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​​Chaos in cannabis: is the Novel Foods process fit for purpose?

Chris Tasker of Global Cannabinoid Solutions explores cognitive bias, synthetic compounds, the endocannbinoid system and animal testing in cannabis.

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​​Chaos in cannabis: is the Novel Foods process fit for purpose?
Home » News » CBD » ​​Chaos in cannabis: is the Novel Foods process fit for purpose?

In this article, Chris Tasker, founder of Global Cannabinoid Solutions discusses the Food Standards Agency’s (FSA) Novel Food process and the complexities surrounding regulation.

Imagine this scenario, you are bringing new wave products to the UK. These products have been illegal for 50 years prior and only recently given the government go ahead. You want to destigmatise these products and help the public understand these products.

How on earth do you meaningfully reconnect your products with the British public? The fringe of Cluadia Winklemen was one of the first clear advertising assets for the CBD realm to leverage and one that meant that the masses have finally been introduced to the novelty of CBD.

Read more: Mixed response from CBD industry to publication of FSA product list

As someone who has researched this molecule in the lab and studied its properties in gut conditions and in colon cancer, I am a big fan of CBD and cannabinoids. However, the industry narrative that has been built overlooks a great deal of the fundamental science. Best estimates place the bioavailability of CBD at approximately 6 to 10 per cent, meaning just  a tenth of what is consumed is actually absorbed and utilised by the body (Lim et al., 2020; McGilveray, 2005; Millar, Stone, Yates and O’Sullivan, 2018; Xu et al., 2019).

A cautionary note to all of those operating in this space and trying to position themselves strategically for the future: cognitive bias is rampant in novel debates such as this. Politicians and professionals alike are highly susceptible to making these mistakes. How many of the below cognitive biases have you seen in the cannabis industry?

Image courtesy of: https://www.mercatus.org/publications/regulation/behavioral-economics-and-biased-regulators

Is CBD a drug, is it dangerous? No, it’s a novel food

The regulation of cannabinoid products has caused quite a stir for the CBD industry. You can cut the confusion with a knife at the money, for consumers and businesses alike. Confusion is because the facts are shaky and the cannabis debate has been limited by the delegation of CBD as a novel food. Current international scientific knowledge has surpassed the UK’s government interpretation of CBD and THC, leaving our policy decisions falling far short of the mark. 

Read more: Could ACMD recommendations put the UK CBD market out of business?

How often do you start a book and read just the first page? Would you then subsequently be able to draw conclusions about the contents of the book and proceed to make regulations on that basis? It’s a risk.

The cannabis industry, if the truth be told, would love to be selling THC, hoping to see the same profits of adult cannabis consumption following the trends of North America. 

The Home Office has made a very clear distinction that “CBD good, THC bad”. Rather harsh given they are chemical twins that share the same chemical formula (C₂₁H₃₀O₂). There is, however, much more to this story than what the Home Office permits (*cue iceberg). 

The job of reigning in the CBD sector and tackling the tip of the iceberg has been delegated to The Foods Standards Agency (FSA). In doing so, the debate has been limited to a conversation around CBD as an ingredient. This overlooks decades of research and intelligence that we hold around cannabis. 

The Endocannabinoid system (ECS) is the inconvenient reality that is confusing the industry space. CBD seems like a small molecule needing only a simple fix, but, it is part of a far larger story – the ECS. If we are to treat this molecule as a “novel food” we should surely be looking to apply novel testing methods. There are a few considerations to the novel foods testing approach that warrant a little further discussion and context.

The ECS

Little, if any, of the expensive toxicology data seems to have factored the ECS into the testing process. Given that cannabinoids such as CBD are actively interacting with this system and its receptors, it would be pertinent to explore and understand the impact of these ingredients on this fundamental physiology. 

The ECS is the entire basis for CBD products. This represents a large oversight in the study process if this has not been investigated. This system is present in every cell in the body and is fundamental to human health and the efficacy of cannabinoids in the body. Could these products be altering or damaging the ECS in some way? We do not know.

Animal models

There has been a lot of prideful flaunting of toxicology data since the first wave of progress updates from the FSA. 

It is worthwhile noting that animal models do not provide the most clear-cut data. Early toxicology testing is often performed using animals to simulate the effects of a new substance on the human body. Interestingly, one of the main criticisms of early cannabinoid research has been that the majority of data exists in the form of animal and cell models. 

