The regulator’s action is of two distinct kinds, and it is worth keeping them apart. Two of the three cases concern advertising, promotional claims made for infant-formula products that, in a category where marketing is tightly restricted by law, the FSSAI says were not permissible. The third is a quality question: a follow-up formula sample that, on re-testing, fell short on biotin, a required micronutrient. None of this is a finding of guilt. These are adjudication cases the company will now answer, and no penalty has been imposed.
New Delhi: The Food Safety and Standards Authority of India (FSSAI) has initiated legal action against Nestle India Limited, filing three separate adjudication cases in respect of alleged non-compliance with food-safety norms in its infant-nutrition products.
The regulator said it had examined the products NAN Excella Pro Stage 1, Lactogen Pro 1, and a follow-up formula, along with their promotional material available on e-commerce platforms, and had found grounds to proceed in respect of each.
What the FSSAI flagged
According to the regulator, in the case of NAN Excella Pro Stage 1, it flagged claims relating to “5HMOs” (human milk oligosaccharides) and “Whey Protein”, and in the case of Lactogen Pro 1, it observed a claim describing whey protein as easy to digest. The third case concerns a follow-up formula sample that, as reported, was found not to conform to the prescribed biotin content on re-analysis, biotin being a micronutrient that infant formula is required to contain within specified limits.
On the basis of these findings, the FSSAI filed three separate adjudication cases against Nestle India, one in respect of each product. As reported, no final penalty has been stated, the matters being at the stage of adjudication before the designated authority.
Why the claims matter: a tightly regulated category
The promotional-claim cases have to be understood against the special legal regime that governs infant food. Unlike ordinary packaged products, infant milk substitutes and infant foods are subject to stringent restrictions on advertising and promotion, both under the food-safety framework and under the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (the IMS Act), which is designed to protect breastfeeding and to prevent the marketing of formula in ways that may influence parental choice. In that setting, claims that highlight particular ingredients or benefits of an infant formula are scrutinised far more strictly than they would be for a general consumer good.
It is important to be precise about what an adjudication over a promotional claim is, and is not. A challenge to a claim of this kind is, at its core, a question of advertising and labelling compliance, whether the representation was permissible and substantiated, not, by itself, an assertion that the product is unsafe to consume. The distinction matters, because a regulatory action about how a product is marketed can be, and often is, wrongly read as a statement that the product is harmful.
The biotin finding
The third case, concerning the follow-up formula sample found non-conforming on biotin, is a standards question rather than an advertising one. Infant and follow-up formula must contain specified nutrients within prescribed ranges, and a sample falling outside the permitted biotin level would be a deviation from those standards. On the reported facts, the finding relates to a sample on re-analysis; whether it is confined to that sample or extends to other batches is the kind of question an adjudication and any follow-on testing would examine. Here too, the initiation of a case is the beginning of that inquiry, not its conclusion.
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The background
The action comes against the backdrop of heightened regulatory attention to infant nutrition in India. In 2024, the Swiss investigative organisation Public Eye and the International Baby Food Action Network (IBFAN) alleged that Nestle added sugar to infant-food products, including Cerelac, sold in India and other lower- and middle-income countries, while comparable products in some richer markets did not contain added sugar. The Central Consumer Protection Authority asked the FSSAI to examine the composition of the products, and the FSSAI announced pan-India testing of baby-formula products of Nestle and other manufacturers. Nestle India, at the time, defended its products, stating that its formulation for young children was done on a global basis and that its added-sugar content was within the limits prescribed by the FSSAI.
On the day of the FSSAI’s announcement of the three cases, shares of Nestle India were reported to have fallen around two per cent on the stock exchange.
Why it matters
The proceedings sit at the intersection of consumer protection and one of the most sensitive product categories in the market, food for babies. Because infants cannot choose for themselves and their parents rely heavily on both the label and the marketing, the law casts an unusually strict duty on manufacturers of infant formula, and gives the regulator a correspondingly firm hand over the claims they may make. The FSSAI’s decision to proceed on the promotional claims reflects that strictness: in this category, a claim that might pass muster on a general food product can attract action.
At the same time, fairness requires the two kinds of allegation to be reported for what they are. The claim-related cases are, in substance, about advertising and labelling compliance, and do not, on the material available, assert that the products are unsafe. The biotin case is a standards-conformity question tied, on the reported facts, to a sample. A parent reading this news should understand that a manufacturer facing an adjudication over how a product was promoted is not the same as a product being found dangerous, and that no such safety finding has been recorded here.
It must be stressed that these are adjudication proceedings, not concluded findings. Nestle India has not yet been heard in the adjudication, no penalty has been imposed, and the company will have the opportunity to contest the alleged breaches, defend its claims and substantiation, and respond on the biotin sample. Adjudication under the Food Safety and Standards Act can end in a range of outcomes, from penalties or directions to modify claims or labels, to a dropping of the case if the manufacturer’s defence is accepted. What has happened so far is that the regulator, having examined the products and their online promotion, has found a prima facie basis to proceed; the merits are yet to be decided.
Matter: Three adjudication cases initiated by the Food Safety and Standards Authority of India against Nestle India Limited in respect of NAN Excella Pro Stage 1, Lactogen Pro 1, and a follow-up formula
Announced: September 18, 2026
Basis: Alleged impermissible promotional claims (NAN Excella Pro Stage 1 and Lactogen Pro 1) and non-conforming biotin content in a follow-up formula sample
Status: Adjudication proceedings; no penalty imposed; allegations untested; Nestle India yet to be heard.