S. No.

Compliance Requirement

Key Requirement / Particulars

1.

Purpose and Target Conditions

Product must be specially processed/formulated to meet particular dietary requirements arising from specified physiological or health conditions, including low weight, obesity, diabetes, hypertension, pregnancy/lactation, geriatric population, celiac disease and other health conditions.

2.

Medical Advice Declaration

Label must clearly state whether the product is required to be taken under medical advice.

3.

Permitted Product Formats

May be manufactured/sold in single-use packaging or dosage forms such as granules, capsules, tablets, pills, jelly, semi-solids, sachets, measured liquids/powders and similar forms.

4.

Enteral Use

Products may be formulated for oral feeding through enteral tubes; parenteral use is prohibited.

5.

Excluded Products

Ordinary foods merely enriched/modified with nutrients for mass consumption/general health are excluded. Products intended to replace the complete diet under Food for Special Medical Purpose are also excluded.

6.

Permitted Ingredients

Ingredients must be from the specified Schedules I, II, III, IV, VI, VII or VIII.

7.

Nutrient Modification

Scheduled nutrients may be modified where necessary for the intended use of the product.

8.

New Nutrients

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

9.

Vitamins & Minerals

Nutrients may exceed the recommended daily allowance where permitted, but must not exceed the limits prescribed in Schedule III.

10.

Formula Food – All-Day Replacement

Where formula food replaces all meals for slimming/weight management, energy must be 800–1,200 kcal (3,350–5,020 kJ) per day.

11.

Individual Servings

For all-meal replacement formula foods, each serving should provide approximately one-third or one-fourth of total daily energy where 3 or 4 servings are recommended respectively.

12.

Formula Food – Meal Replacement

Formula food replacing one or more meals must provide 200–400 kcal (835–1,670 kJ) per meal.

13.

Maximum Energy – Major Diet Replacement

Where the product replaces the major part of the diet, total energy intake must not exceed 1,200 kcal (5,020 kJ).

14.

Protein Energy Contribution

25%–50% of available energy, when ready-to-serve, must be derived from protein.

15.

Maximum Protein

Total protein must not exceed 125 g/day.

16.

Protein Quality

Protein quality must comply with the specified Protein Digestibility Corrected Amino Acid Score (PDCAAS) requirements.

17.

Weight-Control Formula Protein

Protein having a PDCAAS of 0.8 or more may be used in formula food for weight-control diets.

18.

Essential Amino Acids

Only L-forms of essential amino acids may be added for improving protein quality, except methionine, for which the DL form is permitted.

19.

Fat Content

Not more than 30% of available energy may be derived from fat.

20.

Linoleic Acid

Not less than 3% of energy must be derived from linoleic acid in glyceride form.

21.

Vitamins & Minerals – All-Meal Replacement

Formula food replacing all meals must provide at least 100% of the recommended daily allowance of vitamins and minerals in the daily intake.

22.

Dietary Fibre

Formula food for special dietary use must contain adequate dietary fibre.

23.

Disease Claims

No label statement/claim may imply prevention, cure, treatment or diagnosis of a specific disease, or interference with normal physiological functions, unless approved by the Food Authority.

24.

Structure/Function Claims

Statements regarding structure, function or general well-being may be made where permitted by the Food Authority and supported by generally accepted scientific data.

25.

Mandatory Product Name

Label must carry “FOOD FOR SPECIAL DIETARY USE”, followed by “Food for……” specifying the relevant physiological or health condition.

26.

Weight-Control Declaration

Products specifically prepared for weight management/control must carry “For weight control and management” in close proximity to the product name.

27.

Restricted Consumer Warning

Label must state that the product is not to be used by pregnant, nursing/lactating women, infants, children, adolescents and elderly persons except when medically advised.

28.

Target Consumer Information

Label must specify the target consumer group, rationale for use and properties/characteristics making the product useful.

29.

Age Group Declaration

Where formulated for a specific age group, this must be prominently stated.

30.

Nutrient Modification Declaration

Label must specify the nutrient that has been reduced, deleted, increased or otherwise modified compared with normal requirements, together with the rationale.

31.

Medicinal Use Warning

Prominent warning “NOT FOR MEDICINAL USE” must be displayed.

32.

Excess Consumption Warning

Appropriate warning must be provided where excessive consumption may present a danger.

33.

Parenteral Use Warning

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

34.

Safety & Precaution Information

Applicable warnings/precautions, known side effects, contraindications and product-drug interactions must be declared.

35.

Nutrient Declaration

Nutrient quantities must be expressed as a percentage of the recommended daily allowance wherever appropriate.

36.

Osmolality/Osmolarity Information

Information on osmolality, osmolarity or acid-base balance must be provided where appropriate.

37.

Storage Warning

Label must state that the product should be stored out of reach of children.

38.

Food Additives

Only additives specified in Schedule VB, Schedule VE or Schedule VF may be used.