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February's Directory Push: US/UK edition

From The Hemp Hound Agency


We're in to 2023 with a bang, with new members, renewals, and updates to take you through!


Let's start with some juicy bits first, drip-fed of course for the big reveal. Some companies have been getting rid of evidence from social media that shows they didn't have products available on or before 13/02/20, even though I've screenshotted the posts, saved the URL's, posted them in articles and presented them to the industry as well as the FSA... *sigh


For those who don't know, there's a public interest disclosure complaint lodged by myself in regards to the FSA's handling of Novel Foods, which to any American reader is what regulation is called over here. There's one or two familiar names in that complaint as well who have already made their presence felt stateside, and there should be a reply to this complaint within a week's time from the Food Standards Agency (FSA).


Public Interest Disclosure, CJ to the FSA
.pdf
Download PDF • 8.65MB
Again for the US readers, have a look because you're see some familiar names.


Further to this, I believe I've found the basis of several companies argument for allowing products to stay on the FSA's public list, despite not qualifying for the Novel Foods Amnesty as defined on the very day of the 13/02/20 deadline itself.


That's right, two sets of rules - we were told 'on the market', but who explained what that meant to the industry? What's more, the rules weren't suppose to change post-Brexit, whether we stayed in the EU or not, but they did on 31/12/20, and no one told us of that either.


Confused? Well be that no more!!!


In essence, one of four things is happening:


  • The FSA don't care about those companies who they have received complaints about due to not having products on the market on 13/02/20 despite them being on the FSA's public list, which states that all products listed were on the market on 13/02/20


  • The FSA are scared that they might've got things terribly wrong, and don't want to check over applications they've given a green light to


  • The FSA didn't know about the BEIS definition of 'new to market product', and when challenging someone on the basis of the EU definition, were introduced to solicitors who held up a more up to date government document, and NDA associated with their clients Novel Food Application, hence the constant dismissals when questioning the specifics of certain applications

  • The FSA did know about the BEIS definition of 'new to market product', and chose not to share that update, or any in regards to the consultation and creation of that document with the CBD industry, knowing full well that the 'undesirables' either didn't have the time to check for any updates like this that may effect their business, or wouldn't be able to afford solicitor fees to find out what a few seem to be benefitting from.


Either way, there are two sets of rules at play, and that became evident when I found myself on a webinar hosted by the Association for Cannabinoid Industries (ACI), which was attended by the head of Novel Foods, as well as two representatives for Buckinghamshire and Surrey Trading Standards.


We'll go into that a little more later, and touch on what's been happening in the US, but we've got a few things to get through first, so without further ado...



New members



We've got two very interesting companies who seem quite complimentary to each other despite not being related in any way. A farmer, with 20 years worth of hemp tea blending experience, likes the natural approach and has a label that looks like they mean business vs an EU farmer and extractor, with UK interests, and who can break down the plant and create custom products of all kinds...



Ok, so I've portrayed this as a fight night special, so for the sake of creative writing...


In the red corner: Crop England, who are 4th generation farmers, and ply their trade in Lincolnshire.


Don't take the well spoken duo of Mike and Jackie for granted though, because there's some hippy tendencies here, and an obvious love for the plant, and all the good that it can do both for the consumer and the environment.


Teas and oils are on offer, with all the raw material being grown on a 200 acre site. They're also exploring the potential of growing for cold press extraction, and they are open to discussing growing for the needs of companies should their license requirements with the Home Office allow for it.


There's also the potential to visit the farm, and lets be honest, who wouldn't want to go and see a 200 acre farm in the UK that is working towards supplying UK grown, produced and manufactured hemp products?


And as for 20 years worth of hemp tea blending experience, there's not very many people who can boast that level of experience in any industry, let alone anything related to cannabis.


Crop England are listed for Wholesale Hemp & CBD Suppliers, White Label, and Farms & Related Services, and are more than happy to talk to you about how they could help you with your needs whether from the field, or with finished products.



And if you check out the flag for Lincolnshire, you see why it's fair that they have the red corner.

So now in the blue corner, from the Czech Republic, welcome Hemp Point.


