As officials clamp down on hundreds of products, including a brand backed by David Beckham, the future could be changing for cannabidiol On Thursday, November 5, and Monday, November 9, respectively, I attended "CBD: Wonder Ingredient or Potential Snake Oil?"—a virtual workshop that covered topics related to the cannabidiol (CBD) industry overthe course of two half-day sessions. Cannabidiol is a non-psychoactive (non-mind-altering) compound found in the cannabis plant— otherwise known as marijuana. The boom of the CBD industry begs the questions, what do CBD products really do? Is there any true benefit? Or is this just another ‘cash grab’?
Is CBD a miracle cure or snake oil?
They call it the “green rush”. When 23-year-old Jonny Alberto co-founded his CBD company, The Good Level, last year, he joined a flow of fortune seekers who had built a £690 million market – the biggest in Europe, and worth more than that of Vitamin C and D supplements combined. But as with the original gold rush, as deposits were depleted and workers disappointed, it is crunch time for CBD.
If you are unfamiliar with CBD (cannabidiol), you need only look on high street shelves, where it is sold in countless formats: oils, liquids for e-cigarettes, sprays, supplements, shampoos, skincare, gummy bears, chewing gum, tampons and even dog chews. Holland and Barrett alone stocks more than 200 CBD lines, from £1.99 for a can of CBD-infused juice to £99.99 for 30ml of premium CBD oil.
CBD is one of more than 100 compounds found in the hemp plant. Unlike THC – Tetrahydro-cannabinol – it is legal in the UK, and doesn’t have psychoactive effects, so it won’t get you “high”.
Puffed up by endorsements from celebrities including Anthony Joshua, Claudia Winkleman and David Beckham (who bought a five per cent stake in the company Cellular Goods), CBD rapidly rose in popularity following the legalisation of medicinal cannabis in 2018.
Customers come to Alberto’s shop in west London to buy CBD oils and balms they hope will solve sleeplessness, anxiety or chronic pain. But if they ask Alberto what CBD does, he’s not allowed to tell them. “It’s tough. We don’t recommend doses anymore, and making medical claims is not something we’re allowed to do.”
CBD is what the Government labels a “novel food”, meaning it has no history of consumption before 1997 (even if some experts argue otherwise). It’s not a medicine, owing to a paucity of clinical evidence, and it cannot be marketed with health claims – but Alberto says some sellers get around this by saying “it may help, or has a possibility to help” with certain conditions.
Now The Food Standards Agency (FSA) has begun to regulate the market and has published a list of sanctioned CBD products that “have a credible application for authorisation”. They have been assessed based on scientific information including compositional data and a toxicology report. More than 900 applications were submitted, but only “around 70” made the cut. Those that didn’t succeed lacked credible information or did not submit it in time. Products not on the list – including those from Beckham-backed Cellular Goods – must be removed from sale.
A report from Emily Miles, the FSA’s chief executive, to the board in December 2021 identified the potential for “adverse side effects” from CBD based on a report from the Committee on Toxicity and said “the quality of applications was lower than we anticipated… While we haven’t yet been shown enough evidence to say that CBD is unsafe, nor is there enough evidence to show that it is safe.”
Professor David Nutt is the UK’s foremost expert on neuropsychopharmacology and the author of a new book, Cannabis (Seeing Through the Smoke): The New Science of Cannabis and Your Health. “If you put it to a survey, you’d probably find 50 per cent of people using CBD say it improves their sleep. In my mind, that’s pretty good evidence. But it’s not a clinical trial.” In any case, he insists CBD is “ridiculously safe”.
The lack of clinical trials shouldn’t matter, he argues, as CBD is sold as a health supplement rather than a medicine. “We don’t demand most of the things you buy in food shops to have a pharmaceutical analysis of purity.”
The new legislation has caused problems for entrepreneurs. Tony Calamita, CEO of Love Hemp, has spoken of his struggles to open a bank account in a climate of mistrust for CBD brands. A market that was experiencing double-digit growth has nosedived; share prices for Cellular Goods have tumbled by more than 80 per cent in the past six months.
Yet despite the fact that sellers can’t brag about CBD’s benefits, there is no shortage of anecdotal evidence or users willing to evangelise on its behalf. It is pitched as a panacea for all manner of modern ills, and said to alleviate anxiety, insomnia, inflammation and low mood. Users fervently swear that it treats conditions as varied as arthritis, PTSD and Crohn’s disease.
