Regulating CBD in the UK: FSA guidance, legislation & market potential
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.
Cannabidiol has become a trendsetter in the wellness world. Multiple scientific research trials prove its beneficial properties. Manufacturers, pursuing this trend, keep expanding the range of CBD products to edibles and cosmetics. However, just like any food supplement, CBD is subject to strict regulations and safety standards.
The Food Standards Agency (FSA), the body that regulates the legal flow of CBD in the UK, has made an announcement that marked a tightening of rules regarding the quality of product content and defined some safety protocols of CBD use by vulnerable groups. In this article, we'll discuss how it may affect the CBD industry in the long run.
So, without further ado, let's start with the basics.
What is the Food Standards Agency?
What are the responsibilities of the FSA?
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, and it is safe and honest. 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. The department was created in 2001. Scotland has also formed its own independent department named Food Standards Scotland in April 2015. Some aspects of the UK food labelling and food compositional standards fall into the scope of the Department for Environment, Food and Rural Affairs (DEFRA). In Britain, the Agency takes responsibility for food’s safety-related labelling issues. FSA offices in Wales and Northern Ireland are responsible for local labelling and standards policy.
Nutrition policy, as well as nutrition labelling regulations, were transferred from the FSA to the Department of Health and Social Care in England and to the Welsh Government's Department of Health and Social Services in Wales. The Food Standards Agency offices in Scotland and Northern Ireland are responsible for their nutrition policy.
The FSA is managed by a board appointed by the Secretary of State for Health and Social Care. The board is advised by the Committee on Toxicity, the Advisory Committee on Novel Foods and Processes, the Science Council, the Advisory Committee on the Microbiological Safety of Food, and the Advisory Committee on Social Sciences.
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. Since 2003, every consumer can see the decision-making process on the live webcasts.
The board develops the strategy of the FSA and takes responsibility for protecting the interests of British consumers and overall food welfare. Some of the issues it deals with include approval for products with CBD content, nutrition and health claims in Northern Ireland after the UK's exit from the European Union. The board ensures that all decisions or actions of the FSA consider scientific data and prioritise the interests of consumers.
The FSA designs periodic five-year strategies and publishes it on the website. The latest strategy, covering the period from 2015 to 2020, was named 'Food We Can Trust'. The strategy describes priorities for the future, considers growing risks around food safety, affordability, and sustainability in the UK, and plans how to meet these challenges. Adherence to the strategy ensures that people can trust the food they buy, that it is safe to consume, and there is 100% transparency of the food content. The supporting strategic plan helps to ensure that consumers have access to valid information and are protected at any time. The approaches of the plan include:
- Science, evidence, and knowledge to tackle the current risks regarding food, and to consider potential challenges
- Legislative and non-legislative tools to influence companies' activity in the interests of consumers
- Policy- and decision-making about the food industry
While developing the strategy and critical themes for the future, the FSA engages with stakeholders, such as:
- Consumers and consumer organisations
- Scientific community
- Representatives of the food industry
- Trade bodies
- Local authorities
- Government departments
- Non-governmental organisations
- FSA representatives
The FSA 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 goal of the FSA is to provide food industry players with confidence that it will protect both the safety of the consumer and the reputation of UK food both within the country and international export markets. The FSA controls that companies take food safety seriously while taking action against any businesses that compromise the protection of the consumers. For that reason, the FSA establishes guidelines and standards affecting each part of the industry.
What is the Food Hygiene Rating Scheme?
The FSA has also created a scheme that helps consumers to choose where to eat or shop for food and gather valid information about the businesses' hygiene standards, named the Food Hygiene Rating Scheme. The scheme assesses businesses based on a rating score, where five means excellent hygiene standards and zero is an indication that urgent improvement is required. Businesses with low ratings must implement immediate improvements to their hygiene standards. The local authority food safety officer reserves the right to take action from providing advice and guidance to closing down the business entirely until it is safe for the consumers.
The rating includes:
- Food handling
- Food storage
- Food preparation
- Cleanliness of business premises
- Management of food safety
The food hygiene rating doesn't cover food quality, customer service, presentation of the food and culinary skill, comfort of the premises.
Displaying the sticker with a hygiene rating is a good advertisement for businesses that comply with the requirements of food hygiene standards. Placing a sticker in the premises is legally required for businesses in Northern Ireland and Wales and voluntarily for companies in England.
What is CBD and its benefits?
Cannabidiol is one of the most prevalent and active compounds found in the Cannabis sativa plant. Even though it is a chemical twin of THC, a psychoactive compound, it causes no "high” effect and is proven to have potential health benefits.