In regards to cannabis, they hail from a country that's a little more forward thinking than most, which is reflected in the services on offer


From manufactured oils both reflective of the plant or with a customised cannabinoid profile, to capsules, water soluble CBD, CBG oils, cosmetics, and hempseed oil and hemp-based superfoods... I mean, what else could you possibly need?


Hemp point are one of the few companies who extract from their own biomass, and they are also able to supply low THC hemp bud to countries where it is allowed for sale.



Hemp Point can be found listed for: Wholesale Hemp & CBD Suppliers, Specialist Supplier (under cosmetics and extraction), White Label, and Farms & Related Services.


They will also be exhibiting at the CBD Show at London on the 22nd and 23rd of March this year, so if you fancy a one to one conversation with the team, why not pop in and say hello?




And now to renewals


Bnatural are one of those companies who have gone from strength to strength, especially after winning the Best Oil category at the 2020 Hemp & CBD Expo despite going against more mainstream and well established manufacturers.


This family run enterprise makes all the right noise for those looking for stock to sell or to white label, which included the option of custom made products as well as an existing range that covers everything from CBD oils, cold press hemp oils, pet treats, CBD chocolate and so much more.


You can find Bnatural on the following lists: Wholesale Hemp & CBD Suppliers, White Label, and Specialist Suppliers.


Little Hemp Shop is the South West's premier supplier of hemp and CBD products, and was established in 2018 by Husband and Wife team Marc and Sally Honey.


Starting at the time with half a kilo of hemp to make tea, they expanded to include their own in-house manufactured products as well their own CBD infused coffee, which means if you ever pop to see them in their unit or at Plymouth indoor market, you are sure to pick up the aroma of freshly roasted Arabica beans even if you're there to pick up any of the other great products they have in stock.


You can find Little Hemp Shop in the following lists: Hemp & CBD Wholesale Supplier, White Label, and Specialist Supplier.



And Finally


Orange County were the first company to join The Hemp Hound Agency.


Founded in 2019, they have been one of the success stories of the UK hemp and CBD industry, and have sustained phenomenal growth over that time.


Some would say that their gummies are the star of Orange County's product range, but then they would be the ones who haven't had a chance to try the other amazing goodies that they have on offer.


Not only can you find Orange County in Selfridges, but you can also find them on the following lists: Wholesale Hemp & CBD suppliers, White Label, and Specialist Suppliers.



As with anything you buy in this industry


You should always make sure that your products a verified by 3rd party means, that's why The Hemp Hound Agency is proud to have two independent labs listed on the directory, so if you want absolute certainty on your products, check out IFS-Labs or AL-Bioservices.


And for more awesome companies on The Hemp Hound Directory, click here.



And now, back to those updates.



So it seems I've managed to find out how some companies may have been circumventing the rules that have been implied to Novel Foods, and that's because there are two sets of rules at play.


The criteria for products which can remain on sale from 1 April 2021 has been updated. Previously, only products which were on sale at the time of the FSA’s announcement (13 February 2020) and were linked to an application which had been validated by 31 March 2021 were to be included. To maximise the opportunity to pass validation, this now includes all products on sale on 13 February 2020 and linked to an application submitted before 31 March 2021 that is subsequently validated.
Emily Miles, Chief Executive of the Food Standards Agency, document updated 09/05/2022 despite being release on 11/03/2021

Who remembers this update? If you do, it'll be because it's one of the few that are actually posted online in regards to product status. Past there though, it looks pretty sparse on the information front. Interesting update though nonetheless, and you have to ask why that was amended, one year after 13/02/20, and less that 3 weeks before Novel Foods applications needed to be submitted.


That being said, if you scroll through the FSA's LinkedIn posts dated to 3 years ago, and then scroll to 2 years ago, you will see no updates about CBD on 12/02/20 (Tox data from GW), and no updates on 13/02/20 when deadlines were first mentioned.


We've then got to scroll right up to July/August for the FSA's announcement of a round table talk that had been partnered with UKAS, which focuses more on the analytical side of the industry.


All things considered, you can be certain that 'new to market products' probably wouldn't have been discussed at this meeting on 18/08/2020!


