An opinion on the updated Novel Foods list, from The Hemp Hound Agency
The 31st of March was the day that CBD company owners have been waiting a whole year for, 'the' updating of the Novel Foods list, but to quote the ending of any love scene from a cheesy B-movie, "how was it for you?"
Well for me, as well as a fair few others in the industry, it feels like the April Fool's that was a day early. Quite a few stakeholders, companies and industry players weren't even made aware that an update was coming until it was noticed by The Canna-Consultants that there was an FSA press conference for industry journalists one day before the update, and that companies and industry figures weren't invited.
Was it to tell 'them' before 'us' that only 3,500 of the supposed 5,000 odd listings were getting put up, or was it just to be out of arm shot of awkward questions? Who knows, either way this is but one chapter of the entire Novel Foods fiasco that shows to me that the companies who helped build this industry are a mere afterthought, which I feel is highlighted by the frustrations of companies who are questioning why they can't see their names on a list they spent a lot of money to be on.
My opinion on the update it's self is this: What a joke!!!
I don't know if anyone's thought this through at Novel Foods HQ, but if you insist on strict requires and rigid deadlines, surely it's only fair that all the companies who're still "awaiting evidence" are listed at the same time, no?
And let's just touch on the 5 validated companies who are now looking resplendent on that list, if anyone can show that they (and David Beckham) had products on UK shelves before February 2020, please let me know. Equally for those who are validated for synthetic CBD products, can any tell me the difference between left-handed and right-handed molecules, and why there shouldn't be more stringent testing on these products outside of the Toxicology data that other CBD products derived from a natural source require?
You know what, I've got another one. It's a biggy, so please bear with me. If someone could REALLY point out the need for animal trials, when CBD products have been on the market before 2016, and no-one has been ill specifically from CBD products in all that time, that'd be awesome?
So let me ask you, what one word would you use to describe the Novel Foods saga? Don't answer now, just hold that question in the back of your grey matter for a bit, whilst I explain 'the joke'.
I'm going to pretend from this point that The Hemp Hound Agency doesn't exist, and I'm going to proceed on the basis that my company called LuvBud from 2016 managed to get off the ground and submitted a Novel Foods Application back in March 31st 2021. Effectively, I'm going to walk a mile in your shoes, unless you're not a Size 9, in which case I'll assume...
I will look at three scenarios in this: What the update means to the companies who are already validated, what it means if you were listed in the update, and what impact missing 'the cut' can have on companies that do have an application in.
So, lets start from the top:
A validated LuvBud from the get go
Assuming my Wife and I had £1.5 million to spend for top of the range toxicology test reports and had been listed as validated before the update, I'd be rubbing my hands in glee! It's one thing being on a list with 4 other validated companies, it's another when you're one of the 5 validated companies surrounded by a sea of others with the words "awaiting evidence" next to every single one. I'd be straight onto the marketing team with one simple instruction, "spin it!"
Yes, you could argue that it shows your competition is nipping at your heels, but then how long will it take EIHA, ACI, and all the other applicants to provide the evidence that is still outstanding?
LuvBud gets added to the list
After 1 year of waiting, LuvBud is up! There would definitely be a sense of relief, not just for the sake of sales but also to have confidence moving forward... only, you can't have too much confidence, because "awaiting evidence" is seen everywhere.
I would be concerned, and if anything feel as if LuvBud was there to make up the numbers, and possibly to highlight the 5 companies that were validated before the update on the 31st of March. But then, LuvBud's on the list.
This is pretty much where I would look to someone for some answers, there's been some serious money thrown in to consortium applications, how can they all be awaiting evidence? It doesn't make sense to me at all, in fact if you simplify the situation, the only way it would make sense is if there's been a misunderstanding of the requirements for toxicology reports across the industry, or, the FSA really should have accepted the need for an extension when a certain Trade Association requested it due to the impact of Covid, and are now at the mercy of more applications than they can shake a stick at!
Either way, the fact that the FSA haven't made too much head way in creating a safe but 'fair' industry is telling, so I would be trying very hard to find out when the next update is scheduled, and if there was the possibility for other companies to be validated by then.
LuvBud has an application in, but wasn't listed on the update.
