By Rahool Sarjua and Kahwing Fung, 13 February 2020
2019 was a big year for cannabidiol (CBD) based products with new products appearing on shelves almost every week. Today the UK Food Standards Agency (FSA) has released new advice for consumers and set a deadline of 31 March 2021 for CBD businesses to submit novel food authorization applications for products containing CBD. The FSA's announcement will come as no surprise, following on from enforcement of CBD products as novel foods by regulatory bodies in other European Member States.
Key points to note from the FSA's news release:
- Hemp and related products, such as cold-pressed oils or hemp flour containing naturally-occurring CBD (to which CBD extracts have not been added to) are NOT considered novel as there is evidence to show a history of consumption before May 1997.
- Businesses have until 31 March 2021 to submit and have fully validated, novel food authorization applications.
- FSA advises vulnerable groups (including pregnant women) not to consume CBD products and healthy adults not to consume more than 70mg of CBD a day (about 28 drops of 5% CBD oil) unless under medical direction.
What are Novel Foods?
A novel food is defined as food that had not been consumed to a significant degree by humans in the EU before 15 May 1997. In order for a food to be authorized, it must satisfy safety and food labeling, and if a novel food is intended to replace another food, it must not differ in a way that the consumption of the novel food would be nutritionally disadvantageous for consumers.
Some of the concern amongst regulators were the potential adverse health effects from the consumption of CBD products on pregnant and breastfeeding women or those taking medication, as Professor Alan Boobis, Chair of the Committee on Toxicity, stated,
'My committee has reviewed the evidence on CBD food products and found evidence there are potential adverse health effects from the consumption of these products. We are particularly concerned about pregnant or breast-feeding women and people on medication.
We don’t know enough to be sure about such a risk but I am pleased with the sensible and pragmatic approach the FSA is taking. The committee will continue to keep these products under review in the months ahead.'
As a result of such concern, the FSA advises that vulnerable groups, which include pregnant and breastfeeding women or those taking medication, should avoid consuming CBD products. In addition, the FSA also suggests that even healthy adults are advised to consume no more than 70 mg a day (28 drops of 5% of CBD) unless directed by a medical practitioner.
Rahool Sarjua, who advises clients on cannabis regulatory and commercial contracting, commented,
‘With the newly set deadline being 31 March 2021, we are of the view that CBD businesses should ensure that valid novel food authorization applications are in hand, if they wish to sell their products containing CBD. After this date, only products with a valid application will be allowed to remain on the market. Until this deadline, businesses are allowed to continue selling their CBD-based products, provided that they are correctly labelled and are safe to consume and do not contain illegal substances under existing drugs legislation. Following the FSA's news release, it appears they will be taking more active steps on enforcement from now on. This is welcomed news for many businesses who have been looking forward to appropriate guidance by the FSA.’
His colleague, Dylan Kennett added: ‘We as a firm have a global view of this industry, as we regularly find ourselves advising in this space in the UK and abroad. The FSA's recent guidance brings much welcome clarity on issues of enforcement. In contrast to other European Union member states (such as Germany or Italy), the UK's FSA has thus far taken relatively few actions against businesses selling CBD-based products when it comes to enforcing the Novel Foods Regulation.
‘This can also only be a good thing for consumers and legitimate market participants, given the number of incidences we hear of of inferior products that are on the market which often breach the thresholds on THC or contain no CBD at all. Here the regulator is putting its foot down, on what has become a ‘wild-west’ of the cannabis industry.’
Impact of Brexit
The FSA's news release does not give further guidance on the role of the European Food Safety Authority in the after 1 January 2020, which is when the transitional period under the EU Withdrawal Agreement ends. However, the fact that the UK's FSA is looking to address safety concerns, it is likely that the FSA will continue to regulate CBD-based products and will continue to follow the Novel Foods regime.
Professor Alan Boobis, Chair of the Committee on Toxicity, said: 'My committee has reviewed the evidence on CBD food products and found evidence there are potential adverse health effects from the consumption of these products. We are particularly concerned about pregnant or breast-feeding women and people on medication. 'We don’t know enough to be sure about such a risk but I am pleased with the sensible and pragmatic approach the FSA is taking. The committee will continue to keep these products under review in the months ahead.'