In Switzerland, products containing hemp or Cannabis sativa L (cannabis), are regulated by a set of laws and regulations that are intertwined, complex and create a level of legal uncertainty that lawmakers have realised needs to be addressed. The main rules surrounding cannabis are regulated by the laws and regulations on narcotics, therapeutic products, health insurance, foodstuffs, chemicals, cosmetics, utility articles, tobacco substitutes, plant varieties and seeds.

To facilitate matters, this chapter will provide an overview of only the most important aspects of cannabis laws and regulations, and draw a distinction between:

• cannabis products containing a tetrahydrocannabinol (THC) content of above 1%, which are considered prohibited narcotics under the Federal Act on Narcotics and Psychotropic Substances (the “Narcotics Act”, NarcA); and
• products with a THC content below 1%, which have been popularised and aggregated into a somewhat untechnical jargon as “CBD products”, which stands for products containing cannabidiol, and which are not subject to the NarcA and so are more freely marketable.

Due to recent developments, also regarding the use of other cannabinoids (CBG, for example), the following statements, in so far as they relate exclusively to CBD, can in principle also be applied to other (non-psychotropic) cannabinoids. Both THC and CBD have garnered notoriety as the most prominent cannabinoids over recent years; however, research has shown that well over 140 cannabinoids, which are naturally occurring compounds found in the cannabis plant, can be identified (THC, THCV, CBD, CBG, CBT, CBN, CBL, CBE, etc).

Cannabis Products With THC of 1% and Above

The Narcotics Act, NarcA

The use of narcotics is primarily regulated by the NarcA. The implementation of the NarcA is today governed by four ordinances:

• on the control of narcotics (BetmKV);
• on the addiction to narcotics (BetmSV);
• the register of narcotics, psychotropic substances, precursors and auxiliary chemicals (BetmVV-EDI); and
• the Ordinance on Pilot Trials under the NarcA (BetmPV). 

The BetmKV governs the activities of the Swiss Agency for Therapeutic Products (Swissmedic) in the area of granting authorisations for the legally permitted handling of controlled substances and the associated controls, and is of importance for the industrial use of these substances.

The BetmSV regulates the measures for prevention, therapy and harm reduction as well as the exemptions for the restricted medical use of cannabis-containing medical products and the corresponding controls.

The BetmVV-EDI lists all controlled narcotics and psychotropic substances and determines to which control measures they are subjected.

Lastly, the BetmPV regulates the requirements for conducting scientific pilot trials with narcotics of the cannabis type in accordance with Article 8a NarcA.

Cannabis is classified as a prohibited narcotic if its THC content exceeds 1%, unless it is used for medical purposes. An amendment to the NarcA in force since 1 July 2011 provides for a restricted decriminalisation of the preparation of a negligible quantity of cannabis for one’s own consumption (10 g). Cannabis products with a THC content lower than 1%, on the other hand, can be legally produced and marketed.

Pursuant to the NarcA, the Federal Office of Public Health (FOPH) may issue exceptional licences for cultivating, importing, producing and placing on the market narcotics containing an effective concentration of cannabinoids, where this is not prohibited by an international agreement and these narcotics are needed for scientific research, for the development of medical products or for restricted medical use. The prescription for medical purposes of unauthorised cannabis-based medical products which contain a THC level of above 1% is permitted under certain circumstances. Such an exemption permit from the FOPH is required:

• to develop medical products with prohibited narcotics;
• to use prohibited narcotics for limited medical purposes; and
• to use an authorised medical product with prohibited narcotics for any purpose other than the approved indication.

However, according to the new legal situation, which came into effect on 1 August 2022, such exceptional authorisation from the FOPH is no longer required for cannabis with a THC content of 1% and above, if it is used for medical purposes. In other words, doctors are now free to prescribe cannabis to their patients as part of their regular treatment.

The long-sought relief of the recent medical cannabis reform is still considerably new and will be described in further detail in the adjacent Trends & Developments article.

Therapeutic products law

Legal basis

The regulations on the use of medical products and medical devices are mainly set forth in:

• the Federal Act on Medicinal Products and Medical Devices (the “Therapeutic Products Act”, TPA);
• the Ordinance on Pharmaceutical Products (VAM);
• the Ordinance on Advertising of Pharmaceutical Products (AWV);
• the Ordinance on the Approval of Medicinal Products (AMZV);
• the Medicinal Products Licensing Ordinance (MPLO); and
• the Medical Devices Ordinance (MedDO).

These laws and regulations apply to therapeutic products according to the TPA, including medical cannabis products.

Authorisation

Ready-to-use medical products may be placed on the market only if authorised by Swissmedic. The application for obtaining a market authorisation for medical cannabis products with indication must include, for example, detailed documentation on the results of physical, chemical, galenic and biological or microbiological tests, as well as the results of pharmacological and toxicological tests and clinical trials. The applicant must also prove that the medical products are of high quality, safe and effective and that the medical product in question does not pose a risk to the safety of consumers.

