EIHA’S RUDE AWAKENING
BAD NEWS WAS ALWAYS COMING FOR EIHA CONSORTIUM MEMBERS
For many, many months now we at The Canna Consultants have we have repeatedly informed market participants that those who had subscribed to the EIHA Toxicology Consortium were going to get a Rude Awakening – ever since we saw that the products which would be covered by the toxicology submission would be limited to a CBD strength of 10% and would only be Hemp Oil tinctures.
We were repeatedly told by Brands who had happily handed over their case to ensure their longer-term advancement that that wasn’t the case and that it couldn’t have been the case because, were it to have been the case, then it would undoubtedly have been a material disclosure required to be made before EIHA banked the cheque for the Brand’s entry to the consortium, or accepted the Direct Debit instruction for the Subscription.
We make no comment about whether it was a required material disclosure (although we expect that there will be a few law firms who will be agreeing that it was, and that the failure to mention it gives a cause of action to the aggrieved party), but we would certainly consider it to be an expected disclosure – how could it not be you may ask in unison with us?
If only that were the only shock coming to EIHA consortium members (and to the rest of the CBD industry given the nature of what we can now disclose).
A GOOD DAY TO BURY BAD NEWS
There is an art in Public Relations in which the publisher seeks to hide their own bad news on a day when people’s attention is directed elsewhere. Members of the EIHA Toxicology Consortium will be forgiven if their attention is diverted away from the bad news that we have identified above, however, it only gets worse for them because the more fundamental news is not unconnected, but at the heart of the CBD industry – and the likely futures of their respective businesses.
That is because EIHA has dropped the even bigger bombshell to the members of its Toxicology Consortium that their toxicology submission will only support the case for safety to a maximum daily ingestible amount of 17.5mg CBD. The EIHA document of which we have had sight asserts that this is not “new information” but a matter which has been raised repeatedly with members since June of this year, however, given the exposure that we have to those members – they appear to have a different recollection of what was said over that time, and they are somewhat shocked.
THE SUITABLILITY FOR SALE OF PRODUCTS RELYING ON THE EIHA TOXICOLOGY DATA AND THEIR CONTINUED PRESENCE ON THE UK FSA “PUBLIC LIST OF CBD PRODUCTS”
The change in EIHA’s advised maximum daily intake for which safety can be established from 70mg to 17.5mg CBD represents a 400% reduction in that presently quoted by the UK Food Standards Agency.
As the regulator in the UK, the FSA has thus far been in a position that it did not know what the maximum safe level of CBD ingestion was, but recommended 70mg per adult per day. Now however, it is overtly aware that the Applicant in respect of the RP 427 Dossier itself asserts that safety for the CBD which is the subject of application RP 427 cannot be established above 17.5mg per day – it is an open declaration to the regulator which the regulator, in our opinion, cannot and should not ignore.
In our view, this mow means that every product which is included within the UK FSA Public List of CBD Products and which is linked to Dossier RP 427 must now be reconsidered for the suitability of its continued inclusion in that list because the toxicology data and Dossier as submitted:
- will not support safe usage at anything above 17.5mg CBD per day;
- will not support any product other than a Hemp Oil Tincture; and,
- will not support that Hemp Oil Tincture which is at a strength greater than 10%.
We suggest that to do anything else risks the regulator being complicit in the exposure of the population to product which are unlawful per se and which the applicant openly acknowledges that it cannot establish a safety case for usage in excess of 17.5mg per day.
DRASTIC INFORMATION REQUIRES DRASTIC CHANGES
Furthermore, EIHA indicate that members must change the product labelling on their products to reflect the maximum safe intake of 17.5mg CBD per day and that the product of “not to be taken with meals”.
It will be a question for the risk appetite of all of the EIHA members as to how swiftly they make such amendments and whether they permit their current products (which mostly reference an acceptable daily dose of 70mg CBD per day) to remain on sale, given that they are now overtly aware that the very entity which commissioned the toxicology study is positively informing them that a dose in excess of 17.5mg CBD per day is not to be regarded as safe.
THIS HAS FAR WIDER IMPACT THAN SIMPLY THE EIHA APPLICATIONS
While it may be the case that EIHA has stared this “Hare running”, it will not simply be their own applications which are impacted by it – the repercussions will spread to every single application that has been made, both to the UK FSA and the EU Commission.
The reality is that most of the CBD Isolate applications that we have seen are for ingredients which have a CBD purity in excess of 98% and, while it is for every applicant to establish the case for safety of their own ingredient at their individual discrete level, the regulatory scientists cannot fail but be influenced by the knowledge gained from one Dossier when considering the next – because the science is universal.
THERE IS STRENGTH IN NUMBERS, BUT ALSO FAILURE IN NUMBERS AND THERE IS NO GREATER SAFETY THAN INDEPENDANCE
When watching “Blue Planet” I find myself looking for the outsider, the one who does not follow the crowd, the one who is willing to be different and has the strength and fortitude to make the hard decision of independence, knowing that the future may be more lonely, but that it will the future that itself wishes, not that which it is forced to follow.
It is with that thought when we see a shoal of fish bundles tightly in a ball, each of the swirling around, not knowing what they are doing or why, unable to see anything other than they immediately neighbour doing exactly that which they are doing. We then see a large whale swimming towards the shoal, mouth gaped open and oblivious to the individual fish, but concentrating on the collective. Then the shoal is no more, simply a historic collective now inside the belly of the whale.
In August of this year we at The Canna Consultants submitted independently-commissioned Toxicology Study data to the UK FSA in respect of client applications and within that data our Toxicology Consultants at DevelRx were able to establish a clear safety case for consumption. No doubt ourselves and others who have been able to present a similar safety case will be provided with the premise which underlies EIHA’s limitations and be asked to comment thereon in respect of our own applications.
At The Canna Consultants we believe that ourselves and DevelRx will be able to address any concerns that may be raised, because of our ability to directly access all of the data from the commissioned study – something which the Brands directly impacted by EIHA’s decision will not be able to do because EIHA has intentionally ring-fenced access to the data and has ensured that only it has complete control.
THE REGULATORY ROLLER-COASTER
As a worldwide regulatory consultancy we support businesses in all areas of the regulated cannabis industry and also governments who seek to apply that regulation, as a result of which we have access to a wider platform of data than many market participants, associations, trade bodies, and many governments as well.
There will be some whose knee-jerk reaction is that this sounds the Death Knell for the Cannabinoid Wellness Industry and with that we cannot agree. EIHA’s position is yet another bump in the regulatory road, but one which is founded on a very limited amount of data from a study commissioned by a single entity (albeit one which does not lack for confidence or a sense of its own importance), and we believe that there is a far greater and wider gamut of evidence which supports safety at a considerably higher daily ingestion level.
In the regulatory field the three greatest assets are knowledge, time and hindsight. In our experience many involved seek to use the latter two to claim a manifestation of the former – at The Canna Consultants we like to call it in real time.
Remember what we always say: Be Careful Who You Listen To.
