UK Food Standard Agency position on the CBD — In-depth review and explanation & industry impact
Like any other food supplement, CBD products are subject to various labels — whether it’s vegan-friendly, organic, or full-spectrum. And like other foodstuff, CBD products also have to comply with strict safety standards — and to ensure they deliver on the promises made on these labels.
In the UK, this process falls under the remit of a body called the Food Standards Agency. The latest announcement from the Food Standards Agency — that it has concerns about the safety of CBD products for pregnant women, breastfeeding mothers, and people taking medication — has stirred up the media and raised many questions. In this article, we’ll discuss what this buzz is all about.
What is FSA, and how does it work?
FSA stands for Food Standards Agency. It is an independent government department in the United Kingdom, with a remit for the food industry within England, Wales, and Northern Ireland.
The FSA has headquarters in London and offices in York, Birmingham, Wales, and Northern Ireland. It began with the Food Standards Act being introduced in the House of Commons in 1999. The Act aimed to establish the Food Standards Agency, giving it the necessary functions and authority in relation to food safety and standards.
The department was created in 2001. At that time, the Ministry of Agriculture, Fisheries and Food, covered the health aspect of the farming, food processing industries, and food safety. It felt insufficient to have only one government department covering this issue, so FSA was created to share the responsibility. Since April 2015, Scotland has formed its own government department named Food Standards Scotland. In 2010, some aspects of the UK food labelling regulations in England were passed from the FSA to the Department for Environment, Food and Rural Affairs (DEFRA). In England, the Agency is responsible for food safety-related labelling issues, while the FSA offices in Wales and Northern Ireland keep responsibility for all labelling and standards policy.
In England and Wales, nutrition policy, along with nutrition labelling, have been passed from the FSA to the Department of Health and Social Care in England to the Welsh Government’s Department of Health and Social Services. The FSA offices in Northern Ireland and Scotland are responsible for their nutrition policy.
The FSA is led by a board with responsibility for overall food welfare for the general public. It is advised by independent expert committees, such as the Committee on Toxicity, the Science Council, the Advisory Committee on Novel Foods and Processes, the Advisory Committee on the Microbiological Safety of Food, and the Advisory Committee on Social Sciences.
The board ensures not only health protection and consumer confidence and interests of British consumers but also:
- Approvals for products with CBD content
- Strategic planning for the FSA
- Surveillance of food risks
The board also deals with more specific issues, such as nutrition health claims in Northern Ireland following the UK’s exit from the European Union.
The Food Standards Act of 1999 provided the Agency with the statutory right to publish the advice it gives to Ministers, something it does regularly on matters concerning the production, procession, distribution and purchasing of food. Since 2003, every consumer has an opportunity to see the decision-making process in action on the live webcasts. The Board meetings end with a question and answer sessions where online viewers can ask the Board questions.
The FSA reviews and considers a number of social, environmental, economic, technological factors that are likely to influence the food industry. An example is a vast increase in sweet snacks available on UK supermarket shelves due to the ongoing globalisation of the country’s food supply. As the UK imports food from more than 180 countries, the FSA has to think about protecting the interests of consumers in the UK.
The FSA publishes periodic five-year strategies to set out its priorities. Its latest strategy — which covers the period from 2015 to 2020 — was named ‘Food We Can Trust’.
The idea behind the strategy is that the FSA must use scientific evidence, information, and influence so people can trust that the food they buy is safe to consume and there is complete transparency of the food content. The strategy sets out the growing challenges around food safety, affordability, and sustainability in the UK. It also explains how to meet these challenges. The supporting strategic plan sets out approaches to ensure that consumers are empowered, protected, and informed at any time.
