Dietary supplements: Legal Issues and Requirements in Russia

May 29, 2022

BRACE ©

The market for Biologically Active Food Supplements (Russian name for dietary supplements) (hereinafter also – "BAFS", "Dietary supplements") is one of the most rapidly developing markets in Russia. According to DSM Group, in 2021, the capacity of the commercial Dietary supplements market in Russia amounted to 341 million packages worth 85.6 billion rubles. In value terms, the market grew by 16.2% relative to 2020. In physical terms, the sales volume of additives increased by only 0.8% [1].

The active growth of this market segment attracts the attention of regulators. In particular, the labeling of BAFS is being introduced, and control over their advertising and online sales is being tightened.

This article discusses the main legal aspects of the circulation of BAFS in Russia.

Definition and Status of Dietary supplements

The fundamental difference between Dietary supplements and medicinal products lies in their purpose. Medicinal products are intended for the prevention, diagnosis, and treatment of diseases. BAFS are food products.

The legal definition of BAFS is given in the Technical Regulation of the Customs Union 021/2011 "On Food Safety" (hereinafter – "TR CU 021/2011").

Biologically active food supplements (BAFS) are natural and (or) identical to natural biologically active substances, as well as probiotic microorganisms, intended for consumption simultaneously with food or for incorporation into food products.

Thus, BAFS are classified as food products. Consequently, the general requirements for food products established by the legislation of the Russian Federation and the acts of the Eurasian Economic Union (EAEU) apply to them.

State Registration of Dietary supplements in Russia

Unlike most food products, for which conformity assessment is carried out in the form of a declaration of conformity, Dietary supplements are subject to state registration.

State registration of Dietary supplements is carried out by the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor).

The state registration procedure includes:

• Acceptance and registration of the application;
• Examination of the documents submitted by the applicant;
• Expertise of the results of studies (tests) of samples of the specialized food product;
• Making a decision on state registration or refusal of state registration;
• Assigning a number to the certificate of state registration and entering information into the Unified Register of Specialized Food Products;
• Issuance of the State Registration Certificate (SRC).

The SRC confirms the compliance of BAFS with the hygienic safety requirements established by the Technical Regulations of the Customs Union (TR CU 021/2011 "On Food Safety", TR CU 022/2011 "Food Products in Terms of Their Labeling", TR CU 029/2012 "Safety Requirements for Food Additives, Flavorings and Technological Aids").

The validity period of the SRC for BAFS is indefinite (except for cases where limited validity periods are established for certain types of products).

Information on registered BAFS is entered into the Unified Register of State Registration Certificates, which is publicly available on the website of the Eurasian Economic Commission.

It is important to note that the circulation of BAFS without an SRC is prohibited. Violation of this requirement entails administrative liability under Art. 14.43 of the Code of Administrative Offenses of the Russian Federation (CAO RF) in the form of a fine: for officials – from 10,000 to 20,000 rubles; for persons engaged in entrepreneurial activities without forming a legal entity – from 20,000 to 30,000 rubles; for legal entities – from 100,000 to 300,000 rubles. In case of harm to the life or health of citizens, the fine for legal entities can reach 600,000 rubles with confiscation of the production items.

Labeling Requirements for Dietary supplements in Russia

Requirements for the labeling of BAFS are established by TR CU 022/2011 "Food Products in Terms of Their Labeling" and TR CU 021/2011.

The labeling of BAFS must be understandable, easy to read, reliable, and not misleading to consumers (purchasers). The inscription, signs, and symbols must be contrasting to the background on which the labeling is applied.

The labeling of BAFS must contain the following information:

• Name of the product;
• Composition of the product;
• Quantity of the product;
• Date of manufacture;
• Shelf life;
• Storage conditions;
• Name and location of the manufacturer (and the person authorized by the manufacturer);
• Recommendations and (or) restrictions on use;
• Indicators of nutritional value;
• Information on the presence of components obtained using GMOs;
• Single sign of circulation of products on the market of the Customs Union (EAC).

Additionally, for BAFS, the labeling must indicate:

• Information on the composition and content of biologically active substances;
• Recommendations for use;
• Contraindications for use;
• A warning: "NOT A MEDICINAL PRODUCT".

It is prohibited to indicate in the labeling of BAFS that they have therapeutic properties or to refer to specific diseases.

