- Is CBD Legal in the UK?
Is CBD Legal in the UK?
As the demand for CBD products keeps increasing, many people in the UK are left wondering about the legality and regulations surrounding this natural compound.
In this comprehensive piece, we will answer the question, 'Is CBD legal in the UK?' We will also explore the ins and outs of CBD legality in the UK and delve into the roles of various regulatory bodies, such as the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations 2001, and the Food Standards Agency (FSA).
We will also discuss the classification of CBD as a novel food, the application process for relevant products, and the implications for businesses and consumers alike.
Furthermore, we will examine the guidelines set forth by the FSA and the Medicines and Healthcare products Regulatory Agency (MHRA) on CBD use, safety recommendations for pregnant and breastfeeding women, precautions for individuals on medication, and daily intake limits for healthy adults.
Finally, we will provide guidance on navigating the CBD market in the UK, including tips on identifying legal and compliant products, the importance of third-party lab testing, and educating consumers on safe and responsible CBD use.
Join us as we unravel the complexities of CBD legality in the UK and empower you with the knowledge to make informed decisions about incorporating CBD into your daily routine.
Understanding CBD Legality in the UK
The legality of cannabidiol (CBD) in the United Kingdom is complex, with various rules and regulations governing its use and sale. To better understand the legal status of CBD in the UK, it is essential to break down these regulations into simple subsections.
Controlled Cannabinoids and Their Restrictions
According to UK regulations, CBD products must not contain any controlled cannabinoids. Controlled cannabinoids are substances that are subject to restrictions under the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001.
It is crucial for UK CBD products to be free from these substances to be considered legal. These include:
- Delta-9-tetrahydrocannabinol (Δ9-THC)
- Delta-8-tetrahydrocannabinol (Δ8-THC)
- Tetrahydrocannabivarin (THCV)
- Cannabinol (CBN)
- Cannabinol derivatives
A note on THC-A -Although the cannabinoid THC-A in its pure form is not classified as a controlled substance under the Misuse of Drugs Act 1971 or Misuse of Drugs Regulations 2001, it is generally treated with caution due to its ability to degrade into THC. Consequently, many authorities approach THC-A with the presumption that it will ultimately become a controlled substance through degradation.
Legal Exemptions for CBD Products
For UK CBD products to be sold and used legally, they must also meet certain legal exemptions. According to the Home Office's guidance on the supply of products containing CBD, a product may be considered exempt from control if:
- The controlled drug in any component part is packaged in such a form, or in combination with other active or inert substances, that it cannot be recovered by readily applicable means or in a yield that constitutes a risk to health.
- The product must not be sold or promoted as having medicinal benefits.
- The product must have Novel Foods authorisation from the Food Standards Agency.
These exemptions ensure that only safe and effective products are available for consumers in the UK.
The Role of the Misuse of Drugs Act 1971
The Misuse of Drugs Act 1971 significantly determines the legality of CBD and CBD products in the UK. This Act classifies C. sativa L. as a controlled substance, making it illegal to grow, buy, sell, and possess.
However, CBD is a non-intoxicating cannabinoid extracted from the C. sativa L. plant, and as such, it is subject to various exemptions that allow for its legal use and sale.
The Act states:
"It is an offence to possess, supply, produce, import or export any controlled drugs...where the activity is not authorised in accordance with the appropriate regulations."
Thus, CBD products must be free from controlled cannabinoids to comply with the Misuse of Drugs Act 1971.
The Role of the Misuse of Drugs Regulations 2001
The Misuse of Drugs Regulations (MDR) 2001 further impacts the legality of CBD in the UK. These regulations provide additional guidance on controlling and classifying substances, including cannabinoids like CBD.
Under the MDR 2001, 'pure' CBD products (including synthetic versions) are not classified as C. sativa L.-based products for medicinal use. They are not controlled drugs, as they have no THC content and don't contain any other controlled cannabinoids.
CBD as a Novel Food in the UK
In the United Kingdom, novel foods are defined as any food that was not consumed to a significant degree within the UK or the European Union before 15 May 1997. This means that these foods do not have a 'significant history of consumption.' CBD (cannabidiol), in the form it’s currently sold, is considered a novel food in the UK, as it falls under this definition.
