A review of some topics of interest for the UK hemp and CBD industry
Well... Pureis and Cannaray... I didn't see those two applications being authorised, two years ago, when highlighting to the Food Standards Agency (FSA) that they had allowed their inclusion into the CBD amnesty when they didn't qualify, and added their validated products onto their public list for CBD products despite those companies not having any products available to the consumer on or before 13/02/20... honest, Guv!
But, just before the announcement that Pureis' and Cannaray's novel applications were authorised, I was informed by a client that they (not Pureis and Cannaray) had attended a meeting with other food-focused businesses, which was also attended by the head of novel foods.
Three points were raised which I feel need to be addressed:
1 - The FSA is engaging with the Advertising Standards Authority (ASA) to target medicinal claims
2 - The FSA are looking at product labels to ensure no one has altered them to reflect the consumer safety advice they very publicly announced on 12/10/23
3 - The ACNFP weren't happy with RP427
They are all concerning points, which I feel require an opinion.
So here is part one of a three-part article series. The focus is on the FSA engaging with the ASA to target medical claims. Parts two and three will be released within the coming days, and I hope you agree that the issues raised are extremely important.
So, are the FSA engaging with the ASA in some way, and if they are, why are they not engaging with the Medicines and Healthcare products Regulatory Agency (MHRA)?
I have a suspicion as to why, which matches something I've been saying for the best part of two years.
The TIGRR Report!!!
Point 356 is what you need to look at
Now, you might think that this is 'only' about medicinal CBD, but as you read further from here, you'll notice a big problem that affects the supplemental CBD industry.
Further to that, we need to touch briefly on who is managing the intent of TIGRR. That used to be the Department for Business, Energy and Industrial Strategies (BEIS), but that split into three departments in 2023. The entity from that split that took over the management of TIGRR is the Department for Business and Trade (DBT).
This I feel can be verified with the link below, which involves an email exchange between myself and DBT, who seem very hesitant to respond to a Freedom of Information (FOI) request launched in January this year which asks one question.
Please can I have all files relating to GW Pharmaceuticals, from your department (DBT), from the point your department was created up to the present day (05/01/24).
FOI request, submitted via whatdotheyknow.com
As for BEIS, most wouldn't have seen this, but in every meeting held by the Centre for Toxicity (CoT), a representative of BEIS was present.
Past the point where BEIS splits, DBT takes over.
However, that doesn't necessarily mean much, until we look at an FOI response I received from the FSA in March of this year.
The email this was extracted from was from the FSA to all local authorities, and was dated 12/02/2020
And beyond that, we have the Life Sciences Sector Deal 2 document, released by BEIS in 2018, which shows that they were invested in GW Pharmaceuticals at the time.
Before we get to the point of this article, I just have to say that Theresa May created BEIS, who were launched two weeks after she became the PM in 2016.
And if you know her history with GW Pharmaceuticals, what I've just told you should raise an eyebrow or two
The MHRA are destined to control the UK's interests with medicinal CBD and cannabinoid-based products, so why aren't the FSA liaising with them and not the ASA?
The reason why the MHRA can't be approached is because under pressure, it would be hard to explain past enforcement for blurring the lines between foods vs. medicines against what can be seen in the current landscape.
How many of the inner circle do you think have connections to the MHRA, either due to on-going medicinal trials or through access to accredited facilities?
The answer is, most, if not all
There are independent trials, and trials with Universities, all of which the MHRA would have been kept in the loop with.
What would you assume, back before any novel food deadlines were announced, the MHRA would do to a CBD company selling food supplements but also detailing on their website that they were sponsoring 15 clinical trials?
"These products are not designed to treat, diagnose or cure any ailment, condition or disease..."
How do you get around that?
Yet that's what we have, specifically in this case with Brains Bioceuticals.
To date, we are involved in over 15 clinical trials using Brains CPD API, exploring its effects on treating COVID-19, epilepsy, anxiety, insomnia, opioid addiction and muscle inflammation. Once the results of the clinical trials are available, Brains Bioceutical will have the research and empirical data needed to solidify our leadership and expertise in the use of phyto-cannabinoids to treat major diseases and improve patient outcomes.
Quote from 'Brains Bio Three Year Anniversary', dated 07/03/22
As you can see from the date, that's one month after their products had been validated in the novel foods Amnesty, despite their products not being launched at that time.
According to the FSA though, that's OK, because they had products 'on the market' before 13/02/20 (???), and further to that, they contributed towards the creation of the TIGRR report (P. 129).
The question is, if I made a complaint now to the MHRA saying "Brains are blurring the lines between foods and medicines!", would the Borderline Medicines department step in to address the matter, or would they pass, and throw out the words 'commercial sensitivities'?