The reliability of animal models is under increasing scrutiny with literature reviews highlighting the poor quality of animal data as well as the limitations of using this data to draw conclusions about humans (Bracken, 2009). The differences are pretty clear when we consider we are comparing the effect of a product on a rat in a cage with a human in a complex 21st century environment.

The use of animal models has been questioned since their early introduction into medicine. Despite their wide use, three major conditions undermine this confidence and explain why animal experimentation, regardless of the disease category studied, fails to reliably inform human health: (1) the effects of the laboratory environment and other variables on study outcomes, (2) disparities between animal models of disease and human diseases and (3) species differences in physiology and genetics (Akhtar, 2015). 

Animal model research can have varying results depending on the methods being deployed. The methods used in animal studies that do not appropriately use randomisation and blinding are more likely to report a difference between study groups than studies that employ these methods (Bebarta, Luyten and Heard, 2003). 

A large portion of animal studies usually fail once they are moved into humans due to bias or to the failure of animal models to mimic clinical disease adequately (Perel et al., 2006). This doesn’t paint a tremendous picture for the efficacy of the studies in the Novel Foods process but, wait, there’s more.

A 2019 paper by Van Norman reviews some of the holes in the animal model rationale and the potential impact of these false conclusions. The implications for making the wrong decision regarding animal testing and drugs are 1) falsely identifying a toxic drug as “safe” and 2) falsely labeling a potentially useful therapeutic agent as toxic (Van Norman, 2019) .

Within this study the author references some of the notable examples of cases in which animal trials did not predict severe human toxicity. 

Isuprel for treatment of asthma caused over 3,500 deaths in Great Britain alone, despite safety in rats, guinea pigs, dogs, and monkeys, all of which had received doses far exceeding those administered in humans. Thalidomide caused devastating phocomelia in an estimated 20,000 to 30,000 infants before it was withdrawn. Animal tests failed to reveal significant teratogenicity in 10 strains of rats; 11 breeds of rabbit; 2 breeds of dog; 3 strains of hamsters; 8 species of primates and various cats, armadillos, guinea pigs, swine and ferrets.”

Another question to ask is around the reproducibility of animal studies even within species whicheven when carried out under rigorous protocols, is questionable.” 

Using a database of more than 800,000 animal toxicity studies performed for 350 chemicals under rigorous guidelines, a reviewer found toxicity was repeatable just 70% of the time in the same species. Another reviewer found that results for a single chemical often differed with animal model, strain, dose and delivery route. About 26% of chemicals demonstrated contradictory results on repeat testing in the same species. ….. Although animal toxicity testing has been the stalwart basis of “ensuring” safety of in-human clinical testing and use, examination of the published data raises significant questions about whether it is reliable and should be abandoned or at least significantly curtailed in favor of other potentially more reliable methods.(Van Norman, 2019).

I encourage you to read more about this subject for yourself. Animal studies are an interesting approach but not the only approach available to the FSA. My final note on the point of animal studies is that there is also often no measure of the number of animals used in a trial. Given the scale at which this testing is also taking place and as a nature enthusiast, I would be keen to see the furry toll of this expensive process. 

Synthetic and plant derived CBD

Now, although CBD may be deemed as “novel food”, the source of that molecule is also important. If we are concerned about plant-derived cannabinoids, there is even less data on synthetic cannabinoids in humans. 

A recent study was unable to find any difference in their effects in cells, but this area I would argue deserves additional diligence as some of the synthesis processes are truly novel. Synthetic CBD will certainly have a future due to the potential efficiency of production but we are only in the early phases of understanding the impact of these compounds.  

I would hope that given the added novelty of synthetic CBD, perhaps more substantial testing may be warranted given our understanding of synthetics versus plant-derived ingredients. The safety of plant-derived CBD and other phytocannabinoids has been demonstrated in humans numerous times. 

There is certainly a heavy focus on the cannabinoid elements which are not where the majority of risk really lies. Given what we do know about the safety of plant-derived CBD, the safety concerns around cannabis products revolve mostly around contamination through heavy metals, pesticides, fungi and extraction residue, not the CBD itself. I will swiftly follow this up by stating what could be dangerous is the inadvertent mixing of CBD with prescription medication causing accidental toxicity.

Concerns were initially around liver toxicity. Initial data which encouraged further toxicity studies due to liver toxicity was supplied by GW and based on their epidiolex drug which contains ethanol which may have been a contributing factor.  

