TRIALS will start next month in a bid to to assure regulators that oral CBD use is safe.
US testing firm VaildCare has secured $100,000 each from seven companies to undertake tests on up to 1,000 regular CBD users.
Major brands including Charlotte’s Web Holdings, Columbia Care HempFusion and Kannaway have agreed to participate in the trial.
They expect the result will assure the US Food and Drug Administration (FDA) that oral CBD is safe to consume at set levels.
This comes as similar collaborative efforts are under way in Europe to demonstrate CBD safety to the UK’s Food Standards Agency – as earlier reported on BusinessCann.
Too Many Bad Actors
New York-based Dr Rosemary Mazanet, Chief Science Officer for Columbia Care, told BusinessCann: “We’re very happy to be doing this.
“It’s an opportunity for the companies that have real quality products, that have spent the time and the money developing these, to really prove that. It will allow us to differentiate ourselves from the people that don’t. There are a lot of bad actors in the market.
“All seven companies are confident in each others products and this will carve us apart from the others who are not willing to do this.”
This necessity to demonstrate CBD safety follows recent U-turns by regulators on both sides of the Atlantic.
After previously regarding CBD as safe, in line with WHO guidelines, the FDA changed its stance in relation to CBD saying it posed ‘real-risks’ to health.
Regulators’ Safety Warnings
That was in November, 2019, and in February this year, the UK’s Food Standards Agency (FSA) shifted its position on usage, too.
The FSA suggested a cap of 70mg of CBD a day and expressed concerns in relation to its potential harm to the liver.
It cited research data from UK firm GW Pharmaceuticals which shows that CBD in very high doses, at up to 700mg a day – such as in its Epidiolex drug – could damage the liver.
Dr Mazanet continued: “We need to refute these claims and put them to rest. So we have to show them that in the doses that regular people are taking, these products are safe.”
She also criticised GW for not making its data on lower-concentration CBD use available to the industry.
Columbia Care branched out in Europe last year and is a member of the UK-based trade group the Association for the Cannabinoid Industry (ACI).
It will use the data in the trial to support its application for Novel Food Authorisation of its products for the UK market.
It will be providing tinctures or soft gels at daily dosages of around 30mg a day to trial participants.
The ACI says moves are under way to establish similar joint-industry trials for UK and European businesses.
ACI member Tony Calamita, Managing Director of UK CBD brand Love Hemp, welcomed the development during an interview with BusinessCann, saying. “This is a unique effort. It’s a fact finding mission for the industry and I think it’s fantastic.
“It will be great to see what the data is from people who aren’t involved in big pharma.”
Nuts & Bolts
Trial participants have all been vetted to confirm they have been using branded, oral CBD products for at least 60 days prior to the study.
They will download an app that allows them to document their CBD use and resulting effects for 30 days, and provide a blood sample for analysis across four liver-function tests.
This data will be combined with personal history, blood tests and product data to provide researchers with the opportunity to understand multiple variables across populations, products and lifestyles.
The FDA has been involved in the design of the trial, which may form the basis for regulations to govern the US CBD industry. It is also designed to allay the safety concerns of some wary consumers.
Chase Terwilliger, CEO of CBDistillery, one of the seven participants, said that without this additional data from qualified experts, the FDA is unable to develop an appropriate regulatory scheme specific to CBD.