The Food Standards Agency's (FSA) deadline is fast approaching for companies to submit a novel food application for their cannabidiol (CBD) consumables. The FSA has set a deadline of 31 March 2021 for businesses wishing to sell their CBD products in the UK to submit their applications for authorisation. Despite the ongoing disruption caused by COVID-19, the FSA has not announced any extension to the deadline.
Applications should be submitted for all CBD extracts and isolates proposed to be used. The FSA requires "full applications" to be submitted, requiring detailed information on, amongst other things, the CBD product's production process, compositional data, proposed uses and anticipated intake and toxicological information. The FSA has stated that product safety will be an important part of the application and, without directly relevant toxicology studies (or, where results are not yet available, a justification for the delay and timings for the results), an application is unlikely to be authorised.
Each CBD product contained in an application must be manufactured in the same way as detailed in that application. Having a trusted supply chain is therefore paramount for CBD companies.
The FSA guidance makes clear that submission of a novel foods application is the only route to compliance for CBD products. After the deadline, businesses without a novel food application face having their CBD products removed from the market.
Once submitted, the FSA can take up to 30 working days to validate the application and confirm that the application contains the required information and complies with the application requirements. After this time, the FSA states "these validated applications will then continue through an authorisation process that ensures novel foods meet legal standards, including on safety and content." The FSA continues to refer to the application guidance issued by the European Food Safety Authority, and while this guidance is detailed as to the format and requirements of the application, the guidance for what evidence is required for the safety assessment (i.e. that CBD is safe for human use) is left to the applicant. This process could therefore allow the FSA to demand further information or safety data from CBD companies, after their application has been submitted and validated. We expect to see requests for further data from the FSA during this process, possibly under a stop the clock regime to allow for further evidence to be submitted.
As we have previously noted, one of the widely reported concerns about CBD is its long-term effects on individuals (in particular, on liver function). There currently exists little guidance on the evidence companies must submit to demonstrate that CBD is safe for human consumption. It will be interesting to see if the FSA publishes any commentary, following the validation process of applications – in particular on how companies can satisfy the safety requirements and the calibre of any necessary evidence.