A reply from the Food Standards Agency (FSA), to The Hemp Hound Agency.
On the 12th of April 2022, The Hemp Hound Agency released an article called 'A letter of concern to the FSA'.
I'm happy to say that Paul Tossall from Novel Foods has replied, and it's my duty to the industry to give you his replies, and my further responses, which are below.
This article will be sent to Paul and the FSA as soon as it's released.
When it comes to where Novel Foods is now though, some serious questions about the process need to be addressed, but there's also some historic issues that have a bearing on where we are now.
As an Industry Directory & Signposting Service, I didn't expect The Hemp Hound Agency to be challenging the powers that be, but someone has to ask some questions, and there's a lot to catch up on, so let's crack on.
Thank you for getting back to me.
As the ex-point of contact for an Trade Association for two and a half years before the creation of The Hemp Hound Agency, I've watched key points in the history of the CBD industry from the front row. Before that, my wife and I had a CBD company, but I have been around cannabis for a lot longer than that, and the subsequent industries that surround the plant.
My interests as a whole is 'Food before Medicine', which cannabis and cannabinoids have always been, however there is a blatant push for the hemp and CBD industry to become pharmaceuticalised, and it's also very blatant as to who would benefit most from such a move.
Can I just describe what the industry sees right now?
The MHRA tried to define CBD as a purely medicinal compound in 2016.
The FSA were asked by the HO in 2017 to class all cannabinoids as Novel, rumour has it that Ruth Willis (Ex-Novel Foods Chief) was replaced from her position because she wasn't prepared to define whole plant products as novel.
2018 the VMD outlaws CBD pet products on HO direction, and not from appropriate studies from industry or veterinary professionals.
2019 brought round two of Novel Foods, with the FSA not exactly getting directly involved until 13/02/2020... at least publicly. If memory serves, you and your team were assigned just before the initial announcement on Novel Foods at EFSA level, but please do correct me if I'm wrong.
Of course in 2018 medicinal cannabis was legalised, but just before that, two very high profile politicians were reported to have conflicts of interest with cannabis via their connections with HO. One of those was with GW (Theresa May), which is interesting as we find Novel Foods being run on the basis of 16 GW lab reports. The other is connected with British Sugar, who grow hemp to supply GW. Rumour has it that the latter, Victoria Atkins, was Drugs Minister when the HO first approached the FSA in regards to Novel Foods in 2017.
Since 2019 though, that's where things get interesting. The ACI formed off the back of the CMC (20/11/2019), by 13/02/2020 they were prepared to respond to your updates on Novel Foods literally on the drop of a hat. Since then, it appears to the industry that there is some sort of special relationship between yourself and the ACI, which is troubling when they have only 20 members out of the 1000's of UK companies who have some angle on CBD products.
This isn't about the ACI/CMC though, I've done my bit on them which you can find here, and it's brought to light quite a few things which has led me to ask the CMA to add them to a complaint, to which you are part of.
Your part in this equation is interesting:
You refused a request for a time extension for Novel Applications from the Cannabis Trades Association (CTA) in 2020 due to Covid, stating that you saw no evidence that the outbreak was affecting companies who were creating applications. One year after, we had, and still have 5 companies validated, and the rest who only just started to get added before the one year anniversary of the applications deadline are 'awaiting evidence', which raises the question of 'who indicated to you that an extension wasn't necessary?'
You instructed Trading Standards (TS) up and down the country to make a catalogue of products available before 13/02/2020. But you're asking companies to prove who as on the market before then, without asking the same question to the 5 validated companies.
One validated company is selling synthetic CBD products that weren't available before 13/02/2020, thus riding the industry amnesty route set out by the FSA with a product that is more 'Novel' than ANY plant derived CBD product.
You are allowing 16 lab reports from an industry competitor to restrict the CBD industry - You could say 'upon direction from the CoT', but sometimes you don't need eyes to see, especially as the CoT disregarded all of the evidence used by the World Health Organisation (WHO) which determined 2,400mg a day was safe, as opposed to those 16 lab reports that suggest 70mg, less than 3% of what WHO think is safe, is an acceptable RDA.
If you were a layman, what would the above timeline look like to you? I'm interested, because to me, it's like someone is trying to control the path of the cannabinoid industry at the expense of those who made it what it is today, and you're part of that move.
There are very visible lines between GW, HO, yourself and ACI/CMC, and you're all connected by those 16 lab reports that focus on pharmaceutical grade CBD isolate. Beyond that, there's a move to keep Contamination to a minimum, so a clampdown on controlled cannabinoids and testing requirements is called for. We both know that any update in this area has the potential to effect Novel Foods applications as they stand, it might even lead to companies closing due to putting all their resources into this endeavour.
