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Three Points to Discuss Part 3 - The Curious Case of RP427

In the backdrop of comments recently made by the head of novel foods comes an industry conundrum surrounding a novel foods application belonging to a major trade association.


The European Industrial Hemp Association and RP427


This is Part 3 of a 3-part article series that looks into comments made by the head of novel foods on 18/04/24, in a meeting help by food business operators. Those comments were:


  • The FSA is engaging with the Advertising Standards Authority (ASA) to target companies making medicinal claims on their food-focused products


Part 1 of the series looks into why the FSA wouldn't address those concerns with the Medicines and Healthcare products Regulatory Agency (MHRA) directly, whose guidance the ASA will be working by.


It is a topic that all hemp and CBD companies need to be aware of, because the ASA are but a stepping stone to the MHRA being more active in the industry, and let's be honest, there are too many claims flying about for products with labels that state they are "Not designed to diagnose, treat, or cure, any condition, ailment, or disease".


There's a reason why the MHRA went quiet at the start of novel foods, and there's a reason why the FSA are engaging with the ASA, and I believe it's all to do with the fact that the MHRA have been waiting since 2018 for consumers to view CBD products as medicinal.


The ASA have no true power other than to name and shame. If the FSA are engaging with them, it wouldn't take long before the ASA 'need' the help of the MHRA to enforce their own guidance on companies who are selling medicines under the guise of being a food.


If that happens, novel foods will be the least of people's worries, and take that from someone who worked with a trade association who at one point had very strong ties with the MHRA, and who saw exactly how they work.



  • The FSA are keeping an eye on companies to make sure they are not changing their labels to reflect the 10mg Advised Daily Intake (ADI) advice they gave, very publicly on 12/10/23, to the consumer via a very organised press campaign


We know that the FSA has threatened companies with expulsion from the CBD amnesty if they were to rebrand, or alter the dynamic of their products or labels in any way.


Part 2 of the article series looks into that angle of novel foods, and asks ethical questions about the intent of the FSA when not allowing companies to reflect their publicly announced consumer advice, through fear of being ejected from a process that the FSA effectively started in February 2020.


If novel foods is all about consumer safety, shouldn't the FSA allow companies to change their labels, regardless of their focus on products rather than the ingredient, and to reformulate their products to reflect the consumer safety information they announced in October 2023?



  • The Advisory Committee on Novel Foods and Processes (ACNFP) isn't happy with RP427...


And that is where we are now, because whilst the ACNFP are not happy with that application, it turns out that the FSA 'are', and that raises serious concerns for the process as it stands.



Now, before I continue

I have to make this very clear. I am in no way 'attacking' RP427, I am just pointing out something that has the potential to have a big impact on the way that novel foods progresses from here.


I know a lot of companies who are attached to that application, and I feel they are in danger of being frustrated through misrepresentation by EIHA.


After all, you would think that those who were looking to join that application back in 2020 with, for example, full or broad-spectrum gummies, would have been told by EIHA that the focus of the application would only cover one product dynamic that certainly wasn't full or broad-spectrum, or gummies.



But to my understanding

Those who joined that application were asked to submit data to cover all products, as well as strengths, but I've also been informed by some that when it came to submitting that data, EIHA wasn't exactly in a hurry to accept it. What's more, it's understood that EIHA sat on their toxicology data from March until November 2022, and continued to charge subscription fees to applicants and sub-license holders whose products were outside of the sole dynamic represented within that data.


I am surprised that companies have been paying their subscriptions without questioning why their products have not been represented in a process where the FSA are supposedly working on a 'by product' basis, and I am certainly questioning whether legal action would be an option, should companies be ejected from novel foods due to there being missing data gaps that they had paid EIHA for. But then, this situation is messier than you think, which I hope you'll agree with as you read on.



