Kratom Becomes a Regulated Psychomodulatory Substance – Products Can Be Sold Only Under Licence
The Government published a new regulation designating kratom as a regulated psychomodulatory substance. This marks the start of a new regulatory system that enables legal and controlled sales exclusively through licensed retail stores and e-shops. The regulation takes effect on 12 November 2025, following the publication of the Decree on Psychomodulatory Substances in the Collection of Laws on 7 November 2025.
11 November 2025 - The Government published a new regulation today in the Collection of Laws designating kratom as a regulated psychomodulatory substance. This marks the start of a new regulatory system that enables legal and controlled sales exclusively through licensed retail stores and e-shops. The regulation takes effect on 12 November 2025, following the publication of the Decree on Psychomodulatory Substances in the Collection of Laws on 7 November 2025.
“Including kratom among psychomodulatory substances is an important step towards ensuring controlled handling of this product — meaning, above all, that it will no longer be available to children and adolescents. It is now crucial for the state to focus its oversight on illegal sales channels while protecting those entrepreneurs who have invested in licences and adapted to the new rules,” said Jindřich Vobořil, Chair of the Board of the Institute for Rational Drug Policies. “This strict regulatory model could serve as a blueprint for other low-risk substances. Of course, the key to success lies in the state’s active enforcement of compliance with the law.”
Starting 12 November 2025, the sale of kratom alongside food products, such as in convenience stores, vending machines and all unlicensed outlets, will be prohibited. Sales will be allowed only in specialised shops and licensed online stores holding valid permits from the Ministry of Health. A list of licensed vendors is available on the Ministry’s website to provide both traders and consumers with a clear overview of authorised points of sale.
“We recommend that the Government focus its enforcement efforts primarily on illegal distribution channels, such as corner shops, vending machines and unlicensed distributors. In turn, responsible operators who have invested in licences and complied with new legal requirements should be guaranteed a predictable and supportive regulatory environment, free from unnecessary administrative or inspection burdens,” said Tomáš Prouza, Vice President of the Czech Chamber of Commerce.
Those most responsible businesses have already applied for and paid the licence fees, even though it is merely two months before the end of the year. In January 2026, the licences will need to be renewed and the fees covered, as the new licensing period begins with the start of the calendar year.
“It is excellent that this new legislation is entering into force, unique in Europe and a potential model for other countries. From a public health perspective, it significantly improves safety and addresses systemic issues that cannot be solved through repression alone,” said Jan Farkač, Chair of the Board of the Institute for European Legislation (ÚPEL). “A regulatory framework is inevitably more complex and demanding than a simple ban, requiring cooperation between public administration, the expert community and the business sector. Next year will be decisive for the success, legitimacy and long-term sustainability of the regulation. Our institute stands ready to actively participate in the next steps.” The Institute for European Legislation represents both the professional community and businesses operating in the market.
The new regulation introduces not only market control but also a transparent risk-assessment process for psychomodulatory substances, strengthened support for addiction and health services, and a sustainable financial model to ensure the stability of the system. The financial framework is designed to be long-term, fair and resistant to market distortions, using excise tax as the main regulatory instrument, with licensing serving as an entry and monitoring mechanism.
Successful implementation will depend on consistent enforcement, especially monitoring for illegal sales outside the licensing framework and enforcing the ban on sales to minors, as well as on effective cooperation between public authorities, experts and businesses. Regular evaluation of the regulation’s impact will also be vital — including assessments of public health, user behaviour, market development and crime trends — allowing timely adjustments to legislation when necessary.
To ensure effective coordination, it is recommended that an inter-ministerial coordinating body, such as a National Addiction Agency, be established to connect ministries, experts and practitioners. System stability will also be strengthened through permanent funding for expert risk assessment of psychomodulatory substances, providing the evidence base for future regulatory or prohibition decisions.
The coming year will be decisive for the regulation of psychomodulatory substances. Successful implementation can serve not only as an inspiration for Europe but also as proof that an innovative and humane approach to psychoactive substances is both possible and economically superior to prohibition and repression.
About the Institute for Rational Addiction Policies
The Institute for Rational Addiction Policies is an independent policy platform advocating for science-based, socially responsible approaches to addiction and public health. Through research, analysis and expert dialogue, it promotes modern and effective public policies that deliver measurable results in prevention and health protection.
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