How the UK’s Association For the Cannabinoid Industry is Proving the Safety of CBD
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Novel foods regulations in the UK and Europe have been the source of much confusion for CBD businesses over the past few years. In early 2021, with just one month left until applications were due in the UK, questions still persisted over how companies could source the data they needed for these applications, and which types of company would need to apply.
The Association for the Cannabinoid Industry (ACI) is a members organization for businesses active in the UK and European cannabis extract markets. The ACI has become a powerful force within the industry after establishing a CBD Safety Study Consortium and coordinating a collective effort to assist businesses submit their novel foods applications on time.
To learn more about what CBD regulations and the market looks like now in 2023, Analytical Cannabis spoke to Dr. Parveen Bhatarah, the regulatory and compliance associate at the ACI.
The UK position on CBD, explained
Post-Brexit, the Food Standards Agency (FSA) assumed the responsibility of regulating all ingestible CBD products on the UK market. Following in the footsteps of the European Food Safety Agency (EFSA), which had come to a similar decision the year before, the FSA announced in February 2020 that all CBD-containing ingestibles would have to gain approval as a “novel food” in order to remain on shelves after March 31, 2021.
After initially releasing a few dozen names after the March deadline, the FSA published its full list of “CBD products linked to novel foods applications” in April 2021. This list, containing more than 12,000 products, names all of the products that were on the market prior to the initial novel foods announcement in 2020 and have a novel foods application that has been received and validated by the FSA.
It is important to note that currently no CBD products have been fully authorized by the FSA; the public list merely identifies which legacy products are on the road toward authorization. Additionally, any new edible products will require a full authorization from the FSA before they can be sold in the UK. Still, the public list is important as it does allow consumers to make more informed judgements about the products that they are buying.
Inside the ACI’s landmark toxicology trials
As a part of the novel foods application process, CBD companies were required to present relevant toxicology data proving the safety of CBD or show evidence that they were working towards completing such a study. Such studies can be very costly, especially for the nascent brands active in the cannabis sector.
In order to help its members with fulfilling this requirement, the ACI launched its own CBD Safety Study Consortium in 2020 with the intent to gather further data on the safety of broad-spectrum CBD products. The consortium members would split the cost of running new toxicology studies on samples of broad-spectrum distillate, with the resulting data being used to support their applications.
“We decided that rather than using the CBD isolate, we decided to use a CBD broad spectrum [product],” Bhatarah told Analytical Cannabis recently. “After discussions with the FSA prior to starting the toxicology study, they wanted to see what are the impacts of other cannabinoids present in the CBD [product].”
Some CBD isolate formulations such as Epidiolex – which is approved for use to treat rare seizure disorders – have already shown tolerable safety profiles in clinical trials. However, as Bhatarah explained, there is also significant interest in broad-spectrum CBD products that contain other cannabinoids in varying amounts, and these also deserve to be studied closely.
“In total, we completed three studies, OECD 471, OECD 487, and OECD 408, which are 90-day rat studies,” Bhatarah continued. “We completed them, and all of them gave us a very positive outcome.”
In addition to these standard toxicology tests, the ACI’s work on CBD also included two dose range finding studies, which Bhatarah says yielded a no observable effect level (NOEL) and some hypothetical daily allowance values.
In early November 2022, the ACI submitted its complete toxicological package to the FSA and is currently awaiting any updates or feedback on the package.
What’s next for European CBD?
Across the English Channel, questions over novel foods and CBD’s status still persist. In June 2022, the EFSA announced that it would be pausing its processing of novel foods applications relating to CBD, citing a lack of data on the safety of CBD consumption.
“EFSA’s scientists cannot currently establish the safety of cannabidiol (CBD) as a novel food due to data gaps and uncertainties about potential hazards related to CBD intake,” the agency said at the time.
The EFSA specifically highlighted a number of concerns, including potentially detrimental effects on the liver, gastrointestinal tract, and on reproductive function.
“We are advising all our consortium members, for this very reason, to ensure that your label covers that this is not suitable for vulnerable people as well as for pregnant women,” Bhatarah said. “But the EFSA wanted the evidence on what will be the impact of that. And you can't generate that data just like that – it’s not a 90-day study because you have to go through the full animal studies and also the gestation period for animals to be pregnant and then the babies to be born.”
The EFSA also noted that while a lack of data from animal studies was one factor, it would also consider long-term trials on humans to be necessary. However, the agency would not want individual applicants to begin carrying out such human studies for ethical reasons.
Shortly after this announcement, the ACI said that it would be “taking these details and formulating a suitable plan to answer these questions and continue to support our members’ applications. We will be consulting with EFSA and FSA to create an action plan for how to tackle these data gaps.”