Joint Subgroup of the Advisory Committee on Novel Foods and Processes (ACNFP) and Committee on Toxicity (COT) on CBD and Hemp Derived Products. Minutes of the 7th CBD Meeting held on the 4th of July 2023

These minutes are subject to confirmation by the Subcommittee. 

Members are required to declare any personal interest in matters under discussion; where Members have a particularly close association with any item, the Chairman will limit their involvement in the discussion. In cases where an item is to be discussed in their absence, a Member may make a statement before leaving. 

Minutes of the 7th meeting of the Joint Subgroup of the Advisory Committee on Novel Foods and Processes (ACNFP) and Committee on Toxicity (COT) on CBD and Hemp Derived Products, held on 4th of July 2023, online using Microsoft Teams.

Attendance

Committee Chair

Dr Camilla Alexander-White - Chair of ACNFP

Committee Members

Professor Alan Boobis - Chair of COT

Mrs Alison Austin - ACNFP

Dr James Coulson - COT

Professor Shirley Price - COT

Professor Gunter Kuhnle - COT

Dr Cheryl Scudamore - COT

Apologies

Prof. Gary Hutchinson - COT

Dr Lesley Stanley - ACNFP

Dr Simon Wilkinson - COT

Dr Mac Provan - COT

Dr Stella Cochrane - COT

Mrs Ruth Willis - Technical Secretary ACNFP

Dr Olivia Osborne - COT Secretariat

Secretariat

Mr Ben Haynes - Lead Secretariat for Subgroup

Dr Tahmina Khan - ACNFP Secretariat

Mrs Afielia Choudhry - ACNFP Secretariat

Mr. Will Smith - ACNFP Secretariat

Dr Cath Mulholland - Technical Secretary COT

Miss Victoria Balch - ACNFP and subgroup Administrative Secretariat

Miss Sophy Wells - ACNFP and subgroup Administrative Secretariat

Executive summary

The Joint Subgroup of the Advisory Committee on Novel Foods and Processes (ACNFP) and Committee on Toxicity (COT) on CBD and Hemp Derived Products has considered the introductory datasets and assessment criteria available to the FSA for the group B CBD ingredients during their meeting on 4th July 2023. They identified several issues that need to be addressed in order to proceed with the safety assessment of CBD Novel Food applications containing a range of cannabinoids.   

1. Apologies and Announcements

Apologies were received from Dr. Simon Wilkinson, Dr. Lesley Stanley, Dr. Mac Provan, Dr. Stella Cochrane, Prof. Gary Hutchinson, Mrs Ruth Willis and Dr. Olivia Osborne. 

2. Welcome and introduction

The Chair welcomed the members, representatives from the FSA, the observers and the Secretariat team.

3. Minutes from the March and May meetings

CBD/05/06/MINS

The Chair noted that the status of minutes from the previous subgroup meetings was to be addressed by the lead Secretariat.  

The lead Secretariat thanked the members for their continued patience whilst awaiting the package containing the minutes which had been reviewed by FSA staff. The Secretariat explained that the minutes documents from the previous two meetings have been available for some time. To ensure all final comments had been made by all members, the Chair requested that the minutes be recirculated in the coming week to allow for final commentary by those members not in attendance. The documents were declared ready to be cleared and signed off if no further comments need to be made. 

4. Item 1 – CBD Group B Assessment Criteria

CBD/07/01

The Subgroup was asked to advise on the approach to the assessment of the group B applications in light of the review of the three previously identified group B studies. The Secretariat explained that as data quality is a key consideration of the Subgroup, members were therefore asked whether the three previously identified group B studies from May 2023 could support identification for a quality standard for studies. 

The increasing complexity of group B CBD ingredients compared to group A has called for further discussion on how the data supplied for this group of ingredients can be best used to support the novel food assessment of these ingredients. The purpose of item 1 was to explore the two available approaches for review of data provided for group B ingredients, with the aim of identifying the assessment approach for applications and their supporting studies in this group.

The Chair proposed the idea that even with a defined set of criteria for group B, having access to all of the available data for group B applications regardless of quality would only help to reinforce the Subgroups eventual conclusions for this group of CBD applications. The criteria provided by the Secretariat was concluded to be akin to those that are required by traditional 90-day standards, albeit with additional caveats to incorporate the context of the difficulty of analysing CBD as a novel food. Members agreed that the additional criteria of ‘consideration of test item used which is pertinent’ was very important here. 

The Chair proposed that it would be easier to discuss this item alongside the data provided in item 2. Within the studies presented, the most integral criteria that needs to be ensured by applicants is a thorough consideration of the characterisation data of material i.e., if unknowns are reported it is important that the applicant has considered what the remaining % of the product is, as well as the additional cannabinoids. 

When determining a definitive list of assessment criteria for group B applications, members agreed that applicants must be clear on test item vehicle data, the rationale for the chosen vehicle and the full characterisation of their ingredient. 

Members continued with a review of the assessment criteria, alongside the datasets of item 2. Members declared that the three 90-day studies provided matched the already concluded need for criteria which is based on the characterisation of the novel food. It was noted that the group B ingredients had some unknown / other cannabinoid content. The Chair proposed that criteria could be set for group B, if the subgroup can define how much of an unknown can be allowed in a group B CBD products. It was reiterated that by seeing all of the currently available data for group B, regardless of quality, the subgroup could theoretically define a set level for cannabinoids and additional components which applicants must abide by. 

