Comparative nutritional analysis of four commercial infant formulas: compliance with food and drug administration regulations and developmental appropriateness across 0-6 and 6-12-month stages

Nidhi Srivastava; Ayush Jain; Siddhant Mehrotra; Suyog Sindhu; Rakesh Kumar Dixit

doi:10.18203/2349-3291.ijcp20261527

Authors

Nidhi Srivastava Department of Pharmacology and Therapeutics, KGMU, Lucknow, Uttar Pradesh, India
Ayush Jain Department of Pharmacology and Therapeutics, KGMU, Lucknow, Uttar Pradesh, India
Siddhant Mehrotra Department of Pharmacology and Therapeutics, KGMU, Lucknow, Uttar Pradesh, India
Suyog Sindhu Department of Pharmacology and Therapeutics, KGMU, Lucknow, Uttar Pradesh, India
Rakesh Kumar Dixit Department of Pharmacology and Therapeutics, KGMU, Lucknow, Uttar Pradesh, India

DOI:

https://doi.org/10.18203/2349-3291.ijcp20261527

Keywords:

Infant formula, FDA regulations, DHA, Probiotics, HMOs, Nutritional composition, Developmental stages

Abstract

Background: Infant formula serves as the primary nutritional source for non- breastfed infants, requiring strict adherence to regulatory standards while meeting developmental needs across different age stages. Objectives were to comparatively evaluate four commercially available infant formulas (Nestlé NAN PRO, Similac Advance, Aptamil Gold, and Nestlé Lactogen PRO) against Food and Drug administration (FDA) nutrient specifications and analyze their compositional appropriateness for stage 1 (0-6 months) and stage 2 (6-12 months).

Methods: Label-based comparative analysis of macronutrients, micronutrients, functional lipids Docosahexaenoic acid/ arachidonic acid (DHA/ARA), bioactive components [(probiotics, prebiotics, human milk oligosaccharides (HMOs), and added sugars. All values were normalized per 100 kcal and compared against food and drug administration (FDA) minimum and maximum requirements.

Results: All four formulas met FDA macronutrient specifications. Stage 2 formulations showed 14-48% protein increases and 40-300% sugar increases compared to stage 1. Aptamil Gold demonstrated the most comprehensive functional profile with five HMOs, GOS/FOS prebiotics, and DHA/ARA across both stages. NAN PRO maintained DHA/ARA consistency but discontinued probiotics in stage 2. Similac Advance exhibited the highest added sugar content in stage 2 (30 g/100 g) while retaining milk fat. Lactogen PRO emphasized digestibility through probiotics but lacked long-chain polyunsaturated fatty acids (LC-PUFAs). Iron content across all brands (6.5-9 mg/100 g stage 2) exceeded FDA minimum requirements, appropriately addressing post-6-month Anemia risk.

Conclusions: While all formulas comply with FDA nutrient specifications, significant compositional heterogeneity exists in functional ingredients and added sugars, potentially impacting gut microbiome development, neurocognitive outcomes, and metabolic programming. These findings underscore the importance of evidence-based formula selection aligned with individual infant nutritional needs.

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