Only one ready-to-use medical product with a THC content above 1%, Sativex, is fully approved in Switzerland. Sativex can be prescribed without special permit for spastic convulsions in multiple sclerosis patients only (ie, its application is very limited in scope).

In the context of cannabis-based medicinal products, reference can also be made to Epidyolex, a ready-to-use medicinal product without THC but including cannabidiol. Epidyolex was approved by Swissmedic on 10 February 2021, and is used as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients two years of age and older.

The manufacture of medical products and pharmaceutical excipients whose manufacture requires a licence must conform to the recognised rules of Good Manufacturing Practice (GMP). The MPLO refers to the GMP guidelines of the EU (Annex 1). Thus, in Switzerland the EU’s GMP guidelines are applicable.

The GMP guidelines provide the minimum requirements that a manufacturer of medical products must meet to ensure that their products are consistently of sufficiently high quality for their intended use. This includes risk management, documentation, continuing improvement processes as well as internal and external audit requirements. Each manufacturer must determine and document in writing how it complies with and implements the GMP guidelines.

An audit must verify whether all the required boxes of the GMP standard were ticked and thus that the products meet the safety and quality standards. Swiss-domiciled companies with a valid establishment licence for the manufacture of medical products may apply to Swissmedic to obtain a GMP certificate through its eGov GMP-GDP online portal. 

Exemption from authorisation

The Therapeutic Products Act also provides for the market placement of medicinal products that are exempt from authorisation. These include medical cannabis products manufactured as an extemporaneous preparation (“magistral formula”) – that is, medicinal products prepared according to a doctor’s prescription by a public pharmacy or a hospital pharmacy for a given person or group of persons. The conditions for the use of medicinal products that are exempt from authorisation are restrictive. Such use is mainly considered in order to ensure supply if no authorised drug is available for this purpose. Due to these requirements, extemporaneous preparations can and may only be produced in small quantities. Their prior authorisation is impossible for time reasons, and also is not necessary, since the protection of public health is ensured by the fact that the prescribing physician and the pharmacist preparing the drug (or the manufacturer) have appropriate training and are controlled by the authorities.

As mentioned above, medical cannabis products as magistral formulas, produced by a pharmacy based on a medical prescription, no longer require exceptional authorisation from the FOPH under the NarcA. The same applies to an approved drug containing cannabis (eg, Sativex) that is dispensed “off-label” for an indication other than the one for which it has been approved.

Health insurance law

The reimbursement of costs for medicinal products by the compulsory health insurance (OKP) generally requires that the medicinal product is included in the list of specialties (SL) of the FOPH. To be included in that list, the medicinal product requires both a licence from Swissmedic and proof of its efficacy, usefulness and cost-effectiveness (WZW).

In Switzerland, it is considered that there is limited evidence for the efficacy of cannabis in the treatment of chronic pain, nausea in chemotherapy and spasms in multiple sclerosis, etc. Accordingly, no medicinal product, not even Sativex, is on the FOPH’s list of specialties for reimbursement by the compulsory health insurance.

Only in cases of hardship, and upon request for a cost approval by a physician, is reimbursement by the OKP of a medicinal product not listed in the SL possible. It is considered a case of hardship if the use of the product is expected to provide a major therapeutic benefit against a disease that may be fatal for the insured person or result in severe and chronic health impairments, and no other effective and approved treatment method is available due to a lack of therapeutic alternatives. Unfortunately, the medical cannabis reform did not provide relief in terms of reimbursement by the OKP, and no adjustments were made to the reimbursement requirements.

A Health Technology Assessment (HTA) report published on 30 April 2021, on behalf of the FOPH, was prepared to clarify the scientific evidence regarding the efficacy and cost-effectiveness of medical cannabis products and to differentiate between the various patient groups. The HTA ultimately decided that the efficacy data on medical cannabis use for chronic pain and spasticity was inconsistent (ie, studies with comparable patient populations and similar types of medical cannabis did not show consistent results pointing in the same direction) and inconclusive (ie, none of the studies was able to draw a definitive conclusion on the efficacy of medical cannabis). As a result, the WZW criteria for medical cannabis have not been confirmed.

Cannabis Products With a THC Content Below 1%

Cannabis products with a THC content below 1% are not captured by the scope of the NarcA. Of all the known cannabinoids in the cannabis plant, CBD stands out as the most prominently marketed cannabinoid in the cannabis market. On 19 December 2022, Swissmedic, the FOPH, the Federal Food Safety and Veterinary Office (FSVO) and the Federal Office for Agriculture (FOAG) jointly released an updated version of “Products containing cannabidiol (CBD): Overview and implementation guide”, the main elements of which are set out below. 

CBD products can only be marketed legally if they comply with the Swiss legislation that is applicable to their respective classification. The range of CBD-containing products is extensive and includes raw materials such as cannabis buds or flowers with a high CBD content, extracts in the form of oils or pastes, ready-to-use products such as capsules, food supplements, liquids for e-cigarettes, tobacco substitutes, scented oils, chewing gums and ointments, some of which are offered as personal care products.

