A SURPRISING ABOUT-TURN IN HOME OFFICE POLICY IN RESPECT OF “EXEMPT PRODUCTS” UNDER THE MISUSE OF DRUGS REGULATIONS
THE PREVIOUS POSITION OF THE HOME OFFICE ON THE INTERPRETATION OF THE DEFINITION OF “EXEMPT PRODUCT” WITHIN THE MISUSE OF DRUGS REGULATIONS 2001
Until this point the Home Office has had a clear policy in respect of the interpretation of the three criteria to qualify as an “Exempt Product” under the MDR 2001.
That policy was that ingestible CBD products which contain any amount of controlled cannabinoids (such as THC) failed Limb (a) of the three-limbed test within the definition of Exempt Products within the MDR 2001 because:
- the product as a whole is designed for ingestion; and,
- the greater includes the lesser, irrespective of whether one has a positive desire for the lesser to be there, or indeed a positive desire that it were not there.
Thus, they considered that once established that an ingestible CBD product contained controlled cannabinoids – at any level – then the law as currently defined meant that the product failed Limb (a).
THE RECOMMENDATIONS OF THE ADVISORY COMMITTEE ON THE MISUSE OF DRUGS SUPPORTED THE HOME OFFICE ANALYSIS
The conclusions of the ACMD were published in December 2021. In explaining those conclusions, the ACMD stated:
“The first limb [i.e. Limb (a)] is being interpreted still to be met if the controlled drug is present as an impurity, rather than a major intended component, within the 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 definition was designed for diagnostic purposes and so could be better designed for scientific use. For example, to permit its application for other scientific purposes, such as the supply of small quantities of controlled drugs to act as reference materials to support forensic and toxicological analysis.
The ACMD, having concluded that the current exemption definition was being mis-interpreted, they recommended a specific pathway for ingestible CBD products which included, amongst other things:
(i) That it would be appropriate to set specific limits for the content of ∆9-THC and its precursor ∆9-THCA in consumer CBD products; and,
(ii) The dose limit for total ∆9-THC (∆9-THC plus ∆9-THCA) should be 50 micrograms in a unit of consumption.
THE CANNA CONSULTANTS POSITION HAS ADVOCATED FOR THE ESTABLISHMENT OF AN ACCEPTABLE CONTAMINANT LEVEL
At The Canna Consultants we have long been proponents of the position that – whether we or those in the industry like it or not – the Home Office interpretation was correct based upon the wording (and background) to the MDR 2001. The accuracy of that analysis was further overtly confirmed by the ACMD in December 2021 – both in their statement and in their recommendations, because you do not need to change that which is already perfectly lawful and permissible.
The real issue for ourselves at The Canna Consultants has been the need for the regulatory authorities (in this context the Home Office, in conjunction with other regulatory agencies, such as the MHRA and the FSA), to set an acceptable level of controlled contaminants below which the ingestible CBD products that would otherwise fail Limb (a) on a “strict liability” basis would be deemed compliant with Limb (a), or for the introduction of a specific exemption for such a situation.
If you were to review our Position Papers from 2019 onwards you would find that we have previously expressed ourselves as follows (emphasis now added):
- What level of THC is “detectable” for the purposes of examination and testing and the Misuse of Drugs Act 1971, because in principle virtually everything is detectable if your equipment is sufficiently capable, and culpability for criminal liability should not rest with who has the best/newest/most capable testing machine?
- The regulatory authorities in the UK have not yet provided any advice on what is a “detectable” level of THC. The government needs to engage with the industry in order to help those market participants who are willing to truly engage with them to better define what conduct and product formulae are acceptable, equally, the industry needs to take responsibility for complying with the law.
- As a means of progress we encourage the government, through the auspices of the FSA and Home Office, to define what an acceptable detectable level of THC in products is, pursuant to which manufacturers will then have a maximum tolerance to remain within.
- We know that due to the feeding of hemp biomass to cattle we now have what is, unless the practice is prohibited, an effectively permanent contaminant level of THC within milk and the onward food-chain. Therefore, it would seem that an argument that there can be no acceptable level of THC contamination in food products, would be an academic one.
- If that is correct, then one could suggest that a sensible approach would be to then define what an acceptable level of controlled cannabinoid presence (THC/CBN) could be in foodstuffs generally, or in cannabis-derived products specifically.
- Given that no-one seriously believes that individuals consume cannabinoid products which contain technically measurable, but pharmaceutically insignificant amounts of controlled cannabinoids (THC/CBN) in order to achieve psychoactive results, then one could quite properly define them as “residues” of the natural origin of the end product or undesired “contaminants” to that product.
- To do so would not offend food law and regulation and if agreement could be found for the level at which acceptability was defined, then it is unlikely to have unintended consequences for those government departments charged with the control and eradication of narcotic drugs. The question within this debate would be – what is an “acceptable” level below which the presence of “controlled cannabinoids” could be deemed an acceptable contaminant?
