The Food Safety and Standards Authority of India (FSSAI) has issued new rules for nutraceuticals and health supplement called Food Safety and Standard (Health Supplements, Nutraceuticals, Food for Special Dietary use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.
Table below has shown the difference between the Nutraceutical and Health Supplement.
|1||Definition||Shall provide a physiological benefit and help maintain good health.||May be used to supplement the normal diet of a person above the age of five years.|
|2||Ingredients||May extract, isolate and purify nutraceuticals from food or non-food sources, that is preparing amino acids and their derivatives by bacterial fermentation under controlled conditions.||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.|
|3||Product/Packaging Form||food-format of granules, powder, tablet, capsule, liquid, jelly or gel, semi-solids and other formats or packed in sachet, ampoule, bottle, and in any other format as measured unit quantities except those formats that are meant for parenteral administration||Shall be marketed in single use packaging or in dosage forms namely, capsules, tablets, pills, sachets; jelly or gel, semi-solids and other similar forms or any other forms of liquids and powders designed to be taken in as measured unit quantities.|
|4||Packaging Information||Every package of food containing nutraceutical shall carry the following information on the label, namely:-
|Every package of health supplement shall carry the following information on the label, namely.-
Food Safety and Stanadards Authority of India. (2016). Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.