Unfortunately, in the stampede to open up and regulate the market, little has been produced in the way of consumer-friendly information, leaving consumers at the mercy of the industry.  The spectrum of perspectives and pools of conflicting information make this conversation incredibly hard to navigate for newcomers.  

Taking a step back

The FSA is in need of a lot more help than they are getting. The decisions being made are going to have billions of pounds of impact over the coming years. Distilling a complex societal cannabis conversation down to CBD as a novel food comes with a lot of wider contextual considerations.

The FSA has been given the Impossible task of regulating the complex cannabinoid products using an area of science that is still being untangled by researchers due to prohibition-related delays in research.  

Was this the most efficient proposal for such a large volume of companies given that each dossier typically takes a year to be assessed?

It seems that the product-side of the conversation has overshadowed the discussion around building clear public safety measures and information for consumers. Given the first guiding principle of the FSA is public safety, equipping consumers with the appropriate tools to hold the industry and its products accountable would be a fundamental step in this safety process.  Granted, there is a 1.5 page document for consumer guidance, but this is comparatively dwarfed by volume of the marketing content. 

As we have chosen to treat CBD as a novel food, we should be utilising similarly advanced  assessment methods to move with the rate of scientific advancements. This could include the ECS data and mechanisms underlying the effects of CBD which are still unknown to science.

About this article

A large part of what we do is harm reduction at various levels of society and this article is our appeal to the industry to take the science behind this sector seriously if it wants to compete internationally. 

This sector has so much potential but we are currently being tied in knots. We are a long way from where we should be and a great deal of the wider cannabis science is being overlooked. With all of its resources, I do hope to see the UK learn from these early teething problems and begin to lead this sector on the global stage. 

Decriminalising the wider population for cannabis possession and investing in endocannabinoid research would be a great start. We established Global Cannabinoid Solutions to arm entrepreneurs in this space with the science of cannabis to help them navigate these knowledge gaps and avoid some of these common pitfalls. If you are struggling with this sector, speak to us. 

Are you or your company:

  • Overwhelmed by conflicting cannabis information?
  • Frustrated by the lack of progress in your cannabis business?
  • Unsure where to invest your time and money?
  • Seeking to develop your knowledge of cannabis?
  • Struggling to differentiate your brand?

Then drop me an email at [email protected] to see how we can help you overcome these challenges.

       

References:

  • Akhtar, A., 2015. The Flaws and Human Harms of Animal Experimentation. Cambridge Quarterly of Healthcare Ethics, 24(4), pp.407-419. 
  • Bebarta, V., Luyten, D. and Heard, K., 2003. Emergency Medicine Animal Research: Does Use of Randomization and Blinding Affect the Results?. Academic Emergency Medicine, 10(6), pp.684-687.
  • Bracken, M., 2009. Why animal studies are often poor predictors of human reactions to exposure. Journal of the Royal Society of Medicine, 102(3), pp.120-122.
  • Lim, Sin Yin, et al. “Model‐Based Analysis of Cannabidiol Dose‐Exposure Relationship and Bioavailability.” Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, vol. 40, no. 4, Apr. 2020, pp. 291–300, 10.1002/phar.2377. Accessed 4 May 2022. https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/phar.2377 
  • Millar, S., Stone, N., Yates, A. and O’Sullivan, S., 2018. A Systematic Review on the Pharmacokinetics of Cannabidiol in Humans. Frontiers in Pharmacology, 9.
  • Perel, P., Roberts, I., Sena, E., Wheble, P., Briscoe, C., Sandercock, P., Macleod, M., Mignini, L., Jayaram, P. and Khan, K., 2006. Comparison of treatment effects between animal experiments and clinical trials: systematic review. BMJ, 334(7586), p.197.
  • Van Norman, G., 2019. Limitations of Animal Studies for Predicting Toxicity in Clinical Trials. JACC: Basic to Translational Science, 4(7), pp.845-854. 
  • Xu C, Chang T, Du Y, Yu C, Tan X, Li X. Pharmacokinetics of oral and intravenous cannabidiol and its antidepressant-like effects in chronic mild stress mouse model. Environ Toxicol Pharmacol. 2019 Aug;70:103202. doi: 10.1016/j.etap.2019.103202. Epub 2019 May 30. PMID: 31173966.