This includes:
- science, evidence, and information to meet the current challenges, and to consider potential risks for the future
- highly effective legislative and non-legislative tools to influence companies’ behaviour in the interests of consumers and find ways to empower them
- policy-making and delivery in relation to the food industry
Throughout the development of strategy, priorities, and critical themes for the following years, FSA engages with external and internal stakeholders and consumers, such as:
- Consumers and consumer organisations
- Scientific community
- Food industry representatives
- Trade bodies and local authorities
- Government departments
- Non-governmental organisations
- FSA representatives
FSA has also created a Food Hygiene Rating Scheme that helps consumers to choose where to eat or shop for food and be aware of the businesses’ hygiene standards. The scheme provides businesses with a rating score from 0 to 5, which is then indicated on their premises and online. The rating reflects standards of food hygiene found at the time of inspection. However, it is the responsibility of the business to conform to food hygiene law at all times.
The rating covers:
- Food handling
- Food storage and preparation
- Cleanliness of premises
- Management of food safety
Businesses in Northern Ireland and Wales are required by law to show their ratings at the premises. In England, it is preferable but not necessary. You can browse the ratings online or make a Freedom of Information request.
The FSA aims to give all food industry players the confidence that a strong and independent regulatory will protect consumer safety, as well as the reputation of UK food both within the country itself and within international export markets. The FSA seeks to ensure all companies take food safety seriously whilst also taking action against any businesses that compromise consumer safety. In order to do this, the FSA seeks to set transparent guidelines as to the standards affecting each part of the industry.
Alexey Pikovsky, CEO and co-founder of Alphagreen, commented: “The industry is shifting from being very unregulated initially to getting more transparent with more regulatory guidance in recent months. However, more work still needs to be done, and brands need to stay up to date with changes and regulatory input.”
What is CBD and its benefits?
Cannabidiol (CBD) is a compound found in hemp — otherwise known as Cannabis Sativa L. plants. It has gained popularity due to the growing recognition of its health and wellness benefits, as well as its growing use in food supplements and lifestyle products. Out of all cannabinoids, CBD is most commonly used for medical and wellness purposes due to the absence of psychoactive effects.
CBD is a cannabinoid, meaning it can interact with the endocannabinoid system (ECS) with the human body. There are endocannabinoids naturally produced by the body, which can combine with phytocannabinoids that come from plants, such as hemp or marijuana.
ECS is a vital part of every human body. This complex system consists of cannabinoids, CB1, and CB2 cannabinoid receptors and enzymes, which are distributed in body tissues. ECS regulates the cardiovascular, nervous, and immune system functions inside cells and helps to form an appropriate cellular response. The majority of cannabinoids can bind to both types of cannabinoid receptors. However, CBD doesn’t directly trigger the receptors. Instead, it changes the ability of receptors to bind to cannabinoids. Additionally, CBD may occupy specific enzymes, enhancing natural levels of endocannabinoids, and prevent the body’s natural endocannabinoids from damage.
These valuable benefits of CBD make it effective for the human body. Multiple studies suggest that CBD may be useful for various health conditions, such as chronic pain, anxiety, depression, and neurological disorders.
In the UK, CBD extracts are sold as food and as food supplements. They are widely available in health and wellness shops, cafes, and online.
CBD products sold as food, or as a food supplement, include:
- CBD oils and tinctures
- CBD pills and capsules
- CBD edibles
- CBD-infused food and drinks
The use of cannabidiol is legal in many countries across the globe, including the UK. Where it has been studied by industry and medical bodies worldwide, CBD has been found to be safe for humans when consumed within the prescribed dosage limits. However, the official status of CBD and its legality is a complex matter and should be discussed more in-depth.
Is CBD considered a novel food?
Since January 2019, CBD has acquired novel food status. Generally, novel foods are those that have no “history of consumption” and have not been widely consumed in the EU until May 1997. Novel foods include synthetic foodstuffs made via new technologies. In addition to this, exotic fruit and vegetables that have not traditionally been consumed within EU markets are also considered to be novel. Examples of novel foods include:
- New foods, such as phytosterols used in cholesterol-reducing spreads
- Extracts from existing food, such as Antarctic Krill oil or new sources of vitamins
- Agricultural products eaten elsewhere in the world, for example, chia seeds, noni fruit juice or baobab
- Foods derived from new processes, for example, UV-treated bread and milk
FSA takes responsibility for ensuring that novel foods on the market are safe for consumers.
