The Moldovan Medical Journal, February 2018, Vol.

61, No 1

RESEARCH STUDIES

DOI: 10.5281/zenodo.1186164
UDC: 613.292:615.1

Pharmacists’ role in managing food supplements

Abstract
Background: Every year, the value of the world market of Food Supplements (FS) increases considerably, especially following the accepting the role of
nutrition in maintaining health. The share of official importers of medicinal products on FS market is not significant and the procedure for placing food
supplements on the market is not sufficiently regulated. All these conditions create major health risks for FS consumers.
Material and methods: In order to study the complexity of the field of food supplements and to highlight the existing problems in this field at the national
level, and also to determine the pharmacist’s role in releasing food supplements and counseling patients, was used comparative method for registering
the dietary supplements in Romania and the Republic of Moldova.
Results: The complex assessment of food supplements in the Republic of Moldova and Romania and elucidation of the pharmacist’s role in dispensing of
food supplements were carried out in order to prevent the abuse and non-rational use of the FS. For this reason it was carried out a comparative analysis
of the legal framework for FS in both mentioned countries and the study of the national food supplements market was performed according to the criteria
of the producers and importers that are present on the market.
Conclusions: Legislation on food supplements in the Republic of Moldova is incomplete and unsatisfactory formulated. The value of the food supplements
market is constantly increasing making this area attractive. The prevalence of economic interests over the medical interests may have adverse consequences
for the health of the population. The pharmacist has the primary role both in implementing the necessary legislative changes and in counseling patients
to prevent the non-conforming use of food supplements.
Key words: food supplement, legislation, food supplements market, risk, population health.

Introduction ment of the FS market has been created [1]. FS have begun
As early as in 90s, the food supplements market (FS) to extend their coverage area in the EU due to the wide-
was almost non-existent in the Republic of Moldova and spread recognition of the role of nutrition in maintaining
as well, in its neighboring countries, which is a total dif- health. FS consumption, as well as consumer confidence in
ference from the current situation. Excessive consumption their effects increases each year, constituting an easy solu-
of food supplements (FS) is becoming more and more cur- tion to the problem of maintaining health in the accelerated
rent issue, taking into consideration the concern of modern pace of contemporary life.
people about healthy living and eating, as the environment The global market value of the FS has exceeded $ 80 bil-
becomes more unfriendly and the life more stressful. lion USD, on the background of modern people concern for
Along with the benefits that population has through the a proper health status and quality of the life [2].
technology in the most areas of life, this is also a prerequisite Based on the Directive 2002/46 / EC of the European
for the environmental degradation of the environment. Parliament and of the Council of 10th of June 2002 on the
The ecological issue has been worldwide discussed harmonization of the legislation of the Member States relat-
and considered one of the main global problems faced by ing to food supplements, “food supplements” means food
people. There are a lot of studies carried out all around the stuffs intended to supplement the nutrition and which are
world, demonstrating the damage caused by the ecologi- concentrated nutrients or other substances with a nutrition-
cal status of the environment and its effects on the quality al or physiological effect, alone or in combination, marketed
of life. According to WHO data till 2050 around 25% of via different forms of issue, such as capsules, pills, tablets,
the European population will be over 65, a large number powders, liquid in vials, other similar forms of liquids and
of countries face demographic challenges, the aging of the powders intended to be taken in small measured unit quan-
population, etc. Under these conditions, an increased atten- tities. In the “Dietary Supplement Health and Education Act
tion is paid to healthy lifestyle: reducing stress, physical ac- of 1994” it is foreseen that FS are food products and not
tivity and, last but not least, an appropriate nutrition regime. medication.
Due to this reason, a favorable condition for the develop- The phenomenon of the increase of FS consumption is