All phytocannabinoids, including CBD, can interact with the endocannabinoid system (ECS) responsible for keeping physiological functions in balance. The human body can also produce cannabinoids on its own. Additionally, the ECS has two types of receptors, called the CB1 and CB2. CB1 receptors can be found in the brain and all over the body, while CB2 receptors are present mostly in the immune and gastrointestinal system. THC can attach to CB1 receptors that are responsible for pain, coordination, movement, emotions, mood, memories, appetite, and many other processes. CB2 receptors are mostly spread in the immune system and affect inflammation and pain. Previously, it was thought that CBD attaches to CB2 receptors; however, scientific studies proved that CBD does not connect to any of these receptors directly. Instead, it makes the body use more of its own cannabinoids and is likely to block some of the psychoactive effects of THC. Studies discovered that cannabidiol can be useful in various health conditions, such as pain, anxiety and sleep disorders. Moreover, it seems to have potential benefits when treating more severe disorders, such as multiple sclerosis and type 1 diabetes.
Now CBD comes in every imaginable form:
- CBD oils and tinctures
- CBD capsules and pills
- CBD-infused edibles, such as gummies
- CBD-infused e-liquids for vaporisers, and many more
Generally, CBD is considered safe and well-tolerated if consumed within the prescribed dosage limits, but it may cause minor side effects. Prior consultation with a specialist is needed, especially when taking other medications.
Why is 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. 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 micro-organism 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
The Food Standards Agency takes responsibility for ensuring that novel foods available on the market are safe for consumers.
In compliance with Regulation (EU) 2015/2283 of the European Parliament and the Council, the novel foods are required to go through a pre-market safety assessment and authorisation to be legally sold in the EU.
Food extracts, additives, and flavourings used in the production of food also require pre-market safety assessment and authorisation. The requirements for these food categories can be seen in Legislation Guidance to Compliance for food additives. Hemp and cannabis-related products, including cold-pressed oils, are not novel due to the evidence of a history of consumption before May 1997.
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:
- German novel food list
- EU Novel food catalogue
- Italian lists of various plants permissible or not permissible for food supplement use
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. 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 for consumers and determined a deadline for the businesses within the CBD industry to submit valid Novel Foods Applications before March 31, 2021.
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 statements concerning CBD
Customer research on CBD extracts
In 2019, Agency Community Research and 2CV, global consumer research agency, were commissioned by the Food Standards Agency to conduct research among CBD users to understand:
- behaviours and approaches regarding CBD use
- awareness of the 'novel food' status of CBD
The research included an online survey with 352 CBD users (229 current users) followed by a qualitative online bulletin board with ten respondents from the survey. The findings were as follows:
- One-third of respondents claimed to be former CBD users, while two-thirds of those who had used CBD before would like to continue to use it in future. Nearly a quarter of survey participants are regular users, whereas four in ten said they used it occasionally. More than three-quarters of current users have been using CBD products for less than a year.
- Tinctures are the most popular CBD product among the respondents. They are followed by e-liquids, pills and capsules, creams, and ointments. Under a third of users purchased CBD products from health food stores and under a quarter of them bought CBD from specialised online retailers or online marketplaces. Most users accounted for the quality of the product when choosing a type of CBD. Other factors that were also considered by respondents included the price, retailer and brand reputation, and CBD concentration. The respondents used CBD mostly for pain relief. However, they also mentioned that CBD was useful for managing anxiety, depression, sleep, relaxation and mental health.
- Nearly two-thirds of respondents confirmed CBD benefits for overall health and/or specific medical conditions, such as anxiety, stress, arthritis, and back pain.
- More than a third of CBD users mentioned they would be bothered if they could no longer buy CBD products at the stores.
- Most respondents claimed that they are confident that the purchased CBD products are of high quality and not mislabelled. Although the majority suppose that CBD is regulated, a sizeable minority expressed concern regarding the legal status of the CBD they had bought previously.
- Most respondents didn't know about the Novel Food status of CBD. When they found out what this meant, some bulletin board respondents expressed concerns. There were mixed responses to the speculation that CBD may not be available from mainstream retailers. For some of the users, it would be a sufficient barrier to stop using it, while others would simply buy it elsewhere.
FSA statement about CBD
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 must be submitted no later than March 31, 2021.
After this date, only brands and products with 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 aim of FSA's announcement is to align the UK and EU's positions on CBD. The authorisation would ensure that novel foods meet legal standards and regulations, including its safety and transparency of the content.
The FSA has stated that deadline for novel food applications does not apply to:
- 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 announcement will not affect those who take prescribed CBD products or cannabis.
FSA consumer advice on CBD extracts
The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) has 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 has 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.
Business advice on CBD as a Novel Food
In February 2020 the UK's Food Standards Agency announced that food businesses that make products or supplements containing CBD should submit novel food authorisation by March 31, 2021. Most of the applicants are manufacturers, but others such as trade bodies and suppliers may also apply. 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. After this deadline, only products with a submitted valid application will be allowed to be on the market in England, Northern Ireland and Wales. As for Scotland, novel foods regulations are covered by Food Standards Scotland.