RECENT DEVELOPMENTS EMANTING FROM THE JERSEY HEMP CASE
We have now had sight of the Home Office’s Grounds of Defence in respect of an action taken against it by Jersey Hemp concerning its decision that latter’s products failed Limb (a) of the Exempt Products definition within the MDR 2001.
The two most pertinent aspects of the Home Office’s Defence are (emphasis added):
9. The Defendant now accepts that a proper approach to limb (a) of the EPC [Exempt Product Criteria] would assess a variety of factors/evidence, which could include but would not be limited to the product’s stated purpose; the product’s advertising, packaging and presentation; the product’s administration technique, the product’s labelling, marketing and supply chain, and manufacturing technique.
10. Furthermore, the Claimant seeks a mandatory order requiring the Defendant to conclude that the Claimant’s products satisfy the EPC, and a declaration that the products do so. In the light of the evidence in this case, the Defendant is prepared to concede that the Products meet limb (a) of the EPC. Limb (a) is the sole focus of Grounds 1 and 2, but for the avoidance of doubt, the Defendant also accepts that the batch of the Products which was tested by Eurofins and whose composition is shown in the Analytics also met limbs (b) and (c) of the EPC and was therefore an exempt product. Whether any future batches of the Products would satisfy limb (c) of the EPC would, of course, depend on the composition of those batches.
So, it would seem that despite their previously steadfast approach – which was entirely supported by the wording of the regulations and the opinion and conclusions of the Advisory Committee on the Misuse of Drugs in December 2021 – that the Home Office has decided to change its Policy.
THE TIMING OF THE POLICY CHANGE AND THE FAILURE TO NOTIFY MARKET PARTICIPANTS OF IT
The Policy change is clearly beneficial to the industry as a whole because:
- subject to not overtly promoting the existence of the controlled Cannabinoids in their products; and,
- being able to prove that the controlled Cannabinoid levels ae below 1mg (Limb (c)) MDR 2001,
then all other manufacturers are entitled to benefit from the change in the application of that Policy.
It is notable in that context then that the Grounds of Defence which are now published demonstrate that this has been the Home Office Policy since at least 16th November 2023 – over 4½ months – and yet there has been no public announcement of that change to the market as a whole.
It must be beyond doubt that the Home Office could not have failed to appreciate that this was a change in their Policy (and a very significant one) and that it would have been crucial to the understanding of the market as a whole. In those circumstances questions must be asked as to why the Home Office have failed to inform the market or bring their change in Policy to the attention of those to whom it is most relevant – those in the market.
THE CONSEQUENCES OF THE POLICY CHANGE: NOVEL FOOD AUTHORISATIONS
The establishment of an acceptable level of controlled Cannabinoids has been on the cards for over 2 years since December 2021 following the ACMD’s recommendations that such a level be established (following its affirmation as to the failure of such products to meet Limb (a)). What that level would be was open for debate, but the new position of the Home Office would appear to set that level as 1mg per container (which was not that recommended by the ACMD).
The Home Office’s establishment of a new Policy, (which appears to set an acceptable contaminant level for aggregate controlled Cannabinoids within CBD products at 1mg per container), should free up the Food Standards Agency to Authorise those CBD Novel Food applications (subject to the FSA being satisfied as to the safety of CBD in general) which are somewhat in stasis.
We are unaware as to whether the FSA were consulted or notified by the Home Office before or since this change in Policy, but we will certainly be pressing them for an answer as to whether 1mg per container is a contaminant level that they will deploy in their assessment of the Novel Food applications over which they have jurisdiction.
CLARIFICATION OF THE POLICY CHANGE
In order to bring clarity for all market participants, and to establish whether the Home Office will seek to in some way limit this position to that of Jersey Hemp (which they should not given that their change has been one of principle in respect of Limb (a), rather than its specific application to Jersey Hemp), we have already approached the Home Office and invited their response to the following questions which are of general application to all:
QUESTION 1
The starting point is the lowest level of contamination, therefore:
1. Can an ingestible (non-medicine) consumer CBD product and which contains a detectable level of controlled Cannabinoids (including but not limited to 9-THC) meet your Policy in respect of Limb (a) of an “exempt product” under MDR 2001?
QUESTION 2
If the answer is “Yes”, then in seeking to establish the upper potential limit we would ask:
2. Does an ingestible (non-medicine) consumer CBD product which contains controlled Cannabinoid contaminants at a level ≤ 1mg per container meet your Policy in respect of Limb (a) of an “exempt product” under MDR 2001?
QUESTION 3
If the answer is “Yes” then, in order to seek to establish what level of controlled Cannabinoid contamination is acceptable on a policy basis, we seek:
3. At what level of detection/contamination (on the basis of aggregate weight per container) would a product move from meeting the definition within Limb (a) to failing it (assuming that the contaminant level was nevertheless ≤1mg per container)?
As and when we receive a response from the Home Office1 we will, as always, bring that to the attention of the whole of the market.
1We have been informed that we are unlikely to receive a response until the end of this month due to periods of annual leave.
