The company has received Novel Food validation with final authorisation expected later this year.
The green light from UK authorities follows approval by the European Commission and the European Food Safety Authority (EFSA) in January.
All new foods require Novel Food status in the UK and Europe before products can be launched on the market, which now includes CBD nutraceuticals.
Brains Bio CEO & chairman Rick Brar comments: “Having successfully achieved a validated application status gives us a complete package of technical and safety data, along with toxicology reports being deemed as complete. This second milestone puts us at the forefront of this emerging market opportunity.”
Commercial value
The value of the UK CBD market is greater than vitamin C and D combined, according to a recent survey, commissioned by the London-based Centre for Medicinal Cannabis (CMC), and supplied by Brains Bio.
The data forecasts double digit year-on-year growth over the next three years and suggests current annual UK value spending of €359.4m (£300m) will reach €1.2 bn (£1bn) by 2025.
Additional figures demonstrate significant consumer support for CBD products: 46% of Europeans view them ‘favourably’ and 77% believe the ingredient “should be accessible in some way”.
Brar said: “Brains Bio will be the first company to bring true pharma-grade regulated products to the global nutraceutical market. Consumers demand quality: we are one of the only companies on the market using pharma-grade CBD backed by clinical research. Plant-based, natural products are the backbone of the nutraceutical industry.”
He confirms that the company is carrying out several clinical trials to assess the ingredient’s efficacy and is currently in phase three of a trial for refractory epilepsy.
Clinical validation
Research into medical applications of CBD has been ongoing for several years, including clinical trials for the treatment of epilepsy and seizures, according to a report published by the UK Committee on Toxicity of Chemicals in Food.
However non-medicinal CBD-containing products are becoming increasingly popular and can be found in beverages, ‘chewables’, and chocolate. There are also several CBD products on the market in the cosmetic sector.
Brains Bio’s CBD active pharmaceutical ingredient (API) has been tested by the INRS Laboratory, a World Anti-Doping Agency (WADA) facility.
Screening reports confirm that CBD API is free of THC (tetrahydrocannabinol), pesticides, and other banned substances listed by WADA, which has removed CBD from its banned substance list.
Brar said: “Brains Bio is the first of its kind in the industry to get such confirmation from a WADA-accredited laboratory for the purity of its CBD and the absence of prohibitory substances; it is one of the only companies in the world producing EU-GMP CBD API (Active Pharmaceutical Ingredient) in an MHRA approved laboratory in the UK.”
Once final approval has been confirmed, Brains Bio will manufacturer the CBD ingredient at its UK Discovery Park site in Sandwich, Kent.
BSPG Laboratories is a wholly owned subsidiary of Brains Bioceutical.
The company also supplies the UK healthcare industry with medical CBD products, available to consumers under prescription.
