Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.

These Regulations provide standards for and regulate the use of Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food. Regulation 3 contains general requirements in respect of articles of food sold in capsule format, or as tablets and syrups and states that they shall fulfil quality requirements and standards as specified in Indian Pharmacopoeia, British Pharmacopoeia or United States Pharmacopoeia. The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research or Codex Alimentarius Commission, as the case may be. It also states that the articles of food must conform to the regulations made in respect of packaging, labelling, contaminants, toxins and residues. Regulation 4 makes provision with regards to nutritional or health claims by food business operator in respect of an article of food. Regulation 6 & 7 provide for conditions for Health supplements and Nutraceuticals. Regulation 8 & 9 deal with food for special dietary use and food for special medical purpose. Regulation 13 prohibits manufacture or import of novel food for commercial purpose without the prior approval of the Food Authority.