Public Interest Disclosure update
From The Hemp Hound Agency
On 21/09/2022, I received a reply from the FSA in regards to the Public Interest Disclosure that was launched on 15/07/2022.
In that disclosure, complaints were raise in regards to:
Companies with validated products that weren't available before 13/02/2020
Companies whose products breach MoDR 2001 sect 2 (1mg rule)
The Monopoly Market that has emerged from Novel Foods for CBD products
Food crimes which I believe are being either endorsed or committed by the FSA's handling of Novel Foods
The FSA has replied twice, on 18/08/2022 and of course one week ago. Both times I have been asked to refine my complaint as there seems to be uncertainty of what exactly the FSA are being accused of.
Here is the PDF file of the initial complaint.
You can find their reply below, as well as the response from The Hemp Hound Agency:
Dear Mr Sykes,
I trust this finds you well.
Please accept my apologies for not coming back to you sooner, It has been a hugely busy week!
I have gone through your email and have added some notes below which hopefully help in clearing up any confusion.
Having spent some time reviewing the contents (which extend to over several thousand words and include over 50 links), I am afraid I have to report that I am still not fully certain what exactly you are accusing the FSA of doing, or not doing and when and by whom.
I feel I have been clear enough, in fact I sought advice from several legal entities on this matter, as well as in regards to the format of the document itself.
Forgive me for saying this but I'm dyslexic, so putting any of this together takes me a considerable amount of time. I put it in a format I felt those in the CBD industry would understand, and that would be easy for me to explain should I be offered a call to discuss my concerns further.
So far you're the only person who has indicated to me any uncertainty in regards to the refined document that you asked for, which is surprising, but to be as clear as possible, I am concerned that the very FSA Guidelines put out around Novel Foods for CBD Products are being breached by a few companies, which has led to the FSA either knowingly or unknowingly validating their products. This is not only creating a huge amount of confusion in the industry, but by default is also creating an unfair market place.
I also want to stress that in the new summary document you make clear that your concern about the FSA extends back to what you refer to as it making and breaking rules since 2017. Our complaints policy makes clear that you should raise issues within 1 month of becoming aware of them.
"You make clear"? That's not the case at all, in the summary I indicate that I have watched Novel Foods unfold from 2017, not that this is the starting point of my complaint!
2017 is mentioned twice, and only in the first paragraph of the summary. The complaints draw attention to 2017 as it's well known that the Home Office approached the FSA at that point to ask that all cannabinoids were deemed as Novel Foods. The then Head of Novel Foods, who I believe was Ruth Willis and is still employed by the FSA, accepted that isolated cannabinoid extracts were Novel, but not whole plant extracts.
The reason for stating this is because I have submitted evidence to show Paul Tossall, who I believe was instated as head of CBD Novel foods just weeks before it was re-announce in 2019 at EU level, is on record as saying in 2022 that Novel Foods for CBD products started in 2019, which is misleading.
In regards to your complaints policy, I went by your whistleblowing policy, and informed you as soon as I had correlated the facts that I presented to you. All the other connections that led me to believe that there is a Monopoly Market forming came as a result of analysing facts from articles I had written beforehand.
On that basis, and that there is a continuation of the listed issues, I believe that I am within the 1 month timeframe of explaining the complains as I am aware of them.
On the issue of a lack of clarity allow me to illustrate one extract of your submission which carries the title “Validated CBD products that were not on sale in the UK before 13/02/20”. In this section you go onto list several products and whilst you outline a chronology attached to each, its not clear what it is you are saying the FSA has done, or not done, in each case.
Are we looking at the same document? More so, are we reading the same document? There's no chronology there, just nine companies who each have one or two links that shows they did not have products available before or on 13/02/20.
With all due respect, this is a complaint that focuses on the FSA's handling of Novel Foods for CBD products. You have had access to this complaint in 2 different formats now for about 2 months, can I ask how you're uncertain in regards to the significance of that date?
For me to be able scope any investigation can you please keep in summary format the following;
What the issue is
Validated CBD products that were not on sale in the UK before 13/02/20 (p.3-7) - The FSA have validated products created after 13/02/20, listed them, and allowed them to remain on sale despite stating on 13/02/20 that any such products would have to go through the entirety of the Novel Food process. The public list was supposed to represent an amnesty, companies with products on sale at the deadline could remain on sale as long as they submitted an application by 31/03/21. Companies who created products after that point had to submit applications, and those products would not be allowed on sale until they are fully authorised.
