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Regulating CBD in the UK: FSA guidance & legislation
By Anastasia Myronenko

Regulating CBD in the UK: FSA guidance & legislation

Summary

Over the last two years, there has been significant debate in the CBD industry as to how the UK should regulate CBD moving forward. On the one hand, you have the progressives, who want CBD unregulated due to its scientifically reported medical benefits, and on the other, you have the pragmatists, who want to see regulation to improve the quality assurance of products, even if this could cost the industry the ability to trade full-spectrum products. In between these two viewpoints, you have various entities vying for their own, unique recommendations.

But ultimately, the responsibility resides with the Food Standards Agency (FSA), which is the authority in charge of setting food hygiene and safety regulations in the UK. As hemp-derived products are relatively new to the UK market, the decision was made by the FSA at the start of 2020 to class CBD as a novel food. This means there are a number of new stipulations and requirements which suppliers, producers and brands must abide by if they wish to continue trading their products across the UK market.

We have put together this in-depth article which covers all aspects of the FSA and its enforcement so you can be confident, prepared and act quickly for any problem that may arise now the deadline has come to a close.

What is the Food Standards Agency and What are its Responsibilities?

The Food Standards Agency (FSA) is an independent government department responsible for food hygiene and food safety in England, Wales and Northern Ireland. With the use of their expertise and influence, the FSA ensures that people can trust the food they buy and eat.

The story began with a Food Standards Act introduced in the House of Commons on June 10, 1999. The primary goal of the Food Standards Act was to establish the Food Standards Agency and empower it with particular functions concerning food safety and standards under other Acts. The FSA has a head office in London and offices in York, Cardiff, and Belfast. Scotland has also formed its own independent department named Food Standards Scotland in April 2015.

The FSA is managed by a board appointed by the Secretary of State for Health and Social Care. The board is advised by independent scientific advisory committees, comprised of more than 120 independent experts appointed via open competition. They help to ensure that advice from the FSA to consumers is based on the best and the latest scientific evidence.

The board holds the meetings in public and publishes meeting agendas, papers, and decisions. Anyone can attend meetings to see the board’s discussions about food policies via the prior registry by sending an email to [email protected] The attendees have an opportunity to ask questions and voice concerns at the meetings or by emailing the Board Secretariat. The Agency has a statutory right to publish the advice it gives to ministers regarding production, procession, distribution, and purchasing of food.

FSA Advice for Consumers

 alphagreen  Regulating CBD in the UK: FSA guidance & legislation

The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) published a detailed scientific report on CBD. COT is a British independent scientific committee that advises the Department of Health and Health Care, the Food Standard Agency, and other government organisations concerning chemicals’ toxicity. Based on the COT report and the latest scientific information, FSA published advice for consumers on CBD products.

In the announcement made in February 2020, the FSA doesn’t recommend CBD use for the following vulnerable groups:

  • breastfeeding and pregnant women
  • people taking any medications

According to some scientific studies, mentioned in the COT report, CBD can affect the liver. Healthy adults are not recommended to take more than 70mg of CBD per day, which is equal to 28 drops of a 5% CBD product. However, this advice doesn’t guarantee the effectiveness of this dosage. It means that higher amounts may potentially cause adverse health effects.

In general, the FSA encourages people to think carefully before taking any CBD products and consult with a physician beforehand. The FSA keeps reviewing the latest safety information on CBD to provide support for consumers’ choice and balance it while protecting public health.

Background to CBD Regulation in the UK

 alphagreen  Regulating CBD in the UK: FSA guidance & legislation

Most of the global cannabis industry have been frustrated due to lack of clear regulation, given that they operate in a “booming market”. Preliminary scientific research suggests the benefits of cannabinoids, yet many jurisdictions have aired a cautious approach with cannabinoid regulation.

Cannabis laws vary in different countries depending on ownership, distribution, cultivation, methods of use, and medical usage. CBD extracted from hemp or marijuana falls into three legal categories:

  • Fully legal, such as food supplements;
  • Medicinal products;
  • Strictly controlled or not regulated.

In 2020, the Medicines and Health Products Regulatory Agency considered CBD compounds, derivatives, and by-products made of industrial hemp legal in the UK.