The British Food Standards Agency (FSA) has been responsible for handling CBD as a novel food in the UK. In 2019, the FSA assigned ingestible CBD products with this classification under the Novel Food Directive.
Now, to legally sell their products, CBD brands must obtain authorisation by submitting a novel food application to the FSA. This application process ensures that CBD products adhere to safety and quality standards, ultimately protecting consumers.
A product must be present on the FSA's public register of applicants to be legally available for sale. The register is updated when the status of an application changes.
Criteria for Novel Food Status
A food or food ingredient is given novel food status when it meets specific criteria defined by UK authorities. In the context of the European Union (EU) and the United Kingdom (UK), the term "novel food" is governed by the EU Novel Food Regulation (EU) 2015/2283 and the UK Food Standards Agency (FSA), respectively.
The criteria required for a food to be classified as a novel food are as follows:
- Lack of significant consumption history: A food is considered novel if it has not been consumed to a significant degree by people within the EU before May 15, 1997. This date serves as a benchmark for determining whether a food product has a substantial history of consumption within the region. If a food has been consumed only in limited quantities or in specific regions, it may still be classified as novel.
- New or modified molecular structure: If a food or food ingredient has a molecular structure that was not present in the food supply before May 15, 1997, it may be classified as a novel food. This includes products derived from new sources or created through innovative manufacturing processes that result in a significantly altered molecular structure compared to their conventional counterparts.
- New extraction or isolation methods: A food may be considered novel if it is derived from a source using a new or modified extraction or isolation method that was not commonly used before May 15, 1997. These novel methods may result in a product with different properties, characteristics, or effects on human health compared to the traditionally obtained products.
- Foods derived from plants, animals, or microorganisms: If a food product is obtained from a new or genetically modified plant, animal, or microorganism species or from a new strain, variety, or breed that was not significantly consumed within the EU before May 15, 1997, it may be classified as a novel food.
- Foods produced using new production processes: A food may be deemed novel if it is produced using a new production process that results in significant changes to its composition, nutritional value, or how the human body metabolises it.
It is essential to note that the novel food status does not automatically imply that a food is unsafe or of low quality. Instead, it indicates that the food has not undergone sufficient safety assessments and evaluations to ensure its safety for human consumption.
To legally market a novel food, companies must obtain authorisation by submitting an application to the appropriate regulatory authorities, demonstrating the safety and compliance of their products with relevant regulations.
The Novel Food Status of CBD
Although hemp has a long history of consumption, CBD itself has been classified as a novel food because it has not been consumed to a significant degree within the EU before May 15, 1997. The extraction and isolation methods used to obtain CBD from hemp are relatively recent innovations, resulting in a product with distinct properties and characteristics compared to traditional hemp-based foods.
Due to this lack of significant consumption history and the differences between CBD and conventional hemp products, CBD is considered a novel food requiring safety assessments and authorisation before it can be legally marketed.
The Application Process for CBD Products
The application process for UK novel food authorisation, as mandated by the UK FSA for CBD products, is a crucial step to ensure the safety and compliance of these items in the market. This process consists of several stages, allowing for the thorough evaluation of relevant products before making them available to consumers.
To begin the application process, the interested party must first compile a dossier containing detailed information about the CBD product they wish to introduce to the market. This dossier should include comprehensive data on the product's safety, production methods, compositional information, and any relevant scientific research.
It is essential that applicants provide sufficient evidence to demonstrate that their CBD product is safe for human consumption and complies with UK regulations.
Upon submitting the dossier, the FSA will thoroughly review the provided documentation. This evaluation may involve requesting additional data or clarification from the applicant, if necessary. The FSA's primary focus during the review process is to ensure the product's safety for consumers and its compliance with existing regulations.
Once the FSA has completed its assessment, it will provide a recommendation regarding the novel food authorisation. If the application is successful, the CBD product will be granted authorisation and added to the list of approved novel foods. This signifies that the product has met the necessary safety and regulatory requirements and is now permitted for sale in UK shops.
