Confusion Reigns In UK CBD Market As Regulatory Vacuum Allowed To Continue
Executive Summary
Major retailers LloydsPharmacy and Holland & Barrett remain unfazed by the regulatory chaos surrounding cannabidiol (CBD) in the UK, while pharmacy groups become increasingly concerned that their members may be selling controlled substances due to the possible presence of tetrahydrocannabinol (THC).
While the UK’s Food Standards Agency considers how to implement the European Food Safety Authority’s decision to classify cannabidiol (CBD) as a novel food, concerns are now being raised by pharmacy groups as to whether CBD oils being sold as food supplements could be considered controlled drugs due to the presence of psychoactive by-product tetrahydrocannabinol (THC).
However, major retailers are standing firmly behind their decision to begin selling CBD products. LloydsPharmacy owner McKesson Corp. and health foods specialist Holland & Barrett have both insisted to HBW Insight that its CBD products meet current regulatory requirements and thus can be legally sold in the UK.
HBW Insight approached the retailers for comment after the National Pharmacy Association – a trade association for independent community pharmacy professionals in the UK – declared in no uncertain terms that selling CBD products with any level of THC, however small, was equivalent to selling a controlled drug.
“If a product contains any amount (even trace amounts) of controlled cannabinoids – such as THC, even unintentionally – it will be subject to controls as it would be classified as a Schedule 1 Controlled Drug under The Misuse of Drugs Regulations (MDR) 2001,” NPA stated on its website.
“Members who are considering selling or supplying cannabis, cannabis-based products for medicinal use, cannabis oil products, or any CBD products or derivatives must ensure that they ascertain before doing so the status of such products, and whether they require a product licence (marketing authorization), or otherwise,” NPA explained.
“Failure to do so (and to be able to satisfy this requirement to NPA Insurance), will mean that in the event that a third party claim is made against the member’s professional indemnity policy, or a request is made by the member for legal defence or representation to respond to a regulatory or criminal investigation, that indemnity, legal defence or expenses cover may not be provided,” it added.
NPA’s statement follows a letter from the Royal Pharmaceutical Society – another high-profile UK-based pharmacy association – which called for the country’s Home Office to clarify the level of THC permitted in CBD oils, claiming that pharmaceutical and medical literature in the UK had “misinterpreted” national regulations. (Also see "UK Body Calls For 'Clear Guidance' On THC Levels In CBD Oils" - HBW Insight, 12 Jul, 2019.)
RPS pointed to a Home Office guideline that raises concerns about the ability of CBD manufacturers to isolate CBD in pure form without also accidentally smuggling in psychoactive by-products like THC, thus potentially falling foul of MDR.
Retailers Stand By Their CBD Products
In the midst of all this chaos and confusion, major retailers such as McKesson’s LloydsPharmacy and Holland & Barrett’s health food stores are resolved in their decisions to begin selling CBD products. (Also see "European CBD Market Snapshot: UK Leads As Retailers Get On Board With FSA Decision Pending" - HBW Insight, 28 Jun, 2019.)
In the case of Holland & Barrett – which according to its website www.hollandandbarrett.com currently stocks six separate CBD supplement brands – only one of these brands, Holistic Herb Premium CBD Oil, specifies that “each and every batch is tested to ensure there is no THC (0.000%) present.”
One brand, Jacob Hooy, by contrast, clearly states that its CBD oils may contain THC up to 0.05%, thus potentially contravening MDR.
Asked whether it would, in response to NPA’s guidance, consider removing this product from its shelves, Holland & Barratt told HBW Insight that: “The CBD oil products we sell comprise food supplements not medicines, as evidenced by packaging and labeling, and are not designed for administration of controlled cannabinoids.”
“Our CBD Oil products are manufactured specifically to limit the presence of controlled cannabinol derivatives, in particular, THC,” it added.
LloydsPharmacy, on the other hand, only sells one CBD brand, Celtic Wind Crops. On its website www.celticwindcrops.com, the manufacturer publishes independent batch testing results for all of its CBD products, which confirm that controlled substances delta-9-tetrahydrocannabinol (THC), tetrahydrocannabivarin (THCV) tetrahydrocannabivarin carboxylic acid (THCV-A) were “not detected” in these products.
Asked to also comment on NPA’s guidance, McKesson told HBW Insight: “The CBD oil we supply is not a licensed medicinal product and is classified as a food supplement. Therefore, our guidance for pharmacy teams when supplying this product is based on the advice obtained directly from the manufacturer.”
“We take great care with all of the products we select for our customers, including making sure that they are legitimate, legal and safe to use,” McKesson added. “It’s important for customers to consult their pharmacists or prescriber if they have any specific health issues to receive appropriate care and advice.”
Walgreens Boots Alliance Inc. – which sells CBD products in its Boots outlets –was also approached for comment but has so far not been contactable.