Over-the-counter CBD is different to medical cannabis, which includes the high-strength CBD legalised for the treatment of certain rare types of childhood epilepsy in 2018.
This is where it gets technical. “What you’re buying over the counter is pure cannabidiol extract,” says Nutt. “There is a difference between cannabidiol which is extracted from the cannabis plant, and cannabidiol which is part of the hemp plant, where you get all the other elements to get what we call the ‘entourage effect’. The former is legal, the latter is controversial. My belief is that the whole plant is better than the pure extract.”
Alberto is one of a handful of sellers making “full spectrum” CBD oil, which contains the other compounds Nutt refers to, but still no more than the legal limit of 0.2 per cent THC. His company is excluded from the FSA’s clampdown on a technicality, as cold-pressed CBD oil is not subject to the same laws as oil extracted by different methods. For businesses and consumers, the rules are hazy.
“CBD sellers are in a double bind… it’s a lose-lose situation for them,” says Nutt. “[The FSA] is looking for reasons not to allow it rather than ways to facilitate it… because it’s got the word ‘can’ in it, ‘can’ is cannabis, and cannabis is dangerous.”
As with any industry, Alberto says there are goodies and baddies. There are cowboys “just trying to make a quick buck”, he says, “and those are the people that the FSA needs to kick out. The good guys in the industry really want the legislation to come in… There are big players on the market who have illegal amounts of THC. The FSA are starting to shut people down – there are a few that have been shut already.”
Research conducted by the Centre for Medicinal Cannabis in 2019 found almost two-thirds of the over-the-counter CBD products analysed contained less than 90 per cent of the CBD advertised on the label, some contained more, and 45 per cent contained illegal levels of THC.
If you look closely, is the over-the-counter CBD market little more than a puff of hot air? Even Nutt admits there is a placebo effect at play. “If you’ve got a little bit of anxiety, maybe 30 milligrams of CBD might have a similar effect as having a drink. It probably isn’t going to work, but who knows? It gives you some moral courage.”
Other experts say no, over-the-counter CBD almost definitely won’t work. “I think it just caught on in the public imagination, despite the fact that we’ve only ever seen therapeutic benefit with very high doses, and they’re still very early trials,” says Lucy Chester of King’s College London’s department for psychosis studies. “If someone finds something they think is working for them, then it works – but there’s just not the evidence behind it.”
Dr Mikael Sodergren, head of Imperial College London’s Medical Cannabis Research Group, has been treating patients with CBD and medical cannabis at his Harley Street practice since it was legalised. The medical CBD prescribed in his clinic, he says, bears no resemblance to “wellness products”, which are of unknown quality.
“The CBD we prescribe as medicine has to undergo GMP [Good Manufacturing Practice] processing and tick all the boxes for the Medicines and Healthcare products Regulatory Agency. Neither of those things are applicable to high street CBD, which is essentially unregulated,” he says. “The third point is that the doses we use medicinally are an order of magnitude higher.” Participants in a study for the efficacy of CBD might be given 600mg in one dose, whereas the FSA (and so CBD brands) suggest no more than 70mg over the course of a day.
Extracting CBD from the hemp plant is an art as well as science, and some variation is natural. “CBD is what we call a ‘dirty drug’ – it affects lots of different receptors, but not the ones you’d think,” Chester says. “One of the reasons CBD research is quite confusing is we’re still not entirely sure how it works.”
If it’s a con, it’s a convincing one. As well as those who say CBD improves their sleep and reduces anxiety, people say it can cause physical healing of biblical proportions. “There was one guy who came in the other day who had had a stroke seven years ago and hadn’t been able to walk properly since,” says Alberto. “And four or five days later he returned and said, ‘I can’t believe it.’ So for those people, it really changes their life.”
Depending on who you ask, CBD is snake oil, a medical miracle, a rip-off or a wonder drug. The watchdog is wary, but CBD has already captured the consumer’s imagination.
Alberto insists CBD will become so widely accepted that it’s as commonplace as echinacea or multivitamins. “In some states in America, people have it in the medicine cabinet, just in case someone’s got a headache or someone’s in pain,” he says. “That’s where it’s going to go in the UK.”
Only time – and, hopefully, research – will tell if his optimism will pay off.