Then there's 3 posts shared by the FSA in regards to the head of Novel Foods attending a webinar hosted by the ACI, The Grocer (paid by the ACI), and Columbia Cares (an ACI member), and then a few posts into 2021 before the Novel Foods application deadline.


Ask the FSA what other events for the Hemp & CBD Industry they promote attending and the reply will be none, other than UKAS' round table event that is.

So where and when did the FSA define '13/02/2020', and what was a 'new to market' product on that date? The Hemp Hound Agency's article called 'Communication issues' has all of the information you need.


But it doesn't just cover how we're working by two sets of rules, it also covers how some companies have pulled down posts that have been highlighted within the public interest disclosure complaint that was lodged by myself, and specifically the ones who have been highlighted as working by unannounced rules.



Cannaray, Pureis, 4MP... I see you, and I take it you see me


That information has been passed to the investigating officer of my complaint, along with further evidence and an explanation of how it fits into my public interest disclosure complaint that focuses on the FSA's handling of Novel 'regulation' Foods.



And to wrap this up


Recently in the US, the FDA released a statement suggesting that those on Capitol Hill need to regulate CBD and cannabinoid based products, so I thought I would just go through the similarities of what's happened in the UK verses what could happen in the US.

UK

US

Name

Novel Foods

'Regulation'

Status

Ongoing since 2019, although originally brought up in 2017

Talked about, and the FDA does have guidance for CBD products, but it's currently unenforceable due to state laws and the size of the industry, which is why they have asked policy makers to intervene

Governing bodies

Food Standards Agency (FSA)

Food and Drug Administration (FDA)

Status of CBD

Accepted as a food supplement, however the Medicines and Healthcare Regulatory Authority (MHRA) tried in 2016 to redefine CBD as a purely medicinal compound and reserves the right to try again if the industry is perceived by the consumer as a medicinal

Sold as a dietary supplement against FDA direction, who view CBD as a medicinal compound.

Status of THC Delta 9

Licenses for hemp farming covers strains up to 0.2% THC and are named on the EU approved hemp strain list, but farmers or required to destroy controlled parts of the plant after harvesting for stem and seed only. Prohibited under MoDA '71, and restricted under MoDA '01 sect 2 (1mg rule) for consumer products.

Allowed up to 0.3% naturally grown from hemp which is used to make products, or higher should the content be derived from CBD isolate that has been forced through an unnatural decarboxylation chain. Past there the individual states have different legislation based on the legal status of cannabis

Controlled cannabinoids

Trans-delta-9-tetrahydrocannabinol-C5, Cis-delta-9-tetrahydrocannabinol-C5, Delta-9-tetrahydrocannabinol-C4, Delta-9-tetrahydrocannabinol-C3 (Delta-9-tetrahydrocannabivarin), Delta-9-tetrahydrocannabinol-C1, Delta-8-tetrahydrocannabinol, Cannabinol-C1, Cannabinol-C2, Cannabinol-C3, Cannabinol-C4, Cannabinol-C5, Cannabinol methyl ether-C5... (also keep an eye on CBDv, I predict that there will be a move for that soon!)

No, at least not from what I can see, especially on the back of the 2018 hemp farming bill

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Products

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​Pet products

Outlawed in 2018 with direction from the Home Office, and without fact-based studies or professional opinions

FDA state that whilst they have not received any reports of adverse effects from pet CBD products, they are aware of studies that suggest the potential for them... which begs the question of what studies have been conducted with the intention of seeing how long it takes to get a rabbit over buzzed?

Cosmetics

Guidance seems similar in respect to language and how product can, or shouldn't be sold

The FDA don't like them, Guidance seems similar in respect to language and how product can, or shouldn't be sold

Delta 8 and associated rare cannabinoid based product

Most of us look at what's on sale in the US, how it's created, scratch our heads, and then crack on with our own stuff knowing that the vast majority of all things in this area are off limits in UK law

The FDA have a problem with CBD and THC being defined as a dietary supplement, and on the basis that they weren't consumed in that manor before research began on those compounds, so there's no way on earth that Delta 8 products or anything that is derived from CBD in an unnatural process will stay on the market if the FDA's guidance gets the green light