However, there are some important regulatory subtleties:

  • Buying/Possessing CBD

Since August 2019, the guidance on THC limit was updated from “1 mg per pack” to “no THC” with a recommended limit of detection up to 0.01%. The limitation was changed to promote “best practice” for businesses. New recommendations are based on the “exempt product” laws and Home Office guidance. Regulation 2 of The Misuse of Drugs Regulations (2001) indicates that once specific criteria are fulfilled, up to 1mg of a controlled substance is permitted per a product container (the Home Office defines “container” as a package/bottle/bag etc., rather than a single serving). Therefore, any product that contains more than 1mg of a controlled substance per container may be rendered illegal.

It’s important to consider that many laboratories offering CBD testing services may not accurately detect 1 mg of THC. CBD products are licensed for usage in the UK if they are certified by the British Cannabis Trades Association and contain zero THC traces. However, it is better not to take CBD products when going abroad. Some countries may have much stricter regulations of cannabinoids.

  • Importing CBD

There are no special requirements for importing CBD into the UK if THC level is less than 0.01% verified by an accredited ISO laboratory.

  • Selling CBD in the UK

Vapes and Cosmetics

CBD products for sale may be subject to different regulations depending on their type. Vape products should comply with non-nicotine e-liquid regulation, such as The General Products Safety Regulations. Cosmetics require submitting a Cosmetic Product Safety Report (CPSR) according to EU Regulation No 1223/2009.

CBD as a Medicinal Product

CBD can also be sold as a medicinal product from a licensed medical distributor or as a food supplement. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) stated that products containing CBD that are advertised, supplied and sold for medical purposes or making health claims, require a licence, referred to as a marketing authorisation. To get such authorisation, a manufacturer must submit clinical trials data to show the quality, safety and efficacy of a CBD product.

CBD labelling

Care for Excellence (NICE), The National Health Service (NHS) and the National Institute for Health control the sale and consumption of CBD products on the UK market. NICE has a guideline for cannabis-based medicinal products for different health conditions. If advertised as a food supplement, CBD products must be correctly labelled in compliance with The Food Supplements (England) Regulations 2003. The label should include information about CBD content, manufacturer information and have no medical claims.

CBD Flowers

The sale of CBD flowers and buds is prohibited even if they are THC-free and if they are of an EU approved origin. Ground cannabis leaves are considered to be legal in the UK and can be sold in stores. According to the FSA announcement of February 13, 2020, new products on the UK market, including CBD products, must submit a Novel Food application. Products that entered the UK market before February 13, 2020, require a validated submission or approved novel food application by March 31, 2020.

  • Selling CBD in other EU countries

Each European Union Member Country has its own laws and regulations regarding CBD, that may be more or less conservative than the UK laws. Local rules should be taken into consideration.

  • CBD and Animals

Veterinary Medicines Directorate (VMD) defines veterinary products containing CBD as veterinary medicines that should be regulated accordingly. CBD products for animals must get a marketing authorisation before they can be sold or supplied in the UK. So far, no CBD products have been authorised in the UK for veterinary practice. A veterinary specialist may prescribe a legally obtained CBD product for human consumption to an animal. Administration of unauthorised CBD products with no veterinary prescription is forbidden and considered an offence under Regulation 8 of the VMR. Businesses supplying CBD products for humans must not recommend their products for animals.

It is important to mention that CBD content is not limited. There is more concern that manufacturers are more likely to overstate CBD levels than exceed specified limits. So far, there are no standard tests for verifying CBD concentration, hence why different laboratories have shown different results for the same CBD products. When it comes to correct labelling, manufacturers should provide the highest possible quality control and deliver consistent products.

Why was CBD considered a Novel Food?

The novel food status of CBD was confirmed in January 2019. The term “novel food” refers to any foods that have no “history of consumption”, meaning they were not widely used to a significant degree within the EU before May 15, 1997. The Food Standards Agency takes responsibility for ensuring that novel foods available on the market are safe for consumers.