So, on 19/04/24, I was informed by a client that the head of novel foods had made some comments the day before, which we've already covered

What was not made clear was whether anyone in that meeting was either associated directly with EIHA, or were part of RP427. What I do know, though, is that the client who informed me of this is not an EIHA member, or part of that application, so you have to wonder what gave the head of novel foods the confidence to say what has been suggested, and in an open room. What is also known is that on 23/05/24, the ACNFP released the minutes to their meeting in February, and it shows that the discussion on RP427 had been delayed until their meeting on 17/04/24, the day before my client sat in a room and heard the head of novel foods say that the ACNFP weren't happy with that application.



ACNFP minutes for their February meeting

Advisory Committee on Novel Foods and Process. Minutes of the 164th Meeting held on the 7th of February 2024



There is every reason why the ACNFP should not be happy with RP427

The main issue is that the application itself is specifically for 10% CBD isolate in hempseed oil, but out of the 3,269 products associated with that application, it is very noticeable that a large percentage of them do not match the sole product dynamic covered.



  • 270 listings mention 'capsules'

  • 54 mention 'drink'

  • 87 mention 'chocolate'

  • 522 mention 'MCT'

  • 35 mention 'olive oil'

  • 405 mention 'gummy'

  • 471 mention 'gummies'

  • 53 mention 'water soluble'

  • 100 mention 'tea'

  • 79 mention 'coffee'


That's 2,076 out of 3,269 products, or 63.5% of products tied to that application that are not 10% CBD isolate in hempseed oil. But that issue doesn't stop there, 238 products are labelled as full-spectrum, and 468 as broad-spectrum.


What's more, a lot of the products above have been validated.


And then there's an obvious issue. The products themselves are actually catalogued, as you can see with the breakdown above, but the safety data for them wasn't included, so it's like EIHA did half a job, which in itself suggests laziness at best, and incompetency at worst.


So when it comes to the other point that was also postponed, that being 'Approach to CBD applications where a conclusion on safety cannot be reached', you would assume that it was in relation to RP427, because the other two applications discussed on the day were for Pureis and Cannaray, and we already know that their applications were authorised on 29/04/24.



CBD safety


When I heard that the head of novel foods had said what he did on 18/04/24, I thought the writing was on the wall. So I contacted companies that I knew had products listed on RP427, and after recounting what had been reported to me, I suggested that they contacted EIHA to ask if there had been any updates on the status of that application.

After all, if the head of novel foods had suggested to an open room full of business representatives that the ACNFP were not happy with RP427, you would assume he had already notified EIHA of that beforehand

This was somewhat confirmed, in that some of my contacts indicated that EIHA were due to have a meeting on 21/04/24, to discuss the status of their application, but a couple of days after that, I was informed by two contacts associated with RP427 that they were told that the FSA were happy.


So, how can the FSA be happy with an application that the ACNFP isn't happy with? Well, if you have a look at the screenshot below, you will see exactly how that 'could' be the case.

Is the ACNFP being overruled?

Advisory Committee on Novel Foods and Process. Minutes of the 164th Meeting held on the 7th of February 2024


Does an assessor in meetings like this have the final decision on applications, regardless of the input from the ACNFP?


That concerns me, and for two reasons. The first is because I've seen how some panels have been ignored over time, more so with the Advisory Council on the Misuse of Drugs (ACMD) when they've given an opinion that the government didn't want.


The classic case for that involves cannabis in 2008 - The ACMD advised that they saw no public concern about strong strains, such as skunk, but the government used a study from GW that highlighted a lack of CBD in street cannabis, and used that as an excuse to reclassify cannabis from a Class C to Class B drug, against the ACMD's advice. That being said, I've also seen how those panels are used to further certain agendas by allowing conflicted individuals, either directly or otherwise, not to declare interests.


The second concern is that I have evidence to show that Mr Tossall hasn't played by the rules that he has resided over for novel foods, and if he has overridden the ACNFP, that would be the icing on the cake.


Some of that information also covers EIHA and one of their directors, who represents Charlotte's Web (CW) and Savage Cabbage (SC).


Some of their products were validated in early 2022, despite having 195mg of THC Delta-9 per 100ml container, even though the FSA had active guidance, which still stands, that stated products could not be regarded as controlled substances.



When is a drug a food?