I'd just like to point out that the longer those products stay on the public list, the longer the FSA are effectively endorsing a lie and misrepresenting that list to the public in regards to what was and wasn't on sale and available to them on and before 13/02/2020.
Validated CBD products that breach MoDR 2001 Section 2 (p.8-9) - The FSA have validated drugs as food, despite having access to lab reports for those products and supposedly checking them over before validation. I managed to find the attached lab reports online, and attached them to the refined document as soon as it was determined that a breach of MoDR had occurred.
What if it is determined that the FSA have been complicit in the breaching of MoDR? That's why I brought up RP840, that application was rejected in part due to an extract that exceeded MoDR by kilo of extract, and not the final product. One of Charlotte's Web's products has 195mg of THC per 100ml container. This is actually has just a fraction less controlled cannabinoids by weight as RP840's used extract per kilo, yet one product was validated (Charlotte's Web), while the other was rejected and not even added to the list on that basis. This is an example of the unfairness I spoke of, surely they should have both been rejected?
Monopoly Market (p.10-16) - There is evidence to show that the FSA are residing over a Monopolies Market, and not just on the basis of what I have stated clearly above. I've been able to show that the FSA has favoured a trade association (ACI) that doesn't exist on Companies House, how that trade association has links to GW/Jazz Pharma and how 16 lab reports from GW/Jazz for isolated CBD were used to define requirements for wholeplant CBD products going through Novel Foods. I've been able to show that GW/Jazz Pharma is a direct competitor to the hemp and CBD industry as a whole, and how they had an undeclared interest at all of the COT meetings that decided to use the 16 GW lab reports for pharmaceutical grade isolates to define the requirements for CBD Novel Foods. GW/Jazz have a declared 20+ year strong working relationship with the Home Office, who were supposed to be holding the FSA's hand on all things related to controlled cannabinoids (MoDR Sect 2, 1mg rule). GW/Jazz are calling for a reduced limit for controlled cannabinoid levels, with the ACI, in CBD supplements whilst maintaining 148 patents mostly involving various combinations of cannabinoids both controlled and uncontrolled.
Food Crimes (p.17-18) - I have also provided evidence that suggest the FSA are endorsing food crimes, which I have also appropriately listed. They include the misrepresentation of all hemp and CBD products that aren't created with isolated CBD, substitution and misrepresentation by not insisting synthetic CBD products be defined and labelled as such instead of 'ultra pure', and further to this ultimately diminishing, or compromising, the authenticity of whole plant hemp and CBD products by these actions.
In regard to my Conclusion (p.19) and drawing on Article 7 of the Human Rights Act 1998, I was referring to fair governance, which isn't happening. I feel I have adequately demonstrated that, not just here but also in the original document I provided.
When you became aware of it and over what timeframe do you feel the issue applies
Becoming aware of something doesn't mean that the 'something' makes sense, is correct, or is provable. In this case however, my awareness to being able to raise these issues as a Public Interest Disclosure to the FSA was at the point of me submitting my initial complaint.
I have watched what has unfolded within the Hemp and CBD industry as a whole since 2016, it wasn't until I started writing articles in line with investigative journalism in 2021 that I became suspicious of what could be defined as questionable behaviour from a regulatory authority, and it wasn't until 2022 when I submitted my complaint that I thought those claims were valid, provable, and within the public interest.
What the FSA (name(s) of staff if available), did, or didn’t do, which therefore gives rise to a complaint.
Paul Tossall, for dismissing evidence to show the potential for fraudulent applications within Novel Foods for CBD products. You can't say 'lying to the FSA is taken very seriously' when refusing to accept evidence that prompted that statement. Further more, he should have directed myself and others to a complaint procedure, but didn't.
Past there, I have no idea who has signed off products with 195mg of THC D9 as validated, neither do I know who validated products from a company that was officially launched 15 days after the deadline for products on sale by.
I don't know who rejected RP840 on the basis of THC and CBN being present when there's other products validated that are presented in the refined document you asked for that are defined as drugs.
