ONE of the CBD industry’s leading figures fears it may not exist come April next year unless it is able to secure enough data to show CBD is safe.
Steve Moore, Strategic Counsel and Director at the Centre For Medicinal Cannabis, says the only way for the industry to proceed is to produce sufficient safety data to satisfy regulators.
He said: “This is absolutely fundamental to the future of the industry. There is no other way and the regulators are adamant this will have to happen.
“The bottom line is that this is a food safety assessment and, given what we are all living through at the moment, any deviation from safety standards means you cannot operate responsibly.
“At this stage it’s not a matter of how it will be enforced, or whether it will be delayed as a result of Covid-19. The FSA (Food Standards Agency) is fixed and won’t be deviated.
“Any business that thinks come April next year they’ll be able to proceed as they are now is taking a negligent view.”
Concerns Over Liver Damage
In February this year the FSA put the British CBD industry on notice that it has a little over a year to sort out its act.
This had followed expert input from its medical advisors, The Committee on Toxicology (CoT), which had raised concerns over CBD usage and its potential to damage the liver, as well as possible negative reactions with other drugs, in particular the blood-thinner Warfarin.
The FSA said that from March 31, 2021, it would expect all UK CBD companies to have a Novel Food application authorised.
Those companies which fail to do so will face enforcement action, which could see their CBD products removed from sale, says the FSA.
Novel Foods Pushback
Novel Foods are foods with no history of consumption before 1997, and the Novel Food authorisation process is a safety mechanism designed to ensure all products are fit for human consumption.
Many businesses were in the CBD sector long before Novel Food appeared and they object to its designation, saying CBD – as a constituent of hemp oil – has been used for hundreds of years.
They align with the World Health Organisation which says ‘CBD is well-tolerated with a good safety profile’.
However, Mr Moore added: “It really doesn’t matter what the World Health Organisation has to say, it is CoT that has to be satisfied that CBD is safe, and at the moment that is not the case.”
Last year the Centre For Medicinal Cannabis (CMC) established the Association for the Cannabinoid Industry (ACI) to help clear the path towards a safe and regulated UK industry.
Its members include leading companies such as Mile High Labs. It became the first UK-based company to submit a Novel Food application last week – it ran to more than 300 pages.
New Lab Tests Required
Mr Moore said: “We are working with many companies to get the safety data that is necessary to complete the Novel Food dossiers.
“This evidence then goes to CoT, and if the evidence that CBD is not toxic is weak, and if CoT aren’t happy with the data, then there will not be any CBD on the shelves.”
The ACI and its member companies are to undertake laboratory studies, including rodent tests, to assimilate the necessary data, and it is in regular dialogue with the FSA’s toxicologists to ensure the studies will fill these gaps.
Mr Moore added: “CoT has raised concerns on the impact of CBD consumption at low doses. They have real concerns about its impact on the liver.
“When the last CoT report was published (in January this year) we spent weeks searching for data to show CBD is safe, to provide additional clinical trials and studies, but there wasn’t any.
“It doesn’t exist and we need to produce it in the next year so we can get to the stage where CoT are happy that CBD is safe.
“It is unlikely the FSA will approve CBD products until the CoT is satisfied. The Government is not going to do that work, so it’s down to companies and organisations like ourselves.”
Health And Wellness
CBD is something of a health and wellness phenomenon. Recent research from the CMC found that six million people in the UK have tried CBD and the market CBD is already three times bigger than the Vitamin C market – £300m to £110m, respectively.
“This move towards a well-regulated industry will be good news for UK consumers. As this happens we will see the larger, listed, companies enter the market,” added Mr Moore.
A Food Standards Agency spokesperson said: “CBD extracts are considered novel foods under food law and we expect companies to comply with the novel foods process, which includes submitting safety information about their products. From April 1, 2021, only products which have submitted a valid novel food authorisation application will be allowed to remain on the market.”
The stance of the FSA mirrors that of Food & Drug Administration in the US which last year said CBD posed ‘real risks’ to health, and, that it expects CBD-infused product developers to pursue a drug-trials’ validation route.
* Over the coming weeks BusinessCann will be taking an in-depth look at how businesses can continue to operate in the CBD industry after March 31, 2021.