A position piece from The Hemp Hound Agency
On 09/11/22 The European Industrial Hemp Association (EIHA) sent an email to their members, informing them that they had submitted toxicology data for both Isolated and Synthetic CBD products attached to Novel Food applications that they are managing.
Let me be blunt, those toxicology reports signify a clear danger to the industry, let alone the EIHA membership, and for various reasons.
The skin and bones of the report are:
No one should take more than 17.5mg a day of either Isolated CBD or Synthetic CBD
Products shouldn't exceed 10%
These products are for short term use only
They've had this data since April 2022
The problems that arise from this are:
17.5mg RDA
I'm no scientist, but if the World Health Organisation suggested 2,400mg of CBD a day was safe to ingest, you'd have expected them to look at many reports, studies, and any other legitimate source of credible information to determine that.
Whilst it's known that the COT dismissed the same data used by the WHO in favour of 16 lab reports from GW/Jazz Pharmaceuticals (GW) to determine 70mg as an acceptable RDA, we are still talking pharmaceutical level reports.
So why do alarm bells ring when I hear 17.5mg? GW's lab reports are for Isolated CBD, and the FSA deem Synthetic CBD as a perfect replica, so 17.5mg for both make sense, but at the same time doesn't. It's too low, there's no doubt about that!
I've heard from a few people on this, with two suggestions often being repeated. The first is that the wrong type of lab rat was used, where as the other is that 17.5mg is confused between the level of no observable effect vs that were an observable effect is detected.
Either way, the overall consensus is that those lab reports are either wrong, or have been interpreted incorrectly.
10%
EIHA further state that as well as the 17.5mg RDA, no product should be over 10% in strength.
This raises the question of adverse events, specifically that if the recommended RDA is founded on accurate scientific analysis, why have we not seen any real number or trend documented by the MHRA?
It's suggested that 1.6 million people are taking CBD regularly in the UK, and it's easy to argue that a lot of those people are taking CBD Isolate products that are over 10% in strength. CBD Isolate to my knowledge has been available in the UK from before 2016, so you could argue that there should be a noticeable amount of adverse events to justify the suggestions being made by EIHA on the strength of the toxicology report for CBD Isolate.
We've also got to consider medicinal use here, where some patients are ingesting 100's of milligrams a day, and in some cases, could be doing so to manage life long conditions. What adverse effects are being reported there, where CBD isolate as well as other cannabinoids can be found in a refined format? If GW's lab reports even suggested that 17.5mg a day was a sensible limit, and that it's best managed by no more than a 10% strength product, would there be ethical grounds for administering something as strong Epidiolex?
Again the general consensus is that this 10% product threshold cannot be correct.
Short term use
1.6 million regular users users of CBD, and we're talking about an industry that was legitimatised by the MHRA in 2016 when they tried to redefine CBD as a purely medicinal compound.
In 2017 Novel Foods was first announced by the FSA, with CBD/cannabinoid Isolates being identified as Novel, so you can push CBD isolate back to being available to the consumer around or before 2014.
Now I'm going to direct you to the MHRA's adverse event list for CBD, but I'm going to ask that you don't take it too seriously. The reasoning for that is apparent if you happen to look at the brands and products associated with CBD, with a lot of them providing high THC medicinal cannabis, and in some cases with very little CBD in at all.
The number of adverse events in itself is what I'm highlighting here, see if we were to assume that even 10% of 1.6 million people take a CBD Isolate based products (160,000) at over 10%, logic would dictate that we would have more events recorded on a year by year basis than the peak year of 2021, where 70 events occurred.
In essence, if EIHA's report is accurate, we should be seeing 100's of adverse events rather than the 44.8 we see on average in the last 5 years. That being said, I view the MHRA's data as having very little credibility in sight of their understanding of CBD, certainly in 2006, and I would hazard a guess and say that no one has died from CBD use per say, and that most of the adverse events are from unregulated products. This means that it's more than probable that the adverse events attributed legitimately to regulated products is likely to be less than 10 a year.
The consensus here is that whilst most agree that synthetic CBD should only be used on a short term basis (if at all), there is enough publicly available information to suggest that the long term use of CBD isolate based 10%+ products is fine.
They've had this data since April 2022
And what's worse is that EIHA have been chasing up fees for products that exceed 10%, whilst knowing that the information they held didn't support the legitimacy of 10%+ products on the market.
Now forgive me, but I thought trade associations were supposed to be honest with their members, but this seems the complete opposite of that!
