On 9 July 2024, the State Duma passed Bill No. 638771-8 “On Introduction of the Draft Federal Law ’On Amendments to Certain Legislative Acts of the Russian Federation’” (the “Bill”) in first reading, which focuses on changes in the regulatory regime for the circulation of dietary supplements in Russia.
The proposed amendments would introduce significant changes affecting the circulation of dietary supplements and, to a certain extent, bringing it closer to the regime established for pharmaceuticals and medical devices.
Distribution of information on non-compliant dietary supplements
According to the amendments proposed in the Bill, the Federal Law No. 29-FZ of 02.01.2000 “On the Quality and Safety of Food” (the “Food Quality Law”) will expressly prohibit the distribution of information containing proposals for retail sale, including by distance selling, of dietary supplements:
- which are dangerous and (or) of poor quality according to organoleptic indicators;
- which are inconsistent with the information provided, including:
- have in their composition the regulated substances in inappropriate quantities,
- contain contaminants that have been formed in the production process and may have a harmful effect on humans and future generations, information about which has not been communicated to the consumer,
- have no expiry date or expiry date of which has expired,
- the parameters of which do not meet the requirements established by law, standardization documents, technical documentation.
- where falsification has been detected;
- in respect of which traceability cannot be confirmed1;
- which do not have labelling containing information on food products provided for by the legislation of the Russian Federation, or in respect of which there is no such information;
- which are not accompanied by shipping documents.
Moreover, the Bill provides for the possibility of entering websites that violate the above restrictions into Roskomnadzor's Unified Register of Prohibited Internet Resources.
It is anticipated that these measures, including the blocking of a website listed in the Unified Register, will help protect citizens from purchasing dietary supplements of low-quality as well as counterfeit products, and will also encourage online sellers, including marketplaces, to more thoroughly check the products sold on their platforms.
The Government will establish specifics of manufacture and use of dietary supplements
The Bill provides for the establishment of criteria for the quality of dietary supplements and the raw materials from which they are manufactured, depending on their impact on human health, as well as conditions for ensuring compliance with such criteria.
It also provides for the possibility of establishing the specifics of dietary supplements use in Russia and the specifics of the sale of dietary supplements manufactured by domestic manufacturers.
These criteria and specifics shall be established by acts of the Government of the Russian Federation.
Supply of the certain categories of citizens with dietary supplements
The Bill proposes to supplement the Food Quality Law with Article 25.7, which provides for the possibility for medical professionals to prescribe to certain categories of citizens dietary supplements which:
- are registered,
- meet quality and safety requirements in accordance with the Russian legislation.
Dietary supplements will be prescribed in accordance with methodological recommendations established by the Ministry of Health where medical grounds are present. The Ministry of Health will also develop a list of dietary supplements, and development of diseases risk factors list where dietary supplements may be prescribed.
More restrictions on healthcare professionals
The Article 74 of Federal Law No. 323-FZ of 21.11.2011 “On the Fundamentals of Public Health Protection in the Russian Federation” (the “Health Protection Law”) provides for several restrictions for medical professionals when interacting with developers, manufacturers and subjects of circulation of medicines and medical devices.
The Bill proposes that the following restrictions in connection with the circulation of dietary supplements should apply to medical professionals:
- prohibition on accepting gifts and money from companies engaged in the development, manufacture or circulation of dietary supplements (the “Subjects of Circulation”);
- prohibition on entering into agreements with Subjects of Circulation on prescribing or recommending dietary supplements to patients;
- prohibition on obtaining samples of dietary supplements from the Subjects of Circulation for distribution to patients;
- prohibition on providing inaccurate and (or) incomplete information about the dietary supplements used in a course of treatment, including concealing information about the availability of similar dietary supplements in circulation.
Extension of the state control of the quality and safety of medical activity scope
The Article 87 of the Health Protection Law is to be amended by indication that under the state control the compliance of medical activities subjects with the requirements established by an authorised body is to be checked in relation with the prescription of dietary supplements to citizens.
Potential implications for the industry
The Bill is aimed at integration of dietary supplements into the healthcare system, which may have a positive effect both for dietary supplement manufacturers and for citizens of Russia.
The novelties suggest strengthening control over the manufacture and sale of dietary supplements, which should also have a positive impact on the final products sold to consumers, which currently often do not meet traceability standards.
Subjects of circulation of dietary supplements, as well as medical organisations, can expect increased control and supervisory activity, which may entail additional costs and the need to revise existing business processes.
According to the text of the Bill, it is expected that it will come into force on 1 September 2024. Provisions on federal control of the quality and safety of medical activities should become effective on 1 March 2025.
At the same time, amendments to the text of the Bill can be expected based on the results of additional discussion in the State Duma.
1 We remind that starting from September 2023, the regulations providing for mandatory Track&Trace labelling of dietary supplements with Data Matrix codes and entering information into the “Chestny Znak” traceability system came into force.