NOVEL FOODS APPLICATION HAS BEEN SUBMITTED

As of Thursday the 18th of February 2021, Always Pure Organics has submitted three dossiers to the FSA for CBD-based Novel Foods; one for our Swiss Isolate, one for our Colombian Isolate and one for our Colombian Distillate.

This was a long and arduous process, which would not have been possible without the assistance of several parties. DevelRx have provided extensive toxicology guidance and excellent advice regarding the design of toxicology studies, The Canna Consultants have proven invaluable at navigating the red tape and legislation regarding Novel Foods, and FERA have provided top-notch analysis of the products we submitted.

In addition to the assistance provided by the parties mentioned above, the FSA themselves have been incredibly helpful throughout. A first draft dossier was submitted to them in December on an informal basis, with extensive feedback provided in early January. The FSA then reached out to us for a discussion regarding the feedback in a meeting with the relevant members of the FSA. This meeting was greatly beneficial in finalising our dossiers, and we have enjoyed consistent discussion with the FSA through their designated email for the miscellaneous questions that have arisen throughout the process.

We hope that the Novel Foods process will prove to be beneficial for the market in both the UK and rest of Europe overall, which we see arising from three main facets. The first is that more stringent regulations will improve the quality of products in the market, which will subsequently increase consumer confidence. Greater confidence should lead to improved market growth. More stringent restrictions on products will also help to legitimise the industry, something that has always been an issue with CBD being sourced from Cannabis. If the market is perceived to be more legitimate, the chances of investment from recognised bodies is improved, again increasing market growth. The final beneficial aspect comes from the UK being a front runner in establishing a regulated CBD market. This puts the UK at a distinct advantage for all the factors mentioned above as it will be able to take advantage of them first, and it also creates an example for other countries to follow for establishing their own regulated markets. Even if these countries decide not to follow the UK’s route to compliance exactly, they will at least be able to learn from how it was implemented and use that to design their own regulated markets.

As this is a new process for ourselves, the FSA and the CBD industry as a whole, we expect Novel Foods to be less of a project that gets finished and then moved on from, and more akin to a work-in-progress that will develop over time until all parties are satisfied. There are still several questions that remain to be answered, one of which relates to the adding of new products to an application. There has been no guidance from the FSA regarding updating an application to allow for new brands, products or raw material suppliers. This is perfectly understandable when considering that they are focused on making sure their process for companies getting validated is correct and running smoothly, but such questions will need to be dealt with at some point in the future.

Based on the timeline provided by the FSA for submissions, we hope to have a decision regarding the validation status of our respective dossiers before April. From the amount of work that has gone into them, we feel confident that we will receive validation, but this of course is entirely reliant on the FSA’s decision. Whatever the outcome, we will continue to serve our customers to the best of our capacity to ensure their needs are met.

As of Thursday the 18th of February 2021, Always Pure Organics has submitted three dossiers to the FSA for CBD-based Novel Foods; one for our Swiss Isolate, one for our Colombian Isolate and one for our Colombian Distillate.

This was a long and arduous process, which would not have been possible without the assistance of several parties. DevelRx have provided extensive toxicology guidance and excellent advice regarding the design of toxicology studies, The Canna Consultants have proven invaluable at navigating the red tape and legislation regarding Novel Foods, and FERA have provided top-notch analysis of the products we submitted.

In addition to the assistance provided by the parties mentioned above, the FSA themselves have been incredibly helpful throughout. A first draft dossier was submitted to them in December on an informal basis, with extensive feedback provided in early January. The FSA then reached out to us for a discussion regarding the feedback in a meeting with the relevant members of the FSA. This meeting was greatly beneficial in finalising our dossiers, and we have enjoyed consistent discussion with the FSA through their designated email for the miscellaneous questions that have arisen throughout the process.

We hope that the Novel Foods process will prove to be beneficial for the market in both the UK and rest of Europe overall, which we see arising from three main facets. The first is that more stringent regulations will improve the quality of products in the market, which will subsequently increase consumer confidence. Greater confidence should lead to improved market growth. More stringent restrictions on products will also help to legitimise the industry, something that has always been an issue with CBD being sourced from Cannabis. If the market is perceived to be more legitimate, the chances of investment from recognised bodies is improved, again increasing market growth. The final beneficial aspect comes from the UK being a front runner in establishing a regulated CBD market. This puts the UK at a distinct advantage for all the factors mentioned above as it will be able to take advantage of them first, and it also creates an example for other countries to follow for establishing their own regulated markets. Even if these countries decide not to follow the UK’s route to compliance exactly, they will at least be able to learn from how it was implemented and use that to design their own regulated markets.

As this is a new process for ourselves, the FSA and the CBD industry as a whole, we expect Novel Foods to be less of a project that gets finished and then moved on from, and more akin to a work-in-progress that will develop over time until all parties are satisfied. There are still several questions that remain to be answered, one of which relates to the adding of new products to an application. There has been no guidance from the FSA regarding updating an application to allow for new brands, products or raw material suppliers. This is perfectly understandable when considering that they are focused on making sure their process for companies getting validated is correct and running smoothly, but such questions will need to be dealt with at some point in the future.

Based on the timeline provided by the FSA for submissions, we hope to have a decision regarding the validation status of our respective dossiers before April. From the amount of work that has gone into them, we feel confident that we will receive validation, but this of course is entirely reliant on the FSA’s decision. Whatever the outcome, we will continue to serve our customers to the best of our capacity to ensure their needs are met.

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Andrew Megahy1

Andrew Megahy

Lead Scientific Officer Linkedin