In case the FSA identifies any concerns or shortcomings in the application, the applicant may be asked to address these issues before the product can be granted authorisation. It is crucial for applicants to collaborate closely with the FSA during this process to ensure their CBD product meets the required standards and ultimately achieves authorisation.
Overall, the UK novel food authorisation process is designed to protect consumers by ensuring that CBD products entering the market are safe and compliant with UK regulations. Applicants must be diligent in providing accurate and comprehensive information about their products and be prepared to work closely with the FSA throughout the process.
Criteria for UK CBD Products to Achieve Novel Foods Authorisation
For CBD products to obtain novel foods authorisation in the UK, they must meet specific criteria set by the UK FSA. These criteria aim to ensure that CBD products are safe for human consumption and comply with UK regulations.
The key criteria for CBD products to achieve novel foods authorisation are as follows:
- Comprehensive safety assessment: Applicants must provide a thorough safety assessment of their CBD product, including toxicological data, information on the absorption, distribution, metabolism, and excretion (ADME) of the product, as well as any potential allergenicity or interactions with other substances. The safety assessment should demonstrate that the CBD product poses no risks to human health when consumed as intended.
- Production process and quality control: Applicants must provide detailed information on the production process of their CBD product, including extraction methods, purification steps, and any other relevant manufacturing processes. Additionally, they should describe the quality control measures in place to ensure that the product is consistently safe, of high quality, and free from contaminants, such as heavy metals, pesticides, or residual solvents.
- Product composition and specification: A comprehensive description of the CBD product's composition, including the concentration of CBD and any other cannabinoids, terpenes, or other constituents, is required. Applicants must also provide information on the product's stability, shelf life, and any potential changes in its composition over time.
- Nutritional information and proposed use: Applicants must provide information on the nutritional value of their CBD product, including its impact on the dietary intake of essential nutrients. They should also describe the intended use of the product, recommended dosage, target population, and any specific age groups, if applicable.
- History of consumption or previous use: If available, applicants should provide evidence of the CBD product's history of consumption or previous use, particularly in the context of other countries or regions where it might have been consumed. This information can support the safety assessment and provide additional context for the product's intended use.
- Scientific research and publications: Applicants are encouraged to include relevant scientific research, publications, or clinical studies that support the safety, efficacy, and quality of their CBD product. This evidence can further demonstrate the product's compliance with UK regulations and help facilitate authorisation.
By fulfilling these criteria and providing comprehensive documentation, CBD product manufacturers can demonstrate their commitment to safety and quality, increasing their chances of obtaining novel foods authorisation from the UK FSA.
Implications for CBD Businesses and Consumers
The novel food ruling has had a significant impact on the CBD industry in the UK. Hundreds of CBD companies are still waiting for authorisation, a process that has frustrated many. New products cannot be placed on the market without authorisation, while products on the market on 13 February 2020 can remain on shelves, provided they are on the list of active applications.
The authorisation process has been challenging for many CBD companies, with some experts suggesting that it is causing the CBD market to stagnate. The cost and stringent requirements set by the FSA have made it difficult for many companies to meet the necessary criteria, potentially reshaping the entire CBD nutraceutical marketplace.
For consumers, the novel food ruling means that only CBD products that have undergone the authorisation process can be legally sold in the UK. This ensures that the products have been through an independent safety assessment, providing a level of protection for consumers.
However, the slow-moving authorisation process may limit the availability of new CBD products in the UK market, potentially affecting consumer choice and access to these products.
Food Standards Agency (FSA) Guidelines on CBD Use
As part of the Food Standards Agency's efforts to ensure the safety and legality of CBD products, they have released a set of guidelines on CBD use. These guidelines cover various aspects of CBD consumption, including safety recommendations for pregnant and breastfeeding women, precautions for individuals on medication, and daily intake limits for healthy adults:
Safety Recommendations for Pregnant and Breastfeeding Women
The FSA strongly advises against using CBD during pregnancy and while breastfeeding. This recommendation is based on recent findings by the government's Committee on Toxicity (COT), which suggests that there may be potential adverse health effects from consuming CBD products.
Pregnant and breastfeeding women are considered vulnerable groups, and the FSA advises them not to consume CBD products unless under medical direction.
