FSSAI Files Cases Against Nestle Over Infant Nutrition

The Food Safety and Standards Authority of India (FSSAI) has initiated three adjudication cases against Nestle India. Specifically, the regulator flagged improper promotional claims alongside a case of sub-standard infant formula. The authority examined popular infant formula products, including NAN Excella Pro Stage 1 and Lactogen Pro 1. Consequently, this enforcement highlights rigorous regulatory oversight in pediatric clinical nutrition across India.
Regulatory Violations and Sub-Standard Infant Formula
Laboratory tests revealed non-compliance in a follow-up formula manufactured by Nestle India. In particular, the chemical analysis showed inadequate biotin concentrations under statutory benchmarks. Biotin represents a critical micronutrient required for infant metabolic function and neural development. Therefore, FSSAI ordered a secondary re-analysis at a referral laboratory. However, the referral laboratory confirmed that the formula sample remained sub-standard. As a result, the regulator filed formal adjudication proceedings against the manufacturer.
Violations Under the IMS Act and Labeling Regulations
In addition to nutritional deficits, FSSAI identified unlawful promotional statements on digital platforms. The regulator scrutinized claims regarding five human milk oligosaccharides (HMOs) on NAN Excella Pro Stage 1. Furthermore, marketing for Lactogen Pro 1 asserted that its whey protein was easy to digest. According to FSSAI, these claims violate Regulation 4(2) of the Infant Nutrition Regulations of 2020. This regulation strictly restricts promotional text that increases the saleability of infant foods. Additionally, the statements breach Section 3 of the Infant Milk Substitutes (IMS) Act of 1992. The IMS Act strictly prohibits commercial advertising of infant milk substitutes to protect breastfeeding.
Clinical Implications for Pediatric Practice
Nestle India maintained that its formulations comply fully with all national standards. Nevertheless, Indian pediatricians and clinicians must maintain strict vigilance regarding infant feeding guidelines. Healthcare providers should continually advocate exclusive breastfeeding for infants during the first six months of life. Moreover, doctors must remain objective when counseling families who require supplementary formula feeding. Practitioners should avoid endorsing commercial claims that brand formulas as equivalent to human breast milk. Thus, maintaining adherence to statutory guidelines ensures optimal infant health and safety.
Frequently Asked Questions
Q1: Why did FSSAI initiate legal action against Nestle India?
FSSAI filed three adjudication cases due to unlawful promotional claims on infant formula labels and sub-standard biotin levels found in a follow-up formula.
Q2: Which Nestle products are involved in the regulatory dispute?
The regulatory scrutiny specifically involves NAN Excella Pro Stage 1, Lactogen Pro 1, and an unnamed follow-up infant formula.
Q3: How does the IMS Act govern infant formula marketing in India?
The IMS Act strictly prohibits advertising and commercial promotions for infant milk substitutes to protect and promote exclusive breastfeeding practices.
References
- FSSAI takes legal action against Nestle India over sub-standard infant formula - ETHealthworld
- The Indian Express - FSSAI moves against Nestlé over baby formula claims and biotin test
- The Times of India - FSSAI takes action against Nestle for baby food tags





