CBD and Novel Food regulation in the UK


CBD and Novel Food regulation in the UK
© iStock/José Antonio Luque Olmedo

Always Pure Organics Chief Scientific Officer Andrew Megahy explores the challenges facing the UK’s CBD sector.

There has been a remarkable shift in attitude towards cannabis worldwide, even just over the last few years. Canada, for example, went the route of full legalisation for recreational use in 2018. Many US states have implemented some form of legalisation; and in Europe, Switzerland has decriminalised its use. In the UK, some cannabis-based medicinal products (CBMP) have been approved for use, but recreational usage is still illegal.

However, there is one component of the Cannabis sativa plant that exists in somewhat of a grey area, despite ongoing work to categorise it. Cannabidiol (CBD) has grown immensely in popularity recently, and the global CBD market was estimated at around $9bn at the end of 2020. Despite this, there is still a considerable lack of understanding surrounding the substance, both on a consumer and governmental level. There are steps being made to address this issue, one of which is the UK’s Novel Foods process.

CBD was declared a Novel Food in Europe back in January 2019. Despite this, the UK was the only country to require companies to submit an application for their CBD products, giving a deadline of 31 March 2021. The Novel Food Application (NFA) process requires that applicants submit incredibly detailed information on their products, such as compositional analysis; nutritional content; absorption, distribution, metabolism, and excretion (ADME); and toxicology information, with the end goal of proving its safety to the UK’s Food Standards Agency (FSA).

There are some challenges involved in completing this process, one of which is the ever-present issue of Brexit; and the others largely related to the unique situation that CBD presents. New foodstuffs are typically not sold before being proven to be safe, whereas CBD has been on the UK market since at least 2018. This led to the strange situation of a mostly unregulated market operating freely, with no oversight on product quality or safety. Requiring an NFA was the only real route to creating a safe and regulated market that fit with the designation which the European Commission had assigned to CBD.

Regulating the CBD market

Despite not having any regulations in place, the market in the UK had already been operating successfully for several years by the time Novel Foods legislation was introduced, leading to the question of whether regulation was urgently required.

CBD and Novel Food regulation in the UK

There have been numerous independent articles looking at the quality of CBD products on the market, both in terms of CBD content and safety criteria such as heavy metal or pesticide contamination (these are genuine concerns, as the cannabis plant tends to absorb far more through its roots than other plants) or levels of controlled cannabinoids such as cannabinol (CBN) or tetrahydrocannabinol (THC), which is always a risk since they are all sourced from the same plant. This last point is especially pertinent due to the recent update from the UK government relating to the permissible levels of controlled cannabinoids, clarifying that any more than 1mg total of controlled cannabinoids per container is unacceptable. Every article investigating the levels of these psychoactive contaminants has found that the majority of products contained some level of unsafe substances, with additional findings of CBD levels well below those advertised.

Clearly, there was a desperate need within the market for some form of regulation. Products being consistently shown to be unsafe or with contents which are not in line with what is advertised is not only dangerous to the consumer, but it erodes their confidence in the market as a whole. Safety concerns should of course be the priority, but it is also important to bear in mind the more wide-ranging effects that poor press coverage can have on the industry, be it from media articles about low-quality products or from word of mouth by dissatisfied consumers.

One of the major reasons people purchase CBD is the health benefits it can potentially provide, something that is completely undermined by a market filled with products which do not have the advertised levels of CBD or which contain unsafe substances. The necessary first steps to creating a safe market that consumers can have confidence in, subsequently leading to growth and investment, is some means of regulating the multitudes of products that are available. As mentioned above, the Novel Foods Application process was the most suitable route to achieve this.

Finally, the UK ‘leading the charge’ regarding the Novel Foods process has some interesting implications for the market. The first is whether the EU Member States will wait to see how the UK deals with the process and how its citizens respond to the decision. Doing so will likely give them a better idea of how to implement their own form of regulation, including potential pitfalls to avoid. However, beginning the process independently may give them an advantage similar to the one the UK can look forward to: being one of the frontrunners in having a fully regulated CBD market. While Novel Foods regulation may restrict what products can be sold and who can sell them, it guarantees that anything that remains on the market will be safe, reliable and effective. This in turn will almost guarantee market growth, especially from larger entities and investors who have avoided the already rapidly growing market due to the uncertainty surrounding its continued legality.

Brexit and other challenges

The Novel Foods process has not been entirely smooth for the FSA and market participants so far because, as with most industries, Brexit has caused major complications. The main complication is because, previously, the European Food Safety Authority (EFSA) handled all Novel Food applications. This means that the FSA has no prior experience in processing Novel Foods and is therefore having to learn the system (which it has adapted from the EU approach) from scratch.

To further complicate matters, the fact that CBD products were already part of an established market meant that a compromise had to be made about how the regulations were implemented. A flat ban on CBD products until they were authorised would have effectively killed the industry for several years, leading to loss of jobs and a downturn in economic growth, something that was already an issue with the introduction of COVID-19 lockdowns at the beginning of 2020. Eventually, the decision was made to allow products that were already on a shelf by February 2020 to remain in place as long as they obtained a validated application by 31 March 2021.

CBD and Novel Food regulation in the UK

Unfortunately, due to a combination of the Novel Foods team being new and not having much time to build up experience in their role and the sheer number of applications submitted, this deadline has come and gone. To be clear, we fully support the Novel Foods team and understand the difficult situation they have been put in, with Brexit pulling vital resources away and staff having to learn and master a very in-depth regulatory system in a very short period of time. Regardless, the resulting situation is one of uncertainty, as market participants find themselves in a position where they are not sure whether the products they have spent months proving the safety of are legal to sell.

Always Pure Organics (APO) currently falls into this category of market participants awaiting a response. We submitted three dossiers to the FSA towards the end of February 2021, for a combination of isolate and broad-spectrum distillate products. The toxicology requirements were met by a company called DevelRx, experts in the field who have experience with cannabinoids specifically from previous work on Epidyolex, with general regulatory and legal assistance from a foodstuffs perspective provided by The Canna Consultants. Compositional…


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