intolerance Scheme three days before the 15/01/2019 EU announcement on the novel status of cannabinoids.

Was he placed in that position? It's a fair question, the timing of everything is too convenient after all. Mr Tossall assumed his position right about the time of that EU announcement, but why didn't he when Mrs Willis left four months beforehand?

As for Mr Tossall stating that he wasn't in the industry when the FSA and HO had a meeting in 2017, that may well be the case, but there's no way that someone would get a job like that without a level of briefing beforehand. That briefing should have included Novel Foods 2017, and notification that from that point up until January 2019 only CBD isolates were deemed as Novel Foods due to the extraction process.

Mr Tossall doesn't acknowledge that though, but what he says next is of serious concern.

"These questions combined with discussions with some CBD businesses also asking if CBD was novel led to discussions with the EC that resulted in the clarification at the EU Working Group in January 2019." - So was it between September 2018 when Mrs Willis was reassigned, and January 2019 when Mr Tossall was appointed, that the FSA approached the EU with concerns raised by the HO? Yes it was!

Just before Mr Tossall states this, there's a sentence of interest that feels like it should have been after the part in regards to the EU - "I am informed this is [the reason why the Home Office contacted] because to grant a licence to handle controlled substances the Home Office need to have a legal route for putting the resulting product on the market" - The concerns I have with that is that the HO have only just (2020ish) pulled together all the license requirements and fees onto one web page, and I believe they are still to award a domestic extraction license (without being tied to an R&D project) to anyone other than GW/Jazz.

When it comes to anything extraction related in the UK, the HO have always been against it, but it's not the only thing that they've been against, and now we know from Mr Tossall that they had input of sorts into approaching the EU to ask for a second opinion on CBD products.

Novel Foods according to the FSA is a legally binding agreement between the EU and all member states. The UK made a distinction in 2017 which stated that CBD isolates were Novel, and full or broad spectrum extracts weren't, so does that mean that the FSA asked the EU to revise that distinction on the behest of the HO?

If the FSA did that, wouldn't it mean that Mr Tossall's response of "It is not for the Home Office to deem a food novel or not, or to ask a food to be defined as such. This didn't happen" is stating what should have been the case, but not what actually occurred?

It wouldn't be the first case of the HO advising other government departments, the VMD for example outlawed CBD pet products in 2018 purely off direction from the Home Office and without consulting any studies or veterinary professionals with knowledge in this area, but the Home Office have no powers over such products (Ultra Vires?).

Then there's the tag team they seem to be part of with GW/Jazz to consider, who they've had that 20+ year strong working relationship which basically works by the HO demonising Skunk, as it protects the Skunk that GW/Jazz grow, as well as the hemp that British Sugar grow to supply GW/Jazz with all their CBD needs.

Regardless of how you look at the picture, the HO is there at the back, prodding the likes of the MHRA, FSA and VMD with a stern scowl on their face that says "play ball, or else!". Are they the puppet master though? Of course not, that would be GW/Jazz... the ones who grow skunk, who had their first patent for CBD awarded in 2004, who (I believe) approached the MHRA in 2016 to try and get them to define CBD as a purely medicinal compound, who (I believe) got the HO to approach the FSA in 2017, and who probably sent the HO back to the FSA in 2018 (most likely from September after Mrs Willis had been reassigned) to talk about approaching the EU to get cannabinoids defined as Novel in October 2018.

There's more I can touch on there, especially when it's specifically to do with GW/Jazz's relationship with the HO. Insisting on the 1mg rule (Misuse of Drugs Regulations (MoDR) '01 Sect 2) right up until January 2021 when the CTA held a meeting with the HO, only to then suggest that MoDR doesn't apply, and then seeking recommendations for levels of controlled cannabinoids within supplemental grade products from the Advisory Committee on the Misuse of Drugs (ACMD) after then police minister Kit Malthouse questioned whether people could harvest them for more illicit use.

Doing so 2 months before the 31/03/21 deadline for submitting Novel Food applications... we all know that there was nothing innocent about it, just as there wasn't when the HO questioned testing requirements to ensure an accurate reading when testing controlled cannabinoids at very low levels.

