Food for Special Dietary Use (FSDU) refers to foods formulated to meet specific nutritional requirements resulting from physiological or pathological conditions. With increasing global health challenges, the demand for such specialized nutrition products is on the rise. This manuscript provides a comprehensive overview of the definition, classification, examples, and global regulatory frameworks of FSDUs, including guidelines from FSSAI (India), FDA (USA), and EFSA (EU). It highlights the role of FSDUs in supporting dietary needs of targeted populations and outlines labelling, safety, and compliance requirements.
Food for Special Dietary Use (FSDU) is a regulatory category encompassing food products specially designed to fulfil the nutritional needs of individuals with unique physiological or medical conditions (FSSAI, 2021). These foods differ significantly from conventional dietary products, both in formulation and intended use.
According to the Food Safety and Standards Authority of India (FSSAI), FSDUs are defined as foods specially processed or formulated to satisfy the distinctive dietary needs arising from specific health conditions or physiological states, such as metabolic disorders, pregnancy, or advanced age (FSSAI, 2021).
The primary purpose of FSDUs is to provide essential nutrition to individuals unable to meet their dietary needs through normal food intake due to disease, disorder, or particular health stages.
FSSAI’s regulatory framework for FSDUs includes:
The U.S. FDA governs FSDUs under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which includes:
FSDUs in the U.S. are regulated differently from foods for special medical purposes (FSMPs) or medical foods, with fewer pre-market approval requirements but stringent labelling expectations.
The European Food Safety Authority (EFSA) supports FSDU regulation through:
FSDUs represent a vital segment within the broader functional and clinical nutrition industry. As demand increases, regulatory agencies play a crucial role in ensuring safety, efficacy, and transparency. Future innovations must align with both scientific evidence and regional compliance mandates to ensure consumer trust and therapeutic benefit.
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