In a January letter to the Advisory Council for the Misuse of Drugs (ACMD) the Home Office Minister Kit Malthouse asked it to determine a safe level of trace THC and other psychoactive cannabis compounds in retail CBD products. With the current THC level set at one milligram (1mg) – equivalent to a speck of dust – per closed container (no matter what size) the fast-growing industry is hoping for clear guidelines and subsequent regulatory certainty. However, the new proposals which recommend permitted THC levels – and its acid precursors – in a ‘single serving’ of 50 micrograms (50mcg) have been criticised for being ‘too low’. Perhaps the key concern emerging from the industry is that to achieve these levels of THC, CBD isolates will come to dominate the market. The ACMD has acknowledged some testing facilities may not be able to perform robustly enough to determine such minute levels of THC and so it has called for a review of the UK testing regime. However, recommendations to remove consumer CBD products from the Misuse of Drugs Act have been warmly welcomed. And the proposals have been welcomed for aiming to bring some much-needed clarity to the industry. Why A 50mcg Limit? In determining this limit the ACMD says its working group scoured research literature and concluded ‘that a ∆9-THC (Delta 9 THC) dose of 1 milligram (mg) was unlikely to produce significant psychoactive effects’. It then applied two additional uncertainty factors to account for differences in ‘age and body size’ and a second to take account of ‘variations in concurrent use of more than one product’. And, this brings the recommended level down to 50mcg – or 0.05mg. If an average adult – weight 70 kgs – is taken into the equation, the acceptable single dose intake of THC is then 0.714mcg per kg of body weight (mcg/kg/bw). However, this is cautious in comparison to Canada, for example, where this level is 14mcg/kg/bw, whilst EIHA is asking Europe to raise its level from 1mcg to 7mcg/kg/bw. Isolates To Dominate In order for the industry to adhere to such a level then the ACMD says on p20 of its report: “These typical limits are feasible for industry to achieve using an isolate containing 0.03% ∆9-THC – as a percentage of CBD content – with the appropriate level of dilution.” Product Weight Complications The ACMD acknowledges that setting a weight limit for THC has its disadvantages in relation to the different type of consumer products.. It says: “Producers of products for which a single serving is of low weight – oils, capsules – would therefore have to use initial CBD isolate of higher purity, with lower levels of ∆9-THC, than producers of products where the single serving is of higher weight – chocolate bar, drinks – and it highlights the ‘significant financial implications ’this would have But concludes: “Setting a level for controlled phyto-cannabinoids that would apply to all consumer CBD products has the advantage of being the simplest to do in legislation.” Testing Capabilities Concerns had been raised over the capability of testing labs to detect THC at minuscule levels, as reported by BusinessCann earlier. The ACMD recommends that laboratories assessing compliance should be accredited to the ISO standard 17025:2017 and producers should use laboratories which hold that accreditation to perform their quality assessment testing. It also says that tests on CBD products should be performed by the Defence Science and Technology Laboratory two years after the implementation of the regulations to check the level of compliance. Law Changes And Novel Food The ACMD has also responded to concerns over the status of consumer CBD products within the Misuse of Drugs Regulations 2001. This had become an issue for the industry when the Policing Minister’s letter was first published as BusinessCann reported at the time. In order to achieve this it has recommended changing the wording of the legislation so as to ‘unambiguously exclude consumer products and any products intended for human consumer other than in scientific research’. The UK CBD industry is currently being funnelled through the Novel Food process by the Food Standards Agency which has seen many in the industry express concerns that full-plant extract CBD and hemp oil will be excluded from the consumer market, once implemented. These recommendations will only serve to fuel these concerns. Long-standing cannabis advocate Peter Reynolds, of industry body CannaPro, has been contesting the Novel Food process for some time, he dismissed this latest ‘regulatory overreach’ saying: “The market will continue as it wishes and it is less controlled now than it was. Nobody cares anymore. “It’s a free for all. Say what you want about your product, whether you’re a conman or honest, there’s no rules. No one cares.” What Happens Next? The ACMD report has been passed to the Home Office and it will now look to enact a legal framework for consumer CBD products Industry Reaction Stuart McKenzie, CEO Reakiro said: “It’s a good move forward for the industry, the recommendations are good. The more clarity for the industry the better. “It’s a good starting point; it sets a standard for the industry and we can lobby from there, the indecisiveness over THC standards and the Novel Food process is currently holding the industry back. “The main retailers are still waiting for clarity, and this is just not helping the industry. Anything like this is good, its shows how far the industry has come and that these products are not going to be pulled off the shelves, “While we would like full spectrum extracts – if goes down this route it is not great – but it is something we have to learn to live with. This is part of the solution, but not the whole solution. Overall its a positive step forward for the industry. Richard Lindup, Chief Legal Officer, Always Pure Organics The report is of considerable interest to us. The ACMD’s aim was to identify the levels of controlled drugs in consumer CBD products that have psychoactive effects and