On September 1, 2025, Federal Law No. 150-FZ dated June 7, 2025, 'On Amendments to Certain Legislative Acts of the Russian Federation' (hereinafter referred to as 'Federal Law No. 150'), will come into force, introducing a number of changes affecting the regulation of dietary supplements1.
The Federal Law No. 150 introduces amendments to three federal laws:
- Federal Law No. 29-FZ dated January 2, 2000, “On the Quality and Safety of Food”;
- Federal Law No. 323-FZ dated November 21, 2011, “On the Fundamentals of Public Health Protection in the Russian Federation”;
- Federal Law No. 149-FZ dated July 27, 2006, “On Information, Information Technologies, and Information Protection.”
Creation of a special list of dietary supplements and the procedure for their prescription
The Ministry of Health, in agreement with Rospotrebnadzor, establishes a list of dietary supplements and guidelines for their use. To be included in the list, dietary supplements must comply with quality and efficacy criteria established by the Government of the Russian Federation and the technical regulations of the EAEU. Currently, dietary supplements are subject to state registration within the EAEU as specialized food products, as stated in paragraphs 1, 2 of Article 24 of the Customs Union Technical Regulation TR CU 021/2011 "On Food Safety" approved by Decision of the Customs Union Commission No. 880 dated December 9, 2011 (hereinafter referred to as the "EAEU Regulation"). As noted in the explanatory note to the new law, this regulation does not contain requirements for the quality of dietary supplements and only addresses issues of their safety. The list referred to in Federal Law No. 150, in turn, involves the establishment of quality criteria.
Healthcare professionals will be able to prescribe dietary supplements from the above list to patients if there are indications for their use in accordance with the procedure jointly established by the Ministry of Health and Rospotrebnadzor. Also, healthcare professionals and heads of medical organizations, when prescribing dietary supplements, are subject to the restrictions of Part 1 of Article 74 of the Federal Law "On the Fundamentals of Health Protection in the Russian Federation", namely:
- prohibition on receiving monetary funds from dietary supplement manufacturers (with exceptions);
- entering into agreements with them regarding prescription or recommendation of dietary supplements to patients;
- receiving samples of dietary supplements for distribution to patients (with exceptions);
- providing false and/or incomplete information about prescribed dietary supplements, or concealing information about their availability on the market;
- holding meetings with representatives of manufacturing companies (with exceptions).
Blocking websites distributing information on prohibited dietary supplements
Rospotrebnadzor will be authorized to block websites containing information offering the retail sale of dietary supplements prohibited in the Russian Federation without prior court approval. Previously, such blocking required Rospotrebnadzor to file a lawsuit2, but now the agency can act unilaterally under a procedure to be established by the Russian Government3.
Conclusion
The key aspects of dietary supplement regulation now mirror those applied to pharmaceuticals and medical devices. The relevant acts of the Government of the Russian Federation, the Ministry of Health of the Russian Federation and Rospotrebnadzor, to which Federal Law No. 150 is referred, should complement the new regulation.
Due to the increased regulatory impact from government agencies, dietary supplement manufacturers are likely to face new internal verification procedures when selling and distributing information about sales on certain sites (marketplaces). However, the new powers of Rospotrebnadzor regarding the extrajudicial blocking of websites with information containing a proposal for the retail sale of dietary supplements prohibited for circulation in the Russian Federation should have a positive impact on countering the spread of counterfeits on the market, which will contribute both to the interests of dietary supplement manufacturers and prevent potential harm to the health of citizens from consuming prohibited products.
1Our review of draft law No. 638771-8 'On Introducing the Draft Federal Law "On Amendments to Certain Legislative Acts of the Russian Federation"', which was adopted in the first reading, is available here.
2Item 2 of Part 5 of Article 15.1 of Federal Law No. 149-FZ dated July 27, 2006 'On Information, Information Technologies and Information Protection.
3Rules for adoption of decisions by federal executive bodies authorized by the Government of the Russian Federation regarding certain types of information and materials disseminated via the 'Internet' information and telecommunications network, the distribution of which is prohibited in the Russian Federation, approved by Decree No. 1101 of the Government of the Russian Federation dated October 26, 2012.