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This week, the UK Food Standards Agency (FSA) held its monthly board meeting to discuss, among other things, the future direction of CBD regulation in the UK.
Following last week’s surprise announcement of a roadmap for the final stages of a number of CBD novel food applications, which would set a precedent for CBD regulation across the globe, the meeting sought to answer some of the key questions raised by the report.
Despite the welcome progress, the session will likely have rung alarm bells for many in the industry, amid numerous suggestions the FSA is leaning towards a 0% THC approach for CBD products.
Robert Jappie, leading cannabis lawyer and partner at law firm Fieldfisher, told Business of Cannabis: “The direction of travel is clear and it’s not good news for advocates of full spectrum products. The FSA board leans further towards a position of ‘as little THC as scientifically possible’ rather than a permissible limit. There’s a clear desire to distinguish their position from the Home Office’s enforcement limit of 1mg.”
The meeting
Held on the morning of Wednesday December 11, 2024, the meeting sought to focus on the progress and next steps in managing the risk of CBD products, following confirmation three initial safety assessments had been completed earlier this year.
As part of the final risk management phase, the FSA has asked for the board to approve five key principles guiding CBD risk management and discuss their application to the novel food process.
While positive’s for the industry were discussed in terms of increased transparency, efficiency and collaboration in the approval process moving forward, the rhetoric surrounding THC levels in CBD products soon showed signs the industry could be heading for even tighter restrictions.
The FSA’s Tom Vincent, who published the aforementioned report late last month, began by inviting discussion on two key topics, one of which referred to THC levels.
FSA Board Member, Mark Rolfe
He started by reiterating that as THC is a ‘controlled substance’, the Home Office have recently confirmed that ‘products with very low levels of THC can be considered exempt and freely traded’.
As such, ‘revised licensing conditions for the storage and transport of these products have also been outlined’ for CBD businesses, and according to the FSA ‘it will now be easier to obtain a licence to store or transport bulk materials containing low levels of THC’.
Notably, there are now also suggestions that companies dealing with bulk CBD ingredients may now be required to secure a Controlled Drugs Licence, which are notoriously difficult to obtain.
Aim for 0% THC
The first interjection came from FSA Board Member Mark Rolfe, who took issue with a number of Mr Vincent’s points, primarily that CBD should be treated the same as every other novel food.
He told the board: “I disagree with the notion that CBD is no different from any other novel food. Its inescapable link to controlled substances sets it apart.
“I also take issue with the claim that it’s almost impossible to extract THC completely. From my experience and test results of legitimate CBD products, it is feasible to achieve zero detectable THC and other illegal cannabinoids using advanced spectrometry methods.
“This is not a technical limitation but often a matter of cost. Regulation should encourage this level of purity to ensure consumer safety.”
He went on to suggest ‘setting a clear regulatory expectation for zero detectable THC and other illegal cannabinoids in products’.
Although Mr Vincent responded by explaining that the acceptable levels in products are expected to be ‘significantly below the exemption level set by the home office’, emphasising that these are ‘trace levels’, Chair Susan Jebb appeared to confirm this was the way the FSA intended to go.
After Anthony Harbinson, FSA Board Member for Northern Ireland, questioned whether ‘there is an acceptable level of THC’, and whether manufacturers can ‘reaslistically achieve these levels’, Ms Jebb said the organisation should aim for 0% THC.
“Of course, we should focus on minimising THC levels, but I believe Mark’s point is that our starting principle should guide companies toward aiming for no detectable THC,” she posited.
“This is a distinct approach from setting a permissible minimum level. The language in our guidance should strongly convey that the expectation is for undetectable levels, rather than a defined upper limit.”
Furthermore, Rebecca Sudworth, Director of Policy, saught to clarify that ‘the Home Office guidelines specifically address enforcement under drug laws, including the one milligram per container limit, but this is not our starting point for food safety.’
“We treat THC as we would any other contaminant. Our expectation is that contamination levels should be as low as possible, and we will rely on our scientific advisory committees to determine safe levels for CBD products.I want to be clear that this should not be confused with the Home Office’s drug enforcement parameters.
“That said, I think there’s a slight cross-purpose here. Mark’s point emphasises that the guidance to companies should provide a strong steer that the goal is no detectable THC. That’s quite different from defining a permissible threshold. The language should clearly communicate that the expectation is undetectable levels, rather than a specific maximum limit.”
The public list
Other matters, including the fate of applications currently under consideration, were also discussed briefly, though little clarity was given by the board.
These focused specifically on products currently on the temporarily sanctioned ‘public list’, which enables products to remain on sale without official authorisation.
Board member Fiona Gately raised concerns around ‘potential discrepancies’ between the newly authorised products set to enter the market ‘with specific conditions’ and those which remain on the public list.
“Products currently on the public list and still on sale may not be subject to those same conditions of sale. How do we navigate this gap during the transition period to ensure consistency and compliance?”, she asked the board.
“Additionally, I have a technical question: will a condition of sale include the requirement for a license for transport, considering the potential risk of THC residue in the product? You’ve mentioned this as a Home Office requirement, so I assume it will need to be factored into the overall regulatory framework.”
These questions were not directly addressed during the meeting, but will be at the front of mind for businesses still waiting for clarification on how to move forward.
Addressing a question submitted by Devina Sankhla, Food Policy Advisor, British Retail Consortium (BRC) regarding a notification process for those on the public list that have been rejected, Mr Vincent said: “I can confirm that such removals are displayed on our website and included in updates via the Market Authorizations Newsletter, which stakeholders can subscribe to.”
In terms of next steps the Chair explained that officials will revisit and refine the principles discussed, incorporating input from the board, and will share an updated version via correspondence shortly.
A report on this progress is scheduled for the next board meeting. Once finalised, the principles will guide the development of risk management proposals, which will then proceed to public consultation, ideally early next year.
The board notes that to ensure proper sequencing, the consultation should ideally be launched before the next board meeting, with updates provided via correspondence as needed.
“}]]This week, the UK Food Standards Agency (FSA) held its monthly board meeting to discuss, among other things, the future direction of CBD regulation in the UK. Following last week’s Read More
