Lady Chanelle McCoy and Caroline Glynn had a pretty lousy New Year’s Eve.
While the rest of the country was getting drunk in front of the TV and waving farewell to a cursed 2020, they were sat in front of computers waiting for the minute hand to reach midnight.
Then they did what almost no one else in the timezone was doing at that precise moment: A spot of admin.
At one minute past midnight they submitted their application for authorisation under the UK Government’s new novel food regulations for CBD products – and this week, their less-than glamorous New Year’s Eve paid off.
Their company, Pureis CBD, was one of the first to have its products validated by the Food Standards Agency. At time of writing they are one of just three companies officially on the path to full authorisation and a valuable pass to remain on shelves in the UK.
Despite receiving over 750 applications, the FSA granted validation – the first stage on the way to full authorisation – to just 23 products (11 of them from Pureis, two from CBDex and ten from 4MP).
The roll out of the new regulations has plunged dozens of CBD companies into uncertainty and left the sector reeling – but McCoy and Glynn couldn’t be happier.
Boasting decades of pharmaceutical experience and plenty of business background to boot (not to mention McCoy’s celeb status in Ireland as a TV investor on Dragons’ Den and wife of champion jockey Sir AP McCoy), the pair are fully behind the FSA’s effort to clean up the CBD sector and have come out swinging against their competitors.
Pulling no punches, the pair said the regulator has been fair throughout and even too lenient with the ‘cowboys’ who are ‘hindering the growth’ of the industry.
McCoy told Cannabis Wealth: “I don’t have any sympathy for companies who are complaining about the FSA. They are doing a good job, it’s all about consumer safety, to bring safe products to the consumer.
“Everybody, including us, was given a deadline. We knew the new legislation came in January 2019, everybody knew.”
For most of its life, Pureis CBD has been a two person outfit but the firm put £1.5m into safety trials ahead of the novel food deadline. That’s on top of costly stability and analytical testing on the raw material – which is imported across the Atlantic and approved by US regulators – in their products.
They launched their clinical safety trials weeks after the announcement of the new rules in early 2019 and say their readiness is why they were the top name on the first validated register.
McCoy said: “We haven’t had any extra help here, this is a level playing field, we are all being treated the same, we just decided what we were doing very early on and decided to follow the legislation.
“That’s why we are where we are today and why other companies who complained and lobbied against the FSA are now complaining that they’re not on the list. They didn’t adhere to and embrace the guidelines quickly.”
She added: “We did nothing extraordinary here, we really didn’t…we just did what we were supposed to do on time.”
They have already started going beyond phase one safety trials carried out on rodents (the benchmark for FSA regulators) and committed £4m worth of funding for phase two efficacy trials to try and establish their CBD product as a bonafide medicinal treatment for insomnia.
Glynn says the company has a ‘very big R&D pipeline ready to go’ once regulatory matters are tied up.
McCoy told Cannabis Wealth she was concerned about the levels of THC in CBD products across the UK market, calling it ‘the reality of the industry’ and that ‘it’s up to the regulators to clean that up’.
The appearance of just 23 products on the list out of over 750 application shocked industry insiders and watchers.
More are expected to be added between now and June but it was striking for many to see just how few companies had their products ticked off and advanced to the next round of checks on day one.
McCoy said: “That to me just shows the compliance culture within other companies…and in this industry.
“We are coming from the pharmaceutical industry, we were appalled that there were only three brands on the list.
“There is certainly a culture in the industry of not adhering to what the legislators are trying to do and that then tells you…that there are not enough professional people in the industry that clearly care about consumer safety.”
She added there are ‘a lot of cowboys out there and they are really hindering the growth of the CBD industry because people are really struggling to trust CBD products’.
The FSA has already changed the deadline once for companies to allow more time to file applications and this week revealed the creation of a new ‘on hold’ status for companies which haven’t provided full lab data but have given a ‘robust’ commitment to do so.
On this point, the pair are less generous about the FSA and feel like the regulator could have been stricter.
Glynn said: “It should be companies like us saying ‘actually, this isn’t fair’. We did exactly what you asked us to do when you asked us to do it and…and now you’re changing to make it a little easier.
“Ultimately, this is all about safety and where is the cut off for safety?”
McCoy added: “We’re a bit cross that there’s another [on hold] list coming out and people are going to be allowed on the market who haven’t even done their clinical studies
“What the hell is that? That’s not fair to us – why should they be allowed to stay in the market again when they haven’t proved they’re safe to the consumer. I don’t know why they’re complaining.”
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