News Explainer: FSSAI takes legal action against Nestlé India over infant formula claims

India’s food safety regulator has opened a new front against Nestlé India, filing three separate legal cases over how the company labels and markets two infant formula products, plus a lab finding that a batch of follow-up formula fell short of a key nutrient standard.

The Food Safety and Standards Authority of India (FSSAI) said Friday it had examined NAN Excella Pro Stage 1 and Lactogen Pro 1 — along with their promotional material on e-commerce platforms — and found problems with specific claims. For NAN Excella Pro Stage 1, it flagged references to “5 HMOs” (human milk oligosaccharides) and “Whey Protein.” For Lactogen Pro 1, it questioned a claim describing whey protein as “easy to digest.” Separately, lab testing on a sample of a Nestlé India follow-up formula found its biotin content did not meet prescribed standards.

FSSAI says the labelling claims violate Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020 — a rule restricting promotional language meant to boost the saleability of infant foods — and Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992, which bars advertising of these products altogether. The regulator says it had already sought an explanation from Nestlé before proceeding with formal action.

Nestlé India has pushed back, saying its products comply with all applicable regulations and that the labels were previously approved by FSSAI’s own expert committee. The company says it has resubmitted a detailed defense of the claims as factual and scientifically supported, and says it will continue cooperating with the regulator.

Why India regulates infant formula so tightly

Infant nutrition sits in its own stricter regulatory category in India, governed by both the 2020 regulations and the standalone 1992 Act, precisely because the consumers — infants — can’t evaluate marketing claims themselves and depend entirely on parents making decisions based on label language. That’s why India is unusually restrictive about “saleability-boosting” claims: regulators worry that language implying a formula closely mimics breast milk, or offers specific health benefits, can steer feeding decisions away from medical guidance. HMO claims and digestibility claims both sit close to that line, which is likely why they drew scrutiny here.

The biotin shortfall is a different kind of problem — not a marketing dispute but a quality-control one, since biotin is a required nutrient tied to infant metabolic development, and India sets binding minimum levels for it. That generally makes it the more serious of the two issues, since it concerns what’s actually in the product rather than how it’s described.

The bigger pattern

This isn’t an isolated incident for Nestlé in India. The company faced a major crisis in 2015 when Maggi noodles were pulled from shelves nationwide over lead-contamination findings, and more recently came under FSSAI scrutiny after a 2024 report by the Swiss NGO Public Eye alleged Nestlé added sugar to baby food sold in India and other lower-income markets, while formulations sold in Europe didn’t contain it. This week’s cases are procedurally separate from both of those episodes, but they extend a recurring pattern of regulatory attention on Nestlé’s infant and baby-food lineup in India specifically.

FSSAI will need to weigh Nestlé’s resubmitted defense before deciding on any penalty or corrective order. Unlike the 2015 Maggi case, there’s no indication so far of a product recall or manufacturing halt — this is currently a labelling-compliance and quality-standard dispute working through adjudication, not a safety ban.