Action: Secretariat to provide the 90-day subchronic reports of all available group B applications over the course of the summer.

5. Item 2 – Return to the CBD Introductory paper

CBD/07/02

The Subgroup were provided with an introduction to the range of datasets to expect from Group B focused meetings for the second time. The introductory paper incorporated the results of three particularly detailed studies, in order to provide a reliable depiction of the range of compositions and results that group B will bring compared to the previous group A discussions.

The need to consider all the data provided in the studies and critically evaluate the conclusions was noted. An area of particular focus was the specification and characterisation reports provided by the applicants, in order to verify if the conclusions reached by the study teams were robust and whether an early verdict could be gauged for group B ingredients. 

Within the studies, a range of compositions and specifications were seen with differing levels of the CBD purities and cannabinoids. It was proposed by the Chair that it would be useful to assess the characterisation of each product study-by-study. Discussions began with the study 1 of the data package. Members discussed that the study team did not characterise the carrier vehicle very well or provide details on the full composition of the CBD ingredient, with a particular percentage of the composition declared unreported. Additionally, a general observation for the first dataset was that the mixture of cannabinoids, which is a common composition for group B, would product observations of adverse effects that were expected to be seen and this would likely lead to a lower intake level that can be approved when the context of a mixture is applied.

A lack of characterisation of what the study teams tested or what was administered to the rats over the period of 90 days meant that the characterization was inadequate for mixtures i.e., CBD to CBG. This was concluded to be apparent for all three of the studies, which meant read across between them was impossible to be concluded. It was also concluded that when considering a gold standard for group B, then stability and characterisation information is important i.e., the stability and degradation in the carrier vehicle and this was not apparent for all three studies. 

The idea that the subgroup should have specifications, that if the product matches, was proposed and was agreed to be a sufficient method of analysing the differing compositions and characterisations of each application. Levels would need to be set for total other cannabinoids and details on the characterisation of ‘unknowns’ in the total compositional analyses and detail what these ‘unknowns’ may be. However, members would need to consider variations in characterisations to demonstrate comparability i.e., the vehicle used for the test item.

Actions from this item – The Secretariat is to consider a potential call for data on characterisation data for each group B ingredient. 

6. Item 2 – Return to the Cannabinoid composition and receptor activity paper

CBD/07/03

The cannabinoid composition and receptor activity paper was presented a second time to members which included the previously discussed two sets of information, alongside the additional KDI and potency data which was actioned at the May meeting. Comments were made on the reasoning for reviewing the data on receptor activity for a second time: it is useful to understand more about the mixtures of cannabinoids and how they work at receptors in order to identify any specific risks; to identify any concerns with specific cannabinoids or similarly to identify where there is low risk from specific cannabinoids; to inform decisions on an acceptable level of cannabinoids, other than CBD, in a CBD novel food product. 

Members expressed that the paper was a nice compilation of the published data. Members discussed the importance of distinguishing between several different things that are occurring. There are those trying to develop cannabinoids for beneficial purposes and finding evidence that supports their claim, and mechanistic studies, which are more pharmacology based than the supplements given in food. It was concluded that potency and exposure are the most important factors to consider here, and members must work out whether there is anything meaningful occurring with the levels of the cannabinoids that are likely to be in the products as consumed or used. 

It was discussed that the receptor potency information could suggest a few approaches and questions to be taken and answered by the subgroup in further discussions. If ADI's were to be used for Group B products, would they be sufficiently protective? Is there a problem with the low levels of other cannabinoids having a synergistic or entourage effect, or are the cannabinoids at such a level that if you assume they just add up all the cannabinoids together and apply a common ADI, it would be sufficiently protective? 

The topic of appropriate characterisation from the previous items was also discussed here. Members discussed that it is important to consider the potential for unknowns in the specifications of products going forward and whether these have the potential to have a major effect on those taking CBD or at what level are these unknowns allowed to be present in the final products. 

Members concluded that it would be beneficial to produce a table that the FSA have on the website that presents a list of all the cannabinoids that you might find in CBD products. From this, the evidence from the applicants and the characterisation they have presented can be assessed. An example was given of a baseline of 75% CBD at worst. So, for Group B products if there is a situation where a product has 75% CBD, applicants could have up to 25% of other cannabinoids on some of which are on this list and then apply the evidence from the receptor activity table.  

Members discussed that it was important that the batch-to-batch product characterization is assessed, especially in the context of CBG as the review indicated CBG to be the main other cannabinoid at levels of up to 10 or 11%. It was suggested that if the subgroup were provided information on the maximum levels of all cannabinoids, a potency:proportionality ratio could be created where if the CBG is within 1%, for example, and the potency is less than tenfold, then it could be declared negligible for the specific product. 

The committee discussed whether there were any specific concerns raised from evaluating the literature data on receptor activity and cannabinoid composition. A specific concern was raised regarding the potential for unknown cannabinoids being present in CBD products i.e., cannabinoids present in the products which are not tested for and therefore do not appear in the compositional analyses. This is in part due to the fact there are many more cannabinoids naturally occurring in the Cannabis sativa plant than are tested for in typical compositional analyses of CBD products. 

Actions from this item – The Secretariat is requested further literature data on the bioavailability of Group B CBD products, noting that the test vehicle is of high importance.  

It was also requested that the potency data be represented graphically, to allow for further analysis of the differences between cannabinoids. 

7. Date of the next meeting

The next meeting is scheduled for Tuesday 7th November 2023. It will be held online via Microsoft Teams.