[[{“value”:”
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Food Standards Agency (FSA) have both issued regulatory updates on CBD this week.
Each attempts to offer some much-needed clarification on the largely stagnant industry, which has been in a transition period for several years, leaving operators unable to bring any new products to market or plan for the future.
Notably, the FSA appears to have walked back previous suggestions that it would seek a 0% THC limit in CBD novel food products, which will come as a relief for many businesses.
Meanwhile, the MHRA looks to be seeking to draw a clear line between approved CBD medicines and consumer CBD products, cautioning any companies making medical claims about their consumer products.
Response from the FSA’s Director of Policy
In December 2024, the FSA held a board meeting to discuss the progress of its CBD Novel Foods approval process, in which hundreds of CBD companies are still engaged.
Although many industry stakeholders had hoped the session would provide some clarity and reassurance, it ultimately raised more questions than it answered.
The Cannabis Trades Association (CTA) wrote to the FSA following the meeting, seeking answers to several key issues for its members.
In a response from the FSA’s Director of Policy, Rebecca Sudworth, some more details have now come to light, which we’ve summarised below:
Acceptable daily intake
The CTA criticised the FSA for their rigid enforcement of the controversial 10mg acceptable daily intake (ADI), arguing that the limit is being misapplied as a legal cap rather than advisory guidance, and were applying this as a blanket ADI to all CBD products despite evidence of clear differences between isolate, distillate and full spectrum.
In response, Sudworth said that this ‘consumer advice relates to all CBD products’, but that its advisory committees were currently looking into ‘other forms of CBD… including full spectrum products’, and the administration would ‘review any further advice they issue on CBD levels’.
THC levels
The FSA appears to have softened its position on the allowable levels of THC in CBD products. During its December 2024 board meeting, the board signalled that it planned to ‘clearly communicate that the expectation is undetectable levels (of THC), rather than a specific upper limit’.
Now, despite strong suggestions it would target a 0% THC cap, significantly limiting the range of CBD product which would be legally available in the UK, the FSA says its advisory committees are due to publish their findings on the food safety implications of THC in ‘April/May’.
“This advice will include a safe upper limit for THC”, Sudworth said, adding that this cap would not require approval from the Home Office.
Bulk licencing
As the Home Office recently confirmed, ‘products with very low levels of THC can be considered exempt and freely traded’, under the Exempt Product Definition (EPD).
In December, the FSA suggested ‘revised licensing conditions for the storage and transport of these products have also been outlined’ for CBD businesses, and ‘it will now be easier to obtain a licence to store or transport bulk materials containing low levels of THC’.
Notably, there were also suggestions that companies dealing with bulk CBD ingredients may now be required to secure a Controlled Drugs Licence, which is notoriously difficult to obtain.
Asked whether this licencing and facility inspections could be carried out by the FSA, avoiding the inertia of the Home Office licencing process, the administration seemed to reject this as a possibility.
“We are aware of the need for bulk suppliers to have licenses. This is a Home Office requirement so we cannot comment further.
“The Home Office is advised by the Advisory Committee on Misuse Drugs on the status of THC in consumer CBD products from a drug perspective.
“Following the current law, we are required to use the Exempt Product Definition (EPD). The EPD is a Home Office policy which is a part of Home Office legislation (the Misuse of Drugs Regulations).
“It would be inappropriate for the FSA to consult on another department’s legislation and policy. The FSA can consider compliance with wider legislation as an ‘Other Legitimate Factor’ when setting the ToA (terms of authorisation) and making recommendations to Ministers. Products using CBD as an ingredient must comply with their ToA to remain an authorised novel food.”
Processing order
With eight applications now proceeding to the final ‘risk management’ phase, following approval of their safety assessments (including five since the start of the year), these applications must now be recommended for approval, then given the final green light by a government minister.
According to the FSA, this cannot take place until its planned 12-week consultation is completed.
While no solid date is set for the consultation, the FSA says that the launch date will be ‘dependent on the resolution’ of its risk managers across the country, who are now ‘addressing several points to be ready for consultation’.
“We will outline the timetable for this process in due course,” it added.
Sudworth clarified that this consultation ‘will be covering the specific proposed ToAs for the first three CBD applications’ which cleared the safety assessment phase, namely Chanelle McCoy/Pureis (RP07), Cannaray (RP350), and the EIHA Consortium (RP427). It also suggested more safety assessments are ‘due out soon’.
Only after this consultation will recommendations be made to health ministers in England, Wales and Scotland.
The public list
The board failed to answer a number of questions regarding the fate of the public list, a temporary list enabling some products to remain on sale without official authorisation during the process.
Questions arose over the potential of new products to be included on the list, breaking the block on any new CBD products coming to market in place since the process began in 2021.
According to Sudworth, the list will ‘remain closed to new products’ and no ‘further white labelling’ will be allowed.
“If a food business does introduce a new product to the market, it will not get the tolerance offered to products on the list. If new products are added to the market, the relevant local authority can consider taking enforcement action,” she cautioned.
Once ministers authorise CBD products, the FSA says it will ‘issue further advice on how the list will operate’, as the ‘context in which the list operates will have changed’.
MHRA updates
This week, the MHRA updated its CBD guidance for the first time since 2016, using language that suggests that a firm line will be drawn between consumer CBD products and CBD medicines, and any blurring of these lines would be clamped down on.
The MHRA affirmed the status of CBD as a medicine, removing the qualification of it as an ‘opinion’, suggesting a more concrete regulatory position.
As such, any CBD product that makes a medical claim will be ‘considered to fall within the definition of a medical product’, and must hold marketing authorisation.
New cautionary language has been added in 2025, reinforcing that future classification can change based on MHRA evaluation.
2025 guidance explicitly distances MHRA from non-medicinal regulatory advice and places responsibility on the company.
2025 introduces an explicit reference to THC and the Home Office’s role regarding psychoactive substances and drug control laws.
A new section was added in 2025 recognising FSA’s classification of CBD as a novel food, expanding the regulatory context.
“}]] The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Food Standards Agency (FSA) have both issued regulatory updates on CBD this week. Read More
