2. Product Categories

Nutraceuticals
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

Nutraceuticals

Definition

Nutraceuticals are a category of foods that consists of extracts, isolates, and purified chemical compounds that have a physiological benefit and help to maintain health. (Section 3 (g) 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]

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.

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].

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) [3] 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) [4] 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.

The nutraceuticals are meant to provide a physiological benefit and help maintain good health and are not intended to treat or cure any medical condition, disease, or disorder. 

Examples [2]: Formulations made out of plant or botanical extracts or other ingredients specified under Schedule VI of the Regulations.

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. 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. The Drugs and Cosmetics Act and Rules, the Drugs and Cosmetics Act, 1940 (23 of 1940)

https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf

4. The Narcotic Drugs and Psychotropic Substances Act,1985

https://legislative.gov.in/sites/default/files/A1985-61.pdf