THE international head of one of the world’s leading CBD businesses has outlined his understanding of a route to compliance for brands to continue trading in the UK post-Brexit.
Colorado-based Mile High Labs signified its global intent after securing $35m in a Series A funding round less than two years ago – still a record initial capital raise in the cannabis space.
London-based Christian Hendriksen was subsequently appointed as Vice-President of International Expansion, just a few months after the European Union announced all CBD edibles must conform to its Novel Food authorisation pathway.
Mr Hendriksen is a firm advocate of the need to establish a well-regulated, global CBD food supplement industry to protect consumers.
‘Guidelines Have Been Almost Non-Existent’
He said: “Where we struggle globally as a CBD industry is on the regulatory side. We have a general lack of clear regulation in the US and Europe as to what quality standards a product must be.
“Should it be produced under EU-GMP or general food GMP? What is the maximum daily dose? How much CBD can you put in a product? On all of this the guidelines have been almost non-existent, and, at best, vague.
“One of the challenges for the industry is the lack of clear guidelines from the US FDA (Food & Drug Administration), where we are in this limbo. Mile High Labs has invested in quality, but some will look to get cheaper products to market and there is nothing to stop them doing that.”
In Europe efforts are under way to establish a regulated market with the announcement in January 2019 that all edible CBD products must adhere to the Novel Food pathway.
300-Page Novel Food Submission
Mile High Labs, as a compliant company, was one of the first CBD wholesale brands to submit a Novel Food application to the European Food Safety Authority – it covered over 25 topic areas and ran to more than 300 pages.
With the UK currently in a transition period as it leaves the EU, its domestic food regulator – the Food Standards Agency (FSA) – issued its own Novel Food compliance guidelines in February of this year.
However, despite numerous attempts to secure definitive guidance on how businesses can continue to trade past the FSA deadline of March 31, 2021, it’s fair to say that there is still a great deal of confusion and uncertainty amongst market participants.
Two of the most prominent grey areas are over the need to undertake in-vivo – or animal tests – to determine how safe CBD is in specific doses and with various delivery mechanisms? And secondly, how much work a brand or product manufacturer needs to undertake to ensure compliance?
Both questions are of concern for the ingredient manufacturers, with the second being of relevance to the brand, or final product manufacturers.
‘No Need For Animal Testing’
On both of these points Mr Hendriksen spoke candidly to BusinessCann.
On the issue of CBD toxicity testing, he said: “We (Mile High Labs) are confident of the data package we have submitted. We are confident it contains all of the necessary information to be validated and eventually approved.
“But, of course we will work with the regulators if they find something that they think is insufficient or needs elaboration.
“While there may potentially be the need for animal testing, it will depend on the quality of the data submitted, and the subsequent interpretation and review of that.
“From the point of view of our application, we don’t feel as though we need to add any data in relation to any potential safety concerns.”
Novel Food Framework Ingredient Based
On the second sticking point, questions have been raised as to how various delivery mechanisms may affect bioavailability, and the shelf-life stability or potential degradation, during secondary manufacturing, of the final CBD product.
He said: “The Novel Food framework is an ingredient-based one, and it is upon us as an ingredient manufacturer to show that the ingredient is safe and consistent from batch to batch and then, after that, there is the part about putting it into finished products.
“With a finished product, if you are a brand and want to make a tincture, for example, you can do that leveraging our application.
“We are not of the opinion that it is incumbent upon the brand to generate their own Novel Food application, as they would not have the necessary data to do so.
“So we are working with our customers to ensure they are Novel Food complaint but that is not the same as saying we are putting their Novel Food application together.”
Brands Need Stability And Degradation Data
A widely-quoted study into CBD bioavailability showed it can vary widely depending on the way it is ingested into the body.
Mr Hendriksen said: “Carrier oils and flavouring do not impact to any great degree on bioavailability but they do impact on stability and brands need to generate their own data in this regard.”
Mr Hendriksen believes there is no need for a brand to therefore seek a separate Novel Food authorisation.
He believes a brand will be complaint if it is able to demonstrate to regulators, say, for example, UK trading standards, that it is using a validated Novel Food SKU, and has generated its own secondary data.
He said: “We are working with our customers to show what homework needs to be done and this essentially comes down to two things: there is no degradation during manufacturing and data needs to be generated on the stability, the shelf life, of the product in question.”
95% Of Data Generated By Ingredient Manufacturers
He described it in the following way: “The Novel Food application in relation to the manufacturing process equates to around 60% of what is required, the toxicology a further 35% which leaves 5% for the finished product.”
This approach had also been Mile High’s proposed strategy for the European market but this has turned sour for all market players following the recent unexpected turn of events, reported comprehensively by BusinessCann.
Mile High Labs view CBD as a food, not a drug, and he says it has communicated this view to the European Commission.
The company is based in 400,000sq ft factory in Colorado and is entirely a CBD manufacturing company with no cultivation.
Global Expansion Moves Target Middle East
Its Mile High ‘Monster’ mobile machine is deployed into its growing partners’ fields and is capable of processing 50 acres of hemp a day, into oil.
The company established a European distribution base in Belfast, last year, which can supply continental customers within two working days.
It currently sells into 28 jurisdictions, in all five continents, and Mr Hendriksen recently returned from the Middle East as the seemingly unstoppable CBD juggernaut spreads across the globe.
“We manufacture a high-quality isolate with no THC. Businesses want safe and consistent products, no matter where they are based and Mile High Labs can deliver that, every time,” he added.