At the end of September the UK’s Food Safety Standards Agency (FSA) issued updated guidance that clarified the strict need for companies looking to gain novel food authorisation for CBD products, in the UK, to provide detailed toxicology studies, in order to demonstrate product safety.
The FSA has placed a deadline of the 31st of March 2021 for businesses, marketing products in the UK, to submit, and have a fully validated, novel food authorisation application in place. This places considerable urgency on the industry to produce substantial evidence that can clearly determine that there is no significant risk from consuming CBD ingredients.
Currently there are few studies that can be relied upon, meaning that the need for clinical-grade research across the industry is paramount.
The FSA guidance follows similar advice from the FDA in the U.S. and represents a growing demand from regulators to ensure that the burgeoning CBD sector doesn’t represent potential harm to consumers.
Following the FSA issuance, a consortium of CBD companies led by the UK’s Association for the Cannabinoid Industry has announced details of a new toxicology study that will attempt to provide broad data that can be used to evidence that CBD is safe for consumers.
The study will address the existing gaps in data identified by COT (including whether CBD causes potential drowsiness, liver toxicity or has any interaction with other drug substances) and generate analytics accordingly. It will also provide the safety information mandated by the novel foods application process.
The ACI has commented that they are satisfied that any company that does not have such original derived data will not have their novel foods dossier validated by the FSA.
The FSA guidance states: “An important part of any application will be a consideration of the product’s safety. Applicants will need to include details of the toxicological studies they have undertaken, or propose to undertake with clear details of the reasoning for these particular tests. Where all information isn’t available at the time of submission, a justification for the delay and when results will be available must also be included. Without such information it is unlikely we will be able to validate an application”
“By bringing together this group of companies we are leading the way not just for the industry in the UK but across the world.” states a recent ACI release. “No other country has provided the clear regulatory framework for compliance that exists in the UK. The safety information generated in this study will respond to future demands of regulatory authorities in the US and EU.”
Critically, the approach follows the path of one OECD 408 rodent study where data is usable by all participating members and is consequently more ethically aligned with minimising animal usage than the scenario of many products each undertaking their own study.
The consortium includes the following companies:
Source | Association for the Cannabinoid Industry