CBD products linked to novel food applications - Pub 19/03/21, last updated on 12/10/23


Before I continue, I've just got to state something that I hope has been obvious from other articles that I have written.


I'm not adverse to controlled cannabinoids, and I personally feel that MoDR is a pain.



In any other format of conversation, I'd use stronger words there, which i feel would still resonate with others within the UK hemp and CBD industry

But that being said, rules were made, published and announced, which includes in regard to when a food becomes a drug, and that's when the product in question has more than 1mg of any controlled cannabinoid, or substance, per container, regardless of size.




The road to legal compliance


So when I see that some companies are having their products removed from the public list, by Mr Tossall's department, despite them not double checking products that have been highlighted to them as exceeding that 1mg rule, I feel quite angry, and more so because as the member point of contact for the CTA between 2018 to the end of 2020, I was one of those who was advising companies on how to stay on course.


That advice came with two points: Only apply for products that were provably available to the consumer on or before 13/02/20, and, be mindful of MoDR.


So, regarding CW/SC and the FSA, there are three overlapping issues:


  • The FSA has stated that the Misuse of Drug Regulations (MoDR) 2001 has not been identified in their 'road to legal compliance' for the CBD industry. But If that's the case, why does their online guidance state that products cannot be regarded as controlled substances?


In essence, the FSA has validated a drug as a food. What's more, they have ignored that for over two years, and despite myself and others pointing out that issue.


  • But products associated with RP427 have been removed from the public list for breaching MoDR, which reaffirms that it is within their 'road to legal compliance'

And that's as recently as February this year...


I think we can agree that there is a level of double standards at play here, but it gets worse.



  • EIHA, to my knowledge, has not stood up for any company associated with RP427 who has had products removed from the public list for breaching MoDR


I wonder if that's so no attention is drawn to CW/SC products, even though the FSA know full well that those products breach MoDR. But then, the extract used by CW/SC to create their products at the starting point of novel foods clocks in at 0.21% THC, which means that if we are following EU regulations as they stood at the point of Brexit and we were not considering MoDR, CW/SC products still would not be legitimate in the UK.



Charlotte's Web ab reports
COA for CW/SC Mint oil - Report now removed from CW website


This isn't the only time that EIHA could be viewed as doing the UK hemp and CBD industry a disservice

See, when we were informed of the 10mg ADI on 12/10/23, which was created by combining the data of Cannaray's, Pureis' and EIHA's toxicology data for RP427, what we weren't told was that the definitions of 'not novel' hemp products was changed as well, courtesy of a campaign by EIHA and DG Sante to get hemp fan leaves defined as not novel for making tea.


Originally, the FSA simply had 'Cold press hemp oil and derivatives were not novel' for guidance, but now we have what you can see below.



New definitions for not novel hemp products.

Cannabidiol (CBD) guidance for England and Wales - Pub 13/02/20, last updated (with new definitions) on 12/10/23


Thank you EIHA for potentially putting the cold press hemp oil industry under threat by getting fan leaves, without flowering or fruiting tops, defined as not novel for tea!


Luckily though, I have several files that show where the FSA stood before that change in definition, and as you can see, they recognised the whole plant, dried and milled, as useable for tea and infusions.



Client email

Email from the Novel Foods Team to a client

The new definition effectively leaves the door open for the FSA to influence the cold press industry, and in a way that could have negative and detrimental consequences.



At the end of the day, EIHA are not exactly doing anyone any favours

But then, neither is Mr Tossall.


Some of you will know that in 2022 I launched a complaint against the FSA's handling of novel foods. Mr Tossall was named in that complaint, as he had dismissed actionable evidence to show that he and his department had validated products against the rules set by the FSA for CBD products. Some of those products highlighted in that complaint were from CW/SC, based on them being validated despite breaching MoDR.


Now strangely, Mr Tossall was allowed to look over the findings of the complaint, to check for inaccuracies, before the response was submitted to me. That is of course, despite being named directly in that complaint, but that's a side issue in regards to this article.


He knew that CW/SC products breached MoDR, and that it was the reason why they were named in my complaint.