Imagine getting half of your products listed, you'd be annoyed right? So imagine if you were part of an application, the list gets updated with companies on the same application, but you're not there in any way...
I would be furious, as are a few people that I know, and I think they're justified to be so. The FSA have potentially put these companies at a market disadvantage, despite them obliging every hurdle that has been placed in front of them.
Some of these companies are big as well, some have even been about longer than 2016 when LuvBud was created, and have many companies tied direct to their application. I personally would be spitting feathers if I was one of them, in between every call from stockists and sublicense holders who are all asking questions that can't quite get answered until the FSA release further updates.
3, 2, 1, back into the room for The Hemp Hound Agency!
So there you go, my honest assessment of what that list update has brought to the industry, and it's only pretty for those 5 validated companies.
I'll stick my hands up here and now, I am so glad LuvBud isn't operating, I'm better at keeping others calm in a situation than I am myself. But even in 2016 we saw an attempt to restrict the CBD industry through the MHRA, and then with the first rumblings of Novel Foods from the HO and FSA in 2017. That was then followed by the VMD banning CBD pet products in 2018 at the request of the Home Office, which itself was followed by a ramping up of Novel Foods in 2019, which the HO have been directing from the side lines.
Then we had a police minister, questioning whether the miniscule amount of various THC compounds in food supplements can be extracted by criminal elements, and whether impracticable levels should be set which would effectively eliminate full or broad spectrum products. This triggered the HO to request the ACMD look into all controlled cannabinoids, and for BEIS to release suggestions for testing requirements and limits for cannabis based products... all smack bang in the middle of a process that hasn't even got past the validated stage yet, at least for 5 companies anyway.
Here's my absolute worst fear of all this - The HO at some point are going to release further directions on controlled cannabinoid levels, and for standardised testing for products of that nature. What's to say that this direction, whenever it comes, effectively means that half, or more applications are invalid because they breach a redefined Misuse of Drugs Regulation?
This whole process, if defined as a theme park ride, isn't one I'd want to willingly jump on, but then I love all aspects of cannabis and I've got something to say...
If you ask me, I'll tell you straight that I think the CBD industry and wider Cannabis Community is getting played, and the HO are at the wheel. But who's giving 'them' their directions? With the tax that has been generated in some countries who have either legalised or decriminalised cannabis being hard to ignore, there has to be something else that has caught their eye, and by 'caught their eye' I mean 'interests to protect'!
It's not about 'reefer madness' anymore, it's about profit margins for Big Pharma, specifically GW. Here's your proof, a quote directly from them to the FDA:
“In opening the door for consumer-market CBD products, FDA risks further diminishing the likelihood that more cannabis-derived product will be developed into proven medicines for these patients.”
Now are you seeing what's going on, or do I have to mention that GW have patents for 48 preparations that contain CBD, 26 for THC, and a shed load more for ones that have a combination of controlled cannabinoids in? Do you see that the one company whose lab reports are forming the basis of CBD Novel Food requirements, is in fact the main competition to the UK CBD industry as a whole?
There's a game of cat and mouse going on here, and slowly, but surely, peoples access to cannabis as a whole is being restricted due to a battle for what is acceptable levels of cannabinoids in a food supplemental product vs everything else the Pharmaceutical industry can nail down. Don't get me wrong, there is of course a more blatant battle to deny everyone access to cannabis in refusing a debate or referendum on the topic of recreational cannabis use, despite there being an over 50% approval rating for the liberation of cannabis laws and guidelines since 2019.
I'm sorry to say this, but I think this industry has been put in a situation where it's stumbling blindly towards a preplanner conclusion, and I hate to say it but I don't think we're all invited to the after-party. GW's never going to 'own' the market, but their influence is defining the requirements to be in it. The validated companies that are surrounded by others "awaiting evidence" shows that most, if not all have direct connections to pharmaceutical companies. Most of the companies who're still waiting for validation OR inclusion on the Novel Foods list though... not so much. Those companies are there, and ready to weather any storm the HO throws at them.
It's worth mentioning at this point that there have been whispers of GW launching their own food supplemental product, if that ever happens, I would assume that as definitive proof that they have more sway than they should. They would have effectively prepared a market by removing or inhibiting those within it.
