Preterm Infant explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Regulation 12 sets the standard for food for special medical purpose (FSMP) intended for infants from birth to 24 months, and bars its advertising. Regulation 13 sets a nutrient table and two extra label statements for preterm infant milk substitutes, needed for babies born before 37 weeks.
The text is read as amended up to 30 August 2022 (FSSAI Compendium Version II dated 04.01.2024, which marks some provisions published in a corrigendum dated 31.03.2021). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in. Makers of these specialised products can look at our central FSSAI licence service.
FSMP for infants is for use under medical need, and "No food business operator shall advertise the infant formula for special medical purpose intended for infants". Its composition follows infant formula or follow-up formula except where modified for the condition, and its safety and benefit must be scientifically demonstrated. A preterm infant milk substitute is for babies born before 37 weeks, till they attain 40 weeks of age or as prescribed by a physician, and its label must say it is taken under medical advice only.
Regulation 12: food for special medical purpose intended for infants
The standard applies to FSMP intended for infants from birth to 24 months, in liquid or powdered form, intended for use, where necessary, as a substitute for human milk or formula in meeting the special nutritional requirements arising from the disorders, diseases or medical conditions for whose dietary management the product has been formulated.
Regulation 12(1): composition
- (a) A product based on ingredients, from known and well established sources, suitable for human consumption.
- (b) The composition shall be based on sound medical and nutritional principles. Nutritional safety and adequacy shall be scientifically demonstrated to support the growth and development of the infants for whom it is intended, and its use shall be demonstrated by scientific evidence to be beneficial in their dietary management.
- (c) Except for preterm infant milk substitute, energy content and nutrient composition shall be based on the requirements for infant formula and follow-up formula, as applicable to the intended age group, except for the compositional provisions that must be modified for the special requirements arising from the disease, disorder or condition.
- (d) Optional ingredients as specified under infant formula may be added to ensure the formulation is suitable as the sole source of nutrition and for dietary management.
- (e) Suitability for the intended special medical purpose and the safety of the substances shall be scientifically demonstrated, and the formula shall contain sufficient amounts to achieve the intended effect.
Regulation 12(2) and 12(3)
Regulation 12(2): no food business operator shall advertise the infant formula for special medical purpose intended for infants. Regulation 12(3): FSMP for infants shall comply with the additive provisions in regulation 7(2) (infant formula) and regulation 10(2) (follow-up formula), as applicable; the additives in Schedule I(d) for special nutrient formulations may also be used. See our articles on infant formula and follow-up formula.
Regulation 3(1) separately requires approval of an article and its label where no standard is specified, and regulation 3(9) relaxes the standard pack size rule of the Legal Metrology (Packaged Commodities) Rules, 2011 for FSMP intended for infants. On the label side, the proviso to regulation 4(1)(a) dispenses with the mother's-milk statement where breastfeeding is contraindicated on medical grounds for the condition the product is intended for.
Regulation 13: preterm infant milk substitute
The preterm infant milk substitute is required "for babies born before 37 weeks only and till they attain 40 weeks of age or as prescribed by physician".
Regulation 13(1): the nutrient table
The substitutes shall meet a table of 37 serial numbers. Its columns are the nutrient, the requirement per 100 kcal and the requirement per kg/day. A few entries as printed:
| Serial | Nutrient | Per 100 kcal | Per kg/day |
|---|---|---|---|
| 1 | Fluids | - | 135.00-200.00 |
| 2 | Energy, kcal | - | 110.00-130.00 |
| 3 | Total protein, g | 3.20-4.10 | 3.50-4.50 |
| 4 | Total fat, g | 4.40-6.00 | 4.80-6.60 |
| 8 | Carbohydrate, g | 10.50-12.00 | 11.60-13.20 |
| 9 | Sodium, mg | 63.00-105.00 | 69.00-115.00 |
| 15 | Iron, mg | 1.80-2.70 | 2.00-3.00 |
Serial number 4 also carries sub-lines for linoleic acid and alpha-linolenic acid. The table then runs through DHA, EPA (Max) and ARA, the minerals, and the vitamins to inositol (serial 37). Some units differ from those in the standards for term infants (for instance chromium in nanograms), so the compendium itself should be read for each entry.
Regulation 13(2): extra label statements
The containers or labels of preterm infant milk substitute shall indicate:
- (a) the words "FOR THE PRETERM BABY (BORN BEFORE 37 WEEKS)" in capital and bold letters, with the product name in the central panel; and
- (b) a statement "RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY" in capital and bold letters.
How the two regulations differ
| Point | Regulation 12 (FSMP) | Regulation 13 (preterm) |
|---|---|---|
| Age group | Birth to 24 months | Babies born before 37 weeks until they attain 40 weeks, or as prescribed by a physician |
| Composition | Based on infant formula or follow-up formula, modified for the condition | Own table of 37 serial numbers per 100 kcal and per kg/day |
| Advertising | Barred (12(2)) | Not separately barred in regulation 13 |
| Added label words | Left to the other regulations | Two capital-and-bold statements (13(2)) |
Advertising of infant milk substitutes in general is also governed by the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (named in regulation 3(8) and not explained here) and by the Advertising and Claims Regulations.
An invented example
Neo Care Nutrition develops a powder for infants with a metabolic condition that restricts a nutrient, based on follow-up formula but with that nutrient changed. It is FSMP under regulation 12: its safety and benefit must be shown scientifically, and the company may not advertise it. Neo Care also launches a premature-baby formula. The label carries "FOR THE PRETERM BABY (BORN BEFORE 37 WEEKS)" in capital and bold letters with the product name on the central panel and the medical advice statement; the lab report is checked against the 37-row table, including the per-kg figure for fluids.
Need help with FSMP or preterm formula?
These categories carry scientific evidence duties, an advertising bar and label statements that are easy to get wrong. Our central FSSAI licence team can help prepare the licence and the dossier, and check the label wording before printing.
Key takeaways
- FSMP for infants covers birth to 24 months and follows infant formula or follow-up formula standards, modified for the condition.
- Its safety, adequacy and benefit must be scientifically demonstrated.
- Advertising of infant FSMP is barred by regulation 12(2).
- Preterm infant milk substitutes serve babies born before 37 weeks, until they attain 40 weeks of age or as a physician prescribes.
- Preterm labels carry two capital-and-bold statements, including medical advice only.
Read next
- Regulations 10 and 11: follow-up formula and traditional foods
- Regulations 14–16: lactose-intolerance, hypoallergenic and IEM foods
- Regulation 7: the infant formula standard
- Infant food and baby food standards: an overview
Disclaimer: Based on the FSSAI regulations named above as consolidated in FSSAI's compendium versions or as published in the Gazette, with the later notifications the article names (consulted on fssai.gov.in on 2-3 October 2026). Later notifications and the Food Safety and Standards Act, 2006 provisions referred to should be checked. This article is general information, not legal advice; check the official text before acting.