Examples of novel food include:

  • Food ingredients with a modified molecular structure
  • Micro-organisms, algae or fungi
  • Foods of animal and plant origin
  • Foods made by using new production processes that result in significant changes of the structure or composition of a product, affecting metabolism, nutritional value, or level of undesirable substances
  • Foods consisting of minerals and engineered nano-materials

Additionally, exotic fruit and vegetables that have not traditionally been consumed within EU markets are also considered novel and require authorisation. However, there is a simplified route to authorisation and reduced data requirements for products that were in use more than 25 years by a significant number of people in a country outside the EU. The European Food Safety Authority (EFSA) created guidance for traditional foods from third countries.

The examples of novel foods include:

  • New foods, e.g. phytosterols used in cholesterol-reducing spreads
  • New microorganism cultures, e.g. certain probiotic bacteria
  • Extracts from existing foods, e.g. new sources of vitamin K
  • Agricultural products from third countries, e.g. baobab and chia seeds
  • Foods made with new processes, e.g. UVC-treated milk

Despite Britain leaving the European Union at the start of 2021, Novel Food regulation in the UK mimics compliance guidelines set by the European Parliament and Council in Regulation (EU) 2015/2283 . This regulation states that novel foods are required to go through a pre-market safety assessment and authorisation to be legally sold in the EU.

All EU-authorised novel foods are mentioned in the Union list of novel foods.

The major principles behind the Novel Foods scheme are to ensure:

  • safety for consumers
  • transparency of information provided on the labels
  • that novel food does not replace another existing food or an ingredient in such a manner that puts consumers at a nutritional disadvantage (i.e. using a synthetic substitute for an existing natural ingredient)

There is no universal list of all novel foods. Their status can be checked on separate resources:

European Commission has also created guidance on the history of consumption to determine if a product requires authorisation.

CBD extract and isolate products have been recognised as novel food and added to the Novel Foods Catalogue. However, hemp and cannabis-related products, including cold-pressed oils, have not been included in the Novel Food Catalogue due to the evidence of a history of consumption before May 1997.

The catalogue has no legal status and is used for recording decisions regarding the novel food status of foods and food supplements. The FSA issued CBD safety advice on safe levels of CBD consumption (70mg per day) for consumers and determined a deadline for the businesses within the CBD industry to submit valid Novel Foods Applications before March 31, 2021.

Industry opinion on CBD as a Novel Food

Cannabis industry bodies, such as the Cannabis Trades Association, have joined a Novel Foods process but assume that submitting Novel Foods Applications may challenge the industry. Cannabis Trades Association is one of the largest and oldest cannabinoid trade associations for the UK and Europe, that aims to:

  • promote good practices for the businesses
  • give practical guidelines to the industry and general public
  • ensure that cannabis- and hemp-users have access to valid information

CTA fully welcomes a Route to Compliance for the industry-players that supports consumer safety and provides more transparency to the processes needed for its members’ products to remain on the shelves. However, it is of the opinion that natural (non-synthetic or isolate forms) CBD products do not fall within the Novel Food list scope.

Moreover, the European Industrial Hemp Association does not agree with such a status of CBD. It argues that given a long history of legal consumption of its components, including leaves and flowers, hemp extracts obtained through traditional extraction processes should have the status of traditional food.

On the other side, the UK’s Centre for Medicinal Cannabis (CMC) insists that CBD products are novel and promotes minimum quality standards and the requirement for marketing authorisation.

FSA deadline for Novel Food applications

In February 2020, the FSA announced a deadline for the UK manufacturers of products or supplements containing CBD to submit valid novel food authorisation applications or withdraw products from sale.

All the applications had to be submitted no later than March 31, 2021. Most of the applicants are manufacturers, but others, such as trade bodies, have also applied. So far, it is the only way of compliance for CBD products as there is no other arrangement for any specific business or industry sector.

Now that this date has passed, only brands linked to submitted applications will be allowed to remain on the market in England, Wales, and Northern Ireland. Food Standards Scotland (FSS), the national regulator in Scotland, has stated that CBD products on the market do not comply with the novel food regulations and companies should take “immediate action” to get authorisation as a novel food.

The FSA has stated that deadline for novel food applications does not apply to:

  • cosmetics;
  • products making medicinal claims;
  • products containing THC and other controlled drugs.

