'Good science is the route to a safer and more successful CBD industry'
As Novel Food regulations for CBD products come into effect, Jersey Hemp speaks to Shomi Malik of The Association for the Cannabinoid Industry about the importance of robust, relevant scientific data in moving the industry into the mainstream
It’s fair to say there are some inconsistencies in the CBD industry at the moment. The non-intoxicating, cannabis-derived wellness supplement (full name cannabidiol) has been around for years and is hugely popular – as many as 6 million people in the UK alone had tried it in 2018, and that is only growing – yet until recently it has been completely unregulated, meaning the quality of products has varied wildly and many potential consumers still have misgivings.
A 2018 survey by UK industry body the Centre for Medical Cannabis (CMC) tested a range of bottled CBD oils – the most popular way of taking CBD – and found that while some were “very high quality and[…] good options for today’s consumers”, others showed trace amounts of unwanted elements such as solvents and heavy metals, as well as technically illegal levels of the psychoactive compound THC. Perhaps most significantly, almost 40% contained less than half the amount of CBD stated on their packaging and one expensive product, sold in a major high street chemist, turned out to contain no CBD at all.
Things have been similarly haphazard when it comes to the science behind CBD. Studies so far suggest it is broadly safe, at least for short-term use, and there is good evidence that it has real therapeutic potential for health conditions including anxiety, chronic pain, sleeping problems, certain forms of epilepsy and even some cancer symptoms. But research has been piecemeal, unsystematic and, crucially for the industry, less focused than it could be on demonstrating to policy makers that CBD is a product they can trust.
However, for those keen to see a regulated industry built on relevant scientific data, things are starting to move in the right direction, with the introduction of the first legal framework for CBD products, the UK Food Standards Agency’s Novel Food requirements.
"Products that don’t comply with Novel Foods risk being taken off shelves"
According to European Union and UK Food Standards Agency (FSA) guidelines, Novel Foods are those which “had not been consumed to a significant degree by humans in the EU before 15 May 1997” (the date when the first rules on Novel Food became active). Within Novel Food, CBD falls into the category of newly developed foods, alongside things like the plant extracts phytosterols and phytostanols used in cholesterol-reducing spreads.
Now that CBD has been classified as a Novel Food, all CBD products must be evaluated and authorised for marketing and sale. As of 1st April 2021, anyone who wants to continue selling their products in the UK must have had a valid application accepted by the FSA, which includes detailed specifications of the products and how they are made. Products that don’t comply are technically illegal and risk being taken off shelves by Trading Standards. The European Union is also intending to use the Novel Foods rules to regulate CBD sales in its member states, although it’s further behind than the UK, with each country in charge of its own timeline.
Many believe that bringing CBD under Novel Foods is to some extent a case of squeezing a square peg into a round hole, since the classification is actually designed for products that are not already part of an established market in the way that CBD is. Nevertheless, those who want a regulated industry see it as a significant step forwards.
Shomi Malik is External Affairs Director at The Association for the Cannabinoid Industry (ACI), a UK membership body and the sister organisation of the CMC, which carried out the 2018 investigations into the quality of CBD products. Despite admitting that Novel Foods is “ill-fitting” when it comes to the specific requirements of cannabis, Malik believes it’s been important to the relationship with policy makers to “meet them in the middle”, demonstrating that at least a significant section of the industry is keen to engage. For the ACI, the route to further opening up the market is by generating relevant scientific data that will help convince those policy makers, and thereby consumers, of the safety and efficacy of CBD and other non-intoxicating cannabinoids (closely related cannabis compounds). Malik is therefore critical of the vocal members of the industry he says are against regulation.
"If you want this in the mainstream, that will only happen through science"
“At the end of the day, as a trade organisation and policy advocacy group trying to push the entire cannabis conversation forward in a responsible way, for us it is pretty binary,” Malik tells Jersey Hemp. “Responsible means science-backed, and not just shooting from the hip, not just saying because [cannabis] has been around for thousands of years we can use anecdotal evidence.