Thoughts
Every cloud is supposed to have a silver lining, but it's hard to see any glint of hope. I've already talked to effected parties, and I can tell you there's a lot of frustration with EIHA right now, so at best we're looking at damage limitation.
First and foremost, that data needs to be re-evaluated, to ensure that the tests have been conducted appropriately. The data itself needs to be scrutinised to ensure that it was recorded adequately, and ultimately, interpreted correctly. If it wasn't, we can breathe a bit, but if it was, I fear for the implications this data set will have on the industry as a whole.
Simply put, that data has to be wrong! Disregarding the WHO, do you think that GW would've got it so wrong with their lab reports, or the Centre for Toxicity (COT) when they interpreted those reports to determine a 70mg RDA? I believe that Novel Foods is being run to protect GW's interests, so if it was more 17.5mg or there about, you can rest assured that they would have let the COT, and ultimately the FSA know that this was actually the case... if I'm right in my assumption that is.
This is starting to sound like a colossal mess!
So what about the implications of these toxicology reports? That depends on the FSA, whose options I believe are as follows:
They could say "Why not? We'll adopt that 17.5mg RDA as standard!", and that'll be any product above 10% gone
This is not the best case scenario, and what's worse is that the FSA are known for using data from one source. WHO data was ignored for 16 lab reports from GW, so if there was an agenda at play here, what's to stop GW relaying to the FSA that 17.5mg works for them?
It's not an idol thought by any means, but there's further grounds for why this RDA is an issue. EIHA have indicated that they suspect a higher RDA for their full spectrum studies which will be released early next year, but what's that got to do with the price of eggs?
Think of it this way, people have tried to get a distinction between Isolated and wholeplant extracts recognised by the FSA since Novel Foods 2.0 ramped up in 2020, rightly arguing that they are two different products, or ingredients if you will.
What is the FSA's incentive to all of a sudden allow two different RDA's for these products? There is none, and that's the problem, so even if the full spectrum toxicology studies come back saying a higher number than 17.5mg, it's likely that the FSA will go with one number.
And if they go with 'that' number, then there will be serious implications for every other application that has been submitted for CBD Novel Foods. The numbers are going to be far apart from everyone else, let alone GW's, so that will lead to further questions along the line of "Your labs say an RDA of Xmg of CBD, but this one says 17.5mg, what's your thoughts on this?"
They could recognise discrepancies between applications and suggested RDA's, and ask for clarity
This is the preferred option, and despite of all my reporting on Novel Foods over the last 8 months, I would happily give all the FSA team a hug and buy Paul Tossall a pint if this was to happen.
Someone should see that there is a massive difference in suggestions between the lab reports of a world leader in cannabinoid science and medicine vs the labs that EIHA used, or on how the information was interpreted at least, so we can only hope that the right person picks up that report, and asks for 'confirmation of it's findings'.
If that someone does, EIHA really need to apologise for their blunder and promise to get the 'right' report to them as soon as possible.
They could recognise discrepancies between applications and suggested RDA's, and order that every application and sublicense be looked at independently
This is the flipside of the point above, and the issue here is that if there is any inconsistency within Novel Foods, this is likely to happen.
It's been suggested over time that the Home Office (HO) are waiting for some sort of uncertainty which could lead to them ordering independent toxicology studies, something like this where independent lab reports call into question the lab reports used to formulate the requirements for CBD Novel Foods could well be that trigger!
The reason why this isn't good is because the HO and/or FSA will then have a chance to set the parameters of any centralised study, and we already know that GW have a 20+ year strong working relationship with the HO, who in turn initially approached the FSA about Novel Foods in 2017.
It's a tricky situation, further compounded by FERA who are a lab used by the government, and like throwing 130 page lab reports out that make everyone else's look like they might get stuck onto the fridge later, because mummy's proud...
In regards to what may or may not be the 'worst case scenario', this could be the one. Your lab reports could be compared to a master study, and any serious discrepancies could lead to further questions or applications being struck out. Equally it could lead to a sensible benchmark being set by the HO that reflects the here and now, who knows? That being said, this route could stretch the amount of time needed to complete Novel Foods, and that's not good at all!
They could reject the data on the grounds that it seriously conflicts with the data that has set the Novel Foods standards and requirements for CBD products
This is the second most preferred option, but EIHA might have to pay a little more for that information to be re-looked at. That being said they are subject to contracts of sorts, and you'd like to think that this cost wouldn't be filtered down to their membership should it happen.
Some of the above options have the potential to effect every product on the FSA's public list, here's hoping that this never happens...
