Thousands of CBD Products Enter Final Stage of UK Novel Foods Approval

The UK’s long-running project to regulate CBD (cannabidiol) products has taken another major step forward, seeing thousands of products make it to the final phase of the novel foods approval process.  Yesterday, the Food Standards Agency (FSA) announced that its 12-week public consultation to discuss the authorisation of three applications, which represent nearly 3000 CBD isolate products.  After almost a decade, this marks the final step towards the UK becoming the first country to officially regulate the non-intoxicating cannabis extract, in what the European Industrial Hemp Association (EIHA) called ‘a crucial milestone confirming the safety profile of hemp-derived CBD’.  It comes just six weeks after the new board of the FSA met with industry stakeholders to discuss its plan of action to move the process forward, a promise that, so far, it appears to be delivering on. 

First products reach the final stage of the novel foods approval process

Three applications have now passed the ‘risk management’ phase, meaning that the FSA is preparing to make recommendations to government ministers to officially authorise these products for sale, becoming the first regulatory body in the world to do so.  These three dossiers, RP07, RP350, and RP427, were the first to pass through the risk assessment phase last year. The former two received their first positive safety assessments in April, and RP427 followed in August.  Chanelle McCoy, the producer of Pureis, said in a press release: “This progress comes after a decade of time and significant investment in a comprehensive suite of Safety Clinical and toxicology studies to support its Novel Food application since its initial submission in January 2020.   The company’s namesake, founder and CEO said she ‘commends the FSA’ and that this work has set a ‘new global standard’ for CBD regulation, which she hopes can be replicated across the world.   Daniel Kruse, President of EIHA and CEO of EIHA projects GmbH, commented: “Years of coordinated investment and research have brought us here. Achieving the safety assessment and now advancing into the risk management phase shows that cooperation works. At the same time, the coming months will be crucial: the details matter, and we must make sure this framework can truly support both industry and consumers.” 

• April 30, 2024

• Chanelle McCoy / Pureis
• RP07
• 11 products

• April 30, 2024

• Cannaray
• RP350
• 43 products

• August 15, 2024

• EIHA Consortium
• RP427
• 2718 products

Public consultation phase: ‘The details matter’

On August 28, 2025, the FSA announced the launch of a 12-week public consultation, which will shape the key elements of the request to government ministers for approval.  This is perhaps the most critical phase of the process to date, as it will inform the regulatory pathway for CBD products for years to come, and potentially influence models elsewhere in the world.  With many of the stipulations for approval remaining highly controversial this will represent a last-ditch effort to iron out some of these issues with the regulator.  Each of the three application holders has now received a draft risk management recommendation from the FSA.  Over the course of the next three months, the consultation will seek to establish the terms of authorisation, such as permitted food categories, the 10 mg/day acceptable daily intake (ADI), and the required safety labelling As Francesco Mirizzi, Managing Director of EIHA, noted: “It is… important to underline that the consultation period will be key: we will raise a number of points to ensure that the final authorisation, definition and conditions for CBD novel foods are fit for purpose, viable for businesses, and safe and transparent for consumers.” The FSA’s consultation, launched on 28 August 2025 and open until 20 November 2025, invites feedback on the three applications, targeted at food businesses, trade associations, enforcement authorities, consumer groups and the wider public across England, Wales and Northern Ireland, with Food Standards Scotland (FSS) running a parallel process later in the summer. The consultation seeks views on the proposed terms of authorisation, including permitted uses, labelling and safety conditions, alongside any evidence on the economic or consumer impacts of authorising CBD foods.  Under the Windsor Framework, authorised CBD products placed on the GB market would also be eligible for sale in Northern Ireland through the Northern Ireland Retail Movement Scheme, although NI-based firms would not be permitted to manufacture their own CBD foods. Responses can be submitted via the FSA’s online survey or email. Once closed, the FSA and FSS will publish a summary of responses within three months and use this input to inform final recommendations to ministers before any authorisations are granted. According to the Cannabis Trades Association (CTA), which has played a key role in engaging with the regulator on behalf of industry stakeholders, alongside EIHA, a number of key issues are set to form the bulk of discussion over the coming months. 

• Daily intake: The fixed 10 mg/day limit does not reflect body-weight differences; a mg/kg model could provide more accurate guidance.
• Product scope: Restricting approvals to isolates and synthetic CBD risks excluding broad-spectrum hemp products favoured by consumers, potentially driving demand to the unregulated market.
• Labelling: Full warning statements may be impractical for small packs; a tiered model with core on-pack messages and extended information via QR code or leaflet is suggested.
• THC limits: The proposed 0.00001% w/w threshold is unrealistic given testing variability and inconsistent with the Home Office’s 1 mg/container exemption; harmonisation is needed.
• Data protection: Five-year exclusivity could disadvantage SMEs relying on the Public List; an equivalence route would help balance innovation and fair access.
• Enforcement: Divided responsibilities between local authorities (Novel Foods) and police (controlled substances) create complexity; stakeholders argue for a joint FSA–Home Office protocol.

