Wellbeing is driving a new grocery category. Foods are being developed around an ingredient with a level of flexibility that is attractive to all classes of health conscious consumer. What is the mystery ingredient? Cannabis! Not the illegal Class B drug, or the prescription-only medicinal product regulated by the MHRA, but the non-psychoactive extract from flowers and leaves of the Cannabis sativa plant, known as cannabinoids.
Cannabidiol (“CBD”) is one of the chemical compounds found in the Cannabis sativa plant that can be imported into the UK legally, provided the source plant does not contain more than 0.2% THC (i.e. it must be non-psychoactive). CBD products containing more than 1mg of THC cannot be sold legally in the UK.
Hemp is a member of the Cannabis sativa family and can only be grown under licence from the Drugs and Firearms Licencing Unit (“DFLU”) in the UK. To comply with the Misuse of Drugs Act 1971, the leaves and flowers cannot be processed and must be destroyed. Only the fibre, stalk and seed can be used - the “green” material is prohibited. Hemp oil is made from pressed seeds and used commercially, but it cannot be sold as a food.
CBD as a Food
Until recently, CBD could be sold in the UK as a food supplement. However, perhaps driven by the rapid rise in popularity of CBD – itself possibly driven by the changing attitudes to medicinal Cannabis (containing THC but permitted only by medical prescription) – the European Commission (“EC”) has now intervened. As of 1 February 2019, following a submission by the EC working group on Novel Foods, CBD has been reclassified as a novel food that requires authorisation under Regulation (EU) 2015/2283 (“Novel Food Regulation”).
The entry in the Novel Foods Catalogue for CBD has changed, confirming that “…extracts of cannabis sativa l. and derived products containing cannabinoids are considered Novel foods…”. The UK Food Standards Agency (“FSA”) has also updated its novel food guidance, stating that it “accepts the clarification from the EU that CBD extracts are considered novel foods” and that it is “committed to finding a proportionate way forward by working with local authorities, businesses and consumers to clarify how to achieve compliance in the marketplace in a proportionate manner.”
This means that, although the European Food Standards Agency are presently considering an application regarding the novel food status of CBD for use in food supplements for adults, the current position in the UK is that the use of CBD as a food is not lawful. As a result, there is a significant risk that the FSA will take action to ensure CBD food products are taken off the market until a decision has been made in respect of the pending novel food application.
Consequences of categorisation as a Novel Food
The effect of the alteration in the Novel Food Catalogue means that all extracts of hemp and derived products containing CBD that were previously permitted in foods are now considered novel and can no longer be placed on the market whilst the novel food application is pending.
If confirmed, food products containing CBD would encounter greater difficulty being marketed in the UK, as they would need pre-market approval. As set out in the Novel Food Regulation, to obtain such approval an applicant would need to either:
- demonstrate a significant history of use of the ingredient as a traditional foodstuff that has been in common usage since before 1997;
- submit a notification for a traditional food from third countries (provided a history of safe use in a third country for at least 25 years can be demonstrated); or
- submit a dossier for the registration of a novel food.
Whilst a new streamlined novel foods application process was implemented in January 2018, an approval is still expected to take at least 9 months.
In early April 2019, CBD industry group CannaPro published a copy of its letter to the FSA challenging the reclassification of CBD as a novel food. CannaPro has threatened to bring judicial review proceedings against the FSA’s decision and asserted their members rights to compensation for associated losses due to the “misclassification” of their CBD products as novel foods. The group has invited the FSA to revert to the previous classification of CBD as a food supplement.
Food businesses wanting to take advantage of the rising market are faced with unsettling uncertainty, and will either need to wait for the outcome of the pending application, or grasp the nettle and submit its own novel foods application. It is ironic that a product intended to promote wellbeing is unlikely produce a calming effect on any business currently seeking to enter the market.