CBD extracts that contain THC or other controlled cannabinoids will likely fall under the scope of the Misuse of Drugs Act 1971. Further data is available in a factsheet on cannabis, CBD, and other cannabinoids, published by the Home Office.

Products that are not consumed orally, such as cosmetics, skin creams and topicals, are not subject to the regulator’s deadline. FSA announcements will not affect those who take prescribed CBD products or cannabis.

Novel Food Deadline Day Disruption

 alphagreen  Regulating CBD in the UK: FSA guidance & legislation

The previous position of the FSA was in order to lawfully sell CBD from April 2021, CBD products had to be included in a validated submission. This means that not only did you have to submit your dossier before the 31st of March, but you also needed validation. Once you were validated, you could continue to trade whilst you’re waiting for your submission to be considered for full authorisation.

Previous position:

To lawfully sell from 1st April 2021, products had to include in a VALIDATED submission.

New position:

“Applications are subject to an 8-day admin check, and it can then take up to 30 working days for an application to be validated.”

However, this position changed on the 11th of March, as the FSA announced that the previous conditions set for CBD businesses would not be workable within the deadline. This was frustrating for many companies as they had worked hard to get their dossiers in before the deadline and were expecting validation to be confirmed before the 1st of April.

The new regime put in place by the FSA now only requires a dossier to have been granted pre-validation approval after an eight-day admin check. We have already seen a number of companies celebrating that they have been granted this pre-validation approval from the FSA.

To date, we are unaware of any business which has received full validation other than Pureis CBD. We understand that Pureis CBD was able to achieve early validation because it submitted its application before January for synthetic CBD products to the EFSA who then transferred the dossier straight to the FSA. This early submission for a synthetic product enabled this company to get ahead of the game.

What is the reason for this disruption?

It seems that one of the more muddled things that have come out of Brexit is the way in which we have adopted the EU laws that underpin the Novel Food regime. The problem is that it doesn’t include any of the detail you might expect you need for applications like this, which tend to be complex and vary significantly from business to business.

If you compare it to medical device authorisation, you’ll see that there is a complex and detailed regulatory framework. This provides companies with the necessary guidance needed to make a successful submission.

What if the FSA refuses your application?

With Novel Food regulation there is relatively little in the way of guidance on how to submit the applications. The most concerning issue is that there doesn’t appear to be an appeal mechanism.

As there is no appeal mechanism, what do you do if the FSA refuses to list your products on the public registers?

The key takeaway is to not be afraid of the FSA and be prepared to take them on if you do not agree with their decisions. Firstly, you can try and reason with the FSA and engage with them directly. If they don’t change their position then the only option would be to go for judicial review. CBD companies will have a strong argument that the FSA’s Novel Food regime is procedurally irregular. When there is a lack of  procedural clarity from a public authority there are good prospects that a JR would be successful.

Pre-Validation – is this a Breakthrough for Full-spectrum CBD?

 alphagreen  Regulating CBD in the UK: FSA guidance & legislation

After the FSA moved the goalposts on dossiers being validated before the deadline, CBD brands will now be granted pre-validation approval if they pass administrative checks. There has been a lot of speculation in recent months as to whether full-spectrum CBD products will be granted authorisation after the Novel Food deadline. But on the 23rd of March, the European Industrial Hemp Association (EIHA) released a statement confirming that it’s full-spectrum submission had been granted pre-validation approval from the FSA.

This was a big deal as there has been much debate as to whether or not full-spectrum products can achieve Novel Food compliance due to the controlled cannabinoid content. Now CBD products can be traded freely from April 1st onwards. As you can imagine, the EIHA are delighted about this and consider it to be a positive step for the industry moving forward.

Advisory Council on the Misuse of Drugs (ACMD) – THC Consultation

The flip side to this news is that on the 26th of March, the ACMD announced that they were starting a consultation for THC content in CBD products. This followed a letter from the Minister for policing, Kit Malthouse, who wrote to the ACMD asking for some information as to what should be considered the minimum controlled cannabinoid content in CBD products. The ACMD has responded by asking for submissions in an open consultation.

This means anyone can make a submission, with evidence and representations, in relation to seven questions posed by the ACMD. After this process is finished, the ACMD will make a recommendation to the government on what should be an appropriate upper limit of THC in CBD products.

