Clarification of the UK limits of controlled substances in CBD & Cannabis extracts
On Jan 13th 2021 the UK Government Chemists have published ‘guidance’ on the limits of controlled Cannabinoids used in foods and cosmetics. This provides additional clarity for those looking to submit a novel foods dossier in the UK on CBD products.
The wider market has typically been concerned with THC as the main psychoactive but under UK law there may be many and at least 12 as discussed in the source link below (See Table 1 & 2 of gov guidance). The presence of these in a product (e.g. food or cosmetic) has been considered as the illegal presence of a scheduled substance (narcotic in this case). However, there has been the discussion of a potential exemption from such control if products meet 3 criteria under the Misuse of Drugs Regulation (MDRs) including:
“ ... (‘c) no one component part of the product or preparation contains more than one milligram of the controlled drug ...’
This exemption comes along with a number of issues requiring clarification, such as 1 mg in how much product? 1mg of one or all controlled substances? Does the exemption apply to foods (the exemption was put in place for lab tests kits and not foods as its original intention).
The latest guidance provides some clarity on this issue, but as below it still leaves unanswered questions.
Which cannabinoids are controlled substances?
The Misuse of Drugs Act (MDA) does not identify the individual psychoactive cannabinoids, referring to a generic definition:
“Cannabinol derivatives means the following substances, except where contained in cannabis or cannabis resin, namely tetrahydro derivatives of cannabinol and 3 -alkyl homologues of cannabinol or of its tetrahydro derivatives”.
Prior guidance by the Advisory Council on the Misuse of Drugs (ACMD) have already provided guidance on this with at least 12 cannabinoid compounds identified as falling within this definition. However, care needs to be taken for example during stability testing and analysis that pre-cursor compounds that can convert to controlled substance are assessed. A single certificate of analysis (COA) on a product freshly produced will not potentially be the same composition that is present in that COA 2-3 months later.
What is the 1mg Threshold?
The important aspect from home office and now gov chemists “guidance” on what 1mg threshold means is that they view it as per container (Per bottle or Tub) rather than at the per dose basis. This view results in analytical terms significant variation in the actual concentration of the controlled substance depending on the size of the container e.g. 10g vs 2000g. The issue here is one of the requirements for exemption as a controlled substance is that the substance (e.g. THC) is not readily recoverable. It’s much more likely in the case of a 10g product (container) to be recoverable than that within a 2000g container. In addition, this also has implications for analytical analysis (for detail from link below).
What are we not told here?
Although a recognition by a government representative (in old terms when we were an EU country “emanations of the state”) that controlled substance(s) and their presence and the interpretation of an exemptions are a confusing issue are welcome; it does not clarify the legal position for foods. Similarly, does the 1mg threshold apply to foods, are foods designed for the administration of a controlled substance? At what concentration is a controlled substance readily recoverable?
There are no comments here from the home office and even the disclaimer states the guidance is not authoritative or representative of a legal view. Thus, in our view industry going into the novel foods system or placing products on the market up until the March deadline in the UK should consider seeking independent legal advice on a case by case basis.
Source: https://bit.ly/2MZaPo5