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Dietary Supplements' Regulation: Are We Doing Enough to Protect the Children? A Narrative Review
Jelena Jovičić-Bata1, Nataša Milošević1, Neda Gavarić1
1Department of Pharmacy, Faculty of Medicine, University of Novi Sad, Hajduk Veljkova 3, 21000 Novi Sad, Serbia.
Insights
Regulatory inconsistencies in the European Union and Serbia pose risks to pediatric dietary supplements (DS). Addressing these gaps is crucial for ensuring children
Area of Science:
- Public Health
- Regulatory Science
- Pediatric Nutrition
Background:
- High prevalence of pediatric dietary supplement (DS) use necessitates stringent regulation.
- Current regulatory frameworks in the EU and Serbia exhibit inconsistencies, potentially compromising pediatric DS safety.
Purpose of the Study:
- To critically evaluate regulatory and practical issues concerning the definition, labeling, advertising, and use of pediatric DS in the EU and Serbia.
- To identify inconsistencies and gaps in legal and policy frameworks impacting pediatric DS safety.
Main Methods:
- A comprehensive review of legal and policy frameworks in the EU and Serbia.
- Analysis of peer-reviewed literature on pediatric DS definition, labeling, and advertising.
- Assessment of marketing practices and their impact on consumer safety.
Main Results:
- Identified five critical regulatory concerns: unclear product definition, lack of uniform composition standards, safety risks from ambiguous standards and age cut-offs, misuse of labels/unfair advertising, and limited healthcare provider involvement.
- Highlighted the absence of age-appropriate reference values for pediatric DS.
Conclusions:
- Regulating pediatric DS is complex due to population diversity.
- Regulatory systems require adaptability to scientific advancements and market changes to prioritize children's health and safety.
- Swift resolution of inconsistencies is essential for effective pediatric DS oversight.
Background:
As the overall prevalence of dietary supplements (DS) use in pediatric populations is high, these products should be strictly regulated. However, regulatory frameworks for DS in the European Union and Serbia share inconsistencies and ambiguities which may compromise pediatric DS safety.
Objective:
To identify and critically assess the regulatory and practical issues in defining, labeling, advertising, and use of pediatric dietary supplements in the EU and Serbia.
Methods:
This review focused on identifying and assessing inconsistencies, gaps, and other regulatory challenges, as well as marketing practices affecting consumer safety through the assessment of legal and policy frameworks of the European Union and Serbia, and peer-reviewed articles, pertaining to the definition, labeling, and advertising of pediatric dietary supplements, that were assessed for contextual evidence on related, evidence-based, and practice-based information.
Results:
The analysis identified five critical areas of concern within the current regulations for pediatric DS: (i) the absence of universal and clear product definition, (ii) the lack of uniform, age-appropriate composition standards, (iii) potential safety risks related to ambiguous composition standards, arbitrary age cut-offs, and lack of age-appropriate reference values specific to DS, (iv) misuse of labels and unfair advertising practices, and (v) practical aspects of pediatric DS use and the limited role of healthcare providers in it.
Conclusions:
Regulating pediatric DS is a complex task due to the diversity of the pediatric population. Regulatory systems must be ready to swiftly resolve all inconsistencies and adjust to new scientific developments and market changes in order to ensure our primary goal-children's health and safety.
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