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JM Wholesale sees 750 products included on FSA CBD list

The CBD stockist has described the development as a milestone for the company.

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JM Wholesale sees 750 products included on FSA CBD list
Home » News » CBD » ​​Chaos in cannabis: is the Novel Foods process fit for purpose?

Following a partnership with the European Industrial Hemp Association (EIHA) and active participation with the Food Standards Agency (FSA), JM Wholesale has had more than 750 items included on the public CBD list.

Earlier this year the FSA published its list of CBD products linked to what it deems as credible Novel Food applications. Products included on the list will be advancing through the final stages towards authorisation, expected by 2023. 

More than 900 applications for thousands of UK products have been submitted for approval, with the majority being rejected for lacking basic information such as toxicity levels.

JM Wholesale has announced that it has now had 750 of its products included on the public list.

Read more: FSA CBD list now closed for applications

Thomas Lowe, operations director at the Leicester-based company, said that, after 200 per cent business growth in the past 18 months and a resulting move to major new premises, JM Wholesale is now perfectly placed to consolidate its position as the UK’s premier CBD wholesaler.

Lowe commented: “We have a larger range of approved CBD products than any other distributor and this moment is another milestone for our company.

“We’ve worked hard to ensure that our customers and our business are protected, by getting rid of any products not published on the FSA’s website, regardless of how big those brands are.

“In fact we’ve always loved finding unique products, including those where the CBD can be absorbed in different ways. That way, more people from different walks of life can enjoy CBD no matter how they prefer to access it.

“From our distribution centre we now provide the largest range of isolate and full spectrum CBD products in the UK, all of which are 100 per cent accepted by the FSA.

“We are the first distributor to add the relevant Novel Food classification numbers to all of our relevant listed products.

“The past few months have been extremely challenging for our industry but we have made efforts to take an active role in the novel food submission process. We anticipated regulation of this industry, we were determined not to let it stand in the way of the growth of our business, and we’ve participated accordingly.

“All in all, this is excellent news for our customers and partners.”

The company has stated that it has experienced rapid growth off the back of increased awareness of the health benefits of CBD products in the UK, and that, alongside its consumer business, it also exports to suppliers in the UK and in 170 countries worldwide.

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FSA CBD list now closed for applications

An additional 6000 products added to the Food standards Agency’s (FSA) CBD list.

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FSA CBD list now closed for applications
Home » News » CBD » ​​Chaos in cannabis: is the Novel Foods process fit for purpose?

The FSA has confirmed that the UK’s list of CBD products linked to credible Novel Foods applications is now closed.

The FSA has updated its public list of CBD products that can be marketed in England and Wales, adding almost 6000 products. These are products that are linked to a credible application submitted for authorisation to the FSA, and are not new to the market.

The organisation has confirmed that the public list, which was initially published in March, is now closed and has stated that any further requests to have products put on the public list or evidence sent are no longer being accepted.

Read more: FSA adds thousands of additional CBD products to public list

The FSA has previously reminded consumers that products on the list will be able to remain on the market as they progress towards final authorisation, but that, although these products are classed as “credible”, it does not guarantee they will be authorised for sale.

Rebecca Sudworth, director of policy at the FSA, stated: “This has been a long and complex process and we are grateful for the help and cooperation of the CBD industry as we reach this important milestone on the path to bringing CBD products into compliance and protecting consumers. 

“The only changes we envisage being made to the list now will be to reflect the status of products as we move to authorisation, and any routine corrections.

“We have seen the list, which contains almost 12,000 products, grow considerably since March when we first published it. The publication of the initial list prompted a number of companies to come forward with new evidence linking large numbers of individual products to existing applications, and so we made a final call for evidence to support businesses in achieving compliance for their products. 

“We think it is important we get this right, and it is encouraging that so many companies want to get their CBD products on the path to authorisation.”

Read more: Authorised UK CBD products expected by 2023

Businesses wanting to sell their products in Great Britain should now apply to the FSA’s regulated products process and those wanting to sell in Northern Ireland should apply to the European Commission. However, as new applications will not be eligible for the public list, they should not be put on sale until they have been authorised.

Validated applications on the CBD list are currently moving on to a full risk assessment stage of the application process, and those that are shown to be of a low enough risk must also go through a risk management process before a recommendation can be made to Ministers on authorisation.

At the time of the list’s initial publication in March, the FSA confirmed that, with a lengthy process still to go, it is unlikely any applications will be considered for authorisation before early to mid-2023, with any additional authorisations potentially taking another few years.