Workshop: “CBD: Wonder Ingredient or Potential Snake Oil?” A Student Perspective
On Thursday, November 5, and Monday, November 9, respectively, I attended “CBD: Wonder Ingredient or Potential Snake Oil?”—a virtual workshop that covered topics related to the cannabidiol (CBD) industry overthe course of two half-day sessions. Cannabidiol is a non-psychoactive (non-mind-altering) compound found in the cannabis plant— otherwise known as marijuana. The seminar could not have been timelier given the fact that on Tuesday, November 3, 2020, New Jersey voters approved Public Question 1, which legalizedthe use of adult recreational marijuana in the state—a decision that could boost the New Jersey economy by as much as $126 million annually. This event was made possible by the Rutgers University Center for Dermal Research and its esteemed director, Dr. Bozena Michniak-Kohn, and focused on issues ranging from regulation to manufacturing to intellectual property.
CBD: Wonder Ingredient or Potential Snake Oil? Day 1
To kick off this insightful event, Dr. Daniel Siegel, a clinical professor of dermatology at SUNY and Chief Scientific Officer (CSO) for the scientific advisory board of Greenway Therapeutics—a medically focused biopharma company—gave a presentation titled “Therapeutic Potential of Cannabinoids in Dermatology and Beyond.”
Siegel, along with Greenway Therapeutics president and CEO Michael Milane, MD, has pioneered a new product called Canno TM Cream, which features a nanoparticulate CBD cream that seems to be effective and fast-acting in reducing redness and inflammation of the skin.
Continuing the momentum from the first speaker, David Steinberg, president of Steinberg & Associates, a cosmetic regulatory consulting firm specializing in concept-to-market compliance for topical and OTC products, gave a comprehensive overview of the CBD regulatory landscape.
Next, Keith Woelfel, the director of research and development (R&D) for Caliper Foods, a consumer packaged goods (CPG) company, addressed a truly complex topic in his presentation “CBD: CMC (chemistry, manufacturing, and controls) Challenges.” He provided insight into a critical issue, which is the irregularity of testing for purity and extract percentages of CBD. Different labs may come up with different results, and the exact science for testing still needs to be refined, streamlined, and regulated into one singular system. Caliper has made it their mission to refine and master this process. Rounding out the first half-day session, Shahnam Sharareh, Esq., a patent attorney with , enlightened us about the many intellectual property issues surrounding the CBD industry.
Day 1: Summary – CBD can be a wonder ingredient if used for the right purposes. The industry is working its way through some regulatory struggles, which are exacerbated by companies making unchecked and unverified claims about the benefits of their products. By coming together and setting the best practices for testing and processing, the industry can head in the right direction.
CBD: Wonder Ingredient or Potential Snake Oil? Day 2
The second session on November 9 began with a panel discussion, “Corporate Banking, Employment, and Investment Considerations,’ which featured several partners of law firm Fox Rothschild LLP, which specializes (among other things) in cannabis law, environmental law, intellectual property, and regulatory and compliance issues . Moderated by Shahnam Sharareh, who also holds a doctorate in pharmacy (PharmD), panelists included attorneys Jonathan Lagarenne, who discussed corporate banking, Bob Nagle, who discussed employment and HR considerations, and Mark Yacura, who discussed regulatory and due-diligence considerations.
After a brief break, Fox Rothschild LLP partner Joshua Horn gave a comprehensive overview of the ever-evolving CBD landscape in his presentation “CBD Update on the Latest Importation, Transportation, and Intrastate Sales and the Ever-evolving Matrix of State Compliance Regulations,” and referenced industry stakeholders including the United States Department of Agriculture (USDA) and US Food and Drug Administration (FDA). The FDA has had to tighten restrictions on serious claims made by companies that produce CBD ingestible—statements such as, “this CBD tablet will cure your cancer!” However, they have not really tackled the topical field (lotions, creams, etc.).
A high-level view of the CBD process from farm to consumer.
In the final session, Robert Falcone, senior manager of regulatory affairs at Prestige Consumer Healthcare, outlined many FDA and USDA perspectives on CBD and hemp-derived CBD products. We explored how the 2014 Farm Bill initiated a pilot program for hemp growth and usage, and how the 2018 Farm Bill expanded upon that for commercial production. There are still many questions that remain about the safety of CBD, and Dr. Falcone posed some of the more interesting, intricate, and important questions that require research and clinical trials in order to answer.