Between 2018 to 2020, I saw the MHRA order companies to strip their websites back to the bare bones for posting anything with the sniff of overstating, so when they stopped, I noticed
Was their stepping back intentional? I believe so, even in sight of the global issues and any certain management requirements for yellow card lists for reactions to Covid vaccines.
Here's the thing though: the MHRA tried to define CBD as purely medicinal in 2016. A public backlash apparently put an end to that.
But in 2018, the head of the Borderline Medicines department stated to a room full of industry stakeholders and company representatives that "We're [MHRA] just waiting for the consumer to view your products as medicinal, then we'll be back to say hello"
And then in 2023, I was attending a webinar where a solicitor shared a slide from the MHRA, which stated they reserve the right to define CBD as medicinal.
That bottom line says it all...
There's always been intent, and from my reckoning, that intent first became visible in 2016, approximately two months after Epidiolex had completed Phase III trials.
Whether there's anything in connection to those events is anyone's guess, but then, the UK hemp and CBD industry did end up being governed in novel foods by 16 lab reports for Epidiolex.
What's more, the CoT, who deliberated over those lab reports in January 2020, did have two unnamed observers from GW (P.5) attending the very meeting where those lab reports were scrutinised.
But further to that, we already know GW had designs on CBD supplemental and cosmetic-based products, and that the Home Office has supplied GW with seized cannabis to test for CBD content.
Patent GB2438682A, filed in 2006
But I'm getting ahead of myself. This article is about the FSA engaging with the ASA, not about who ultimately influences a competitor industry
And simply put, I believe that if the FSA is engaging with the ASA, is a tactical move.
The intent is to let everyone overstate their products, and let the ASA publicly shame some companies before the MHRA feel 'obliged' to step back in.
This is where those in the inner circle like Pureis, Cannaray, and Brains Bioceuticals, will be perfectly placed, because they already have ties to show their products are effective against certain conditions, or are engaged in R&D to do so. From there, a secondary strangle hold will be placed on the industry, because despite the fact that products 'are not designed' to diagnose, treat or cure any condition, ailment or disease, we all know that overstating does bring customers who are looking for something that's defined outside of being a food supplement.
That certainly doesn't mean that overstating is right, though!
But equally, it's easy to see that should I be right in my analysis of the situation at hand, the vast majority of companies would be at a disadvantage.
That being said, companies and trade associations were always under the impression that lines couldn't, and shouldn't, be blurred.
Now, however, the vast majority of companies are making claims to some degree, even though according to the MHRA's Guidance Note 8, you can't say anything.
There have been no approved food claims for hemp and CBD products, and if you go by the letter, you're not even supposed to mention the Endo-Cannabinoid System, or that the phytocannabinoids in your product could interact with it in any way.
That guidance is in danger of being ignored, to the point that the MHRA will have to take notice, after the ASA have called some companies out beforehand to highlight a manufactured problem
Because after all, the MHRA are waiting in the wings for the consumer to view your products as medicinal. Then they'll step in.
But it's not just the MHRA's absence that needs to be considered, see between 2018 to 2020, the Centre for Medicinal Cannabis (CMC), who launched the Association for the Cannabinoid Industry (ACI) in November 2019, did something that brings the FSA into play.
To explain, I just have to touch on my past, which includes being the member point of contact for the Cannabis Trades Association (CTA) between 2018 to 2020.
The CTA back then were very focused on industry compliance due to working with the MHRA from 2016, when that public backlash stopped the latter's attempt to define CBD as a medicinal compound, which in part led to the creation the CTA.
The CTA and MHRA also worked together to author Guidance Note 8, although it was the MHRA who had final approval over the wording of the document.
That's not where the conversations end, though
If you thought novel foods started in 2019 with deadlines being announced in 2020, you'd be wrong. The FSA announced it first in 2017, before I worked for the CTA, and was focused on isolates and nanoparticle products, but they didn't enforce or manage it as we see now.
The CTA wasn't just talking to the MHRA at the time; they announced novel foods Mk.1 to the industry, on behalf of the FSA, but some didn't want to play ball. The CMC, and later the ACI, seemingly encouraged companies to sell CBD isolate-based products, but despite the CTA raising the issue with the FSA, nothing was done.
But then there were the medical claims, being made by their members on their wares, which were seemingly signed off by the FSA.
I'm not kidding either, yet the MHRA wouldn't go there...
But there might be a reason for that. I can tell you that the MHRA enforced compliance against CTA members more so than companies who weren't members, and that's where I saw them clampdown.
Some of those compliance breaches were tiny in comparison to what we can all see today, and you have to ask whether I'm right, and the MHRA are waiting for their perfect storm.
But those who've contributed to us getting to this point need to ask themselves two questions
Are you aware of the difference between foods and medicines?
