Current Position

Currently there are a range of food products and supplements being sold that contain Cannabidiol (CBD) extracts. The European Commission has recently clarified that CBD extracts used in food and food supplements should be considered as a novel food, meaning certain products containing CBD on sale will now need a safety assessment before the food is marketed to comply with the Novel Foods Regulations.

The Food Standards Agency (FSA) is working with the industry and other key stakeholders to develop guidance for enforcement officers on a proportionate response in relation to products already on the market, and to encourage and support businesses to make applications for safety assessments and authorisation of their products under the Novel Foods Regulations.

These products are distinct from “cannabis-based products for medicinal use”, which were recently rescheduled under the Misuse of Drugs Regulations 2001. Any enforcement action taken in relation to cannabis oils sold as food products will not affect the availability of products prescribed, by specialist doctors, as medicines or authorised for use in clinical trials.

Novel Foods Regulations

A novel food is a food or food ingredient which does not have a significant history of consumption in the EU before 15 May 1997. This date is when the law came into force and requires that a food business shows clear evidence that the food was eaten before then anywhere in the European Union. If a food business cannot show that there is a history of being eaten before that date, then the food or novel use of an ingredient in a food has to go through a food safety assessment conducted by the European Food Safety Authority and be authorised by the European Commission in consultation with Member States before being marketed.

There are specific rules on what evidence is acceptable. For foods and supplements containing CBD, none of the food businesses and trade bodies operating in the UK have been able to show any evidence that meets the requirements. Evidence has not been provided in other Member States either, and therefore these foods have been clarified as novel. As a result of this decision, the European Commission’s Catalogue of Novel Foods has been updated and food products and supplements will need to meet the requirements of the Novel Food Regulations in the UK.

Status of CBD and Hemp

Some companies, wrongly, assumed that since hemp oil was not considered to be novel that the same assessment would apply to CBD extract. However, CBD is a highly purified extract of the cannabis plant. Hemp oils from cold compression have previously been shown to have a significant history of consumption before 1997 and so are not legally considered novel foods. However, the extraction processes for CBD results in products which are very different from hemp or hemp oils.

Other applicable laws

Manufacturers of foods and supplements containing CBD extracts must also consider other applicable law, and must not:

• make any unauthorised health claims (Regulation (EC) No 1924/2006)

• market their product for a medicinal purpose (Directive 2001/83/EC)

• contain THC or any other controlled cannabinoids – which is a matter for the Home Office under the Misuse of Drugs Act 1971 and Misuse of Drugs Regulations 2001, concerning controlled drugs.

Enforcement action and subsequent removal from the market may additionally result for breaches of this legislation.

Further information:

Nutrition and Health Claims guidance available at:

https://www.gov.uk/government/publications/nutrition-and-health-claims-guidance-to-compliance-with-regulation-ec-1924-2006-on-nutrition-and-health-claims-made-on-foods

https://ec.europa.eu/food/safety/labelling_nutrition/claims_en

MHRA Guidance Note 8, (in particular Appendix 10), available at:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/759581/012__GN8_-_final_2018_combined_doc_Oct.pdf

The Home Office’s position on Cannabis and CBD products is set out in their Factsheet available at:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/778357/Factsheet_Cannabis_CBD_and_Cannabinoids_2019.pdf

Department of Health and Social Care.