The Food Standards Agency (FSA) published a list of permitted CBD products, and their manufacturers, on 31 March 2022. The emergence of the long awaited list has presented more questions to answer.
We asked Laura Williamson, Technical Advisor to the Association for the Cannabinoid Industry, to clear up some of the biggest issues.
What led to the regulation of CBD as a novel food?
Back in 2019, the European Commission classified cannabis extracts as novel foods. The UK’s FSA followed suit and after lobbying by ACI for a proportionate implementation plan, in February 2020 set a deadline for all products on the market to have submitted their novel food applications by 31 March 2021.
At this point it was made clear to those in the industry, that sufficient dossiers would require toxicology data, and that no new products were to be brought to market without full pre-market authorisation.
Why is this list only the first stage of the regulatory process?
Using a pre-market authorisation protocol in retrospect has meant the FSA has been met with challenges; timely enforcement being pertinent. How could they begin to enforce their new legislation, and remove non-compliant products from shelf, without having any authorised products? Authorisation can take 18 months.
Their solution was this ‘Public List’: in March 2021, the FSA requested information from applicants including proof that products were on sale before 13 February 2020. Applicants that had provided all required information, including full data sets, were validated, and placed on the validated list. Applicants that had provided robust plans to produce the required data were placed on the ‘awaiting evidence’ list.
It’s thought this will help Trading Standards officers decipher which applicants and their associated products can be stocked by retailers because they have shown robust plans to be compliant, and which companies had not engaged with the process at all. The latter can be removed from the market.
Why are some products not on the public list?
There are four main reasons why a CBD product, or manufacturer, might find they have been left off the list.
- Applications were not filed before 31 March 2021. The deadline was set back in February 2020, giving industry members a year to put plans into place to generate the necessary data and submit a novel food dossier. Any applications submitted after the deadline are processed for pre-market authorisation, meaning they should not be on sale until full authorisation is granted.
- Products were not on the market before 13 February 2020. This cut-off date was set and made clear by the FSA. The market should be as it was on that date. No products, or brands should have launched since then without pre-market authorisation, and currently no cannabinoid extracts are authorised in the UK.
- Lack of preparation for safety evidence. A novel food dossier requires a wealth of data to support the product’s safety including stability, pharmacokinetic, and toxicological analysis. The Committee on Toxicity’s review found several data gaps in the literature for CBD, especially in the areas of reproduction and immunology, thus the FSA – still referring to the EFSA guidance on novel food applications – suggested an OECD408 Repeated Dose 90-Day Oral Toxicity rodent study.
Whilst many applicants deemed rodent studies too costly, an ethical conundrum, or were ill-advised that they were unnecessary; they have now found themselves having to remove these products from the market.
- An error occurred and may be corrected. Since the list went live, the FSA has acknowledged there may be minor edits to the list over the coming weeks, including the addition of products which were subject to administrative errors, resulting in temporary exclusion.
Can I still white label products?
Earlier this year, the FSA issued an explanation around the issue of white labelling. Whilst the industry seems keen to produce conjecture about the situation, especially with regards to white labelling, the FSA’s stance is clear.
While the 3,536 products on the list are permitted to remain on the market for the time being, pending full authorisation, there can be no new products, no new brands launched, not even a rebrand of a validated product. However, business-to-business sales may continue.
An FSA spokesperson confirmed this to Cannabinoid Insight in February.
“Only products which were on the market at the time of our announcement on CBD (13 February 2020) and for which the FSA has received an application which is subsequently validated or agreed as sufficiently progressing towards validation will be allowed to remain on the market.”
“Business-to-business sales of white label products can occur, but any business-to-consumer sales of a finished product must have pre-market authorisation, if it was not on sale before 13 February 2020.”
This means that even now that the validated and pre-validated list is in the public domain, no new brands or products are permitted to enter the UK’s CBD marketplace without a full novel foods authorisation.
For more information, see the FSA’s business guidance.