The concern here is that although the EIHA announcement is positive for full-spectrum, the AMCD is now questioning other minor cannabinoids such as CBN, THCV and THCA. If they start focusing and enforcing regulation on these other controlled cannabinoids, it might spell the end for full-spectrum CBD products. Again we will have to wait and see how this plays out, but make sure you get your submissions into the ACMD as it is an important step to determine whether they accept full-spectrum oils.

 alphagreen  Regulating CBD in the UK: FSA guidance & legislation

Public Register 1: Product Information Submission

Public Registers of approved companies and products will be established by the FSA. These lists will document products that have been granted pre-validation approval, and then further down the line, full authorisation. But what information are companies expected to submit to gain a place on the registers and what information will the registers show?

The FSA sent out a spreadsheet that showed the details that businesses needed to disclose for the public registers. You will need to submit your Novel Food application reference number for the public registers which verifies that you have made a submission.

  • You will need to provide a Product ID or Barcode for each one of your products.
  • You will then have to release details on products linked to a validated application.

To make this easier to understand, we have created a fictional licensed producer and manufacturer called London Hemp and a fictional CBD brand called Jappie CBD.

 alphagreen  Regulating CBD in the UK: FSA guidance & legislation

These examples show that London Hemp has listed every variation of product the business trades for the Public Registers – London Hemp produces 5%, 10% and 15% variations of a CBD product. This means that you can’t list a 5% product and then start trading a 15% variation – they are classed as different products.

If you own a brand that gets its product from a manufacturer or producer that has submitted its Novel Food dossier, you will still need to disclose a range of details for the FSA. Jappie CBD buys its whitelabelled products from London Hemp, but still needs to confirm with the FSA that its products are linked to London Hemp’s submission. You will see in the far right-hand column on the spreadsheet that Jappie CBD has provided the reference number to London Hemp’s Novel Food submission.

This is how the Public Registers will work – it won’t just be for companies that have submitted a dossier and received validation, it will also include all of the products that they are making for other companies. This means that the Public Registers will be vital for how enforcement is going to take place, so just make sure you are listed and you will be good to keep on trading.

Commercially Sensitive Information

Some companies are not going to be happy about having to disclose commercially sensitive information in the public domain. However, others will see this as an opportunity for market research.

There is some comfort provided to businesses in that once you have listed the products and suppliers you are using on the Public Register, you will have to keep using that supplier for the time-being unless there are exceptional circumstances.

There also appears to be a mechanism through which you can ask the FSA to not register details that are commercially sensitive. You will need to have a verifiable reason for this that is accepted by the FSA, so it might not be an option for all businesses.

White-Labelling Concern

There was concern that the Noval Food regime would mean that white-labelling companies were going to be squeezed out as they were not expected to make a primary submission. In most cases white-labellers don’t have control of the manufacturing process for the active ingredients. So where do white-labelling companies fit into this?

We can’t predict the fate of White-labelling companies post-Novel Food. But what we have seen over the past couple of weeks is the merging of White-Labelling companies with licensed producers. Recently, the licensed company Gencanna acquired the white-labeller Taylor Mammon which is one of the more well-known whitelabelling companies in the UK. We have also seen Mile High Labs and Sativa Group plc who are not just manufacturing their own active ingredients, they are now also offering white-labelling services to businesses. So if you look at this evidence, it does seem that the position of white-labelling companies may be in jeopardy.

Although this could be the case for the industry moving forward, we suspect that companies have known this for a while and are taking the necessary precautions to deal with this accordingly.

Public Registers 2: New Products Restriction

 alphagreen  Regulating CBD in the UK: FSA guidance & legislation

The FSA wrote to all companies who had submitted a Novel Foods dossier and set out how these public registers were going to work. There are two conditions to remain on sale from the 1st of April 2021.

In this letter they stated that only CBD products which were on sale at the time of the FSA deadline announcement of the 13th of February 2020 would be able to stay on sale post 31st March 2021. The letter also told companies that they must be linked to a validated Novel Food application to remain on sale.

How Do You Prove being “On the Market”?

