The UK’s Food Standards Agency (FSA) has announced some significant updates to its multi-year CBD Novel Foods approvals process, finally offering hundreds of long-suffering businesses some light at the end of the tunnel.
Following suggestions from the FSA late last year that it planned to ‘clearly communicate that the expectation is undetectable,levels (of THC), the regulator has softened its stance, and has now provided a new upper limit and guidance.
Furthermore, while the controversial 10mg Acceptable Daily Intake (ADI) guidance for CBD has been maintained, Business of Cannabis understands that is strictly advisory, meaning that this limit per serving ‘will not be mandated’.
New reformulation pathways for companies who remain in the approval process have also now been opened, meaning those who believe their products will not fall within these guidelines (established long after dossiers were submitted), can ‘reformulate’ or dilute their products and see them retained on the ‘public list’, meaning trading can continue.
While the FSA have not said so publicly, sources close to the process have informed us that full authorisations should be granted by Autumn 2026, and the FSA is moving to push applications through as quickly as possible.
What has changed?
The new guidance comes ahead of a planned 12-week consultation period, which will see the FSA engage with industry regarding the final stage of the approvals process, in which a government minister must give final approval.
It also comes after a significant personnel overhaul at the FSA, and its scientific advisory body the ACNFP (Advisory Committee on Novel Foods and Processes), including new policy leads, science teams and a new Chief Scientist, Professor Robin May.
With this in mind, and with growing interaction with industry representative groups like the Cannabis Trades Association (CTA), the FSA’s new guidelines appear to be tailored to pulling this long-stagnant process out of the mud, and providing a pathway for businesses to move forward.
10mg ADI (Acceptable Daily Intake) guidance:
One of the most controversial and continually contentious aspects of the approval process to date was the FSA’s decision to adopt the ACMD’s (Advisory Council on the Misuse of Drugs) recommendation to significantly reduce its recommended daily intake from 70mg to just 10mg.
Following the shock decision in 2023, already years into the process, it has been largely unclear whether this reduced ADI was now a defacto cap for products.
This view appeared to be largely confirmed until just months ago, with the gradual drip of applications moving past the safety assessment stage all adhering to the ADI of 10mg, despite a number of applications initially calling for a higher ADI.
- The FSA has now confirmed that it will ‘not mandate these changes’ for products on the List.
- Sources close to the process echoed this, stating in no uncertain terms that the 10mg ADI is ‘advisory’ only, and will not be enforced.
- Companies have been encouraged to change their labelling to reflect this ADI, but this has been framed as a in a framework that has been likened to alcoholic beverages’ recommended daily units included on labelling.
- In its presentation to members of the media, the FSA said ‘CBD products exceeding the provisional ADI… can remain on the List’, but noted that it ‘is our expectation that businesses move to meet our standards as best practice’.
- Warning statements for under-18s, pregnancy, breastfeeding, and those on medications.
- Labelling must state whether CBD is plant-based or synthetic.
- It is understood that dossiers containing robust safety data justifying a higher ADI, which the applicant is prepared to defend, will still be able to pass the risk assessment phase.
- No full publication of the data leading to this decision will be released, as toxicology data is partially confidential, though summaries are in published safety assessments.
THC upper limit guidance:
During a monthly board meeting in December 2024, the FSA signalled that it was leaning towards a 0% THC approach for CBD products, causing major concerns for any applications containing ‘full spectrum’ CBD products.
The regulator now appears to have rolled back on its position, and has now aligned itself with the Home Office enforcement limit.
- A new safe Upper Level has now been established – 1 µg/kg body weight/day (0.07 mg/day for a 70 kg adult)
- Similarly, this is an advisory safety threshold, not a hard legal cap.
- CBD products ‘exceeding the THC safe upper limit can remain on the List’, and as above, will not be discounted from passing the safety assessment if justifiable data is strong.
- However, a product must not exceed 1mg THC per container. This is the only enforceable limit of the update, and is understood to be a non-negotiable from the Home Office.
Reformulation pathway:
- With these limits ‘setting a new standard’, the FSA says it ‘recognises that businesses may want to reformulate their products to be within recommended CBD and THC limits’.
- As such, it will now allow ‘limited reformulation’ of products on the public list.
- It emphasises that ‘reformulations are permitted for safety reasons only’, and the FSA will require a statement from the company confirming this.
- Reformulation allows changes to:
- Product composition (CBD/THC levels)
- Supplier
- Branding/name
- Labelling
- ‘Products on the List must still use CBD ingredients that meet their associated novel food application composition, production process and specification’.
- Product name and supplier changes will be permitted.
- These products will be able to remain on the public list, and traded, and updates will be made to the list where necessary.
- New SKU’s can be added, but only if it is a replacement or amendment to the original CBDID product SKU, not a truly separate new product line.
Controlled Drugs Licence requirements
During December’s board meeting, there were also suggestions that companies dealing with bulk CBD ingredients may now be required to secure a Controlled Drugs Licence, which are notoriously difficult to obtain.
- While not included in the FSA’s presentation, it is understood that this has now been confirmed.
- Any bulk CBD ingredient or product that exceeds 1mg THC per container, will now require a CDL, according to sources.
- This could have major implications for those importing bulk ingredients to manufacture their CBD products.
Industry reaction to the new guidelines have, as ever, been mixed. Some have welcomed it as a fresh start, seeing it as a signal that the FSA are shifting towards finding solutions rather than creating problems.
Others continue to be frustrated at the strict limitations on CBD and THC levels, unclear guidance, and missteps which have seen a near fatal reduction in the UK’s CBD sector.
Caroline Coen, Co-Founder and Chief Scientific Officer for Pureis, the first company to receive a positive safety assessment for synthetic CBD, said: “We welcome the FSA’s guidance and the clarity it brings. It’s an important step toward safeguarding consumer trust and elevating product consistency. Pureis was built on the principles of safety, science, and regulatory foresight and we’re proud that our Ultra Pure CBD can offer an FSA compliant solution to brands navigating these changes.”
In a LinkedIn post, Chief Regulator Officer & Scientific Advisor at ADACT Medical, Damien Bove, said: “The FSA gives to the CBD industry with one hand and takes away with the other.
“Today the FSA have suggested that companies can re-formulate products on the public list for safety purposes, to bring daily dosing for a 70kg adult to 10mg of CBD per day and THC no higher that 70ug / day. If you need to change the product name then inform the FSA, if you don’t you can go ahead, if you need to change suppliers to achieve the safety then go ahead.
“After many years in limbo the industry is finally seeing some movement, however these low ADIs are going to dramatically impact the utility of these products.
“With the evaluation of CBD isolate notification expected to complete in October this year and broad spectrum this time next year, industry needs to work together to demonstrate ADI safety above 10mg/day.”
This article was originally published by Business of Cannabis and is reprinted here with permission.
The post FSA Publishes New Guidance On THC Limits And Recommended Daily Intake For CBD Products appeared first on Cannabis Health News.
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