recommend appropriate limits. Having also made our own submission to the ACMD, we are pleased that it has looked at this issue in considerable detail, and has consulted the industry, the police and other bodies. The ACMD’s role is to give Ministers advice on measures that ‘ought to be taken’. It is our view that the legislative changes recommended by the ACMD should provide greater clarity, which is much needed and long overdue. We hope therefore that they will be implemented promptly, for the benefit of society and the industry. The ACMD makes some important points, including: -that the legal threshold of controlled drugs in consumer CBD products is wrongly believed by many people to be 0.2%; -that consumers are unlikely to use CBD products to achieve psychoactive effects, because of their low level of ∆9-THC and even lower levels of other phytocannabinoids; -the confusion resulting from the common industry method of expressing content levels; -that testing methods, which are crucial to determining the legality of products, vary widely, causing uncertainty. The report focuses attention primarily on ∆9-THC, because the potency of other phytocannabinoids is much lower or, in the case of ∆8-THC, unknown. The format of the legal limit is as important as the limit itself. The ACMD rejects both a single level for all consumer CBD products and a percentage of CBD content as impracticable. Instead it recommends that different levels be set for different CBD products, recognising that the amount of a product a person uses on a single occasion – a ‘unit of consumption’ – depends on the type of product. The report cites three examples of a typical ‘serving: 0.45 grammes of oil; a drink, 524 g, and a chocolate bar 100g. Setting ∆9-THC levels by weight as a percentage of the weight of the product would be better than as a percentage of CBD content. We agree. That this approach would future-proof legislation is obviously an advantage. The ACMD propose that 1mg should be set as the amount below which ∆9-THC would be likely to cause psychoactive effects. It makes two mathematical adjustments to reach its recommended level: a factor of 10 to take account of differences in age, body size and individual variation in response, and then by halving that figure to take account of variations in use or concurrent use of more than one product. The report does not explain the reasons for choosing these particular factors. The resulting legal limit recommended by the ACMD is 50mcg of each phytocannabinoid per unit of consumption. Testing methods are obviously crucial in determining the legality of consumer products. The ACMD found wide variations in methods, leading to uncertainty and confusion, and therefore made two recommendations: that the Home Office commissions a ring trial to determine the capability of laboratories to detect the levels of controlled drugs in consumer products; and that the development of more accurate testing for controlled phytocannabinoids be supported to allow testing capabilities to develop (i.e. improve). The ACMD adds that the analytical methods used should be accredited to ISO 17025:2017 to ensure the validation of methods, quality control and independent assessment of testing methods. We agree with these recommendations for the reasons given by the ACMD. Steve Oliver & Matt Lawson – The Canna Consultants Matt Lawson: Are CBD Products Exempt Under the MDA? For years we at The Canna Consultants have witnessed ‘market leaders’ and ‘legal experts’ making pronouncements about the existence and applicability of what are variously described as the ‘0.2% rule’ and the “1mg rule”, concerning the permissible THC content in cannabinoid products. The ACMD’s assessment is the same as ours at TCC has always been: The first limb is being interpreted still to be met if the controlled drug is present as an impurity, rather than a major intended component, within a preparation or product intended for administration to a human being. This ambiguity has allowed the exempt product definition to be used for consumer CBD products. The ACMD recommends changing the first limb of exempt product definition to refer to the ‘preparation or other product containing the controlled drug’ rather than the ‘controlled drug’. Steve Oliver: Controlled Cannabinoid Levels While we acknowledge that the ACMD’s recommendation that an acceptable level of each Controlled Cannabinoid is 50mcg ‘per unit of consumption’ (where a unit of consumption or ‘single serving’ is the typical quantity of a CBD product consumed on one occasion) is the full answer to what the ACMD was asked, it is – in reality – only half the answer to the question. What the ACMD have not said anything about is the aggregate weight of Controlled Cannabinoids within a consumer product (lets call it a Retail Unit). The 50mcg per Consumption Unit cannot be a measure of what is permitted on the shelves vis-à-vis the Retail Unit because in order to pivot from being a ‘CBD Company’ to a ‘THC Company’ all a manufacture would need to do is: -define its “Consumption Unit” as being 1 drop (which is typically 0.05ml); and, -utilise a strain in which the extraction contains 50mcg THC per 0.05ml of the end product. -In so doing, every 10ml bottle of their CBD product would contain 10mg of THC (50mcg/drop x 200 drop), a 20ml bottle would contain 20mg THC and so on. To put this in context, academic reports identify 5mg THC as being a dose at which mild psychoactive effects are produced, similar to a standard unit of alcohol. In Washington State, where Adult-Use THC products are lawful, manufacturers sell 10mg THC products with the intention of getting the user ‘high’. Matt Lawson: The real answer will not come from the ACMD, but from Abuse Liability Assessments and Drug Policy, because (on the assumption that the 50mcg recommendation will be accepted in the terms in which it is offered), the question really is: What weight of Controlled Cannabinoids will the Government be comfortable with in a single Retail Unit?