In order to determine the applicable legislation, the product must be assigned to the corresponding product category based on the relevant factors such as composition, intended use and dosage. 

As an initial step, however, it must be determined whether the CBD product is a raw material or ready-to-use product. CBD products considered as raw materials are governed by the Chemicals Act and the Chemicals Ordinance. If no intended use can be determined for a cannabis-based raw material, it should be placed on the market in accordance with the legislation governing chemicals. Lastly, the Federal Act on Product Safety (PrSG) acts as a fallback catch-all legislation for products for which there is no other specific applicable law. 

CBD offered as chemicals

CBD-containing products may be marketed legally as scented oils. Manufacturers must classify, package and label the product in accordance with the provisions of the Chemicals Ordinance (ChemO) after having assessed that substances or preparations they intend to place in the market do not endanger human life, health or the environment.

However, if the presentation of the products indicates, or suggests, other uses that are covered by other legal provisions, their marketability must be assessed according to these provisions. This may be the case, for example, where a “scented oil” is sold in a cartridge for e-cigarettes, in which case foodstuffs/utility articles legislation applies for the assessment of marketability. The same would apply, for example, where cannabis oils containing full spectrum hemp extracts would be labelled as having a specific nutritional value.

The requirements of the general ruling issued by the Swiss Chemicals Notification Authority on 24 March 2022 must also be taken into account. According to this general ruling, CBD-containing scented oils (ie, ready-to-use products) may only be placed on the market or sold to consumers if they contain a denaturant in a suitable concentration to prevent misuse (ie, oral application).

CBD sold as medicinal products

Ready-to-use CBD-containing products with a medical intended use are regarded as medicinal products under the TPA, which require authorisation by Swissmedic to be placed on the market. Companies that manufacture, distribute or dispense medicinal products containing CBD always require a corresponding authorisation from Swissmedic or the respective canton.

Epidiolex, a ready-to-use CBD monopreparation prescribed for the adjuvant treatment of two rare forms of epilepsy, was approved by the United States Federal Drug Administration (FDA) on 28 June 2018. This was the first time a ready-to-use CBD medicinal product was approved anywhere in the world. Recently, on 10 February 2021, the same preparation was approved in Switzerland under the name of Epidyolex.

Pharmacies can also prepare and dispense CBD-containing medicinal products as extemporaneous preparations (ie, as a magistral formula), based on a prescription of a specialised physician in Lennox-Gastaut syndrome and Dravet syndrome or other treatment-resistant forms of epilepsy. The medicinal product must be prepared with CBD that has been produced in compliance with GMP to a quality standard that, as a minimum, satisfies the requirements of monograph C-052 on cannabidiol of the current German Drug Codex DAC/NRF, and the preparation itself at the pharmacy level must comply with the GMP requirements of the current Pharmacopoea Helvetica (Ph Helv). Furthermore, the position papers of the Association of Cantonal Pharmacists regarding “Cannabis medicinal products” and “Formula medicinal products, manufacture and placing on the market” should be consulted in the current versions.

CBD sold as cosmetics

According to the Ordinance on Foodstuffs and Consumer Products (LGV), cosmetic products are broadly defined as “substances or preparations intended to come into external contact with certain parts of the human body, such as the skin, the hair system, the nails, the lips or external intimate regions, or with the teeth and the mucous membranes of the oral cavity, for the sole or predominant purpose of cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or influencing body odour” (unofficial translation).

Cosmetic products must be safe, and the safety of the individual ingredients must be documented in a safety report. References of any kind to disease-curing, disease-soothing or disease-preventing effects of cosmetics (eg, medicinal or therapeutic properties) are prohibited.

CBD has gained widespread popularity as an ingredient in cosmetic products in recent years (skin care oil, skin cream, lip care oil, mouthwash, toothpaste, bath capsules, mouth spray, dental gum, etc). The use of synthetic CBD is not specifically regulated and can be used in the formulation of cosmetic products if the requirements set forth in the LGV are met.

Regarding the use of naturally derived CBD in cosmetics – ie, CBD derived from the cannabis plant – the Implementation Guide provides as follows.

Article 54 (1) LGV refers to the list of substances prohibited in cosmetic products in Annex II of Regulation (EC) No 1223/2009 on Cosmetic Products, Entry No 306, which reads: “Narcotics, natural and synthetic: All substances listed in Tables I and II of the single Convention on narcotic drugs signed in New York on 30 March 1961”.

Schedule I of the signed Single Convention on Narcotic Drugs of 1961 (the “Single Convention”) lists cannabis, cannabis resin, cannabis extracts and cannabis tinctures. According to the definition in Article 1 of the Single Convention, “cannabis” means “the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated”. “Cannabis resin” is further defined in the Single Convention as “the separated resin, whether crude or purified, obtained from the cannabis plant”.