In order to prove you have been on the market prior to the 13th of February 2021, the FSA has asked businesses to provide proof of sale. Acceptable documents include receipts, invoices, sales contracts, VAT receipts, itemised bills, bank statements and letters of correspondence with suppliers and manufacturers.

Why has the FSA imposed this restriction?

The reason the FSA has implemented this restriction is that they want to encourage existing brands to focus on achieving Novel Food compliance for their existing products. The FSA has admitted that this would effectively kill product innovation in the sector for a couple of years, as businesses would have to wait until full authorisation was permitted which estimated to take up to 18 months.

Our Opinion

This in our view is the biggest downside to the Novel Food regime. Companies are spending hundreds of thousands of pounds in some cases to achieve Novel Food compliance. They should therefore be able to commercialise that position. This means being able to take on new clients and new customers by being able to produce new products.

We suspect the FSA brought in this product restriction due to government pressure. CBD and Novel Foods have been on the agenda for years now, but the industry has grown very quickly with little oversight from the FSA. It appears the new product restriction is a political decision, rather than a commercial one.

Can I Challenge the FSA on the New Product restriction?

The new product restriction appears to be a central part of FSA policy. However, there are serious doubts as to whether the restriction is justifiable from a product safety perspective.

For instance, what happens if you were new to the market and you went to a Novel Food compliant manufacturer and white labeller and took their 5% product which had all been approved by the FSA, and sold it under your own brand label?. According to the FSA’s rules, this would still be considered a new product, even though all that you would have done is put a different label on the front of the product.

Such a restriction is going to be difficult for the FSA to justify on the grounds of consumer safety, and therefore we consider that there may be grounds for a successful challenge to the FSA position. If you bring a completely new product to market then you are likely to be subject to enforcement, but if you are using the same, safe product as many other Novel Food compliant brands in the industry, there appears to be little reason as to why you shouldn’t be allowed to sell your product.

The argument here is that Novel Foods is about the safety of the product. By obtaining a novel food compliant product from a compliant supplier, then you would have a safe product.

Public Registers 3: The Lists

 alphagreen  Regulating CBD in the UK: FSA guidance & legislation

We have been permitted to share information obtained from the FSA by Greer Deal at GRS. Greer is one of the top regulatory consultants in the sector and has been managing CBD Novel Food submissions for many established businesses. She has been communicating with Paul Tossel from the Novel Food department at the FSA, and advises accordingly:

The public list will consist of two registers:

  1. CBD products linked to validated Dossiers:

This will include all the applications which contain all the necessary data for a Novel Food application, and have therefore been validated by the FSA. If you completed your dossier with all the toxicology data, stability testing and everything else you are required to submit, will go straight on to the validate dossier list.

  1. CBD products linked to ‘pending validation’ dossiers:

This will include applications that are incomplete but demonstrate a commitment to submit the missing information. This would mean that you provide evidence that you have engaged in laboratory testing in relation to the toxicology studies and other data that you are required to submit.

The EIHA are carrying out substantial studies on the safety of THC and CBD for the toxicology assessment required by the Novel Food regime. The data from these studies will be submitted at a later date and the FSA will then move the submissions to the validated list.

Both of these lists will allow you to continue to sell from the 1st of April onwards. So as long as you are on one of these lists, you are able to continue trading.

Why have these Two Lists been Introduced?

The reason this has been introduced is that the Novel Food regulations say you cannot validate a submission without all of the key data being submitted. The FSA has therefore devised the pending validation list in order to allow companies enough time to fulfil these often long and expensive scientific studies. This will allow businesses to keep trading while they complete the studies, and then once they submit the data, the FSA will then grant validation.

The information that is required for Novel Food compliance is set out in the European law and it’s reasonably detailed. But what is interesting is there’s nothing in the regulations underpinning having multiple lists for different stages of the application – there is only reference to the one validation list. The FSA has created a pre-validation list of its own accord to accommodate those companies still engaged in studies.

The lack of transparency and clarity behind this decision is going to be difficult to defend from the FSA’s stance. Without concrete rules and guidance from the FSA about making these last-minute decisions, it puts the authority in a legally vulnerable position.

Public Register 4: Retailers

 alphagreen  Regulating CBD in the UK: FSA guidance & legislation

Established retailers will be expected to consult the public register before deciding whether to stock a brand or not.