Before the novel foods can be legally sold in the EU, it must go through a pre-market safety assessment and authorisation according to the Regulation (EU) 2015/2283 of the European Parliament and the Council of November 25, 2015.
The novel food must consist of either:
- Food or ingredients with a modified molecular structure
- Food made of microorganisms, fungi, or algae
- Food produced from plants or animals and their parts
- Food produced by a new production process that results in significant changes in the composition or structure of a food, affecting metabolism, nutritional value, or concentration of undesirable substances
- Vitamins, minerals, and other substances consisting of engineered nanomaterials
Food additives, extracts, and flavourings used in the production of food are not subject to the novel foods legislation. They do, though, require pre-market safety assessment and authorisation. The information about regulatory requirements can be seen at the Legislation Guidance to Compliance for Food additives of 2015.
All EU-authorised novel foods are included in the EU’s list of novel foods.
The underlying principles behind the Novel Foods scheme are to ensure:
- safety for consumers
- transparent information on the labels
- that novel food that replaces another existing food (i.e. a synthetic substitute for an existing natural foodstuff) must not differ in such a way that the consumption of the Novel Food might be nutritionally disadvantageous for the customer.
Pre-market authorisation of Novel Foods based on evaluation in line with the above principles is necessary.
Businesses have to submit a novel food application if they want to market their goods in a way that is not listed in the Union List.
There is no universal list of novel foods, but their status can be checked on the following resources:
- EU Novel food catalogue
- German novel food list
- Italian lists of plants permissible or not permissible for food supplement use
Moreover, the European Commission provides guidance to determine if a product requires authorisation under the Novel Food Regulation.
CBD products have now been added to the Novel Foods Catalogue. The catalogue is used as a way of recording decisions on the novel food status of foods and food supplements. Even though the catalogue has no legal status, the recorded decisions do. According to the catalogue, CBD extract and isolate products are legally considered novel foods. In February 2020, the FSA issued its first CBD safety advice on safe levels of CBD consumption for consumers, and set a deadline of March 31, 2021, for the players of CBD industry to submit valid Novel Foods Applications.
Cannabis industry bodies have engaged with the Novel Foods process, arguing that the need to submit Novel Foods Applications will place undue burdens on the industry. One example is the Cannabis Trades Association, one of the largest cannabinoid trade associations for both the UK and Europe. Its aims are to:
- Promote good practices within the industry
- Provide practical advice to the industry and general public
- Ensure that those who consume legal cannabis and hemp products are well-informed
Even though the CTA duly supports regulation that ensures consumer safety and that provide clarity to the industry, it has also suggested that natural (i.e. not isolates or synthetics) CBD products should not be considered Novel Foods. Additionally, the European Industrial Hemp Association does not agree with such a designation of CBD, arguing that, as the crop has been consumed for centuries, its components and extracts shouldn’t be considered new or novel. The appeal remains pending.
FSA statements about CBD
Customer research on cannabidiol (CBD) extracts
In 2019 the Food Standards Agency commissioned Agency Community Research and 2CV, global consumer research agency, to conduct research with CBD users aiming to:
- understand why consumers use CBD, how long they have taken it for and how content they are about the effects
- comprehend consumers’ understanding of CBD’s legal status and find out a possible reaction if CBD was no longer easily available for purchase
- understand if consumers are aware of CBD’s status as a novel food
Small-scale research included an online survey with 352 CBD users and gave the following results:
- Two-thirds of those who had used CBD intended to take the substance again in future (whereas one-third of respondents classed themselves as former CBD users). Around a quarter of users said they took CBD regularly while four in ten said they used it occasionally. More than three-quarters of current users have used CBD for less than a year.
- Tinctures are the most common form of a CBD product among the survey participants. On the scale of popularity, tinctures are followed by e-liquids, pills and capsules, creams, and ointments. Less than a third of users buy CBD products from health food stores and a little under a quarter from online CBD specialist retailers or online marketplaces. Most users consider the quality of the product when deciding on a type of CBD product. Other factors — including the price, retailer reputation, brand reliability and CBD concentration — were also taken into consideration by respondents.
