Community pharmacy contractors must exercise extensive due diligence to ensure the CBD products they stock comply with the latest FSA rules…
The UK is fast becoming the leading market in the world where a clear legal and regulatory framework for cannabidiol (CBD) to be sold as a food supplement has emerged.
This is positive news for consumers, manufacturers and retailers to know what “goodand-proper” looks like and enables retailers, including pharmacies, to be asking the right questions now to determine what brands they should be stocking.
According to a 2019 market sizing report, undertaken by The Centre for Medicinal Cannabis, the UK CBD market was valued at over £300 million and growing at a rate that would bring it to £1bn by 2025.
The same report highlighted that less than 5 per cent of sales of CBD in the UK was generated from pharmacies (the majority being from UK-based online retailers).
Despite that, regular consumers of CBD highlighted they wanted increased knowledge from health care professionals, greater regulation and more information on the products themselves.
Overall, this picture represents a significant growth opportunity for pharmacists and pharmacies.
However, the FSA has laid out certain criteria which companies must abide by in order to be sold legally.
It’s critical that pharmacies are aware of these rules to ensure that they perform adequate due diligence, apply professional ethics and don’t purchase stock which they will not be legally allowed to sell.
Legal clarity
In an announcement on February 13, 2020, the FSA set a deadline for CBD companies to have a validated novel foods application for each CBD product they sell by March 31, 2021. Validation is the first step to full authorisation.
Full authorisation can take up to three years to complete whereas validation can take around 12 months, this includes gathering the necessary data and gaining validation.
With the UK leaving the European Union on December 31, 2020, the FSA will be responsible for processing these novel foods applications.
According to the FSA, any product that was on the market before the February 13 announcement has until March 31, 2021 to be validated. Should they fail to get validated, the product will not be legal to sell and they must withdraw from the market.
That product can then only be legally sold once they have full authorisation from the FSA. Given that the typical shelf life of CBD products is two years and full authorisation could take three, this could be a costly situation.
This window of opportunity only applies to products that were already on the market before February 13, 2020. Any new products must have full novel foods authorisation to be legally sold in the UK so any product not on the market prior to this date should not be stocked.
EU confusion
There was recent confusion when the European Commission announced that they were pausing all non-synthetic CBD novel foods applications whilst they reviewed whether CBD should in fact be classified as a narcotic and not a novel food.
This relates to a line in the 1961 United Nations global treaty on controlled drugs concerning extracts from hemp flowers. This is the source of the most naturally produced CBD. For products containing CBD manufactured via chemical synthesis the novel food applications have not been paused.
However, the UK Home Office has always held a position that pure CBD containing no controlled substances such as tetrahydrocannabinol (THC) is not categorised as a narcotic and not subject to the Misuse of Drugs legislation.
As the UK has now left the European Union, decisions taken in Europe will not have an effect on the UK CBD market. The FSA has made it clear that they are in sync with the Home Office.
As the EU CBD industry is left in limbo there now exists a huge opportunity for UK CBD brands operating in a market with full legal clarity.
It is important that CBD products do not contain THC (or other controlled substances) to avoid contravening the Misuse of Drugs Regulations. Pharmacy owners have a legal and ethical responsibility to determine the products they stock have been reliably, validly and independently tested to demonstrate they are free of illegal controlled substances.
Due diligence
“It’s all about due diligence,” says Dr Andy Yates, pharmaceutical lead for The Association of the Cannabinoid Industry (the ACI).
“Pharmacies need to future proof their relationship with the CBD brands they stock. They need to know what steps the company is taking to ensure that their products gain novel foods validation from the FSA before the March 31, 2021 deadline and how they test their products to ensure they are not contravening the controlled drugs laws.
“They should also not stock any product which was not being sold prior to February 13, 2020. Failure to apply this thinking could burden the pharmacy with expensive products they cannot legally sell. It’s likely that they could then fall foul of Trading Standards who have made it clear they will enforce.”
Meanwhile, it’s worth noting that the ACI exists to ensure that the UK CBD industry develops into a sustainable and responsible industry that can lead the world. It provides support to retailers, brands, manufacturers and raw material suppliers. Pharmacists who need guidance on the due diligence they must undertake for the CBD products they stock are encouraged to contact them via their website.
