Submission of evidence on cannabinoids in commercial cannabidiol (CBD) products

CannaPro has responded to the Advisory Council on the Misuse of Drugs (ACMD) call for evidence on cannabinoids in CBD products.

A. Cannabis Professionals (CannaPro) is the trade association for the UK’s cannabis, CBD and hemp businesses. CannaPro is a division of CLEAR Cannabis Law Reform, the UK’s longest-established and largest membership-based cannabis policy group.

B. CannaPro currently represents approximately 100 of the leading CBD businesses in the UK. We certify and monitor businesses as legally compliant with all laws and regulations relating to their business and with CannaPro’s own standards. Our members range from the largest CBD businesses, eg. Love Hemp, to one or two person micro businesses.

C. Members of the executive committee of CLEAR have been involved in the development of the UK CBD market since its earliest days as far back as 2012. We were responsible for the establishment of liaison between the industry, the MHRA and the FSA in 2016. Our board members Professor Mike Barnes and Crispin Blunt MP (Mr Blunt is no longer a member of our board) have facilitated our liaison with these authorities and provide scientific, medical and political advice.

D. ‘CBD products’ has always been a euphemism for what were originally low-THC cannabis extracts and oils derived from industrial hemp. In recent years, isolates of CBD have been developed and also what are called ‘broad spectrum’ CBD products which typically have had even trace amounts of THC removed.

E. It is important to note that under the United Nations Single Convention on Narcotic Drugs 1961, industrial hemp and products derived from it are designated as ‘not controlled’. The convention has the status of a treaty in international law so, in fact, the Misuse of Drugs Act 1971 is in breach of that treaty as it restricts actions concerning industrial hemp and products derived from it. Under the treaty there should be no controls on any cannabinoids or other compounds in products derived from industrial hemp, including ‘CBD products’.

F. The most significant and important point to make about ‘CBD products’ is that there is no evidence of anyone, anywhere in the world, coming to any significant harm from their use. It is, of course, impossible to prove a negative but CannaPro has seen no such reports and the nature of our business is that if such reports existed, we would have seen them.

G. There is some limited evidence of side effects from very large doses of CBD isolate, specifically the GW Pharma product, Epidiolex but these are confined to relatively minor adverse events such as diarrohea and somnolence. In any event, the doses concerned are massively larger than the maximum recommended daily dose for CBD products of 200mg. Epidiolex dosage is between 10mg per kg and 20 mg per kg, between 750mg and 1500mg per day in an average adult.

H. Despite the absence of any evidence of any harm and an unequivocal safety endorsement from the World Health Organization in 2018, the European Commission (EC) embarked on a misguided over-regulation project under its ‘novel foods’ regulations. Despite Brexit and for no justifiable reason, the FSA has chosen to continue with this and is presently stumbling through missed deadlines towards some sort of ‘novel foods’ regime in the UK. It has achieved nothing except to impose massive, unnecessary costs on the industry and, in any case, will be largely unenforceable, through the complexity of the regulations, the lack of enforcement resources and educated consumers who know what they want and what works for them.

I. Comprehensive evidence was supplied to both the EC and the FSA demonstrating that ‘CBD products’ and/or low-THC cannabis extracts and oils do not meet the definition of ‘novel foods’ and are traditional products even if now extracted and processed by modern techniques (which do not in themselves make the products ‘novel’). For reasons which are not clear, both organisations chose to ignore or refused to consider this evidence and have ploughed on regardless.

J. CannaPro has long advocated for better regulation of the CBD market but in ways that are necessary and will help to protect consumers, not the imaginary and groundless concerns that ‘novel foods’ regulations seek to address. Our suggestions have repeatedly been submitted to the FSA and the MHRA since 2016 but have been ignored. In particular, we had a constructive relationship with the FSA until it unilaterally changed personnel and imposed its ‘novel foods’ plans without any proper consultation.

K. The regulations that are required for CBD products fall into three categories: A. processing, B. labelling and C. claims of benefit. A. Processing regulations are the same as for any other food product and are mainly around hygiene, cleanliness and avoidance of contamination. B. Labelling regulations need to codify the best practice that already exists in the industry and crucially must be accurate as to contents. Trading Standards departments should be conducting random tests to ensure compliance. C. Claims of benefit need to be compliant with the Human Medicines Regulations 2012, specifically there should be no claims of medicinal benefit.

L. Despite many reports of unlawful claims under the Human Medicines Regulations 2012, the MHRA has failed woefully to take enforcement action. Offences are committed on a daily basis by rogue CBD businesses but also by publishers, including national newspapers, which earn commission on products sold in response to advertorial in which claims of medicinal benefit are very frequent, or publish advertisements which make such claims Multiple reports to the MHRA and to the Advertising Standards Authority (ASA) have been met with almost complete disinterest.

M. In response to the council’s specific questions

  1. As referred to above, under the United Nations Single Convention on Narcotic Drugs 1961, cannabinoids in products derived from industrial hemp are not subject to any controls. However, we recognise this is a moot point as the Misuse of Drugs Act 1971 itself breaches the convention on this issue. We presume that the concern over “acceptable levels of constituent cannabinoids in CBD products” relates to psychoactive cannabinoids.  The only cannabinoids that are psychoactive within the accepted definition are derivatives of cannabinol (CBN), so this includes delta 9-THC, CBN and THCv  as specified but also other rare THC molecules such as delta 8 and delta 10.  For all practical purposes the only relevant cannabinoids are CBN and THC molecules.
  2. Tiny, microdoses of psychoactive cannabinoids may cause a detectable effect in humans at a level below that of self-awareness but there are not potential harmful effects at these levels in adults. For practical purposes, we refer to the well-established ‘single-serving’ level in legal jurisdictions of 5mg. At this level or below, a harmful effect in adults is highly unlikely. It should also be recognised that most ‘CBD products’ contain multiple servings, for oils up to a month’s supply, so 5mg of CBN and/or THC in a 10ml bottle of oil has zero potential for harm.
  3. Warm and dark storage conditions with CO2 and moisture present may theoretically transform non-psychoactive cannabinoids into psychoactive compounds but in practice this is highly unlikely, certainly not to a level where there is any potential for harm. https://www.liebertpub.com/doi/10.1089/can.2020.0021
  4. In CannaPro’s judgement, a combined level of psychoactive cannabinoids in a single-serving standard use of a ‘CBD product’ of up to 1mg would not produce a psychoactive effect in adults.  Thus, a typical 10ml bottle of oil containing 30 – 40 servings if used in accordance with the directions could contain up to 30mg.  However, we recognise the possibility of intentional or unintentional overconsumption, or accidental consumption by a child. Therefore, we recommend a maximum of 5mg in a 10ml bottle or ideally a maximum percentage level of 0.05%.  It is vital that the current absolute limit of 1mg is changed to a percentage limit.
  5. We are not aware of any evidence of cannabinoid impurities in ‘CBD products’ causing adverse reactions or harms. We emphasise that, as above, we are not aware of any adverse reactions or harms in CBD products except in very high doses of CBD isolate.
  6. We require independent laboratory reports, certificates of analysis, specifying cannabinoid contents and tests for heavy metals and contaminants. Ideally, we would like to see GMP standards developed specifically for ‘CBD products’.  These would not have to be as rigorous as GMP standards for medicines

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: