Last month, UK regulators held two key meetings on the future shape of novel foods regulation in the country, seeing many businesses hope that some much-needed clarity may be provided regarding the status of CBD.
CBD was featured prominently on the agendas of both the Food Standards Agency’s (FSA) board meeting and the Advisory Committee on Novel Foods & Processes’ (ACNFP) two-day meeting, both of which took place over September 17 and 18.
Despite this, CBD was barely mentioned in the FSA’s meeting until questions were raised by the industry. More crucially, although the ACNFP’s agenda for Wednesday 18 was almost entirely dedicated to discussions around CBD, no one from the industry was invited to attend, and the discussions were kept private.
With the UK’s CBD industry having shrunk by 40% over the past five years, according to figures from the Cannabis Trades Association (CTA), frustration among operators at the lack of transparency continues to mount.
While industry groups have demanded greater involvement and insight into how the continually shifting goal posts are calculated, the FSA seemed to signal that it was willing to work more closely with the industry and recognised the urgent need for progress after numerous delays.
The core issue that continues to loom over the UK’s CBD industry is consumer guidance from the FSA that the recommended ‘acceptable daily intake’ (ADI) for CBD products is just 10mg.
In October last year, long after the Novel Foods process was underway and CBD businesses had spent considerable funds to sumbit their applications, the FSA made the shock announcement that it was dropping its recommended daily intake from 70mg to 10mg.
This meant that many single-dose products already in process, such as CBD beverages, capsules and gummies, will now contain levels of CBD over the new limit, requiring them to either relabel or reformulate their products, potentially rendering their applications void.
However, the ‘new scientific evidence’ on which this decision was based remains opaque, other than that, it is understood to be based on a single application’s toxicological studies.
It also remains unclear whether this means applications that do not meet this new 10mg limit will be allowed to progress in the Novel Foods process.
In May, the first two applications to be issued ‘positive safety assessments’ were revealed by the FSA, both of which did adhere to this strict limit.
With so little certainty surrounding CBD regulation, the lack of transparency on the part of the ACNFP is causing an already frustrated and struggling industry further unnecessary distress.
The CTA, which attended the FSA meeting and submitted a number of questions to the (invite only) ACNFP meeting, hammered home this issue on behalf of its members.
In their submission to the ACNFP, the CTA argues that this limit, based on studies of isolated CBD, disregards full-spectrum CBD products, which include other beneficial compounds.
“This limit is based solely on studies of isolated CBD, rather than the full spectrum and distillate products that make up a significant portion of the market… and applying this across the entire industry overlooks crucial differences between product types.”
The CTA argues this one-size-fits-all approach ignores scientific evidence supporting higher safe limits.
They went on to cite ‘hypocrisy’ in the regulatory process, after being told that each CBD application would be judged on its own merits.
“The imposition of a blanket ADI of 10mg contradicts this stance,” it continued.
“How can the ACNFP justify setting a standard based on one data set, while disregarding other scientific evidence? Studies have indicated that much higher ADI limits could be safely applied, yet these findings have been largely ignored.
“This inconsistency is creating confusion and frustration within the industry, as companies are being held to standards that may not reflect the full body of scientific evidence available.”
Not only are the ACNFP meetings not open to the public, but almost all of the discussions around CBD are classed as ‘reserved business’, a classification reserved for sensitive topics like commercially sensitive information or national security issues.
This means that the minutes from these meetings are also redacted or restricted from public access.
The CTA has called for more transparency into what specific studies were used to determine this ADI, why other data sets aren’t being considered, and whether this ADI will be subject to change based on new evidence.
“The industry deserves access to the scientific summaries and conclusions that informed this decision. After all, if the ADI is going to be applied across the board, it needs to be backed by comprehensive and transparent evidence.”
It also called out inconsistencies within the process, alleging preferential treatment and more regulatory support to some larger companies.
This was echoed by Hemp Hound’s Cefyn Jones, who told Business of Cannabis: “The lack of transparency from the ACNFP and FSA as a whole is extremely concerning, but judging by the progression of novel foods so far, it’s not surprising.”
He added that he believes there are companies in the process that didn’t have products on the market before February 13, 2020, despite the FSA still having published guidance stating that all companies were required to prove consumer sales on or before that date.
“We already know that companies have been able to circumvent that requirement though, despite the FSA removing companies from the process for not being able to prove sales by that deadline date.”
During the FSA meeting on the same day, the CTA levelled these issues at the board, laying out the disillusionment of businesses trying to operate within the legal framework and the ineffectiveness of the current regulatory framework.
In response, Chair of the FSA Board Professor Susan Jebb, requested that the CTA formally write to her with suggestions on how to expedite the Novel Foods process for CBD products.
The board reportedly recognised the urgency of the situation and indicated that January 2025 could be a target date for accelerating the regulatory framework.
The post CBD Regulations in the Spotlight: Industry Calls Out Lack of Transparency From UK Regulators appeared first on Business of Cannabis.
