The ACI welcomes the recent clarifications from The Advisory Council for Novel Foods and Processes (ACNFP) relating to the data requirements for CBD novel foods applications. The ACNFP, who are an advisory committee to the FSA, highlighted the following key points, which emphasise the importance of ACI’s consortium approach to generating this data.
- Relying on publicly available data will not be sufficient for a novel foods dossier to be authorised
- Therefore, toxicology studies will be required
- A consortium approach will be accepted, provided the justification is sound
- Finished products are required to have their own dossiers
The ACNFP published the minutes from their last meeting, which focused on:
- The most recent Committee on Toxicity (COT) position paper on CBD
- CBD Novel Food dossiers already received by the ACNFP
- Gaps in the data packages
- Advice for applicants
According to the ACNFP’s website, their role is “to carry out the safety assessment of traditional novel food notifications. Concerns are usually raised if there is a lack of information or there is a clear safety concern.” The committee convenes every six months for formal meetings and workshops where they review dossiers and briefing papers. ACNFP’s advice is then, “shared with FSA risk managers to inform if objections are raised and a further assessment of the identified risk is needed.”
Safety concerns due to data gaps
As the COT report underscored significant safety concerns, and highlighted the lack of publicly available safety data, the ACNFP will play a pivotal role in the process of dossier assessments.
The commentary so far relating to the COT position paper gives a clear indication of what data the FSA and ACNFP are expecting to find in dossiers. This is a direct result of the concerns raised by COT and is highlighted in ACNFP meeting minutes from 10 September 2020.
“The Committee noted that the primary source of current toxicology data is from studies to support the authorisation of >98% pure CBD as a medicine, with brand name Epidiolex. This is a CBD-based medicine licenced to treat certain forms of epilepsy. The Committee noted that medical trials are not designed to support the safety of food products as exposure patterns, co-consumption, purity of the CBD and recorded outcomes differ and therefore results from these studies may only be useful in supporting novel food applications for CBD in certain circumstances. The ACNFP noted that there are still gaps in the toxicological data package around systemic toxicity and human bioavailability.”
It is reasonable to infer from this that relying solely on the publicly available data, specifically, Epidiolex data, will not be sufficient to satisfy the FSA and therefore further toxicity studies will need to be conducted.
Do finished products need an application?
The next point from the minutes also provides crucial insights relating to finished products.
“The Committee noted that there will likely be variation between the purity of the extracts destined for use in foods and proportions of minor components present between different novel food applications and therefore product specific characterisation data will be important. Members also noted that bioavailability is likely to vary considerably between CBD in different matrices or co-consumed with foods and data to support the properties and human systemic exposure from each product will be important.”
They also noted the following.
“Members generally considered that separate applications should be submitted for each product, but they could share study data and evidence between them if the use of such data can be scientifically justified as part of their risk assessment.”
Dozens of brands have contacted the ACI to ask for clarity on what the responsibility of a brand is in regards to their products. It is clear from the above, that individual finished products will potentially require further bioavailability studies to prove their safety and will be required to be included in a novel foods dossier.
The information expected in a novel foods dossier
The ACNFP shed light on what their expectations are for a dossier, through their comments on the two dossiers they have reviewed (informally) already. They expressed concerns that, “both applications used data from the Epidiolex submission to support the safety of their product but did not provide safety data on their specific product.” They clarified this by explaining, “the purity of the CBD used for medical trials may not fully reflect CBD in food use. Therefore, the Committee agreed that applicants should carry out their own toxicological data where their CBD substance differed from medical grade or provide bridging studies to make sure the toxicology data being used to assure safety was relevant for the purity and composition of their CBD product.”
Again, it is clear that relying solely on existing literature will not be sufficient for a successful application, and it is the responsibility of the companies in the sector to produce the data (toxicological and ‘bridging’ studies) something that has been inherent in ACI’s strategy from the outset. The ACI have maintained that toxicology studies would be required, as would further bioavailability studies, potentially at a product level.
ACI’s CBD safety study consortium approach
The ACI launched our CBD safety study consortium to generate this data and share the burden of costs. There have been questions in the industry whether or not this approach would be acceptable. It appears the approach is valid as ACNFP states in their minutes that, “a shared package of toxicology studies would be acceptable in circumstances that could be scientifically justified.”
This term, ‘scientifically justified’ is in line with the ACI’s approach to achieving compliance through the novel foods framework (and has been used in our presentations from the beginning); as long as there is a robust scientific justification of how the consortium approach will work, we are confident of the success of the consortium. The ACI has built internal scientific, toxicology and regulatory expertise, from the pharmaceutical and food industry, and is working with established external partners to ensure that the highest science and regulatory standards are applied.
One study for multiple applications
A question that is frequently asked is, how one toxicology study can be used for multiple companies’ products. With the ACNFP now stating that a toxicology package can be shared, they explore whose responsibility it is to set the required range for tolerances.
According to ACNFP, “Applicants of small and medium-sized companies have also requested a reference range of acceptable levels of cannabinoids and other components of their products to account for variability between company’s batches.” However, they point out that “ [ACNFP] Members were very wary of setting numerical limits for tolerances. The database as it currently stands, does not provide enough information for the committee to be able to do this. Each product will be different. The applicants know the details of their product and the onus is on them to be able to scientifically justify the information they have provided.”
From this, we can see it is clear that the responsibility of setting a range in order for one data package to be representative of many products, falls on the responsibility of the group sharing the data package, and not the regulatory authorities. The ACI have already commenced on this exercise of defining the purity profile and purity range, and will share the results with the relevant authorities before the dossiers are submitted.
To reiterate:
- Relying on publicly available data will not be sufficient for a novel foods dossier to be authorised
- Therefore, toxicology studies will be required
- A consortium approach will be accepted, provided the justification is sound
- Finished products are required to have their own dossiers
The ACI is pleased to see that the official bodies who will oversee the UK’s novel foods applications fully vindicate our approach to achieving novel foods compliance; whether through our consortium, or our consultancy service on finished products.
Please contact us to discuss how the ACI can help you achieve novel foods compliance for your products in the most cost-effective and robust way. Time is of the essence, and the requirements could not be any clearer.