“If you want this to be accepted, if you want this in the mainstream – if you want consumers understanding this because there’s a clear policy environment – that will only happen through science. That is not going to happen by a bunch of cannabis activists shouting from the rooftops ‘this is cannabis, treat us differently’. Quite the opposite – treat us the same! If I want to put a biscuit on the shelf and I’ve got to generate data to prove it’s safe, well, why don’t we do that for cannabinoids? Because we’ve approached it like this we are seeing a much more receptive environment with the policy makers.”
But what about those ‘rooftop shouters’ who are against regulation – could they have a point? Perhaps they worry that big business is going to come in and take over in an industry that is currently built on small independent producers?
Malik, who once sold CBD as part of his own small business, is not convinced. “It’s not from any ideological perspective. I wouldn’t say it’s because they believe in the right for small traders to continue trading. I think they use that because optically it’s a very nice narrative to get behind – small business versus big business – but I just think that they entered into this space thinking they could sell a product with impunity; now that regulation’s come into focus there is required investment to meet any regulatory standard and they haven’t geared themselves up [for that] – so it comes from a place of losing business but it’s dressed up as an ideological thing.”
He also believes that producers who aren’t willing to accept regulations pose the greatest problems for consumers.
"How do you make sure that the guy picking up a £90 bottle in the second largest pharmacy in the country isn’t picking up a bottle with zero CBD in it"
“It's these types of products and these types of companies that give the industry a bad name, that stunt the growth, that give publishing houses with an anti-cannabis agenda the ammunition to say ‘look at these transgressive cannabis activists that are looking to sell us products without any regulation or any enforcement’.
“How are you going to make sure that the guy picking up a £90 bottle in the second largest pharmacy in the country isn’t picking up a bottle with zero percent [CBD] in it, which is what [the CMC’s] report found. A lot of these purveyors of poor-quality products are obviously the ones that stand to lose the most, and therefore shout the loudest when regulation comes into force.”
One of the bones of contention for both producers and policy makers is defining the legal levels of the controlled, intoxicating cannabinoid THC in CBD products. CBD is produced from low-THC strains of cannabis called hemp, which in the UK are allowed to contain no more than 0.2% THC by dried weight (nowhere near enough to get you high). That level is generally reduced further by the refinement process and yet it’s impossible to completely remove all trace of THC. In many European countries, and in the US where the legal limit of THC in hemp is 0.3%, the concentration of THC allowed in CBD products is simply the same as in the plants it’s made from. But the UK being the UK, things are done a little differently.
Instead of using a percentage as a limit, Home Office rules say that any single container – no matter what it's size – can only contain 1mg of THC. To put that into context, a 10ml bottle of CBD oil containing 1mg of THC would be 0.01% THC, while a 30ml bottle containing the same amount would be 0.003% THC. So a smaller container of CBD oil would have a much higher percentage of THC than a larger one, although both would still be at a level far below what is allowed in other countries.
"Not adhering to Novel Foods is a Trading Standards issue. Not adhering to controlled substance laws is a Home Office and narcotics issue"
A widely shared misconception, however, is that levels of up to 0.2% THC are legal in CBD products in the UK, quoted by numerous websites selling those products. It’s unclear to what extent this is due to ignorance of the law or because it suits their purposes but Malik is concerned that some companies whose products contain this much THC may soon end up regretting it.
“Not adhering to Novel Foods is a food safety issue and a Trading Standards issue,” he says. “But not adhering to controlled substance laws is a Home Office and narcotics issue[…] A lot of companies are selling up to 0.2% THC [CBD products] and I expect a lot of those companies to get a knock on the door.”
However, the ACI’s aim is not to strengthen enforcement of the existing laws but to help change them.
The organisation advocates a move to measuring THC in CBD products by percentage and, due to the difficulty of accurately recording levels below certain thresholds, suggests that any products containing less than 0.03% should be treated as “zero THC” and not subject to the Misuse of Drugs Regulations. The ACI also believes that products containing between 0.03% and 0.2% THC should still be allowed to be sold over the counter.