Continue reading...
CBD was featured prominently on the agendas of both the Food Standards Agency’s (FSA) board meeting and the Advisory Committee on Novel Foods & Processes’ (ACNFP) two-day meeting, both of which took place over September 17 and 18.
Despite this, CBD was barely mentioned in the FSA’s meeting until questions were raised by the industry. More crucially, although the ACNFP’s agenda for Wednesday 18 was almost entirely dedicated to discussions around CBD, no one from the industry was invited to attend, and the discussions were kept private.
With the UK’s CBD industry having shrunk by 40% over the past five years, according to figures from the Cannabis Trades Association (CTA), frustration among operators at the lack of transparency continues to mount.
While industry groups have demanded greater involvement and insight into how the continually shifting goal posts are calculated, the FSA seemed to signal that it was willing to work more closely with the industry and recognised the urgent need for progress after numerous delays.
What happened?
The core issue that continues to loom over the UK’s CBD industry is consumer guidance from the FSA that the recommended ‘acceptable daily intake’ (ADI) for CBD products is just 10mg.
In October last year, long after the Novel Foods process was underway and CBD businesses had spent considerable funds to sumbit their applications, the FSA made the shock announcement that it was dropping its recommended daily intake from 70mg to 10mg.
This meant that many single-dose products already in process, such as CBD beverages, capsules and gummies, will now contain levels of CBD over the new limit, requiring them to either relabel or reformulate their products, potentially rendering their applications void.
However, the ‘new scientific evidence’ on which this decision was based remains opaque, other than that, it is understood to be based on a single application’s toxicological studies.
It also remains unclear whether this means applications that do not meet this new 10mg limit will be allowed to progress in the Novel Foods process.
In May, the first two applications to be issued ‘positive safety assessments’ were revealed by the FSA, both of which did adhere to this strict limit.
With so little certainty surrounding CBD regulation, the lack of transparency on the part of the ACNFP is causing an already frustrated and struggling industry further unnecessary distress.
The CTA, which attended the FSA meeting and submitted a number of questions to the (invite only) ACNFP meeting, hammered home this issue on behalf of its members.
One-size-fits-all approach
In their submission to the ACNFP, the CTA argues that this limit, based on studies of isolated CBD, disregards full-spectrum CBD products, which include other beneficial compounds.
“This limit is based solely on studies of isolated CBD, rather than the full spectrum and distillate products that make up a significant portion of the market… and applying this across the entire industry overlooks crucial differences between product types.”
The CTA argues this one-size-fits-all approach ignores scientific evidence supporting higher safe limits.
They went on to cite ‘hypocrisy’ in the regulatory process, after being told that each CBD application would be judged on its own merits.
“The imposition of a blanket ADI of 10mg contradicts this stance,” it continued.
“How can the ACNFP justify setting a standard based on one data set, while disregarding other scientific evidence? Studies have indicated that much higher ADI limits could be safely applied, yet these findings have been largely ignored.
“This inconsistency is creating confusion and frustration within the industry, as companies are being held to standards that may not reflect the full body of scientific evidence available.”
Greater transparency
Not only are the ACNFP meetings not open to the public, but almost all of the discussions around CBD are classed as ‘reserved business’, a classification reserved for sensitive topics like commercially sensitive information or national security issues.
This means that the minutes from these meetings are also redacted or restricted from public access.
The CTA has called for more transparency into what specific studies were used to determine this ADI, why other data sets aren’t being considered, and whether this ADI will be subject to change based on new evidence.
“The industry deserves access to the scientific summaries and conclusions that informed this decision. After all, if the ADI is going to be applied across the board, it needs to be backed by comprehensive and transparent evidence.”
It also called out inconsistencies within the process, alleging preferential treatment and more regulatory support to some larger companies.
This was echoed by Hemp Hound’s Cefyn Jones, who told Business of Cannabis: “The lack of transparency from the ACNFP and FSA as a whole is extremely concerning, but judging by the progression of novel foods so far, it’s not surprising.”
He added that he believes there are companies in the process that didn’t have products on the market before February 13, 2020, despite the FSA still having published guidance stating that all companies were required to prove consumer sales on or before that date.
“We already know that companies have been able to circumvent that requirement though, despite the FSA removing companies from the process for not being able to prove sales by that deadline date.”
Some optimism
During the FSA meeting on the same day, the CTA levelled these issues at the board, laying out the disillusionment of businesses trying to operate within the legal framework and the ineffectiveness of the current regulatory framework.
In response, Chair of the FSA Board Professor Susan Jebb, requested that the CTA formally write to her with suggestions on how to expedite the Novel Foods process for CBD products.
The board reportedly recognised the urgency of the situation and indicated that January 2025 could be a target date for accelerating the regulatory framework.
The post CBD Regulations in the Spotlight: Industry Calls Out Lack of Transparency From UK Regulators appeared first on Business of Cannabis.
Continue reading...