Day 2: Summary While CBD can definitely be of use and is not outright harmful to the body, it is important to study every aspect of the chemical and how it may affect the body over a long period of time. Another amazing development in the world of CBD has been the approval of Epidiolex—the first CBD drug approved by the FDA which can be used for individuals with two subtypes of epilepsy that are commonly associated with seizures.
CBD has the potential to be a wonder ingredient that might be able to help with anxiety, pain, and skin disorders. However, the field is saturated with products that make false claims that—while harmless to the consumer (aside from the money they waste buying a product that has no benefits)—serve to discredit the true value and curative properties that many CBD produces may possess. In this sense, CBD can be a snake oil. More safety studies, tighter regulation, and investigation into how CBD works and helps in the body will help pave the way for CBD to distinguish its place as a medical therapy. In the meantime, there are a number of CBD products out there that can be a useful remedy, just make sure to do your due diligence and research as a consumer!
CBD, ‘Snake Oil’ or Life-Changing?
This week Volteface examines the emerging and seemingly booming CBD industry. In this piece we had the opportunity to discuss the topic with Paul Moore, patient advocate and Chief Executive Officer at Green Machine CBD. Moore discussed the vast potential applications and benefits that the CBD business offers to both the UK and Europe.
CBD is a non-psychoactive compound found in the cannabis plant. Unlike THC, CBD is legally sold over the counter as a wellness product or ‘novel food’. As aforementioned, due to not having psychoactive properties, CBD products will not get the user ‘high’. Whilst this classification as a novel food forbids companies from making medical claims, the product is licensed in two MHRA-approved medicines, Epidiolex and Sativex.
Whilst novel food companies cannot make medical claims, this has not stopped CBD users from reporting a plethora of benefits. Popular belief in this new-age medication is undeniable: In the first four months of 2020 alone we have witnessed £150 million pounds spent on CBD products in the UK alone. This interest in the emerging CBD industry is further reinforced by the 8 million British citizens who now buy CBD products.
CBD is now legal and available in over 10 countries including the UK and USA, while almost all other cannabinoids in the UK are controlled substances under the Misuse of Drugs Act 1971.
However, while this certainly indicates an interest in these products, this is far from evidence of their legitimacy. We have all seen the huge emergence of beauty and culinary CBD products in the UK, however what do these products really do? Is there any real benefit? Or is this just another industry ‘cash grab’?
Mike Power writing for the Guardian in 2019 refers to CBD salesmen as the “snake oil salesmen of the modern wild west” citing many examples of the undeniable ‘cash grabs’ which have emerged from the CBD industry. The most notable example was the sale of ‘CBD water’ sold in clear bottles resulting in the CBD swiftly degrading due to the sensitive nature of the compound.
By Power’s own admission, however, the health benefits of CBD (like THC) are undeniable as we have seen by not only the reforms in the UK but across the world.
The findings of this report have only been further reinforced by the animal testing of CBD products. As these studies indicated, CBD could be used to treat a multitude of medical conditions. These range from Alzheimer’s, Parkinson’s, Huntington’s disease and even a reduction in the growth of cancer.
It is important to highlight here that we live in a free market society. Thereby in any industry some ‘cash grabs’ will emerge, particularly when there is lots of money to be made. Thus these ‘cash grabs’ do not diminish the value of legitimate CBD brands. One such example of a legitimate CBD brand to flourish since the initial boom is CBD business Green Machine, run by Paul Moore.
Volteface spoke with Moore about how he became involved in the CBD industry and the challenges that CBD businesses in the UK face in 2021.
Moore began his journey in 2016 after he was diagnosed with rheumatoid arthritis. Doctors told Moore that his only option was strong steroids and treatment which would leave him hospitalised for 2 weeks every 2 months, as well as wheelchair bound just 6 months after starting his initial treatment.
Therefore, seeing the ludicrous physical cost of these treatments, Moore began investigating alternative forms of relief. This interest in turn led Moore to investigate the vast potential applications of cannabis-based medicines.
When exploring alternative medicines, Moore personally witnessed the vast power and application of cannabis-based medication through CBD. As previously mentioned, while other cannabinoids remain illegal in the UK, CBD is not and therefore Moore saw an opportunity to help others just like him in a legal and safe environment. Moore went on to open not only his first CBD store but additionally the UK’s first CBD dispensary in 2017.