"You need an understanding that everything will contain THC – it’s about establishing a base lower limit of what will cause harm and intoxication"
The difference between the approach of the ACI and its members compared with that of certain others in the industry, reiterates Malik, is that it is pursuing those changes by engaging with policy makers and by producing scientific data that will boost their understanding and confidence in CBD.
“Right now, any hemp-derived CBD product will contain trace elements of THC – no matter what the lab reports say in terms of ‘non-detect’ [amounts below a detectable level]. Non-detect just means my machine’s been calibrated to a set level to not detect it, it doesn’t mean that it’s absent of THC. And if there is no standardisation in the analytical world, if you send a sample off to five different labs you’ll get five different results.
“If The 1971 Misuse of Drugs Act says you’re allowed 1mg per container but there’s no statutory definition of container – is it a 10ml bottle or a ten-ton shipment of raw materials? – in that environment how are you going to adhere to the 1 mg rule. What you need is an understanding that everything will contain THC but it’s about establishing a base lower limit of what will cause harm and intoxication – and then write policy off the back of science.
“Through this science-backed approach we can say, ‘here you are Mr Home Office, you are scared of removing the 1mg rule – you are scared because you don’t know what the effects of intoxication would be because it’s never been quantified. Well, why don’t we go and quantify it and come back to you.’”
Malik is quick to point out that policy makers’ concerns are often understandable – and that, too, is to do with a lack of the right data. He references a report published by the Committee On Toxicity (COT), which advises the FSA. It claims that there are significant dangers to liver health associated with taking CBD. This has been translated directly into the FSA's official warnings about dosage limits. However, the data came from clinical trials performed using very high doses of a pure CBD medicine called Epidyolex (used to treat rare forms of epilepsy) and has since been disputed by research based on more realistic conditions for the average CBD user.
“It’s inappropriate to base safety concerns in a food setting – which is what these over-the-counter CBD products are – on clinical data because food safety data is high-frequency and low-dose; clinical data is the opposite, it is high-dose, low-frequency,” says Malik. “So from a scientific standpoint it’s borderline irresponsible, I’d say. But at the same time, if the regulators who don’t understand this compound are privy to the only data that says there are liver damage concerns, it’s perfectly understandable.”
So what are the next steps towards putting convincing data about the safety of CBD in front of regulators and policy makers? The required research demands “significant investment and significant expertise,” says Malik. But via its consortium model, the ACI is already in the midst of work that he believes will provide “first-of-its-type data that will show that CBD is safe, categorically, in a food safety setting. It’s data that will clear up a lot of the ambiguity and hesitancy.”
Others are taking a similar approach internationally. A recent study by US research company Validcare, sponsored by a group of leading US CBD producers, has produced preliminary data that suggests that in everyday settings – as opposed to clinical use – CBD has no adverse effects on liver health in human subjects.
Malik is confident there is more of this type of science to come, and that the initial impact is yet to be felt.
"We want to prove it’s better so we have better policy, so we can sell more"
“I think as the industry is incentivised to produce more data you can only see things going in the right direction,” he says. “The thing is, this is not solely an altruistic endeavour, we want to prove it’s better so we have better policy, so we can sell more. And because we’re at the beginning of this journey – it’s exactly that, we haven’t finished any of these iterations, we just started producing the data, we haven’t seen the trickle-down effects into the market.”
So is Malik optimistic about the future of the CBD and cannabinoid industry? While he admits he’s “slightly trepidatious about the next twelve months” due to the reticence of sections of the market to engage with regulation, he says things are undoubtedly moving in the right direction and he can envisage a time – whether it be in five years or in a generation – when CBD will be as mainstream an ingredient as vitamin C.
“You can take a snapshot of the market right now and say ‘bit of a joke, not enough data, no-one’s producing the data’ or you can zoom out and say ‘on a five-year timeline we’ve gone from no data and no meaningful engagement with the regulators to medicinal cannabis being legalised on November 1st 2018 and an OTC market from April 1st’. The UK is about to have the first pureplay, over-the-counter CBD market with a regulated environment, so things are improving. And both can be true at the same time.
“Things aren’t good enough right now, but things are getting a lot better – I’m really excited!”