Should we expect the introduction of mandatory labeling for biologically active supplements in the Russian Federation?
According to the Russian Government Decision No. 1556, from July 1, 2020 , all operations related to drug circulation will be controlled in the information monitoring system. The monitoring system is already working for drugs from the list of high-cost nosologies. In addition to drugs, certain categories of goods are already subject to digital monitoring: tobacco products, perfumes, some clothing items, shoe goods, etc. However, biologically active supplements (BAS) are not included in this list. Should the requirements of mandatory labeling also be expected to affect these products?
It should be said that conversations about the need to introduce measures of additional control over the application of dietary supplements have been conducted for a long time. According to the media holding “RBC”, back in July 2019, the head of the Rospotrebnadzor Anna Popova addressed the Ministry of Industry and Trade with a letter on the extension of mandatory marking on dietary supplements, sports food and drinking water. According to Anna Popova’s opinion, means of digital identification will reduce the illegal circulation of products. Besides, a member of the State Duma Committee on Health Protection Alexander Petrov said not so long ago about the elaboration of the issue of introduction of mandatory labeling for biologically active supplements. He said the committee was constantly receiving complaints that people under the guise of drugs were being sold BAS. It is currently planned to include a section on BAS in the List of selected types of goods subject to mandatory identification labelling, but the option of the creation a separate Law is also under consideration.
However, official sources do not have any documentation of the introduction of mandatory labeling for BAS in the near future.
It should be noted that the use of means of digital identification will probably still reach BAS, as falsified and counterfeit goods are a big problem for this category goods. According to the Federal Service on Surveillance for Consumer rights protection and human well-being (Rospotrebnadzor), the inclusion of various pharmaceutical substances in adulterated BAS is widespread, which can pose a threat to the life and health of the consumer. For example, medicinal substances such as vardenafil and tadalafil, which have broad spectrum of contraindications, have been found in some BAS designed to improve erectile function.
In addition, falsified dietary supplements for weight loss often include sibutramine , a medicinal substance that increases the sense of saturation and reduces the need for food. However, the instruction on the use of the registered drug Goldline (which includes sibutramine) contains a very impressive list of contraindications and side actions.
Currently, information on the results of verification of compliance with the requirements of technical regulations can be found on the State Information Resource in the field of consumer protection (SIR) — link.
Unfortunately, this resource will not show the details about violations, but the name of the discrepancy indicator (for example, “Falsification”) for a particular product and region can be found there.
Thus, adulteration of BAS is a very urgent problem for this category of products. The situation is also complicated by the close relationship of drugs and biologically active supplements, so the introduction of mandatory labeling in the near future is a very likely innovation.
- Resolution of the Government of the Russian Federation dated 14.12.2018 N 1556 (ed. 20.03.2020) “On Approval of the Regulations on the System of Monitoring the Movement of Medicines for Medical Use”
- Order of the Government of the Russian Federation dated 28.04.2018 N 792-r (ed. 30.03.2020) “On approval of the list of selected goods subject to mandatory marking by means of identification”