Insights / 19-02-2020

The Novel Food announcement by the FSA landed last week and created major waves in the CBD world. By then we had all been waiting on this guidance from the regulator for a long time. It wasn’t the announcement that I would have wanted, but like Brexit, whether you were for it or against it, it has happened. At this point in time, any kind of clarity is welcome.

Now we await the formal protocols of the application process but there is enough information around for us to start getting into the detail.

The Timetable

The CBD industry has a deadline on 31st March 2021 to work towards. Producers of the active ingredients (CBD isolates, etc…) must submit a valid marketing authorisation application to the FSA by this date. What constitutes a valid application? There are a number of categories that have to be satisfied in order for your submission dossier to be considered complete. Provided you make submissions in all categories then your application should be deemed valid, but be in no doubt, there will be no cutting of corners.

The word on the street is that the FSA expects to be able to consider your application and provide their decision within 18 months of your submission. I have concerns over such an ambitious target but that is only because we’ve been disappointed several times before by UK regulators trying to meet such self-imposed timetables.

The Application Process

This is about safety. Are the products being sold to consumers safe for long term and regular use? Those opposed to novel foods will claim that hemp and her extracts have been consumed by humans for millennia so of course they are safe! However, in a novel food application it is the scientific data that matters. For producers of CBD extracts you will be expected to submit data in relation to a number of issues. Are your batches of product consistent? What impurities do they contain? What are the implications of long-term use? Are there seasonal variations in your products? How do you justify the shelf-life assessment of your product? No one will have ten years’ worth of data on these issues, but under standard laboratory practices it is possible to establish sufficient information to satisfy these questions over a period of three to six months. The big wholesalers will already be collecting substantial data in this regard and therefore should be well underway to be ready for submission of their dossier.

A Collaborative Approach

It appears that collaboration is being encouraged. If there are companies producing very similar products then it is entirely possible to work together, pool data/resources and make a joint submission. This has the benefit of sharing the substantial cost burden. The counter argument is provided by Intellectual Property considerations. There is potentially a market advantage to be gained by submitting detailed information on your own safety data and manufacturing processes, thus securing an element of exclusivity upon approval.

SMEs

What about those businesses outside of the big wholesalers? If you are buying in your CBD extract and then creating your own range of finished products, will you have to submit your own novel food application? The answer is no, but with several caveats.

The issue here is whether your finished product has been cited in your supplier’s application and has the necessary data been submitted by your supplier accordingly. If your finished product has been included in your supplier’s application then you will not require your own marketing authorisation. Again, this encourages a collaborative approach between suppliers and businesses buying from them.

This will undoubtedly create real barriers for SMEs in the market and increase costs. The attitude of the FSA (and the CMC/ACI behind them) is very much one of ‘tough luck’. Their attitude is that if you can’t afford to carry out studies to establish the safety and stability of your products then you shouldn’t be selling them in the first place. This is incredibly harsh, as remember, we all under the impression that hemp and her extracts were not novel until the EFSA initiated this process last year.

Practical Advice

Whether you like it or not, this issue has to be dealt with as things currently stand. Safety of products brings consumer confidence and market stability, which is something we can all support. If you are a producer of wholesale CBD extracts then you should already have started preparing your submission data. There is sufficient time to establish the data you need, but do start soon if you haven’t done so already.

If you are a manufacturer of finished products, then you should be speaking to your supplier of your active ingredient. Ensure that data in respect of your product range is submitted as part of your supplier’s dossier.

The application process is designed to help manage and mitigate any long term safety issues associated to CBD.  Cannabis is a risk sector, and navigating this industry means taking action to manage and mitigate that risk. Novel foods is part of this now.