Dietary Supplements’ Regulation: Are We Doing Enough to Protect the Children? A Narrative Review

TL;DR

This paper reviews how dietary supplements for children are regulated in the EU and Serbia, highlighting gaps that could harm children's safety.

Contribution

The paper identifies five critical regulatory issues affecting the safety and proper use of dietary supplements in children.

Findings

Current regulations lack a universal definition for pediatric dietary supplements.

Labeling and advertising practices often mislead consumers.

Healthcare providers have a limited role in guiding pediatric supplement use.

Abstract

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.