III. CONTENT AND COMPOSITION HEALTH SUPPLEMENTS IN INDIA
Pursuant to the Food Safety and Standard (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 (hereinafter Food Safety and Standard Regulations, 2016), health supplements “shall contain concentrated source of one or more nutrients, namely, amino acids, enzymes, minerals, proteins, vitamins, other dietary substances, plants or botanicals, prebiotics, probiotics and substances from animal origin or other similar substances with known and established nutritional or beneficial physiological effect, which are presented as such and are offered alone or in combination, but are not drugs”.
Schedules I, II, IV, VI (enzymes only), VII, VIII of the Food Safety and Standards Regulations, 2016, specify the list of ingredients that a health supplements may contain. Additives listed in Schedules VA, VE and VF may also be used.
Furthermore, when adding nutrients to a health supplement, the nutrient’s recommended daily allowance as specified by the Indian Council of Medical Research and the Codex Alimentarius Commission, must not be exceeded.