Precautions for Individuals on Medication
The FSA guidelines also highlight the importance of taking precautions when using CBD products if you are on any medication. Due to the limited research on CBD and its potential interactions with other medicines, it is advised that individuals consult with a healthcare professional before using CBD. This precautionary measure is in place to ensure the safety of those at risk of experiencing adverse effects due to potential drug interactions.
One reason for this caution is that CBD can impact the function of the cytochrome P450 (CYP450) enzyme system, which is responsible for metabolising a wide range of drugs in the liver. When CBD interferes with this enzyme system, it can alter the way certain medications are metabolised, potentially leading to increased or decreased drug concentrations in the bloodstream. This can result in reduced effectiveness or heightened side effects of the medications.
A well-known example of this phenomenon is the "grapefruit warning" often seen on medication labels. Like CBD, grapefruit and grapefruit juice can also inhibit the CYP450 enzyme system, leading to similar interactions with various medications. The grapefruit warning serves as a cautionary note, advising patients to avoid consuming grapefruit products while taking specific medications due to the potential for drug interactions.
By consulting with a healthcare professional, individuals on medication can receive personalised advice on whether it is safe to use CBD alongside their current medications. This can help minimise the risk of any adverse effects and ensure the safety and well-being of those using CBD products.
Daily CBD Intake Limits for Healthy Adults
According to the FSA guidelines, healthy adults should not consume more than 70mg of CBD per day (about 28 drops of 5% CBD) unless under medical direction. This daily intake limit is based on the latest scientific information available, including data from the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT).
The COT, an independent expert committee, conducted a comprehensive review of CBD's potential adverse health effects and found that doses higher than 70mg per day may pose potential risks to consumers, such as liver toxicity. This intake limit aims to protect public health while still allowing consumer choice.
The FSA recognises that CBD products have gained popularity due to their potential health benefits. It seeks to strike a balance between providing access to these products and ensuring the safety of consumers. The 70mg daily limit is intended to minimise the risk of any adverse effects associated with high doses of CBD while still permitting the use of CBD for potential wellness purposes.
MHRA and Its Role in CBD Regulation
The Medicines and Healthcare products Regulatory Agency (MHRA) is a key player in regulating CBD products in the UK. As an executive agency sponsored by the Department of Health and Social Care, the MHRA's primary responsibility is the regulation of medicines, medical devices, and blood components for transfusion.
In the context of CBD, the agency ensures that products used for medical purposes comply with the legal requirements outlined in the Human Medicines Regulations 2012.
Overview of the Medicines and Healthcare products Regulatory Agency (MHRA)
The main objective of the MHRA is to protect public health by ensuring that medicines, medical devices, and other healthcare products meet appropriate safety, quality, and efficacy standards. The agency works diligently to maintain the highest level of regulatory compliance across the healthcare sector.
In relation to CBD products, the MHRA focuses on those classified as medicines, ensuring that they satisfy the necessary legal requirements. The MHRA actively investigates complaints regarding unauthorised CBD products marketed with medicinal claims and takes appropriate enforcement action when necessary to maintain public safety and confidence in the industry.
MHRA's Stance on CBD as a medicine
The MHRA's stance on CBD as a medicine is that products containing cannabidiol (CBD) intended for medical purposes should be classified and regulated as medicines. This viewpoint emerged in 2016 when the MHRA acknowledged the increasing number of CBD products on the market, claiming various medicinal benefits.
The agency determined that CBD products advertised with medicinal claims should be subject to the same regulatory standards as other medicinal products. This classification means that CBD intended for medicinal use must adhere to the rigorous safety, quality, and efficacy standards established by the MHRA under the Human Medicines Regulations 2012.
To be legally marketed as a medicine in the UK, CBD products must undergo a comprehensive evaluation and obtain marketing authorisation from the MHRA. This process involves providing extensive data on the product's safety, efficacy, and quality, including clinical trial results, manufacturing details, and pharmacological information. The MHRA reviews the submitted data to determine whether the CBD product meets the necessary standards for use as a medicine.
It is essential to note that the MHRA's stance applies specifically to CBD products with medicinal claims. CBD marketed as a food supplement or cosmetic product is regulated by the UK FSA and does not require MHRA approval.