Why do that, and whilst a whole industry is going through a process where these kinds of changes could have a detrimental effect on their businesses? There is only one reason, and it comes with 16 lab reports for a pharmaceutical grade extract that's being used to clampdown on the hemp and CBD industry.

In essence, this is what I believe the reply to this question should be:

"The Home Office asked for a distinction on whether or not all cannabinoids were Novel Foods in 2017, but the FSA said something that the Home Office, or GW Pharmaceuticals, didn't quite accept, so the Home Office came back in 2018, with 'some companies' to try again. This involved removing the then head of Novel Foods from her position and talking to the EU one month after to get the original FSA distinction on cannabinoids by the removed head of Novel Foods from 2017 revised so that it's not just CBD isolate that is Novel, and then we shared 16 lab reports from GW with EU member states so that their influence means that GW/Jazz have a stranglehold over the plant... because they have a big interest in 'food safety', and then we appointed a new head of Novel Foods." Alternative response from the FSA, sourced from The Hemp Hound Agency

That October 2018 meeting though, it's another case of the FSA failing to communicate anything about important movement within the hemp and CBD industry. As with Deloitte's contract to independently review Novel Foods Regulations, I believe the FSA should have consulted the industry in regards to redefining CBD as a Novel Food before approaching the EU. I mean, they couldn't really, I suspect that Mrs Willis knew nothing about the concerns of the HO and the CBD companies Mr Tossall mentions, but then she had been removed from her position one month before the EU meeting that led to all CBD and cannabinoid extracts being defined as Novel Foods, and of course Mr Tossall wasn't instated until the official announcement from the EU was made.

"I am unaware of who was in the meeting you asked about. I tried to find any records of who was at the meeting but could not so; it is from others’ recollections that it is my understanding that GW was not a member at that time and not present at this meeting." - So there 'was' a meeting, were certain requests may or may not have been made, but no records were kept of it... Considering we're talking about the Civil Service now, that's very concerning!

Then we have "GW was not a member at that time", what on earth does that mean, member of the board, member of a secret FSA club that we can't find out about online, what exactly?

There is the possibility of other members being associated with GW, undeclared conflicts were discovered within the Centre of Toxicity (CoT) meetings that led to GW's 16 lab reports being used against an industry, and that was due to connections with Reading University. Another has possibly materialised, from Reading University within the Advisory Committee on Novel Foods & Processes (ACNFP). The professor, who I won't name, was appointed (I believe) on 07/07/22, but there's no mention of being tied to a university that has heavy links to GW within his listed interests, and the ACNFP will be the ones who determine how wide the Novel Foods door opens to that public list with over 12,000 products on there.

Mr Tossall refers to any presence of GW in that meeting, but I want to take you back to the implied pressure from the HO, and Mr Tossall's statements of "it didn't happen" and "others' recollections".

Mrs Willis, who I think still works for the FSA, stated to more than one person that there was a perceived pressure from the HO to define all cannabinoids as Novel. Why would she do that if it wasn't happening, and more to the point, who directed the HO to contact the FSA and apply this pressure?

GW (not GW/Jazz at this point) may or may not have be in that meeting, that there's no records of, but their interests were, as can be seen now with 16 lab reports, undeclared interests in the CoT meeting that led to those reports holding prominence, and an EU lobbying document that shows they have an active interest into food safety... amongst other things of course.

Why not ask her if she felt that 'someone else' was in that meeting other than her and the HO? It sounds like there was, especially if it's not in the HO's place to dictate to or pressurise the FSA into defining any food as Novel.

That being said, I don't want her to get in trouble for doing her job. I fear that may have been the case in 2018, yet from all accounts she seems to be a nice and genuine person... maybe that was the problem, or maybe she was replaced because she didn't keep records, who knows.

Then, as we're going by recollection, we have the quote from Guy Coxall, who I believe to be of sound mind. He was at a meeting, in 2017 with Mrs Willis, presumably shortly after she had a meeting of sorts with the HO, and who according to Guy Coxall expressed a concern that the HO were pushing for all cannabinoids to be defined as Novel Foods.