There is of course Dr Gunter Kuhnle, who isn't an employee of the FSA but he is on the COT panel that determined the course of Novel Foods for CBD products and did not declare interests to Reading University, who have ties to GW/Jazz through research grants, and that both have a focus on CBD and cannabinoid based products.
Then there's the fact that the FSA accepted, from the COT and without a shadow of scrutiny, a report with recommended requirements for CBD Novel Foods from those 16 lab reports, from GW/Jazz Pharma, and knowing full well that the dynamics for wholeplant products are not matched by lab reports for pharmaceutical grade isolated cannabinoids. It's probable also that the interests of Dr Kuhnle would have been know by other members of the COT, which further questions why they were not declared considering the topic matter.
Outside of that, there's the apparent relationship with the ACI, who formed 3 months before the 13/02/20, which has more that been noticed over that time. Why is the FSA engaging with a trade association that doesn't legitimately exist, and more so, why has the FSA engaged more with them over the course of Novel Foods than with any other association or organisation who happened to exist a lot further back than the ACI's November 2019 launch?
This complaint is primarily due to the actions of the FSA and Paul Tossall: If you can confirm who signs off applications that have been called into question, that would be really appreciated. If you can tell me why the FSA have willingly allowed themselves to be led by GW/Jazz, that would also be appreciated, but not as much as knowing why previous attempts to provide evidence of fraudulent applications has been dismissed with no direction to any complaints procedure.
The fact of the matter is that there are question marks over the FSA's conduct in regards to Novel Foods for CBD products, and whether they are observing the core values that civil servants are supposed to uphold.
‘integrity’ is putting the obligations of public service above your own personal interests
Far be it for me to question the FSA's integrity, but if I sent you evidence to show that some companies had validated products despite breaking either the FSA deadline rules or for being more a drug than a food, I would hope that like now, I could talk to someone about those complaints. If you weren't the right person to talk to though, I would hope that you would direct me appropriately to the complaints procedure, and not dismiss my evidence whilst saying “send in your evidence, we take lying to the FSA very seriously”.
Is there integrity when it comes to the FSA endorsing food crimes, when they are supposed to police them?
Is there any integrity shown when it becomes obvious to the industry that there is a 2 tier system for Novel Foods? I refer to applications now being adjudicated on a 'case by case basis' of course, and that there are products that have been validated that I believe have been proven to break established rules and guidelines set out by the FSA.
Is there any integrity in Novel Foods for CBD products? That's one question that I would hope to ask should I have the chance to have a call in regards to my submitted complaint.
‘honesty’ is being truthful and open
Honesty to me would be accepting evidence and looking into it, or at the very least directing people appropriately to a complaints procedure. It would also be things like answering legitimate industry questions, like “why are 16 lab reports for pharmaceutical CBD isolates from an industry competitor being used to determine the requirements for wholeplant CBD products, which weren't Novel between 2017/18 according to the FSA, but then were in 2019?”.
Just admitting that Novel Foods for CBD products existed in 2017 would be a start, but we as an industry can't even have that despite a good chunk of the companies on the Public List operating at the time.
Then there's the public list itself, is 'it' honest to the consumer, the ones who the FSA have a duty of care to, and the ones they tell that any product listed was available on or before 13/02/20?
Further to those consumers, is it honest that the FSA have embraced suggestions from an association that doesn't exist showing that the consumer wants isolated CBD products when 2 recent polls show this not to be the case?
Is it honest that there was an undeclared interest to GW/Jazz Pharma at the COT meeting that determined the requirements for CBD Novel Foods, which in them self were devised from 16 lab reports from GW/Jazz Pharma?
Is it honest that synthetic CBD products are labelled as 'ultra pure' on the public list, and is it honest that these products don't even have to be physically labelled as synthetic CBD?
What about the companies who have jumped through every hoop that the FSA has placed in front of them, is there any honesty when they can clearly see validated products that break the rules whilst also seeing that the FSA are turning a blind eye to them?
‘objectivity’ is basing your advice and decisions on rigorous analysis of the evidence
I've already indicated that evidence has been dismissed, so that's objectivity out the window.