The Implementation Guide goes on to conclude that, therefore, the use of “cannabis” (buds and fruiting tops from which the resin has not been extracted) and products prepared from them (eg, hemp extracts, CBD) are prohibited in cosmetic products. Cannabis resin obtained from any part of the cannabis plant may also not be used to introduce CBD into cosmetics. Seeds and leaves not accompanied by the flowering or fruiting tops, however, may be used to produce cosmetics.

On 19 November 2020, the European Court of Justice (ECJ) concluded in its judgment C-663-/18 (the Kanavape case) that CBD extracted from the fruiting or flowering tops of the cannabis plant, and not only from the seeds and leaves, “is not a drug within the meaning of the Single Convention”. The ECJ clarified that “since CBD does not contain a psychoactive ingredient in the current state of scientific knowledge […] it would be contrary to the purpose and general spirit of the Single Convention to include it under the definition of ‘drugs’ within the meaning of that convention as a cannabis extract”. It is to be expected that a similar/analogous decision will also be made by the Federal Supreme Court of Switzerland in the near future.

Cosmetic ingredients have an international designation, an INCI (International Nomenclature for Cosmetic Ingredients) term. Each ingredient is also listed in the Central European Register of Cosmetic Ingredients (CosIng) either with or without restriction. Following the publication of the decision in the Kanavape case and upon request of the European Industrial Hemp Association (EIHA) to lift the existing restriction on the use of cannabis extracts in cosmetic products, the European Commission has lifted the restriction on CBD and has revised the entry as follows: “Cannabidiol – derived from extract or tincture or resin of cannabis”. It did the same for cannabigerol, or CBG, which is another known minor constituent of cannabis. While the CosIng database is not legally binding, the listing of ingredients is regarded by authorities and courts in the EU member states as a strong indication of their legality in cosmetic products.

Most importantly, however, on 1 August 2022, a long-awaited amendment to the BetmVV-EDI corrected a persistent legislative redactional error which classified cannabis resin as a prohibited narcotic independent of its THC content. Today, cannabis resin is only considered a prohibited narcotic if its THC content exceeds the 1% threshold, which finally levels the playing field with all other cannabis preparations such as cannabis oils, extracts and tinctures. Against this backdrop, prohibiting cannabis resin in the preparations of cosmetic products is in violation of Swiss law. Besides,  in view of a harmonisation with recent practice in the EU, as well as of the ECJ’s conclusion that “it would be contrary to the purpose and general spirit of the Single Convention to include CBD under the definition of ‘drugs’ within the meaning of that convention as a cannabis extract”, it would be desirable and, in the authors’ view, in line with current legislation, to adapt the described practice in the Implementation Guide to the effect that CBD derived from cannabis extracts from the flowering and fruiting tops should also be allowed in cosmetic products.

Lastly, current developments in the enforcement practice of various cantons regarding CBD cosmetics are encouraging. CBD cosmetics have, by now, become more established and the discussion regarding the demarcation of cosmetics versus foodstuff, provided the cosmetic product in question is correctly labelled and advertised, has waned. CBD oils with a CBD content of up to 12% sold as cosmetic skin care oils and proper documentation (including a product information file containing toxicological data) have further been accepted by various cantonal enforcement agencies.

CBD sold as utility articles

CBD-containing liquids for e-cigarettes are classified as utility articles that come into contact with mucous membranes under the Federal Act on Foodstuffs and Utility Articles (the “Foodstuffs Act”, FSA) as well as the LGV, and may be sold unless they release substances in quantities that pose a risk to health. It is further not permitted, in principle, to add CBD to liquids for e-cigarettes in pharmacologically effective doses.

However, this rule is superseded by the requirements of the Cassis De Dijon principle, according to which CBD-containing liquids may be sold in Switzerland if they have been lawfully placed on the market in an EEA or EU state. In addition, since the regulations on technical barriers to trade aim to prevent discrimination against domestic suppliers compared to internationally operating suppliers, CBD-containing liquids may currently be lawfully marketed in Switzerland (and, at the latest, after the new Tobacco Products Act enters into force in 2024).

Refill containers for e-cigarettes containing CBD are subject to the provisions of chemicals legislation. Distributors must carry out self-regulation and implement labelling and reporting obligations (product registration for chemicals).

On a side note, it may be added that paraphernalia and smoking accessories such as bongs, vaporisers and grinders (without CBD) may be sold without restriction if they comply with the FSA, the LGV and the PrSG.

CBD sold as tobacco substitutes

Hemp with a total THC content of less than 1% does not fall under the NarcA and can be sold as a tobacco substitute for smoking. Tobacco substitutes are a part of Swiss food legislation and are subject to the Tobacco Ordinance (TabV), independent of the Swiss Federal Tribunal’s decision that hemp containing CBD is not considered a tobacco substitute according to the Tobacco Tax Act (TStG).

