The UK's Food Standards Agency (FSA) has issued the first two 'robust safety assessments' for CBD (cannabidiol) products as part of its long-standing novel food approval process.
Pures, a subsidiary of Chanel McCoy, became the first UK company to receive a positive risk assessment for a synthetic CBD application on 29 April 2024.
Cannaray similarly received its first-ever positive risk assessment for an isolated CBD application. This means both companies can proceed to the next stage of authorization, risk management.
The industry has also very much welcomed the news, with each company hailing this development as a 'milestone' for both their brands and the broader CBD industry.
This is the first significant development in UK CBD novel food products in more than a year and suggests the FSA may finally be making progress on the backlog of applications that have stalled the industry for years.
Jamie Bartley, Cannabis Industry Council Co-Chair and CBD/Hemp APPG Secretariat Leader, and Damian Bove, Chair of the CIC CBD Working Group, told Business of Cannabis: The deadline has passed.
“The consumer CBD industry has been in limbo for some time, negatively impacting its economic outlook and preventing a level playing field in the market.
“We hope these approvals will lead to gradual changes in the approval process and that many other products will receive safety approval in the near future.”
what happened?
The FSA (and Food Standards Scotland), with the support of the Advisory Committee on Novel Foods and Processes (ACNFP), said that the two applications were 'sufficient to ensure that the novel food is safe under the proposed conditions. “We provided significant information,” he concluded. of use.
“The expected intake and proposed use in food and dietary supplements were not considered nutritionally unfavorable,” the FSA reported.
Chris Rundle, Director of Regulatory Product Risk Assessment at the Food Standards Agency, said: The evaluation concluded that these new CBD edibles are safe when consumed up to 10mg of CBD per day in accordance with consumer advice. These applications move to the next stage of the authentication process.
“The FSA and FSS are the first regulatory authorities to complete and publish a safety assessment of CBD as a novel food. The progress of these applications will ensure that applicants have access to high-quality data to support the assessment and authorization process. It shows the importance of providing
Chanel McCoy, CEO of Chanel McCoy Health, indicated that the brand has been working for nearly a decade to get to this point, and the brand is now ready to expand its product portfolio. said that
“This is a monumental achievement and a complete transformation for the CBD industry,” she added.
“We are proud to be at the forefront of driving innovation and establishing best practice in the UK CBD industry,” Cannaray managing director Howard Radcliffe said in a statement on social media.
The Cannabis Traders Association (CTA) said: “We are pleased to see that the FSA is finally clearing up the historical document that has been on the ACNFP agenda since February 2024.”
“We think this is clearly good news as the revised new food processes for CBD and other food products will come into force by June.”
However, after reading the full report on Cannaray's application, the industry group noted that “the lower limit is not supported by the recommendations.”
“This only covers isolated and synthetic CBD as a food ingredient…Our understanding is that the revised new food process will come into effect in June and its bulk ingredients will contain 50 micrograms of cannabinol and CBD. As long as it meets the 10mg ADI, it is subject to change as more data becomes available.”
Acceptable Daily Intake (ADI) 10mg
In October last year, the FSA released a shocking update to its consumer guidance on recommended daily doses of CBD.
The FSA has lowered its recommended daily intake from 70mg to just 10mg, according to new “scientific evidence” purportedly derived from toxicological studies submitted by the industry itself.
This means that many single-dose products such as CBD drinks, capsules, and gummies will contain levels of CBD that exceed the new standards.
Industry insiders immediately expressed concerns about the move, calling it “high-handed.” Both successful applications adhere to this limit, which raises the question of which applications exceed this threshold.
A few days later, in response to the ACMD report published on 24 October, Minister for Crime and Police Chris Philip said the government intended to accept the recommended limit of 50 micrograms per unit of intake for THC and other controlled cannabinoids. He said that.
A consumption unit or “single serving” is defined as a typical amount of CBD product consumed at one time, but industry representatives have cited the need for further clarification on what constitutes a typical serving of CBD. is expressed.
new food process
The FSA published a 'public list' of verified CBD applications in June 2022 and continued to verify compliant applications in the following months.
This is a detailed description of all CBD product applications that meet the FSA's strict and costly requirements for formal authorization.
Publicly listed products were allowed to remain on the market while undergoing a multi-step safety assessment process, but companies were unable to bring new products to market until this approval process was completed. There wasn't.
With the industry in limbo, the FSA's lack of clarity, repeated delays and shifting goalposts have led to significant frustration from a financially strapped industry.
So while the news that the application has moved forward is very important, it is unclear whether the Financial Services Agency will be able to achieve its goal of granting the first official approval this summer.
Now that the product has passed the risk assessment process, we move on to the risk management phase.
According to the FSA, this will take into account “other legitimate factors in its use, such as labeling considerations”. And a public consultation will be held before advice is sent to national ministers on whether to approve it. ”
“Subject to the Minister's approval, the authorization will be written into law and become a statutory instrument, subject to Ministerial scrutiny before the authorization comes into force.”
But this final step will soon be streamlined amid proposals to overhaul new food processes in an effort to allow the FSA to address industry complaints and keep regulations in line with developments in the sector. There is a possibility.