- The main reason for CBD usage is pain relief. The participants also mentioned that CBD was helpful for managing anxiety, depression, relaxation, sleep and mental health.
- Almost two-thirds of respondents stated CBD benefits for overall health and/or certain medical conditions, such as anxiety, stress, arthritis, and back pain.
- More than a third of CBD users claimed to be reliant on it or mentioned that they would be bothered if they could no longer find it at the stores.
- Most respondents said they considered they were buying high-quality CBD products which had been labelled correctly. The majority assumed that CBD is regulated, while a minority was unsure about its legal status. In general, survey participants said they felt confident about the legality and quality of CBD products they bought from retailers.
- Most respondents were not aware that CBD had the status of Novel Food. When they found out that this meant, some people expressed concern. There were various responses to the idea that CBD may not become available from mainstream retailers. Some of the consumers would stop using it, while others would simply buy it in other places.
FSC statement about CBD
In February 2020, the FSA set a deadline for the CBD industry to provide more information about CBD products and their contents. Valid Novel Food authorisation applications must be submitted by March 31, 2021.
After the deadline, only brands and products with submitted applications will be allowed to stay on the market. Authorisation aims to ensure that novel foods meet legal standards, including its safety and content. FSA statement on CBD extracts applies in England, Wales, and Northern Ireland. Food Standards Scotland covers regulations on novel food in Scotland.
It’s important to note that even though FSA regulates CBD as a novel food, it does not refer to:
- Cosmetics
- Vapes
- Products that make medicinal claims
- Products that contain THC and other controlled drugs.
Where CBD extracts may also contain THC or other controlled cannabinoids, they will likely fall under the Misuse of Drugs Act 1971. Further data is available from the Home Office, which has published a factsheet on Cannabis, CBD, and other cannabinoids.
FSA announcement will not concern those who take prescribed CBD products or cannabis.
FSA consumer advice on CBD extracts
The FSA encourages people to think carefully before taking any CBD products and does not recommend CBD to people in vulnerable groups unless specified by a medical specialist.
In its February 2020 announcement the FSA advised against CBD consumption for the following groups:
- pregnant and breastfeeding women
- people taking any medications.
According to some scientific studies, CBD can affect the liver. Healthy adults are advised to take no more than 70mg a day, which is equal to 28 drops of 5% CBD. This recommendation doesn’t guarantee the effectiveness of this particular dose. However, bear in mind that higher amounts may potentially cause adverse health effects. New precautionary advice comes from the recent findings by the government’s Committee on Toxicity of Chemicals in Food, Consumer Products, and the Environment (COT). It is an independent scientific committee that provides advice to the Food Standard Agency, the Department of Health and Health Care, and other Government organisations concerning chemicals’ toxicity. Here you can check a 2020 scientific report on CBD. FSA keeps reviewing new safety information on CBD when it becomes available.
Business guidance on CBD as a novel food
Since the FSA announcement in February 2020, food businesses should submit novel food authorisation applications for their CBD extracts and isolates. It is the only way of compliance for CBD products since no additional arrangement was offered for any specific business or industry sector.
All the applications should be submitted to the European Commission via an electronic portal. It is strongly recommended to send a duplicate application to FSA so they could consider the documents. FSA can then provide businesses with guidance and answer any queries when the UK has diverged from EU rules from January 1, 2021. When an application is ready, FSA may be contacted at novelfoods@food.gov.uk.
Companies should submit novel food authorisation applications by March 31, 2021. From that point onwards, only products with a validated application by the FSA will be allowed to be on the market. The deadline is applicable in England, Wales and Northern Ireland. Novel foods regulations in Scotland are provided by Food Standards Scotland.
Article 4 of the Novel Food Regulations is a helpful tool that provides consultations for a business to check the novel status of the product. However, the submission of Article 4 request doesn’t mean compliance for novel food, including CBD.
