UK Regulators have warned the country’s CBD industry to comply with Novel Food rules or face having their products taken off their shelves.
The Food Standards Agency (FSA) given the CBD industry a deadline of March 31, 2021 to submit valid Novel Food applications.
It has also issued a health warning to mums-to-be and those taking medication not to use CBD. And advised vulnerable groups not to take CBD, and healthy adults to take no more than 70mg a day.
In a February press release Emily Miles, Chief Executive of the FSA, said: “CBD products are widely available on the high street but are not properly authorised.
“The CBD industry must provide more information about the safety and contents of these products to the regulator before 31 March 2021, or the products will be taken off the shelves.”
While welcoming aspects of the statement The Cannabis Trades Association (CTA) – Europe’s largest association of its kind, with over 1,200 members in 35 countries – has raised some concerns.
It said: “We are still of the opinion that natural – not isolates or synthetic forms – CBD products do not fall under the scope of the Novel Food schedule.
“The CTA fully supports regulation as it ensures consumer safety and gives clarity to the processes required for its members’ products to remain in stores across the country.
“Further to the highlighted safety concerns, the CTA agree that CBD as a food supplement should not be administered in high daily doses (above 200mg as approved in 2016 by the Medicines and Healthcare products Regulatory Agency), and consumers should always seek approved medical guidance if taking other medications or during pregnancy.”
The European Industrial Hemp Association (EIHA), which has members in over 26 countries, said it welcomes the clarity the FSA announcement has provided the industry.
Although, it went on to say it would have preferred a higher recommended daily dose and expressed disappointed at the FSA’s failure to acknowledge that CBD in whole plant extracts have been used in Europe for hundreds of years and are therefore, not novel.
Industry Support For FSA
The Association for the Cannabinoid Industry (ACI) welcomed the FSA’s ‘regulatory and precautionary advice’.
In a statement it said: “We believe it establishes a clear trajectory towards the development of a safe and legally compliant CBD industry in the UK.
“Today’s update will be welcomed by consumers, the industry, and retailers alike. It will generate significant levels of industry investment in research and product quality which will place the sector on a sustainable path.
“Until now, it had grown in the shadows of the necessary regulation any such industry requires, perpetuating a lack of consumer confidence and business confusion.
“The whole industry is now on notice and we are confident it will respond with urgency to the new clarity the FSA have provided.
“The foundation goal of the ACI is to facilitate the creation of an ethical, high-quality and innovative cannabidiol industry in the UK. With the publication of this new guidance, we are emboldened in this mission. We will now intensify our work with the FSA, trading standards other Government departments to make this a reality.
The thousands of European CBD brands are served by hundreds of global suppliers varying in size from small family farms to large corporate outfits delivering in bulk.
However, this FSA announcement could result in the number of suppliers being reduced to little more than a dozen.
ACI member Colorado-based Mile High Labs is a supplier of white-label CBD to the European market and it is in the process of completing a Novel Food application.
Isolates to Dominate CBD Market
At this stage Mile High is solely submitting a Novel Food application for its CBD isolate.
London-based Christian Hendriksen, Vice President of International Expansion for Mile High Labs, sees the Novel Food pathway for CBD as crucial in delivering safe and compliant product.
Mr Hendriksen told CBD Testers: “It’s not a trivial task. It takes time to generate the relevant data and also to assemble it into the actual form that is required.
“The application process means you have to characterise your products in very great detail.
“Our isolate is more than 98% pure, but with distillate or broad spectrum extracts you will have to account for every individual compound, all of the other cannabinoids and terpenes, and assemble the associated data to demonstrate their safety.
“With extracts, there will be inherent variability from batch to batch, as CBD levels vary, but to secure a Novel Food authorisation it is necessary to demonstrate a high-degree of manufacturing consistency.
“Isolates are products which are easier to characterise, so in the short term this is where the focus will be – until people have more time to generate data for their broad-spectrum product.
“There is a chance that isolate will dominate the CBD food segment in the short term until companies, including ourselves, have had time to generate data.”
Just A Dozen UK Suppliers?
Mr Hendriksen believes there will be no more than a dozen validated UK CBD suppliers come next spring.
“Many will simply not have capacity and resources to get through the Novel Food process and the FSA is effectively saying ‘you have to do it or you are out’.
“From a small business perspective it is not a good thing, it makes it extremely tough to compete.”
The FSA’s new Novel Food rules could also open the door for the entry of the major global consumer brands into the UK CBD market.
Concerns over the lack of a clear regulatory CBD framework has previously proved a deterrent to the Coca-Cola’s of this world.
@The FSA’s stance on Novel Foods applies only to food additives, not vaping products or cosmetics which are governed by separate regulations.