But let's not stop there, did you know that GW have multiple patents for CBD based preparations that involve CBD, stretching back to 2004? Are you aware that they also have multiple patents for cannabinoid combinations that involve the controlled cannabinoids, which will ultimately be restricted in the CBD industry? On that basis, is it appropriate that we don't at the very least have one of those 16 lab reports from a competitor of GW, and do you think that the industry as a whole could view the fact that 16 lab reports from one company suggests that 'the company' in question has more influence on a competitor industry than they should?
GW are known to express their feelings in regards to cannabinoid based markets, I trust you've seen the quote attributed from them to the FDA?
I'm hoping that you can see there are some very serious concerns in the industry, so much so that I've felt it important to lodge that complaint to the Competitions and Markets Authority in regards to perceived anti-competitive behaviour from GW due to their influence on a competitor industry, that is facilitated by the HO, who are directing you.
The ACI are part of that complaint due to their recent activities which includes fake lists, and for reporting companies to TS for not being on your list when they are.
Now I'm going to delve in to the wider parts of Novel Foods that are within your control. This will be by answering to you replies to my original email below.
Hemp Hound (HH): According to the FSA's own guidelines, companies not selling CBD products before 13/02/2020 would not be able to go through the Novel Foods process as is with the CBD industry as a whole. It was understood by the industry that if you had created new products after that deadline, they would have to be removed from sale until they are fully authorised
Food Standards Agency (FSA): First wrong, second right. They can still go through the process but cannot sell products until authorised to do so. Indeed we have had over 100 subsequent applications after the submission date. They can continue towards authorisation but they do not qualify to have products added to the public list
My apologies, but your reply was what I meant.
HH: May I draw your attention to Pureis, one of the first company to get listed, and instantly as "validated". Simply by looking at their first lab report it can be seen that they had no product available in the UK before 13/02/2020
FSA: We won’t talk about individual cases. To get on the public list the company must have supplied information that shows they fit the criteria.
Ordinarily I'd agree with you, however they are important, as are a couple more of the validated companies.
HH: The path to validation requires someone in the FSA to check that all required documents are in order, so someone should have been checking dates.
FSA: There may be some confusion here on terminology. Validation is not affected by the criteria to get on the public list. Validation requirements are set out in statute. The criteria for the public list is a tool we have proposed to help local authorities with decision making on enforcement
This question is in regards to validated companies, and whether or not someone in the FSA confirms certain aspects of data that is submitted before that company moves to being validated, like whether a product was on shelves before 13/02/2020 or not. So can you please confirm whether anyone in the FSA signed off on the validated companies having products before 13/02/2020, or whether the validated companies word was just taken at face value?
HH: This is definitely not the only company, there are serious question marks in regards to Bod Australia and Brains Bioceuticals (and others) UK market activity pre 13/02/2020.
FSA: If you can provide proof that any company has falsified the evidence we have used to make our decisions on the public list we would welcome it. Deliberate misleading us would be treated very seriously.
If you have a look on Pureis website for their lab reports, you will see that their first product has a title of Form: 001. The link was in the last email. Please refer to the dates for the cannabinoid profile test and microbial test, then look at the date the certificate was issued. That's enough proof right there, and every lab report for every product past there is dated after the 13/02/2020 deadline.
Then we have Brains Bioceuticals, who are launching their Novel Foods Approved range this spring.
On the basis of these two alone, I would ask that you look at the other 3, some of them were incorporated barely 2 months before the FSA product deadline, which raises questions in itself.
HH: It would seem that Pureis were validated before 12/07/2021, before they had physical products in the UK.
FSA: Validated applications are added to our list of applications. As said above where an application has requested addition of products to the CBD public list they have had to supply evidence that we have evaluated. They would not make the list without such evidence.
Please refer to the evidence on Pureis and Brains Bioceuticals above, if you are saying that they have supplied evidence that has been evaluated, please could you re-evaluate their evidence, and if I'm right, can you confirm if there will be an investigation into the persons who signed off their evidence or not?
HH: There are a lot of companies still waiting to be put on the Novel list, who did have products available before any deadline and jumped through every hoop that was placed in front of them by the FSA.
FSA: To get on the public list the company must be linked to an active application. Many of the companies claiming they should be on the public list are not linked to an application or unable to supply the necessary information to allow a risk assessment (e.g. relevant toxicology study data). Where they can prove this, or have now supplied the missing information we have been asking for, in some cases for many months, they can be considered for addition to the public list. We have generously given an extension for provision of this information to 26th May but after this no new requests for additions will be considered as we need to finalise the public list.