But lets cut to the chase though, this has highlighted wider issues!
EIHA sat on that information, yet they still took money from companies that would ultimately be affected by it. There's no way to butter that up, so I'd rather not say what I truly feel about that.
But apart from this, if EIHA have dropped the ball in what can only be described as 'in the most spectacular of fashion', do we need to look into them further?
I'm glad you asked, let's start with the synthetic application!
I've heard of this through whispers, and if they are right, a company with validated products maybe affected by these revelations.
Even if that's wrong, I only have this one question to ask on the topic. Why would the 'European Industrial Hemp Association' submit a Novel Foods application for synthetic cannabinoid products???
There's not enough question marks in the world for that one, it feels like they've stabbed the plant in the back.
But further to this
Whilst there's blatant damage that has been done by EIHA's toxicology reports and surrounding suggestions, they are also influencing others beyond these reports, which leads to a serious concern or two.
The Cannabis Industry Council (CIC) for example recently joined EIHA, and the Cannabis Trades Association have been promoting EIHA's prices in regards to Novel Foods applications. Together, they form the All Party Parliamentary Group (APPG) for CBD, although if you look into their focus, they are more broadly about cannabis with a paper that covers everything from the legalisation of recreational cannabis to carbon tax credits for hemp farmers.
Are they aware of the implications of these lab reports, and if so, why have they not taken this time to comment?
Well to the CTA's credit, Mrs Marika Graham-Woods did address the matter, and stated the following to The Canna-Consultants:
"For those organisations who could not afford to run their own toxicology testing there were few places to get data. The CTA did not direct our members to EIHA nor did we handle their dossier applications.
What we have done is work intensively with the FSA and Novel Foods process to get 100 bulk producers and white labellers products tested, to speed up the process.
We continue to help the FSA streamline the process as the CTA, and as a member of the SAB APPG CBD."
This statement comes despite the CTA's main website clearly showing a box to the bottom right of the screenshot below for help with Novel Foods submissions, despite this they have neither any Novel Foods applications submitted, nor the knowledge base to help people directly as they made all of their frontline staff redundant in March of this year.
To ease any other doubt, the screen shot below shows the CTA advertising the price of having access to EIHA's long term toxicology data in February of this year. This was presented by Mr Stephen Oliver of The Canna-Consultant after Mrs Graham-Woods stated she disagreed that the CTA had passed companies on to EIHA for all Novel Food applications enquiries.
Mrs Graham-Woods further replied with the following:
BTW your (Canna-Consultants) screenshot was from February when the CTA were trying to ensure that CBD companies could remain on the FSA Public List (which we achieved). If you look carefully you will see that we give information about the EIHA consortium costs, which is not the same as passing our members on to them.
I have subsequently asked Mrs Graham-Woods the following questions: why advertise EIHA's prices (without competition or comparison) if you're not directing companies to their services, and can the CTA confirm what they did in February this year that helped companies stay on the public list when all that was on said list at that time was a handful of validate products, none of which belonged to any member of the CTA. She is yet to reply.
And the CIC?
It was always going to raise an eyebrow when the CIC 'joined' EIHA, what gives? It's no surprise that they're keeping quiet though, and that's because it was set up to not rock any boat regardless of the flag that's hoisted.
The CIC is a non-confrontational organisation, designed to bring all of the cannabis sectors together to work for change. The problem there is that it still marginalises, with the 2 powerhouses present within that organisation being the APPG for CBD, and anyone who has facilitated the push for medicinal cannabis being the number one concern.
I'm not saying that the CIC are part of this confusion directly, but they are part of the glue that holds the APPG together
And the APPG in question?
Their silence is also to be expected, even though EIHA's toxicology reports will have a bearing on their white paper for CBD products, which turned into the white paper for everything cannabis, yet CBD products and Novel Foods still forms a healthy portion of it.
So that's another non-boatrocker!
And why would they, rock the boat that is? They're obviously friends, and friends watch out for each other. Take that one company who's also part of the APPG for example that's got a market share it's not entitled to. Savage Cabbage, whose founder is on the board of EIHA, have products validated by the FSA that are effectively drugs inside of UK legislation... no one bats an eye in regards to that company/APPG member, so compliance obviously is disregarded when you're in the 'inner circle', or so it would seem.
Whilst questions surround that, one also resides in the fact that Savage Cabbage have had a CBDa focused product removed from the FSA's public list, and that the founder stated after this that it suggested different toxicology reports were required for products of that nature other than CBD toxicology reports.
Ermmm... yes, that's exactly what it does!
