2. Product Categories

Food for Special Medical Purposes
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 Medical Purposes (FSMP)

Definition

Food for special medical purposes is food intended for a category of foods for special medical uses, which are specially processed or formulated and presented for the dietary management of patients and may be used only under medical supervision. They are intended for the exclusive or partial feeding of patients with limited or impaired capacity to take, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients contained therein, or who have other special medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for special dietary uses, or by a combination of the two. (Section 3 (d) 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 dietitian 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.

However, formats namely, tablet/capsule/pills/liquid drops, gummies, jelly, chewable, and mouth-dissolving strips are not permitted. An FBO may formulate food for special medical purposes in a format meant for oral feeding through enteral tubes 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 FSMP - Details of the requirements can be referred to in (Section 6 (4.1) and (4.2) [1]): 

1. Weight management
2. Food intended for Special Diagnostic Purposes 

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 Medical Purpose (FSMP) applies under Section 6 (4) [1]:

1. Applies to the foods especially meant for the dietary management of persons with specific medical conditions or diseases or disorders.
2. The articles of food for special medical purposes, other than those intended for infants, may either be nutritionally complete food which, when used in accordance with the manufacturer's instructions, shall constitute the sole source of nourishment for the persons for whom they are intended or nutritionally incomplete food with formulation specific for a disease, disorder or medical condition, but are not suitable to be used as the sole source of nourishment. 

Accordingly, FSMP may be classified into the following three categories:

1. ‘Nutritionally complete food with a standard nutrient formulation’, which when used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom they are intended.
2. ‘Nutritionally complete food with a nutrient-adopted formulation specific for a disease, disorder or medical condition’, which when used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom they are intended.
3. ‘Nutritionally incomplete food with a standard formulation or a nutrient adopted formulation specific for a disease, disorder or medical condition’, which is not suitable to be used as the sole source of nourishment.

Note: the food specified in items (B) and (C) of sub-clause (ii) may be used as a partial replacement or as a supplement to the person’s diet.

Subcategories of FSMP applied:

1. Weight Management
   1. Applies to formula foods for use in very low-energy diets for weight reduction intended as a total replacement of diet. These foods are defined as foods for special medical purposes and must be used under medical supervision by individuals with moderate or severe obesity.
   2. It does not apply to prepackaged meals presented in the form of conventional foods.
2. Food intended for Special Diagnostic Purposes - applies to formula foods used during Special Diagnostic Purposes. 
   

Examples [4]:

A. Nutritionally complete food with standard nutrient formulation: Food specially prepared for weight reduction and intended as a total replacement for a complete diet, People suffering or recovering from serious illness, people recovering from stroke or severe food allergy, for patients with trauma, infection and surgery, enteral formulas for gastroenterological conditions. 

B. Nutritionally complete food with the nutrient-adopted formulation: Special dietary formulas for persons suffering from chronic metabolic disorders including food protein allergy, fatty acid metabolism, gastrointestinal disorders, kidney disease, MCT (Medium Chain Triglycerides) containing formulas for malabsorption conditions, patients with inflammatory bowel disease, etc. 

C. Nutritionally incomplete food with standard formulation or a nutrient-adopted formulation: For persons suffering from acute metabolic disorders, gastrointestinal disorders, kidney disease, protein substitute for metabolic conditions, 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)

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

3. The Narcotic Drugs and Psychotropic Substances Act,1985

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

4. 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)