Focusing on food safety in relation to the international regulatory framework for dietary supplements: A mini review

Dietary Supplements (DS) represent a rapidly expanding segment of the global food market and are widely consumed in Western countries to support nutritional and physiological needs. Despite their broad availability and cross-border commercialization, DS are regulated through markedly different legal frameworks across jurisdictions. This mini-review compares the regulatory approaches governing DS in the European Union (EU) and the United States (US), the two largest global markets, to identify regulatory strengths, key differences, and potential gaps relevant to food safety and consumer protection. A comparative narrative analysis of the EU and US legislative frameworks was conducted, focusing on safety evaluation requirements, authorization of novel ingredients, labeling rules, health claims, and post-market surveillance mechanisms. The EU adopts a predominantly preventive and pre-market–oriented regulatory model, requiring prior authorization for novel foods and scientific substantiation of health claims through the European Food Safety Authority (EFSA). In contrast, the US regulatory framework, established under the Dietary Supplement Health and Education Act (DSHEA), relies largely on manufacturer responsibility and post-market oversight by the Food and Drug Administration (FDA). These divergent regulatory philosophies reflect a balance between precaution and market flexibility, with implications for risk detection, enforcement capacity, and consumer trust. In the context of increasing e-commerce and globalized supply chains, understanding these differences is essential. Strengthening regulatory cooperation and enhancing nutrivigilance systems may help address current limitations and support more consistent consumer protection in the international dietary supplement market.