DevelRx, along with The Canna Consultants, a team of experts providing policy and legislation consultancy to governments and regulators on medicinal cannabis and the cannabinoid industry, have recently written to the Food Standards Agency (FSA) and the UK Home Office regarding the scientifically unjustified, and ethically unacceptable, replicate toxicity testing in animals that is being requested by the FSA, on cannabidiol (CBD).
CBD is a cannabinoid compound, purified from hemp plants, that has been added to a growing number of food products (e.g., oils, tinctures, or confectionary) over the last 2-3 years. These products were brought to the market in the UK and EU and not considered to be subject to regulation. However, in January 2019, CBD was classified as a Novel Food by the EU (and hence UK) and from February 2020, the FSA, acting on guidance from its scientific advisors, the Committee on Toxicology (COT), have requested that manufacturers of food products containing CBD, submit an individual Novel Food application to the FSA for Authorisation of their CBD ingredient and products manufactured from it. This would require for each application, unethical multiple toxicity testing in animals of the same Novel Food product as the different isolates and distillates of CBD have virtually the same chemical composition. Furthermore, CBD has been approved for medical use in humans (Epidyolex; GW Pharmaceuticals) and has already been extensively investigated in both animals and in man. The requirement of the FSA for multiple toxicity testing for CBD is therefore contrary to the principles of the 3R's (reduction, replacement and refinement) to avoid unnecessary use of animals in experiments.
Further information about our challenge to the replicate, toxicity testing demands of the FSA on CBD can be found here
The issue we raised has been highlighted by BusinessCann, a platform for the cannabinoid industry. See the article here