Approved by the Decree of the Government of the Russian Federation of 13.04.2026 No. 398.
Quality of dietary supplements: mandatory conditions
A product is considered to be of high quality only if four requirements are met simultaneously:
1. A valid certificate of state registration of the dietary supplement from the manufacturer (or from an authorized person under the contract).
2. Availability of identification marking and registration of information about the additive in the state system for monitoring the circulation of marked goods.
3. Confirmation of compliance with safety indicators and quantitative content of active ingredients (according to the manufacturer’s technical documentation). The assessment is conducted by an accredited laboratory in the Russian Federation.
4. Compliance with the requirements of the technical regulations of the Eurasian Economic Union (EAEU).
Dietary supplement effectiveness: options for confirmation
One of the points is enough:
a) Publications in scientific journals (including reviews) with information on the composition, dosage, and method of administration of the supplement. The materials must demonstrate health benefits or a positive effect from interactions with food or medications. Submissions must be made in national scientific citation systems (RSCI, White List) and/or international databases.
b) The presence of information on the effectiveness of dietary supplements or individual biologically active substances in current clinical guidelines.
c) The manufacturer’s own data on efficacy studies (clinical trials, observations) confirming the positive effect on the body or interactions with food and medications. Documentation must include information on dosage and course of administration.
Effective Date: May 1, 2026
The document was developed by the Ministry of Health in pursuance of the federal law of September 1, 2025.
Based on the criteria, a list of dietary supplements can be formed that doctors have the right to prescribe if there are indications.