Therefore, it is lawful to sell tobacco substitutes containing CBD or other cannabinoids as dried flower, buds, or as cigarettes/cigars, for example. However, existing food legislation must be observed, which includes the obligation to self-regulate and to notify the FOPH before placing products on the market.

According to the TabV, tobacco substitutes must satisfy the prerequisites applicable to the smoked tobacco products they replace (eg, herbal cigarette packaging must contain photographic warnings). The substitutes must not pose a direct or unexpected threat to health.

In 2024, the new Tobacco Products Act (TobPA) will enter into force. Under the TobPA, all tobacco-based and similar products (ie, with a similar purpose) will therefore be regulated under the TobPA, and Swiss food law (according to the LMG, LGV, etc) will no longer apply to such products.

CBD sold as foodstuffs

The use of non-controlled cannabinoids in foodstuffs will be discussed in 3.2 Use of Non-controlled Cannabinoids in Food, which also includes some comments on the consumption of THC.

Reform of Switzerland’s hemp seed legislation

As of 1 January 2021, all provisions of the seed legislation relating to the production and sale of hemp seed and seedlings, which includes cannabis with a THC content of below 1%, were repealed. Previously, only approved varieties of hemp grown for oil and fibre that were listed in the Federal Office of Agriculture’s (FOAG) varieties ordinance or the EU’s Common Catalogue of Varieties, which is still in force, could be placed on the market for commercial use in agriculture. This is a significant competitive advantage for Switzerland as an innovation hub for the development of hemp seeds and varieties compared to the EU.

For the agricultural production of hemp, the provisions of plant health legislation and direct payments legislation must be respected; for the use of hemp as animal feed, the provisions of the Animal Feed Law must be observed.

Switzerland is a federal state, which means that powers are divided between the Confederation, the cantons, and the communes, according to the principle of subsidiarity. The Confederation, in principle, only undertakes tasks that the cantons are unable to perform, or which are expressly allocated to the Confederation by the Federal Constitution.

As discussed in 1.1 Source of Regulations, regulations affecting the cannabis market span a very wide spectrum of the law. It would go beyond the scope of this guide to describe the authorities responsible for enforcement on both a federal and cantonal level for each area of law. However, a short overview will be provided of the enforcement authorities in the laws related to narcotics, therapeutic products, foodstuffs and utility articles (which include cosmetics) and chemicals. 

Enforcement of the NarcA

As a result of Switzerland’s federal political system, the cantonal law enforcement agencies (ie, the public prosecutor’s office) are principally charged with enforcing the NarcA, with the help of the police.

The clear statement of the law that the enforcement of the NarcA lies within the competence of the cantonal law enforcement agencies was relativised by the fact that it had always been assumed that the narcotics sector was subject to special supervision by the Confederation. Consequently, the Office of the Attorney General of Switzerland could, under certain circumstances, order investigations itself if the criminal acts were committed in whole or in part abroad or in several cantons. This competence continues to exist. Thus, there is a parallel investigative competence of the Confederation in this area.

The Confederation exercises oversight over the implementation of the NarcA. It conducts controls at the border (importation, transit and exportation) and in customs warehouses and bonded warehouses. The Confederation and the cantons work together to fulfil their tasks under the NarcA and co-ordinate their work; they may call on the assistance of other organisations concerned.

Non-compliance with the NarcA is a criminal offence. Under the NarcA, any person who without authorisation (among others) cultivates, produces, stores, sends, transports, imports, exports or carries in transit narcotic substances, or possesses, keeps, buys, acquires or otherwise obtains narcotic substances is liable to a custodial sentence not exceeding three years or to a monetary penalty.

As mentioned in 1.1 Source of Regulations, medicinal cannabis products with a THC content of 1% and above may be prescribed with a special authorisation by the FOPH, which develops Switzerland’s health policy and works to ensure that the country has an efficient and affordable healthcare system in the long term.

Enforcement of the TPA

Swissmedic is responsible for the duties assigned to it by the TPA. It is involved in the entire life cycle of a medicinal product through its duties in the areas of authorisation, approval and monitoring of medicinal products. Swissmedic is run by the Confederation with the co-operation of the cantons, as an institution under public law with its own legal personality.

It is important to note that Swissmedic’s areas of responsibility are closely related to those of other authorities or implementing bodies; for example, regarding the delimitation between medicinal products and cosmetics or between medicinal products and foods, where the FOPH and the Federal Food Safety and Veterinary Office (FSVO) are involved – all areas relevant for the emerging cannabis market.

Furthermore, Swissmedic has, among others, the competence to authorise ready-to-use medicinal cannabis products and to grant a licence for imports of therapeutic products (including medicinal cannabis) if the applicant complies with the requirements of the Medicinal Products Licensing Ordinance.