Mainstream retailers are highly unlikely to stock a product that is not on the lists. Any doubt about the regulatory position and they will stop selling a brand or product immediately. They will not risk Trading Standards intervention. You may get some who are willing to break the Novel Food regulations, but it is doubtful that even the smaller retailers would want to take this risk.

Where can you Access the Public Register?

 alphagreen  Regulating CBD in the UK: FSA guidance & legislation

We expect the FSA to release an online portal that you can access via its website. This will be available to everybody to log on and see what’s on there and what’s not. How often the FSA updates the register is still unknown at this point. We expect the products that have been approved by the FSA will get on the list straight away and as time progresses we assume that they will have to update the register on a regular basis.

Business advice on CBD as a Novel Food

Challenging the FSA

 alphagreen  Regulating CBD in the UK: FSA guidance & legislation

At the moment there is no appeal process or set mechanism for challenging a decision of the FSA. Therefore, as previously stated, Judicial Review is the only available route to overturning an FSA decision.

A Judicial Review could be brought by a business that has been refused validation of their submission, or by a company who is deemed not to have been on the market prior to 13th February 2020.

It is important to note that judicial review is a lengthy and expensive process. However, it can be highly effective. The main arguments would be that the FSA failed to adopt an evidence based procedure and failed to put in place clear guidelines as to how the regime should operate. We think all of these points combined would be the basis of the argument for a business to challenge the FSA under judicial review.

At the moment there is no appeal process or set mechanism for challenging a decision of the FSA. Therefore, as previously stated, Judicial Review is the only available route to overturning an FSA decision.

A Judicial Review could be brought by a business that has been refused validation of their submission, or by a company who is deemed not to have been on the market prior to 13th February 2020.

It is important to note that judicial review is a lengthy and expensive process. However, it can be highly effective. The main arguments would be that the FSA failed to adopt an evidence based procedure and failed to put in place clear guidelines as to how the regime should operate. We think all of these points combined would be the basis of the argument for a business to challenge the FSA under judicial review.

The problem with the judicial review is that it takes a lot of time to prepare. In order to move quickly, everything has to be ready to go at the point at which you make the application. A company can lodge an urgent challenge, but it is important to note that this isn’t like an ordinary civil claim – there is a great deal of work to be done before you make the submission as the case has to be ready from the get-go.

If you are concerned that a listing on the public registers may not be forthcoming, then it would be wise to commence work on interim application as soon as possible. The application should clearly explain the mistakes that have been made by the FSA, and why the process has been unfair to your business.

Can I Still Sell my Products whilst I am Challenging the FSA?

Yes, it is possible to secure interim relief as part of your Judicial Review. A court may agree to allow you to continue selling whilst your application is being considered.

The one important thing to remember is that the FSA does not want to get embroiled in lengthy and expensive litigation. You may find that just the threat of the judicial review is sufficient to persuade them to change their position.

The reality is that you won’t have a choice – either you take a strong position to get them to change their position, or you can’t sell your products. Judicial Review is very expensive. Therefore a consortium application – whereby a group of businesses with the same grievance act as together – is going to be the best solution.

What if you need to change your supplier?

The FSA position is that a brand should stay linked to its supplier. You are not supposed to change suppliers unless there are exceptional circumstances. There isn’t a concrete definition for what classes as exceptional circumstances, so you have to be prepared to justify your position.

Again, the FSA may have difficulties in enforcing this, because as long as you’re switching from one Novel Food compliant supplier to another, then your product will still be safe for consumption. The FSA will not have capacity to crack down on every tiny infringement – they are more likely to go after the most flagrant breaches of the regulations.


Anastasiia Myronenko

Verified by a Healthcare Professional

Anastasiia Myronenko

Anastasiia Myronenko is a Medical Physicist actively practicing in one of the leading cancer centers in Kyiv, Ukraine. She received her master’s degree in Medical Physics at Karazin Kharkiv National University and completed Biological Physics internship at GSI Helmholtz Centre for Heavy Ion Research, Germany. Anastasiia Myronenko specializes in radiation therapy and is a fellow of Ukrainian Association of Medical Physicists.