This draft regulation is intended to supersede the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016. The regulations list out the permitted delivery formats for each supplement category and the related permitted ingredients (along with their purity & permissible quantity), additives, along with the labeling requirements.
This draft regulation covers the food products that are specially processed or formulated for certain dietary or nutritional purposes. Such food is different from normal food and only intended for the population above the age of two years for oral consumption in defined quantities and duration. These products should not include products for parenteral use.
Categories included in this regulation include - Nutraceuticals, Health Supplements, Prebiotic food and Probiotic food (Pre-Pro), Food for Special Medical Purpose (FSMP) and Food for Special Dietary Use (FSDU).
- Nutraceuticals food category consists of extracts or compounds having a health benefit.
- Health supplement food category consists of products that are concentrated source of nutrients.
- FSMP food category is for special medical use for dietary management of patients.
- FSDU food category is for products that are specially processed or formulated to satisfy particular dietary requirements due to particular physical or physiological condition and/or specific diseases and disorders
- Prebiotic food contains added ingredients with non-viable components confer health benefits to the consumer by modulation of gut microbiota.
- Probiotic food contains live micro-organisms.
No person should sell, manufacture, pack, market or import any food products unless they comply with the requirements laid down in these regulations.
The products falling under these rules should not contain a drug as defined in the Drugs and Cosmetics Act, 1940 (23 of 1940). Products such as steroids, hormones, narcotics, or psychotropic substances must not be present in these. The products claiming prevention, cure, or mitigation of any specific disorder, disease, or condition do not fall under these regulations.