Collateral Damage to the Whole of the UK CBD Industry From one Consortium's Poor Study - The Canna Consultants

THE WHOLE OF THE UK CBD INDUSTRY SUFFERS THE COLLATERAL DAMAGE CAUSED BY ONE CONSORTIUM’S POORLY DESIGNED STUDY

In November 2022 we published two Position Papers analysing what we considered to be the inevitable consequences of EIHA’s the submission to the FSA of toxicology data which was unable to establish the safety of CBD intake in excess of 17.5mg per day. The two Papers are EIHA’s Rude Awakening, published on 8/11/22 and Consequences of EIHA’s Isolate Toxicology Submission, published on 10/11/22.

Observers will note that in the former of those Papers we make the following observation (page 3 for any doubters):

“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.”

Remember the mantra that one shouldn’t shoot the messenger, because the delivery of the message does not mean that the messenger desires the outcome of the message – they are simply identifying the inevitable consequences that are to come.

And so it is, it has taken 11 months, but what we said was an inevitable consequence of EIHA’s actions has now been reaped upon everyone in the UK CBD market.

FSA’S REDUCTION IN THE RECOMMENDED CBD DAILY INTAKE FROM 70mg PER DAY TO 10mg

As we observed 11 months ago, when regulatory scientists are provided with data by an applicant who asserts the quality and accuracy of the data, then they cannot fail but act upon it. It is to be noted that we do not criticize the FSA for acting upon the data with which they have been provided – what else can they do?

What we do criticize is the design of a study which had insufficient layering of test levels such that it was necessary to fall all the way to the lowest test point at 17.– they didn’t have any gaps in between to salvage the results at any higher level than 17.5mg per day. No parachute always equals a hard landing. So we ask again: “Was this incompetence or cost saving”?

IT IS CLEAR TO US WHERE RESPONSIBILITY LIES

There is no doubt in our minds that those responsible for this dagger-blow to the whole of the UK industry will blame the FSA, citing their reduction of the 17.5mg per day level down to 10mg, but this is a smokescreen for their own liability and seeks to blame the Scorpion (of “The Frog and the Scorpion” ilk) for being what it is.

Regulatory scientists are by their very nature risk averse – public safety is the number one priority and caution (and often over-caution) is their natural home – and when provided with data which shouts “we can’t establish safety at your current level of 70mg per day, but only at 17.5mg per day” will inevitably result in those same scientists thinking “we were not cautious enough, we better make sure that we err on the side of caution this time”. And so, they have done.

The appalling representation by self-proclaimed industry leaders (and it’s not just EIHA) should once and for all be called into question. Even the industry and food publications which refused to acknowledge the warnings of 11 months ago must share some blame – a paid-for editorial is as (un)reliable as a quick Google search. Those still in the industry are wising up – they have paid, and continue to pay, the price for having listened to the wrong mouthpieces, simply because they were the loudest, or the most well-funded, or had the most members or were European.

INCREASING THE LEVEL IS POSSIBLE OVER TIME, BUT ITS LIKE A GOLF HANDICAP

The FSA’s position is that they will keep the recommended daily limit under review as they continue to receive more toxicology data as part of the Novel Food applications which they are assessing, there will be no swift reversals.

The industry should accept that this will be the applicable figure for years to come. Those who play golf will be aware that your handicap plummets on the back of one round, a single piece of data and takes an absolute age to increase – and no matter how much data you supply to demonstrate that the one low figure is an aberration and completely out of kilter with all of the other data that can be provided, it still creeps up glacially slowly.

No TCC clients subscribed to any Trade Association collegiate toxicology studies and, as a result, are insulated from the worst direct long-term effects of those who did. We have no doubt that the data that they each independently hold (and which did not result in multiple replicate studies) will provide them with long-term insulation against the 17.5mg debacle, however, in the meantime the whole of the industry will pay the price for what might be considered the arrogance of a self-styled “leader”.

WHAT OF THE PRODUCTS ON THE PUBLIC LIST?