If you are, why are you suggesting that your food products, which are not designed to diagnose, treat or cure any condition, ailment or disease", can provide some level of medicinal benefit?
Look, I like most entered this industry thinking I could stick the middle finger up at Big Pharma whilst selling something affordable that could significantly improve people's quality of life, but then I started to see cannabis as a food, and foods are just as important as medicines.
After all, you can't treat someone's arthritis if they've died of starvation
But the problem is, Big Pharma always seems to get the last laugh. By allowing companies to overstate their products, and yes, I do believe they have that level of influence, they would have seen who are finding those products effective, and they would have taken notes...
Right now, I would hazard a guess and say that any such notes would suggest that the consumer views CBD as a medicine more than a food.
But that's not something that can't be challenged
Once upon a time, up until the point where the ACI was born and the CTA were working with the MHRA on creating Guidance Note 8, the MHRA 'allowed' companies to indicate the following:
Products weren't designed to diagnose, treat or cure any ailment, condition or disease
Products were designed to 'top-up' the ECS
The ECS, when fed with what it needs, could help regulate core bodily functions such as mood, memory, appetite and the sleep/wake cycle
With all bodily functions working as they should do, you could reach a state of homeostasis
But then came niggles:
You can't say 'top-up', because that's altering a physiological state, which is what a medicine does
You can say cannabinoids, but you can't mention the ECS, or that your products are designed to top it up
And of course, those previous claims weren't actually 'allowed'
But I wonder if there is in fact a window to allow for some claims. See, some level of claims were accepted, even if there wasn't the guidance or legislation to allow for them.
And if we look abroad, there are countries where more general claims can be made in line with overall wellbeing, and the management of minor conditions, without products then being viewed as a medicine over a food.
Currently, I'm working on a white paper which will provide an opinion on why full-spectrum and broad-spectrum products should be removed from novel foods.
The simple fact of the matter is that cannabis has been in our diet for millennia, and cannabis as well as any extract, contains cannabinoids.
The point from there is distinguishing between reformatting, and redefining a old food, and arguing that redefining is not reformatting, and as such, those products are not novel foods.
The basis of the argument rests on historical data, and a fruity decision
A judge recently ruled within a judicial review that the FSA is too rigid with the rules and regulations that it follows, specifically in regards to what evidence can be used to prove that foods have been consumed before May 1997. That ruling was made due to the FSA determining that monk fruit decoctions were a novel food, without considering consumption records for the Chinese communities in the UK, EU or in China.
The issue as such was that most of the information provided came from records that preceded the digital age, which was just starting to emerge in the '90s.
And the type of evidence?
Well, historical, and that proved the ingestion of monk fruit more so than monk fruit decoctions.
And if that's the case, that should apply to cannabis, and cannabis extracts which contain CBD and other cannabinoids,
I hope to have that white paper completed by the end of this month, but what window is there to apply a similar argument for the MHRA to consider allowing a level of health related claims on supplemental CBD products?
That would be called a 'Traditional Herbal Registration'
And that, in essence, is a white paper which includes evidence that the herb in question has been used for at least 30 years for the condition you're applying for.
I know of evidence to show that cannabis was an active ingredient in a balm which was used to treat sores, in the 1600s, in Wales.
But I'm not just restricted to evidence that can be found for use in the UK, so when I've finished the white paper of not novel foods, I'll look to create one for certain claims for cannabis extracts which include CBD.
Hopefully, you folks and others can help me push those papers to ensure that those who are meant to read them, don't just skim through and forget.
But in the meantime...
I don't expect many of you to heed this warning of the wider implications of the FSA engaging with the ASA to target companies who are breaching the MHRA's Guidance Note 8, but at the same time, I've warned you nonetheless.
What's more, there maybe a suggestion that the FSA has already started liaising with the ASA, but it's only a suggestion, so I won't share their recent ruling.
But the fact of the matter is that we're fast approaching a crossroads where something has to give. Claims are rife, and the ASA will only be able to do so much before the MHRA has to step in. I personally feel that will happen after the inner circle is through the door with authorised novel food applications, when the rest of the industry is looking at Deloitte inspired reform, which isn't that far away.
A suggestion for that comes from the FSA's review of the Deloitte report into Novel Food Regulations.
"leading to a conditional authorisation and supervision model, similar to that used in other sectors such as pharmaceuticals"... see what I mean?
And if you want to see just who Deloitte are, and who they've worked with for over 20 years, click here.
I'll give you one clue, the company in question is also the one with links to BEIS, DBT, and the one who had unnamed observers attending CoT meetings to discuss their 16 lab reports for a medicinal product that is predominantly made with CBD
If you would like to know more about the Hemp Hound Agency, or to as a member or supporter, email cefyn.jones@hemphound.co.uk
