CBD and Novel Foods – Read this article for all the answers!

Sorry... that should read ‘all the questions!’?

Having taken some time to read the various responses and speak to several industry professionals.?I think that is it fair to say that the FSA announcement regarding the deadline for the CBD Industry and Novel Foods?was well received... or was it?

Regardless of how you feel about the inclusion of CBD into the EU Novel Foods list, the time for fighting back is in my humble opinion over. All sectors of the industry should now come together to work with regulators and enforcement agencies for the benefit of the consumer.

Any company selling ‘CBD Extracts’ after 31 March 2021 will need to have submitted a valid Novel Foods authorisation application.

So, to the questions:

What is the definition of a valid application?

Is the UK’s FSA creating its own mechanism to authorise Novel Foods applications? And If so, will that mechanism / route to compliance be recognised across Europe in light of Brexit? Conversely will a European Novel Foods application be recognised by the UK FSA?

The inference at this point is that it will be the EU Novel Food route that will be used, however that appears to be in direct conflict to the government position of departing from the use of EU regulation.??

Mark J. Tallon, LLM MA PhD stated on LinkedIn that

“valid means a validity check completed. This is covered in both implementing legislation for article 4 and 10 applications (note FSA don’t state what application). So a submission on 31st would not be compliant as the validity checks need to be carried out prior to that date. Example article 5 of REGULATION (EU) 2018/456.”

CBD Extract (Novel) vs Hemp Extract (Not Novel)

When is a CBD Extract really a Hemp Extract? This needs putting to bed very quickly. It would appear that there seems to be a lack of understanding on the part of the FSA as to what is or is not a ‘CBD Extract’ or indeed a ‘Hemp Extract’. I have had an issue with the name ‘CBD’ plastered on every product imaginable since this industry developed in the UK. To me the name 'CBD' is a misnomer and the array of products that are labelled as such is not only misleading for the consumer put creating confusion for the UK authorities.

In an email to the industry on the 17th of January 2020, Karen O’Connor - FSA Novel Food Policy Lead and Novel Foods Team wrote and I quote:

“I would also like to take the opportunity to confirm that there have been some incorrect reports that CBD extracts and hemp products (such as cold-pressed seed oils) are the same. This is not the case, as whilst hemp has a history of consumption before 15 May 1997, this is not the case for CBD extracts. As such CBD extracts, and products they are added to, are novel foods, whilst hemp itself is not.”

This statement adds to the confusion,?‘CBD Extracts’ and whole plant ‘Hemp Extracts’ are clearly two different things. The latter is merely a direct extract from the hemp plant (Cannabis Sativa L) which common sense would suggest is therefore not novel.

The point being that if you label a product a ‘Hemp Extract’ and to produce that from a recognised extraction method (e.g. CO2, cold pressed), and if the cannabinoid content reflects that of the naturally occurring levels in the hemp plant then this cannot be ‘Novel’ by definition??

The problem is the THC / Controlled substance levels in that naturally occurring 'Hemp Extract' unfortunately these will invariably be in excess of the current 1mg UK Law and to artificially change them would then make the product Novel.... Catch 22.

I get the impression that the FSA needs to have a steer on the definition of a ‘CBD Extract’, as it appears to me that they view any product with levels of cannabinoids that are higher than that which naturally occurring in the plant or products containing isolated cannabinoids are?indeed ‘CBD Extracts’ and therefore Novel. A position that the CTA UK and EIHA have not disputed to my knowledge.

Have we been dealing with a huge misunderstanding all along?

THC (and all other controlled substances)

Having spoken to my colleagues in the European Industrial Hemp Association I am rapidly forming the opinion that THC and other controlled substances are going to be a hot topic in order to gain authorisation, even if you have a valid application (UK or EU) in play this may indeed be derailed.?The fly in the ointment being that THC and other controlled substances are listed in Tables I and II of the single Convention on narcotic drugs signed in New York on 30 March 1961. When listed as a component in a Novel Food application they are in my humble opinion most likely going to be rejected unless workable levels are agreed.?

The acceptable level of controlled substance in products has been an ongoing issue for a number of years, the general understanding of controlled levels lends itself to confusion.. a point in case is the regular and incorrect stated level 0.2% THC in a final product (often quoted in mainstream media). The home office guidance and law puts the ‘threshold’ at 1mg in the container approximately a 17mg difference from 0.2% when in a 10ml bottle. The 1mg law is unhelpful at best, especially when considering ‘Hemp Extracts’.

Wouldn't it be sensible for the UK law to reflect the EU position of 0.05% THC in products which would equate to approximately 4.55mg in a 10ml bottle, which I understand is similar to the natural levels in a true 'Hemp Extract'?

It is almost as if these rules / views have been conspired to work against the industry?

In my opinion urgent research is needed to establish what the safe levels of controlled substances are per kilogram of body weight. We know that CBD although psychoactive in its own right has a counteracting effect on the psychotropic effects of THC and other controlled substances, so my big question is about impairment? At what levels would you become impaired??And at what levels would you fail a WADA or roadside drugs test??Surely this would be a good starting point for defining acceptable limits.

Complexity and Intellectual Property

There are of course several legal issues to be addressed which I have alluded to earlier in this article, protecting your application investment is just one of them. I spoke to Robert Jappie a partner at Ince this week who said:

“There will of course be a number of companies who are unnerved by the FSA’s announcement, understanding the Novel Foods regulation and the route to compliance are critical. Many companies will also be concerned about how to protect their investment, Ince are ideally placed to assist manufacturers in achieving ‘Valid’ application status and providing advice and guidance on how to protect the IP of their products.”

Summary

So in summary, lots and lots of questions. The industry is on a new journey to compliance which can only be a good thing, especially if consumer safety is at the heart of it.?

Robert Sidebottom is a Director for Dushey Med Ltd and CBD Manufacturing.