Then there's my recollection, and when it comes to the history of Novel Foods, I feel like I could be defined as an expert on the topic.

My work history is known, as is The Hemp Hound Agency. In 2017, my wife and I went to the CTA AGM and heard the then chairman Mike Harlington state that they (CTA) had talked to the FSA, and that there was a push by the HO to define all cannabinoids as Novel, but that the then head of Novel Foods had accepted that to be the case with isolated CBD, but not with wholeplant full or broad spectrum extracts. I then started working for the CTA from 2018 and often liaised with Mr Coxall, and watched the Novel Food saga unfold from there.

It doesn't take a genius to know that Mrs Willis' distinction did not fit someone's agenda being that Novel Foods for CBD products is the polar opposite to that of 2017, and if you really want to stretch your imagination, there are a few reasons why it could be assumed she was got rid of so that any approach to the EU would be hidden from the hemp and CBD industry. Mrs Willis after all did communicate a concern to the CTA, who in turn communicated that concern to the UK hemp and CBD industry at the time.

Then there's the fact that Novel Foods from 2017 wasn't policed, and when it comes to the emergence of the CMC and ACI, it was outright ridiculous. The rise of isolate based products gained momentum, and the FSA stayed quiet, that is until 2018 where they approached the EU to reverse their own distinction and place the UK and EU hemp and CBD industry in turmoil off the back of the HO and 'some' companies asking whether or not CBD was Novel...

My biggest frustration with this reply though isn't so much that there's questionable moves at play going purely by the response, it's that despite Mr Tossall stating "it is my understanding that GW was not a member at that time and not present at this meeting.", it's clear to see that the FSA either willingly or otherwise opened up the UK and EU hemp and CBD industry to attack from what could be described as the sole competitor to that industry, and they did so by going back on a previous position that for one and a half years meant that hemp derived wholeplant full and broad spectrum CBD products were deemed as not novel.

There is something that's come out of that frustration though, and that's in regards to 'secret meetings' held in regards to Novel Foods, when there's no head of Novel Foods, in October of 2018. Funnily enough that's the same month that Theresa May (then PM) and Victoria Atkins (Drugs Minister) were reported to have conflicts of interest with cannabis. It's also one month after the VMD were advised by the HO to outlaw CBD pet products, and one month before the legalisation of medicinal cannabis in the UK.

Is it fair to say the HO had a busy couple of months then?

It's that meeting though, I've been wondering when it was, and it all came down to a quote from Chanelle McCoy from Pureis after her products had been validated despite not being available before 13/02/20 as fully tested products.

She said words to the effect of "we all knew what was happening in January 2019, I have no sympathy for companies who're struggling with their Novel Food Applications"

What did 'we' know though? I can tell you what 'I' know - any announcement of a meeting passed me by, but then I had only worked for the CTA for four and a half months by the time anything was said in January. It must of slipped everyone else by too though, because the uproar when Novel Foods was announced was big, but there was an opportunity for the industry to meet at Brussels in March of that year to argue against the announcement.

If there's a meeting like that, you'd like to think it means that nothing is set in stone, especially as every stakeholder (practically) in the UK and EU hemp and CBD industry was invited to attend. It seems like it was just for show though, because the decision even though announced in January 2019 was actually made in October 2018, after the FSA had been questioned on the Novel Status of CBD products by the HO and a couple of companies, possibly after Mrs Willis was repositioned in the FSA and her position left vacant until Mr Tossall was installed.

If I'm right, then the HO were more than just busy, they were redefining the landscape for cannabis at EU level. And if it was them who orchestrated all of this, then the CBD companies Mr Tossall also eludes to are probably known to the HO, and the only companies the HO wanted to know in regards to cannabis back in 2018 is the two that were identified as having links to May and Atkins, and that was GW and British Sugar respectively.

Of course you'll always have your groupies, and that's where your Cannaray's, Pureis, Bod Healthcare and whatnot come in. I've mentioned in previous articles how they all have pharmaceutical ties which in essence puts them in the inner circle, they'll play by the rules and adapt where needed, knowing full well that the little companies won't be able to keep pace.

