AS the UK’s new regulated CBD market beckons BusinessCann has learnt that less than 25% of applications have so far been passed on to the Validation phase.
The FSA has confirmed that by the end of February it had received 404 CBD Novel Food applications – it refers to these as ‘regulated product applications’.
It went on to say that 89 of these have ‘passed the initial Administrative check’ and 138 – over one-third – ‘have been assessed and not passed the Admin check’.
This leaves 227 applications outstanding with the FSA adding: “Other applications are either being processed or have been paused while we request further information.”
With so many applications still to be assessed or requiring further information BusinessCann asked the FSA if the March 31 deadline is to be pushed back.
This was its answer on Friday, February 28: “We are working to check and validate all novel food applications as quickly as possible and have increased the amount of resources available to validate applications within 30 working days.
“A list of CBD products linked to validated applications will be published on our website on 1 April.”
However, this position has changed this week. In a new statement it said: “We will be publishing a list of CBD products linked to validated applications on our website in April.
And later it added: “We are only able to publish the list on 1 April if we receive timely information back from industry about the products linked to their application. This information also needs to be verified by us before publication. It’s in the industry’s interest to submit this information to us in good time so we expect that they will have done so before April.”
Matt Lawson is Co-founder and Director of The Canna Consultants, which has submitted almost a dozen applications on behalf of its clients.
He said: “The high failure rate is perhaps only to be expected given the flippancy with which many in the industry treated the requirements of the application process.
“It is hard to imagine that the FSA will extend the deadline to assist applicants who have failed to provide adequate data within the time period of which they have been aware for over a year.”
He added: “I’m not sure that they will fundamentally change the April 1, deadline, but they may change when they publish the results to give themselves time to process after having made the Validation decisions – we expect that not every application will name every brand that it covers and they will want some time to double-check the specifics.”
Stuart McKenzie, CEO of leading European hemp and CBD firm Reakiro, said: “While it’s disappointing and concerning that only one-third of applications have been passed to the validation phase to date, it is pleasing that the FSA have confirmed significant resources have been committed to ensure the balance of applications will be processed by the deadline.
“All parties have invested significant financial and technical resources behind their applications and if there was a delay it would be only fair and reasonable to expect the deadline to be extended.”
What To Make Of This?
The 404 Novel food applications acknowledged by the FSA are from ‘Bulk Ingredient’ suppliers and is probably around the figure many anticipated, once again demonstrating the vibrancy of the UK CBD sector.
Piggy-backing on to these 404 applications will be hundreds more from ‘Finished Goods’ companies – brands in other words – for the wide variety of CBD products on the UK market such as tinctures, soft gels, capsules and gummies.
This latest news seems to back this up these claims and will be causing concern amongst many brands in the UK market place.
It is also worth noting that these figures may be out of date – being three working days old – as the landscape is changing rapidly.
What Is the FSA Saying?
A Food Standards Agency spokesperson told BusinessCann: “Applying for novel food authorisation is the only route to compliance for CBD products so over the last year we have encouraged all businesses to submit their applications as soon as possible. It is really important that people who choose to buy CBD products know that they are being checked for safety.
“We have received a large number of applications close to the deadline and are processing these to determine whether they contain sufficient information to continue through the authorisation process.”
The spokesperson went on to say that ‘passing an Admin check only means that an application is able to move on to the Validation stage – and does not give an indication of whether it will be validated’.
And continued, ‘Applications which do not meet the criteria required to pass the Admin check are given feedback on information missing and invited to resubmit.
The spokesperson went on to say that ‘Validated applications may not end up being authorised if the information provided does not allow the independent expert scientific committees to assess safety’.
More From TCC On Validation
This point was picked up by Steve Oliver, Co-founder and Director of The Canna Consultants. He said: “With so many different organisations claiming they have the formula to success it will be interesting to see which way the FSA approaches the Validation process.
“Will common sense and reference to the publicly available human data prevail at sub 70mg per day?
“Or will the many substandard clinical trials conducted outside of GLP (Good Laboratory Practice) and the anticipated ‘replicate testing’ prove the key to unlocking the door towards authorisation.
“One thing is for sure, this is a marathon not a sprint and there are many issues to be resolved; not least the 3 ‘R’s (Replacement, Reduction and Refinement) with regard to animal testing and multi-agency oversight of any trials.
“UK companies may be at a distinct disadvantage here, were the Home Office to review the proposed clinical trials and forbid their commencement; something which many senior science professionals believe is wholly justified given the fact the MHRA have reviewed the GW data for Epidiolex.
“Using that available data to identify potential concerns – as the Committee on Toxicity has and then forbidding its use to address them is an issue that will rumble on. There is a lot more to this issue than the March 31 deadline.”
Extra FSA Resources
At the end of January in a release to the industry the FSA set out its stall for companies wanting to remain on the UK CBD market by saying it required 30 working days for Validation and eight days for the Admin process.
This effectively set a deadline for Mon February 8 for applications to be submitted, however with applications still being submitted the FSA says it has ‘increased the amount of resources available to validate applications within 30 working days’.