On 13 February the Food Standards Agency ("FSA"), which regulates food and food businesses in England, Wales and Northern Ireland, announced that extracts of cannabidiol ("CBD"), contained in any edible products, must be subject to a validated novel foods authorisation application by March 2021.
Whilst this announcement provides some much anticipated clarity on the FSA's approach to enforcement of the novel food regime in relation to CBD products, failure to comply with the deadline could result in potentially serious damage to businesses with their products being pulled from shelves in the UK.
However in response to the FSA's statement, the Cannabis Trades Association stated that they "welcome a route to compliance for the industry and its members" adding that it "fully supports regulation as it ensures consumer safety and gives clarity to the processes required for its members’ products to remain in stores."
The Novel Food Regime
Under the Novel Foods Regulation, a novel food cannot be legally marketed in the European Union without undergoing a pre-market safety assessment and receiving authorisation from the European Commission.
In January 2019, the European Commission updated the Novel Food Catalogue to include extracts of Cannabis sativa L. and derived products containing CBD on the basis that a history of wide human consumption before May 1997 could not be established. Whilst the Novel Food Catalogue is not legally binding, it is used as a reference point by many authorities in the European Union, including the FSA, for the purpose of the Novel Food Regulation.
Despite the ever increasing rise of edible CBD products available to purchase in the UK, there are currently no authorised CBD extracts on the market. This is because the FSA has previously seemed reluctant to take enforcement action against businesses offering edible CBD products for sale, providing little incentive for companies to apply for authorisation. Until now, this has created uncertainty for businesses operating in this space, in turn, stifling external investment from the larger investment funds.
Novel Food Application Process
Until 31 December 2020, businesses must submit a dossier of information to the European Commission. From 1 January 2021, when the transition period under the UK's withdrawal agreement from the European Union comes to an end, any application for a novel food authorisation for the UK will need to be submitted to the FSA, in accordance with the UK authorisation process. In the meantime the FSA has stated that they would recommend any applications are submitted to them for review in addition to the European Commission in order to speed up the application procedure in January 2021.
The dossier of information must contain, amongst other things, details of the production process; composition of the food; nutritional information; clinical data and details of absorption which will most likely be costly and time consuming for businesses to produce.
Once received, the application will either be rejected for incompleteness or validated. If validated, the application will then go on to be assessed. It can take up to nine months for a risk assessment to be completed when further information is not required.
If the application is successful, the European Commission will issue an implementing regulation adding the CBD extract applied for as a food/ingredient to the list of approved novel foods within seven months.
Any CBD extract or isolate which differs from the authorised extract will require a further application for authorisation under the Novel Food Regulation.
Additional FSA Guidance
The FSA also advised those who are pregnant, breastfeeding or taking any medication not to consume CBD products and advised healthy adults to take no more than 70mg a day (about 28 drops of 5% CBD) unless under medical direction. Businesses selling CBD products are expected to be aware of this advice and should “be able to inform consumers” of the recommended daily dose for healthy adults, and of the potential risks to those in vulnerable groups.
Despite the potentially costly and time consuming process to submit a validated application by March 2021, the FSA's timeline certainly provides businesses selling CBD products with much needed clarity on the legal status edible CBD products in the context of the novel food regime. However, there are still further regulatory blind spots which the industry needs clarification on as it continues to grow. In particular, further guidance from the Home Office on the Exempt Products status, under the Misuse of Drugs Act 1971, for CBD products containing less than 1mg of THC per container, is essential for the industry to reach its full growth potential in the UK.