They probably knew that there was a meeting in October 2018 to discuss reversing the UK distinction of only CBD isolate being a Novel Food, and probably knew as indicated by Chanelle McCoy that the announcement in January 2019 'was' set in stone, and they all were probably the companies who indicated to the FSA that there was no need to extend Novel Food deadlines as the industry wasn't being affected in anyway by Covid lockdowns.

Everyone has their part to play, just as the ACI do with the FSA by being the only 'trade association' to truly endorse Novel Foods. It gives the FSA's direction an easier ride if some industry body embraces their actions, just as the 131 validated products out of 12,115 are being embraced by the chair of the FSA to claim that Novel Foods for CBD products is a roaring success so far.

"the first time a CBD product was placed on the market it became a novel food." - Unless of course the FSA stated that they're not a Novel Food, which was the case in 2017 when a CBD industry had already been established, so did the HO ask the FSA on behalf of GW for all cannabinoids to be defined as Novel, only not to get what they wanted, so pushed for one that suits the needs of GW/Jazz?

If they did, then at what point are we talking Ultra Vires?

3. This one is one I'm struggling with in regards to research - can you tell me if there is any point where drug law in the UK can influence the sale of legitimate foods?

• A food is defined as something designed to be eaten that is not a narcotic (there are other exemptions too). So, in this manner drugs law does influence what is legally considered a food. There are many legal requirements for food so the “legitimate food” would depend on what part of food law you are referring to when you call them legitimate. Edible products may not qualify as foods due to the presence of illicit substances. CBD is an unauthorised novel food so technically is not ‘legitimate’ on these grounds. Other food laws will take into account the definition of food.

First Thoughts: Outside of Novel Foods, this is the type of question I feel I should be asking. It's sensible, and I like Mr Tossall's response as it can lead to a debate on all cannabinoids being defined as 'legitimate foods'.

Is cannabis misrepresented in law? Yes, and for a myriad of reasons, and that's before the fact that the side effects of recreational use the politicians are fond of quoting are more associated with CBN rather than THC.

Is that or any of the reasons as a result of the actions of Mr Tossall? I very much doubt it, but he is the point of contact for these things, and if there was ever the chance to discuss the validity of all cannabinoids in a supplemental format having the right to be defined as a food whether Novel or not, I would jump at the chance.

Of course if that was to happen, I'd like to give Mr Tossall a rundown of where I'd go. CBN isolated in 1898, CBD in 1940, THC in 1964 (RIP Dr Raphael Mechoulam), the ECS discovered in 1988 (point where cannabinoids can be argued as foods), and Novel Foods Regulations starting in 1997.

There's also the point of GW whose first patent for CBD was granted in 2004, so it was a food before a medicine, and if there is still the issue of illicit substances also being foods, surely retained EU Regulation 1881/2006 Article 2 Sect 2 means that the FSA chooses a safe level for consumption (Think poppy seeds) rather than the HO.

My final point would be simple, CBD and other cannabinoids are arguably having major impact on medical conditions, however some of them may or may not exist as a result of someone's Endo-Cannabinoid System being starved of a legitimate food...

I think it'd be a good debate, absolutely, and I say debate in respect of knowing that Mr Tossall can only do his job, and it would take a bit more than just a debate to effect any change.

But back in the room for Novel Foods...

Points of Interest:

Would it not be fair to say that CBD products 'were' legitimised in 2017 when Mrs Willis defined and announced wholeplant full and broad spectrum products as not novel to the CTA?

Then of course, why haven't the companies identified with validated products that exceed the 1mg rule in my public interest disclosure complaint had their wares removed from the FSA's public list?

This is why there's a real fear with the FSA awarding Deloitte a contract to review Novel food Regulations, we obviously have the fact that their connections include everyone who would directly gain from CBD being a medicine rather than a food, but also because there was a specific part of the contract that said there would be a partial focus on what can be defined as a 'not novel' food, and when an Article 4 submission would be required.