However, these products must not be marketed with any medical claims and must comply with the FSA's novel food authorisation process and other relevant safety and quality standards.
Licensing and Approval Process for CBD Medicinal Products
The MHRA's licensing and approval process for CBD medicinal products in the UK involves several steps, as outlined below:
- Classification as a Medicine: The MHRA classifies CBD products intended for medical purposes as medicines. This classification means that these products must adhere to the same safety, quality, and efficacy standards as other medicinal products.
- Application for Marketing Authorisation: To legally market a CBD product as a medicine in the UK, the manufacturer must submit an application for marketing authorisation to the MHRA. The application process involves providing extensive data on the product's safety, efficacy, and quality.
- Submission of Data: The applicant must submit data from clinical trials, manufacturing details, and pharmacological information to demonstrate the product's safety, efficacy, and quality. This information helps the MHRA evaluate whether the product meets the required standards for use as a medicine.
- Evaluation by the MHRA: The MHRA thoroughly reviews the submitted data and assesses the product's risk-benefit balance. This evaluation process can be time-consuming and may involve consultations with external experts or the submission of additional data by the applicant.
- Granting Marketing Authorisation: If the MHRA determines that the product meets the required safety, quality, and efficacy standards, it will grant a marketing authorisation. This authorisation allows the product to be legally marketed as a medicine in the UK, with the necessary legal requirements and controls in place.
- Post-Marketing Surveillance: After receiving marketing authorisation, the CBD medicinal product will be subject to post-marketing surveillance. This involves monitoring the product's safety and efficacy in real-world settings, reporting any adverse reactions, and conducting periodic safety update reports. If new safety concerns arise, the MHRA may take regulatory action, such as updating product information or revoking marketing authorisation.
Ensuring Safety and Quality Standards for CBD Products
The MHRA works diligently to ensure that CBD products meet the necessary safety and quality standards. This includes monitoring the market for unauthorised CBD products with medicinal claims and taking appropriate action when needed.
The agency also collaborates with other regulatory bodies, such as Trading Standards Service and the Advertising Standards Agency (ASA), to ensure CBD is responsibly marketed and advertised.
Impact of MHRA Regulations on the CBD Industry
The MHRA's regulations have had a significant impact on the CBD industry in the UK. By requiring companies to obtain marketing authorisation for CBD products classified as medicines, the agency has helped establish a clear framework for the safe and responsible marketing of these products.
This has increased consumer confidence in the quality and safety of CBD products available in the UK market. However, the stringent regulatory requirements may also present challenges for smaller companies with limited resources, potentially limiting the variety of products available to consumers.
Which CBD Product Types are Legal in the UK?
CBD products are legal, but the legality of each type largely depends on whether it meets legal exemptions, has FSA novel foods approval, and adheres to other relevant regulations, there are some small differences according to product type.
This section will explore the legal status of various CBD product types in the UK.
Is CBD Oil Legal?
Yes, CBD oils are legal in the UK as long as it meets specific requirements. The oil must be derived from an EU-approved industrial hemp strain, and be free from THC and other controlled substances. Additionally, CBD oil products must be registered as novel foods with the FSA, ensuring they meet safety and quality standards.
Are CBD Capsules Legal?
CBD capsules are legal in the UK, provided they meet the same requirements as CBD oils. They must be made from EU-approved industrial hemp strains, contain no controlled cannabinoids, and be registered as novel foods with the FSA. Compliance with these regulations ensures that CBD capsules can be legally sold and consumed in the UK.
Is CBD Flower Legal?
CBD flower is not legal in the UK, even if it is derived from EU-approved industrial hemp strains and contains no controlled cannabinoids. This is because the UK government considers CBD flowers to closely resemble the C. sativa L. plant, which is a controlled substance. As a result, the sale and possession of CBD flowers are prohibited under the Misuse of Drugs Act 1971.
Are CBD Gummies Legal?
CBD gummies are legal in the UK, as long as they adhere to the same regulations as other CBD products. They must be derived from EU-approved industrial hemp strains, contain no controlled cannabinoids, and be registered as novel foods with the FSA. By complying with these requirements, CBD gummies can be legally sold and consumed in the UK.