Submitting Article 4 does not imply that unauthorised novel products are permitted on the market. Whether a business submits an Article 4 request, it is expected to wait for a decision to be made before putting products on the market. However, there are hundreds of CBD extract products on the market without authorisation. At the same time, submitting an Article 4 request does not change the enforcement position and provides no protection against enforcement for unauthorised novel foods on the market.
Any business is able to check the novel food status of CBD extracts on the novel food page or request the consultation.
FSA has issued consumer advice on CBD consumption for healthy adults and vulnerable groups. Therefore, sellers of CBD products should be aware of this information and be prepared to inform customers on the recommended dosage for healthy adults, and the potential risks for pregnant or breastfeeding women or those who take medications.
FSA regularly discusses CBD with trade bodies and organisations involved in the novel food and CBD industry. So far, FSA has not endorsed any specific trade body’s approach to compliance for CBD extract products and has not concluded any specific agreements with individual trade bodies. All businesses marketing novel CBD products are treated equally.
Local authorities enforce the novel food legislation. They have been recommended that businesses should keep selling the existing CBD products till March 31, 2021, on condition they are labelled correctly, safe to consume, and do not contain substances that are in line with drug legislation.
Are CBD products legal in the UK?
CBD products keep gaining popularity due to broad media and social media coverage. Multiple scientific studies keep reporting about the pros and cons of this compound. Despite its proven benefits, cannabinoids are still in some kind of a regulatory vacuum. Cannabis laws all over the world vary on the aspects of ownership, distribution, cultivation, methods of use, and medical usage.
Generally, according to cannabis legalisation of each country, CBD made of hemp or marijuana falls into three main categories:
- Fully legal and accessible for a broad public;
- CBD for medicinal purposes;
- Strictly controlled or not regulated.
In 2016, the Medicines and Health Products Regulatory Agency (MHRA) in the UK officially recognised and classified CBD as a medicinal ingredient. The action was taken to keep the entire control of patients’ health. As of 2020, MHRA considered CBD derivatives, compounds, and by-products made of industrial hemp 100% legal in the UK.
Here are some regulatory differences depending on actions in relation to CBD:
- Buying/Possessing CBD
In August 2019, the guidance on the limit of THC was updated from “1 mg per pack” to “No THC trace” (recommended limit of detection: up to 0.01%). The change of limitation was made in order to encourage businesses to follow a “best practice.” It takes into account the corresponding Home Office guidance, the “exempt product” laws, and the fact that many laboratories offering independent CBD testing services may not reliably detect 1 mg of THC. CBD products are, therefore, licensed for usage in the United Kingdom if they are certified by the British Cannabis Trades Association or CTA, and contain no THC traces. However, it is not recommended to take CBD products when going abroad. Even though many EU and other countries allow them, some countries strictly prohibit cannabinoids.
- Importing CBD
There are no strict requirements for importing CBD into the UK if THC level does not exceed 0.01% verified by accredited ISO lab.
- Selling CBD in the UK
Sale requirements depend on the product category. According to EU Regulation No 1223/2009, cosmetics require Cosmetic Product Safety Report (CPSR). Vape products should conform to non-nicotine e-liquid regulation, such as The General Products Safety Directive. CBD is allowed to be sold from a licensed medical distributor or as a nutritional supplement. If sold as a supplement, CBD products must be properly labelled according to The Food Supplements (England) Regulations 2003. A proper label should contain CBD content and ingredients, manufacturer information, and no medical claims. Since February 13, 2020, new products on the market, including CBD products, require a Novel Food application. Products that appeared on 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 EU Member Country has its laws regarding CBD, which may be stricter than in the UK. Local laws should be considered.
Veterinary Medicines Directorate (VMD) considers that veterinary products with CBD content are veterinary medicines. CBD products for animal use require a marketing authorisation before they can be marketed or supplied in the UK. There are no CBD products authorised in the UK for veterinary use. Therefore, a veterinary surgeon may prescribe to a pet a legally obtained CBD product for humans. Administration of unauthorised products containing CBD without a veterinary prescription is prohibited and considered an offence under Regulation 8 of the VMR. Companies that supply CBD products for human use must not indicate or recommend their products for animals.
