Comparative evaluation of Food for Special Dietary Use (FSDU) and Food for Special Medical Purpose (FSMP) product regulatory framework in India, EU and US

Abstract

Nutraceuticals are naturally occurring compounds that is used globally due to its varied health benefits that extends beyond to basic nutrition. Various types of compounds are included in the umbrella term of nutraceuticals, including vitamins, minerals, herbal extracts, and dietary supplements. For better understanding and defined use of specific nutraceuticals in specific conditions, nutraceuticals are classified into various types, including Foods for Special Medicinal Purpose (FSMP) and Foods for Special Dietary Use (FSDU). FSMP are foods or nutraceuticals that are formulated in such a way to meet specific nutritional needs for managing medical conditions. FSMPs are designed to complement medical treatments, aiding in recovery, and improving quality of life. FSDU are formulated to meet the nutritional needs of individuals with specific dietary requirements or restrictions. FSDU are essential for ensuring individuals receive adequate nutrition while adhering to dietary restrictions. The regulatory framework for FSDU and FSMP varies significantly between countries. Each country has its own set of laws and regulations governing the production, labelling, and distribution of these products. These regulations ensure that FSDUs and FSMPs meet specific safety, efficacy, and nutritional standards relevant to local health policies and consumer protection laws. The review aimed to compare the regulatory frameworks for FSMP and FSDU across India, the US, and the EU. It focused on understanding differences in regulatory requirements for these products in each jurisdiction. By analyzing these regulatory landscapes, the study sought to highlight variations that impact manufacturers, healthcare providers, and consumers in these regions.