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.
Farmceutica’s Novel Food approach sees it become one of the first to take a vertically-integrated route to compliance.
This allows manufacturers of CBD products and their downstream brands to feed off its two base ingredients; the broad spectrum distillate and CBD isolate.
A second approach involves a horizontally-integrated dynamic where a group of bulk ingredient suppliers join forces to present Novel Food applications. This is being pursued by the Association for the Cannabinoid Industry in the UK
The global CBD market is booming and set to be worth tens of billions of pounds over the coming years. Although expectations have been tethered by regulators’ concerns and the European Commission’s U-turn which sees it now look upon CBD as a narcotic drug.
Some Background To This Story
In 2018 the World Health Organisation described CBD as ‘being well-tolerated with a good safety profile’.
However, a kick-back began 18 months when, first the US Food & Drug Administration said CBD posed ‘real risks’ to human health.
And, in February this year the FSA changed its stance from saying CBD is safe to registering concerns over a number of issues including its impact on the liver, pregnant women and breast-feeding mums.
It also set a daily recommended dose of 70mg of CBD a day – equivalent to one mg per kilogram of body weight. Both of these regulatory interventions were related to data from studies by UK firm GW Pharmaceuticals makers of the CBD drug Epidyolex, which showed negative effects on mice at doses of over 600mg per kg.
Here in the UK, the FSA informed the industry that it needs to produce its own toxicology data to demonstrate that CBD is safe and that will be required to remain on the market.
The FSA has set a date of March 31, next year, for companies to submit Novel Food applications, which will allow them to do so.