Yesterday, UK watchdog the Foods Standards Agency (FSA) published the list of CBD products linked to credible applications that could eventually be authorised for legal sale in the country.
With the UK being the first country in the world to attempt a regulated CBD market, the process of getting there has left the industry waiting in limbo for more than two years.
Companies that appear on the list have provided the FSA with toxicological data to demonstrate the safety of the CBD contained in their products, meaning they can now progress in the process toward potentially being authorised as safe products for human consumption.
Today, CBD industry bodies have provided a mixed response to the development. Whilst some have stated the certainty will create innovation, investment and new jobs in the sector, others believe that the process has caused damage at a time of need in the British economy and could promote the black market.
Read more: Authorised UK CBD products expected by 2023
In 2019, CBD products were classed as a ‘novel’ food product by the European Union (EU), and in the UK, are now, investable CBD products are being assessed by the FSA for safety before being permitted for sale. However, CBD was classed as a safe product by the World Health Organization (WHO) in 2018.
Founder of the Cannabis Industry Council and expert in medical cannabis, Professor Mike Barnes, has described the process as having achieved immeasurable damage to a thriving and safe industry.
Barnes commented: “The long-awaited FSA report on Novel Food status of CBD products is now available. What a monumental waste of time and money. The WHO and even WADA have already opinionated that CBD is safe.
“There is no valid evidence to say otherwise except from old studies of huge doses of CBD (several hundred times the human dosing) of liver damage. All this has achieved is immeasurable damage to a thriving, safe industry at a time post-Brexit and post-Covid when the Government needs to be nurturing new enterprise not stifling it with unnecessary bureaucracy.
“All that was needed was for the MHRA to actually enact the existing regulations to prevent companies making unjustified medical claims and to insist on a full Certificate of Analysis to confirm what is in the product and that it meets legal controlled cannabinoid limits.
“What the FSA has done has played into the hands of big CBD companies, restricted consumer choice, put many small companies out of business and pushed the CBD market towards isolates which are less efficacious and with more side effects than broad-spectrum products.
“Well done FSA – will the government take the cannabis and hemp industry seriously please? Let’s create hundreds of thousands of new jobs, generate tens of millions of tax income and provide good, safe products for the real wellness and medical issues for millions of people in this country.”
President of CLEAR UK and founder of trade association Cannabis Professionals (CannaPro), Peter Reynolds, echoes Barnes’ sentiment.
Yesterday, in a blog on his website Reynolds shared his opinion: “The only evidence on which the FSA’s concern for any harm is based in experiments on rats by GW Pharmaceuticals with its CBD isolate medicine, Epidiolex, administered at doses hundreds or thousands of times the equivalent in humans. And the conflict of interest is obvious.
“I am no enemy of GW, on the contrary, I admire the company and its work but it has the only licensed CBD medicine and its interest would be to restrict access to non-licensed products.”
He went on to state: “All that the FSA’s intervention in the CBD market will achieve, aside from the enormous damage to businesses and jobs, is to promote the black market. For consumers, the situation is only going to get worse.”
UK industry body, the Association for the Cannabinoid Industry (ACI) has welcomed the news, stating that it “feels vindicated” for the work it has done with CBD companies in submitting Novel Foods applications. It has highlighted that 100 per cent of the companies it represents have appeared on the list, with its Initial read out from the data showing that 64 per cent of all applications on the list have come from ACI members.
ACI founder Steve Moore commented: “Although the regulatory device was devised in Brussels, most European member states haven’t, on the whole, implemented it. In the US there is currently a bill going through Congress that which would mandate the FDA to take a similar approach, which would take effect from next year.
“So the UK in a sense, in this particular category of consumer cannabinoids, is I think is pioneering and has invested more in the process and the other jurisdiction in the world.”
Moore says the benefits of the certainty from the list are threefold: proving companies can meet regulatory requirements, providing consumers with reassurance of the safety of the products they are buying and enabling innovation and investment in the sector.
The European Industrial Hemp Association (EIHA) has described the development as a “milestone moment”, noting that both EIHA Projects GmbH Novel Food Applications for isolate CBD and full spectrum extract have been accepted by the FSA and now appear on the ‘on-hold’ list.
Read more: FSA says authorities will need to step up CBD enforcement
Tony Reeves, EIHA Board Member, UK, commented: “This is certainly a ‘milestone’ moment for our many UK consortium members and a most welcome validation of the approach taken by EIHA to one of the most challenging issues faced by the European CBD industry.
“I would like to thank the FSA team for engaging in open discussions throughout this long process; I am sure we will have many more as our applications move towards ‘authorisation.’ Most importantly, I would like to thank all members of the consortium for the trust they have placed in us. I look forward to working with you all to help the development and expansion of this most important sector.”
Catherine Wilson, EIHA Advisory Committee, UK, commented: “We very much welcome this long-awaited, proof of compliance from the FSA. The pragmatic approach adopted by the FSA reflects both sides of the market: as it aims to ensure a high level of consumer safety whilst maintaining consumer choice and supporting the efficient functioning of the internal market.”
Lorenza Romanese, MD EIHA added: “I think the UK has understood the importance for European operators of having both forms of CBD extracts secured on the market, and that is why it is ready to study science-based results.
“A legal market for CBD extracts with the associated clarity that brings will guarantee the quality of these products and facilitate a more professional savoir-faire. On this special day, I’d like to thank ChemSafe, EIHA service provider, that supported this project since 2019.”
However, the EIHA also stated that there are “some inaccuracies, inconsistencies and indeed a few surprising absences on this list, and we will review these over the coming days and continue our open discussions with the FSA.”
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