2. Product Categories
- 4 Mins to read
- DarkLight
2. Product Categories
- 4 Mins to read
- DarkLight
Article summary
Did you find this summary helpful?
Thank you for your feedback
Food for Special Dietary Uses (FSDU)
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
Category Name
Food for Special Dietary Uses (FSDU)
Definition
Food for special dietary use is a category of foods, which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition and/or specific diseases and disorders and which are presented as such. The composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature if such ordinary foods exist. FSDU which are intended to be used as an adjunct for the management of diseases/disorders only under medical prescription and supervision shall normally be categorized under FSMP. (Section 3 (c) of [1])
Specifications/Target Age
Target age: 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. [1] And a statement that the product is not to be used by pregnant, nursing, and lactating women or children under 5 years, adolescents, and elderly, except when medically advised by a physician or certified dietician or nutrition professional.
Delivery format [1]: 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.
In addition, the Food Business Operator (FBO) may formulate an article of food for special dietary use in formats meant for oral feeding through an enteral tube unless otherwise restricted under sub-categories of FSDU but shall not be used for parenteral use.
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 [1].
Subcategories of FSDU - Details of the requirements can be referred to in (Section 6 (3.1) [1]):
- Weight management
- Food for Sportsperson
Additional Information
Scope covered [1]: 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) [2] 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) [3] 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.
Food for special dietary use (FSDU) under Section 6 (3) [1]:
- Applies to all prepackaged foods for special dietary uses, in case of weight management, obesity, diabetes, high blood pressure, pregnant and lactating women, geriatric population, celiac disease, sleep management, food for sportspersons, and other health conditions.
- Any other special dietary use products containing the approved ingredients shall need prior approval from the Food Authority by submitting the representation along with scientific justification.
- FSDU shall not include normal food which is merely enriched or modified with nutrients and meant for mass consumption, intended for improvement of general health for day-to-day use, and do not claim to be targeted to consumers with specific disease conditions and also not include the article of food intended to replace complete diet covered under food for special medical purpose.
Subcategories of FSDU applied:
- Weight Management
- Applies to foods which, when presented as "ready-to-serve” or when prepared in conformity with the directions for use by the manufacturer, are presented as a replacement for all or part of the total daily diet for use in weight control.
- It does not apply to prepackaged meals controlled in energy and presented in the form of conventional foods.
- Food for Sportsperson - Applies to foods that are presented as food for sportspersons in formats meant for oral consumption and to be used only under medical advice by a physician or certified dietician or nutritional professional and shall not be applicable to liquid products/beverages and premixes (to be reconstituted) which are specified under Appendix A; Food category system 14.1.4 of FSS (FPS &FA) Regulations [4].
Examples [5]: Meal replacement products intended for slimming/weight management/weight control products, sports supplements, specifically designed dietary formulations for pregnant and lactating women, geriatric population, celiac diseases, etc.
2.2 Product & Definition
N/A
2.3 References
1. 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
2. The Drugs and Cosmetics Act and Rules, the Drugs and Cosmetics Act, 1940 (23 of 1940)
3. The Narcotic Drugs and Psychotropic Substances Act,1985
https://legislative.gov.in/sites/default/files/A1985-61.pdf
4. Compendium of Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011
5. 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)
Was this article helpful?