In February last year the FSA told the CBD industry that to stay on the UK market they needed to have their applications for Novel Food products Validated by March 31, 2020.
An FSA statement published yesterday highlighted how it had changed this position and would now accept applications until March 31.
It also ‘shifted the goalposts’ by saying it will allow applications it would have previously regarded as sub-standard to remain on the market until these applications have set out ‘robust plans to provide any necessary information’.
FSA ‘Struggling To Cope’
Many in the industry have been left aghast at the change in position after spending hundreds of thousands of pounds aligning with the FSA’s initial guidance.
However, there will be some in the industry who will welcome this move as it allows them time to align with the requirements, but for many diligent market participants, closely aligned to the FSA’s previous guidance, it is being taken as a low blow.
It appears that the FSA is struggling to cope with the number and quality of applications, despite significantly boosting the number of staff assigned to the task.
BusinessCann recently reported that 138 – over one-third – of the 404 applications it had received by the end of February ‘have been assessed and not passed the Admin check’.
The FSA still had a further 227 to consider and with more applications pouring in every day it appears to be struggling to cope.
Yesterday’s change of stance was announced as following: “The FSA will also publish a list of products associated with applications which have not yet fully met the legal requirements to be validated but have set out sufficiently robust plans to prove they are fully committed to delivering the remaining information required.
“This will include evidence of plans to complete the risk assessment process, with a clear deadline for submission of the outstanding information.”
Moving The Goalposts
Steve Oliver, of The Canna Consultants, which has submitted applications on behalf of almost a dozen of its clients said: “With today’s announcement we would suggest that the FSA have significantly moved the goalposts after the start of the match.
“The question is why they didn’t listen to the industry and begin with the ‘submitted by March 31’ suggestion we made to them 12 months ago.
“ They have now placed themselves under under-pressure, post-Brexit with the ‘validated by March 31’ only to then change it and create a further category of application to cover their failings with only weeks to go. Are the FSA ‘making it up as they go along’?
Greer Deal, a Director at Global Regulatory Services, told BusinessCann: “Food Standards Agency this is not fair on the CBD Industry and those of us who have ‘busted a gut’ to support companies in order to submit their applications in time for validation by March 31, 2021.
“I have always supported regulators because I know they have a tough job to do but, in this instance, it’s difficult to remain supportive when confusion and moving of the goalposts is caused by the regulator themselves.”
In a statement to BusinessCann the FSA said: “We will publish a list of products associated with applications which have not yet fully met the legal requirements to be validated but have set out sufficiently robust plans to prove they are fully committed to delivering the remaining information required.
“This will include evidence of work underway to gather the outstanding information, which is considered to be of good quality, and a clear and proportionate deadline for submission of the evidence.
“Failure to submit the remaining evidence in a timely fashion will result in the relevant products being removed from any published list.”
Three Stages To The Novel Food Process
The first is the Administrative check, to ensure all the required documentation is in place, the second is Validation; ensuring it matches the requirements, including details on safety and toxicology and finally Authorisation.
The Authorisation process can take a further year and once complete allows products to be sold in the UK.