CBD oil

The FSA’s bespoke approach to CBD novel foods applications has caused delays

The Food Standards Agency has said it expects to be able to issue full authorisations for CBD products in the UK by spring 2025.

Responding to concerns over ongoing delays in CBD regulation raised by the Association for the Cannabinoid Industry (ACI), FSA CEO Emily Miles said she was hopeful the body could begin fully authorising CBD products for sale in the next 12 months, “assuming the legal status of CBD products containing traces of THC is confirmed by the Home Office”.

She rejected claims from the ACI that the FSA had failed to comply with time limits for novel foods validation set out in EU law.

“The novel foods legislation we inherited from the EU does set out a time limit for the FSA to adopt an opinion once an application has been validated,” she said. “In many cases, data provided by applicants has been poor or its relevance to the application is unclear and so they have not yet been able to be validated.

The FSA, Miles said, had “provided applicants with several chances to improve their dossiers”, to enable their applications to progress.

She acknowledged, however, that the bespoke approach the body had taken towards CBD had “created greater resource demands” than for other novel foods, which was slowing the progress of applications toward full authorisation.

The pace of applications through the risk assessment phase was “dependent on the quantity and quality of information submitted in the individual applications,” she added.

ACI CEO Steve Moore, however, told The Grocer the association believed the FSA had “repeatedly failed to communicate transparently and promptly about its needs” and was in breach of “regulatory best practices”.

“We continue to believe that the agency has failed to comply with the relevant law, which stipulates strict time limits for implementation of novel foods regulations,” he added.

Presently, CBD products that are linked to novel food applications submitted to the FSA before 26 May 2022 are allowed to be sold in the UK, pending full regulatory approval.

Earlier this month, the first two CBD applications were moved to the ‘risk management’ phase of the novel foods approval process.

The applications will now face further scrutiny of “other legitimate factors” that could pose a risk to consumers. They will then be sent for ministerial approval to await full authorisation for sale.

For this to happen, however, an amendment to the misuse of drugs act is needed to account for trace levels of THC present in CBD products.

Moore said this was likely to hinder FSA’s ability to meet the spring 2025 deadline.

“Given the FSA’s track record, we are sceptical about whether we can expect the first authorisations of CBD products in spring 2025,” he said. “These concerns are compounded by the fact the Home Office has not outlined a firm timeline to its legislative reforms around THC content, as well as potential disruption from the upcoming general election.”

Ongoing delays, he added, had impacted incumbent CBD brands, even causing some to exit the sector.

“Investors have already taken note of the uncertainty caused by these delays, and consequently many businesses in this sector are struggling to raise capital, or have been forced to quit the market entirely,” he said. “While the UK had an opportunity to lead the global CBD market, the FSA’s approach has jeopardised that ambition.”