On February 13, 2020, the UK’s Food Standards Agency (the “FSA”) updated its business guidance on how it intends to regulate products for consumption containing cannabidiol (“CBD”). The FSA has advised that it is setting a deadline of March 31, 2021 for the CBD industry to submit a valid novel food authorization applications in order for CBD products to remain on the market after that date.
Regulation of CBD as Novel Foods in the UK
CBD is a compound that can be found in the cannabis plant (including hemp). The sale of CBD products for consumption in the UK is regulated by the FSA, which itself has been guided by EU regulations from the European Food Safety Authority (the “EFSA”) and the European Commission.
On January 15, 2019, the EFSA classified CBD, which has no psychotropic effects, as “novel food” for the purposes of the EU Novel Food Catalogue. This meant that, almost overnight, in order for any CBD products to be lawfully sold in any part of the EU such products would need to have successfully completed either of the following EU processes:
- consultation application process for CBD food businesses that can demonstrate a significant history of consumption for their CBD extracts from before May 1997; or
- pre-market safety assessment and authorisation process which could take up to 18 months from submission of an application, by a CBD food business, for a product’s review.
Efforts by several participants in the CBD industry to lobby the EFSA regarding the classification of CBD as novel food resulted in the EFSA agreeing to review its decision. However, there is currently no indication that the EFSA will change its position.
Products to Remain on Shelves with New FSA Guidance
While the UK left the EU on January 31, 2020 (fulfilling the result of the Brexit referendum), it has agreed to continue to abide by all of its laws until at least December 31, 2020. In the meantime, the FSA made it clear that CBD food businesses should still apply to the European Commission for authorisation of their CBD extracts and isolates.
However, the guidance released by the FSA will allow CBD food businesses to sell their existing CBD products to the public in the England, Wales and Northern Ireland so long as they have submitted a CBD product application for review by the FSA before March 31, 2021 and they continue to comply with product description, labelling and safety requirements.
Specifically, the FSA guidance states that CBD producers in the UK:
- need to submit, and have fully validated, novel food authorisation applications with the FSA by March 31, 2021, as after that date, only products for which the FSA has a valid application will be allowed to remain on the market. This deadline only applies to England, Wales and Northern Ireland. Any deadline in Scotland will be set by Food Standards Scotland;
- can continue to sell their “existing” CBD products during that time, provided they are not incorrectly labelled, are not unsafe and do not contain substances that fall under drugs legislation; and
- should not sell new CBD extracts or isolates until they have submitted the necessary application with the FSA and received appropriate feedback from the FSA who may be considering “no-action letter” type guidance for some applicants.
The FSA’s announcement has been welcomed by industry observers as providing clarity for market participants, investors and consumers, and ensures that CBD products will be subject to quality assurance and product safety standards. However, sellers of CBD products that choose to continue selling “existing” CBD products prior to submitting the required novel food authorisation application(s) must be keenly aware of the obligation imposed on them to ensure the accuracy of such products’ labels, including the indicated concentration of CBD and ingredient lists. This is especially true for retail distributors who are uninvolved in the production of the CBD products they sell.
It should be noted that the FSA’s guidance does not apply to products containing tetrahydrocannabinol (THC), which is governed by the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001 and require a Home Office controlled drugs licence.
The FSA also advised those who are pregnant, breastfeeding or taking any medication not to consume CBD products and advised healthy adults to take no more than 70mg a day (about 28 drops of 5% CBD) unless under medical direction.