The UK Food Standards Agency has announced a deadline of 31 March 2021 for companies marketing cannabidiol (CBD) extracts as foods or food supplements industry to submit novel food authorisation applications.  After 31 March 2021, the FSA stated that only products with a fully validated novel food authorisation application will be permitted and all other novel CBD products will be removed from sale.  In online guidance for businesses the FSA strongly recommend that applications are sent to the FSA for consideration – as well as to the European Commission as usual – so that they may progress swiftly through the UK authorisation process from 1 January 2021, at the end of the UK’s Brexit transition period.

The move follows an update in January 2019 to the EU Novel Foods catalogue, which classified CBD as a novel food on the basis that there was inadequate evidence of its use as a food before 15 May 1997.  The catalogue is non-binding but in practice is followed by EU Member States.  Indeed, recently, courts in Germany have held that the catalogue is indicative and can be relied upon, as it reflects the current views of the European Commission and the competent authorities in the Member States.

The UK’s 31 March 2021 deadline only applies to novel CBD products that are already on the market and does not include products that are not yet on the market, meaning that no new CBD products will be allowed on the market without the appropriate authorisation, according to the FSA.  Accordingly, the FSA has advised local authorities that businesses may continue to sell existing CBD products until the deadline (provided they are not incorrectly labelled, are not unsafe and do not contain substances that fall under drugs legislation), but no new CBD products should be sold until they have been authorised.

The FSA is responsible for regulating CBD as a novel food and the authorisation regime outlined above will apply to CBD products sold as food or as food supplements, including: oils, drops or tinctures, gel capsules, sweets and confectionery, bread and other bakery products and drinks.  The FSA is not responsible for products such as cosmetics, vapes, medicinal CBD products or products containing controlled drugs such as THC, which fall under different regimes, including rules governing medicines and controlled substances.

The FSA has also issued precautionary consumer advice on the consumption of CBD.  This follows the Committee of Toxicity (COT) considering the available scientific data on the safety of CBD and publishing an update outlining their findings.  The FSA has followed the COT’s recommendations and advises that vulnerable groups (those who are pregnant, breastfeeding or taking medication) should not consume CBD at all, and healthy adults should limit their consumption to no more than 70 mg of CBD a day, unless advised otherwise by a doctor.  Businesses selling CBD products are expected to be aware of this advice and should “be able to inform consumers” of the recommended daily dose for healthy adults, and of the potential risks to those in vulnerable groups.

Photo of Thomas McGuire Thomas McGuire

Thomas McGuire is a trainee solicitor in Covingon & Burling’s London Office.

He received a B.A. from The University of Sheffield and a M.A. from King’s College London.

Photo of Katharina Ewert Katharina Ewert

Katharina Ewert helps major national and multinational companies in the food, medical device, pharmaceutical and cosmetics sectors to navigate regulatory, litigation and procurement risks. With a strong background in general EU law and procedure, Katharina provides strategic advice to clients in a changing…

Katharina Ewert helps major national and multinational companies in the food, medical device, pharmaceutical and cosmetics sectors to navigate regulatory, litigation and procurement risks. With a strong background in general EU law and procedure, Katharina provides strategic advice to clients in a changing regulatory environment. Katharina is a member of Covington’s Diversity and Inclusion Committee.

Katharina is a member of Covington’s Diversity and Inclusion Committee.

  • In her work with a broad range of life sciences companies, Katharina regularly:
  • advises clients on all aspects of food development and marketing, including the regulation of ingredients, labelling and advertising;
  • helps companies in evaluating health and nutrition claims for foods and food supplements, as well as marketing claims for cosmetics;
  • provides strategic advice to major companies in the medicines and device space on national and EU public procurement considerations;
  • assists clients in navigating the implications of Brexit; and
  • represents clients in administrative proceedings in the national and EU courts.

Katharina’s pro bono work includes advising charities on corporate, commercial and public procurement matters.

Katharina gained valuable experience during a secondment the in-house legal team of a global pharmaceutical company.

Photo of Brian Kelly Brian Kelly

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union…

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Brian as part of our “world-class [regulatory and public affairs] team and describes him as a notable practitioner who is “very ambitious, thorough with a sharp intellect”. The Chambers UK Guide quotes clients saying: “his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases.”

Brian’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, procurement/tenders (including emergency use tenders, EU-wide tenders, Covid-19-related tenders), product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Brian has also been advising on UK and European “Brexit” related issues including tariffs.

Brian has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Brian is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts.

Brian is an honorary lecturer at University College London.