Proving CBD’s Safety in the UK
CBD has never been more popular in the UK. According to recent market research, more than 8 million Brits bought into the cannabis chemical in the first four months of 2020, spending more than £150 million in the process.
But despite trading on ideas of wellness and tranquility, the industry is far from calm.
Back in January last year, the European Commission announced that products containing cannabis extracts should be considered as “novel foods,” and so shouldn’t be sold without further testing and a novel foods authorization from the European Food Safety Agency (EFSA).
The following February, the UK’s own Food Standards Agency (FSA) concurred and announced that any CBD oil, drink, or treat without its own novel foods approval will be “taken off the shelves” by March 2021.
But then, if all that weren’t enough, just this July, the European Commission paused over of its 50 CBD novel applications to review whether hemp-produced CBD should actually be classified as a narcotic or not.
Yet, for all this uncertainty, there could be opportunity. As the UK’s Brexit transition period is scheduled to end by January 2021, it’s thought that CBD companies operating in the UK will be exempt from the European Commission’s recent decision. As such, the immediate future of the continent’s CBD market could be in the hands of UK companies – but only if they can first pass their novel foods review from the FSA.
And to do that, many have sought the help of the Association for the Cannabinoid Industry (ACI), a prominent CBD trade body in the UK that represents such brands as Charlotte’s Web, Materia, and Mile High Labs.
To find out more about their safety studies, the future of CBD in the UK, and what it takes to pass a novel foods assessment, Analytical Cannabis caught up with the ACI’s regulatory lead, Dr Parveen Bhatarah.
A good novel
“In order to give a fairly bespoke individual support to our members, we set up in-house consultancy to assist the regulatory matters,” Bhatarah tells Analytical Cannabis.
To begin an FSA novel foods application, a CBD producer must first gather records on its lab standards, regulatory compliance, and the state of its testing equipment. Other details, such as a company’s labelling commitments, hemp biomass intake controls, testing requirements, and CBD isolate specifications, may also be required. And when an applicant is a member of the ACI, these records can be sent straight to Bhatarah for review.
“What I realized was that all parties in the CBD space were saying, ‘I need the novel food application, I must have the novel food application,’” she says. “And when you have that initial discussion, they say, ‘Yes, we have a very good process.’ But when we start talking to them in one-to-one discussion, we realize that actually some of the companies are very naïve – they need a lot of handholding to take the novel food application for the CBD.”
But even if a company’s production and testing processes are watertight, and their novel foods status looks promising, there’s a concern that their product will still be scrutinized. After all, the FSA has already advised anyone who is pregnant, breastfeeding, or taking medication not to consume CBD products. And over in the US, the US Food and Drug Administration has previously warned that CBD-containing products “have the potential to harm” consumers.
So, determined not to take any chances with its members’ applications, the ACI also launched its own series of studies into CBD’s safety this June.
“It is important that we have all the safety data in place for regulators to satisfy any concerns about the CBD,” Bhatarah tells Analytical Cannabis.
“In order to do so, it's important that we generate all the safety data to support that information and declare that the product which we are bringing to the market is safe.”
Working with the formulated products company Advanced Development & Safety Laboratories, Bhatarah’s team will analyze CBD products submitted by member companies with high performance liquid chromatography (HPLC) techniques.
A 90-day-long rodent study will then be conducted, which will assess the effects different means of delivery (ingestion, absorption, and inhalation) can have on the liver, and if there are any groups (children, adolescents, pregnant women) vulnerable to CBD’s effects.
All findings, data, and toxicology reports will then be shared with the FSA and other regulatory authorities.
“It's very important when you are analyzing primary CBD that, [for] your end users and consumers, it is safe and has no issues attached to it,” Bhatarah says.
While the original plan was to collect data from four categories – CBD isolate, narrow spectrum, broad spectrum, and full spectrum – the study has since been downscaled to include just two product types.
“One will be the CBD isolate, one will be CBD food spectrum,” Bhatarah clarifies. “And we will be starting the tox[icology] data fairly soon in August; we have already made arrangements.”
Setting a standard
The ACI’s toxicology studies may just be beginning, and the FSA’s deadline may be looming, but that hasn’t put Bhatarah off from immediately jumping into some more CBD research.
“So [all] that will be the first aspect of the novel food application. And then there is a long-term effect; what is the safe THC limit?” she tells Analytical Cannabis. “And that is a very interesting question that I really would like to answer. And the real answer will be if I do that THC-tox study.”
Such a foundational study certainly wouldn’t go amiss when regulators are increasingly considering the safety of cannabis extracts. After all, the European Commission only recently announced its preliminary view that extracted CBD should be considered a narcotic and adjourned over 50 novel foods applications from CBD companies as it makes its final decision.
While an immediate blow for the involved companies, the wider implications are even more chaotic; if the new narcotic stance is formally adopted, all hemp-derived CBD could be banned from the European Union’s single market, which would jeopardize hundreds of European businesses.
But, as the UK’s will formally leave the EU’s customs union and single market come January 2021, the country’s own CBD companies are currently exempt from such concerns. So, although at the expense of European peers, UK companies could find themselves the ‘industry leaders’ of the continent, and the ACI’s research could become even more exemplary.
“I'm surprised [the European Commission] have taken that decision. I think it's just too late,” Bhatarah says.
“However, I had long discussions with the FSA on that, [which] have views that we can't be party to the EU decision because of Brexit now, and [so] we are continuing with applications here in the UK. And, in fact, they are working at a pace to ensure that they will be able to review and validate applications in time themselves.”
“My view is that although I didn’t like their decision, the EU’s decision, on the other hand I feel that it is the absolute golden opportunity for [the] UK to set the roadmap for the rest of the world for the CBD industry, and show the path for the future.”
This article originally appeared in Analytical Cannabis' Technologies and Techniques for Cannabis Testing eBook in September 2020.