All the novel food applications should be submitted to the European Commission via an electronic portal. Businesses are strongly recommended to duplicate applications to FSA so they could consider the documents, provide companies with guidance and answer any questions when the UK diverges from EU rules from January 1, 2021. When an application is ready, the Food Standards Agency may be contacted at [email protected].
Manufacturers should consider the following information required for an application:
- The effects of the recommended consumption and test for different scenarios.
- Data to prove that a CBD product is safe for use over a prolonged period of time, as traditional food supplements may have longer consumption periods than medicines.
- Instructions on what to do if someone outside the product's target demographic uses the product and what may happen in such a situation. One example is children who may be attracted by colourful gummies or chocolates.
- Correct labelling with recommended CBD use information, the list of all ingredients used in a CBD product and information on allergens and any other active compounds that could put some consumers at risk.
- The stability of a product and storage instructions, i.e. what may happen to active ingredients being exposed to high temperatures or pH levels.
- A controlled production process resulting in the same CBD product content and quality of every batch.
The authorisation only applies to an authorised CBD product. This means the manufacturer must use the same production processes, advertise products for the specified use, and provide the same safety evidence as it is defined in the authorisation. It's important to note that the authorisation may not be specific to the applicant, and the final product may be branded in various ways. For that reason, once the applicant is granted confidentiality, the information about key points of production and the evidence base may stay confidential for the next five years. Whether CBD products are bought from other suppliers, the businesses must ensure that products are appropriately authorised and use them in compliance with the authorisation.
Novel food approval acquisition seems to be a challenging and slow process. The FSA website provides detailed guidance on what steps to take to compile the information required for an application. After submission, applicants can wait up to several weeks to find out if the application is valid and can proceed to the risk assessment phase, which can take several months.
So far, no CBD products have acquired a novel food status. However, the EFSA decisions about the assessed applications are expected soon.
After March 31, 2021, trading standards officers may take action against manufacturers who have not applied for novel food authorisation.
There is a helpful tool, Article 4 of the Novel Food Regulations, that provides consultations for a company to check the novel status of the product. Submission of Article 4 does not mean that unauthorised novel products can be permitted on the British market. Once a business submits an Article 4 request for consultation, it is expected to wait for a decision to be made before placing products on the market. However, at the moment, there are hundreds of CBD extract products on the market without legal authorisation. Submitting an Article 4 request does not change the enforcement position and doesn’t provide protection against enforcement for unauthorised novel foods on the market.
The novel food status of CBD extracts can be checked on the novel food page or via consultation request.
In February 2020, the FSA has published advice on CBD consumption for adults, and the potential risks for pregnant and breastfeeding women or those who take medications. Manufacturers and sellers of CBD products should be aware of these recommendations and be prepared to inform their customers. Pharmacists may want to consider placing CBD products behind the counter in order to be able to provide recommendations on CBD dosage and limitations to customers before they make a purchase.
Even though the FSA regularly discusses CBD with trade bodies involved in the novel food and CBD industry, it has not approved any specific trade body's approach to compliance for CBD products and has not concluded any particular agreements with individual trade bodies. That's why all businesses selling novel CBD products are treated equally.
Local authorities have been informed that businesses are allowed to keep selling current CBD products till March 31, 2021, on condition they are correctly labelled, safe to consume, and do not include substances that are subject to drug legislation.
First responses to the FSA announcement
So far, no CBD products have gained novel food status or were authorised. TTS Pharma, a leading supplier of legal, high quality, safe cannabinoid products, has decided to set a good example and become the first business to place a legal CBD oil onto the UK wellness market. TTS Pharma has submitted a novel food application and claimed that its CBD oil is entirely free of THC and CBN within the limits of detection of less than 0.0001%, which has been confirmed by an independent laboratory. The supplier shared that an unclear supply chain that is difficult to track and trace is one of the most important issues within the industry. TTS Pharma mentioned that most of the CBD oil on the market coming from Russian or Chinese hemp may be contaminated and contain harmful substances due to polluted manufacturing environments. Even US-sourced CBD oil may be genetically modified.
To facilitate the creation of a transparent and traceable supply-chain system, TTS has established its own 'track-and-trace' system named CHOtrak. The in-line production controls the origin of material throughout the supply chain to ensure that customers get the highest quality product, that meets all regulatory standards.
