25 Sep, 2020

 

ACI Announce Landmark Safety Study Consortium as Regulator Clarifies Toxicology Requirements for Novel Foods

Over the past five years Cannabidiol (CBD) has grown into one of the most popular wellbeing products in the UK with sales now totalling over £300 million. This growth in demand for the second most prevalent of the active ingredients of cannabis has taken place against the backdrop of an emerging, often confusing regulation regime. Today there still remain some fundamental unanswered questions regarding its safety for human consumption.  In February 2020 the UK Food Standards Agency set out a new deadline for the industry to apply for European Union safety evaluations as a “novel food” and also provided consumption guidelines to consumers. Over the past year the Government Committee on Toxicity (COT) has been undertaking an ongoing review of CBD safety which has highlighted the need for new toxicology data. 

Today the Association for the Cannabinoid Industry (ACI), in partnership with Advanced Development and Safety Laboratory (ADSL), is announcing the launch of a landmark study with a consortium of CBD companies who are together committed to building a sustainable, safe and fully compliant industry in the UK. 

ACI & ADSL launch landmark study with a consortium of CBD companies

This announcement comes a day after the UK FSA issued further clarification on the importance of generating new toxicology data: 

“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”

This 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. We are satisfied that any company that does not have such original derived data will not have their novel foods dossier validated by the FSA. Only products with this validation will be allowed on the market after 31 March 2021. 

By bringing together this group of companies we are leading the way not just for the industry in the UK but across the world. 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. 

Finally, and critically, this consortia 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.

To find out more information about joining this study please contact us or call 0800 310 10 54.

See this list of all companies in the consortium.