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THE PRACTICAL CONSEQUENCES OF THE CHANGE OF THE HOME OFFICE’S POLICY ON CONTROLLED CANNABINOIDS CONTENT IN CBD PRODUCTS
Earlier this week we brought to the attention of the whole of the market information that we had received which demonstrates that the Home Office appears to have made a significant, and unpublished, change of Policy in respect of the acceptance in principle of contaminant levels of controlled Cannabinoids in ingestible CBD products. You can see the full document here.
In this document we will recap the nature of that change and go on to the address the manner in which the Home Office is likely to implement that new Policy in practice and the consequential effects on the approach of the UK Food Standards Agency (FSA) when assessing the multitude of CBD Novel Food applications which are currently in stasis due to this issue.
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.
RECENT DEVELOPMENTS – THE PRINCIPLE
We have now had sight of a document filed with a Court by the Home Office which sets out its (new) position in respect of Limb (a) of the Exempt Product definition within MDR 2001.
The aspect of the document relevant to this principle is:
10. …[the Home Office] is prepared to concede that the [CBD] Products meet limb (a) of the EPC … and … that the batch of the Products which was tested … also met limbs (b) and (c) of the EPC and [is] 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 and now approach CBD products on the principle that CBD products can meet Limb (a) of the MDR2001. However, the assessment will not stop with the principle, but will also consider the practicality.
RECENT DEVELOPMENTS – THE PRACTICALITY
The aspect of the document relevant to the practical application of the Policy is (format changed from a single sentence to a list for ease of consideration):
9. …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:
(i) the product’s stated purpose;
(ii) the product’s advertising;
(iii) the product’s packaging;
(iv) the product’s presentation;
(v) the product’s administration technique;
(vi) the product’s labelling
(vii) the product’s marketing;
(viii) the product’s supply chain; and,
(ix) the product’s manufacturing technique.
Therefore, it would appear that in considering the practical assessment of whether Limb (a) is met, that the Home Office will make an assessment of such evidence as is available which sheds any light on the manner in which the product is being promoted to the public, as per the references in (i) to (vii) above.
If a product is being imported into the UK and the Home Office are being consulted in respect of permission for the transit, then it would appear from what they have said above that they will take heed of such material as is available in respect of the product’s packaging and promotion. This will no doubt be from requests for packaging and labelling proofs, but may also stretch to reviews of websites and advertisements where the product has been marketed in the UK or elsewhere in order that they can make a consideration as to whether the manufacturer is intending for the consumer to administer controlled Cannabinoids, or whether such ingestion is incidental to the primary purpose – the ingestion of CBD.
One is drawn to the conclusion that where the marketing and promotion of the product draws attention to the presence of controlled Cannabinoids in the product, then the Home Office are likely to conclude that the administration of such elements is intentional on the part of the manufacturer (because they would be trading on the back of them) and they would conclude that in those circumstances that the product would fail Limb (a). Equally, where the marketing and promotion of the product makes no mention of the controlled Cannabinoids (other than potentially within a published COA), then the implication is that the product would “pass” their new assessment criteria under Limb (a) and, subject to compliance with Limb (c), the product would be permitted as an Exempt Product under MDR 2001.
It is unknown how the products supply chain and the manufacturing technique (see (viii) and (ix) above) will (or could) impact on an assessment of Limb (a), but perhaps clarification will come when the Home Office provides greater clarity on this new Policy.
THE WIDER IMPLICATION AND APPLICATION OF THE APPARENT NEW REGIME TO THE ASSESSMENT OF INGESTIBLE CBD NOVEL FOOD APPLICATIONS
As we have noted previously, the establishment of an acceptable controlled Cannabinoid contaminant level is having an impact on the potential progress of a multitude of CBD Novel Food applications which are currently with the UK FSA.
This is because (subject to the FSA’s assessment on the safety of CBD per se, in respect of which they are now in possession of significant volumes of toxicological safety data), the issue of the presence of controlled Cannabinoids within the products was causing the FSA something of a headache in circumstances where the Home Office’s Policy (as confirmed and supported by the ACMD’s recommendations) was that the presence of controlled Cannabinoids at any level would render the product incapable of being a “food” because the presence of the controlled Cannabinoids rendered the product a “drug”.
Now that the Home Office appear to have set the acceptable level of controlled Cannabinoids at 1mg per container (see the commentary in this week’s earlier document here), it would remove the brakes from any product applications which meet that criteria and in respect of which the FSA were satisfied as to the safety of their CBD content.
FURTHER CLARITY
As we have indicated, we have approached the Home office for clarity on the propositions of principle which may be drawn from their apparent change in Policy and, following receipt of that clarification, we will then press the UK FSA for confirmation of their implementation proposals predicated on that new Policy.
Obviously, as and when we receive this information, we will bring it to the attention of the whole of the market – for free – in order that everyone has the same playing field upon which to trade.
