The FSA has been very quiet on the topic of CBD, that is until February 2020 when they made their first definitive statement aimed directly at CBD producers and manufacturers in the UK. We’ve been chatting to some of the top experts and representatives in the industry and want to share what we’ve learnt so far.
What is the relationship between the FSA, novel food products and CBD?
CBD (a chemical compound that occurs naturally in cannabis plants) has only recently been removed from the plant and sold as an extract and these extracts are used in a variety of food products. Because it was only added to the EU Novel Foods Catalogue in 2019, CBD extracts were confirmed as a novel food product because they do not have a history of consumption prior to May 1997. CBD products, therefore, needs to be evaluated and authorised before they can be legally sold.
And the FSA? The Food Standards Authority is the body responsible for the regulation of CBD as a novel food, the word to focus on here is ‘food’, they do not give oversight to CBD extracts used in vapes, cosmetic products, extracts that contain THC or medically prescribed consumption. While the FSA is the CCA (Central Competent Authority) for food safety, local authorities are responsible for the enforcement of food laws.
OK, so the FSA are the people in charge of decision making around CBD products that are consumed, let’s have a look at what that means for CBD producers and manufacturers…
What does the FSA have to say about CBD as a novel food and the application process?
In February 2020, the FSA released a statement declaring CBD products in the UK as a novel food which has serious implications for the CBD industry. CBD manufactures, and producers are required to submit a novel foods application, and the authorisation process is currently being put in place to ensure that CBD as a novel food meets legal standards related to safety and content. This application process applies only to manufacturers and producers and, if you white-label those products, you will be covered. There is still some clarification needed here, but CTA members can expect updates as and when they happen.
Emily Miles, Chief Executive of the Food Standards Agency, was quoted as saying, “CBD products are widely available on the high street but are not properly authorised. The CBD industry must provide more information about the safety and contents of these products to the regulator before 31 March 2021, or the products will be taken off the shelves.”
In essence, the FSA is saying that companies need to submit a Novel Foods application. Any company that submits an application will not have their products removed until the application has been approved or rejected, and enforcement will only take place in March 2021. But this only applies to products that have been on the market since 2018 and there is a strict proviso that the application needs to be validated (not merely submitted) by March 2021. Note that this is an interpretation of the FSA statement, and it should not be taken as advice.
The one aspect that is slightly different to prior interpretations is that businesses can continue to sell existing CBD products even if they have a pending application as long as they are correctly labelled, are safe to eat, and do not contain substances that fall under the Misuse of Drugs Act. Before the release by the FSA it was understood that once an application had been submitted, all products had to be removed until the application was validated.
Read the full statement here.
This application process has some serious implications for CBD businesses, so who is leading the conversation around how to remain compliant, and what are the best steps to take? Well, that would be the CTA.
Who is the CTA?
The Cannabis Trades Organisation (CTA) is the world’s largest association for the cannabinoid trade with over 1200 members and 6500 sellers across 35 different countries. It was founded in the UK in 2016 and is a force to be reckoned with as they deal with over 100 government departments internationally, and have a membership that sold over £2.7bn worth of products in 43 different countries in 2019.
The CTA represents many of the UK’s cannabinoid sellers and is committed to ensuring that their members work in full compliance with the relevant laws and regulations that govern CBD.
They work hard to maintain their relationships with official agencies and to keep the channels of communication open in order to best look after their members. They maintain that their members’ products are compliant and have no safety concerns for people who consume cannabinoid products as long as they remain within the guidelines. These guidelines include MHRA recommendations that CBD as a food supplement should be limited to under 200mg per day and that they should consult with their doctor if they are taking other medications or are pregnant.
What is their stance on the latest FSA statement?
Following the Food Standards Agency’s (FSA) first public statement around the legalisation of CBD extract and products, the CTA followed up with a press release of their own. Their stance is that natural CBD (excluding isolates and other synthetic forms) does not fall under the scope of the Novel Food schedule.
They went on to note that they welcome compliance measures for the industry, and give their full support to regulations that will ensure customer safety and provide clarification around the processes that members need to follow to remain compliant. They also aimed to address the panic that many smaller members are experiencing, saying that, “In reality, not all members will be affected by the proposed legislative changes.”
The full press release is available here.
The CTA has continued to remain firm on their stance that CBD extracts are not novel, and therefore should not fall under the Novel Food regulations. And they, therefore, do not recommend submitting an application.
What are the implications of submitting an application?
There are three important implications by submitting an application:
- You agree that natural CBD extracts should be classified as a Novel Food.
- You have the necessary funds to see the process through, and the costs can run into the hundreds of thousands.
- You have time to wait it out, with current estimates around 18 months or more to find out whether your application has been approved.
In conclusion, the FSA is saying that if you produce or manufacture CBD products for consumption, you need to submit an application for approval in order to continue selling your products after March 2021. The problem with this, especially for smaller manufacturers, is the prohibitive cost.
The CTA has been the most vocal in offering a counter-point to the FSA’s statement, saying that while they support regulation initiatives for the industry, CBD should not be classified as a novel food.