UK – Linked In Post: Robert Jappie, Lawyer “Interesting developments on the issue of Controlled Cannabinoid limits in CBD products in the last few weeks”
Robert Jappie writes
There have been some interesting developments on the issue of Controlled Cannabinoid limits in CBD products in the last few weeks, and here are my initial thoughts:
1️⃣ We now have formal acknowledgement from both the Home Office and the Food Standards Agency that the Exemption in Regulation 2 MDR (a.k.a the ‘1mg rule’) can be applied to Consumer CBD products. It seems likely that the Jersey Hemp case (whereby a HO official incorrectly ordered the revocation of licences on the basis that the Exemption was not available) is a key factor in this determination.
2️⃣ Remember – the Home Office engaged the ACMD to prepare alternative proposals on how to deal with this issue. Despite the Home Office recommending adoption to the Minister, it looks like the ACMD proposals are dead in the water. Did the Home Office get tired of waiting for Ministerial approval?
3️⃣ We have more detailed guidance from the HO on how the Exemption should be applied, particularly ‘Limb C’ of the criteria. As I read it (and very happy to be corrected on this point…) the position is now ‘1mg’ of each Controlled Cannabinoid. I had always expected the HO to take a ‘cumulative’ position on this, but there we are!
4️⃣ There’s also an indication that companies dealing in bulk ingredients – which will not be able to comply with the 1mg rule – will need a Controlled Drugs Licence. CDLs are extremely difficult to obtain, but the FSA advises that “it will now be easier to obtain a licence to store or transport bulk materials containing low levels of THC.” If UK manufacturers and ingredients suppliers struggle to gain a licence of this nature, then that potentially hands an advantage to overseas manufacturers that supply finished products into the UK.
5️⃣ Companies had been told to expect Authorisations around May/June 2025. However, the advice from the FSA raises doubts on this, with Ministerial approval only being sought around that time – “Our current timetable is to make the first recommendations to Ministers in Spring/Summer 2025, following an eight-week public consultation launching in early 2025.”
6️⃣ What is clear is that we are moving to a ‘Post-Authorisation’ world, and the position on Controlled Cannabinoids needed resolution before submissions could receive final approval. The FSA has already indicated it has little interest in policing the CBD industry thereafter. This will be a matter for Trading Standards, and it will be interesting to see how companies (particularly manufacturers) interpret their commercial opportunities once Marketing Authorisation is received.
I was getting ready to say a fond farewell to the ‘1mg rule’ but it appears it is here to stay. As ever, I’m keen to hear views on this, and in particular where future legal challenges may arise. Relevant links are in the comments.
1️⃣ We now have formal acknowledgement from both the Home Office and the Food Standards Agency that the Exemption in Regulation 2 MDR (a.k.a the ‘1mg rule’) can be applied to Consumer CBD products. It seems likely that the Jersey Hemp case (whereby a HO official incorrectly ordered the revocation of licences on the basis that the Exemption was not available) is a key factor in this determination.
2️⃣ Remember – the Home Office engaged the ACMD to prepare alternative proposals on how to deal with this issue. Despite the Home Office recommending adoption to the Minister, it looks like the ACMD proposals are dead in the water. Did the Home Office get tired of waiting for Ministerial approval?
3️⃣ We have more detailed guidance from the HO on how the Exemption should be applied, particularly ‘Limb C’ of the criteria. As I read it (and very happy to be corrected on this point…) the position is now ‘1mg’ of each Controlled Cannabinoid. I had always expected the HO to take a ‘cumulative’ position on this, but there we are!
4️⃣ There’s also an indication that companies dealing in bulk ingredients – which will not be able to comply with the 1mg rule – will need a Controlled Drugs Licence. CDLs are extremely difficult to obtain, but the FSA advises that “it will now be easier to obtain a licence to store or transport bulk materials containing low levels of THC.” If UK manufacturers and ingredients suppliers struggle to gain a licence of this nature, then that potentially hands an advantage to overseas manufacturers that supply finished products into the UK.
5️⃣ Companies had been told to expect Authorisations around May/June 2025. However, the advice from the FSA raises doubts on this, with Ministerial approval only being sought around that time – “Our current timetable is to make the first recommendations to Ministers in Spring/Summer 2025, following an eight-week public consultation launching in early 2025.”
6️⃣ What is clear is that we are moving to a ‘Post-Authorisation’ world, and the position on Controlled Cannabinoids needed resolution before submissions could receive final approval. The FSA has already indicated it has little interest in policing the CBD industry thereafter. This will be a matter for Trading Standards, and it will be interesting to see how companies (particularly manufacturers) interpret their commercial opportunities once Marketing Authorisation is received.
I was getting ready to say a fond farewell to the ‘1mg rule’ but it appears it is here to stay. As ever, I’m keen to hear views on this, and in particular where future legal challenges may arise. Relevant links are in the comments.