S. No.

Compliance Requirement

Key Requirement / Action Point

1

Permitted Product Category

Ensure the product qualifies as Food for Special Medical Purpose (FSMP) and is specially prepared for particular dietary/medical requirements.

2

Weight-Reduction Products

FSMP may include food specially prepared for weight reduction intended as total replacement of the normal diet.

3

Enteral Feeding

FSMP may be formulated for oral feeding through enteral tubes.

4

Parenteral Use Prohibited

FSMP shall not be intended or used for parenteral administration.

5

Nutritionally Complete Food

May be nutritionally complete and, when used according to the manufacturer's instructions, may constitute the sole source of nourishment.

6

Nutritionally Incomplete Food

May be formulated for a specific disease, disorder or medical condition but shall not be suitable as the sole source of nourishment.

7

Classification – Standard Formulation

Nutritionally complete food with a standard nutrient formulation may constitute the sole source of nourishment when used as instructed.

8

Classification – Disease-Specific Formulation

Nutritionally complete food with a nutrient-adapted formulation specific to a disease, disorder or medical condition may constitute the sole source of nourishment when used as instructed.

9

Classification – Incomplete Formulation

Nutritionally incomplete food may have a standard or disease-specific nutrient-adapted formulation and shall not be used as the sole source of nourishment.

10

Partial Replacement / Supplement

Products falling under disease-specific complete or incomplete categories may be used as a partial replacement or supplement to the person's diet.

11

Permitted Nutrients / Ingredients

Use only ingredients/nutrients specified in Schedule I, II, III, IV, VII or VIII, and enzymes specified in Schedule VI, subject to applicable requirements.

12

Modification of Nutrients

Modifications to specified nutrients may be made where necessary for the intended use of the product.

13

New Nutrient Approval

For a nutrient having no history of use in India or lacking evidence of nutritional/physiological benefit, the FBO may apply to the Food Authority for approval, with scientific justification.

14

Approved Nutrient List

Use new nutrients only after they are approved/specifically permitted by the Food Authority following scientific evaluation.

15

Very Low Energy Diet – Energy

For FSMP intended as total diet replacement for weight reduction, the prepared product shall provide 450–800 kcal/day as the only source of energy.

16

Very Low Energy Diet – Protein

Recommended daily intake shall contain at least 50 g protein with a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 1.

17

Essential Amino Acids

Essential amino acids may be added only to the extent necessary to improve protein quality.

18

Form of Amino Acids

Only L-forms of essential amino acids shall be used, except methionine for which the DL-form is permitted.

19

Linoleic Acid

Very low energy diet shall provide at least 3 g linoleic acid/day.

20

α-Linolenic Acid

Very low energy diet shall provide at least 0.5 g α-linolenic acid/day.

21

Fatty Acid Ratio

Ratio of α-linoleic acid and linolenic acid shall be maintained between 1:5 and 1:15, as prescribed.

22

Available Carbohydrates

Very low energy diet shall provide at least 50 g available carbohydrates/day.

23

Dietary Fibre

FSMP formulated as a very low energy diet shall contain adequate dietary fibre.

24

Vitamins & Minerals

Nutrients may be added above the recommended daily allowance, but vitamin and mineral levels shall not exceed Schedule III limits.

25

Product Name on Label

The words “FOOD FOR SPECIAL MEDICAL PURPOSE” shall appear immediately proximate to the product's name/brand name.

26

Medical Advice Warning

Label shall prominently display “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY” in bold letters and separately from other information.

27

Disease / Condition Statement

Label shall state “For the dietary management of ________”, specifying the relevant disease, disorder or medical condition.

28

Scientific Substantiation

Disease/condition-related statement must be supported by appropriate scientific, clinical or epidemiological data and is subject to Food Authority approval.

29

Nutritionally Complete Declaration

Where applicable, label shall state “NUTRITIONALLY COMPLETE”.

30

Rationale for Use

Label shall explain the rationale for use by the target consumer group and the relevant properties/characteristics of the product.

31

Age Group

Where formulated for a specific age group, the applicable age-group statement shall be provided.

32

Modified Nutrients Declaration

Specify nutrients that have been reduced, deleted, increased or otherwise modified compared with normal requirements, along with the rationale.

33

RDA Information

Where appropriate, express nutrient quantities as percentages of recommended daily allowances.

34

Technical Information

Provide information on osmolality/osmolarity, Renal Solute Load, Potential Renal Solute Load or acid-base balance, wherever applicable.

35

Preparation & Feeding Instructions

Provide appropriate instructions for preparation, feeding and use of the product.

36

Storage Instructions

Provide instructions regarding storage after opening the container.

37

Parenteral Warning

Label shall carry a warning that the product is not for parenteral use.

38

Child Safety Statement

Label shall state that the product is required to be stored out of reach of children.

39

Permitted Additives

Use only additives permitted under Schedule VC, VD, VE or VF.

40

Advertising Restriction

FSMP shall not be advertised for use by the general public.