 and the Food Standards Agency (FSA) have both issued regulatory updates on CBD this week. ){kind=link}
This week, the UK’s Medicines and Healthcare Products Regulatory Agency and Food Standards Agency both released regulatory updates regarding CBD.
The aim of each is to provide some clarifications on an industry that has been largely stagnant for many years. Operators have not been able to plan or bring new products to the market.
It is notable that the FSA seems to have reversed its earlier suggestions of a THC-limitation for CBD novel products. Many businesses will be relieved by this.
The MHRA is also attempting to establish a distinction between CBD medicine and CBD consumer products. It has warned companies that make medical claims for their products.
The Director of FSA Policy has responded.
The FSA will hold a meeting in December 2024 to review the status of the CBD Novel Foods Approval Process, which is still being pursued by hundreds of CBD firms.
The session raised many questions, despite the hopes of industry stakeholders that it would bring clarity.
Following the meeting the Cannabis Trades Association (CTA), a group of its members, wrote to the FSA asking for clarification on several issues.
Rebecca Sudworth is the Director of FSA Policy. We’ve compiled a list below.
Daily intake acceptable
CTA criticised FSA’s rigid application of the 10mg acceptable intake daily (ADI) limit, arguing it was misapplied to be a legal guideline rather than an advisory one. It also claimed that all CBD products were being treated as if the limit applied uniformly, despite clear differences in 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
It appears that the FSA has softened its stance on allowable THC levels 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’.
Sudworth stated that “this advice will include an upper safe limit for THC”, adding that approval by the Home Office would not be required.
Bulk Licensing
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’.
It was also suggested that CBD bulk ingredients suppliers may have to apply for a Controlled Drugs Licence. These are notoriously difficult licenses to obtain.
The administration appeared to dismiss the idea that the FSA could carry out the inspections and licensing of facilities, thus avoiding the slowness in the Home Office’s licencing processes.
“We’re aware that licenses are required for suppliers of bulk goods. As this is a requirement of the Home Office, we can’t comment on it further.
“The Advisory Committee on Misuse Drugs has advised the Home Office on the THC content of CBD-based products for consumer use from a drug standpoint.
We are obliged to follow the current legislation and use the Exempt Product Definition. EPD policy is part of Home Office law (Misuse of Drugs Regulations).
It would not be appropriate for the FSA consult with another department on their legislation or 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. To remain a novel food, products containing CBD must adhere to their ToA.
Order Processing
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.
The FSA says that this can only happen after the 12-week-long consultation has been 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’.
It added: “We’ll outline the timeline of this process when it is convenient.”
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’.
The health ministers for England, Wales and Scotland will only receive their recommendations after the consultation.
Public list
The board did not answer any questions regarding what happened to the temporary public list which allowed certain products to continue to be on sale during the approval process without formal authorisation.
The potential for new CBD-based products to appear on the list was questioned, thereby removing the ban on CBD products entering the market since 2021.
According to Sudworth, the list will ‘remain closed to new products’ and no ‘further white labelling’ will be allowed.
The tolerance granted to other products will be withdrawn if a company introduces new products to the marketplace. “If new products enter the market, local authorities may consider enforcement measures,” warned she.
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 news
The MHRA has updated its CBD guidelines for the first since 2016. It uses language which suggests a clear line between CBD consumer products and CBD medicine, with any blurring being clamped down upon.
- 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.
- The 2025 Guidance explicitly dissociates MHRA non-medicinal advice, and puts responsibility on the companies.
- The Home Office and THC are explicitly mentioned in 2025.
- The regulatory context was expanded by adding a section in 2025 that recognized the FSA’s classification for CBD as a food novel.