THE world’s first large-scale rodent trial to demonstrate the safety of retail CBD products is set to start within weeks – and could help set global industry benchmarks for many years to come.
Fifteen companies have so far agreed to share the cost, upwards of £500,000, with doses of a broad spectrum distillate to be given to scores of rats over a 90-day period.
Taking place in a UK laboratory the aim is to satisfy UK regulators the Food Standards Agency (FSA) that CBD is safe.
This follows guidance from the FSA that the toxicology data generated by the 15-company consortium could be ‘scientifically acceptable’ in an application for a UK Novel Food Authorisation.
Study Is ‘Scientifically Justified’
It’s been a tortuous journey recently for the global industry, but with other jurisdictions also mulling CBD’s safety this tangible move offers the UK an opportunity to establish a lead.
The consortium approach was first floated by the UK Association for the Cannabinoid Industry (ACI) in June.
However, concerns were raised whether the data generated by this study – which will use a broad spectrum distillate of one consortium member – would be transferable to the remaining 14.
Some clarity was provided late last month when the FSA’s advisers; The Advisory Committee on Novel Foods And Processes (ACNFP), issued this guidance
“A shared package of toxicology studies would be acceptable in circumstances that could be scientifically justified.”
This could clear the way for all consortium members to use the toxicology data from the rodent trial in their own applications for a Novel Food authorisation – which the FSA will require for any CBD product to remain on sale in the UK.
‘Each Product Will Be Different’
For white-label ingredient suppliers such an approval will provide the foundation to support Novel Food compliance for their downstream brands.
For ACI brand consortium members such as the Sativa Wellness Group it will need to undertake further bridging studies demonstrating the bioavailability and ADME (Absorption, Distribution, Metabolism and Excretion) profile for each individual CBD product.
The ACNFP says in its guidance: “Each Product will be different.”
And continues: “The applicants know the details of their product and the onus is on them to be able to scientifically-justify the information they have provided.
“Each CBD Ingredient will require analytical data including an impurity profile, cannabinoids etc. Data will also need to be provided on the bioavailability of the ingredient in any proposed food matrices or carrier oils.”
One brand, unconnected with the consortium, shed some light on how it was approaching this in a conversation with BusinessCann.
It explained that it would be submitting four novel food applications for its eight oils and capsule products to cover different flavourings.
Potential Isolate And Broad Spectrum Benchmarks
Dr Parveen Bhatarah, the ACI’s Head of Regulation and Compliance, joined the CBD industry from the pharmaceutical one, and has been on something of a personal journey.
She told BusinessCann that she had been initially uncomfortable with such an approach but had come to the conclusion, following talks with the CBD industry, that there is a ‘reasonable scientific justification’.
She said the ACI had proposed four SKUs for the toxicology tests but member’s preferences mean initially there will be only two; a broad spectrum and a CBD isolate.
Dr Bhatarah said the consortium members are looking at a minimum CBD content of 98% for the isolate, but the broad spectrum was proving ‘more challenging’.
Nevertheless, this will be defined before the trial begins with members looking at a minimum of 80 to 85% of CBD, with annotated levels of additional non-psychoactive and psychoactive cannabinoids and other compounds.
“With a product from a plant materials, there are risk factors,” she said.
Dr Bhatarah believes this ACI’s work is vital in determining future parameters for the global CBD industry.
She said: “This is a significant task we have undertaken. We are setting the foundation for the CBD industry.
“While these terms have been used by the CBD industry, for some time; as a scientist; isolate? broad spectrum? they do not mean anything to me.
“What levels of CBD do they contain? The boundaries haven’t been defined, they haven’t been set and they need to be.”
There Are Still Some Uncertainties
However, there is still some uncertainty over the consortium approach and this is centred around the chosen ingredient for the trial.
Will the FSA be satisfied that the individual test ingredient is sufficiently comparable to that of the other consortium members?
On this, the ACNFP says: “Members generally consider that separate applications should be submitted for each product, but they could share study data and evidence between them if the use of such data can be scientifically justified.”
Paul Duffy, Toxicology Adviser to the ACI, elaborated: “If we pick the right samples for the toxicology studies we are confident we can make a justification to the FSA on why that is a suitable evaluation for all of the other products.
“Our aim is to cover the content of other products with a toxicology evaluation on the primary product in the study. Any additional work that goes into the final products is down to the individual companies in the consortium.
“There are no guarantees. The FSA has said there are no guarantees until it has seen the data. But we are confident our plan will meet most of their needs.”
The ACI is in the process of determining which member’s ingredient will be taken forward as the basis for the trial, and says it is confident this will be ‘sufficiently comparable’ to that of all of the other members.
Where Does This Leave Us?
The ACNPF met in September and as well as discussing the transferability of toxicology data it also analysed two Novel Food applications and identified many widespread issues. See here.
Nevertheless, for those members of the consortium who are able to provide the toxicology data required by the FSA this should speed up the process of securing a Novel Food Authorisation in 2021.
Where does this leave the rest of the industry? The European Industrial Hemp Association is working on a similar consortium approach and has submitted an application for a CBD isolate.
While the FSA has said it does not need to have any toxicology trial data before next March’s deadline, it does need to know how this will be secured.
This still leaves five months for the hundreds of other CBD market participants to determine a suitable way forward and alternative paths are being investigated by other industry participants.
However, it looks as though efforts to secure a Novel Food Authorisation using ‘desktop data’ may not be enough.
Will there be more rodent safety studies? With the two consortia’s data likely to be exclusive to their participants then the answer is probably, yes.
Background To This Story
In 2018 the World Health Organisation described CBD as ‘being well tolerated with a good safety profile’.
However, a kick-back began 18 months when first the US Food & Drug Administration said CBD posed ‘real risks’ to human health.
And, in February this year the FSA changed its stance from saying CBD is safe to registering concerns over a number of issues including its impact on the liver, pregnant women and breast-feeding mums.
It also set a daily recommended dose of 70mg of CBD a day – equivalent to one mg per kilogram of body weight. Both of these regulatory interventions were related to data from studies by UK firm GW Pharmaceuticals makers of the CBD drug Epidyolex, which showed negative effects on mice at doses of over 600mg per kg.
Here in the UK, the FSA informed the industry that it needs to produce its own toxicology data to demonstrate that CBD is safe and that will be required to remain on the market.
The FSA has set a date of March 31, next year, for companies to submit Novel Food applications, which will allow them to do so.
@Update: This story initially reported that a broad spectrum distillate and a CBD isolate would be used in the trials. The ACI has subsequently asked us to clarify this, saying the trial will only use a ‘broad-spectrum distillate for the rodent study and read across the data for the isolate dossier and related finished products, provided finished product input matches the specifications set as per our pre-tox report, after reviewing all of the samples’ test results’.