EUROPE’S largest ever trial designed to establish the safety of CBD products has been announced with 15 participating companies.
The trial, which has been organised by the Association for the Cannabinoid Industry (ACI), will involve toxicity tests on rodents – most probably rats – and will cost up to £1m.
With the Novel Food Validation deadline date of March 31, 2021, approaching, the research is designed to assure UK regulators, the Food Standards Agency, of the safety of the CBD products of the participating companies.
A Need For Safety Data
Steve Moore, of the ACI, told an online press conference: “It’s been clear since CBD has been designated a Novel Food last year that there is a need for more safety data and this must come from this emerging industry.
“This study will help fill the missing gaps in the key toxicology data.”
The 15 companies involved in the consortium include a number of UK firms and some North American companies such as Columbia Care and Gencanna.
The full list is a follows:
- B3 Labs
- Britannia Bud
- CBD Capital
- Echo Pharmaceuticals
- Herbotany Health
- iX Syrinx
- Jersey Hemp
- MGS Pure Extracts
- Sativa Group
- The House of Green
- Vana Labs
- Columbia Care
Noticeable absentees including Mile High Labs, which is still listed as a member of the ACI. The ACI has previously said the initiative will cost between £300,000 and £1m
Fewer CBD Companies In The Market
In February this year the FSA registered concerns over the safety of CBD with its scientific advisers – Committee on Toxicity – highlighting concerns over potential drowsiness, liver toxicity and drug interactions.
Moyra Cosgrove, Head of Nutrition & External Affairs, Naturecan, said: “The starting point of this process is the safety of the customer, that has to come first.
“Increasing consumer confidence is key to growing the CBD customer base and this can be achieved by the process. Some companies will clearly fall by the wayside and won’t go through this process, and this means there will be more business opportunities for the ethical companies who have secured their licences.”
Nick Clarkson, Chief Scientific Officer of the Sativa Group, said: “Because of the scale of the work that is needed in relation to toxicology, we find this consortium is the most cost-effective approach.”
Broad Spectrum CBD To Be Used In Trial
Dr Parveen Bhatarah, Head of Regulation and Compliance, ACI, said the product that would be taken forward as the base ingredient for the trials would be a broad spectrum one, and following initial tests, one product from the 15 companies would be taken forward into the study.
Paul Duffy, Toxicology Adviser to the ACI, said discussions were taking place with the FSA as to the level of variance that would be allowed from the base ingredient chosen for the rodent tests.
Mark Bowes-Cavanagh, Managing Director of Advanced Development and Safety Laboratories (ADSL), who will be co-ordinating the tests, said it was initially working on a 5% variance in cannabinoid profile.
Mr Duffy went on to say that for individual brands and products, separate analysis would be provided by ADSL on the bioavailability and ADME (absorption, distribution, metabolism, and excretion) data of different delivery mechanisms – such as oils or tinctures – and, where applicable, this would also include data on how various flavourings can effect bioavailability.
Mr Moore added: “No other country has provided the clear regulatory framework for compliance that exists in the UK. The safety information generated in this study will respond to future demands of regulatory authorities in the US and EU.”
In the US, as BusinessCann has reported, human trials have begun to establish the safety of CBD with its regulators the Food and Drug Administration registering similar safety concerns to the FSA.