I'm also concerned as there are suggestions from yourself which indicate you've only glanced over the 2 submissions I have made, I never said my complaints started from 2017 and I believe that anyone up to date with CBD Novel Foods would understand the significance of 13/02/20.
Has there been a level of objectivity on the initial reviews of this complaint?
‘impartiality’ is acting solely according to the merits of the case and serving equally well governments of different political persuasions
This is a tricky one, see the wording suggests that civil servants need to adapt to whoever's in power, but the FSA is an agency without a leading minister.
On the basis of fair governance, and that the general public can raise complaints against civil servants should the need arise, I would suggest that impartiality also comes into play when dealing either with the public, or with those in markets that are governed by the FSA.
There is no impartiality, if there was, we wouldn't see companies with validated products that shouldn't be, and evidence of irregularities would have been accepted when initially sent in. If that had happened, I wouldn't have got as far as launching a Public Interest Disclosure complaint.
I appreciate the subject material is complicated and some technicality is unavoidable but keeping the detail as least complex as possible will help
My apologies Mr Sykes, but this was never going to be an easy complaint to deal with, especially as we're talking about multiple ongoing events.
I have provided you with direct evidence to back up my claims, certainly in the fact that someone, or some persons, have signed off products without doing basic checks on the validity of the information provided. For example: if Cannaray has told the FSA that they had products available before or on 13/02/2020, someone has accepted that information without due diligence and at the very least, checked their social media channels.
Here you can see a tweet from Cannaray from 28/02/20 staying that they have launched:
Then there's their LinkedIn profile, active for 3 years with their first year seemingly focused on investments followed by 2 years of CBD related posts:
That should raise questions, but then there's this from The Grocer about Cannaray being a new start-up on 21/02/20: https://www.thegrocer.co.uk/fundraising/cbd-startup-cannaray-targets-multimillion-ipo/602201.article
And finally there's this link that whilst being from 23/01/20, talks about Cannaray setting up in the UK, that they were looking to get on the LSE, and more focused as a medicinal company rather than a CBD food supplemental company, which is reflected in their first year of posts on their LinkedIn page: https://www.healtheuropa.com/cannaray-of-light-healing-people-with-medical-cannabis/96819/
That to me raises one very big question, when did Cannaray have their first legitimate oral CBD products on sale in the UK? As mentioned previously I've been about in this industry since the early days and I know a lot of companies. Of course that doesn't mean that Cannaray didn't have products available in the UK, but you'd assume social media posts don't lie, which brings us back to 28/02/20. The deadline for products on sale by was 13/02/20, Cannaray launched 15 days later, can they legitimately say that products were available to the public before their launch? Pre-orders might be quoted here, but does a pre-order from a retailer satisfy the requirements for when a product is officially available to the public?
There is of course their Facebook profile, and this post dated 29/02/20 states "Following our online launch yesterday, we're taking time this weekend to prioritise our wellbeing and help others feel the best version of themselves." : https://www.facebook.com/cannarayCBD/photos/a.477291066506797/500272924208611/
I believe that people within the FSA have made decisions that the whole industry can see break the rules that the FSA either set, or in regards to MoDR, were supposed to follow. I feel like I've done everything I can to refine the definition of my complaint to this point.
Once I have this, I can turn my mind to considering how any investigation might be scoped. I have no issue in speaking with you but at this stage the picture you have painted is just too unclear for me to judge what points we might explore further.
This is where I have to respectfully ask for that phone call, to answer any questions beyond this point. I believe the complaints procedure allows for contact so that the complaint can be better understood, and considering the complexity of the complaint I feel it would be for the best.
I understand shortly after receiving my last response you posted a message in LinkedIn saying we had asked you to refine your complaint, suggesting that any investigation would take over 3 years if you didn’t. If in fact you have posted this, I would be grateful if you would correct this record as I believe at no stage have I said that any investigation would take that long. My point I recall was that the accusations you make extend beyond a three year period.
Forgive me Mr Sykes, there was clearly a misunderstanding there on my part, although after this reply, maybe we are looking at a 3 year investigation!
Subsequently I am happy to retract that on the basis of this article, and will adjust my original post to reflect this.
I respectfully request the chance for a telephone call to confirm that you understand my complaints now and to talk about this further.
The Hemp Hound Agency