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'Ask The FSA' FAQ's: Cold Press Hemp Oil with an Advertised Cannabinoid Content, and Article 4's

From The Hemp Hound Agency




Here at Hemp Hound HQ, we like to delve into the topics that are relevant to the hemp & CBD industry at any given point, in an unbiased way without it being focused on any particular needs or agendas.


There are lots of hot topics at the moment, and key questions to be asked. The good news is, we've got your backs! So welcome to The Hemp Hound Agency's first 'Ask the FSA'.


This in itself will start off a series of FAQ's with key government agencies who have a hand in the UK hemp and CBD industry, with the questions send focusing on their area of authority, as well as any uncertainties that happen to reside within their sphere of influence.



So without further ado, lets 'Ask the FSA'!


For the sake of anonymity, the following questions have been answered by Mr J. The questions were submitted on 13/09/22 and focus on cold press hemp oil, the right to advertise a nutritional content, and Article 4 submissions for those products. Mr J replied to The Hemp Hound Agency on 17/10/22.


...


Hemp Hound (HH): “I am aware of one company who applied for an Article 4 Submission for their cold press hemp oils who were told not to bother despite the FSA viewing cold press hemp oil as Novel Exempt, I'm also aware of many companies asking the FSA about Article 4's with themselves also being told not to bother. Considering that there is an active list of products that have been awarded Article 4's, why are cold press hemp oil producers being told by the FSA not to bother applying for Article 4's whilst also saying that their products qualify for it?

Mr J (FSA): There is no such thing as ’novel exempt’ food. There are potentially new foods that are not captured by the criteria to be ‘novel foods’ based on historic consumption patterns. All new foods to enter the market are subject to checking against the criteria of being a novel food, this enables a food business to assess if they need to apply for an authorisation before the product is placed on the market.


For some products from cold compressed hemp oil, we have said that they may not be novel because there is evidence to show a history of consumption before May 1997.


We have indicated to food businesses that if they are producing a product which fits within this description then you do not need to apply.


However, this is not the case for CBD extracts or other cannabinoid extracts. CBD extracts can be derived from most parts of hemp or cannabis plants. They are selectively extracted, concentrating CBD and removing or reducing other chemical components. This process means the final product is different from hemp and does not have a history of consumption in this form.


Therefore, if a food businesses’ process is selectively extracting cannabinoids it would be considered a novel food and be required to apply for authorisation.


An article 4 submission is an option for clarity on whether a food is novel or not and needs to go through the novel food authorisation process. This should be undertaken before marketing a product.


As CBD extracts are legally agreed to be novel foods, we are past this point of the process for CBD products. Food businesses can apply for an Article 4 if they require clarity for hemp oil or similar so there is no restriction to access to the validity of a novel food status. It is a food businesses’ choice whether to submit an Article 4.



Thoughts

So the first thing that jumps out is "There's no such thing as Novel Exempt", which is a shame because it rolls off the tongue better than 'Not Novel'. I'm not the only one to get caught out by this either, there's a few companies I know that have been marketing Novel Exempt products, so where does the term that doesn't exist come from? It's a good question, but not important to these FAQ's.


Then we have "For some products from cold compressed hemp oil, we have said that they may not be novel because there is evidence to show a history of consumption before May 1997". "may not be novel", that's an interesting way to put it, it suggests that not all cold pressed oils are on absolutely solid ground.


If there is any uncertainty though, would it be justified? Well yes, which is one reason why I asked the question. The FSA have suggested that they accept cold press hemp oils "may not" be novel, so why haven't they allowed someone to submit an Article 4 for those products to verify that status?


To be fair to the FSA, the definition of cold compression is a bit vague. Anything that's squashed without the direct application of a heat source qualifies for that distinction, but mechanical process in itself can generate heat, so couldn't you just speed the process up to generate a temperature that allows for a better extraction? Well the good news is that there's a boundary, no heat source and no more than 120 degrees C generated from mechanical process, and your cold pressed oil is 'cold pressed'.


Mr J moves on from there to spell out the difference between a crude, not novel non-selective cold press oil vs a selective cannabinoid rich extract. This in itself is a little confusing as it's comparing a finished product against an ingredient that completes a product, but I've heard a rumour what the FSA don't like to refer to cold compression as an extraction method. This seems possible, as Mr J refers to CBD and cannabinoid extracts through his replies, but doesn't refer to cold compression as an extraction method.


That being said, here's an article that outlines the difference between cold press and hot press extraction methods.


Mr J then touches on Article 4's being there so that companies can have clarity and confirmation of their products novel status, but the whole point of these questions was to ask why the FSA are dissuading companies from applying for Article 4's. So how can you get clarity for your products, if the FSA is unwilling to give it?


The last paragraph finishes with "It is a food businesses’ choice whether to submit an Article 4", but is it right for the FSA to choose whether to accept one or not?


...


