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US CBD firms collaborate on large scale safety study: is this the way forward for UK and EU CBD businesses?

Posted on 12 June 2020

A group of seven CBD companies have collaborated with a clinical research firm to conduct a large scale observation study to provide the safety data required by the US Food and Drug Administration (FDA). The aim of the study is to identify if CBD is safe, focusing in particular, on CBD's effects on liver function. The study is planned for the third quarter of 2020, to be completed by the end of the year, and was designed with input from the FDA, the collaborating brands and third party scientists. The study will include a minimum of 700 subjects, including some who are using CBD products for medicinal purposes and a wide range of CBD products. It has been reported that the study will collect basic information from recipients, such as their health history, which CBD products they use, and how much they take. The buy in from the FDA should arguably result in evidence being produced to the standard required by the regulator which, in turn, should assist the FDA in confirming its regulatory scheme for CBD.

As regulators worldwide continue to question and demand evidence of CBD's safety, this collaboration could mark a watershed moment for the CBD industry, paving the way for collaborations between other CBD players. Given the substantial evidence required to demonstrate that CBD is safe for human consumption, we consider it likely that this will be the first of many collaborations between CBD businesses.

The UK Food Standards Agency (FSA) has set a deadline of 31 March 2021 for the CBD industry to submit a fully validated novel food authorisation application, after which time, only CBD products which have submitted a valid application will be allowed to remain on the UK market. Preparing a novel food application is a costly and time consuming undertaking, as a dossier of information must be submitted including, amongst other things, scientific evidence that the CBD element does not present a safety risk to human health. There must also be a pre-market safety assessment of the CBD product. Separately, the FSA has stressed the requirement for CBD businesses to "provide more information about the safety and contents of these products" to it before 31 March 2021.

Given the 31 March 2021 deadline and the amount of evidence required, collaboration between businesses looking to sell CBD products in the UK could be critical to achieving a valid novel food authorisation application and submitting high quality scientific evidence in the timeframe.

Accordingly, we have been advising our clients to date that collaboration is the way forward. Collaboration, of course, has significant cost and strategic benefits, but will require cooperation on common formulations and manufacturing techniques, which will undoubtedly raise issues. Collaborating parties will also need to be clear about each party's monetary contributions, confidentiality obligations and future permitted use of the resulting data.

Please contact Martyn Hann or Emily Dorotheou if you require any further information or assistance with the sale of CBD products.

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