According to the current regulatory set-up in Switzerland, it is permissible to sell and purchase cannabis products, as long as the THC level remains below 1%. As a consequence, the industry currently shows a specific interest in CBD products, i.e. cannabis products containing a low THC, but high cannabidiol level. The regulatory framework applicable to CBD products has to be determined by allocating the relevant products either to a specific product category, such as medical products, ingestible products, utility products (incl. cosmetics) or tobacco products (incl. tobacco substitutes), or to a catch-all group of non-categorised products.
Regulatory framework for CBD products
Products of chemical or biological origin intended to have or presented as having a medicinal effect on the human organism are considered medical products in the sense of the Federal Act on Medical Products and Medical Devices. The manufacturing of medical products, as well as the import, export, trade from Switzerland without the products entering Switzerland, including acts from Switzerland as a broker or agent for medical products, are subject to a governmental authorisation. Furthermore, medical products may only be distributed by a specific group of institutions and persons (e.g. apothecaries, specifically educated experts).
CBD products that are intended or can reasonably be foreseen to be ingested by humans, e.g. hemp tea, hemp seed oil, CBD chewing gums or CBD beverages, are generally subject to the Federal Nutrition and Utility Products Act. Such products need to be safe. Authorisations by the Federal Food Safety and Veterinary Office FSVO (Bundesamt für Lebensmittelsicherheit und Veterinärwesen, BLV) are required for certain ingestible products, in particular products that qualify as novel food. The definition of this term refers to the Novel Food Catalogue of the European Commission, which lists products that were not commonly consumed by humans in Switzerland or an EU member state prior to 15 May 1997. Cannabis extracts and derived products containing cannabinoids (incl. CBD) are considered novel food. Products made from the Cannabis sativa seeds, i.e. hemp seeds, seed oil, hemp seed flour and defatted seeds, on the other hand, do not qualify as novel food and can be sold without an authorisation.
Even if no authorisation is required, institutions processing and distributing ingestible products need to...