The ACI Adds 16 CBD Companies to Its CBD Toxicity Trial
Sixteen CBD companies have signed up to a UK trial that will help determine the toxicity and safety of the popular cannabis compound.
The study, which has been organized by the UK’s Association for the Cannabinoid Industry (ACI), will involve 90-day-long tests on rodents to assess how CBD affects the liver, if it promotes drowsiness, and how it may interact with other drugs.
Participation in the trial, the ACI says, will benefit the novel foods applications CBD companies currently have with the UK’s Food Standards Agency (FSA), which, this February, announced that any CBD oil, drink or treat without such an application will be “taken off the shelves” by March 2021.
The ACI will initially perform tests on products from all 16 participating companies, before submitting one of the broad spectrum products to further toxicology tests.
The sixteen CBD companies currently signed up to the trial include:
- B3 Labs
- Britannia Bud
- CBD Capital
- Columbia Care
- DragonFly CBD
- Echo Pharmaceuticals
- Herbotany Health
- iX Syrinx
- Jersey Hemp
- MGS Pure Extracts
- Sativa Group
- The House of Green
- Vana Labs
To help carry out the safety tests – which could cost between £300,000 to £1 million – the ACI has partnered with Advanced Development & Safety Laboratories (ADSL), a formulated products consulting company in the UK.
“We're doing things such as genotoxic [tests] and micronucleus assays,” Mark Richard Bowes-Cavanagh, ADSL’s managing director, said during a virtual press conference. “We’re doing the Ames test [and] we’ve got the stability cannabinoid testing as well. There's the ADME [absorption, distribution, metabolism, and excretion] data, which we have a lot of for finished products, but don't have for the CBD.”
“And, obviously, we'll be liaising with the laboratory to conduct the OECD 408 [rodent] study that will bridge those gaps that the FSA has mentioned,” he added.
Will the tests benefit an FSA novel foods application?
Following the FSA’s announcement earlier this year, any CBD company that wants to remain with UK retailers must apply for a novel foods authorization with the European Food Safety Authority (EFSA) by March 31, 2021.
But, according to the ACI, any CBD company without toxicology details of its products will not have its novel foods dossier validated by the FSA.
“It's obvious to us that without [toxicology] data, it'll be hard to see how we can move forward in terms of approvals for novel foods,” Steve Moore, a founder of the ACI, said during the virtual press conference.
The stance, if tightly enforced, could jeopardize the novel foods applications of many CBD companies that aren’t part of the ACI’s new toxicology trial or similar studies.
In response to industry confusion, the FSA clarified its guidance and added some caveats last Thursday, September 24.
“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,” the updated guidance reads.
“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.”
Given CBD’s rapid rise from legally dubious cannabis compound to high street staple, it’s perhaps not surprising that regulators like the FSA are keen to catalogue and review its effects before issuing authorizations. And the toxicity of CBD has been a main point of concern.
Back in February, along with its novel foods announcement, the agency warned pregnant women and breastfeeding mothers not to consume the popular cannabis chemical due of “toxicity concerns.” This caution was based on advice from the UK government’s Committee on Toxicity, which cited studies linking CBD to decreased fetal body weights in pregnant rodent models.
Another recent rodent study, published in Molecules, found that high doses of CBD triggered severe liver damage in mice. However, none of the mice that took lower doses of CBD showed any signs of toxicity. As such, the authors of the paper recommended that additional studies be undertaken to properly inform a safe range of CBD dose levels.
And, alongside its novel foods objectives, the ACI’s new CBD toxicology study aims to do just that.
“The objective of this 90-day study is to explore a range of doses of CBD, and both to identify higher dose effects, but also to help define a no adverse-effect level at the lower doses,” Dr Paul Duffy, the ACI’s lead toxicologist, told Analytical Cannabis during the recent virtual conference.
“And this will be compared with any available information in the public domain, which we also know is inadequate by the FSA’s own guidance. So the study will supplement what is out there to[…] help define what might be an acceptable daily intake amount of CBD.”