The National Health Service (NHS) and the National Institute for Health and Care for Excellence (NICE) strictly regulate the sale and consumption of CBD products in the UK. NICE has published a guideline for cannabis-based medicinal products.
Here are some legal subtleties regarding CBD flowers and buds. Their sale is prohibited even if the THC level is below the recommended concentration and if they are of an EU approved origin. However, ground cannabis leaves are considered legal in the UK and can be sold in stores.
Possible CBD industry impact
In the last few years, the UK has seen a rise in the popularity and availability of CBD products. Whatever your heart desires is there on the shelves ㅡ from CBD oils and pills to CBD gummies and CBD-infused tea. Recent trials have shown that some CBD products on the market may contain potentially dangerous, illegal, or not indicated on label ingredients, little or none of the extract, or illegal level of psychoactive ingredients, such as tetrahydrocannabinol (THC).
On February 13, 2020, FSA announced that businesses from the CBD industry must provide valid information about the contents of their products and safety to the European Commission by March 31 2021. If failed to do so by the deadline, the products may be taken off the shelves. Producers are required to apply for a novel food authorisation, which can reassure the users about the safety of CBD products. FSA’s requirement concerns England, Wales, and Northern Ireland. A local regulator covers the CBD market in Scotland. Even though the UK broke ties with the European Union, it plans to follow food regulations introduced by the European Commission. The same announcement also sets dosage recommendations and warns pregnant and breastfeeding women to avoid CBD.
Other countries, including Australia, Canada, and the United States have confirmed that they review CBD safety in food and nutritional supplements but have not approved sales or issued guidelines on how it should be produced. This can potentially become an obstacle for manufacturers and lead to some confusion about cannabidiol’s legality.
CBD products have been on the UK market for years, so the FSA has decided to take action to create a transparent CBD market with safe products for the consumers. The FSA was hoping that companies would provide valid product information. However, since none of them provided enough documentation or didn’t deliver CBD products for approval in time, the FSA was forced to set the deadline.
The ACI, a new industry body, devoted to supporting a safe, legitimate, and well-regulated CBD market in the UK, is also worth mentioning. Its vision is to create an innovative and sustainable market that meets high standards in CBD products quality, consumer satisfaction, and environmental management. In addition to applying for a novel food authorisation, ACI’s members have committed to removing detectable THC amounts and maintaining testing and labelling standards and keeping marketing ethics. ACI hopes that companies that have submitted authorisation applications would prove themselves reliable for UK regulators. This may provide more ability to promote and sell CBD products without waiting when the application process ends.
FSA’s advice to refrain from consuming CBD products simultaneously with other medications may surprise current users, that have been taking them for managing medical conditions. Even though CBD products are prohibited from making any medical claims, they are promoted to be helpful with everything from stress to alleviating cancer symptoms. It is highly likely to be taken alongside other medicines to increase the impact of a treatment. FSA’s actions are an important step for the protection of public health.
As for the businesses within the industry, it is believed that CBD suppliers that support new legal requirements and actively engage in getting novel foods approval, will get the power on the market. They might even get a chance to charge a premium price for their CBD products. Submitting all the needed documents and getting the approval may be expensive, and not every company in the UK has the resources to afford it. Consequently, it can lead to product shortages in supply and thinning the ranks of CBD products in the UK.
In general, new CBD regulations are likely to improve transparency in the UK market. The updated CBD guidance will provide manufacturers and businesses with more clarity on how to sell CBD foods legally and share valid information with the consumers.
For companies hoping to get a part of the UK’s multi-million pound CBD market, it is a crucial reason to comply.
Alexey Pikovsky, CEO and co-founder of Alphagreen, commented: “We can see the industry will remain one of the fastest-growing industries. The brands which comply with regulation and create trust with customers will be the ones surviving in the long run.”
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.
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