In simplified terms and on a cantonal level, the Cantonal Office for the Control of Therapeutic Products (Kantonale Heilmittelbehörde) in Zurich, for instance, is divided into three operative units: the inspectorate, the laboratory and the administration. The Kantonale Heilmittelbehörde in Zurich is responsible for:

• the control of the production, wholesale trading and dispensing of therapeutic products;
• the market surveillance of therapeutic products (which includes marketability reviews and conformity tests in accordance with recognised pharmacopeias);
• the granting of cantonal licences for the dispensing of medicinal products (pharmacies, drugstores, etc);
• the issuance of professional and narcotic licences; and
• other tasks.

The cantonal pharmacy is mandated to secure a high quality and economical supply of therapeutic products to hospitals, a wide range of institutes and the general population. In the Canton of Zurich, the cantonal pharmacy is also responsible for the production of a wide range of pharmaceutical products. Other cantons have similar structures.

In terms of enforcement, non-compliance with the TPA may lead to a series of administrative (including disciplinary) and penal actions on both the federal and cantonal level.

Enforcement of the FSA

According to the LGV, business operators who manufacture, process, treat, distribute, import or export food, food additives or utility articles must exercise self-control and designate a responsible person who appropriately documents compliance with the requirements of the FSA/LGV. This includes the obligation to secure good manufacturing procedures, the implementation of quality management systems and the obligation to withdraw or recall unsafe food, if applicable.

On their website, the Swiss Association of Cantonal Chemists (ACCS) has published a useful list of local law enforcement authorities for food and utility articles in Switzerland. In Zurich, for example, the Cantonal Laboratory is responsible for the implementation of food safety regulation, including the control of reporting and permitting obligations, as well as the implementation of special protective regulations of non-food or utility articles such as cosmetics.

Authorities charged with the implementation of the FSA and its many ordinances have a wide range of administrative measures they can impose on non-compliant market participants.

While there are numerous organisations that act as self-regulatory bodies to the cannabis industry in Switzerland, three groups stand out in particular.

Interest Group Hemp (IG Hanf)

Interest Group Hemp (IG Hanf) is an association representing the Swiss hemp industry and its members in politics, before authorities and in public. It is by far the largest interest group of market participants in the cannabis industry in the country. The association’s goal is to promote exchange and co-operation among its members and thus strengthen the hemp industry in Switzerland. Its mission is to establish cannabis in society in a sustainable manner and to create a regulated cannabis market in order to ensure that Switzerland plays a leading role in the global cannabis industry.

To secure quality control among its members, IG Hanf established the quality label “Swiss Certified Cannabis”. The label guarantees products and consumer safety, and determines quality standards (in accordance with ISO 9001). Specifically, the goals of the label as stipulated in the guidelines of Swiss Certified Cannabis are:

• to guarantee absolute traceability throughout the production chain;
• to ensure highest security for consumers and customers;
• to build trust with consumers, customers and authorities; and
• to protect against economic damage or loss of reputation.

The Swiss Certified Cannabis label can only be used by certified companies. The application process includes:

• training by a qualified auditor;
• a certification audit on site by an independent and qualified auditor; and
• a decision on the granting of the certificate based on the audit report by the board of directors of IG Hanf.

The guidelines of Swiss Certified Cannabis set standards on quality policy, production, packaging, storage, safety, control, work safety and hygiene, labour, environment and infrastructure.

The Swiss Society of Cannabis in Medicine

The Swiss Society of Cannabis in Medicine’s (SGCM-SSCM) goal is to promote the acceptance of cannabis as a therapeutic product, its legal regulation, as well as its clinical implementation in close co-operation with the FOPH. As an umbrella organisation for professionals from medicine, pharmacy, pharmacology, research and industry, its declared goal is to foster the scientific, rational and destigmatised use of medicinal cannabis as well as simplified, unbureaucratic access to therapies with medicinal cannabis.

Its task is to serve as the Swiss interdisciplinary knowledge and information platform for the medical use of cannabis and cannabinoids and as a networking platform for a wide range of professionals, care-givers, interest groups, etc. The organisation further promotes basic and clinical research and collects valuable data, based on which it elaborates medical recommendations for the most relevant treatment principles. SGCM-SSCM is the Swiss ambassador of the IACM (International Association for Cannabinoid Medicines).

Medcan

Medcan advocates for the interests of patients in Switzerland who take cannabis as a medicine, and provides information on the use and effects of the medicinal plant. The association pursues the goal of ensuring that patients in Switzerland have legal access to cannabis without a great deal of bureaucracy and can use it medically in tested quality and at reasonable prices. Moreover, it demands from the FOPH the further education of physicians regarding possible indications and dosages and the minimisation of the bureaucratic effort involved for obtaining medicinal cannabis. Medcan advocates on a political and on a public level for people who use cannabis for medical purposes.

The cannabis market faces tremendous challenges such as inconsistent cannabis and cannabinoids terminology, significant differences in enforcement between cantons and a constantly changing regulatory environment.

