“OVER the past couple of weeks there have been no updates to the Food Standards Agency’s (FSA) public registers for CBD novel food applications.
It is concerning that it is taking the FSA so long to move applications through to being ‘Validated’ or ‘Pending Validation’.
This confirms my opinion that the size of the UK CBD ingestibles market has been seriously underestimated and that the FSA simply doesn’t have the resource to process these applications within a more reasonable timeframe.
Misunderstanding Or Misinterpretation?
I do believe, however, that some misunderstanding or perhaps even misinterpretation has crept in.
As standard practice, when the FSA raises questions or requests additional information, the e-portal is re-opened for a period of seven days for the applicant to provide a response. If an applicant needs more time, they can ask for an extension.
At Global Regulatory Services we’ve even had the FSA offering an extension to one of our client’s seven-day window for response because their request coincided with the four-day Easter Bank Holiday weekend!
It is important to remember that the Validation phase is to confirm that all the ‘required content’ of the application is present. If any of this ‘required content’ is missing, then legally the FSA cannot progress these applications through to the Safety Assessment phase.
Since January 1, 2021, the FSA is reported to have received 803 applications. Apparently out of these 803 applications, 445 of them have been classed by the FSA as ‘incomplete’. So what does this mean?
Actually, it’s not clear if these are ‘incomplete’ applications at the Administration check phase or Validation phase. Let’s assume that they have all passed Administration, then these 445 ‘incomplete’ applications will be missing ‘required content’.
So, if any of these applications are missing only their tox study or ADME data then these will be moved through, eventually, to ‘Pending Validation’ status.
If, however, any of these applications are missing standard ‘required content’ such as manufacturing controls and the applicant is unable to provide this information during the time their e-portal has been opened for them then the FSA is within their right to refuse the application.
If the FSA does request further information, they will re-open an applicant’s e-portal for a seven-day period. For those companies who have submitted their applications by the March 31, 2021, deadline it is absolutely critical that they upload the requested information via the designated e-portal within this timeline.
If more than seven days is required, however, then it is best to request an extension from the FSA. To date, I’ve not heard of any instances where the FSA has refused an extension. If the applicant does not provide a response whilst the e-portal is open and the FSA is not notified that an extension is required, then the application cannot progress.
At this point, the application is likely to be refused which means that the applicant will have to re-submit but – and this is the bombshell – the applicant is no longer under the protection of the March 31, 2021, deadline scheme.
Instead, a full Novel Food application must be submitted, and, with the availability of toxicity study data still months away for many people, it is likely that a full re-submission won’t be possible until the end of 2021.
In addition, the company is now at the very real risk of enforcement action being taken against them for any product they currently sell in the UK because their products will not be listed on the Public Registers due to be finalised in June, this year.
There has been a lot of noise via Social Media recently about ‘passing’ the Administration check or the FSA confirming they have all the information they need to make an assessment or, at best, actual validation.
It’s important to remember that ‘Validation’ and ‘Pending Validation’ is a positive sign to retailers and consumers that a company is committed to obtaining approval under the Novel Food Regulation and that the sale of their products can continue but, it is not ‘approval’ in itself.
To obtain full approval, the application must successfully pass the safety assessment phase. We are still many months away from achieving that particular milestone.”
By, Greer Deal, FCMI, MTOPRA, Director, Global Regulatory Services