THE initial warm welcome to proposals to make UK cannabinoid regulations a matter for the health authorities – not the criminal ones – have cooled in recent days.
On Thursday last week senior advisors to the Prime Minister led by former Tory party leader Sir Ian Duncan Smith unveiled a raft of proposals to stoke the UK economy in a Post Covid, post Brexit world, as reported in BusinessCann
Included in these were provisions to move licensing for ‘cannabinoid pharmaceutical research and CBD over-the-counter medicines’ out the Home Office and into the Department of Health and Social Care (DHSC) and Medicines and Healthcare Products Regulatory Agency (MHRA).
However, it has now emerged that senior figures in the UK hemp and CBD industry have been left perplexed by suggestions that over-the-counter CBD could be classed as a medicine.
Report Authors ‘Confused‘
This is especially so as the CBD industry is cumulatively spending tens of millions of pounds aligning with the UK Novel Food rules under the auspices of the Food Standards Agency.
The recently formed Cannabis Industry Council (CIC) – which represents businesses, trade groups and professionals – is one such body querying the proposals in The Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) report.
Jamie Bartley, CEO of Unyte Hemp and Chair of the CIC’s Hemp Group said: “We were surprised the authors of the TIGRR report are confusing the UK’s established nutritional supplement CBD industry with the medicinal cannabis industry.
“We urge the report’s authors to clarify that all products derived from industrial hemp are exempt from the legislation around controlled cannabinoids.
“UK medical cannabis clinics are prescribing for around 6,000 patients – as of April this year – with the majority receiving cannabis medications with higher levels of THC.
CBD – A Food Supplement
“By contrast, the UK’s CBD nutritional supplement industry is made up of hemp-based wellness products which contain less than 1mg THC per product.
“Since 2016, the Foods Standards Agency has considered CBD a food supplement. We do not understand why this report suggests that some CBD products should be moved into Schedule 5 over the counter, so treated in the same way as codeine, for example.
“We feel this is an unnecessary move to further regulate hemp-derived food products which could hinder industry growth.
“While we support the call for additional research in the benefits of cannabinoid medicines, it’s important to highlight that it is currently the health and wellness nutritional supplement industry that needs licensing moved out of the Home Office.
“A recent paper backed by the UK industry called for all hemp products containing less than 0.2% THC to be completely removed from controlled drugs regulation and out of the Home Office.”
Similar To Trade Groups’ Suggestions
The recommendations in the TIGRR report echo suggestions made by sister bodies the Centre for Medicinal Cannabis and the Association for the Cannabinoid Industry.
In a paper released in April the CMC/ACI contended that ‘CBD products containing between 0.03 percent and 0.2 percent controlled cannabinoids (THC and others) should be classified under Schedule 5 of the Misuse of Drugs Regulations act of 2001, and so should be lawfully available for over-the-counter supply in the UK’.
The CMC and the ACI were co-founded by Steve Moore, who is a long-established contact of George Freeman MP, one of the three TIGRR report authors.
These recommendations have been viewed by some in the industry as an attempt to stymie the full extract hemp oil market, which has been established for some time in the UK and elsewhere, and falls outwith the emerging Novel Food rules for UK CBD products.
One further point of note on these TIGRR proposals is that over-the-counter medicines classified under Section 5 have generally been through an established MHRA trial programme and initially designated a medicine.
Report Authors ‘Completely Ignorant’
Steve Oliver, Director of The Canna Consultants, explained: “OTC’s will normally have been on prescription for at least three years, with no evidence of harm to users and as such are safe to be sold over-the-counter. That is after going through the full medicines route and if you think Novel Foods is tricky then be careful what you wish for!
“Examples of such medicines include codeine, paracetamol and hay fever tablets. This would be the first time a food supplement has been upgraded to an over-the-counter medicine.”
Commenting on the TIGRR proposals for CBD Mr Oliver added: “The report and its advisors demonstrate a complete ignorance of the law and the industry as the only medicinal products available in the UK are those made by GW Pharmaceuticals.
“The CBD industry is a food supplement industry not a medicinal one.”
One further area of concerns for industry observers is the lack of clarity from TIGRR on how industrial hemp cultivation will be licensed – with industry participants suggesting agriculture, not health.
Mr Bartley added: “The changes that would make a real difference to the industry are around the licensing framework for cultivation and not the way in which the food products are scheduled.
“Hemp is both a nutritional food and a tool to decarbonise multiple sectors. Further regulation will hinder the potential impact hemp can have on the improvement of human and planetary health and the post-Brexit and post-Covid economy.”
These recommendations come as The Advisory Council for the Misuse of Drugs is currently considering what is an acceptable level of THC and other controlled cannabinoids in UK CBD products, sold as food supplements.
This followed a letter from Police and Justice Minster Kit Malthouse in January which said the Government was looking to establish a clear regulatory environment for CBD food supplements in relation to controlled cannabinoid content.
While theoretically there should be no THC, or other psychoactive compounds, in any UK retail products the Home Office currently works on a limit of 1mg per pack – no matter the pack size.
The ranges proposed by Mr Malthouse vary from 0.01% THC to 0.0001%.
If the ACMD settles on the 0.01% guidance this would allow THC levels to increase, for example; 0.01% THC in a 10ml bottle equates to the existing 1mg, but in a 30ml bottle that rises to 3mg.
Medical Cannabis Research Welcomed
Prohibition Partners’ Consulting Services Director Barbara Pastori welcomed the recommendations in relation to medical cannabis research which the TIGRR report says ‘could unlock significant investment into UK medical research into cannabinoids for pain relief’.
“Tailoring regulations to support research into the medical benefits and risks of cannabis is right in line with the spirit of the UN rescheduling of cannabis last December, as well as the repeated calls from national institutes such as NICE who have stated that more research into medical cannabis is needed. Our hope is that these statements will be translated into regulations in the near future,” she said.
BusinessCann reached out to Mr Freeman MP for a comment and is awaiting a response. A spokesperson for the Prime Minister’s office says it will consider and respond to the report’s recommendations in due course.
@We will have more on this next week – including an interview with a Dr Parveen Bhatarah, Regulatory and Compliance Director, at the ACI.