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obvious also in the Republic of Moldova, having, in prin- In Romania, the procedure for registering food supple-
ciple the same premises as in the rest of the countries with a ments differs depending on their composition. Food supple-
different level of development. However, despite this, regu- ments (vitamins and minerals) are registered directly in the
lating the registration and circulation of FS on the Moldovan Ministry of Health, and the FS containing other substances
market, controlling the consumption of the FS, monitoring for nutritional and physiological purposes are registered
the adverse reactions and advising the consumer on FS – at the Institute of Food Bioresources within the Ministry
need to be improved [3, 4, 5]. The incomplete legislation of Agriculture and Rural Development or at the Regional
of the Republic of Moldova and the lack of a set of 7 good Centers of Public Health in Cluj-Napoca, Timisoara or Iasi,
practices in the management of the circulation of the FS, belonging to the Ministry of Health.
the advertising that may suggest to the consumer errone- In the Republic of Moldova, the registration and notifi-
ous ideas about the effects of the FS, may consequently lead cation procedure is carried out at the National Public Health
to the inappropriate and uncontrolled consumption of FS Center (NPHC), food supplements, containing nutrients
and, as a result, compromising the consumer health [6]. The are subject to the registration procedure and those contain-
possibility of purchasing FS without a prescription, not only ing other substances for nutritional and physical purposes
in pharmacies, but also in other ways (online shops, tele- are the subject of notification procedure.
shopping, drugstores, supermarket, natural products’ shops, According to the legislation, the food supplement manu-
etc.), deprive the consumer of getting any professional ad- facturer or the person responsible for placing the food sup-
vice and the often inconsistent advertisement becomes the plement on the market fulfills a registration form to which
sole source of information for the population.
the product label is enclosed in the folio and the food sup-
In this context, we intend to evaluate the complexity of
plement dossier is going to be registered.
factors that have contributed to the current situation in the
The content of the file attached to the request for notifi-
food supplements market in the Republic of Moldova.
cation is different in both countries (tab. 1). The legislation
Material and methods of the Republic of Moldova on the procedure for registra-
tion and notification of FS is incomplete and is incorrectly
The research was conducted to study the complexity formulated. General notions are used, without clarifica-
of the field of food supplements and highlight the existing tions, which make it possible to avoid the necessary rules.
problems in this field at national level, as well as to deter- (e.g.: «documents and information ....», «statements ...»,
mine the role of the pharmacist as the main specialist in the «evidences ...», etc.). It is not mentioned the nature of the
field of dispensing food supplements and counseling the document by whom they should be issued and confirmed.
population to prevent abuse and non-adequate use of food
supplements. Table 1
The study, analysis and synthesis of literature data re- The comparative content of the FS dossier in Romania
garding the circulation of food supplements on Romanian and the Republic of Moldova
and Moldovan markets by using the interpretative and com-
parative method of the legislation and procedures for regis- No Republic of Moldova Romania
tration and placing of food supplements on the market have 1. Information about the Application for Product
been carried out with the purpose to propose different ways applicant’s name and his legal Notification
to improve the regulation and monitoring of FS circulation address
on the national market. 2. Identification data of manufactu- Certificate of registration at
The comparative method involves comparing the proce- rer and importer (if applicable) the Trade Register, its copy
3. Place of production, trade name Product Presentation
dures of registering food supplements in Romania and the
of the product Format for Import Products
Republic of Moldova, comparing the content of the food
- Certificate of Conformity
supplements dossiers and assessing the differences in order and Country of Origin
to determine some possibilities for improving the procedure 4. Original label design and the one List of product ingredients
of registering food supplements. with its translation into the state (quantitative and qualita-
The interpretative method involves performing statisti- language tive)
cal surveys of the national food supplements market based 5. Documents and information Physico-chemical and
on the criteria of FS manufacturers, importers and distribu- certifying that the components microbiological analysis
tors and interpreting the results obtained. of the product are legally ma- bulletin issued by a labora-
nufactured and marketed in the tory accredited by a third
Results and discussion country of origin party
6. Evidence of the components of Product label in Romanian
According to the legislation of Romania and the the product
Republic of Moldova, food supplements are not included in 7. Declaration/Statement that the Packaging certificate, issu-
the category of medicines, therefore the procedure for their product is not registered as a ed in accordance with the
registration and placing on the market differs from the one medicine in the country of origin legislation in force
for medicinal products.

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In 2013, in order to improve the regulations in the field According to the results, almost 30% represents the group
of food supplements in the Republic of Moldova, a draft of importers holding less than 1% on the national market of
Government Decision on the notification of food supple- the FS. The other 70% constitute 20 importers, from which
ments was developed, representing a transposition of: six are official medicine distributors: Tetis International,
· Directive 2002/46 / EC of the European Parliament and Prosanitas Farm – 1%; Esculap-Farm, Farmina SRL – 3%,
of the Council of 10th of June 2002 on the approximation of Dita EstFarm – 4%, IM Becor SRL – 8%. The leader is the
the laws of the Member States relating to food supplements. “Sibimport” importer with 9% (tab. 2).
· Regulation (EC) No 1925/2006 of the European Table 2
Parliament and of the Council as regards the lists of vita- Share of (%) of FS importers registered in the Republic of
mins and minerals and their forms that can be added to Moldova by 01.10.16
foods, including food supplements.
· Regulation (EC) No 1924/2006 of the European No Importer
Market
Parliament and of the Council of 20th of December 2006 on share, %
nutrition and health claims made on foods. 1. Tetis International 1
· Commission Regulation (EU) No 432/2012 of 16th of 2. Prosanitas Farm 1
May 2012 establishing a list of permitted health claims made 3. Vainstein Sanatate 1
on foods, other than those referring to the reduction of dis- 4. SC Farmaco Social 2
ease risk and to children’s development and health.
5. Moebius SRL 2
Recent data on national market values of food supple-
ments are not visible in the information flow. 6. Darurile Vietii 2
In this paper we conducted the statistical analysis of the 7. Virim Impex 2
market by producers, importers and distributors of FS on 8. Vivasan 2
the Moldovan market. 9. PVR Stil SRL 3
As a database served the Register of Food Supplements 10. Farmina SRL 3
of the National Centre of Public Health, which includes the
11. Esculap-Farm 3
following lists:
12. Forever 3
· The list of registered food supplements – 813 trade
names 13. Maiac-Farm 3
· The list of food supplements notified – 1696 trade 14. Ocean Resourse 4
names 15. Zezifora 4
· The list of nutritionally and physiologically registered 16. Dita EstFarm 4
substances – 3 trade names 17. Coral Club 6
· The list of food supplements which have been refused
18. Cosmovis 7
for the registration – 1 trade name
19. ÎM Becor SRL 8
The market share of the producers of food supplements
registered and notified in the Republic of Moldova is de- 20. Sibimport 9
monstrated in figure 1. 21. Others (importers with quota < 1%) 30