Why does it always come down to the companies who haven't applied? I'm not talking about them, I'm talking about the ones still to be listed that you DO have information from. I'm also suspicious as to how is it that you and the ACI always go here as a blanket response.
And lets talk about your generosity, do you think that this point right here reinforces the fact that you should have accepted the CTA call for an extension? Can I also ask how many industries within the food and drink sector managed to get through Covid without any knock on effects?
The 26th of May... That's today, so if a company is one day late with their Tox report, does that mean that company is automatically on the rejected list?
HH: Sir, with the utmost respect, I feel I must inform you that I have submitted a complaint to the competitions watchdog in regards to the handling of Novel Foods, and what you could perceive from what I'm saying here as the creation of an anti-competitive landscape by the very agency who is supposed to create a safe and fair trading environment.
FSA: The FSA’s remit is to ensure food is safe for consumers. Consumers have the right to expect that food on the shelf is fit for consumption. Novel food legislation requires a pre-market authorisation before foods are placed on the market. This did not occur for CBD so none of the 1000s of CBD products on the market have completed a risk assessment. We cannot see how this is anti-competitive to suggest that local authorities prioritise for enforcement decisions those CBD products that will never face a risk assessment so their safety can not be assessed. All CBD products are non-compliant and could be removed from the market if a local authority decided to do so.
You say Novel Foods never happened for CBD products... That's a fib, isn't it?
You were brought in because '2017 Novel Foods' wasn't going anywhere, and you were placed to bring it to the next level. Separating cannabis from cannabinoids, which as we've touched on, only truly benefits GW and their patented intentions.
Isolates were accepted as Novel in 2017, in 2018 the CMC was launched and effectively championed an Isolate based market, and they weren't challenged once for it, certainly not by the FSA anyway!
CBD products had been around long enough to know that there were no negative effects from ingestion, and CBD as a compound has been known about before 1996. You can dismiss that simply with the definition of what is a Novel Food and saying 'cannabis is fine but cannabinoid is new', however you can't dismiss that this excuse is being used with 16 lab reports from one company to influence 100o's of companies who inhabit their competitor industry, feel free to tell me that this is not an anti-competitive action, which you are facilitating!
HH: This however is not my only concern, the other I have is in regards to synthetic cannabinoid products. There is a different 'type' of CBD that is created through genetically modified yeast, in that it's a photoshop, or facsimile. Has the FSA been made aware of the difference between lefthanded, and righthanded CBD molecules?
FSA: Isomers will be considered in the risk assessment if it is necessary
If it is necessary? That sounds like a bit of a grey area if ever I've heard one, and I thought I'd heard them all in this industry!
Are you saying that there's been a risk assessment on plant derived CBD and cannabinoid based products, but there is as yet no need to conduct a risk assessment on synthetic cannabinoids? Forgive me, but that seems a bit outrageous and irresponsible.
HH: If the FSA are aware, are they also aware that synthetic CBD has less binding potential to CB receptors, which reinforces the fact that it's different to plant derived CBD?
FSA: As above, if required then this will be considered in the risk assessment process. The ACNFP (Advisory Committee on Novel Foods and Processes) is an independent panel of experts that reviews the applicant’s safety case and if there is insufficient information or where clarity on risks issues is required can request this from the applicant. If the information is not forthcoming or inadequate, then the application can be stopped.
As above, that stance is all shades of wrong, you're prepared to accept the need for safety assessments for extracts from a plant that humans have evolved with, yet you won't consider that as a basic requirement for anything that is artificial in nature?
Paul, come on mate, that's not right! I'd invite you to convince me otherwise!
HH: Are the FSA also aware that recent newspaper reports suggest that a woman recently died from eating sweets laced with synthetic cannabis without stating whether it was chemical or bio derived?
FSA: Our understanding of this issue was that this was a narcotic disguised as a sweet-like product. As a narcotic is it legally not a food. This product was not a CBD product that we are processing and as a narcotic that has led to harm is a matter for the Police so it would be inappropriate for us to comment further.
I think you're missing the point here, if synthetic THC has caused a death, what's to say ANY synthetic cannabinoid, including synthetic CBD, has the potential for wider, as yet undiscovered implications?
That's still a food issue, and as such any adverse reaction from a synthetic product is down to you and the ACNFP!
HH: Sir, whole plant CBD products are going through Novel Foods on the grounds of safety, and a handful of lab reports from GW Pharmaceuticals. Even though the Novel Foods requirements are focusing on isolate products to the detriment of whole plant products, those isolates are still plant derived, and there's proof of whole plant products being available for (in some cases) over 10 years, and with no ill effect in that time.
FSA: The risk assessment for each application will review the necessary data on a safety case. The ACNFP will form an opinion of the safety of products to contain CBD. If this opinion suggests undue harm then the application will not progress.
