Abstract:
Introduction. Dietary supplements have gained increased popularity worldwide
due to their potential health benefits and their use is often driven by the desire to
supplement an individual's diet with essential nutrients. However, their regulatory status is often unclear, leading to concerns starting with their definition and
ending with their quality and safety. In the Republic of Moldova (RM), there is a
growing market for dietary supplements (DS), and there is a need for a clear regulatory framework to ensure the safety, efficacy and quality of these products.
Aim. The aim of this study is to examine the regulatory framework regarding DS
in the RM, including their registration, labeling, marketing, and safety requirements. This study seeks to provide a comprehensive overview of the regulatory
landscape for DS in Moldova, and to identify any gaps or shortcomings in the current regulatory framework.
Material and methods. A literature review was conducted to identify relevant
legal documents, policies, and guidelines related to DS in the RM. Additionally,
information was collected from National Agency for Public Health, responsible for
regulating DS and from industry sources.
Results. The regulatory framework for DS in the RM is governed by two main
state structures: Ministry of Health of RM and National Agency of Public Health
(NAPH), within the Law no. 306 of 30.11.2018 on food safety and the sanitary
regulation on DS, approved by Government Decision no. 538 of 02.09.2009, which
includes provisions for the registration, notification, labeling, marketing, and safety of DS, that were based on the legislative transpositions of Directive
2002/46/EC of the European Parliament and of the Council of 10 June 2002. According to this directive, DS must be registered or notified with the NAPH and
meet certain quality and safety standards. Additionally, DS labeling must include
specific information about the product's ingredients, dosage, and intended use. DS
are not subject to the same level of pre-market testing and approval as medications. This means that companies can sell DS without first demonstrating that
they are safe and effective. DS can contain fillers or other inactive ingredients, and
the amount of active ingredient can vary from batch to batch, and may also be
contaminated with harmful substances, such as heavy metals, pesticides or even
prescription drugs. Many DS make claims about their health benefits, but these
claims are not always supported by scientific evidence, and companies can make
false claims or exaggerate the effectiveness of their products without consequence.
Conclusions. The regulatory framework for DS in the RM provides some protections for consumers, including requirements for registration, labeling, dosage and
some proof of safety. However, the enforcement of these regulations may be inadequate. There is a need for continued efforts to ensure that consumers have access to safe DS. This may include improving the enforcement of existing regulations, creation of a more standardized and rigorous regulatory framework that
include stricter rules on labeling and advertising, mandatory safety testing, and
clearer guidelines on dosage and ingredients, and increasing public awareness of
the risks and benefits of DS.