Mandatory Digital Labeling

Currently, an experiment on the labeling of BAFS with identification means is being conducted in Russia (from May 1, 2021, to February 28, 2023) [2]. Participation in the experiment is voluntary. However, judging by the experience of implementing labeling for other product groups (medicinal products, bottled water, dairy products), it is highly probable that mandatory labeling of BAFS will be introduced in the near future.

Mandatory labeling involves applying a unique Data Matrix code to each package of the product and transferring information about the movement of the goods to the "Chestny ZNAK" system. This will allow tracking the path of BAFS from the manufacturer/importer to the final consumer and combating counterfeit products.

Advertising of Dietary supplements in Russia

Advertising of Dietary supplements is strictly regulated by Article 25 of the Federal Law "On Advertising".

Advertising of Dietary supplements must not:

• Create the impression that they are medicinal products and (or) possess therapeutic properties;
• Contain references to specific cases of cure of people or improvement of their condition as a result of using such supplements;
• Contain an expression of gratitude by individuals in connection with the use of such supplements;
• Encourage the refusal of a healthy diet;
• Create the impression of the advantages of such supplements by referring to the fact of conducting studies mandatory for state registration, as well as use the results of other studies in the form of a direct recommendation for the use of such supplements.

Advertising of BAFS in each case must be accompanied by a warning that the object of advertising is not a medicinal product. The duration of such a warning must be at least 10% of the advertising space (in print media, outdoor advertising) or at least 10% of the duration of the video (on TV, radio).

Violation of the legislation on advertising of BAFS entails administrative liability under Art. 14.3 of the CAO RF. The fine for legal entities ranges from 100,000 to 500,000 rubles.

Practice shows that the FAS Russia actively monitors compliance with these requirements. The most common violations are equating Dietary supplements to medicines, promising a therapeutic effect, and the absence of a warning that the Dietary supplements is not a medicine [3].

Online Sale of Dietary supplements

For a long time, the possibility of selling BAFS remotely (via the Internet) was a subject of debate.

According to SanPiN 2.3.2.1290-03 "Hygienic Requirements for the Organization of Production and Turnover of Biologically Active Food Supplements (BAFS)", the sale of BAFS carried out through pharmacy institutions, specialized stores for the sale of dietary products, and food stores (special departments, sections, kiosks) [4]. Based on this norm, Rospotrebnadzor and courts often recognized the online sale of BAFS as illegal, blocking the websites of sellers.

However, from January 1, 2021, new "Rules for the Sale of Goods under Retail Sale and Purchase Contracts", approved by Decree of the Government of the Russian Federation No. 2463 dated December 31, 2020, came into force. These Rules do not contain a direct ban on the remote sale of BAFS.

Moreover, the Rules explicitly state that "the sale of food products by remote method is not allowed if such sale is prohibited by federal laws or other regulatory legal acts of the Russian Federation". Since SanPiN is a bylaw and restricts the rights of participants in civil turnover, applying it to prohibit online trade contradicts the current legislation and the position of the Government.

In May 2021, Rospotrebnadzor issued explanations confirming the possibility of remote sale of BAFS, provided that the seller complies with the requirements for information about the goods and ensures the safety of the products [5].

Thus, at present, the online sale of Dietary supplements is permitted, provided that the requirements for bringing information to the consumer, the availability of state registration, and compliance with the requirements of TR CU are met.

However, aggregators and marketplaces must strictly monitor that under the guise of BAFS, unregistered drugs or substances prohibited for circulation (for example, containing potent or psychotropic substances) are not sold. Blocking of pages with such offers continues [6].

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References

[1] DSM Group. Market of Biologically Active Additives in Russia following the results of 2021.

[2] Decree of the Government of the Russian Federation dated April 29, 2021, No. 673 "On Conducting an Experiment on Labeling Biologically Active Food Supplements with Identification Means in the Territory of the Russian Federation".

[3] Decision of the Moscow OFAS Russia dated 24.12.2019 in case No. 077/05/25-14980/2019; Decision of the Moscow OFAS Russia dated 22.09.2020 in case No. 077/05/25-15077/2020.

[4] Clause 7.4.1 of SanPiN 2.3.2.1290-03.

[5] Information from Rospotrebnadzor "On the sale of biologically active food supplements by remote method".

[6] Review of judicial practice on cases related to the placement of prohibited information on the Internet (blocking of sites) for 2020-2021.