HH: I'd like to raise the question of diminishing the authenticity of a food, specifically cold press hemp. If the FSA is effectively dissuading companies from applying for an Article 4, would the FSA in fact be diminishing the authenticity of such products by restricting access to the validity those products would have if they were listed as having an Article 4?

FSA: An article 4 submission under the Novel Food Regulations is not a route to compliance for any novel food which includes CBD. Food businesses can apply for an article 4 if they believe the product has a significant history of consumption before 13th Feb 2020 and can provide suitable evidence to the FSA.


Where a food business is clear that a product is not novel and can prove this conclusively to their relevant local authority then they do not need an Article 4 and can sell their product. Any product on the market remains subject to the rest of food law.


Thoughts


Ok, Mr J has confused a date here. 13/02/20 has no bearing as a date for cold press hemp oils and is in fact the date that CBD products needed to be on sale by to qualify for the CBD amnesty.


That being said, has that date been diminished in importance for CBD products and when they should have been on sale by? There are several companies that I have identified that have validated products that didn't exist on or before that date, yet there are others who have had their Novel Food applications rejected due to them not being available on or before 13/02/20.


Public Interest Disclosure, CJ to the FSA
.pdf
Download PDF • 8.65MB

Back to the question though, and does Mr J answer it? Unfortunately not, in fact we're running around in circles here after only 2 questions.


You can apply for an Article 4, but you don't need one, and if you're still uncertain, contact your local authority (TS). The problem there is that someone from the FSA at some point could say to all TS up and down the UK that cold pressed hemp oil is no longer not novel, which would of course have a detrimental effect on that industry.


This is why I mention "diminishing the authenticity of a food, specifically cold press hemp.", if the FSA are unprepared to validate a not novel product via an Article 4 submission, where does that food stand in the grand scheme of things?



But... mushrooms!!!


One thing's for certain, Novel Foods was not designed for a food as complex as cannabis, and that's before we get to any confusion with extraction methods, or the definition of the final extract.


Whilst it's reasonable to expect some variance in the rules to accommodate cannabinoid based products, you wouldn't expect the whole rule book to be rewritten, right?


Novel, not novel, it's all part of the same direction with avenues to follow on both which are supposed to be ironed out before any products are marketed. So whilst the framework may have been altered to accommodate CBD product applications, you'd like to think that the pathway to validating a product as not novel through an Article 4 submission would be the same for every food.


So how long do you think mushrooms have been consumed in the UK and EU for, it's definitely before May 1997, right? So how is it that two mushroom products have been awarded Article 4's this year, yet cold press hemp oil producers are being told to go to their local TS if they want their products verified?


This doesn't make sense to me unless someone is actively looking for a way to define cold press hemp oil and derivatives as Novel Foods, that it's known someone is looking for that way, and that everyone in the meantime is being put off from submitting Article 4's until that someone finds that way.


"Where a food business is clear that a product is not novel and can prove this conclusively to their relevant local authority then they do not need an Article 4 and can sell their product", surely mushrooms don't need an Article 4 though, and if they still required certainty, why weren't the mushroom farmers just directed to their local TS like cold press hemp oil producers are being?


Seriously, any other food and I might not have batted an eyelid, but mushrooms???


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HH: Can you confirm that cannabinoids have a nutritional value, and that nutritional information can be displayed on any part of a products label?

FSA: In assessing the safety of novel foods, the FSA where appropriate, consider whether a novel food such as CBD, should not be nutritionally disadvantageous compared to similar products already on the market. The nutritional status of a novel food is evaluated as part of the risk assessment process.


Novel foods are subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 and other relevant labelling requirements in food law, for which Defra is the lead government department.


In certain cases, it may be necessary to provide additional labelling information, in particular regarding the description of the food, its source, its composition or its conditions of intended use, to ensure that consumers are sufficiently informed of the nature and safety of the novel food, particularly with regard to vulnerable groups of the population. Food labelling must not be misleading to the consumer.



Thoughts


So for those who don't know, I released an article recently called 'The Cold Press Conundrum', which is about cold press hemp oil and the crazy talk that seemed to come from many directions.


One of the biggest grumbles that I addressed was in regards to displaying nutritional data, specifically in this case the cannabinoid content.


Now you might read Mr J's reply in a way that suggests cold press hemp oils with an advertised cannabinoid content might nutritionally disadvantage CBD and cannabinoid based novel foods, but flip it for a second if you will.


Cannabinoids have been known of for many decades, with the Endo-Cannabinoid System (ECS) itself discovered in 1988. Cannabinoids are nutritional, and it's been accepted for a long time that the best source of naturally occurring Phyto-Cannabinoids to feed our own individual ECS is cannabis. Call it hemp or call it marijuana, it's cannabis, and it's a food source.


So would restricting cold press hemp products from advertising a cannabinoid content be in fact placing those products at a nutritional disadvantage to CBD products that are going through Novel Foods? I mean, does one have to pay now to inform the consumer of what they're actually buying?


It's not the producers fault that cannabinoids occur naturally in the source material that they process, and any sensible company would not just inform the consumer of the products makeup, but also provide lab reports to verify that the cold pressed products are derived from an EU approved hemp strain, and that they don't breach any legislation that covers either drugs or food.