TTS Pharma has commissioned Fera to test 31 CBD products available on the UK market. Fera is the UK and international centre of excellence for research and problem-solving processes in relation to plant and bee health, sustainable agriculture, crop protection, food, and feed quality and chemical safety in the environment. Fera found CBN and/or THC in up to half of the CBD oils sampled for levels exceeding the legal limits, including toxic substances in some of the top-selling CBD products that may lead to health implications. These results indicate that market players may sell illegal and potentially dangerous products. Additionally, less than half of the products contained up to 10% of the stated level of CBD, whereas four samples contained less than 50% of the indicated CBD concentration. These lab reports may indicate a challenge for the industry to improve the stability of cannabis-based products. Many other third-party tests of current products on the UK market have shown that they deteriorate quickly. This potentially explains some discrepancies between the level of CBD and active ingredients indicated on product labels, and the concentrations revealed after testing.
TTS Pharma claimed that "there is an urgent need for greater regulatory control of currently available CBD products to safeguard consumers from making product choices which ultimately may be risking their health."
Are CBD products legal in the UK?
Some players of the global cannabis industry may be frustrated due to lack of clear regulation, given that they operate in a "booming market". Multiple scientific research proves the benefits of cannabinoids, yet they are in some kind of a regulatory vacuum to this day. Cannabis laws in different countries vary on the aspects of ownership, distribution, cultivation, methods of use, and medical usage.
CBD extracted from hemp or marijuana all over the world 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 regulatory subtleties which depend on actions in relation to CBD:
- 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 accredited ISO laboratory.
- Selling CBD in the UK
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 can 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. 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. 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.
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.
How may the FSA announcement affect the market?
The CBD market in the UK undergoes a dramatic growth each year. In 2019, the Centre for Medicinal Cannabis (CMC) reported that up to 6 million people in the UK had tried a CBD product at least once. CBD keeps gaining popularity in the UK despite the classification of all extracted cannabinoids as "novel" in January 2019, that caused some confusion on the market.
The industry had received a share of criticism when the CMC undertook third-party testing of CBD product samples and found out that a significant proportion of CBD products on the market were mislabelled – in some cases containing illegal levels of ingredients. According to recent trials, some CBD products on the market may also include unlisted ingredients, potentially dangerous compounds, little to none of the CBD extract, or illegal levels of psychoactive components, such as THC.
On February 13, 2020, the FSA made an announcement setting a deadline for food businesses to provide valid information about the contents and safety of CBD products to the European Commission. The same announcement provides recommendations on CBD dosage and warns pregnant and breastfeeding women to avoid CBD products. The applications for novel food must be submitted by March 31, 2021. The products that failed to do so may be taken off the shelves. The FSA's requirement affects England, Wales, and Northern Ireland. The CBD market in Scotland is covered by a local regulator.
As the UK plans to leave the European Union at the end of 2020, novel food applications by UK manufacturers after December 31, 2020, are more likely to be made to a new regulating body, rather than the EFSA. At the moment, it seems unclear what will happen to novel food applications that have been submitted before the deadline but should be approved by EFSA when the UK exits the European Union. The UK is likely to recognise an approval granted by the FSA. However, it is unclear whether FSA approval will be accepted by EU countries after the transition.
Other countries, such as Australia, Canada, and the United States had also reviewed CBD safety but have not approved any sales or established production guidelines, which can potentially lead to confusion about CBD legal status in these countries.
Even though CBD products have been present on the UK market for a long time, none of the companies had provided sufficient data to prove the safety of their CBD products. There have been some calls from different bodies to improve regulation within the industry and increase its transparency and reliability. The CMC has even launched the Association for the Cannabinoid Industry (ACI). It aimed to support a legitimate, and well-regulated CBD market in the UK to meet the highest standards in quality, consumer satisfaction, and environmental management. In addition to submitting a novel food application, ACI's members are committed to removing detectable THC, complying with testing and labelling standards and marketing ethics. ACI hopes that businesses that have submitted applications will prove to be reliable for UK regulating bodies, and work under complete transparency.
The FSA's announcement may surprise some users that have been taking CBD products for various medical conditions. Being sold as supplements, CBD products are prohibited from making medical claims, but can still be advertised as useful for issues such as stress and anxiety to neurological disorders. The latest findings of the Committee on Toxicity showed that simultaneous intake of CBD and medicines might affect treatment. Therefore, FSA's actions are aimed at the protection of public health.
The businesses within the industry are expected to actively engage in getting novel foods approval. However, not every market player will welcome the FSA's actions. Larger businesses are more likely to be able to make a CBD application, given sufficient scientific data, product-related information and financial resources. Smaller brands may not be able to afford the application fees and will likely lose to stronger competitors. Transparency of legal CBD sales is likely to tempt huge, non-cannabis food and drink brands to enter the market with CBD-infused products. This may change the positions of suppliers on the market and lead to thinning the ranks of CBD products in the UK.
Nevertheless, the latest FSA requirements are a step in the right direction as they encourage industry players to work together, educate, and support consumer interests and safety.