A TRANS-ATLANTIC collaborative trial which sees 15 different animal species given doses of CBD will conclude next month with the aim of satisfying regulators the popular cannabinoid is safe.
The $2m trial on mice, rats, pigs and other species got underway in the United States in September, initiated by UK firm Farmceutica Wellness in collaboration with the GLP Neuroscience Center in Kentucky.
It aims to establish the safety of CBD following concerns which were voiced earlier this year by regulators on both sides of the Atlantic.
In the UK, the Food Standards Agency’s (FSA) concerns over potential liver toxicity and other issues, and its indication that ‘desktop trial data’ would be insufficient, left the industry with little choice but to embark on animal (in-vivo) studies, despite many ethical concerns.
Julius Bond, Managing Director of Farmceutica, told BusinessCann the trial is designed to secure Novel Food authorisation for the sale of its broad spectrum distillate and CBD in the UK.
Proof CBD Is Not Toxic
And, with the US Food and Drug Administration (FDA) also raising concerns about the potential harmful effects of CBD, it is designed to overcome its concerns, too.
He said: “We designed a research study with the GLP Neuroscience Center in Kentucky to satisfy all the requirement of novel foods, but on much larger scale than any one else.
“This is not your standard three rodents tests. We are testing hundreds of animals, 15 different species, males and females, rats, mice, pigs and others and our aim – with the results we post – is to leave the regulators in no doubt that CBD is not toxic.”
He went on to say the toxicity trial started in September and will finish next month. It is also undertaking two separate CBD stability tests; one with the university and the second with a Government-approved lab, and these will continue for 24 months.
Largest CBD Toxicity Study To date
He continued: “Our aim is to be one of the largest CBD biosynthesis studies to date, examining; toxicology, genotoxicty, sub-chronic toxicity, chronic toxicity, reproductive and developmental toxicity and available human data from literature as well as immunotoxicity and narcology studies.
“We are providing a huge amount of data sets in order to get the most reliable information for a Novel Food dossier.
“We are doing more than just a Novel Food study; This will be more than enough to secure a Novel Food authorisation and provide enough information to leave the regulators in no doubt as to the safety of our products.
“Our whole approach is not over-analyse but to set a high-standard for our products and for the industry as well, and most importantly giving the assurance that is need to end customers and our clients whether they be manufacturers, pharmaceutical companies or API (Active Pharmaceutical Ingredients) labs.”
Farmceutica is a bulk ingredients supplier with the capacity to harvest and process two million cannabis plants annually from greenhouses in Kentucky and Illinois.
Its customers include white-label CBD manufacturers, pharmaceutical companies and those making APIs. One of these is Canadian cannabinoid, bio-science firm EXMceuticals which has a European production base in Lisbon.
Farmceutica is working with its customers to deliver Novel Food applications across a number of SKUs including oils, water solubles, tinctures and capsule-based end products.
Its bold market move will also deliver a competitive advantage in being able to ease any concerns potential new customers may have in relation to Novel Food; allowing them to piggy-back onto its applications to secure compliance.
Regulators U-Turn On CBD safety
It opted to undertake this definitive study earlier this year after closely following the ruminations of regulators on both sides of the Atlantic.
This led to the appointment of chief science officer Dr Brian King, an eminent scientist and a member of the US Hemp Round Table.