| Hygiene of populated places | ISSN: 2707-0441 eISSN: 2707-045X |
Issue 71, 2021 - Pages: 153-158
DIETARY SUPPLEMENTS: REGULATORY ASPECTS OF THE REGULATORY FRAMEWORK FOR SAFE USE BY THE POPULATION
M.G. Levin1, O.M. Holichenkov1, V.I. Lyashenko1
1 STATE INSTITUTION “O.M. MARZIEIEV INSTITUTE FOR PUBLIC HEALTH” NAMSU
SUMMÀRY:
Today, public knowledge about DS is limited to advertising by marketing companies. In the uncontrolled conditions of the market, which is developing especially dynamically in Ukraine over the last decade, there is a lack of knowledge about the possible negative consequences of their use. In this regard, it is urgent to consider the legal framework for regulating the safe use of DS in Ukraine and further ways to improve it.
Purpose: to analyze the regulatory framework for regulating the safe use of DS in Ukraine and further ways to improve it. It is established that today in Ukraine there is no integrated system and regulatory framework for their safe circulation in Ukraine and there are no standards for DS production. Quality control is only about assessing their safety as a food product.
Today, DSs have become the subject of uncontrolled commercial activities with unfair and aggressive advertising and are often advertised as untrue medicines. Both among consumers and among medical staff, the understanding of the term "DS" has become ambiguous, which often leads to serious mistakes and wrong actions.
The danger is also posed by those manufacturers who use unexplored or toxic natural components when creating DS. At the same time, the analysis of data on the safety of DS showed that: they may not be allowed to be used in DS active pharmaceutical ingredients and toxic impurities; in the information materials there is no complete information about the composition and amount of input ingredients; there is no information on contraindications to the appointment; there is no information on the interaction of the components of DS with drugs; in most cases, the safety of DS components for pregnant women and fetuses has not been proven; there is no clear evidence of the effectiveness of DS in their use according to the proposed indications.
Currently, operators of the dietary supplements market have uncontrolled freedom in terms of ensuring the quality and safety of DS and due to the constant growth of the market of dietary supplements, the Ukrainian consumer is not protected from counterfeiting of this type of product.
This is due to the fact that the State Service of Ukraine for Food Safety and Consumer Protection, which is the guarantor of quality control of dietary supplements, does not provide for pre-clinical trials. Therefore, it is difficult to recognize fake or low-quality dietary supplements.
Purpose: to analyze the regulatory framework for regulating the safe use of DS in Ukraine and further ways to improve it. It is established that today in Ukraine there is no integrated system and regulatory framework for their safe circulation in Ukraine and there are no standards for DS production. Quality control is only about assessing their safety as a food product.
Today, DSs have become the subject of uncontrolled commercial activities with unfair and aggressive advertising and are often advertised as untrue medicines. Both among consumers and among medical staff, the understanding of the term "DS" has become ambiguous, which often leads to serious mistakes and wrong actions.
The danger is also posed by those manufacturers who use unexplored or toxic natural components when creating DS. At the same time, the analysis of data on the safety of DS showed that: they may not be allowed to be used in DS active pharmaceutical ingredients and toxic impurities; in the information materials there is no complete information about the composition and amount of input ingredients; there is no information on contraindications to the appointment; there is no information on the interaction of the components of DS with drugs; in most cases, the safety of DS components for pregnant women and fetuses has not been proven; there is no clear evidence of the effectiveness of DS in their use according to the proposed indications.
Currently, operators of the dietary supplements market have uncontrolled freedom in terms of ensuring the quality and safety of DS and due to the constant growth of the market of dietary supplements, the Ukrainian consumer is not protected from counterfeiting of this type of product.
This is due to the fact that the State Service of Ukraine for Food Safety and Consumer Protection, which is the guarantor of quality control of dietary supplements, does not provide for pre-clinical trials. Therefore, it is difficult to recognize fake or low-quality dietary supplements.
KEYWORDS:
biologically active additives, dietary supplements (DS), regulations.
REFERENCES:
1. Davydov S. A Posteriori: BAD i drugie [A Posteriori: BAD and others]. Remedium. Zhurnal o rossiyskom rynke lekarstv i meditsinskoy tekhnike [Remedium. Journal about the Russian Market of Medicines and Medical Equipment]. 2013 ; 10 : 50-55 (in Russian). DOI : https://doi.org/10.21518/1561-5936-2013-10-50-55
2. Pavlova O.N. at al. Sovremennye podkhody k klassifikatsii biologicheski aktivnykh dobavok k pishche [Modern Approaches to the Classification of Biologically Active Food Additives]. Vestnik SamGU. Estestvenno nauchnaya seriya [Vestnik of Samara University. Natural Science Series]. 2007 ; 9/1 (59) (in Russian).
3. Baranovskiy A.Yu. Dietologiya [Nutrition] 4-e izd. St. Petersburg : Piter ; 2012-1024 (in Russian).
4. Glade, M.J. Food, nutrition, and the prevention of cancer: a global perspective. Nutrition. 1999 ; 15 ; 6 (June) ; 523–526. DOI : https://doi.org/10.1016/S0899-9007(99)00021-0
5. Shabrov A.V., Dadali V.A., Makarov V.G. Biokhimicheskie osnovy deystviya mikrokomponentov pishchi [Biochemical Bases of Action of Food Microcomponents]. Moscow : Avalon ; 2003 : 166 p. (in Russian).
6. Pilat T.L., Ivanov A.A. Biologicheskie dobavki k pischhe [Biological Food Additives]. Moscow ; 2002 : 710 p. (in Russian).
FOR CITATION:
Levin M.G., Holichenkov O.M., Lyashenko V.I. Diietychni dobavky: rehuliatorni aspekty normatyvno-pravovoi bazy bezpechnoho vykorystannia naselenniam [Dietary Supplements: Regulatory Aspects of the Regulatory Framework for Safe Use by the Population]. In : Hihiiena naselenykh mists : zb. nauk. pr. [Hygiene of Populated Places]. Kyiv ; 2021 ; 71 : 153-158 (in Ukrainian).