THE use of data which suggests 10 people have died from CBD use has been criticised by senior industry figures.
The Committee on Toxicity (COT) – which provides scientific advice to the UK Food Standards Agency (FSA) – highlighted the deaths when defending its position on the safety of CBD.
The data is gathered by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and is recorded under its Yellow Card alert system which registers adverse reactions to drugs.
In defending its contention that CBD use has not yet been proven to be safe COT Chair Prof Alan Boobis said: “It is not true to say that there have been no adverse reactions reported in the Community.
“Please see link to the MHRA Yellow Card Adverse Drug Reaction (ADR) scheme which includes CBD products and not just medicines.”
‘860 Adverse Reactions’
This data shows that as of the end of February 2023 there have been 860 ADRs and 10 fatalities from cannabidiol (CBD).
Prof Boobis had made the claims in response to a report which suggests that it, and the FSA, had relied too heavily on data from GW Pharmaceuticals in analysing the safety profile of CBD, as previously reported by BusinessCann.
Steve Oliver, Co-Founder of the The Canna Consultants, co-authors of that report, says COT’s decision to highlight the Yellow Card data is unprofessional, damages its reputation, is designed to undermine the CBD industry and support the FSA’s stance on CBD.
He said: “This data is not supportive of either the COT or FSA position and in fact undermines them. Referring to data which when examined does not relate to the CBD products they claim to be assessing is disingenuous at best.
“There have been no deaths and there is no consumer detriment that I am aware of in respect of safety. Mislabelling and poor product quality, yes, but the current regime does nothing to address that. At 70mg per day I challenge the COT to produce evidence that can be peer reviewed of the risk! With effective disclaimers and warnings for the ‘vulnerable groups, they have none.”
‘No Provable Link’
The UK Cannabis Industry Council has likewise dismissed this COT intervention.
Chief Executive Mike Morgan-Giles said: “The CIC is committed to following credible scientific and medical analysis. However, these claims about CBD are virtually meaningless based on the clarifications listed on the MHRA webpage, and nor do they withstand any serious analysis.
“Firstly, many of the alleged reactions are historic – with very few serious Yellow Card reports made since the start of 2016.
“Secondly, the ‘drug analysis’ webpage itself notes that they don’t know how many people have taken a product without experiencing a reaction.
“Thirdly, the webpage notes that they can’t tell the difference between a natural occurrence and an adverse drug reaction.
“Furthermore, they encourage members of the public to submit reports based on their own ‘suspicions’ and clearly state there is no provable link between the alleged adverse reactions and the products.”
Is CBD Safe To Use?
While the World Health Organisation found CBD to be safe, regulators on both sides of the Atlantic are yet to be convinced, and are calling for further evidence from the industry to prove this.
In the UK, the FSA is requiring extensive – and expensive – tests to prove this and permit the industry to continue trading.
Its Head of Science, Evidence and Research, Rick Mumford, told BusinessCann: “The Yellow Card system includes reports from medicinal products containing CBD as well as supplement products.
“There are established limits to the interpretation of Yellow Card data which means, that while these reports are useful background, they only form a limited part of the evidence base.
“Yellow Card reports are not used for specific regulated product applications. Most of the data used to assess the safety of CBD will be that submitted for authorisation of regulated products or published in the peer-reviewed scientific literature.”
BusinessCann has reached out to The Committee on Toxicity (COT) for a response in relation to Mr Boobis’ comments.
‘CBD Is Not A Benign Substance’
As BusinessCann reported recently one major beneficiary from the current stasis in determining CBD safety is the maker of the Epidyolex CBD-based drug.
A spokesman for Jazz Pharmaceuticals, (formerly GW Pharmaceuticals) makers of Epidyolex told BusinessCann: “We firmly believe in the need for systems such as the MHRA’s Yellow Card alert system, which is an important part of the UK’s pharmacovigilance and is focused on ensuring patient safety.
“Over recent years we have seen a proliferation of CBD-containing products across markets globally. We welcome the regulatory oversight of the MHRA and believe that this highlights that CBD is not a benign substance – it can present real safety risks, if not used under the supervision and monitoring of a healthcare professional.
“There is also still much we do not know about CBD’s safety profile as highlighted by regulators around the world including the FDA, the European Food Standards Agency (EFSA), the UK’s Food Standards Agency (FSA) and its Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) and Australia’s Therapeutic Good Administration (TGA).”
The COT’s role is to provide advice to the FSA and other government departments and agencies on the toxicity of chemicals in food and consumer products.
The Yellow Card website also carries data on common drugs such as paracetamol and these report some 603 fatalities and 26,317 adverse reactions.
However, paracetamol has undergone full clinical trials and has a proven positive medical risk/benefit, while that is not yet the case with CBD.
The Yellow Card data for CBD also includes many unlicensed cannabis medicines currently available under prescription, which include THC. BusinessCann has been promised a response from the MHRA on this and is still waiting for a reply.