CBD Oils and other edibles

The MHRA are waiting in the wings to define CBD as a medicinal compound, which they tried to do in 2016, and then warned the industry in 2018 that they will be back, yet the UK CBD industry seems to be playing into their hands. Some people claim their products effective against epilepsy, and other areas where 'certain' companies have patents

In reflection, the FDA are saying quite openly that CBD and THC are medicinal compounds, and they are asking the US government to endorse their way of thinking. Despite that, and as with the UK, CBD products are sold as "not designed to treat, cure or diagnose any ailment, disease or condition" whilst being advertised quite blatantly in a medicinal context

CBD bud/flower

MoDA sect 37 basically states that regardless of THC content, cannabis is cannabis. Where it becomes a product of sorts, MoDR applies but some sort of processing needs to occur before it can be a product, and that doesn't include pre-rolls

There maybe a change in the way you can sell it, dependent on the way it's being sold

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Regulatory issues both side of the pond outside food vs medicines

The UK has a fragmented system of authority, which involves different government offices communicating effectively together. There is a plan to rectify this issue though, which is outlined in The TIGRR Report, and is available below

State law vs Federal law frustrates the FDA, which is why they have asked Congress to intervene

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GW's points of interest

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Political direction

In March 2022, Jazz/GW submitted a document to the Home Affairs Committee's Enquiry on Recreational Drugs, which you can find below. In it they call for cannabis in the UK to remain prohibited, state that controlled cannabinoids are dangerous, and call for more political over CBD

In January 2023 FDA requested political intervention by congress on the CBD industry, whilst drawing attention to the fact that GW's lab reports and the dangers of THC, CBD, and cannabinoids derived under protection of the 2018 Farming Act

Controlled cannabinoids

We know what we can work with, and what we can't

I hate to say this, but I suspect that there will be a push for the US to have a controlled cannabinoid list, similar to that in the UK, and definitely with Delta 8 on it

Post-Brexit US/UK trade deal

Transference of pharmaceutical IP's was a big focus, and the US have just awarded Jazz a patent extension for Epidiolex until 2035

What happens in the US, now happens in the UK

The TIGRR Report

GW was sold to Jazz in May 2021, in June the TIGRR report was released which partly focused on the UK becoming a powerhouse for medicinal CBD and cannabinoid based products, the biggest beneficiary of that move is GW/Jazz

Now that you own the worlds largest exporter of medicinal cannabis based products, and because of that trade deal, the US are now a part of that vision

Epidiolex

The UK have just allowed for patients to be reimbursed for their costs of buying Epidiolex, and it will now be available on the NHS

When Epidiolex was authorised by the FDA in 2018, GW are on record as saying "In opening the door for consumer-market CBD products, FDA risks further diminishing the likelihood that more cannabis-derived products will be developed into proven medicines for these patients.”. Straight after that, the FDA started giving their opining on CBD products.

Patent War

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Jazz/GW will win because of IP protection, and when they do, both the UK and US industries need to ask one question: What does the plant mean to us?

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Signs our industries are being pushed together

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MHRA vs FDA

In October 2022 the Advertising Standards Authority called out 6 companies for medicinal claims, whilst over focusing on one company, for breaching rules set by the MHRA on the differences between foods and medicines. Other than being called out, they were basically slapped on the wrist. There was a bit of confusion though because the claims that were highlighted are claims that 99% of the UK industry are using

In November 2022 the FDA named 5 companies for illegally selling CBD products on the back of medicinal claims. To my understanding the FDA were unable to do anything other than name these companies, and there was confusion due to why these companies had been targeted over everyone else

Cold press, or other recognised sources of cannabinoid rich hemp extracts as a food

In the UK, cold press hemp oil is recognised as a 'not novel' food, which means it has a history of ingestion that extends before 1996. Cannabis is cannabis, and cannabinoids are naturally occurring. The ECS was discovered in 1988, and cannabinoids were isolated before that, so they are accepted in science as a food. A road to that validation as a food is called an Article 4 Submission, which basically means that the food in question is protected in law

If you read the FDA's guidance, you will see that there is a similar opening for those types of products

Lab reports

We've got 16 of them from Epidiolex, a medicinal product, governing the requirements of the food supplemental industry

The FDA have admitted to looking at lab reports from GW

Foods vs Medicines

If you haven't seen it now

That's exactly what this is about

Can GW be 'beaten'?

