The Food Standards Agency (FSA) has said the public list of approved CBD products will be updated ‘as and when applications have been validated.’
The FSA will release a list in bulk form in the interim, indicating the applications which are ‘awaiting evidence’.
A spokesperson for the food safety body met with the Association for the Cannabinoid Industry (ACI) on 3 February, following growing concerns around the release of the public list.
CBD companies with consumable products on the market had until 31 March 2021 to file novel food applications. Almost one year later, the FSA has yet to publish the list of authorised products, a move which will see the UK become the first country in the world to regulate a cannabis extract in food products.
Cannabinoid Insight understands that the list can be expected ‘before summer’.
Deadline looms for presenting new toxicology data
In January, up to 40 companies which submitted applications prior to the 2021 deadline received notices from the public health agency requesting bolstered evidence for food safety. These organisations have now been given a deadline of 28 February 2022 to submit the sufficient data.
Cannabinoid Insight understands this deadline applies mostly to applications submitted with a literature review of existing toxicological data, which provided no evidence beyond that which was previously reviewed by a Committee on Toxicity.
On 21 January, the FSA reiterated previous guidance that any review of pre-existing data would not go far enough in proving the safety of CBD in food.
Paul Tossell, Head of Novel Foods and Radiological Policy Team at the FSA confirmed to Cannabinoid Insight that applications based on literature reviews of studies were insufficient.
“Some applicants have based their safety cases on literature reviews of studies to support their applications, which are not sufficient evidence based on the Committee on Toxicity’s work, which considered summary data on Epidiolex. Therefore, we have asked for these applications to be supplemented with supporting data by 28 February.
“We have advised that there may be options, including accessing other existing data, rather than undertaking further studies to complete the gaps.“
Steve Moore, strategic counsel to the ACI said:
“This does not affect our members. These companies can access toxicological data generated by the ACI, or another consortium, but they cannot use this data as supporting evidence to be included on the upcoming public list. Only as part of a full pre-market authorisation application.”
White Labelled Products
Clarity has also been sought on the issue of white labelling products. It is now clear that products which were on sale prior to the FSA’s February 2020 announcement on CBD as a novel food, are permitted for white labelling purposes. However, this does not apply to new finished products aimed at consumers.
“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.”