WHILST Hannah Skingle has some sympathy with the view CBD has been eaten for hundreds of years it has not deterred her company’s full-throttle approach to Novel Food compliance.
The Dragonfly Biosciences’ Chief Operating Officer says it is submitting applications for a range of Novel Food authorisations.
Ms Skingle says these four core areas include; distillate, broad spectrum, isolate and a CBD extract, with different carrier oils.
She told BusinessCann: “The industry can shout as much as it likes, and say CBD is not novel, but the regulators have said it is.
“This starting position will allow us to develop different products, and be flexible. We may well be adding additional SKUs depending on how product development plans shape-up over the coming year.
“Right from the start as a business, our whole seed to shelf strategy sat at the heart of our brand DragonflyCBD ensuring always that what we were putting on the shelves and online for consumers to buy was a quality product, containing the advertised amount of CBD oil.
“That it was THC-free; a batch number and use-by date on every pack and compliant with all food supplement regulatory status. So, we have always ticked every box, ensuring consumer safety with CBD.”
CBD Industry Milestone
While there has been some speculation that the onerous Novel Food approval process would see the market limited to CBD isolate Dragonfly is setting a high bar for the competition.
With cannabidiol (CBD) being one of over 100 compounds in the cannabis plant Dragonfly’s ability to analyse, test, determine the consistency and safety of each individual batch may be regarded as a milestone for the industry.
Ms Skingle said: “As a company we have invested heavily in our testing, research and development and manufacturing facilities at Dragonfly Biosciences.
“That’s why we work with expert chemists and have our own laboratory for extraction and processing. This includes a High-Performance Liquid Chromatography testing facility so that we can control the process from seed to shelf, guaranteeing the highest and most consistent product quality. Hence, this has not just happened overnight; we have been going through this process for three years.
“We had a long discussion with our scientists and regulatory officers to see what would work for us on this whole Novel Food approach, and our large-scale facility in Bulgaria has allowed us to achieve our ambitions.
“While it has been an interesting journey – ensuring every batch of product is identical – we were able to learn from the botanical food industry, which has very similar extraction processes and needs.”
Dragonfly’s broad spectrum extract includes the cannabinoids CBD-A and CBG, plant waxes and terpenes, with all THC removed during the extraction process. Its range is built for the white-label market.
Ms Skingle continued: “We have a significant focus on wholesale operations, and we have built our category applications with this in mind.
“If our brand partners want to look to innovate, we can explore that with them, and are now in a position to do 100% of the Novel Food application on their behalf.
“All of our results have achieved the required stability testing, compositional testing, toxin testing and have been double-ticked with accredited checks from third-party testers in the UK.”
CBD Is Safe
However, there is still one piece of the jigsaw for all CBD companies looking to secure Novel Food authorisations from UK and European authorities – proving CBD is safe.
Ms Skingle continued: “We wholeheartedly believed CBD is safe, and wouldn’t be doing this if we did not, but we now have to prove in the highest of science terms to the regulators.
“We work closely with a lot of researchers and they say they can’t see any issues in the data they are looking at.”
However, there is an air of nervousness in the industry following the recent announcement from the UK Food Standards Agency (FSA) querying the safety of CBD.
It expressed concerns after its advisory body the Committee on Toxicity (CoT) secured data from GW Pharmaceuticals on its CBD drug Epidyolex.
The CoT said it had concerns over the use of CBD by vulnerable groups and its potential to damage the liver.
Ms Skingle said: “Surrounding the Committee on Toxicity of Chemicals In Food, Consumer Products And The Environment, these concerns need to be put in context.
“As such, the comments have been borne out of an initial preliminary discussion paper that CoT were looking at and so it does not reflect the views of the entire Committee.
“It mainly discusses controlled doses of medicinal cannabinoids and not CBD oil as we know it currently in the form of food supplements. The discussion paper is neither scientifically backed nor evidence based.
“The paper also focused mainly on the prescription medication, Epidyolex, 100mg/ml cannabidiol solution which is very different to over the counter CBD oil products where you just don’t get those side effects and reactions. And, no drug interactions or serious adverse effects have ever been reported for Dragonfly CBD Oil.”
Ms Skingle continues: “The toxicology studies are the biggest expense in this process with genotoxicity data, the impact of CBD on individual cells, the bare minimum.
“But with chronic toxicity – CBD’s impact on humans – this is where it gets complicated.”
CBD Industry To Collaborate
However, there are signs of the industry working together on this.
Ms Skingle said: “It is emerging that the industry is working collaboratively with companies like ourselves, who are aligned with the demands of Novel Food. We are looking collectively at how we can build a chronic toxicity database.
“I just don’t think it is possible for many companies to be doing their own chronic studies we need to work together as an industry.”
The most likely path forward in this regard will be a joint industry study or studies which may well include rodent trials.
She continued: “CBD is safe. If it was not, we would never have created a brand to sell to our customers.
“We’ve been given a breathing period by the regulators, who have been tasked with policing the industry, and maybe if we as an industry had worked in partnership, then it may have been different.”
The Novel Food process sees an application filed with European Food Safety Authority and the FSA, in the latter’s case by March 31, next year. It takes a couple of months for this to be validated and then the authorisation process can take over a year.
Some 40 applications are expected to be submitted and, to date, less than a handful have been validated, including isolates and synthetic CBD.
Last week the European Industrial Hemp Association, which itself has been arguing that CBD is not novel, announced it would be taking forward a joint Novel Food application on behalf of a consortium of companies.
It estimates a total cost running into millions of Euros and Dragonfly says its four-pronged approach has cost almost £1m.
Such financial outlay is beyond the remit of many smaller CBD companies so some may choose to align with one of the firms securing a Novel Food pass.
Dragonfly Biosciences is one of the UK’s best-selling seed to shelf CBD brands. Its DragonflyCBD is stocked by top retailers, such as Boots, Tesco, Sainsbury’s and Harrods.