Both organizations are attempting to provide some much-needed clarity to this largely stagnating industry, which has been in a transformational phase for years. This has resulted in many operators being unable to bring new products to market or develop strategic growth plans.

It is worth noting that the UK Food Standards Agency (FSA) appears to have abandoned its previous recommendation of seeking to limit the THC content in novel CBD foods to 0%, which is likely to come as a relief to many CBD businesses.

Meanwhile, the UK's Medicines and Healthcare products Regulatory Agency appears to be seeking to draw a clear distinction between approved CBD medications and consumer-grade CBD products, warning any CBD companies attempting to make medical claims about their consumer-grade products.

Response from the UK Food Standards Agency (FSA)

In December 2024, the FSA held a board meeting to discuss the progress of its CBD novel food approval process, which still involves hundreds of CBD companies. Although many industry stakeholders had hoped the meeting would provide some clarity and assurances, it ultimately raised more questions than it answered.

After the meeting, the Cannabis Trades Association (CTA) of the UK sent a letter to the FSA, seeking responses from the agency on several key issues.

The response from FSA Policy Chief Sadworth revealed more details:

Daily Intake

The UK Cannabis Trade Association has criticized the FSA (Food Standards Agency) for strictly enforcing the controversial 10 mg daily acceptable intake (ADI), arguing that the limit is being mistakenly used as a statutory cap rather than as advisory guidance. Despite evidence showing clear differences between CBD isolates, distillates, and full-spectrum products, the agency continues to apply this blanket standard to all CBD products.

In response, Sadworth stated that the FSA's advisory committee is currently examining "other forms of CBD... including full-spectrum products," and the government will "review any further recommendations they release regarding CBD levels."

THC content

The UK Food Standards Agency (FSA) appears to have softened its stance on the permitted levels of THC in CBD products. During its December 2024 board meeting, the board had stated that its "clearly communicated expectation is undetectable levels of THC, rather than setting a specific limit."

Currently, despite strong recommendations to set the THC content limit at 0%, which would significantly restrict the range of legally sold CBD products in the UK, the UK Food Standards Agency has stated that its advisory committee will release findings on the impact of THC on food safety "between April and May."

Sadworth stated, "The proposal will include a safe limit for THC," and this limit does not require approval from the UK Home Office.

Batch Licensing

As recently confirmed by the Ministry of the Interior, products with extremely low THC content can be considered duty-free and freely traded under the definition of Exempt Product Definition (EPD).

Last December, the FSA suggested "revising the storage and transportation licensing conditions for these CBD products" and stated that "it will now be easier to obtain licenses for storing or transporting bulk materials with low THC content."

It is worth noting that some have suggested that companies handling large quantities of CBD ingredients may now need to obtain a controlled drugs license. However, it is well-known that acquiring such a license is extremely difficult. When asked whether this licensing and facility inspection could be carried out by the FSA to avoid the inertia of the Home Office's licensing process, the government appears to have dismissed this possibility.

We understand that bulk suppliers are required to obtain a license. This is a requirement from the Ministry of the Interior, so we are unable to comment further. The Advisory Council on the Misuse of Drugs provides recommendations to the Ministry of the Interior regarding the status of THC in consumer CBD products from a drug perspective.

According to current laws, we are required to use the definition of Exempt Product (EPD). The EPD is a policy established by the Home Office and forms part of the Home Office legislation (The Misuse of Drugs Regulations).

It is inappropriate for the FSA to consult on legislation and policies from other departments. When drafting Terms of Authorization (ToA) and providing recommendations to ministers, the FSA can regard compliance with broader legislation as "other lawful factors." Products containing CBD as an ingredient must comply with their ToA provisions in order to be recognized as authorized novel foods.

Order Processing

Currently, eight applications have entered the final "Risk Management" stage (including five since the beginning of this year). After passing the safety assessment, these applications must now be recommended to a government minister for final approval. According to the FSA, this step cannot be implemented until the planned 12-week consultation is completed.

Although the specific date for the consultation has yet to be determined, the FSA stated that the launch date will “depend on” the solutions provided by risk managers across the country. These managers are currently “addressing some issues to prepare for the consultations, and we will establish a timeline for the process at the appropriate time.”

Sadwars clarified that this consultation "will cover the terms of authorization (ToA) for the first three CBD applications that have passed the safety assessment stage," namely Chanelle McCoy/Pureis (RP07), Cannaray (RP350), and EIHA Alliance (RP427). He also stated that more safety assessments are "on the way." Recommendations will only be made to the Health Ministers of England, Wales, and Scotland after this consultation process is completed.

Public list

The committee failed to address a series of questions regarding the fate of the public list, which is a provisional list allowing certain products to continue being sold without official authorization during the approval process.

Questions have arisen about whether new products could potentially be included in the list, which has broken the barriers to the entry of any new CBD products into the market since the procedure began in 2021.

According to Sadworth, the list will "continue to remain closed to new products" and "will no longer allow further white label operations." She warned: "If food companies do launch new products in the market, they will not be granted tolerance for products already on the list. If new products appear in the market again, the relevant local authorities will consider taking enforcement actions."

Once ministers approve the CBD products, the FSA stated it will "provide further guidance on how the list will operate," as "the operating environment for the list will change."

The latest statement from the UK Medicines and Healthcare products Regulatory Agency (MHRA).

This week, the MHRA updated its CBD guidelines for the first time since 2016, with wording indicating that a clear distinction will be drawn between consumer CBD products and CBD medicines. Any actions blurring this boundary will be strictly penalized.

In fact, the MHRA has confirmed the medicinal status of CBD, removing its qualification as an "opinion," signaling a more specific regulatory stance. Therefore, any CBD product claiming to have medical benefits will "be regarded as falling within the definition of a medicinal product" and must hold a marketing authorization.

Key Points of the Medicines and Healthcare products Regulatory Agency (MHRA) 2025 Guidelines:

Added new warning phrasing, emphasizing that future classification may change based on MHRA's assessment.

Clearly specify that the MHRA (Medicines and Healthcare products Regulatory Agency) should maintain distance from non-pharmaceutical regulatory advice and place the responsibility on the companies.

It explicitly mentions THC and the role of the Ministry of Internal Affairs in the legislation on psychoactive substances and drug control.

A new section has been added, acknowledging that the FSA classifies CBD as a novel food, thereby expanding its regulatory scope.

END