"In certain cases, it may be necessary to provide additional labelling information, in particular regarding the description of the food, its source, its composition or its conditions of intended use, to ensure that consumers are sufficiently informed of the nature and safety of the novel food, particularly with regard to vulnerable groups of the population. Food labelling must not be misleading to the consumer."... say no more!


...


In conclusion



Do you ever get the sense that cold press hemp oil is a 'problem'? I don't mean for any associations who're protecting their members interests or big companies who have large slices of the FSA's public list, I'm talking higher up.


The web goes from the FSA to GW/Jazz Pharmaceuticals, with the Centre for Toxicity and the HO in between ruling everything under the thumb of 16 lab reports for a product/extract that is pharmaceutically, and not food focused. GW/Jazz don't want you to sell CBD, let alone any other cannabinoid because at the end of the day, they pretty much own them all, and looking at their list of patents would pretty much verify that.


Mr J above stated that CBD had been legally agreed as a Novel Food, whilst that agreement was with the EU, there was a previous version of Novel Foods in 2017 where isolated cannabinoids were deemed as Novel, but not wholeplant full or broad spectrum products.


Throughout that time, and of course earlier in 2016 when the MHRA tried to define CBD as a purely medicinal compound, there has only ever been one winner in regards to cannabis and cannabinoids, and that is GW/Jazz.


Have they, either directly or through the HO, asked the FSA not to validate cold press hemp oils with Article 4's? I don't know, it wouldn't surprise me, but what I can tell you is that it's not the voices from associations or big companies that are dissuading the FSA from accepting and processing Article 4's!


So I hate to say it, but I fear those who make cold press hemp products maybe a target for a potential attack on the validity of their products with an advertised cannabinoid content, and the only way to put a stop to that is by insisting that the FSA accept and process an Article 4 for cold press hemp oil.


The FSA itself cannot refuse to provide something that verifies the validity and authenticity of your products, dissuade yes, but not refuse!


If I'm right, the FSA are caught between a rock and a hard place. There's evidence that shows cold press hemp oils have existed well before May 1997, and it's accepted that cannabinoids feed the ECS. But if there were still some sort of 'legal agreement' to define all cannabinoids as Novel, outside of the one with the EU (which we've left), that benefits someone who perhaps had 16 lab reports for their pharmaceutical wares define the requirements for an industry more focused on foods, then cold press hemp products would be more than a mere nuisance.


The round up


I'd like to thank Mr J for taking the time to reply, and also state to the reader that I respect that he may not be able to answer to some of my breakdowns and wider thoughts, but then they are more for the reader than for Mr J himself. That being said, he will receive a copy of this article, and is more than welcome to correct me either in email or below in the comment section should I have misinterpreted his replies.


In regards to his reply, I think it's safe to say that questions one and two were not cleared up adequately, but then that is if my analysis is correct, I'd say that the FSA as a whole don't want to, or are not in a position to address this topic just yet. That being said, those mushrooms that have been awarded Article's 4 raise questions which might have been easier to dismiss if they weren't there.


I think the answer to question 3 explains everything though, cold press hemp oil is a problem, because it's got history, as has cannabinoids, which are accepted as nutritional and as such any cold press hemp producer has not just the right to display that information, but also have a duty of care to the consumer by ensuring they are well informed about the nature and safety of the product itself.


A rock perhaps called GW/Jazz, and a hard place called history and scientific fact... I don't envy the FSA there. You can define what is and is not Novel, but an old food in an old format has just as much right to advertise its naturally occurring contents as Captain Birdseye did with fishfingers when it was accepted they naturally contained Omega Oils.



If you have any key questions for the next FAQ's, please do send them to cefyn.jones@hemphound.co.uk



3 Comments


Unknown member
Nov 07, 2022

Article 4 seems a complete red herring to me. If you have a selectively extracted cannabinoid product then it's novel. Why bother wasting time on an Article 4 application?


If you have a non-selectively extracted cannabinoid product then its not novel. Why submit an Article 4 application at all? It's just asking for trouble.


Of course, the important point is that there are a number of non-selective extraction methods other than cold press, so just carry on making your full spectrum cannabinoid products that way. They're not novel.

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Unknown member
Nov 07, 2022
Replying to

Hi Peter,


I think that an Art 4 gives companies that security that isn't quite there with a letter from the FSA saying 'cold compression may not be novel' at best, or at worse from their local TS.


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Unknown member
Nov 07, 2022

Response from the FSA!


"Hi Cefyn,

We’d like to correct the response sent to your second question on Article 4 submissions. The date relating to history of consumption should be May 1997 (not 13 February 2020), so our response should read:

‘Food businesses can apply for an article 4 if they believe the product has a significant history of consumption before May 1997 and can provide suitable evidence to the FSA.’

Apologies for any confusion.

Thanks."


This is in reference to the FSA's reply to question 2.

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