The most obvious challenge market participants face is that cannabis is considered a narcotic drug if the THC content exceeds 1%. Consequently, all efforts by market participants to legally bring products to market are biased by the default assumption that cannabis is an illicit drug. This negative bias leads to heightened scrutiny by enforcement agencies and is not particularly conducive to the success of an emerging new industry.

Some of the most challenging aspects of the cannabis market come to the surface where various areas of the law overlap. The development of a new product can be very challenging when it is unclear, for example, whether it is governed by therapeutics or cosmetics law. A chewing gum containing CBD could be many things – for example, a therapeutic product, a cosmetic product or a foodstuff. Defining the product category and abiding by all regulatory requirements while considering pertinent case law can only be managed with a detailed technical and legal assessment.

Reference can be made to two very useful guides that can help, to some extent, to navigate these complexities:

• the guide on “Demarcation criteria therapeutic products – foodstuffs with regard to products to be taken orally”, published jointly by Swissmedic and the FSVO; and
• the guide on “Criteria for the demarcation of cosmetic products from therapeutic products and biocidal products”, jointly issued by Swissmedic, the FOPH and the FSVO.

Another main challenge in the CBD market is the classification of cannabis extracts or tinctures (CBD oils). They can be qualified as raw materials or as ready-to-use products. While in practice, a lot of consumers ingest CBD oils, such oils cannot be marketed as foodstuff or nutritional supplements without authorisation of their components as novel food by the FSVO or the European Commission (EC). No company in Switzerland, or in the EU, has obtained such authorisation to date. Meanwhile, CBD oils have gained wide popularity as cosmetic skin care or as oral care (mouth spray) products.

Further challenges for participants in the medical cannabis industry are described in the accompanying Trends & Developments article.

The above examples of key challenges do not touch on the many complexities surrounding international trade of medicinal and recreational cannabis products, and on the whole range of other issues and uncertainties that participants in the cannabis market must deal with.

Cannabis-specific regulations in Switzerland are, with few exceptions, limited to narcotics and criminal law. Legal uncertainty is still prevalent in production, trade and consumption of cannabis products of all kinds (cosmetics, foodstuffs, medicines, recreational use), as is inconsistent cantonal enforcement.

In other jurisdictions – such as in many US states where medical and recreational cannabis has been legalised – the cannabis market is meticulously regulated. Other countries are following suit with various regulatory models (eg, Canada, Uruguay).

Considering these developments, a revision of Switzerland’s approach to cannabis regulation appears warranted, as was proposed in a postulate submitted to the Council of States on 18 March 2021 by Thomas Minder, a member of the Council of States. Specific cannabis-related legislation could bring legal certainty throughout the value chain and secure efficient quality control measures. An allocated taxation of cannabis products could generate state revenues and secure the financing of already necessary prevention and health measures, particularly for the protection of youth.

At the same time, cannabis legislation concerning THC limits in Switzerland is considered rather progressive if compared to the EU and the USA, where the threshold from legal cannabis (or hemp in the USA) to a narcotic drug (which in some US states is legalised) is passed when the THC levels surpass 0.2% or 0.3%, respectively. Also, the Ordinance on the Maximum Levels of Contaminants (VHK) allows for significantly higher values of THC intake from food than the THC values in the EU. Switzerland has further repealed all provisions of the seed legislation relating to the production and sale of hemp seed and seedlings and is no longer bound by the EU’s Common Catalogue of Varieties. 

In view of the latest developments in legislative reform of the NarcA regarding medicinal cannabis, as well as cannabis trials for recreational purposes, Switzerland is well positioned to further expand its regulatory edge in the emerging European cannabis industry. 

Companies and individuals in the cannabis market must navigate a complex web of interrelated, constantly changing areas of law. Non-compliance with existing laws and regulations may lead to indictments for criminal offences, to administrative penalties and potentially to civil damage claims.

Recent enforcement measures by authorities included, for example, the shutdown of a retailer’s website for publishing health claims in connection with CBD products, and the imposition of a marketing ban for specific CBD oils.

However, special attention must be paid to compliance with the NarcA. Cannabis resin is illegal, independent of its THC content. Furthermore, cannabis products with a total THC content below 1% must meet the specific requirements of the Therapeutic Products Act, the Foodstuffs Act, the Ordinance on Foodstuffs and Utility Articles, the Chemicals Ordinance and the Tobacco Ordinance, among others, depending on the classification of the product placed on the market. It should be noted that, in addition to the NarcA, other acts such as the TPA also provide for penal provisions.

Please refer to 1.4 Key Challenges.

In Switzerland, only cannabis with a THC content below 1% can be exported. The cannabis legislation of the importing country must therefore be complied with. Generally, in the EU, cannabis-products with a THC content of 0.2% and above are considered narcotic drugs and thus cannot be imported, except for medical purposes with a special permit from local authorities.

A revision of the NarcA, which was adopted on 19 March 2021, will allow for exports of medical cannabis with a THC content of 1% and above. It is estimated that the revised law will be enacted in the autumn of 2022. Further details can be found in the accompanying Trends & Developments article.

