THE CBD industry is being failed by ‘unnecessary’ ‘unethical’ and ‘unscientific’ directions from the UK regulators, claim the authors of a new report.
In February 2020 the Food Standards Agency (FSA) said there was not enough evidence to confirm that CBD was safe and businesses wishing to remain on the UK market would need to provide the scientific evidence to demonstrate it is safe.
The FSA was acting on guidance from its scientific advisors the Committee on Toxicity (CoT) which had reached these conclusions on the basis of data from GW Pharmaceuticals.
However, in a new report The Canna Consultants (TCC), in partnership with drug development experts DevelRx, highlight how the industry is cumulatively being corralled into spending tens of millions on the basis of a wayward assessment of GW’s research by the CoT.
Steve Oliver, co-founder and director of the TCC, told BusinessCann that in assessing CBD’s safety profile the CoT had placed ‘undue emphasis’ on data from just one of 15 trials undertaken by GW to prove the efficacy of Epidiolex.
He continued: “The assessment reported by the FSA and conducted by its advisors in CoT is deeply flawed and an unreliable assessment of CBD’s safety and toxicity.”
CBD Safety Concerns
The data from the contentious Phase 1 GW trial highlighted by the CoT expressed safety concerns over the use of CBD on the liver, as well as possible negative reactions with other drugs, in particular the blood-thinner Warfarin.
As a result, the FSA’s February 2020 warning included advice for healthy adults to take no more than 70mg a day.
Based on this ‘flawed’ assessment, the FSA determined that all CBD products need to undergo extensive toxicity and safety testing in animals before being deemed safe for human consumption.
As a result of this there are now dozens of trials underway on rats, mice, pigs and other animals to determine whether CBD has the negative effects highlighted by the GW outrider, with this work costing the industry tens of millions of pounds.
However, The Canna Consultants and DevelRx contend that with the rest of the GW data not highlighting any safety concerns – even at doses which are up to 20 times higher than that recommended for daily CBD consumption – these tests are unnecessary.
The authors say the insistence by the FSA on the need for these studies is ‘unnecessary because this testing has already been conducted by GW Pharmaceuticals’.
‘Unethical And Unscientific‘
Mr Oliver said: “It is also unethical because animals are being used as surrogates when the question has already been answered by studies on humans. It is also unscientific because no guidance has been provided by the CoT to the FSA on how the findings will be interpreted or the implications arising from them.
“Despite the vast number of studies pointing to the safety of CBD at levels far higher than 70mg per day the CoT focused on findings in five human subjects in a very small, short-term Phase 1 clinical study of only 12 subjects, whilst ignoring the findings from a larger study of 64 patients receiving Epidiolex for 14 weeks.
“The remaining 13 trials demonstrate the safety at 70mg per day and show how futile the quoted snap shots are. This cherry picking is flawed and should cause concern for everyone.”
The report highlights that at over 98% purity the CBD isolates and distillates which are the subject of Novel Food applications by its clients are of similar or greater purity than the CBD in Epidiolex.
He added: “From a safety perspective, there is no biologically relevant difference between Epidiolex and the novel food CBD isolates / distillates in these FSA Novel Food applications.”
Examine The Wider Evidence
Matt Lawson, fellow co-founder and Director of TCC, said: “It is CoT’s review of the Epidiolex safety and toxicity findings which has led to the demands by the FSA for toxicity studies to be performed on every one of the CBD ingredients by each individual CBD manufacturer that has submitted a Novel Food application.
“DevelRx and The Canna Consultants are concerned over what we consider to be the scientifically unjustified, and ethically unacceptable, replicate toxicity testing of cannabidiol that is being demanded by the FSA, acting under guidance provided to them by the CoT.
“We are also concerned about how the CoT appears to have been fixated by one small outlier study, when we would have expected them to examine the wider evidence.”
Paul Tossell, Head of Radiological, GM and Novel Foods Branch, Food Standards Agency, said: “We continue to be guided by the independent expertise of the Committee on Toxicity (CoT). The current advice to CBD novel food applicants on toxicity testing will not change unless CoT receive sufficient evidence to indicate that a change is needed.”
Professor Alan Boobis, Chair of the Committee on Toxicity, said: “The Committee of Toxicity (COT) will be replying to The Canna Consultants in detail once we have had time to consider the report in full.
“The COT did not use a single study but looked at the available data as a whole to draw their conclusions about the safety in use of CBD in food products.
“Based on the limited clinical and non-clinical data available to them in January 2020, they concluded that there was evidence of liver injury at doses of 5mg per kilogram of body weight, interactions with pharmaceutical drugs at 1 mg/kg body weight and somnolence at 10 mg/kg.
“A level of 1 mg/kg bw was identified as a pragmatic maximum intake, above which adverse effects might occur. This could be revised when other data became available.
“The COT were aware that higher doses were tested in the various clinical trials, but even in these studies there were indications of adverse effects and thus such doses would not be appropriate for food use where risk-benefit is not considered.”
To view the report click here