The FSA emphasises that there are currently no authorised CBD products on the market.

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British Cannabis™ launches premium CBD products in Selfridges

The CBD by British Cannabis™ collection will be showcased in the Beauty Hall at Selfridges London.

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British Cannabis™ launches premium CBD products in Selfridges
Home » News » CBD » ​​Chaos in cannabis: is the Novel Foods process fit for purpose?

British Cannabis™ is launching its premium, flagship range of CBD products in Selfridges.

British Cannabis™ will launch its super-premium collection of 100 per cent cannabis supplements and cosmetics in Selfridges on 4 July, 2022.

All of the food supplement products in the CBD by British Cannabis™ collection were recently included on the Food Standards Agency’s (FSA) public list of products that are legal for sale on the UK market. 

The products’ appearance on the list followed the company’s successful submission of Novel Foods applications. 

Read more: British Cannabis celebrates 310 products on FSA CBD list

A recent update by the FSA saw British Cannabis™ ranked as the UK’s largest CBD manufacturer by number of publicly listed CBD products manufactured.

CEO, Thomas Whettem, commented: “This is yet another great milestone in the British Cannabis™ story. It is a testament to the levels of excellence we demand within our supply chain and products, that we are now stocked at an iconic, prestige retailer in Selfridges.

“We set out to create ‘the champagne of CBD oils’, with more beneficial cannabis phytochemicals than any other CBD products compliant and legal for sale today. 

“Our premium, THC-free products are both UK-born and UK-manufactured, thus debuting in Selfridges London seems very appropriate.”

British Cannabis™ launches premium CBD products in Selfridges

CBD by British Cannabis™ products have won multiple awards in recent years, including the Highly Commended 2021, P3 MVP Award for 1000mg CBD Cannabis Oils, ICP magazine’s 2022 CBD Product of The Year, and Your Healthy Living magazine’s 2022 Silver Award for Best CBD Products (for CBD by British Cannabis™ Dermal Patches 500mg).

The 100 per cent cannabis products contain hundreds of other beneficial cannabis compounds, terpenes, flavonoids, phenols and more, whilst still being compliant with regulations and legal for sale within the UK. 

Each product is rigorously tested for accuracy, purity, and THC-free status for consumer peace of mind.

Every product contains the knowledge and expertise that has been amassed over the last seven years of British Cannabis™ existence, evidenced in the growing, extraction, research, development, and manufacturing that saw this British start-up grow to be the leading authority in consumer cannabis products within the UK.

The company launched a television campaign in March 2022 for the range as part of a half a million pound investment in awareness building and consumer recruitment 2022/23.

The campaign aimed to break down barriers to legal cannabis-derived products, gaining broadcaster approval to make more industry-specific references than any campaign to date.

Shown across dozens of premium channels on the SKY and Channel 5 networks, this marked the first time that the SKY network had opened its doors to CBD advertisers on their linear stations since 2019.

Read more: CBD by British Cannabis launches nationwide TV ad campaign

British Cannabis™ managing director, David Ralson, commented: “As proud as we are of our tested, trusted, super-premium CBD supplements and cosmetics, we are equally proud to now be bringing them to the world-class shopping experience at Selfridges, as part of our distribution expansion plans.

“For over a century, Selfridges have brought premium health and beauty products to the forefront in exciting ways – and especially in their new Feel Good Bar. As one of the UK’s original British-made CBD ranges, with a heritage in this young industry of nearly seven years, the match of Selfridges and CBD by British Cannabis™ seems a perfect fit.

“I hope that Selfridges shoppers grow to love and trust our CBD range as much as our existing loyal customer base, who over the years have given us over 1,500 5-star reviews on Trustpilot.”

With sales of wellbeing supplements, superfoods and ingestibles up almost 125 per cent at Selfridges since last year and almost 700 per cent compared to pre-pandemic, The Feel Good Bar will launch as a new permanent wellbeing destination at Selfridges London. 

The bar will be a place for visitors to explore more than 250 of the latest and best products in wellbeing innovation, ranging from gut health to hormones, hangover cures and sleep hacking. 

The destination will be anchored by a new energy-lifting bar concept brought by JENKI, introducing a menu of matcha and alternative drinks that reimagine drinking culture.

British Cannabis™ launches premium CBD products in Selfridges

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