Importers of cannabis products with a THC content of 1% and below must be able to provide proof in the form of a batch-specific analytical certificate for the delivery in question issued by a laboratory accredited to ISO/IEC 17025 or by a GMP laboratory.

The main elements affecting medical cannabis in Switzerland are described in the accompanying Trends and Developments article, along with an overview of impending changes to the current regulatory framework.

The FSA sets forth the rules on the safety and transparency of foodstuffs and utility articles. According to the FSA, foodstuffs are all substances or products that are intended (or may reasonably be expected) to be consumed by human beings in a processed, partly processed or unprocessed state. Medical products, narcotics and psychotropic substances do not fall under the definition of foodstuffs, or vice versa.

Except for a few reservations (eg, novel foods), non-described foods without an authorisation can be placed on the market, provided they meet all the requirements of food law.

Under certain circumstances (described below), cannabis products may also be used in foodstuffs. The main principle in foodstuffs law is that foodstuffs must be safe – in other words, they must neither be harmful to health nor unsuitable for human consumption.

Novel Foods

For foodstuffs that have not been used for human consumption to any significant extent, either in Switzerland or in an EU member state before 15 May 1997 – so-called novel foods – an authorisation by the Federal FSVO or an approval by the European Commission (EC) is required. This applies to extracts of Cannabis sativa L that contain cannabinoids such as cannabidiol (CBD) and food products enriched with extracts of Cannabis sativa L or with cannabinoids such as CBD (eg, hemp seed oil with added CBD, food supplements with CBD), which are classified as novel foods and therefore require an authorisation.

Products of Cannabis sativa L or parts of plants that had a safe and documented significant use as food in the EU before 15 May 1997 are not considered novel foods in Switzerland, provided they originate from an approved plant of Cannabis sativa L. This is particularly the case for hemp seeds, hemp seed oil, hemp seed flour and defatted hemp seeds.

Furthermore, in Switzerland, herbal tea made from leaves of the hemp plant Cannabis sativa L is also not considered a novel food. However, the production, importation or market placement of herbal teas obtained from the herb of the cannabis plant is possible if one furnishes proof that the herbal tea was already consumed as a foodstuff to a significant degree prior to 15 May 1997, and is therefore not classified as a novel food. Novel foods that do not require an authorisation are listed in the FDHA Ordinance on Novel Foods.

Authorisation

As part of the authorisation procedure for novel foods, the FSVO examines whether the product is safe and not deceptive. The basic prerequisite for approval is that the product is classified as a foodstuff and is not covered by the legislation on medicinal products. In the case of foodstuffs containing cannabis, the Ordinance on the Maximum Levels of Contaminants (VHK) is relevant. It regulates the maximum permissible levels of delta-9-tetrahydrocannabinol in foodstuffs (which are generally higher than in the EU).

It is important to note that all foods which, in accordance with the Novel Food Regulations (EC) No 258/97 and (EU) 2015/2283, may be placed on the market in the EU are fundamentally also marketable in Switzerland (except for genetically modified foods). Placing foodstuff with CBD on the European market presupposes the application for authorisation to the European Commission. If the application is granted, foodstuff containing CBD can be also placed on the Swiss market. Hence, the authorisation from the European Commission entails the advantage that the foodstuff can be placed on both the European and the Swiss markets. However, the reverse situation does not apply. Foodstuffs that are not novel foods in Switzerland or that have been authorised as such in Switzerland and are classified as a novel food in the EU require an authorisation from the European Commission for market placement in the EU.

Lastly, authorisations are generally not issued for composite foods. The authorisation requirement always relates to a substance, not to a composite product containing a novel food as an ingredient.

The EIHA Consortium

The European Industrial Hemp Association (EIHA) is Europe’s largest association representing the common interests of hemp farmers, producers, and traders working with hemp fibres, shives, seeds, leaves and cannabinoids.

In 2019, EIHA created a Novel Food Consortium with the aim of submitting a joint novel food application both to the UK Food Safety Authority for the British market and to the European Food Safety Authority (EFSA) for the EU market (which, as mentioned above, would include Switzerland), the costs of which will be shared among its members. It is estimated that the consortium will invest up to EUR3.5 million for financing all relevant and unprecedented toxicological studies on CBD and THC with the help of a qualified service provider (ChemSafe).

A whole range of cannabinoid-containing ingredients will be tested to ensure all food products using these ingredients will be covered by the joint application. For the purpose of the application, a corporation under German law was founded (EIHA projects GmbH), which collects the special contributions to finance the project and ultimately acquires the rights for the distribution of the approved products. EIHA projects GmbH will manage these rights and transfer them to EIHA members, with an established sublicensing system for white label (retail) trading companies. 

Swiss companies aspiring to develop and bring cannabis-based food products to market are advised to evaluate a participation in the EIHA Consortium.

The latest developments regarding a potential legalisation of cannabis use for recreational purposes can be found in the adjacent Trends and Developments article.