BUSINESSCANN recently reported the UK Food Standards Agency (FSA) had received over 400 CBD Novel Food applications from bulk ingredient suppliers.
Over one-third of these had seen their applications fail to pass the initial Administrative stage, significantly reducing their chances of securing Validation and eventual Authorisation.
The main stumbling block for these is likely to be the lack of the necessary data informing their application.
£500,000 For Some Applications
Novel Food is turning out to be an expensive and time consuming process and one, in which, the FSA has little time for sub-standard work.
A robust Novel Food applications will have topped 500 pages, including appendices, and can cost over £500,000, says Steve Oliver of The Canna Consultants (TCC).
In mid-2020, the FSA notified the market that if businesses were able to submit applications before the end of the year they would be able to provide feedback on their applications.
Mr Oliver said a TCC client submitted an application for initial review last year, and that both it and the client found this feedback helpful.
FSA Feedback
“We received 1,500 words of feedback from the FSA on one dossier which at that time did not meet their requirements.
“The FSA were very thorough and comprehensive and we were pleased for the feedback as it helped shape our approach to later applications – it also helped us convince our clients that the FSA wanted chapter and verse.
“The feedback section on cultivation highlighted a host of issues that were required. These included comments to say that we needed to provide further information on the development and registration of the cultivars; they described this section as being ‘very unclear’.
“This assisted with demonstrating to cultivators and extraction partners the detail required. Many companies were quite rightly concerned about proprietary data and were reluctant to offer details of their specific practices,” he said.
He said that once businesses were able to get assurances from the FSA on the confidentiality of the data it helped lever the process.
Asexual Propagation
He added: “The FSA went on to say that we needed to provide further details on the agronomic assessment tests that were mentioned, and evidence certificates – as well as further information on asexual propagation and the chemicals used.
“Then there were comments on the disease management strategy, further details on the chemicals applied, and more details on three stages of fertilisation of the plant and the chemicals applied during pruning and harvest.
“They gave us one month to deal with the objections. They were very thorough and comprehensive and we were pleased for the feedback as it helped shape our approach to later applications.”
He went on to say that this was just one aspect the application and other areas covered included the production process, composition, specifications, and history of use of the CBD product in question. Its proposed use, as well as stability and ADME (Absorption, Distribution, Metabolism, and Excretion) data.
He added: “This feedback was essential to corroborate the requests we had been making, with many in the industry previously believing that a high-level overview was sufficient.”
However, it appears that not all submitted applications have been so thorough. One industry participant told BusinessCann that it has compiled three applications for clients in one week, adding that the FSA portal wasn’t up to scratch.
And, late last week the FSA refined its guidance to allow more time for sub-standard applications to secure the correct data see here – and panel below.
Authorisation Will Require Safety Evidence
At the end of January, this year, 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 initial Administrative checking process.
Passing the Validation phase moves it on to Authorisation phase with the FSA again reminding the industry, last week, that Validated applications may not end up being authorised if the information provided does not allow the independent expert scientific committees to assess safety.
Providing this safety data is proving key – and three main routes to achieving this are being pursued by CBD companies looking to secure Novel Food Authorisations.
The Three Routes To Compliance
The three are:
- In house company toxicity trials on animals – such as those by UK firm Farmceutica
- Consortium trials being undertaken the the Association for the Cannabinoid Industry (ACI) and the European Industrial Hemp Association (EIHA).
- Desktop safety studies from the data which already exists
Farmceutica has undertaken its own £2m trial on a selection of animals, as BusinessCann has previously reported.
Julius Bond, President of Farmceutica Wellness, said: “We’ve always taken a ‘science first’ approach to the industry. And conducting our own independent research was the obvious choice to allow for complete transparency with our submission.”
The EIHA consortium, with almost 200 members, has submitted Novel Food applications to the FSA for a CBD isolate, a synthetic CBD, and a full spectrum, whole plant extract. The ACI has submitted applications for an isolate and a broad spectrum distillate.
Although some observers have raised concerns over the transferability of the data between the Novel Food extracts of consortium members, both organisations say this isn’t an issue.
Both the ACI and EIHA are undertaking rodent trials to demonstrate to FSA’s scientific advisors, the Committee on Toxicity, that CBD consumption is safe.
More Rodent Trials
Gavin Ogilvie, Founder and Managing Director of Always Pure Organics, a Manchester-based CBD manufacturing and global distribution company, has invested almost £450,000 on three novel food applications – two of these are for isolates with the third for a broad spectrum distillate.
With input from some of the country’s leading experts Mr Ogilvie believes there is enough existing evidence from both human and animal studies to satisfy the regulators that CBD is safe.
However, Always Pure Organics is also working closely with TCC, which has committed to undertake any rodent toxicity trials deemed necessary by the FSA, after the Validation reviews.
This would involve a consortium of companies whose ingredients are declared as being ‘substantially equivalent’ following discussions with the FSA.
“The protocol is in place, the CRO (contract research organization) is UK based and the study has been presented to the FSA.” said Mr Oliver.
He added: “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.
“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.”
Novel Food Background
To quickly recap CBD classification as a Novel Food was a controversial determination by the European Commission in January 2019.
In February, last year the UK FSA set a deadline of March 31, 2021, for CBD products to remain on the shelves – and added an additional layer of complexity by raising safety concerns over CBD.
While no-one is known to have ever suffered any significant impacts from CBD use, concerns over its safety emerged from the FSA’s scientific advisors the Committee on Toxicity (CoT) in January 2020.
Using trial data from GW Pharmaceutical’s work on its anti-epilepsy cannabis drug Epidiolex the CoT registered concerns over potential harm to the liver, somnolence, harm to the unborn and reproduction.
In a series of meetings last summer the FSA indicated that it is yet to be convinced that the data exists to demonstrate CBD is safe.
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 UK has set a deadline of March 31, for this although as BusinessCann reported earlier this has now slipped – see panel below. The Authorisation process can take a further year and once complete allows products to be sold in the UK.
FSA ALLOWS MORE TIME
Late last week the FSA refined its guidance to acknowledge the substantial number of applications failing to provide the correct information.
It said: “Applying for novel food authorisation is the only route to compliance for CBD extract products so over the last year we have encouraged all businesses to submit their applications as soon as possible.
“Despite this, we received a large number of applications close to the deadline so in order to process these properly, we have adapted the criteria of products which should be allowed to remain on sale from April 1.
“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 under way 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.
“Local authorities enforce novel legislation. The FSA has issued this guidance to take a pragmatic and proportionate approach to CBD regulation. There are currently no authorised CBD products on the market in the UK.”
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