So at the beginning of this article, I asked you what one word would be best to describe the Novel Foods saga? Well consider it now if you will.
You might think of some hyphenated swear word, and I won't grumble if you did. My word is also hyphenated, but without the vulgarities whether justified or not.
My word is "anti-competitive"
I could have gone for controlled, rigged, or something along those lines, but I think I hit the nail on the head. And it doesn't just extend to dominating the CBD market as I've mentioned beforehand, GW don't want you to have 'Skunk', even though they're growing that same strain for use in their medicinal product portfolio, which if anything reinforces the fact that someone is somehow, relaying everything that jeopardises GW's interest to the HO, who in turn are doing everything possible to ensure nothing rocks the applecart.
So how on earth do we get everyone to challenge what's going on? Because the longer we roll over for them to tickle our bellies, the longer they're in control. We're going to get to a point where exacting pharmaceutical standards really do have the potential to slam the door in the faces of a lot of companies who have helped breathe life into the UK CBD industry.
The hard questions need to be asked, and I need you to help me ask them. Send them in an FOI to the FSA, your MP, someone in the press you know who actually gives a damn about cannabis, and how the HO are effectively allowing GW to dictate our access to a plant that was a food and medicine before they started patenting cannabinoid combinations.
If anyone who uses, produces or consumes cannabis in anyway, be it plant or cannabinoid focused, is to accept any further regulation updates or changes, I believe that it's only fair that those making the decisions answer some very specific questions before we proceed in good faith.
I also think that 'list' needs to be taken down, at least until all products that have applications yet to be listed are placed on it.
The following questions have been separated specifically to the agency it's meant for, and this article will be sent to each and every one named for comment.
The HO:
Has GW Pharmaceuticals, at any point, approached the HO in regards to CBD Novel Foods, controlled cannabinoids in Novel Foods, or to offer lab reports to be used to determine the requirements for CBD Novel Foods?
Has GW Pharmaceuticals in anyway consulted on, or influenced, any guidance that may influence drug law, or the UK's response to the 63rd UN-CND?
Did the HO contact the MHRA in 2016, and request that they redefine CBD as a purely medicinal compound?
Can the HO confirm that GW are, or were, licenced to grow a strain of cannabis called 'Skunk No.1(#1)'?
Can the HO confirm that all controlled cannabinoids are in fact controlled due to GW having patents that lists all of them?
Bonus Question:
Did the HO request that the FSA make all cannabinoids Novel in 2017?
The MHRA:
Did the HO, or GW Pharma, contact in 2016 and request that CBD is redefined as a purely medicinal compound?
The VMD:
What scientific evidence was used to determine that animals don't need, or deserve, a supplementary hemp and CBD product to allow their owners to keep their pets healthy by keeping their Endo-Cannabinoid System topped up?
The FSA:
How many foods, other than CBD products, have gone through a Novel Foods process with Pharmaceutical requirements?
How many foods have gone through the same process, and have required toxicology reports from animal testing to be approved for sale in the UK?
Have the FSA at any point had any interactions with GW Pharma, either in regards to Novel Foods, or in regards to them releasing a food supplement product of their own?
When will the list be updated to cover all Novel Food applicants who met the set deadline for submissions?
Can the FSA confirm whether they are "awaiting evidence" from the applicants themselves, or if it is from the HO and covers topics such as Controlled Cannabinoid levels.
Bonus Question:
Did the FSA demote Ruth Willis from Head of Novel Foods in 2017, because she refused to fully oblige the HO's request of making all cannabinoids Novel?
Was she demoted due to the fact that whilst happy to accept isolated cannabinoids as Novel, she was unwilling to define whole plant extracts as such.
Committee on Toxicology (COT)
Is it appropriate for the COT to dismiss WHO data that was used to determine that 2,400mg of CBD a day is safe to consume, in favour of lab reports from a single, direct competitor to the CBD food supplemental industry as a whole, and to use those lab reports to determine 70mg as an RDA, which is barely 3% of which the WHO deems safe?
Has anyone, whether employed by or with interests to GW Pharmaceuticals, attended any meetings held by the COT that focused on CBD or cannabinoid based products of any nature?