He also knew that the investigating officer/unidentified employment agency worker who dealt with the complaint knew that CW/SC products were highlighted by me for breaching MoDR, and that the investigating officer/unidentified employment agency worker, or the FSA themselves, had worded the response to avoid the issue of controlled cannabinoids.


He knew the complaint response was wrong, or inaccurate, in that CW/SC products were deemed as okay, despite breaching MoDR, because their products were on the market on or before 13/02/20.



Someone is telling porkies...


Basically, Mr Tossall has protected CW/SC, and by extension, EIHA's credibility.



Could he be doing the same by overruling the ACNFP's opinion on RP427?

That is a fair question, because from my understanding, the ACNFP are the ones who decide whether there is enough safety data to recommend an application for authorisation. What's more, regarding controlled cannabinoids, not only has his department enforced MoDR whilst stating it's not in their 'road to legal compliance', they have enforced it both before and after CW/SC Products were validated.


In effect, the FSA and Mr Tossall have a habit of selectively enforcing guidance, so it's not too much of a stretch to think that they would pick and choose when to follow ACNFP advice as well.



But then, what is the point in the ACNFP if the FSA can override the advice of a council they employ to provide safety advice on novel foods?

I don't know, but at the same time, I do know that Mr Tossall is booked as a key speaker for EIHA's conference this week (5th to 7th of June), and that's not exactly the actions of a man who's about to tell someone that their application is missing key datasets, and that by extension the ACNFP aren't happy.


So the question is, what is he about to say? Because he cannot go over there and expect not to be asked about the progress or status of RP427.


In essence, he will have to explain how, or why, the FSA is happy with that application, and I've a few thoughts on that which I'd like to share:


  • The only way I see that EIHA application progressing is by the FSA placing full and broad-spectrum products onto RP438, EIHA's other application, which houses products of that nature, and that wouldn't really be a bad move


But it doesn't solve the issue with the lack of product dynamics represented in the supporting information attached to RP427, and you would assume RP438 as well, unless...



  • The FSA was about to announce that novel foods for CBD was to now focus on the ingredient, as opposed to final products


This is actually a double-edged sword. See, such a move should allow the return of white label options, and for the industry to be innovative, which could by extension bring consumers back. But at the same time, Novel Food Regulations (NFR) focuses on the ingredient, and the FSA's interpretation up until this point, being product-focused, is completely different to that employed by the EU in their format of novel foods for CBD. So, there's an issue that arises, should the FSA choose to take this path. They would effectively be saying that they were wrong, and that would anger companies who were put in a position where they had to spend a lot of money to ensure all their products were represented in their novel foods applications.


It will also anger those who have been calling for novel foods to be ingredient-focused over the last four years, as well as companies who have wound up as a result of the FSA's management of novel foods.


Basically, trust and confidence in the FSA could plummet to an all time low, which I feel will filter down to the consumer.



But don't worry, it seems that the FSA 'might' just have a get-out clause, courtesy of the Deloitte report...

Which in itself was all about reforming NFR, but in essence, the FSA spent £130,000 for a supposedly independent organisation to give them that option.


However, the head of novel foods informed me in 2022, before I became aware of Deloitte winning the contract to review NFR, that the regulations as they stood were sufficient enough to process the early applicants.


Effectively, we've seen Cannaray and Pureis progress to authorisation on the rules as they stand. If for some reason RP427 was authorised, that would mean that three quarters of the industry would be subjected to different requirements.


That of course will be subject to the outcome of the public consultation process, and a subsequent act of parliament.


But there's something you need to know about Deloitte, specifically, their past. For 18 years, they were the financial auditors for GW Pharmaceuticals (GW), and after that, they were named in the documents of sale when Jazz Pharmaceuticals brought GW.



Violating federal securities laws


The reason why you see 'Exhibit 23.3' is because the directors of GW, at the point of sale to Jazz, have been investigated for violating federal securities laws.


But you might ask what Deloitte has to do with this situation. Well, first and foremost, the FSA state that Deloitte's review of NFR has nothing to do with CBD products. However, there are 12,115 CBD products going through the novel foods process, and have been since 31/03/21, so any upheaval in NFR would have a direct impact on those companies more than any others in other industries.