Now Mr Tossall and the FSA say that the review in question isn't about CBD products, and on paper it isn't, but reading between the lines will show you that there's loose ends to tie up, which will ultimately restrict the industry to ultra pure CBD products, and not the likes of full spectrum products, or wholeplant cold press hemp oil with a naturally occurring cannabinoid content.

I know... forever the optimist, right? It really doesn't help either when the FSA awarded a contract to Fera Labs to test 100 products on the public list, and to report any products that go against the ACMD's 2021 advice to the HO that works on 50 micrograms of controlled cannabinoids per serving, and not the 1mg rule (MoDR).

If memory serves, the HO told the CTA that MoDR doesn't work despite their 2019 CBD and Cannabinoid fact file still not being amended, and that the Misuse of Drugs Act 1971 (MoDA) would have to be revised to accommodate the ever growing CBD industry. That amendment has yet to materialise, so shouldn't we still be working by MoDR? Please keep this in mind for Question 5!

4. Has the FSA been in communication with the FDA either in regards to the UK's progress of Novel Foods, or in regards to their own plans for regulation in the US?

• The FSA has links to the FDA and other international regulators to exchange information and update on plans going forward. With regard CBD we met with them after we announced our plans to bring the industry into compliance. The decisions on progress with the public list have been made solely by the FSA; we have not consulted with the FDA on these plans and similarly they have not sought our input into their decision making on handling CBD products. We note with interest the recent announcement that they are seeking further powers to be able to enforce CBD products in the US.

First thoughts:

I feel that I need to remind you that this press request response was sent in before it was discovered Deloitte had won the contract to review Novel Food Regulations, and what the terms of that contract were.

The review will consider the national and international regulatory landscape, and present potential options for a Novel Foods Regulatory Framework assessing the benefits, limitations, risks, opportunities, resource, and time implications as well as the impact on industry and consumers.

The initial request was in regards to the MHRA's historic intentions with CBD products which is ultimately to define them as medicinal; they tried in 2016, said they were waiting to try again in 2018, and a recent webinar from the ACI showed a document were the MHRA 'reserved the right' to define CBD as medicinal.

They're also mentioned in the TIGRR Report as being primed to reside over the UK becoming a powerhouse for medicinal cannabinoid and CBD based products, I believe that this would have benefitted GW/Jazz the most, and it's of interest that Jazz brought GW one month before TIGRR was released. This is why I've always believed that there is a road to unify regulatory paths, GW/Jazz have US companies engaged in a patent war, and the Food and Drug Administration (FDA) have reaffirmed their stance that CBD and THC are medicines and not foods, whilst stating that they've been looking at GW/Jazz lab reports.

Then there's this...

"We note with interest the recent announcement that they are seeking further powers to be able to enforce CBD products in the US."

Why though?

The FDA's issue is state vs federal law, the FSA don't have that problem and have Trading Standards representative offices in over 100 areas.

Is it because they found some lab reports in a Kinder Egg as well?

I know, they're illegal in the US, but a regulatory authority regardless of country stating they've looked at GW/Jazz lab reports always leads to 'regulation'. We've seen it in the UK, the EU, and now comes the turn of the US when Congress find a way to protect GW/Jazz's interests... I mean, define all cannabinoids as medicinal... No no, I meant bring about regulation through securing missing data sets to ensure the safety of cannabinoid based products whether food/dietary supplemental or medicinal in context... with GW/Jazz lab reports...

Points of interest:

I remember seeing a document, possibly even an article that stated the FSA and FDA had a chat after Novel Foods was announced. Was this when GW was introduced to the FDA?

We're talking about the time that Brexit was on everyone's lips, and a trade deal with the US was being shaped. That trade deal came with IP protection rights for pharmaceutical companies on both sides of the pond, and possibly led to Jazz acquiring GW for a more than reasonable price.

We're also talking a time where the FSA went to the EU and asked for all cannabinoids to be defined as Novel Foods, and they would have had to have taken some proof with them to justify their request. Was it 16 bits of proof maybe?

