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CBD Industry’s Anger At ‘Unprofessional Approach’ Of Regulators To Novel Food Process 

AS Brains Bioceutical becomes the latest company to make it on to the Public List of Validated Novel Food CBD applicants, sections of the industry are becoming increasingly unsettled by the ‘unprofessional’ approach of the Food Standards Agency.

In a press release Brains announced it had ‘received confirmation of validation from the FSA, for its natural plant-based Cannabidiol as a Novel Food’. 

Brains Global Chief Operating Officer Dean Billington has told BusinessCann it has spent almost £2m generating the data required to secure UK validation.

Its submission features a 600-page dossier which includes: ‘a full toxicology assessment, stability data, manufacturing data for a minimum of five batches, detailed information on typical CBD exposure and usage, risk assessment and risk mitigation plans and additional supporting data’. 

No Progress With FSA

In announcing its progress to the validation stage of the Novel Food process Brains is following in the footsteps of British Cannabis, as reported by BusinessCann last month.

However, despite both having now been informed they are on the Public List – along with other unnamed companies – the FSA has yet to update its published version.

And this is causing consternation in the industry with Siân Phillips, Executive Director of the Cannabis Trades Association, which represents over 300 CBD companies, criticising the FSA for the way it is handling the process. 

She has called on the regulators to act promptly. “The Public List is already almost one year late and the way this is now being handled by the FSA is very unprofessional.

“This is causing great anxiety among our members, many of whom are waiting to hear how their own applications are proceeding. This drip-drip approach provides some companies with a distinct marketing advantage and is causing much anger and dismay in the industry,” she told BusinessCann.

Nevertheless, in a fresh statement to BusinessCann the FSA is refusing to bow to industry pressure saying the Public List will only be updated when it is ready.

No Guarantee On Authorisation

Paul Tossell, Head of Novel Foods and Radiological Policy Team at the Food Standards Agency: “We’ve written to several applicants to let them know that they have submitted sufficient information to be assessed for inclusion on the CBD public list. The list will be updated in due course as we are still in the process of verifying individual products.”

The FSA would not be drawn on how many applicants it has written to and Mr Tossell continued: “The CBD Public List is split into two sections that are made up of products associated with applications which either:

-have been Validated (this means the applicant has submitted all information required by law to allow their application to proceed to a safety assessment)

-are ‘awaiting evidence’ (also known as ‘On Hold’), with applicants having set out robust plans to complete the risk assessment but yet to supply all the information needed to continue on in the process.”

Mr Tossell added: “There is no guarantee that an application included on the Public List will be authorised. Addition of a CBD product to this list does not mean it is authorised or approved, only that the applicant is seeking authorisation but has not yet gone through a suitable risk assessment.”

On the latter point Ms Phillips said this is similar to an exam in the sense that all of the revision may have been done to pass an exam but success is not guaranteed.

The FSA has received over 800 CBD Novel Food applications and it has rejected over 600 of these. It says it is still processing over 200 submissions. Three applications have been Validated to date. The application from British Cannabis has been placed in the On-Hold section, as reported earlier.

Before final approval – or Authorisation – all Validated applications must ensure ‘the information they have provided satisfies its expert scientific committees on safety’ say the FSA.

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