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What is difference between nutraceuticals and health supplements in india?

December 13, 2019
ANSWER

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.

Description Nutraceuticals 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:-

  1. The word “NUTRACEUTICAL”;
  2. The common name of the nutraceutical;
  3. A declaration as to the amount of each nutraceutical ingredient in the product that either has a nutritional or physiological effect;
  4. Where it is appropriate, the quantity of nutrient shall be expressed in terms of percentage of the relevant recommended daily allowances as specified by the Indian Council of Medical Research even when the nutrient is present along with a nutraceutical as an adjunct and shall bear an advisory warning ‘not to exceed the stated recommended daily usage’;
  5. an advisory warning for ‘recommended usage’ ;
  6. an advisory warning ‘NOT FOR MEDICINAL USE’;
  7. an advisory warning in cases where a danger may exist with excess consumption;
  8. an advisory warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable;
  9. a statement that the product is required to be stored out of reach of children

 

 Every package of health supplement shall carry the following information on the label, namely.-

  1. The words “HEALTH SUPPLEMENT”;
  2. the common name of the health supplement, or a description sufficient to indicate the true nature of the health supplement including the common names of the categories of nutrients or substances that characterise the product;
  3. a declaration as to the amount of the nutrients or substances with a nutritional or physiological effect present in the product;
  4. an advisory warning ‘NOT FOR MEDICINAL USE’;
  5. the quantity of nutrients, where applicable expressed in terms of percentahe of the relevant recommended daily allowance as specified by the Indian Council of Medical Research and bear a warning, “Not to exceed the recommended daily usage”;
  6. a statement that the health supplement is not be used as a substitute for a varied diet;
  7. a warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and published product or drug interactions, as applicable; and
  8. a statement that the product is required to be stored out of reach of children

 

 

Reference

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.

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