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.
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.”
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.
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.
The post Thousands of CBD Products Enter Final Step Towards UK Novel Foods Approval appeared first on Business of Cannabis.
Continue reading...
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
Very important to contribute to this survey if you have been affected by the FSA’s incompetent and probably corrupt handling of the imposition of Novel Foods in the #CBD industry. It has destroyed hundreds of businesses and thousands of jobs. #drugspolicy https://t.co/XMD2J4xS6S
— CLEAR Drugs Policy Reform (@CLEARdrugpolicy) July 25, 2025
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.
The post Thousands of CBD Products Enter Final Step Towards UK Novel Foods Approval appeared first on Business of Cannabis.
Continue reading...
