FSA Publishes New Guidance On THC Limits And Recommended Daily Intake For CBD Products

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.

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.

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.

Reformulation pathway:

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.

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.