When opening a CBD business, Moore emphasises that his primary goal and intention is to support medical patients being failed by traditional clinical medical treatments. Moore also highlights the important role CBD businesses and their owners play in educating the public on cannabis-based medications and their legitimacy.
“When entering local communities Green Machine was met with the same criticism one would expect from opening a new cannabis based business. These complaints largely stemmed from parents considering me as some kind of ‘drug dealer’ accusing me of encouraging drug use. However rather than arguing with these individuals I would offer them to sign a petition for my shop’s removal. I did this under the condition they would sit down for a coffee and give me the opportunity to educate them on what my business does. If they were still unsatisfied, they were welcome to sign the petition.”
This education and patient-focused attitude have clearly succeeded as Green Machine is yet to have a single store removed. Additionally, Green Machine is now expanding to 13 stores by 2022. The company currently holds 10 stores across the UK with 7 located in London alone.
However, while Moore and his business have been met with huge success, unfortunately UK and global legislation makes running CBD business a difficult task. The first legislative obstacle highlighted by Moore is the ‘novel foods status’, where a novel food is defined by food.gov to be as follows.
The issue here is any food that is dubbed ‘novel’ as a result of this definition is then required to be authorised before they can be placed on the UK market. In order to gain approval a novel food therefore must follow one of the two routes retained under EU law, a traditional food notification or a full application.
As of 2019 CBD was classified a novel food and therefore any CBD extract products must apply for authorisation using the procedure for full applications outlined on the government website. This adds an additional challenge for CBD businesses in the UK; with ‘red tape’ and testing standards set so high, it is virtually impossible for small businesses to accommodate.
This is evident by the fact as of April 2021, over a year after the novel food applications were requested from CBD business; only three businesses have successfully qualified . Moore additionally highlights that this constant need to tamper with CBD-based products to render it acceptable for the novel food requirement diminishes the medicine’s efficacy..
“Think of it like frying broccoli. If you cake it in oil and fry it you’ve lost most of your nutritional benefits. In the same way if you put THC or CBD product’s through intense clinical processes you are losing some of the product’s benefits, for example in the UK when medical cannabis is blasted with ionising lasers resulting in worse quality cannabis for medical patients.”
Interestingly, while a patient advocate and Cancard holder, Moore was not always a cannabis advocate. In his younger years, he recalls friends and family being consumed by cannabis, and was subsequently apprehensive to engage with the drug. However, through research following his diagnosis it became increasingly clear that cannabis did not take his friends’ lives away- Rather the responsible party was outdated laws and legislation which have flooded UK streets with dangerous and poorly prepared drugs. We can see evidence of this thesis in a study conducted by King’s College London, which found that 95.9% of seized cannabis in London in 2016 was ‘Sinsemilla’ or ‘Skunk’.
When speaking with Volteface, Moore highlighted how the potential benefits of cannabis range far beyond the physical and mental health of individuals. Moore has now begun investigating how cannabis and hemp can be applied in sustainability efforts to craft a more environmentally friendly and sustainable future. These discoveries have come through his new venture ‘Viken Eco’.
Named after the beautiful village Viken in Sweden currently being damaged by the effects of climate change, this venture focuses on the vast sustainable applications of ‘hempcrete’ for both the construction of houses and their insulation. Moore will additionally be donating the proceeds from this venture to charities working to save animal habitats and building coastal erosion solutions.
Hempcrete is a sustainable substance made from the stem of hemp plants being mixed together with a binder. Hempcrete acts as an excellent building material as it can be both mixed on site and pre-cast off site to form blocks or panels. In addition to being very hard and self-supporting once set, hempcrete is not load bearing, due to the air trapped within the material and the slightly flexible nature of the hemp shiv aggregate. Hempcrete additionally holds a medium density, which means it provides both insulation and thermal mass within the same material.
Moore’s words and insights only further highlight how underused and explored the vast potentials of this plant are. Therefore, one can only conclude that to dub CBD as a ‘snake oil’ seems to ignore both clinical and academic evidence, and patient testimonials.
Moore himself was told he would be left wheelchair bound just 6 months after his available NHS treatments, yet through the power of medical cannabis and CBD treatments, Moore has been able to continue not only walking but creating a life supporting and sustaining business.
This piece was written by Cameron Akerman-Roberts, tweets @AkermanCameron.
An amendment to this piece was made on December 3rd.