Today, UK Food Standards Agency’s (FSA) significant updates were announced to their multi-year CBD Novel Foods application process. This is finally a light at the other end of a long tunnel for hundreds of struggling businesses.
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.
The controversial Acceptable Daily Consumption (ADI) of CBD at 10mg has not been changed. MEDCAN24 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.
Sources close to the FSA process tell us, although the FSA has not publicly stated it, that the FSA will be granting full authorizations by autumn 2026. The FSA wants to move applications as fast as possible.
What’s changed?
New guidance was released in advance of a 12-week planned consultation period during which FSA would engage with the industry to discuss the final stages of the approvals processes, at which point a minister from the government will have the final say.
This comes also after a substantial personnel overhaul of the FSA and its scientific advising body, the ACNFP. New policy leaders and science teams were appointed, as well as a new chief scientist, Professor Robin May.
In this context, the FSA’s new guidelines, which are based on a growing number of interactions with representatives from the industry, such as the Cannabis Trades Association, appear tailored towards bringing this stagnant, long-standing process to life and providing businesses with a path to progress.
The 10mg ADI (Acceptable daily Intake) guideline:
It is no surprise that the FSA has been criticized for adopting the ACMD recommendation (Advisory Council on the Misuse of Drugs), which reduced the daily recommended intake of cannabis from 70mg, to only 10mg.
It was unclear, even years after the 2023 shock, whether ADI had become a de facto limit for the products.
The ADI was 10mg. This is despite the fact that some applications had initially requested 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.
- Labelling for alcoholic drinks has recommended daily unit amounts on the label.
- 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’.
- Under-18s, pregnant women, nursing mothers, and people on medication are all at risk.
- On the label, it must be stated whether CBD comes from plants or is synthesized.
- If the dossier contains robust data on safety that justifies a high ADI (and the applicant will defend it), then the application is still able to move forward to the next phase of risk assessment.
- The toxicology data used to make this decision is confidential and will not be published in full, but summaries of it are included in the safety assessment.
THC upper Limit Guide:
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.
Now, it appears that the regulator has retreated from its previous position and is aligning itself to Home Office’s enforcement limits.
- A new safe Upper Level has now been established – 1 µg/kg body weight/day (0.07 mg/day for a 70 kg adult)
- This is a safety advisory, and not a legal limit.
- 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.
- A product cannot contain more than 1mg of THC in a container. The only limit that is enforceable is this one. It is also understood as a non-negotiable by the Home Office.
The Food Standards Agency @foodgov has today announced its new ‘safe’ limit for THC in CBD products: 1 μg/kg body weight/day (0.07 mg/day for a 70 kg adult). For me, a daily dose of CBD around 100x this amount is ideal for maintaining health. #drugspolicy pic.twitter.com/7hhB2P0X95
— Peter Reynolds (@TweeterReynolds) July 1, 2025
The 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.
- The term “reformulation” is used to describe the process of modifying a document.
- Composition of the product (CBD/THC levels).
- Buy 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’.
- Changes in product names and suppliers are permitted.
- The list will remain public and can be traded. Updates will be done to it if necessary.
- It is allowed to add new SKUs, as long as it’s a replacement, or amending the CBDID SKU. This does not mean that a brand-new product line can be created.
Licence for controlled drugs
In December, it was suggested that CBD bulk ingredients companies may have to apply for a Controlled Drugs Licence. This is notoriously difficult.
- It is believed that while this was not part of the FSA’s presentation, they have now confirmed it.
- According to sources, any CBD bulk ingredient or product with more than 1mg THC/container will need a CDL.
- The importation of bulk CBD to produce CBD products could cause major problems for manufacturers.
The industry has, as always, had mixed reactions to the guidelines. Others have welcomed the new guidelines as an opportunity for a fresh beginning, seeing them as a sign that FSA is moving away from creating problems and towards solving existing ones.
Some are still frustrated with the UK CBD market’s near-fatal decline due to the UK CBD regulations, which include strict limits on CBD levels and unclear guidance.
Caroline Coen (Co-Founder, Chief Scientific Officer, Pureis), the company that was the very first to have a synthetic CBD safety evaluation approved, stated: “We appreciate the FSA guidelines and their clarity.” The FSA’s guidance is an important step towards enhancing product consistency and safeguarding the trust of consumers. Pureis was founded on safety, science and regulatory insight. “We’re pleased that Ultra Pure CBD is an FSA-compliant solution to help brands navigate this change.”
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.
The FSA has suggested today that companies can reformulate their products to improve safety. For example, a 70kg adult could be given 10mg CBD daily and THC at no more than 70ug per day. The FSA should be notified if a product’s name needs to changed. Otherwise, the FSA can approve the change.
After many years of limbo, the industry finally sees some movement. However, these low ADIs will have a dramatic impact on the utility and effectiveness of these products.
Industry needs to come together and demonstrate ADIs of more than 10mg/day.