Then we have the issue of GW's 16 lab reports for Epidiolex, which from 13/02/20 until 12/10/23, gave us an ADI of 70mg.


They seem to have disappeared, which is interesting as from my understanding, the data that was used to determine that previous ADI was within the public domain.



Where those reports gone, and why has that 70mg not been combined with the data derived from the toxicology reports from Pureis, Cannaray, and RP427, is anyone's guess

But what everyone can be certain of is this: novel foods for CBD products is all about protecting GW's interests, specifically with Epidiolex, and that is because there is a Public-Private Partnership (PPP) between them and the British Government. That's a given, as is that a 10mg ADI would widen the window of access for people who are looking at CBD in a medicinal context.


And this is where I believe that EIHA comes in. Pureis have accepted the 10mg ADI, even though their first product to be validated inside of novel foods was a 20mg capsule. Cannaray are the same, they too have accepted the 10mg ADI, even though some of their products suggest that 30mg is a serving size. And then we have EIHA, whose toxicology data suggested an ADI of 17mg for CBD isolate and synthetic CBD-based products.


They'll be told to accept that ADI, if they want their application to be 'safe' on the basis of the FSA being 'happy' with it.

And what you need to know past there is that despite those three lab reports being used to determine that ADI, approximately 200 applications have been submitted, and I believe that all have data that supports a higher ADI than 10mg

That in itself is highly peculiar, because from my understanding, the FSA should use all available information to determine an appropriate ADI, but from what I can see, they've chosen the three lab reports with the lowest ADI, to then force that on the industry in a way that stinks of 'control'.


However, EIHA is not in the position that they might think they are in.


See, the FSA might come to the rescue in some regard, but then the 10mg ADI that they will have to accept just to progress RP427, will mean numerous products above 10/15%, or that exceed 10mg by serving, will disappear as soon as the FSA make that currently provisional ADI mandatory.


RP427 is like a lynchpin, the missing part of the puzzle, which when assembled validates the FSA's 10mg ADI.


If they do accept that ADI though, it won't just affect that application, it'll effect the industry, and not in a good way.


That being said, considering the state of RP427, it's not like EIHA would have much of a choice in their next move.



Counter-arguments

Is there any other way that the FSA 'could' be happy with RP427?


Well, if there were, I've yet to see it.


My problem, as a writer, is that I have to provide you the reader with any alternative explanation that could be a counter to that which I believe could happen.


I've also got to try an maintain a balanced view, but at the same time, that's hard when writing about novel foods, the actions of the people who are managing the process, and the impact those actions have had on the industry as a whole .


We know that there are fundamental flaws in RP427, and that as it stands, the FSA should be following the lead of the ACNFP in not being happy with that application.


We also know that the person who indicated that the ACNFP were not happy with EIHA's application is a guest speaker at EIHA's conference this Friday (07/06/24).


And we further know that EIHA's toxicology data was used to create the 10mg ADI.


Beyond that, the FSA has a catalyst available to them for change, and that is the public consultation period for opinions on NFR reform that is open until the 5th of June (Today!!!).



Public Consultation for Novel Food Regulation reform



Any reform from this will be influenced by the Deloitte Report, which in itself opens the door for the FSA to alter the direction of novel foods to the point of changing from product to ingredient driven.


It also opens the doors to wider reform, which might work out well for the industry, but then the FSA hid the fact that Deloitte had won the contract to review NFR, and the lack of industry stakeholder engagement both by the FSA and Deloitte on that reform suggests that there is intent towards the CBD industry, even though the FSA claim any reform isn't about CBD. If it truly wasn't, why were no dedicated stakeholders in the CBD industry asked about a change in process that would ultimately affect an entire industry that's stuck inside of the regulations the FSA are intent on reforming?



But, if the FSA does use that consultation process as the justification of changing the dynamic

I would simply say this: the decision to do so would have been made well before the closing date of that process, and most likely before the ACNFP's April meeting.


