The UK has become the first country in the world to regulate the public sale of orally-administered, legal cannabinoids following the publication last week of a list of permitted products. The move will serve to “de-risk” cannabidiol (CBD) for investors and spur innovation in the space, according to Steve Moore, founder of UK-based trade group the Association for the Cannabinoid Industry (ACI).
Moore was speaking during a press conference held to announce the launch of the CBD list last week.
Compiled by UK regulator, the Food Standards Agency (FSA), in collaboration with ACI, the list features around 3,500 products containing CBD that have been given a green light to remain on shelves (both physical and virtual) in the UK’s constituent countries of England and Wales.
- These products, which were already available to buy in the UK, are allowed to remain on sale to the general public in England and Wales in line with the UK’s new novel foods regulations, which have been adopted following its 2020 exit from the EU.
- Any products that do not appear on the CBD list can no longer be sold, and vendors continuing to offer them for sale could face penalties.
- However, these products may still be submitted for authorization under the FSA’s novel foods approval process — alongside new products — and as such, might return to the market in the future if successful.
- A separate regulatory process is being established in Scotland; while Northern Ireland remains within the jurisdiction of the EU’s novel foods regime, which is yet to approve any CBD-based food supplements.
ACI has launched a searchable online version of the CBD list.
How it works:
ACI describes inclusion on the CBD list as “a key stage on the path to full authorization, [which is] expected in 2023.”
- Suppliers of CBD products on sale in England and Wales on or before 13 February 2020 were required to submit an application for assessment by FSA with a deadline of 31 March 2021.
- Suppliers whose application dossiers were subsequently assessed to preliminarily meet FSA’s novel food standards have had their products added to the CBD list, which means they can remain on sale while they await full authorization.
- CBD products that entered the market after 13 February 2020, or that failed to submit an application before the deadline, must be removed from sale until such a time that they obtain FSA authorization.
- Having a product added to the list “means you have submitted all the required information as per your dossier, and it has been accepted by the regulators. But that doesn’t mean it has been authorized,” explained Parveen Bhatarah, ACI’s regulatory and compliance lead, who was speaking at the launch event. “All the information you’ve submitted has to be risk assessed; only then the authorization will take place and [as it involves toxicology investigations] that’s why it will take [over a year].”
By the numbers:
- Around 900 applications were submitted before the deadline
- Of those, 71 progressed, leading to 3,500-plus products being added to the CBD list
- 680 applications were rejected
- 42 applications were self-withdrawn by companies that no longer wished to proceed
Why it matters:
Speaking at the CBD list launch event, Moore said the implementation of the regulatory framework will “de-risk” CBD for producers, retailers, consumers, and investors.
“I’ve been speaking to a lot of investors over the last three to four months, and I think they are of the view they needed the reassurances they got today from the FSA in order to continue investing in this category,” he said.
While regulation has led to the immediate prohibition of hundreds of CBD products, it will arguably fuel further innovation in the space as the compliance guide rails become clearer.
“It’s an important milestone, and there’s a group of companies now that can [work further] on their product portfolios,” Moore said. “I think the peak year for innovation will be end-2023, early 2024 [as full regulatory clearance kicks in] and then we’ll see the entry of the big FMCG companies as well.”
Bhatarah added: “FSA’s commitment to regulate this as a novel food before any other national regulator marks the UK’s leading role in cannabinoids globally. We are now at the start of that journey, which is great news for the UK.”
On background:
CBD is one of the cannabinoids – a group of compounds found in cannabis which have a range of effects on the human body when consumed.
It is widely believed to have health and wellness applications, and as a result has increasingly been incorporated into food and beverage products — and dietary supplements — in recent years as the legal environment around cannabis has relaxed across multiple jurisdictions. The legality and regulation of CBD — which by itself does not appear to be psychotropic, but often appears in products alongside other, illegal cannabinoids — remains a gray area in much of the world.
There is some evidence to suggest that CBD has anti-anxiety and anti-psychotic effects, as well as analgesic properties, possible applications in the treatment of movement disorders, and the ability to manage appetite; but none of this is clearly understood, and is still subject to scientific investigation.
CBD can be naturally extracted from the cannabis plant, or produced synthetically through methods such as microbial fermentation – an approach being pioneered by companies such as Purissima in the US [disclosure: AFN‘s parent company, AgFunder, is an investor in Purissima.]
The UK legalized CBD and several closely-related cannabinoids — with certain conditions — in 2018.
Annual sales of UK consumer CBD products hit an estimated £690 million ($898 million) in 2021, according to ACI – likely making it the world’s second largest CBD market after the US.
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