The UK CBD market is growing rapidly and is predicted to be worth more than $1bn by 2025. The first cannabis-based medicine became available under prescription in the UK in 2015 and now the UK high street offers consumers a wide range of CBD products in a myriad of shapes and sizes and for a variety of purposes including foods, medicines, and cosmetics.
When U.S President Donald Trump signed the Farm Bill into law in 2018, it brought with it significant changes to the way cannabis is treated in the U.S. The signs in the UK are that it is starting to follow suit given the high consumer appetite and proliferation of CBD marketing spend here. At the same time, it is clear that there remain a number of challenges for U.S. based companies looking to sell their products to consumers in the UK and specifically how they can advertise and promote their products given the divergence in regulations. The consequences for getting it wrong can be severe, including possible criminal sanctions.
We set out below a list of questions that we are routinely asked by U.S companies looking to sell CBD products into the UK, along with some brief thoughts. This is, of course, a highly complex area and our comments should therefore only be used as an initial steer.
1. Are CBD products lawful in the UK?
The short answer is that it depends! The regulatory definition of CBD is complex and will depend on a number of factors. As a result, there isn't a "one size fits all" definition of CBD.
In order for a CBD product to be lawfully made available for human consumption, it must either meet the exemptions contained in the Misuse of Drugs Regulations 2001 ("MDR 2001") (and therefore be exempt from control) or fall within the definition of a CBPM (Cannabis Based Products for Medicinal Use in Humans) in Schedule 2 to MDR 2001 (and therefore may be prescribed by specialist doctors).
CBD companies must ensure that their products do not contain more than the permitted limit of 0.2% Tetrahydrocannabinol (THC) which refers to the cultivation of the raw plant from approved seed types with THC. In other words, licences can be granted to cultivate such raw plants which contain a limit of 0.2% THC. However, this permitted limit does not relate to the THC content of the final product to be consumed.2. How is CBD regulated in the UK?
Companies in the U.S. promoting their CBD products to consumers in the UK must ensure compliance with applicable CBD laws (e.g. laws relating to the sale, cultivation and supply; licensing requirements; whether or not it is a controlled substance etc.) as well as advertising and consumer protection laws to ensure that any claims are capable of substantiation and not misleading.
3. How can marketers advertise CBD products lawfully in the UK?
Advertisers must first ensure that the product they are marketing can be legally sold in the UK. As mentioned above, the raw product must not contain more than the maximum permitted level of THC and any CBD products that do contain more than this level simply cannot be sold or advertised.
Advertisers also need to consider how their product will be classified. For example they should consider the following questions:
- Is it a controlled substance?
- Is it a food or a food supplement?
- Is it a medicine or presented as a medicine?
- Is it a cosmetic product?
- Is it a non-nicotine containing vaping e-liquid?
The nature of the product will have an impact on licensing requirements and the applicability of certain advertising rules and restrictions. Many products such as foods, food supplements, cosmetics, medicines and e-cigarettes and e-liquids are subject to sector specific advertising rules as well as compliance with general advertising rules. These rules are generally quite strict.
Ads must also be socially responsible e.g. should not be associated with illicit drugs. Although those who are likely to see CBD product ads would generally be aware that CBD is derived from the cannabis plant, advertisers should take particular care to ensure that any imagery and wording which accompanies factual statements about CBD content of a product does not link it to cannabis.
4. How is CBD in food/food supplements regulated in the UK?
In January 2019, the European Food Safety Authority (EFSA) changed the CBD classification in European law, which placed CBD in the Novel Foods Catalogue.
Any ‘novel food’ is subject to the Novel Food Regulation. Products subject to this regulation are not marketable without prior approval from the European Commission.
Therefore, sale of a CBD food is not permitted in the UK unless the business has applied for (and been approved for) a novel food authorization with the European Commission.
When making health claims about foods and food supplements in the UK, businesses should also have regard for the European regulation on Nutrition and Health Claims made on Foods, which provides that general health claims cannot be made unless they are accompanied by a relevant specific authorised health claim as set out in the EU Register for Nutrition and Health Claims.
5. How is CBD in medicine regulated in the UK?
The Medicines and Healthcare products Regulatory Agency ("MHRA") has concluded that products containing CBD that are taken for a medicinal purpose (or which are advertised using medicinal claims) must have a product licence (marketing authorisation) from the MHRA before they can be legally sold, supplied or advertised in the UK.
A US business looking to supply such CBD products for a medicinal purpose will also need to engage with the Home Office to obtain the necessary licences if the product is a controlled substance e.g. contains traces of THC.
6. How is CBD in cosmetics regulated in the UK?
CBD products that are supplied for external use for a solely or mainly cosmetic function must meet the regulatory requirements set out by European regulations. This includes a requirement for cosmetics to have a Cosmetic Product Safety Report (CPSR).
There is a risk that a product could be viewed as a medicine as a result of its presentation, composition or the claims made about the product (i.e. medicinal claims). Therefore, the advertiser should also carefully consider whether it needs to comply with the requirements relating to medicines, as described above.
This is a complex and emerging area of the law and there are significant sanctions for getting it wrong. On the flip side, the UK is becoming a thriving market for CBD products and there are incredible opportunities for first movers that advertise and market their products in a compliant way. We regularly help companies navigate these challenges so that they can lawfully market CBD products in the UK. We also have a network of European offices to ensure compliance across the EU.
Do please get in touch if you would like to know more about our practice and how our industry experts routinely help CBD companies navigate the full range of product labelling, regulatory compliance and advertising challenges in the UK and Europe.
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