Once the consultation comes to a close, and the terms of authorisation have been established, Ministers in England, Wales and Scotland will then decide whether to approve the applications.  Since regulatory reforms came into force in April 2025, ministerial decisions now take effect immediately and are published on the official registers of authorised products, rather than being delayed by secondary legislation. While there is a meaningful change in both the transparency and proaction from the FSA, many questions remain surrounding how companies currently on the public list move ahead or choose to reformulate, an option only announced last month.  Looking further ahead, should a regulatory pathway be formally established, it remains unclear how new players can enter the market.  This article was originally published by Business of Cannabis and is reprinted here with permission.

New analysis has found that NHS access to medical cannabis could boost the UK’s economy by £13.3 billion over the next decade by returning thousands back to work.

Widening NHS access to medical cannabis could add £4.5 billion to the economy over five years, and £13.3 billion over a decade, according to an economic analysis by the Centre for Economics and Business Research (Cebr). The research, commissioned by Curaleaf Clinic, also suggests NHS access could help thousands of people with long-term health conditions return to work, while reducing hospital admissions for those eligible by 28% a year. Since its legalisation in 2018, private prescriptions for cannabis-based medicines have already contributed around £283 million in Gross Value Added (GVA) by helping people get well and back to work. Roughly 2.8 million people in the UK are currently locked out of employment due to long-term illness2. Polling3 conducted alongside the Cebr study, found 62% of those who have been out of work and prescribed medication believe they have exhausted all traditional treatment options. Those behind the research say the findings reveal a missed opportunity to improve lives, relieve pressure on the NHS, and support the government’s five-year plan to get more people working. “Our analysis shows that appropriately prescribed medical cannabis can help people with chronic conditions return to work,” commented Pushpin Singh, Managing Economist at the Centre for Economics and Business Research. “Expanding NHS access would benefit patients while delivering significant productivity gains and cost savings to the UK economy.” READ MORE: Economic analysis finds medical cannabis could save NHS £4 billion each year

Out of work and out of options

Many people who have experienced unemployment due to long-term illness are frustrated with traditional medications. In total, 55% who have been prescribed medication report they provide little relief and 48% say they negatively affect their quality of life. Being excluded from the workforce also takes a heavy emotional toll. Over half report a loss of self-esteem (56%) and declining confidence (52%), while 46% feel helpless. Mental health is also affected, with 47% saying unemployment has harmed their wellbeing and 39% experiencing feelings of embarrassment. Fatma Mehmet, a patient at Curaleaf Clinic, says medical cannabis has helped her regain her independence. “Living with chronic pain took a huge toll on my physical and mental health. As someone independent and career-driven, not being able to get out of bed and go to work made me feel as if my identity was being stripped away,” she says. “When I felt like I was at rock bottom and out of options, I discovered medical cannabis. I now have the ability to work, lead a team, and regain my independence. Expanding medical cannabis via the NHS would mean greater choice for more people, which can only be a good thing.”

A roadmap towards improving access 

However, there is interest in medical cannabis as an alternative therapy with nearly half (44%) who have not previously been prescribed it saying they would consider trying it if it were more widely available on the NHS. Nearly two-thirds of UK adults (64%) believe people with chronic ill-health should have more treatment options to get back to work, while 71% of those directly affected say medical cannabis should be made more widely available if it can help. But 40% of those who have struggled with employment due to a diagnosed long-term health condition are still unaware that medical cannabis is a legally available treatment in the UK, and 33% describe the current system as confusing, inaccessible or unclear. “As a doctor, I see daily how chronic illness doesn’t just affect someone’s health – it removes them from the workforce, creates economic hardship, and leads to a cascade of social and psychological problems that can worsen the cycle of ill health,” says Dr Simon Erridge, Director of Research at Curaleaf Clinic. “This analysis shows that medical cannabis isn’t just a health issue – it’s an economic one too. Our goal is to give people affected by poor health more choice and control in their treatment, helping them build independence and, where appropriate, re-enter the workplace. This report highlights a way forward. “We urgently need a roadmap towards improving access to medical cannabis via the NHS for suitable patients,  with the required investment in essential research to deliver this.”

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Cannabis Health Symposium 2025 – advancing clinical practice in CBMPs

As patient access grows and prescribing frameworks evolve, health professionals need up-to-date, evidence-based guidance. The Cannabis Health Symposium 2025 brings together clinicians, prescribers, pharmacists, and researchers to explore the latest clinical evidence, policy updates, and real-world applications of cannabis-based medicines. What to expect:

• Evidence-led sessions on prescribing, safety, and efficacy
• Policy and regulatory updates for UK healthcare settings
• Practical insights from frontline clinicians and researchers
• Networking with peers, prescribers, and industry leaders

Join us in London for a day of clinical education and discussion on the future of cannabis in healthcare.