No more Mr Nice Regulator: new expectations for the CBD industry

On 13 February 2020, the Food Standards Agency (FSA) announced a deadline of 31 March 2021 for the submission of a valid application for novel food authorisation for businesses selling food and food supplements containing CBD in the UK.

What are novel foods?

Novel foods are foods which have not been widely consumed (and have a history of consumption) by people in the EU before May 1997 and are required to undergo a pre-market safety assessment, and have authorisation, before they can be legally marketed in the EU.

Brief history of CBD

CBD, short for cannabidiol, is a chemical compound found naturally within the cannabis plant. Cannabis itself has a long history of medicinal and recreational use (in the UK it is a controlled drug). In recent times, CBD has been extracted from the plant and sold as a separate product. It has become a popular ingredient in a range of goods, such as oils, confectionary, drinks and supplements, and is widely believed to possess therapeutic properties.

UK regulation of CBD in foods

In January 2019, the European Food Safety Authority (EFSA) changed its stance on the classification of CBD and classified it as a “novel food”.

Initially, the FSA stated that it agreed with EFSA’s stance and indicated it would pursue a ‘light touch’ regulation for CBD products, publishing guidance stating that “we are committed to finding a proportionate way forward by working with local authorities, businesses and consumers to clarify how to achieve compliance in the marketplace in a proportionate manner”.

That guidance has now been withdrawn and replaced by a new position: “Food businesses should apply for authorisation of their CBD extracts and isolates. This is the only route to compliance for these CBD products. No separate arrangement has been made with any specific business or industry sector”.

The UK, while no longer a part of the EU, remains at present bound by European regulation in this area. Novel food applications should be made to the European Commission through a dedicated online portal. Once the Brexit transition period ends on 31 December 2020, the UK position will continue to mirror that of the EU. From 1 January 2021, the FSA will administer the authorisation process for novel foods in the UK. The FSA therefore recommends that they should be provided with copies of any applications made to the European Commission.

In addition, the FSA has advised those who are pregnant, breastfeeding or taking any medication not to consume CBD products. The FSA have said that CBD could be risky for vulnerable groups and suggested an upper limit of 70mg a day (about 28 drops of 5% CBD) for everyone else taking the product unless under medical direction.

What this means for those producing, supplying and selling CBD products

The FSA has confirmed that businesses need to submit, and have fully validated, novel food authorisation applications by 31 March 2021. After this date, only products that have a valid application will be allowed to be sold on the UK market. This means that businesses can continue to sell existing CBD food products without novel food authorisation until the deadline, provided they are not incorrectly labelled, are not unsafe, and do not contain substances that fall under drugs legislation. However, no new CBD extracts or isolates should be put on the market or sold without authorisation.

Businesses who wish to continue to manufacture CBD food products and market them in the UK after the deadline should act now and commence the novel food authorisation application process. Novel food authorisation applications are often complex, time consuming and take a lengthy period to be processed.

Businesses who sell CBD food products manufactured by others should ensure that all product lines were established before the publication of the new guidance. Retailers should not introduce any new CBD food products. As the deadline approaches and once it has passed, retailers will need to ensure that all CBD food products stocked have novel food application.

After 31 March 2021, local authorities will look to take enforcement action against any business found to be selling CBD food products which do not have a fully validated, novel food authorisation application.