Selling cannabidiol (CBD) ‘novel food’ products: make sure you’re up to date
We have worked with the Food Standards Agency on this article which explains what you need to know about how cannabidiol products are regulated and what you must do if your pharmacy is selling a Cannabidiol (CBD) food product.
Cannabidiol (CBD) food products like CBD food supplements, oils and tinctures are classed as ‘novel foods’ under food safety regulations. The Food Standards Agency (FSA) requires that any products being sold must have been submitted for, or have received, market authorisation. Pharmacies selling these types of products should use the new FSA database to check if a product is still going through the application process.
Regulating cannabidiol products
The Cannabidiol (CBD) market has grown rapidly in recent years, despite being an ‘unauthorised novel food’.
Novel food legislation requires pre-market authorisation, including a risk assessment to ensure consumer protection. There are currently thousands of CBD food products on the market which are not authorised under this legislation and have not completed a risk assessment.
Where unauthorised novel foods have been placed on the market in error, the Food Standards Agency (the government department responsible for food safety policy), has guided local authorities to make sure they are withdrawn from sale. This is usually through voluntary withdrawal, but local authorities have powers through food law to intervene if necessary where retailers continue to sell such products.
Given the consumer interest in CBD products, the FSA has proposed a proportionate and pragmatic approach to bring the CBD industry into compliance, rather than total withdrawal from the market.
In February 2020, it announced that CBD food businesses needed to submit quality applications for authorisation by the end of March 2021, or leave the market. Hundreds of enquiries were made to the FSA regulation process - these have been filtered down to several dozen applications. The FSA will assess whether the evidence they provide in their application shows that the products are safe and consider whether they should be recommended for market authorisation.
The FSA has recently launched a searchable database of CBD products which are linked to active applications submitted for market authorisation.
What is a novel food?
Novel foods are products intended for human consumption that are not narcotics or medicines, that do not have a significant history of consumption before May 1997 (when the regulations started).
CBD extracts and their products are stated as novel foods under retained EU law.
CBD at much higher doses can be regarded as a medicine, such as Epidiolex, but ‘novel food’ products are food products like CBD food supplements, including in the form of oils, or tinctures.
Making sure products comply with the regulations
Search the database published on the FSA’s website to find out if a product is included in the list. Products classed as hemp oil by cold compression are not regarded as novel so will not be on the CBD public list.
If you stock and sell a product which is not listed, you should remove it from sale immediately.
Products included in the database are still being assessed, but may not complete the process, or receive authorisation. You should check the register regularly if you stock an item which is still being assessed. If these products do not ultimately receive authorisation or are marked as ‘removed’, they will need to be removed from sale.
Stocking CBD products
Pharmacies and other retailers who stock, or are considering stocking CBD products should use caution when deciding what, if any, CBD food products to sell.
The FSA is not endorsing products on the database, and inclusion of a product still being assessed is no guarantee that it will be authorised.
The FSA have taken the step of publishing the database so that retailers, local authorities and consumers can make informed judgements about what they stock and buy, and to help bring these products into compliance with the law. As no CBD products are currently compliant, local authorities could still enforce against any of them, but the suggestion from the FSA is that they prioritise products not on the final list.
If you have any questions about the regulation and enforcement, you can find more information on the FSA website, contact your local authority food enforcement team or the Novel Food Team at email@example.com.