2. Product Categories
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2. Product Categories
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Health/Food Supplements
India
This section provides the regulatory definition of the food category in scope, or the appropriate food category for the product in scope. Additionally, it provides the food products that belong to this food category along with the definition and specific information on each of these types of food products.
2.1 Category Name & Definition [1-5]
Category Name
Health supplements / Food supplements
Definition
Health supplement is a category of foods, which consists of a concentrated source of nutrients (like proteins, minerals, vitamins, and amino acids) and/or other ingredients with nutritional or physiological effects, singly or in combination, whose purpose is to supplement the normal diet. (Section 3 (e) of [3]).
Health supplements term on the label may be interchangeably used by the terms, namely, Dietary supplements or Food supplements.
Specifications/Target Age
Target age: Health supplements may be used to supplement the normal diet of a person above the age of 2 years old. The products covered intended for children of 2 to 5 years of age, shall only be given under medical advice by a recognized medical doctor or dietician or nutritionist. [3]
Delivery format [3]: Section 5 (1) a)
Products may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly, and other dosage forms but not parenteral, and are meant for oral administration; in the form of powders, granules, tablets, capsules, liquids, semi-solids, drops, pills, gummies, jelly, chewable and mouth dissolving strips, bars, biscuits, candies that are intended to be consumed orally in defined quantities and duration.
General and Specific category requirements can be referred to in Annexure 1 per advisory inputs on the draft notifications of Food Safety and Standards (Health Supplements, Nutraceuticals, Food for special dietary use, Food for special medical purposes, Functional food, and Novel Food) Regulations, 2022 [3].
Example in Section 6 (c) [3]:
For health supplement categories, the individual nutrient content shall not be less than 15% of the RDA as specified by the Indian Council of Medical Research, where a nutrient content claim is being made. Provided that, if the claim of higher nutrient content is made, the nutrient content shall not be less than 30% of the RDA and shall not exceed one RDA in any case. In case such standards are not specified, the standards laid down by an international food standards body, namely the Codex Alimantarius Commission, shall apply.
Additional Information
Scope covered [3]: Section 2 (4) - (7)
(4) The products falling under these regulations shall not include a drug as defined in clauses (a), (b), and (h) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) [4] and rules made thereunder.
(5) The products falling under these regulations shall not contain hormones or steroids or a narcotic drug or a psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act,1985 (61 of 1985) [5] and rules made thereunder and substances listed in Schedules E and E-1 of the Drugs and Cosmetics Rules,1945.
(6) Not intended to treat or cure any deficiency - The Products claiming cure, prevention, or mitigation of any specific disease, disorder or condition shall also not fall under these regulations unless specifically permitted by the Food Authority under FSS regulations.
(7) Mere food forms such as vegetables, for example, bhindi, karela, and other vegetables; cereals, for example, ragi, jowar, millets and other cereals; legumes, for example, rajmah and other legumes; spices, for example, pepper, jeera, turmeric and other spices; fruits, for example, amla, jamun, grapes and other fruits; and other plants or botanicals, minimally processed (cleaned, de-weeded, sorted, dried or powdered), in either as juice or cooked form, shall not constitute here.
Health supplements may be used to supplement the normal diet of a person - shall contain a 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 effects, which are presented as such and are offered alone or in combination but are not drugs as defined in the Drugs and Cosmetics Act, 1940.
They are intended to correct nutritional deficiencies and maintain adequate intake of certain nutrients. They are not medicinal products therefore their use is not expected to treat or prevent diseases in humans.
Examples [2]: Protein Supplements, Vitamins, and mineral formulations with food components intended for general people.
2.2 Product & Definition
N/A
2.3 References
1. The Food Safety and Standards Act, 2006
(Refer Section 22 (1))
2. Guidance notes on Food for Special Medical Purposes
https://fssai.gov.in/upload/uploadfiles/files/Guidance_Note_FSMP_28_08_2020.pdf
(As references to examples)
3. Direction under Section 16(5) of the Food Safety and Standards Act, 2006 regarding Operationalization of FSS ( Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special medical Purpose and Prebiotics and Probiotic Food) Regulations [FSS (Nutra) Regulations 2022
https://www.fssai.gov.in/upload/advisories/2022/04/624ac1be799dbDirection_Nutra_30_03_2022.pdf
4. The Drugs and Cosmetics Act and Rules, the Drugs and Cosmetics Act, 1940 (23 of 1940)
5. The Narcotic Drugs and Psychotropic Substances Act,1985
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