CBD – Could be done for?

13.02.2020

Today the Food Standards Agency (FSA) announced that products containing cannabidiol (CBD) extracts must be the subject of a valid application with the FSA by March 2021, or the FSA will order that they be pulled from the shelves. This applies specifically to CBD extracts found in foods, drinks and oils, and does not apply to CBD extracts contained in cosmetics or vaping products, which are regulated separately.

Sales of CBD containing products have been on the rise in the UK, with more and more products appearing on the high street and available for purchase online. To date, control of such products under the novel food regime has been limited if not absent. It is also worth noting that such products might be subject to the Misuse of Drugs Act if they contain controlled cannabinoids (such as tetrahydrocannabinol (THC)).

However, this period appears to be coming to an end. Earlier today, FSA Chief Executive Emily Miles announced that “the CBD industry must provide more information about the safety and contents of these products to the regulator by March 2021, or the products will be taken off the shelves.”

The novel food regime

In January 2019, the FSA deemed CBD extracts to be ‘novel foods’. This means there has been no evidence of significant consumption of the food or ingredient prior to 15 May 1997 within the European Union.[1] This decision was prompted by the addition of CBD to the EU Novel Food Catalogue, which provides guidance to Member States for enforcing the EU Novel Food Regulations (the Regulations).[2]

Novel foods cannot be placed on the market until they are authorised. Authorisations can be obtained for individual products if the application relies on newly developed or proprietary data. Otherwise, once an authorisation is granted, the relevant food is added to the Union List of authorised novel foods (Union List) and can generally be placed on the market without restriction.

There are currently three active applications for CBD products to be authorised as novel foods. Each is seeking data protection, which if granted, would prevent other businesses from relying on those approvals.

The FSA’s announcement

The FSA has announced that in order to sell CBD extracts, businesses must apply for authorisation under the Regulations. This requires a dossier of information to be submitted to the European Commission. Furthermore, the FSA recommends that businesses send the dossier of information to the FSA first, so the FSA can consider the applications and guide businesses “to ensure they progress at pace through the UK authorisation process”, which will kick in from 1 January 2021.[3]

This comment could suggest that from the start of 2021, any sale of CBD products in the UK will need a separate FSA authorisation under a UK process, and cannot rely on EU authorisation – although this is purely speculation at this point (the same documentation will likely be relevant to both processes). It is not currently clear whether any EU authorisations (whether specific, or generic through inclusion on the Union List) will be ‘rolled over’ in the UK after 1 January 2021, or if a separate FSA authorisation will be required.

In any case, businesses must have their applications fully validated by 31 March 2021, or their products will no longer be allowed to remain on the market. Until that date though, the FSA has stated that CBD products can continue to be sold.

Further issues

This period of ‘novel food’ reprieve does not mean CBD products are immune until next March. The FSA’s firm approach may soon be adopted by other relevant UK regulators.

The Home Office has previously published guidance for the domestic control measures applicable to cannabis related products, including CBD. Although CBD is non-psychoactive, and therefore is not a controlled substance,[4] THC and a range of other cannabinoids are. In order to sell CBD based products in the UK, the Home Office considers that the products should generally contain 0% THC or other controlled cannabinoid. This is a further area of concern for sellers of CBD based products, as achieving 0% THC in any extraction process is notoriously difficult to achieve and difficult to measure. It is conceivable that the Home Office will also take action against CBD products in the near future.

Not only is there the THC issue, but many CBD products are associated with medicinal claims. It is unlawful for these claims to be made without a marketing authorisation being granted by the Medicines and Healthcare products Regulatory Agency. This is another potential exposure for these products.

The FSA have also issued guidance stating that sellers of CBD should inform consumers of the potential risks to those who are taking other medication, breast-feeding or pregnant.

[1] https://ec.europa.eu/food/safety/novel_food/catalogue_en

[2] 2015/2283

[3] https://www.food.gov.uk/business-guidance/cannabidiol-cbd

[4] Under the Misuse of Drugs Act 1971/Medical Device Regulation 2001

Jack Hostick

Author

Zac Fargher

Author