The Association for the Cannabinoid Industry is seeking clarification on the process behind the Food Standards Agency’s recently updated consumer advice for acceptable daily intake for CBD.
This guidance now sets the provisional ADI at 10mg a day, with the departure from the previous recommendation of 70mg a day causing substantial anxiety among brands, manufacturers, retailers and the public.
The ACI is concerned that the joint position paper issued by the Advisory Committee on Novel Foods and Processes and the Committee on Toxicity, which forms the basis for the FSA guidance, is opaque in its reasoning.
Having sought scientific, legal and regulatory advice, the ACI is requesting further clarity from the regulator and relevant committees, with the key questions as follows:
- We understand that the position paper was drafted in March 2023. Why is it being made public only now, some six months later?
- How many datasets submitted by industry as part of novel food applications were considered by the ACNFP and the COT before determining that only three were suitable for providing quantitative data used as the basis for the new provisional ADI?
- What were the criteria applied by the ACNFP and the COT in determining that only the three datasets were suitable?
- Were the data from datasets other than those deemed suitable taken into account in any way for the purposes of the position paper, and if so how?
- For the three studies deemed suitable, what were the quantities of CBD (in mg/kg body weight/day) administered to each group in each study?
- What did the ACNFP and the COT consider to be “the most sensitive, human-relevant, adverse effects in rodents” in those same three studies?
- Which human data was relied on to support the new provisional ADI, and how was it taken into account by the committees in reaching their conclusions?
- Why was a 10-fold uncertainty factor for interspecies extrapolation considered to be appropriate when human data are available for CBD?
- What was the evidence (if any) for possible increased sensitivity on chronic exposure to CBD?
- What was the literature referenced in the position paper that provided evidence that “CBD is immunosuppressive at the level at which the novel food is being administered”?
- Why did the ACNFP and the COT consider that an uncertainty factor of 3 was appropriate to reflect the “possible increased sensitivity on chronic exposure and other data gaps the studies could not cover adequately”, and what evidence did it rely on for this purpose?
- Could you identify the evidence from human studies that a high-fat meal can increase bioavailability of CBD 4-fold?
- Could you identify the human studies relied on by the COT for the purposes of the opinion issued in February 2020 (updated July 2021)?
Given the significant investments in time, effort and financial resources that the CBD industry has committed to the novel foods process, the ACI believes it is reasonable to request greater clarity on these points.
The association and its members are committed to ensuring that individuals who use CBD products are assisted to do so as safely as possible, but believes that the lack of clarity around the latest FSA update undermines the agency’s credibility and is unhelpful to consumers.
The ACI will therefore be submitting these questions to the FSA and the committees, and will update its members and the wider industry when it receives a response.
In addition, we have arranged a Q&A panel to discuss the implications of this consumer advice. Taking place online at 12pm on Thursday 19 October, the session will include contributions from the industry as well as regulatory, scientific and legal experts.
Watch a recording of this webinar here – https://www.youtube.com/watch?v=osMq5hzmR9c
For further enquiries contact Steve Moore.