But, if that 'is' the case, we might need to consider the impact EIHA has over the hemp and CBD industry in recent years, especially in light of them being able to influence definitions on not novel products, and the fact that one of their director company's are escaping scrutiny for having products validated that breach MoDR by 194 times.



What if that influence doesn't end there?

What if the FSA asked EIHA not to include product data outside of 10% isolate in hempseed oil?


It's a big question, and one that needs to be considered for the following reasons:


  • RP427 is seemingly the only application that doesn't include appropriate information for all of the products attached to it

  • The FSA has validated various products in that application that are not 10% CBD isolate in hempseed oil

  • The decision not to include product data in that application must have been taken somewhere before March 2022, which is three months before the deadline for companies to ensure they were attached to 'credible applications'

  • All of the companies I've spoken to that are part of that application are very angry that EIHA did not disclose to them, until November 2022, that their product data had not been included in RP427

  • EIHA haven't exactly done anything in regard to the frustration of their members. In fact, if anything, they've tried to ride that out

  • When it comes to the ADI, since it was indicated that EIHA's toxicology data was used in it's formulation, they have been very quiet on the topic

  • And interestingly, the authorised applications for Cannaray and Pureis seem to accept the ingredient more so than the actual products associated with their applications, even though acceptable product formats are specified in their authorisation documents... just not the products on the public list, or associated strengths.



And we need to be mindful of Cannaray's and Pureis' position in this situation. See, despite Pureis' first validated product being a 20mg capsule, they are in fact the only company who came out in support of the FSA's ADI announcement.



You advocate a 10mg ADI, but you've got 20mg capsules

Business of Cannabis - Pub. 13/10/23


As for Cannaray, well they have accepted the ADI. but I find it very interesting, I find it very interesting that their MD decided to check me out twice on LinkedIn. The first time was on the 11th of April, six days before the ACNFP's second meeting of the year, and the second time was four days before the industry learnt that Cannaray's application was authorised.



Stalking

Screenshot from LinkedIn analytics


Now forgive me if this next comment sounds a little self important, but I've actively named both companies in the same complaint where CW/SC are identified as having very hot products, so I find it very interesting that I was checked out very near to key dates that saw a company that didn't qualify for the CBD amnesty, and by extension a spot on the public list for CBD products, progress to authorisation.



So if EIHA's application is authorised, would it be on the basis of the ingredient, rather than the products?


It has to be the ingredient, because otherwise, simply going by the information on product dynamics I provided earlier in this article, a very large part of that application would be wiped out, or worse, the whole application could have been rejected.


And I'll state again, I am not attacking RP427 as such, and I certainly don't want to see a quarter of the market wiped out.



However, if that did happen, it would be because of EIHA's mismanagement

But then, if that does happen, and assuming the possibility of the FSA asking EIHA not to submit data for the 3,269 products associated with RP427, why did the FSA not say to every other company and application holder that product dynamics weren't necessary?


That is a speculative question based on known events, and the information accessible to me. So I'll wait until 07/06/24, and hopefully, Mr Tossall will say something on the day that adds a little transparency to the situation.


I really do hope that happens, because at the end of the day, something is happening.


What's more, I've provided food for thought in this article that I feel means that Mr Tossall's actions should be observed more, and that's not just on the basis of ignoring actionable evidence, or being able to influence investigations in which he is directly named.


I'd go as far as to say that certain people need to be observed over the longterm, because who they work for in five or so years time might well explain their actions in the here and now.



Mr Tossall, should he read this article, might think that I'm refering solely to him with that comment, but lets be honest, there are others at the FSA that have a hand in novel foods, and I'll be keeping an eye on all of them

I'll tell you this though to wrap up: If I'm right in half of what I've written, it might go a long way in explaining why the love affair with the FSA and the Association for the Cannabinoid Industry (ACI) seems to have gone stale.



It's not about the consumer, it's about control and monopolies


For more information on The Hemp Hound Agency, including services, and membership, or how to help support the fight for a fair industry, email cefyn.jones@hemphound.co.uk

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