Is CBD Vape Juice Legal?
CBD vape juice is legal in the UK, provided it meets the necessary regulations. The vape juice must be derived from an EU-approved industrial hemp strain and contain no controlled cannabinoids.
However, unlike other CBD products, CBD e-liquids don't fall under the novel foods category, so it does not require FSA approval. Instead, CBD vape juice must comply with the regulations set forth by the Tobacco and Related Products Regulations 2016, ensuring that the product is safe for consumption.
Are CBD Topicals Legal?
CBD topicals, such as creams, balms, and lotions, are legal in the UK as long as they meet specific requirements. They must be made from EU-approved industrial hemp strains and contain no controlled cannabinoids.
While CBD topicals do not fall under the FSA's novel foods category, they are still subject to safety and quality regulations. These products must adhere to the Cosmetic Products Enforcement Regulations 2013, which ensure that cosmetics are safe for human use and properly labelled. By complying with these regulations, CBD topicals can be legally sold and used in the UK.
Navigating the CBD Market in the UK
The CBD market in the UK has experienced rapid growth in recent years, with an increasing number of people turning to CBD for its potential health benefits. However, navigating this market can be challenging due to the various legal requirements and regulations surrounding CBD in the country.
This section will explore how to identify legal and compliant CBD products, the importance of third-party lab testing, and how consumers can use CBD safely and responsibly:
Identifying Legal and Compliant CBD Products
In the UK, CBD is legal as long as it contains no controlled cannabinoids and is derived from approved industrial hemp, as per the Misuse of Drugs Act. This means that marijuana derivatives containing THC are not legal to purchase, use, or possess.
When shopping for CBD, it is essential to look for clear labelling that indicates the product's compliance with CBD law. This includes information about the product's cannabinoid content, its classification as a food supplement, and any necessary authorisations. By choosing products that meet these legal requirements, consumers can ensure they are purchasing safe and compliant CBD products.
The Importance of Third-Party Lab Testing
Third-party lab testing plays a crucial role in ensuring the safety and quality of CBD products. Independent laboratories conduct these tests, providing unbiased results that verify the product's contents, including the levels of cannabinoids like CBD and THC, as well as the presence of any contaminants such as pesticides, heavy metals, and microbial contaminants.
These tests are essential because they help guarantee that the CBD products consumers receive are accurately labelled, pure, and free from harmful substances. By choosing CBD that has undergone third-party lab testing, consumers can have confidence in the safety and efficacy of their products.
Educating Consumers on Safe and Responsible CBD Use
To use CBD safely and responsibly, it is essential for consumers to educate themselves about proper usage and potential interactions with other medications or supplements. Some tips for safe and responsible CBD use include:
1. Start with a low dose and gradually increase it as needed, paying close attention to how your body responds to CBD.
2. Consult with a healthcare professional before using CBD, especially if you are pregnant, breastfeeding, or taking any medications.
3. Choose a method of consumption that best suits your needs and preferences, such as sublingual administration (placing the oil under your tongue), oral ingestion (capsules or adding CBD oil to food or drink), or topical application (creams, balms, or gels).
4. Always purchase CBD products from reputable sources that provide clear labelling, comply with UK law, and have undergone third-party lab testing.
By following these guidelines, consumers can ensure they use CBD products safely and responsibly, maximising the potential benefits while minimising any risks associated with improper use or low-quality products.
In conclusion, the answer to the question, 'Is CBD legal in the UK?' is multifaceted, with many regulations governing its use and sale. However, despite this complex legal landscape, CBD products that adhere to the necessary guidelines, such as the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations 2001, and the Food Standards Agency's novel food regulations, are legal and available for purchase in the UK.
As the CBD market continues to evolve, consumers must educate themselves on the legal requirements and safety precautions associated with CBD use. By selecting products that are compliant with CBD UK law, have undergone third-party lab testing, and are used responsibly, consumers can make informed decisions about incorporating CBD into their daily routine.
As regulatory bodies like the FSA and MHRA continue to oversee the industry, ensuring the safety and quality of CBD products will remain a top priority to protect public health and consumer confidence.