My hunch is no... not directly in a court of law anyway, but there is a way to protect the plant and it's active compounds as a food before a medicine

And that comes down to working together, because if we're bound by a trade deal that's effectively giving the plant to GW/Jazz, then one ruling on hemp extract with a naturally occurring cannabinoid content should cover both shores

Also of interest

The MHRA has just released guidance for companies looking to grow unlicensed cannabis for medicinal purposes, which shows there is a transferal of power from the Home Office, who historically have had ultimate power over cannabis in the UK. Both GW/Jazz and those who gain licenses to grow unlicensed cannabis for medicinal purposes now have a shared enemy, the CBD industry and the unlicensed claims made on food supplemental products

The FDA in asking for intervention from Congress also released guidance for companies who are looking to conduct research into the medicinal properties of cannabis and cannabinoids... that leads to patents, which then leads to clampdowns!

Those who said "this looks great" against the flow of the industry

​The Association for Cannabinoid Industries (ACI) came to being 3 months before a key industry deadline for products to be on the market, and instantly started to disrupt the industry with opinions that were being heard outside of that for the wider industry. They are tied directly to GW/Jazz Pharma, and recently held a webinar that I alluded to above on the basis of "What the world can learn from the UK and Novel Foods", but I'd like to think I've saved you the bother with this table

Charlottes Web... well, well, well!!! I came to the CBD world after seeing what they were up to in 2012, so it's a bit off seeing them going against the flow of the US industry, but they're also present in the UK, and they have products validated as food which in fact are drugs in UK law, and despite me highlighting this they've not batted an eyelid. So if they're not prepared to follow the rules in the UK, what makes you think that they'll do the same in the US when other than the FDA and GW, they're the only ones who think the FDA's announcement is good?


In 2016 the MHRA tried to redefine CBD in the UK as a purely medicinal compound, that failed because there was a public backlash. If you in the US want to fight for your industry, you need to educate your consumer base on what is happening. Your trade associations need to come together, and speak with one voice, and I think you need to start working with those in the UK who also want to protect the plant, because we both have the same problem, and that's GW pharmaceutical and their 148 patents!


After all, if a trade deal binds us, it only makes sense to create a UK/US hemp trade association, because otherwise GW/Jazz can do something over there, that's effects us over here... let's talk!


Here's a link that brings you to the FDA's opinion on all things hemp and CBD, and the file below is from a statement released on 23/01/202


FDA Regulation of Dietary Supplement Conventional Food Products Containing CBD Compounds (
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Download • 76KB

Below are all the documents that have been alluded to throughout this article


Summary_of_U.S.-UK_Negotiating_Objectives
.pdf
Download PDF • 512KB
See P. 7 & 8: Intellectual Property, Procedural Fairness for Pharmaceuticals and Medical Devices

Written evidence submitted by Jazz Pharmaceuticals (DRU0054)
.pdf
Download PDF • 111KB
Reading this short document will give you an idea of how close GW/Jazz are to the UK government

FINAL_TIGRR_REPORT__1_
.pdf
Download PDF • 5.40MB
See P. 81 & 82, Proposal 11.15 Regulation of medicinal cannabinoids and medicinal CBD...

28.11.21-COT-Evaluation-FSA-Testing-Demands
.pdf
Download PDF • 339KB
From The Canna-Consultants - This file contains the quote from GW to the FDA: "In opening the door for consumer-market CBD products, FDA risks further diminishing the likelihood that more cannabis-derived products will be developed into proven medicines for these patients.”

Public Interest Disclosure, CJ to the FSA
.pdf
Download PDF • 8.65MB
Even though this file is at the top of this article, some might see the relevance of this document a little more. I'm not saying that our process in the UK has been corrupted, I'm not saying that is hasn't eirther, but I am saying that if you want to know what the world can learn from the UK and Novel Foods, read this document!


For more information on The Hemp Hound Agency, email cefyn.jones@hemphound.co.uk


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