And that's where I sense a big problem, that can't be a cosmic oversight, someone must have given her that impression! All cannabinoids are 'Novel', so why would CBDa get a free ride? It's like trying to justify a lemon with lab reports for an orange... close, but no cigar!
So are we talking about a case of the blind leading the blind?
I honestly can't say, but there's a lot of people banded together right now, and all around EIHA. That's despite EIHA being identified as not being truthful with their members, here's hoping there's no more of that type of thing lurking in the industry!
There is something happening though, 3 organisations seem to be huddled together. There's definitely some agreement of sorts, with EIHA leading the charge for all things Novel Foods. But how does it reflect on the other 2 and the APPG which they're all apart of, if the lead drops the ball?
The CTA promote EIHA's prices for Novel Foods (as well as datasets from one of their director's for isolate or full/broad spectrum applications), so are we talking kickbacks between the two for introductions? The CIC recently announced they had joined EIHA as members, but for what gain if they are already founders of the APPG?
A can of worms has been opened!
And it's not the only one, see compliance is king in this industry, and two of the three major trade associations are disregarding it in the face of everyone who they have preached the virtues of the word to.
Who am I kidding, all three are, but luckily for the ACI, I've bigger fish to fry right now. That being said, there is a P.S at the bottom of this article just for them!
Back on track though, and take for example the public interest disclosure I launched against the FSA in regards to the handling of Novel Foods, there's more than enough people who know about that, including those in the APPG who is populated by:
Savage Cabbage - identified as having validated products with 195mg of THC Delta 9 in, and who also represents not just her interests but also that of EIHA's and Charlotte's Web. This company as stated earlier was only just recently informed that CBDa is novel, as with all cannabinoids, and toxicology data for CBDa would be required if you want to sell products of that nature... worrying!
CTA - Seemingly promoting EIHA and that they are/were running Novel Food applications, and protected in the CIC. Through out Novel Foods the CTA would have advised companies that products which contain more than 1mg of THC Delta 9 would be prohibited. In fact they still claim to police compliance issues to this day, even though they sit at a table with the owner of several validated products that are drugs and not food.
EIHA - Chasing fees for Novel Foods applications, including that for isolate based products, whilst knowing that they were sitting on information that some might not want to pay for. They too should have advised people in the UK of product requirements for Novel Foods, yet they're also represented in the UK by Savage Cabbage, how have several products that are not compliant in the UK.
CIC - Members of EIHA, and founders of the APPG. I wonder how many members actually know of my public interest disclosure, it's been brought up in some meetings I have attended and it was a CIC member who made me aware of the THC content in some of Savage Cabbage's products. The CIC as a whole are more than aware of the requirements for CBD Novel Foods applications, yet one member (two by extension, excluding themselves) of their APPG either endorse or sell a validated product that shouldn't be validated by association.
That's one interesting bunch, and there's no doubt an agenda is there. Is it all around the APPG, or are they just best buddies? Who knows, but if one is leading the others whilst providing questionable data and direction, questions need to be asked of all of them if they don't ask questions themselves.
That's the same in regards to compliance, because EIHA and the CTA as trade associations should be primed for that as their core focus regardless of what area of cannabis is being touched on. If they are ever reminded of that, they should be directed to Savage Cabbage's illegal products and further reminded that they willingly sit on a committee with the founder.
As for the CTA specifically, they need to be reminded of every complaint they have submitted about companies to the MHRA, FSA, VMD and the police, and then asked why they are ignoring compliance now. As their ex-member point of contact, they know that I know the number of complaints submitted by them is very high, so why change the habit of a life time?
Position
If EIHA could ask for that lab report to be retracted due to clerical error, that would be great. Past there, that's up to their members!
In regards to the industry clique that's forming, I wonder if an industry roundtable conversation needs to be had with all those invited being able to question what's going on. If trade association members are reaching out to the likes of me for guidance, then it seems that their members interests and concerns are not being listened to.
PS... for the ACI - You guys really need to have a word with your membership, specifically those who are releasing new products whilst targeting other companies in an attempt to 'thin the herd'. I'm not messing about here, so please tell them all that should I hear of your members targeting others again, I will use your very own UKCBDlist against them. I don't expect you to carry those complaints forward to Trading Standards though, should they happen of course, so I'll make sure I go to the FSA directly with any information as well should the need arise.
If I have to do that, I will be submitting a bill for my time on the basis of doing work that your compliance section should be undertaking!
For any questions or queries, contact cefyn.jones@hemphound.co.uk
