Chanelle McCoy Health and Cannaray Brands are the first two firms to make it to the next stage of the UK’s lengthy and controversial cannabidiol food supplement approval process.
Both Chanelle’s synthetic CBD based Pureis line and Cannaray’s isolate-based CBD products (all 10mg CBD) received a “positive safety assessment” from the UK Food Standards Agency’s Advisory Committee on Novel Foods and Processes (ACNFP), which means they can progress to the next stage of the regulator’s novel food process.
FSA should now be able to complete its risk assessment of these products and eventually make a recommendation to UK ministers, potentially resulting in the first CBD products authorized for use in Great Britain.
Chanelle McCoy Health CEO, Chanelle McCoy, described the decision as a “monumental achievement and a complete game-changer for the CBD industry.”
“We are thrilled Pureis is the first CBD brand globally to receive this positive safety assessment officially from a leading regulatory authority,” she added.
Cannaray managing director, Howard Radcliffe, said advancement to the FSA’s risk management stage was a “testament” to the firm’s “unwavering dedication to excellence and compliance.”
“We are proud to be at the forefront of driving innovation and establishing best practices within the UK CBD industry. This achievement not only validates our efforts but also reinforces our position as a trusted leader in this rapidly growing sector.”
Next Steps
Before being authorized, the FSA will next consider “other legitimate factors” relating to the risk assessment of both Chanelle’s and Cannaray’s CBD products, according to the FSA’s pre-market approval procedure for regulated products, including novel foods.
These additional factors include environmental concerns and “consumer habits, perceptions, acceptability and preferences, including likely consumer behaviors in response to risk and emerging trends,” FSA explains.
ACNFP’s safety assessment and these other legitimate factors “will be combined to form an evidence package,” which will then to presented to UK government ministers. “The ministers will then decide whether the product should be authorized for use in Great Britain.”
These stages will need to progress quickly, if the FSA is to meet its target of having the first CBD authorizations in summer 2024 – a goal mooted at the FSA’s March 2023 board meeting. (Also see "First UK CBD Novel Food Authorizations Not Expected Until 2024 At The Earliest" - HBW Insight, 5 April, 2023.)
1 mg THC Legal
At least one of the complicating factors highlighted by FSA at this meeting seems to have been dealt with. The regulator noted that authorization depended on “planned Home Office legislation on THC limits in consumer products.”
Until recently, ingestible CBD products which contain any amount of controlled cannabinoids such as delta-9-tetrahydrocannabinol (THC) failed the UK Home Office’s criteria for “exempt products” under the country’s Misuse of Drugs Regulation.
However, as the result of a successful action taken against it by Jersey Hemp, the Home Office seems to have changed its policy with regards to CBD, conceding now that these products do meet the exemption criteria of the MDR.
“The establishment of an acceptable level of controlled cannabinoids has been on the cards for over two years since December 2021 following the UK Advisory Council on the Misuse of Drugs’ recommendations that such a level be established,” commented Canna Consultants. (Also see "UK Government Narcotics Advisors Recommend 0.05mg THC Limit For CBD Products" - HBW Insight, 27 January, 2022.)
“What that level would be was open for debate, but the new position of the Home Office would appear to set that level as 1 mg per container (which was not that recommended by the ACMD),” the cannabis consultancy added, in a position paper.
Streamlined Process
Meanwhile, the FSA wants to cut waiting times by seeking agreement from ministers to amend the current legislation so that authorizations can come into effect by publication after ministerial decision and do not have to be listed in full in legislation. (Also see "UK Proposes Accelerating Authorizations Of Novel Supplements Like CBD" - HBW Insight, 11 April, 2024.)
This would mean the very last step for Chanelle’s and Cannaray’s CBD products may not need to happen, potentially speeding up the arrival of the first, authorized UK CBD products.
This proposal – which is open for consultation until 5 June – forms part of a wider move by FSA to shake up how novel foods are authorized to keep up with the pace of innovation in the industry.
The agency has been criticized for its handling of its assessment of CBD novel foods. An all-party parliamentary group for CBD products described the FSA’s novel food approval process as “costly, onerous and lengthy.” (Also see "Review UK’s ‘Onerous’ CBD Novel Food Process, Says Parliamentary Group" - HBW Insight, 31 August, 2022.)
The FSA has itself admitted mistakes. FSA policy head Rebecca Sudworth acknowledged at a 2022 board meeting that the agency could have “better anticipated” the surge in cannabidiol applications received just before the March 2021 application deadline. (Also see "UK FSA Admits It Could Have ‘Better Anticipated’ CBD Application Bottleneck" - HBW Insight, 2 March, 2022.)