There's been no undue harm done from whole plant products, yet here we are in the middle of Novel Foods, governed by 16 lab reports that the COT embraced, actioned by you following their suggestions, and ultimately signed off by the ACNFP... Have I got that right?
If there was substance and transparency through this process, and questions had been answered by yourself and other bodies when the industry needed them, I'm pretty certain we wouldn't be corresponding in such a manner, but again, here we are!
Have you heard the rumour about someone attending the COT meetings with undisclosed connections to GW? Have you seen the ACI/CMC Milestone page that almost looks like they were part of those meetings as well?
And then we go back to the timeline at the top of this email, looking around at the state of play, and wonder just how far some of the tentacles from the main protagonists reach to the ACNFP.
You might think that this statement is suggestive, but it's already been established that the HO control all things cannabis, and GW have already confirmed their 20+ year strong working relationship with them... whatever that means.
HH: How long has synthetic CBD products been about, and how can they not be subject to more stringent requirements for their Novel Food applications? I believe that the lab reports from GW should not be used to determine the requirements for synthetic products, 'apples and pears' springs to mind.
FSA: Applications proposing using synthetic CBD will face the same safety assessment process as those of plant based. As such the ACNFP can form an opinion as described when they are satisfied they have thoroughly reviewed the data provided and the applicant(s) has(have) provided all the responses needed to questions raised.
Synthetic CBD will face the same safety assessments as those of plant based? That's absurd, and if anything is suggestive of the level of common-sense that is present in those ACNFP meetings.
In fact, it's quite suggestive in other ways, too. If there is the common-sense that's supposed to be there in the ACNFP, there's either a level of deliberate ignorance towards cannabinoid products, or there's someone inside with an outside agenda, which would question any 'independence' that body holds.
Now before you think I'm overstepping the mark with my accusations, let's just touch on reasonable doubt: whole plant products are subject to requirements derived from lab reports for isolate, despite wider industry objections, and synthetic cannabinoids will be subject to the same lab reports for plant derived isolates, despite the industry objections I've no doubt you'll receive when your comments are published.
HH: Further in regards to Novel Foods and synthetic cannabinoids, one of the key requirements for this process is for adequate labelling. On that basis, can you please tell me why Pureis is down on the list as having validated 'ultra pure' CBD products, and not 'Synthetic' CBD products? If Novel Foods is driven with consumer safety in mind, surely it is in the industry's interests to be open about products that are phyto-derived or synthetic.
FSA: Labelling of a food product must not be misleading. Synthetic products are likely to be of a higher purity of CBD. As part of the authorisation process consideration is made of any further labelling that is required. No CBD products, regardless of synthetic or plant-based, have been authorised yet so potential labelling issue are still speculative.
Are you not misleading the public list by having Pureis down as having Ultra Pure CBD, when their EU Novel Foods Applications has them down for providing products that are chemically derived? You can split hairs on this, but you've already said that CBD Novel Foods is an exercise to ensure consumer confidence, after all, consumers have a right to make an informed choice and clearly understand what they are consuming.
Just to touch on the topics you didn't reply to
The big one for me is the 16 lab reports, it's like "answer anything, but DON'T mention those reports!!!"
I get that, it must be annoying being asked at any opportunity. My understanding is that the buck of responsibility lies with the CoT, but I understand that you have to accept their findings. If you did that without question, knowing that the 16 lab reports came from a industry competitor who doesn't actually manufacture food products (yet) AND has a plethora of patents for CBD and other cannabinoid focused products, I'm afraid to say that in my opinion, your position would be untenable! You would effectively be selling off what is within the remit of the FSA, back to the HO and GW on the basis of cannabis.
Then there's that time when TS went around all UK CBD stockists to create a dossier of products available in the UK before 13/02/2020, do you remember that at all? I do, because FSA representatives confirmed that to be the case at the Hemp & CBD Expo in 2020. Why are you forgetting or ignoring that?
The last thing is something I didn't mention in my initial submission, but it has been implied, certainly at the beginning of this reply to you, and that's your relationship with the ACI and the CMC. Lets be honest, you must have been talking to the CMC before the ACI was created.
Even by analysing their timeline, you can see that there has been questionable, and antagonistic intentions from the CMC/ACI, and to the best part, you have facilitated them.
You've not been as engaging with the other trade associations as you have with the ACI/CMC, and that's why I'm here. That, as well as to highlight how you're being used, willingly or otherwise, to further the agenda of GW/Jazz Pharma.
Please feel free to reply to this email, knowing full well that I will share any reply to the wider industry, which has more companies in that the 20 that currently reside in the list of ACI members.
The Hemp Hound Agency