Clearly, tinctures and other multi-dose products which are in the UK Public List will need to change their dosage instructions and we believe that the manufacturers will be given time to implement that change.

We are also informed that single-unit consumption products will be invited to reduce their strength to bring them in line with the FSA’s new recommendation, and that doing so will not fall foul of the FSA’s “new to market” policy (which you know from multiple previous Papers is a policy which we disagree with). Again, we understand that time will be allowed for such changes to flow through the supply-chain system.

WILL RETAILERS ACCEPT LITIGATION RISK?

The creation of the Public List was sufficient to cause many regulatory compliant retailers to be willing to stock products which are, but the very nature, inherently unlawful. The position now created is murkier – the FSA is not banning products which have greater than 10mg of CBD in a single serving, but it is advising consumers against their use. This means that retailers of such products are now faced with a dilemma – stock something which is not only unlawful (which has a quasi “get out of jail free” card with it), but something which the food safety regulator says is potentially harmful to the consumer in the dosage at which it is being sold by the retailer.

• We note that one CBD drink, which last year took in £10 million of other people’s money to fund expansion has 15mg CBD per can and one of their competitors, who has recently announced their inclusion in a high-end supermarket’s “Meal Deal” has 30mg CBD per can. Will consumers see the same value in these products (and their premium prices) when they have 2/3 or 1/3 of the CBD content?
• Will those that are selling many 1000’s of mg in a tincture need to re-start their stability studies (or for many who have never been advised that they need to undertake their own product stability studies in the first place, commence stability studies) – why, because 20,000mg that we have seen will, at the new recommendation, need to last 6 years?

If retailers continue to sell single-use products which breach the FSA’s recommended daily safety limit, then they as the retailer are exposed to any Consumer Safety litigation risk (from the Consumer, not the Regulator) for the period that they do so.

Now, any reader of this document will appreciate that the actual health risk to consuming 10mg or 30mg or 70mg per day of CBD is less than negligible, but reality has nothing to do with the perception of litigation risk that may be held by the legal departments of these retailers or, more pertinently, by the legal and underwriting departments of the insurers of those retailers.

The ripples started 11 months ago when EIHA dropped their unhelpful stone into their own little pond, but all of these ponds are interlinked, and their ripples are now disturbing the waters in everyone else’s pond as well.

THERE ARE MORE ISSUES STILL TO TACKLE, BUT THE INDUSTRY IS STILL HERE AND IT WILL THRIVE IN DUE COURSE

There is good news, however, and it is that the UK has a CBD industry – in parts of Europe (Italy) CBD products are being re-classified as narcotics but, not unsurprisingly with the Italian system, that decision was halted before it was even implemented and is now being re-considered.

A change to the law to define the permissible contaminant levels of controlled cannabinoids is a topic that we have been forthright upon for many years (we won’t bore you with the multiple Papers that we have written on it, but they are all available within our Position Papers) – suffice to say that there isn’t a “1mg rule”, there never has been a “1mg rule” and that the permitted levels of controlled cannabinoids is currently zero.

From our engagement with the relevant authorities across the whole of the TCC business sectors (Home Office, FSA, MHRA) it is clear to us that there is a willingness to implement change to the “Controlled Position” and the Home Office are aware that this impacts upon the ability of the FSA to Authorise any CBD products as we move forwards (a product cannot be a food if the law defines it as a drug). As with all matters governmental, priorities ebb and flow and the Controlled Position is one which has, over the last few years, ebbed and flowed more than most – but we have sensed an appetite to make progress from those who might previously have been described as apathetic for such advancement.

We would suggest that what is needed by those who are in the UK market, is for them to stop listening to those “leaders” to whom we have referred within this document and, perhaps, to take greater heed to those – like TCC if we may say so – who have been consistent, credible and steadfast throughout about what the industry needs to flourish, how we believe that that is best achieved and how we believe that we can assist companies to do so.

Don’t shoot the messenger….

Remember what we always say: Be Careful Who You Listen To.