The UK, EU and US have all quoted from GW/Jazz's lab reports for the extract used to create Epidiolex, that initial dance is done. Now all you need is Deloitte to deliver suggestions on how a globally advantageous regulatory system would best benefit the UK's TIGRR intentions... and the US what with them owning GW now, and the EU as they're also using GW/Jazz IP to govern their Novel Food requirements.

I don't think I need to go further with this point.

5. Has the FSA in anyway indicated either to CBD companies or trading standards that there has been any change in the status of the 1mg rule (MoDR '01 Sect 2).

• The 1mg rule is one of the three limbs described in Home Office guidance for CBD consumer products. Any changes to this guidance or related legislation would be for the Home Office, not us.

First thoughts:

Interesting...

Points of interest:

Do you remember that Fera labs contract I mentioned above? Over £160,000 to test 100 products that the FSA placed on the public list.

Some say that Fera are a pseudo-government lab, and others like myself question the amount awarded for testing 100 products.

The contract comes from the FSA, and it clearly states that products that breach the ACMD 'advice' to the HO need to be reported within 24 hours to the FSA - now the HO hasn't formally announced that we're not following the 1mg rule any more, so why would the FSA release a contract that doesn't state products have to be defined against MoDR?

Has the FSA in anyway indicated either to CBD companies or trading standards that there has been any change in the status of the 1mg rule (MoDR '01 Sect 2)? -Well they've told Fera Labs, and I know that Trading standards have enforced on the basis of 50 micrograms per serving, so were do we go from here?

Conclusion

Ultra Vires...

Has the the HO influenced the FSA when it comes to Novel Foods? I believe they have, and Mr Tossall's reply indicates that.

Did the HO approach the FSA in 2017? Yes, but there's no records, only the recollections of people who attended a meeting were the meeting beforehand was referred to, as well as the recollection of myself and others of when the people who attended the meeting, after the one with the HO, indicated clearly to industry stakeholders that the HO were trying to get the FSA to define all cannabinoids as Novel Foods.

Mr Tossall states contact with the HO was to determine their direction for extractions and handling licenses, but there's no records to verify this, and it took the HO two years from that point to release an updated webpage that pulled in all the relevant licenses and prices.

But the HO did ask for a distinction on the Novel Status of cannabinoids, and that question, which was also asked by 'some CBD companies', led to the FSA approaching the EU to ask that all cannabinoids were deemed as Novel Foods, against the distinction made in 2017 by the ex-head of Novel Foods one month after she had been reassigned elsewhere.

So who represented the UK's interests at that meeting if there was no head of Novel Foods, was it the HO, or FSA workers that were directed by the HO with 16 lab reports ready to hand out to EU member states barely one month before the legalisation of medicinal cannabis in the UK?

Basic timeline:

2016 - GW finished medical trials in May, in September the MHRA stated they were looking to redefine CBD as a purely medicinal compound only to step back in October due to the public backlash.

2017 - Mrs Willis, then head of Novel Foods held a meeting with two ex-employees of the CTA, and explained that isolated CBD was Novel. She then indicated that the HO were pressuring her to define all cannabinoids as Novel, which the CTA employees then relayed to there membership at that years AGM, and then the wider industry through other interactions.

2018 - Mrs Willis was relieved of her post as head of Novel Foods in September, in October the EU Committee on Novel Foods met to discuss the status of cannabinoids as a Novel Food, at the behest of the FSA, but without a head of Novel Foods. This was due to some companies asking about the Novel Status on CBD products, as well as the HO, who allegedly needed to know for extraction and handling licensing purposes.

There was no announcement that the FSA intended such an action to the hemp and CBD industry beforehand.

Also of interest in this year was the HO guiding the VMD into outlawing CBD pet products (September), May and Atkins were identified in the press as persons with conflicts due to their links to GW and British Sugar (October), and medicinal cannabis was legalised in the UK (November).

2019 - The 15th of January was when the EU announce the change in Novel Status for cannabinoid extracts and associated products, with Mr Tossall being installed as the head of Novel Foods about this time.

I firmly believe now that there is more than enough evidence to confidently say that the HO have been working outside of their field of influence, and for the benefit for one company. That's not just Ultra Vires, that's also market rigging!