Fig. 1. The market share (%) of the producers of food supplements registered in the Republic of Moldova by 01.10.16

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At the last stage of the statistical study of the national Современного Здоровья” (Laboratory of Contemporary
food supplements market we identified the share of the no- Health).
tified importers of the FS on the national market (tab. 3). · The composition of food supplements included in the
Table 3 list of notified FS is specified in a superficial manner and
Share of (%) of FS importers notified in the Republic of without specifying doses. The composition is completely
Moldova by 09.04.17 missing in the registered FS list. This is an obstacle in com-
paring the composition of food supplements and medicines.
No Importer Market Changing the status of their product from the medicine
share, % to a food supplement, the manufacturer pursues certain
1. IM Becor SRL 5 purposes, all of them having more or less an economic na-
2. Foralux 7 ture:
3. DitaEstFarm 22 1. Avoiding the state control of different levels which is
4. Importers with quota 0 -0,5% 10 mandatory for the medicines – thus, avoiding additional
5. Importers with quota 0,51 -1% 5 costs and obtaining the possibility of saving on the quality
6. Importers with quota 1.1-5% 41
of raw materials and finished products.
2. Avoiding the rigorous requirements imposed on
Since the mandatory implementation of GMP compli-
medicinal products in the registration procedure and the
ance for medicinal products, more and more manufacturers
presence of a detailed dossier including all the characteristics
choose to register their products as food supplements. Even
of the medicinal product. The lack of the requirement to
after the expiring date of the Certificate of Registration of a
declare sources of raw material, the technological process,
medicine, the manufacturer chooses for the following regis-
the lack of the need to justify the validity - which again is
tration to register their product as a food supplement.
done by producers in order to save and get financial benefits.
This fact generated the so-called phenomenon of double
3. Possibility to make active and aggressive promotion
registration of the same active substance on the national
of the product through the media, online space, through
market. Thus, the chemical or plant substance with the same
communication with medical personnel and pharmacists.
dose is found to be registered both, as a medicinal product
4. Including of food supplements in OTC list, which
and as a food supplement at the same time (tab. 4).
makes possible to sell them without a prescription, but only
Table 4
at the recommendation of the pharmacist or based on the
Active substances with double registration status on
advertising information.
the Republic of Moldova market
5. Lack of vigilance and monitoring of the circulation of
these products on the market, and the considerable decrease
Name of in the likelihood that the adverse reactions of these products
Name of the ac- Presenta-
No the medi- Name of FS
tive substance tion will be considered or studied by the pharmacovigilance
cine
1.
authorities.
Silymarinum 140 mg Lagosa SameLive
2.
6. Avoiding the need for post-marketing trials.
Pancreatinum 10000 IU Kreon DIGEX
3.
7. Mandatory implementation of GMP rules for medi-
L- carnitinum 100 mg Cartan Proefect
cines manufacturers.
4. Glicin –
Glicinum 100 mg Glicised These and many other factors influence the decision of
Эвалар
5. Carbune manufacturers to change the status of their medicinal prod-
Carbo activatum 250 mg Toxinol
activat ucts in food supplements.
Inappropriate and abusive use of food supplements can
The substances listed in the table are just a few examples lead to adverse health consequences for the population.
demonstrating the presence of this phenomenon on the na- Nonrational use of food supplements can also cause vari-
tional medicines and food supplements market. Operating ous side effects on all organ systems, generated both by the
with the Food Supplements Register it is very difficult to intrinsic effect of the food supplement and their association
perform an analysis and statistical study in this area for the with medicines. Considering the fact that some food supple-
following reasons: ments are recommended to children and pregnant women
· The list is made in the format of a Microsoft Word file, and the elderly with chronic diseases, there is absolutely ob-
which significantly complicates the statistical analysis. vious need to regulate this area and monitor the circulation
· The same manufacturer or importer is registered in dif- and consumption of these products by the population.
ferent cases under different names, eg., the same producer The pharmacist, being a major specialist in medicines,
is registered as: “Laboratorul Sanatatii Moderne” (Modern has the primary role both in implementing the necessary
Health Laboratory), “Laboratorul Sănătății Contemporane” legislative changes and in counseling patients to prevent
(Contemporary Health Laboratory) and “Лаборатория non-compliant use of food supplements.

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